management report literature review

What is a Literature Review? How to Write It (with Examples)

A literature review is a critical analysis and synthesis of existing research on a particular topic. It provides an overview of the current state of knowledge, identifies gaps, and highlights key findings in the literature. 1 The purpose of a literature review is to situate your own research within the context of existing scholarship, demonstrating your understanding of the topic and showing how your work contributes to the ongoing conversation in the field. Learning how to write a literature review is a critical tool for successful research. Your ability to summarize and synthesize prior research pertaining to a certain topic demonstrates your grasp on the topic of study, and assists in the learning process. 

Table of Contents

What is the purpose of literature review , a. habitat loss and species extinction: , b. range shifts and phenological changes: , c. ocean acidification and coral reefs: , d. adaptive strategies and conservation efforts: .

• Choose a Topic and Define the Research Question: 
• Decide on the Scope of Your Review: 
• Select Databases for Searches: 
• Conduct Searches and Keep Track: 
• Review the Literature: 
• Organize and Write Your Literature Review: 
• How to write a literature review faster with Paperpal? 

Frequently asked questions 

What is a literature review .

A well-conducted literature review demonstrates the researcher’s familiarity with the existing literature, establishes the context for their own research, and contributes to scholarly conversations on the topic. One of the purposes of a literature review is also to help researchers avoid duplicating previous work and ensure that their research is informed by and builds upon the existing body of knowledge.

A literature review serves several important purposes within academic and research contexts. Here are some key objectives and functions of a literature review: 2  

1. Contextualizing the Research Problem: The literature review provides a background and context for the research problem under investigation. It helps to situate the study within the existing body of knowledge. 

2. Identifying Gaps in Knowledge: By identifying gaps, contradictions, or areas requiring further research, the researcher can shape the research question and justify the significance of the study. This is crucial for ensuring that the new research contributes something novel to the field.

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3. Understanding Theoretical and Conceptual Frameworks: Literature reviews help researchers gain an understanding of the theoretical and conceptual frameworks used in previous studies. This aids in the development of a theoretical framework for the current research. 

4. Providing Methodological Insights: Another purpose of literature reviews is that it allows researchers to learn about the methodologies employed in previous studies. This can help in choosing appropriate research methods for the current study and avoiding pitfalls that others may have encountered. 

5. Establishing Credibility: A well-conducted literature review demonstrates the researcher’s familiarity with existing scholarship, establishing their credibility and expertise in the field. It also helps in building a solid foundation for the new research. 

6. Informing Hypotheses or Research Questions: The literature review guides the formulation of hypotheses or research questions by highlighting relevant findings and areas of uncertainty in existing literature. 

Literature review example 

Let’s delve deeper with a literature review example: Let’s say your literature review is about the impact of climate change on biodiversity. You might format your literature review into sections such as the effects of climate change on habitat loss and species extinction, phenological changes, and marine biodiversity. Each section would then summarize and analyze relevant studies in those areas, highlighting key findings and identifying gaps in the research. The review would conclude by emphasizing the need for further research on specific aspects of the relationship between climate change and biodiversity. The following literature review template provides a glimpse into the recommended literature review structure and content, demonstrating how research findings are organized around specific themes within a broader topic. 

Literature Review on Climate Change Impacts on Biodiversity:  

Climate change is a global phenomenon with far-reaching consequences, including significant impacts on biodiversity. This literature review synthesizes key findings from various studies: 

Climate change-induced alterations in temperature and precipitation patterns contribute to habitat loss, affecting numerous species (Thomas et al., 2004). The review discusses how these changes increase the risk of extinction, particularly for species with specific habitat requirements. 

Observations of range shifts and changes in the timing of biological events (phenology) are documented in response to changing climatic conditions (Parmesan & Yohe, 2003). These shifts affect ecosystems and may lead to mismatches between species and their resources. 

The review explores the impact of climate change on marine biodiversity, emphasizing ocean acidification’s threat to coral reefs (Hoegh-Guldberg et al., 2007). Changes in pH levels negatively affect coral calcification, disrupting the delicate balance of marine ecosystems. 

Recognizing the urgency of the situation, the literature review discusses various adaptive strategies adopted by species and conservation efforts aimed at mitigating the impacts of climate change on biodiversity (Hannah et al., 2007). It emphasizes the importance of interdisciplinary approaches for effective conservation planning. 

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How to write a good literature review 

Writing a literature review involves summarizing and synthesizing existing research on a particular topic. A good literature review format should include the following elements. 

Introduction: The introduction sets the stage for your literature review, providing context and introducing the main focus of your review. 

• Opening Statement: Begin with a general statement about the broader topic and its significance in the field. 
• Scope and Purpose: Clearly define the scope of your literature review. Explain the specific research question or objective you aim to address. 
• Organizational Framework: Briefly outline the structure of your literature review, indicating how you will categorize and discuss the existing research. 
• Significance of the Study: Highlight why your literature review is important and how it contributes to the understanding of the chosen topic. 
• Thesis Statement: Conclude the introduction with a concise thesis statement that outlines the main argument or perspective you will develop in the body of the literature review. 

Body: The body of the literature review is where you provide a comprehensive analysis of existing literature, grouping studies based on themes, methodologies, or other relevant criteria. 

• Organize by Theme or Concept: Group studies that share common themes, concepts, or methodologies. Discuss each theme or concept in detail, summarizing key findings and identifying gaps or areas of disagreement. 
• Critical Analysis: Evaluate the strengths and weaknesses of each study. Discuss the methodologies used, the quality of evidence, and the overall contribution of each work to the understanding of the topic. 
• Synthesis of Findings: Synthesize the information from different studies to highlight trends, patterns, or areas of consensus in the literature. 
• Identification of Gaps: Discuss any gaps or limitations in the existing research and explain how your review contributes to filling these gaps. 
• Transition between Sections: Provide smooth transitions between different themes or concepts to maintain the flow of your literature review. 

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Conclusion: The conclusion of your literature review should summarize the main findings, highlight the contributions of the review, and suggest avenues for future research. 

• Summary of Key Findings: Recap the main findings from the literature and restate how they contribute to your research question or objective. 
• Contributions to the Field: Discuss the overall contribution of your literature review to the existing knowledge in the field. 
• Implications and Applications: Explore the practical implications of the findings and suggest how they might impact future research or practice. 
• Recommendations for Future Research: Identify areas that require further investigation and propose potential directions for future research in the field. 
• Final Thoughts: Conclude with a final reflection on the importance of your literature review and its relevance to the broader academic community. 

Conducting a literature review 

Conducting a literature review is an essential step in research that involves reviewing and analyzing existing literature on a specific topic. It’s important to know how to do a literature review effectively, so here are the steps to follow: 1  

Choose a Topic and Define the Research Question:  

• Select a topic that is relevant to your field of study. 
• Clearly define your research question or objective. Determine what specific aspect of the topic do you want to explore? 

Decide on the Scope of Your Review:  

• Determine the timeframe for your literature review. Are you focusing on recent developments, or do you want a historical overview? 
• Consider the geographical scope. Is your review global, or are you focusing on a specific region? 
• Define the inclusion and exclusion criteria. What types of sources will you include? Are there specific types of studies or publications you will exclude? 

Select Databases for Searches:  

• Identify relevant databases for your field. Examples include PubMed, IEEE Xplore, Scopus, Web of Science, and Google Scholar. 
• Consider searching in library catalogs, institutional repositories, and specialized databases related to your topic. 

Conduct Searches and Keep Track:  

• Develop a systematic search strategy using keywords, Boolean operators (AND, OR, NOT), and other search techniques. 
• Record and document your search strategy for transparency and replicability. 
• Keep track of the articles, including publication details, abstracts, and links. Use citation management tools like EndNote, Zotero, or Mendeley to organize your references. 

Review the Literature:  

• Evaluate the relevance and quality of each source. Consider the methodology, sample size, and results of studies. 
• Organize the literature by themes or key concepts. Identify patterns, trends, and gaps in the existing research. 
• Summarize key findings and arguments from each source. Compare and contrast different perspectives. 
• Identify areas where there is a consensus in the literature and where there are conflicting opinions. 
• Provide critical analysis and synthesis of the literature. What are the strengths and weaknesses of existing research? 

Organize and Write Your Literature Review:  

• Literature review outline should be based on themes, chronological order, or methodological approaches. 
• Write a clear and coherent narrative that synthesizes the information gathered. 
• Use proper citations for each source and ensure consistency in your citation style (APA, MLA, Chicago, etc.). 
• Conclude your literature review by summarizing key findings, identifying gaps, and suggesting areas for future research. 

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The literature review sample and detailed advice on writing and conducting a review will help you produce a well-structured report. But remember that a good literature review is an ongoing process, and it may be necessary to revisit and update it as your research progresses. By combining effortless research with an easy citation process, Paperpal Research streamlines the literature review process and empowers you to write faster and with more confidence. Try Paperpal Research now and see for yourself.  

A literature review is a critical and comprehensive analysis of existing literature (published and unpublished works) on a specific topic or research question and provides a synthesis of the current state of knowledge in a particular field. A well-conducted literature review is crucial for researchers to build upon existing knowledge, avoid duplication of efforts, and contribute to the advancement of their field. It also helps researchers situate their work within a broader context and facilitates the development of a sound theoretical and conceptual framework for their studies.

Literature review is a crucial component of research writing, providing a solid background for a research paper’s investigation. The aim is to keep professionals up to date by providing an understanding of ongoing developments within a specific field, including research methods, and experimental techniques used in that field, and present that knowledge in the form of a written report. Also, the depth and breadth of the literature review emphasizes the credibility of the scholar in his or her field.  

Before writing a literature review, it’s essential to undertake several preparatory steps to ensure that your review is well-researched, organized, and focused. This includes choosing a topic of general interest to you and doing exploratory research on that topic, writing an annotated bibliography, and noting major points, especially those that relate to the position you have taken on the topic. 

Literature reviews and academic research papers are essential components of scholarly work but serve different purposes within the academic realm. 3 A literature review aims to provide a foundation for understanding the current state of research on a particular topic, identify gaps or controversies, and lay the groundwork for future research. Therefore, it draws heavily from existing academic sources, including books, journal articles, and other scholarly publications. In contrast, an academic research paper aims to present new knowledge, contribute to the academic discourse, and advance the understanding of a specific research question. Therefore, it involves a mix of existing literature (in the introduction and literature review sections) and original data or findings obtained through research methods. 

Literature reviews are essential components of academic and research papers, and various strategies can be employed to conduct them effectively. If you want to know how to write a literature review for a research paper, here are four common approaches that are often used by researchers.  Chronological Review: This strategy involves organizing the literature based on the chronological order of publication. It helps to trace the development of a topic over time, showing how ideas, theories, and research have evolved.  Thematic Review: Thematic reviews focus on identifying and analyzing themes or topics that cut across different studies. Instead of organizing the literature chronologically, it is grouped by key themes or concepts, allowing for a comprehensive exploration of various aspects of the topic.  Methodological Review: This strategy involves organizing the literature based on the research methods employed in different studies. It helps to highlight the strengths and weaknesses of various methodologies and allows the reader to evaluate the reliability and validity of the research findings.  Theoretical Review: A theoretical review examines the literature based on the theoretical frameworks used in different studies. This approach helps to identify the key theories that have been applied to the topic and assess their contributions to the understanding of the subject.  It’s important to note that these strategies are not mutually exclusive, and a literature review may combine elements of more than one approach. The choice of strategy depends on the research question, the nature of the literature available, and the goals of the review. Additionally, other strategies, such as integrative reviews or systematic reviews, may be employed depending on the specific requirements of the research.

The literature review format can vary depending on the specific publication guidelines. However, there are some common elements and structures that are often followed. Here is a general guideline for the format of a literature review:  Introduction:   Provide an overview of the topic.  Define the scope and purpose of the literature review.  State the research question or objective.  Body:   Organize the literature by themes, concepts, or chronology.  Critically analyze and evaluate each source.  Discuss the strengths and weaknesses of the studies.  Highlight any methodological limitations or biases.  Identify patterns, connections, or contradictions in the existing research.  Conclusion:   Summarize the key points discussed in the literature review.  Highlight the research gap.  Address the research question or objective stated in the introduction.  Highlight the contributions of the review and suggest directions for future research.

Both annotated bibliographies and literature reviews involve the examination of scholarly sources. While annotated bibliographies focus on individual sources with brief annotations, literature reviews provide a more in-depth, integrated, and comprehensive analysis of existing literature on a specific topic. The key differences are as follows: 

References 

• Denney, A. S., & Tewksbury, R. (2013). How to write a literature review.  Journal of criminal justice education ,  24 (2), 218-234. 
• Pan, M. L. (2016).  Preparing literature reviews: Qualitative and quantitative approaches . Taylor & Francis. 
• Cantero, C. (2019). How to write a literature review.  San José State University Writing Center . 

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15 Literature Review Examples

Chris Drew (PhD)

Dr. Chris Drew is the founder of the Helpful Professor. He holds a PhD in education and has published over 20 articles in scholarly journals. He is the former editor of the Journal of Learning Development in Higher Education. [Image Descriptor: Photo of Chris]

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Literature reviews are a necessary step in a research process and often required when writing your research proposal . They involve gathering, analyzing, and evaluating existing knowledge about a topic in order to find gaps in the literature where future studies will be needed.

Ideally, once you have completed your literature review, you will be able to identify how your research project can build upon and extend existing knowledge in your area of study.

Generally, for my undergraduate research students, I recommend a narrative review, where themes can be generated in order for the students to develop sufficient understanding of the topic so they can build upon the themes using unique methods or novel research questions.

If you’re in the process of writing a literature review, I have developed a literature review template for you to use – it’s a huge time-saver and walks you through how to write a literature review step-by-step:

Get your time-saving templates here to write your own literature review.

Literature Review Examples

For the following types of literature review, I present an explanation and overview of the type, followed by links to some real-life literature reviews on the topics.

1. Narrative Review Examples

Also known as a traditional literature review, the narrative review provides a broad overview of the studies done on a particular topic.

It often includes both qualitative and quantitative studies and may cover a wide range of years.

The narrative review’s purpose is to identify commonalities, gaps, and contradictions in the literature .

I recommend to my students that they should gather their studies together, take notes on each study, then try to group them by themes that form the basis for the review (see my step-by-step instructions at the end of the article).

Example Study

Title: Communication in healthcare: a narrative review of the literature and practical recommendations

Citation: Vermeir, P., Vandijck, D., Degroote, S., Peleman, R., Verhaeghe, R., Mortier, E., … & Vogelaers, D. (2015). Communication in healthcare: a narrative review of the literature and practical recommendations. International journal of clinical practice , 69 (11), 1257-1267.

Source: https://onlinelibrary.wiley.com/doi/pdf/10.1111/ijcp.12686  

Overview: This narrative review analyzed themes emerging from 69 articles about communication in healthcare contexts. Five key themes were found in the literature: poor communication can lead to various negative outcomes, discontinuity of care, compromise of patient safety, patient dissatisfaction, and inefficient use of resources. After presenting the key themes, the authors recommend that practitioners need to approach healthcare communication in a more structured way, such as by ensuring there is a clear understanding of who is in charge of ensuring effective communication in clinical settings.

Other Examples

• Burnout in United States Healthcare Professionals: A Narrative Review (Reith, 2018) – read here
• Examining the Presence, Consequences, and Reduction of Implicit Bias in Health Care: A Narrative Review (Zestcott, Blair & Stone, 2016) – read here
• A Narrative Review of School-Based Physical Activity for Enhancing Cognition and Learning (Mavilidi et al., 2018) – read here
• A narrative review on burnout experienced by medical students and residents (Dyrbye & Shanafelt, 2015) – read here

2. Systematic Review Examples

This type of literature review is more structured and rigorous than a narrative review. It involves a detailed and comprehensive plan and search strategy derived from a set of specified research questions.

The key way you’d know a systematic review compared to a narrative review is in the methodology: the systematic review will likely have a very clear criteria for how the studies were collected, and clear explanations of exclusion/inclusion criteria. 

The goal is to gather the maximum amount of valid literature on the topic, filter out invalid or low-quality reviews, and minimize bias. Ideally, this will provide more reliable findings, leading to higher-quality conclusions and recommendations for further research.

You may note from the examples below that the ‘method’ sections in systematic reviews tend to be much more explicit, often noting rigid inclusion/exclusion criteria and exact keywords used in searches.

Title: The importance of food naturalness for consumers: Results of a systematic review  

Citation: Roman, S., Sánchez-Siles, L. M., & Siegrist, M. (2017). The importance of food naturalness for consumers: Results of a systematic review. Trends in food science & technology , 67 , 44-57.

Source: https://www.sciencedirect.com/science/article/pii/S092422441730122X  

Overview: This systematic review included 72 studies of food naturalness to explore trends in the literature about its importance for consumers. Keywords used in the data search included: food, naturalness, natural content, and natural ingredients. Studies were included if they examined consumers’ preference for food naturalness and contained empirical data. The authors found that the literature lacks clarity about how naturalness is defined and measured, but also found that food consumption is significantly influenced by perceived naturalness of goods.

• A systematic review of research on online teaching and learning from 2009 to 2018 (Martin, Sun & Westine, 2020) – read here
• Where Is Current Research on Blockchain Technology? (Yli-Huumo et al., 2016) – read here
• Universities—industry collaboration: A systematic review (Ankrah & Al-Tabbaa, 2015) – read here
• Internet of Things Applications: A Systematic Review (Asghari, Rahmani & Javadi, 2019) – read here

3. Meta-analysis

This is a type of systematic review that uses statistical methods to combine and summarize the results of several studies.

Due to its robust methodology, a meta-analysis is often considered the ‘gold standard’ of secondary research , as it provides a more precise estimate of a treatment effect than any individual study contributing to the pooled analysis.

Furthermore, by aggregating data from a range of studies, a meta-analysis can identify patterns, disagreements, or other interesting relationships that may have been hidden in individual studies.

This helps to enhance the generalizability of findings, making the conclusions drawn from a meta-analysis particularly powerful and informative for policy and practice.

Title: Cholesterol and Alzheimer’s Disease Risk: A Meta-Meta-Analysis

Citation: Sáiz-Vazquez, O., Puente-Martínez, A., Ubillos-Landa, S., Pacheco-Bonrostro, J., & Santabárbara, J. (2020). Cholesterol and Alzheimer’s disease risk: a meta-meta-analysis. Brain sciences, 10(6), 386.

Source: https://doi.org/10.3390/brainsci10060386  

O verview: This study examines the relationship between cholesterol and Alzheimer’s disease (AD). Researchers conducted a systematic search of meta-analyses and reviewed several databases, collecting 100 primary studies and five meta-analyses to analyze the connection between cholesterol and Alzheimer’s disease. They find that the literature compellingly demonstrates that low-density lipoprotein cholesterol (LDL-C) levels significantly influence the development of Alzheimer’s disease.

• The power of feedback revisited: A meta-analysis of educational feedback research (Wisniewski, Zierer & Hattie, 2020) – read here
• How Much Does Education Improve Intelligence? A Meta-Analysis (Ritchie & Tucker-Drob, 2018) – read here
• A meta-analysis of factors related to recycling (Geiger et al., 2019) – read here
• Stress management interventions for police officers and recruits (Patterson, Chung & Swan, 2014) – read here

Other Types of Reviews

• Scoping Review: This type of review is used to map the key concepts underpinning a research area and the main sources and types of evidence available. It can be undertaken as stand-alone projects in their own right, or as a precursor to a systematic review.
• Rapid Review: This type of review accelerates the systematic review process in order to produce information in a timely manner. This is achieved by simplifying or omitting stages of the systematic review process.
• Integrative Review: This review method is more inclusive than others, allowing for the simultaneous inclusion of experimental and non-experimental research. The goal is to more comprehensively understand a particular phenomenon.
• Critical Review: This is similar to a narrative review but requires a robust understanding of both the subject and the existing literature. In a critical review, the reviewer not only summarizes the existing literature, but also evaluates its strengths and weaknesses. This is common in the social sciences and humanities .
• State-of-the-Art Review: This considers the current level of advancement in a field or topic and makes recommendations for future research directions. This type of review is common in technological and scientific fields but can be applied to any discipline.

How to Write a Narrative Review (Tips for Undergrad Students)

Most undergraduate students conducting a capstone research project will be writing narrative reviews. Below is a five-step process for conducting a simple review of the literature for your project.

• Search for Relevant Literature: Use scholarly databases related to your field of study, provided by your university library, along with appropriate search terms to identify key scholarly articles that have been published on your topic.
• Evaluate and Select Sources: Filter the source list by selecting studies that are directly relevant and of sufficient quality, considering factors like credibility , objectivity, accuracy, and validity.
• Analyze and Synthesize: Review each source and summarize the main arguments  in one paragraph (or more, for postgrad). Keep these summaries in a table.
• Identify Themes: With all studies summarized, group studies that share common themes, such as studies that have similar findings or methodologies.
• Write the Review: Write your review based upon the themes or subtopics you have identified. Give a thorough overview of each theme, integrating source data, and conclude with a summary of the current state of knowledge then suggestions for future research based upon your evaluation of what is lacking in the literature.

Literature reviews don’t have to be as scary as they seem. Yes, they are difficult and require a strong degree of comprehension of academic studies. But it can be feasibly done through following a structured approach to data collection and analysis. With my undergraduate research students (who tend to conduct small-scale qualitative studies ), I encourage them to conduct a narrative literature review whereby they can identify key themes in the literature. Within each theme, students can critique key studies and their strengths and limitations , in order to get a lay of the land and come to a point where they can identify ways to contribute new insights to the existing academic conversation on their topic.

Ankrah, S., & Omar, A. T. (2015). Universities–industry collaboration: A systematic review. Scandinavian Journal of Management, 31(3), 387-408.

Asghari, P., Rahmani, A. M., & Javadi, H. H. S. (2019). Internet of Things applications: A systematic review. Computer Networks , 148 , 241-261.

Dyrbye, L., & Shanafelt, T. (2016). A narrative review on burnout experienced by medical students and residents. Medical education , 50 (1), 132-149.

Geiger, J. L., Steg, L., Van Der Werff, E., & Ünal, A. B. (2019). A meta-analysis of factors related to recycling. Journal of environmental psychology , 64 , 78-97.

Martin, F., Sun, T., & Westine, C. D. (2020). A systematic review of research on online teaching and learning from 2009 to 2018. Computers & education , 159 , 104009.

Mavilidi, M. F., Ruiter, M., Schmidt, M., Okely, A. D., Loyens, S., Chandler, P., & Paas, F. (2018). A narrative review of school-based physical activity for enhancing cognition and learning: The importance of relevancy and integration. Frontiers in psychology , 2079.

Patterson, G. T., Chung, I. W., & Swan, P. W. (2014). Stress management interventions for police officers and recruits: A meta-analysis. Journal of experimental criminology , 10 , 487-513.

Reith, T. P. (2018). Burnout in United States healthcare professionals: a narrative review. Cureus , 10 (12).

Ritchie, S. J., & Tucker-Drob, E. M. (2018). How much does education improve intelligence? A meta-analysis. Psychological science , 29 (8), 1358-1369.

Roman, S., Sánchez-Siles, L. M., & Siegrist, M. (2017). The importance of food naturalness for consumers: Results of a systematic review. Trends in food science & technology , 67 , 44-57.

Sáiz-Vazquez, O., Puente-Martínez, A., Ubillos-Landa, S., Pacheco-Bonrostro, J., & Santabárbara, J. (2020). Cholesterol and Alzheimer’s disease risk: a meta-meta-analysis. Brain sciences, 10(6), 386.

Vermeir, P., Vandijck, D., Degroote, S., Peleman, R., Verhaeghe, R., Mortier, E., … & Vogelaers, D. (2015). Communication in healthcare: a narrative review of the literature and practical recommendations. International journal of clinical practice , 69 (11), 1257-1267.

Wisniewski, B., Zierer, K., & Hattie, J. (2020). The power of feedback revisited: A meta-analysis of educational feedback research. Frontiers in Psychology , 10 , 3087.

Yli-Huumo, J., Ko, D., Choi, S., Park, S., & Smolander, K. (2016). Where is current research on blockchain technology?—a systematic review. PloS one , 11 (10), e0163477.

Zestcott, C. A., Blair, I. V., & Stone, J. (2016). Examining the presence, consequences, and reduction of implicit bias in health care: a narrative review. Group Processes & Intergroup Relations , 19 (4), 528-542

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Working capital management: a literature review and research agenda

Purpose – The purpose of this paper is to review research on working capital management (WCM) and to identify gaps in the current body of knowledge, which justify future research directions. WCM has attracted serious research attention in the recent past, especially after the financial crisis of 2008. Design/methodology/approach – Using systematic literature review (SLR) method, the present study reviews 126 articles from referred journal and international conferences published on WCM. Findings – Detailed content analysis reveals that most of the research work is empirical and focuses mainly on two aspects, impact of working capital on profitability of firm and working capital practices. Major research work has concluded that WCM is essential for corporate profitability. The major issues with prior literature are lack of survey-based approach and lack of systematic theory development study, which opens all new areas for future research. The future research directions proposed in this paper may help develop a greater understanding of determinants and practices of WCM. Practical implications – Till date, literature on classification of WCM has been almost non-existent. This paper reviews a large number of articles on WCM and provides a classification scheme in to various categories. Subsequently, various emerging trends in the field of WCM are identified to help researchers specifying gaps in the literature and direct research efforts. Originality/value – This paper contains a comprehensive listing of publications on the WCM and their classification according to various attributes. The paper will be useful to researchers, finance professionals and others concerned with WCM to understand the importance of WCM. To the best of the authors’ knowledge, no detailed SLR on this topic has previously been published in academic journals.

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Big Data Analytics in Management Reporting: A Systematic Literature Review

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Data are sometimes referred to as the new oil (Humby & Palmer, 2006 ) since it is assumed to have similar characteristics. Its value is particularly connected to its refinement as, otherwise, data cannot be used effectively. In principle, this is like crude oil, a commodity that must be refined into gas, chemicals, plastic, or similar outputs of higher value. Data must similarly be broken down and transferred to create a valuable output as well (Palmer M, Data is the new oil. ANA Marketing Maestros. https://ana.blogs.com/maestros/2006/11/data_is_the_new.html , 2006). The reference of data to oil is also mentioned in practice in the context of its overall value in the economy, whereby digital data are characterized as the most valuable resource (Economist, The world’s most valuable resource is no longer oil, but data. The Economist. https://www.economist.com/leaders/2017/05/06/the-worlds-most-valuable-resource-is-no-longer-oil-but-data , 2017). Also, the availability of data for analysis is expected to show strong growth in the future, thanks to advances in technology and data-gathering techniques, which are applied across a diverse range of industries. This development is particularly driven by the large growth of data segments, especially in connection to social media as well as to data from applications in the realm of the Internet of Things. Currently, data growth is expected to exceed the growth in data storage capacity, as stated by the International Data Corporation or IDC (Hariri RH, Fredericks EM, Bowers KM, J Big Data 6(44):1–16, 2019; IDC, Data creation and replication will grow at a faster rate than installed storage capacity. According to the IDC Global DataSphere and StorageSphere Forecasts. https://www.idc.com/getdoc.jsp?containerId=prUS47560321 , 2021). Given the increase in the availability of large amounts of data, the data analytics market revenue is also projected to show strong growth in the near future as well (Statista, Big data analytics market global revenue 2025. Statista. https://www.statista.com/statistics/947745/worldwide-total-data-market-revenue/ , 2020). As a result of advancing digitization, a very large basic spectrum for data-driven decisions of all kinds has been created. In addition, the storage of data has become very cost-effective with the current state of the art. Coupled with today’s vast amount of data, there is enormous potential for companies to transform data into information to generate significant competitive advantages and build valuable knowledge that can support companies. This implies that data management and decision support systems are of great importance to corporate management and corporate management reporting, and this importance can be expected to grow in future (Seufert A, Treitz R, von Dacke M, Control Mag 07/08:48–53, 2017).

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• Volume 83, Issue 11
• Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations
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• http://orcid.org/0000-0002-8832-7475 Myrto Kostopoulou 1 ,
• http://orcid.org/0000-0002-9771-6667 Chetan B Mukhtyar 2 ,
• http://orcid.org/0000-0001-5299-1406 George Bertsias 3 , 4 ,
• http://orcid.org/0000-0002-9812-4671 Dimitrios T Boumpas 1 , 5 ,
• http://orcid.org/0000-0003-2696-031X Antonis Fanouriakis 1
• 1 Rheumatology and Clinical Immunology Unit, Attikon University Hospital , National and Kapodistrian University of Athens School of Medicine , Athens , Greece
• 2 Vasculitis Service, Rheumatology Department , Norfolk and Norwich University Hospital NHS Trust , Norwich , UK
• 3 Rheumatology and Clinical Immunology , University of Crete, School of Medicine , Heraklion , Greece
• 4 Laboratory of Autoimmunity and Inflammation , Institute of Molecular Biology and Biotechnology , Heraklion , Greece
• 5 Laboratory of Autoimmunity and Inflammation , Biomedical Research Foundation of the Academy of Athens , Athens , Greece
• Correspondence to Dr Antonis Fanouriakis; afanour{at}med.uoa.gr

Objectives To analyse the new evidence (2018–2022) for the management of systemic lupus erythematosus (SLE) to inform the 2023 update of the European League Against Rheumatism (EULAR) recommendations.

Methods Systematic literature reviews were performed in the Medline and the Cochrane Library databases capturing publications from 1 January 2018 through 31 December 2022, according to the EULAR standardised operating procedures. The research questions focused on five different domains, namely the benefit/harm of SLE treatments, the benefits from the attainment of remission/low disease activity, the risk/benefit from treatment tapering/withdrawal, the management of SLE with antiphospholipid syndrome and the safety of immunisations against varicella zoster virus and SARS-CoV2 infection. A Population, Intervention, Comparison and Outcome framework was used to develop search strings for each research topic.

Results We identified 439 relevant articles, the majority being observational studies of low or moderate quality. High-quality randomised controlled trials (RCTs) documented the efficacy of the type 1 interferon receptor inhibitor, anifrolumab, in non-renal SLE, and belimumab and voclosporin, a novel calcineurin inhibitor, in lupus nephritis (LN), when compared with standard of care. For the treatment of specific organ manifestations outside LN, a lack of high-quality data was documented. Multiple observational studies confirmed the beneficial effects of attaining clinical remission or low disease activity, reducing the risk for multiple adverse outcomes. Two randomised trials with some concerns regarding risk of bias found higher rates of relapse in patients who discontinued glucocorticoids (GC) or immunosuppressants in SLE and LN, respectively, yet observational cohort studies suggest that treatment withdrawal might be feasible in a subset of patients.

Conclusion Anifrolumab and belimumab achieve better disease control than standard of care in extrarenal SLE, while combination therapies with belimumab and voclosporin attained higher response rates in high-quality RCTs in LN. Remission and low disease activity are associated with favourable long-term outcomes. In patients achieving these targets, GC and immunosuppressive therapy may gradually be tapered. Cite Now

• Systemic Lupus Erythematosus
• Lupus Nephritis

Data availability statement

All data relevant to the study are included in the article or uploaded as online supplemental information.

This is an open access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0). See: http://creativecommons.org/licenses/by-nc-nd/4.0/ .

https://doi.org/10.1136/ard-2023-225319

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WHAT IS ALREADY KNOWN ON THIS TOPIC

Since the 2019 European League Against Rheumatism (EULAR) recommendations for the management of systemic lupus erythematosus (SLE), several studies have been published providing data on alternative therapeutic options and treatment targets. A systematic literature review (SLR) focusing on recent advances was performed to inform the 2023 update of EULAR recommendations for the management of SLE.

WHAT THIS STUDY ADDS

In extrarenal disease, anifrolumab and belimumab were superior to standard of care treatment in a number of high-quality randomised controlled trials.

High-quality evidence points towards better efficacy of combination treatments with belimumab or voclosporin compared with standard of care in patients with lupus nephritis.

Both remission and low disease activity have been associated with lower risk of adverse outcomes in observational studies.

Although treatment discontinuation increases the risk of flares, successful glucocorticoid withdrawal was accomplished in patients with SLE in remission in several cohort studies.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

This SLR provided a systematic update of current evidence regarding the management of patients with SLE, to inform the 2023 update of the EULAR recommendations.

Introduction

Management of systemic lupus erythematosus (SLE) is challenging, owing to the heterogeneity of disease phenotype, the variable severity of involvement even within the same organ manifestation, and the different efficacy of drugs in different patient subgroups and disease manifestations. 1 Patients with SLE will frequently require multiple drugs during the course of their disease to achieve and maintain sufficient control. To this end, it is important that recent years have witnessed significant progress in the form of introduction of new drugs to treat the disease. Anifrolumab, an anti-type 1 interferon receptor inhibitor, was approved in 2021 for the treatment of moderate-to-severe extrarenal SLE. 2 3 Belimumab and voclosporin (a novel calcineurin inhibitor (CNI)) were also approved by the European Medicines Agency in 2021 and 2022, respectively, for the treatment of lupus nephritis (LN), a cardinal manifestation of the disease affecting up to 40%–50% of patients, with significant impact on morbidity and survival. 4 5

These important advances provided the ground for an update of the European League Against Rheumatism (EULAR) recommendations for the management of SLE, which was published recently. 6 To this end, we performed structured systematic literature reviews (SLRs), aiming to update the evidence for the efficacy and safety of different therapies, as well as try to define the optimal therapy of different organ manifestations of the disease. The results of these SLRs were presented to the Task Force members during dedicated meetings to form the current evidence base, on which the formulation of the current recommendations was based. The current manuscript presents in detail the results of these SLRs.

We followed the standardised operating procedures for the development of EULAR-endorsed recommendations and employed the Appraisal of Guidelines Research and Evaluation instrument. Following assembly of the Task Force, the convenor (DTB), one methodologist (GB), one co-methodologist (CBM), and two fellows responsible for the SLR (AF and MK) created an outline of the proposed methodology, as well as the main research questions in the form of Population, Intervention, Comparison and Outcomes (PICOs), which were circulated among Task Force members. A Delphi-based methodology within the Task Force finally identified five research questions: (1) management of general and organ-specific SLE (divided in six subquestions regarding drug efficacy and safety in patients with active SLE, active mucocutaneous, musculoskeletal, haematological, neuropsychiatric and kidney involvement, respectively), (2) targets of treatment, (3) management of patients with SLE and antiphospholipid syndrome, (4) tapering/withdrawal of treatment in SLE and (5) efficacy and safety of vaccination against varicella zoster virus (VZV) reactivation and SARS-CoV2 infection (a generic SLR for infection risk and prevention in SLE was not performed, because there are specific EULAR recommendations on this topic). 7 Separate search strings were developed for each PICO (1–5), resulting in five separate SLRs (the six subquestions of PICO 1 (PICO 1a–f) were examined with a single search string) ( online supplemental file 1 and 2, tables S1.1–S1.10 ).

Supplemental material

Under the supervision of the methodologists, AF and MK performed the SLRs independently in two different databases (MEDLINE through PubMed and the Cochrane Library), with additional inclusion of Lancet Rheumatology (due to non-inclusion of the latter in PubMed). Since this was an update of the 2019 recommendations on general SLE, the current SLRs evaluated all English language publications published between January 2018 and December 2022. All study designs were included (meta-analyses, randomised controlled trials (RCTs), quasi-RCTs, cohort studies, case–control studies, cross–sectional studies) while narrative reviews, case series, case reports, conference abstracts, animal studies, trials in non-English language, trials with population<20 and trials on paediatric populations were excluded. In case a study was captured as an original publication and was also included in a meta-analysis, then only the meta-analysis data were used, to avoid duplicating the evidence from that particular study. Eligible studies were reviewed for snowball references and relevant articles, identified by manual search within the reference list of the originally retrieved publications, were also included. For each research question, a predefined extraction form was used to capture the population set, all relevant interventions, their duration of use, route of administration, dosage, follow-up time and the respective effect estimates, including incidence rate, mean difference, risk difference, correlation coefficient, odds ratio (OR) and relative risk. For each research question, results were synthesised and presented according to the interventions used and the respective outcomes.

Risk of bias (RoB) was assessed using the revised Cochrane Risk of Bias Assessment Tool for RCTs (ROB V.2), the Newcastle-Ottawa scale for observational studies, and the AMSTAR V.2 tool for meta-analyses ( online supplemental file 3 ). In case of disagreements, these were internally discussed until achievement of consensus, and one methodologist was involved when deemed necessary. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist was completed and has been submitted along with the manuscript.

We screened a total of 10 889 articles, of which 578 were selected for full-text review, and 439 were finally included for data extraction (see figure 1 for a detailed flow diagram of the selection process). The results below are presented in terms of general efficacy of drugs in SLE, followed by treatment of specific manifestations, with a focus on LN.

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Flow diagram of the study selection process.

Efficacy and safety of hydroxychloroquine (HCQ) in SLE

Between January 2018 and December 2022, a total of 39 studies (all observational) evaluated and confirmed the association of HCQ with various favourable outcomes ( online supplemental file 4, table S4.1 ). A total of 10 studies reported a negative association between HCQ use and mortality in SLE; a meta-analysis of 21 studies (26 037 patients) found a pooled HR 0.46 for death in patients with SLE receiving HCQ (consistent results in all geographic regions). 8 Fewer (or individual) studies showed a positive effect of HCQ on various outcomes (reduced rate of disease flares, thrombosis, osteonecrosis, infections, among others). Regarding safety of HCQ, the focus was on retinal toxicity. 9 10 The current SLRs identified 10 studies (mostly of poor or fair quality) ( table 1 ); two retrospective cohort studies of good quality (ie, lower RoB) reported retinopathy rates of 0.8% and 4.3%, respectively. Longer duration of HCQ intake and a higher cumulative dose were confirmed as risk factors for retinal toxicity. Regarding other safety issues, a concern for corrected QT (QTc) prolongation was raised when HCQ was used during the early phases of the COVID-19 pandemic; however, a total of six studies found no clinically relevant QTc prolongation with HCQ use.

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Prevalence of HCQ retinopathy in observational studies and associations

The recommended dose of 5 mg/kg in the 2023 recommendations was based on (1) an observational study of good quality, which calculated the threshold for an increased risk of flares near 5 mg/kg/day of HCQ dose, 11 (2) older evidence of good quality, suggesting that risk of toxicity is low for doses below 5 mg/kg real body weight 10 and (3) indirect evidence for a slightly increased risk of flares in patients who taper HCQ versus those who continue (see below, Safety of treatment tapering in SLE).

Efficacy and safety of glucocorticoids (GC) in SLE

Although GC are widely used in SLE, high-quality RCTs assessing the efficacy of different schemes and tapering strategies are still lacking. A single, retrospective study of good quality in 206 patients with LN found higher rates of 1-year complete response in patients who started with ≥40 mg/day compared with those who started with ≤30 mg/day, without increased risk for GC-related damage. 12 Two small RCTs (one with 32 and one with 20 patients, both with high RoB) compared different doses of GC with same background immunosuppression (cyclophosphamide (CYC) and mycophenolate mofetil (MMF), respectively) and found discordant results; one showed equal response rates and the other higher rates in the high-dose GC arm. 13 14

For safety, the SLRs identified a large number of studies examining different cut-offs of average prednisone doses in association with different adverse effects ( online supplemental file 4, tableS4.2 for association with infections and online supplemental table S4.3 for associations with other harms). Most studies pointed towards thresholds of mean 5–7.5 mg/day prednisone, associated with a variety of GC-related side effects in multivariable associations.

Efficacy and safety of immunosuppressive drugs in extrarenal SLE

Immunosuppressive therapies used to treat extrarenal manifestations of SLE include both conventional drugs (azathioprine (AZA), methotrexate (MTX), MMF, CNIs, among others), as well as biologic agents (approved therapies belimumab and anifrolumab, and drugs used off-label, such as rituximab (RTX)). During the period captured by the SLRs, no new head-to-head comparisons between conventional immunosuppressive drugs were identified, rather only limited observational studies (mainly of-low quality) reporting efficacy in selected manifestations (mainly LN). To this end, this part will focus on new data regarding approved biologics.

We retrieved a total of 53 publications of belimumab in SLE, published between 2018 and 2022 (among them, 6 RCTs, 7 open-label extensions of previous RCTs, 11 post hoc analyses of previously published RCTs, 7 meta-analyses and 18 real-world observational studies), overall confirming efficacy of the drug in extrarenal lupus. A Cochrane SLR including 6 RCTs of belimumab in SLE found belimumab to be associated with a pooled risk ratio of 1.33 (95% CI 1.22 to 1.45) and 1.59 (95% CI 1.17 to 2.15) for Safety of Estrogen in Lupus National Assessment—Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) reduction by four points and reduction of GC dose by 50%, respectively. 15 Importantly, after the publication of the 2019 recommendations, belimumab has been tested in phase III RCTs in specific ethnic/racial populations, the Efficacy and Safety of Belimumab in Black Race Patients with SLE (EMBRACE) RCT in 448 African-Americans, 16 and the Belimumab in Subjects with SLE-North East Asia (BLISS-NEA) in 707 patients from North-East Asia. 17 Although in both studies, SLE Responder Index (SRI)-4 responses at 52 weeks were higher with belimumab versus placebo, the EMBRACE did not reach statistical significance (SRI response at week 52 48.7% with belimumab versus 41.6% with placebo (OR 1.40, 95% CI 0.93 to 2.11)). On the contrary, in BLISS-NEA, more patients treated with belimumab were SRI-4 responders at week 52 (53.8% vs 40.1% with placebo, OR 1.99, 95% CI 1.40 to 2.82). Regarding safety of belimumab, a phase IV RCT (BASE, 4003 patients) designed to test safety issues, found slightly higher rates of serious depression (0.35% vs 0.05%; Δ 0.15%, 95% CI 0.02% to 0.58%), treatment-emergent suicidality (1.42% vs 1.16%; Δ 0.26%, 95% CI −0.44% to 0.96%) and sponsor-adjudicated serious suicide or self-injury (0.75% vs 0.25%; post hoc Δ 0.50%, 95% CI 0.06% to 0.94%) with belimumab compared with placebo. 18 Similarly, a pooled post hoc analysis of one phase II and five phase III RCTs of belimumab (total 4170 patients) reported that serious depression was more common with belimumab (0.2% vs 0.1%) although suicide/self-injury was similar (0.3% in each group). 19 Incidence of all other adverse events and mortality was also similar between belimumab and placebo.

In addition to the Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP) trials, the SLR retrieved a total of 17 publications related to the use of anifrolumab in SLE: 2 phase II RCTs (one was in LN), 2 open-label extension studies, 7 post hoc analyses of previous RCTs, and 4 meta-analyses. Despite the discordant SRI-4 data of the two TULIP trials, both studies found significantly greater British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response rates with anifrolumab compared with placebo (pooled OR 2.25, 95% CI 1.72 to 2.95, in a meta-analysis). 20 A post hoc analysis of the TULIP trials found that anifrolumab was associated with lower annualised disease flare rates (rate ratio 0.75, 95% CI 0.60 to 0.95), prolonged time to first flare (HR 0.70, 95% CI 0.55 to 0.89) and fewer patients with ≥1 flare (Δ −9.3%, 95% CI −16.3% to −2.3%), compared to placebo. 21 Regarding GC-sparing potential, another post hoc analysis of both TULIP trials reported sustained reduction to ≤7.5 mg/day prednisone in patients on ≥10 mg/day at baseline in 50.5% for anifrolumab versus 31.8% for placebo (Δ 18.7%, p<0.001), 22 while the above-mentioned meta-analysis (including also the MUSE phase II study of the drug) calculated the respective pooled OR at 2.45 (95% CI 1.69 to 3.54) compared to placebo. 20 In terms of safety, in general, adverse events and serious adverse events were similar between anifrolumab and placebo in RCTs, with the exception of VZV infection; analysis of the TULIP trials found a higher incidence of VZV in anifrolumab-treated patients versus placebo (6.4% vs 1.4%), evident in both interferon-high and interferon-low patients, 22 and confirmed in meta-analyses. 20 23 On the other hand, in the long-term extension of the TULIP studies (placebo controlled, 369 patients), VZV rates by year decreased over time and were lower during the long-term extension period than during the first year of TULIP (6.8 for year 1, dropping to 2.9 in year 4). 24

In RCTs, both belimumab and anifrolumab showed better clinical responses in patients who had abnormal serological markers at baseline (low C3/C4 levels and/or high antidouble-stranded DNA antibodies). 22 25 26

Treatment of specific extrarenal manifestations of SLE

Subquestions 1b–1f of PICO 1 were focused on the efficacy of different immunosuppressive treatments in various organ manifestations of SLE (mucocutaneous, musculoskeletal, haematological, neuropsychiatric and kidney involvement). The results on LN are presented in a separate section. Regarding other manifestations, the SLRs confirmed the paucity of high-quality data for their treatment. For skin disease, belimumab and anifrolumab have documented efficacy in RCTs of their clinical programme; however, belimumab has used the skin component from BILAG, while the more recent TULIP trials of anifrolumab have used the skin-specific Cutaneous Lupus Activity and Damage Index (CLASI) ( table 2 ).

Efficacy of belimumab and anifrolumab on skin disease in SLE

A meta-analysis of six RCTs focusing on skin efficacy of belimumab found a pooled OR of clinical response (BILAG defined) at 52 weeks of 1.44 (95% CI 1.20 to 1.74, I 2 =0%). 27 Clinical response was first noted after 20 weeks of treatment (OR 1.35, 95% CI 1.01 to 1.81, I 2 =0%), sustained through 1 year. In addition, CLASI data for belimumab have been reported in three observational studies (including 62, 67 and 466 patients, respectively), all showing significant reductions from baseline, ranging from 4 to 6 units ( table 2 ). 28–30 Anifrolumab RCTs have used CLASI to assess response; post hoc analyses of both TULIP phase III and the phase II MUSE trial have shown percentage differences in CLASI-A 50 (ie, 50% reduction from baseline) response more than 20% from placebo, almost reaching 30% in MUSE. 22 31 32

Efficacy data on arthritis were more scarce, available only from RCT of belimumab and anifrolumab. The post hoc analysis of the TULIP studies found that anifrolumab was associated with greater percentage of patients achieving ≥50% reduction in active swollen and tender joints (treatment Δ: 12.6% (95% CI 2.4% to 22.9%)). 22 Significant reduction was also noted in a similar analysis of the MUSE phase II study (mean (SD) swollen and tender joint reductions –5.5 (6.3) vs –3.4 (5.9) for placebo, p=0.004). 32 For belimumab, only two small observational, uncontrolled studies (n=81 and 20, respectively) specifically reported a reduction in the number of swollen and tender joints. 33 34

The SLR retrieved very few studies regarding haematological and neuropsychiatric manifestations. For neuropsychiatric SLE (NPSLE), a single meta-analysis on the efficacy of RTX in refractory SLE (including NPSLE) reported a pooled complete response rate of 90% for neuropsychiatric manifestations (95% CI 53% to 99%). 35 No other relevant studies were identified. For immune cytopenias, post hoc analysis of the TULIP trials found a 25% difference in response rate in haematological manifestations, in favour of anifrolumab (56% vs 31% for placebo), but with no further details. 31 A similar analysis of the BLISS trials (published in 2012, thus not included in the current SLR) had not found a difference of belimumab over placebo for haematological manifestations.

Treatment of LN

The SLR identified 98 studies evaluating the efficacy and safety of various treatments in LN. These included 14 meta-analyses (1 of high quality, 9 of low or critically low quality and 4 network meta-analyses), 15 RCTs (5 of low RoB, 6 with some concerns and 4 with high RoB) and 69 studies with other study designs (2 open-label extension studies of RCTs, 2 post hoc studies, 1 integrated analysis and 64 observational studies including 8 prospective cohorts, 53 retrospective cohorts, 2 cross-sectional and 1 case–control study) and varied quality.

14 RCTs (5 head-to-head, 2 dose-comparison and 7 add-on vs placebo trials) involving 2099 LN patients evaluated the efficacy and safety of various drugs as initial treatments for LN ( table 3 ).

Efficacy of initial treatments for LN in RCTs 2018–2022

Regarding comparison of standard of care therapies (CYC and MMF), only two new RCTs, both in Asian LN populations, were identified from the SLR (one with high and one with low RoB). One small RCT of 49 LN patients with impaired kidney function (mean±SD baseline serum creatinine 1.58±1.38 mg/dL) showed similar efficacy between CYC (monthly pulses of 0.5–1 g/m 2 for 6 months) and low-dose MMF (1.5 g/day) after 24 weeks of treatment (19.0% vs 28.6%, p=0.572). 36 In a second RCT, a low versus high dose of intravenous CYC (low dose: six fortnightly intravenous CYC pulses of 500 mg, high dose: 4 weekly six cycles of 750 mg/m 2 ), both followed by AZA, were administered in 38 and 37 patients, respectively. After 52 weeks, patients in the high-dose group had significantly increased rates of complete/partial response (50% vs 73%, p=0.04) and fewer relapses (3% vs 24%, p=0.01) compared with the low-dose group, with no difference in infection rates and death. 37 Although this study was designated as low RoB, it was nevertheless open-label and the sample size was relatively small.

Five RCTs (2 with low RoB, 2 with some concerns and 1 with high RoB) explored the effect of CNIs, either as monotherapy or in combination with MMF, against CYC/MMF. 5 38–41 In an open-label non-inferiority (margin 15%) RCT of 299 LN patients, tacrolimus (TAC) was non-inferior to CYC in terms of complete and partial response after 24 weeks of treatment. When the individual components of response were investigated, TAC was associated with a significant decrease in estimated glomerular filtration rate (eGFR), counterbalanced by greater reductions in proteinuria compared with CYC. 38 Similarly, in another RCT of 83 patients with proliferative LN who received 1:1 TAC or MMF followed by AZA, both arms had comparable remission rates at 12 months (46.3% vs 57.1% p=0.3). 39 Regarding long-term outcomes, TAC was non-inferior to MMF in a study of 150 patients who were previously randomised to TAC or MMF as induction treatment and AZA as maintenance. 42 After 10 years, the TAC group had similar relapse rates compared with MMF and there was also no difference in a composite outcome (reduction in eGFR≥30%, chronic kidney disease stage 4/5 or death). As in the previous SLR, no RCT was identified assessing the role of CNI as monotherapy in proliferative LN in non-Asian populations. In a meta-analysis of trials in Asian populations, TAC outperformed CYC in terms of complete response (OR 2.41 95% CI 1.46 to 3.99, based on seven studies), but had a similar effect when compared with MMF (OR 0.95 95% CI 0.54 to 1.64, based on three studies). 43 Similar results were reported in two recent network meta-analyses. 44 45

Three RCTs investigated the efficacy of multitarget therapy (CNI in combination with MMF, two using voclosporin and one using TAC) compared with MMF or CYC, all pointing towards better response rates with the multitarget treatment. 5 40 41 In AURA-LV, a phase II multicentre RCT, 267 patients were randomised 1:1:1 to receive either voclosporin (23.7 or 39.5 mg, each two times per day) or placebo, in combination with MMF (2 g/day) and low dose GC. At 24 weeks, patients on low-dose voclosporin had significantly increased complete response rates (defined as urine protein-to-creatinine ratio (UPCr) <0.5 mg/mg, an eGFR>60 mL/min/1.73 m 2 or no decrease of ≥20% of baseline eGFR, no administration of rescue medication and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or for 7 or more days during weeks 44–52) compared with placebo (OR 2.03, 95% CI 1.01 to 4.05); in terms of safety, voclosporin was associated with higher rates of adverse events and death. 41 The AURORA trial was a phase III multicentre RCT involving 357 LN patients with class III, IV, V or mixed classes. Patients were randomly assigned to voclosporin (23.7 mg two times per day) or placebo in addition to 2 g/day of MMF and low-dose GCs and were followed for 52 weeks. Complete renal response (defined as in AURA-LV) was achieved in significantly more patients in the voclosporin group than placebo (41% vs 23%, OR 2.65 95% CI 1.64 to 4.27), while both groups had similar eGFR and safety profile during follow-up. Importantly, subgroup analysis showed no benefit from the introduction of voclosporin in class V or when the dose of MMF exceeded 2 g/day. 5 An integrated analysis of pooled data from phases II and III voclosporin trials, as well as a long-term extension study of the AURORA trial (the latter published after the completion of the present SLR) corroborated the previous findings in efficacy and safety. 46 47 In another small (n=56), open-label RCT with longer follow-up (72 weeks), combination treatment with TAC (0.06–0.08 mg/kg/day) and MMF (20–30 mg/kg/day) was superior to intravenous CYC (0.5–0.75 g/m monthly for 6 months) in terms of renal response (81.5% vs 57.7%, p<0.05) and kidney function (mean ± SD serum creatinine 56.7±32.1 vs 72.5±32.5, p 0.019). 40

Four RCTs evaluated the efficacy and safety of biologic agents added to background immunosuppressive therapy. Two phase III trials investigated the add-on effect of belimumab (one of low RoB and the other with some concerns), one phase II trial investigated the add-on effect of anifrolumab (RoB with some concerns) and another phase II RCT investigated the add-on effect of obinutuzumab (low RoB). In the Belimumab International Study in Lupus Nephritis (BLISS-LN), a phase III, double-blind, placebo-controlled trial, 448 patients were randomly assigned to intravenous belimumab (10 mg/kg/month) or placebo added to standard therapy (ie, six pulses of intravenous CYC 500 mg every 2 weeks followed by AZA, or MMF (3 g/day) plus GC 0.5–1 mg/kg/day as initial dose). 4 Patients were stratified according to induction treatment and race. The primary endpoint assessed at 104 weeks was the primary efficacy renal response (PERR) defined as UPCr≤0.7 g/g, eGFR no worse than 20% below the preflare value or at least 60 mL/min/1.73 m 2 and no use of rescue therapy. More patients in the belimumab group achieved PERR compared with placebo at 104 weeks (43% vs 32% OR 1.6 95%CI 1.0 to 2.3). 4 In a secondary analysis, patients with class 5 or with a UPCr>3 g/g did not benefit from the addition of belimumab, in terms of PERR. However, the risk of a 30% and 40% decline in eGFR and the risk of flare were significantly less in patients receiving belimumab. 48 The CALIBRATE study was a phase II open-label RCT in patients with refractory or relapsing LN, assessing the safety and potential benefit from the addition of belimumab to a background treatment of RTX and intravenous CYC. 49 Although the addition of belimumab did not increase adverse events, patients on belimumab and placebo had similar response rates (52% vs 41%, p=0.4). The phase II double-blinded TULIP-LN study randomised 147 patients with biopsy-proven proliferative LN in a 1:1:1 ratio to receive either monthly 300 mg of intravenous anifrolumab (basic regimen), 900 mg of intravenous anifrolumab for 3 doses and 300 mg thereafter (intensified regimen (IR)) or placebo on top of MMF (2 g/day) and GC. 50 The primary endpoint (change in UPCr at week 52 for combined anifrolumab vs placebo) was not met; however, when the two anifrolumab arms were analysed separately, more patients in the IR achieved complete response compared with placebo (45.5% and 31.1% respectively). Importantly, safety concerns were raised due to an increased incidence of VZV infection in the combined anifrolumab groups versus placebo (16.7% vs 8.2%). In another phase II RCT, 125 LN patients were randomly assigned to obinutuzumab, a humanised type 2 anti-CD20 monoclonal antibody, or placebo in addition to MMF and GC. 51 After 52 and 104 weeks significantly more patients in the obinutuzumab group achieved complete response (UPCr<0.5, normal renal function without worsening of baseline serum creatinine by >15% and inactive urinary sediment) compared with placebo (35% vs 23%, p=0.1 and 41% vs 23%, p=0.026, respectively).

This SLR identified only one trial (RoB with some concerns) that was specifically designed to compare different drugs as maintenance treatments. In this RCT, 215 patients with biopsy-proven LN who had previously received intravenous CYC plus GC and achieved remission were randomised 1:1 to leflunomide (20 mg/day) or AZA (100 mg/day) for 36 months. The primary endpoint, time to kidney flare, was similar between groups (16 vs 14 months, p=0.67), and there was no difference in safety profile. 52

Remission, low disease activity and associations with favourable outcomes in SLE

PICO 2 focused on the short-term and long-term benefits of attainment of treatment targets, both in extrarenal SLE and LN. The current SLR identified observational studies in which both remission (defined either per the recent Definition of Remission in SLE (DORIS) definition 53 or earlier definitions) and low disease activity (mainly defined as the lupus low disease activity state (LLDAS) 54 ) are associated with reduced risk for damage accrual ( table 4 ), as well as disease flares and other adverse sequelae (death, serious infections and hospitalisations, online supplemental table S4.4 ). In studies of good quality, range of OR for an increase in SDI were 0.49–0.75 for remission and 0.19–0.88 for LLDAS, versus patients not attaining these targets. Similarly, observational studies in LN examining the association between complete remission at variable time-points and favourable long-term kidney outcomes are shown in online supplemental table S4.5

Association of attainment of remission or LLDAS with risk for damage accrual

Safety of treatment tapering in SLE

PICO 4 addressed the issue of safety of tapering and/or withdrawal of immunosuppressive treatment in patients with SLE who have quiescent disease. Studies were categorised according to tapering of (1) GC, (2) immunosuppressive drugs and (3) antimalarials. For GC, a randomised study (CORTICOLUP) found higher rate of flares in patients with SLE on chronic prednisone 5 mg/day who discontinued GC, versus those who continued this dose. 55 A meta-analysis reported a pooled incidence of 24% (95% CI 21 to 27) and 13% (95% CI 8 to 18) for global and major flares, respectively, following GC withdrawal 56 ; a different meta-analysis focusing on risk factors found an increased risk for flare in serologically active, clinically quiescent disease after GC withdrawal (OR 1.78, 95% CI 1.00 to 3.15), while HCQ use trended towards decreased risk of flare, however results were not statistically significant (OR 0.50, 95% CI 0.23 to 1.07). Individual observational studies of the current SLR are shown in table 5 and support that gradual tapering to discontinuation of GC may be achieved without increasing the risk for flares, especially with slow tapering and long-standing remission prior to complete withdrawal (although most of these did not have a control patient group which did not discontinue GC).

Studies evaluating tapering and withdrawal of glucocorticoids in patients with SLE

Contrary to GC, although a similar RCT of withdrawal versus continuation has not been performed, discontinuation of antimalarials is more frequently associated with increased risk of flares. Four observational studies addressed this issue. Large observational studies from the multicentre Systemic Lupus International Collaborating Clinics (SLICC) cohort, 57 the Toronto Lupus cohort, 58 as well as five other SLE cohorts in Canada, 59 reported higher rates of disease flares in patients with SLE who stopped HCQ compared with patients who continued, with HR ranging from 1.56 57 to 2.30. 58 Tapering HCQ to a lower dose seems to be associated with a lower risk for flare, as patients in the Toronto cohort who tapered had significantly fewer flares versus abrupt discontinuation (45.9% vs 72.6%; p=0.01), 58 while the respective risk for flare in the SLICC study for those with HCQ dose reduction was 1.20 (95% CI 1.04 to 1.38) compared with patients who continued. 57

Finally, regarding withdrawal of synthetic immunosuppressive drugs, a limited number of studies have been published, mainly in LN. The Weaning of Immunosuppressive Therapy in Lupus Nephritis (WIN-Lupus) study randomised 96 patients with proliferative LN in remission after 2–3 years of immunosuppression to treatment discontinuation versus maintenance. 60 Relapses of LN (27.3% vs 12.5%), as well as severe disease flares (31.8% vs 12.5%), were significantly more common in the discontinuation group. An Italian uncontrolled observational study reported a 22.9% relapse rate (19/83 patients) in LN patients who discontinued immunosuppression. Antimalarial treatment and longer duration of remission (>3 years) at the time of therapy withdrawal were associated with lower risk of LN relapse. 61

Safety of herpes zoster and SARS-CoV2 vaccination in SLE

The final PICO focused on prevention of specific infections in SLE, namely VZV and COVID-19, rather than on general preventive measures for infections (vaccinations, etc), for which specific EULAR recommendations exist and are regularly updated. 7 These particular infections were chosen, because of the impact of zoster on patients with SLE (in view also of the potential increased risk with new therapies, such as interferon inhibitors), 62 and the public health problem imposed by the COVID pandemic, most obvious in populations with immunosuppression. 63

Regarding efficacy and safety of the zoster vaccine in patients with SLE, we identified three studies assessing the newer recombinant, adjuvanted vaccine (Shingrix) in patients with systemic autoimmune diseases, which also included a small subset with SLE. A study in 403 patients (16 with SLE) found a flare rate of 7.1% in the SLE group (all were mild), as well as one zoster breakthrough case. 64 Another study on 622 patients (24 with SLE) reported mild flares in 4/24 patients with SLE (17%), all treated only with GC. 65 The third, larger study, using two claims databases from the USA to estimate recombinant zoster vaccination among adults aged≥50 years with systemic autoimmune diseases and possible vaccine-related flares, found no statistically significant increase in flares for any autoimmune disease following either dose of recombinant vaccine (more than 4500 patients with SLE in the two databases, risk ratio for flare in the risk window vs control window 0.9–1.0 in this group). 66 Formerly, the live attenuated vaccine (Zostavax) was tested in a single, high-quality RCT in 90 quiescent patients with SLE (plus 10 healthy controls), testing VZV IgG reactivity and safety at 6 weeks. 67 Both anti-VZV IgG and T-cell spots increased significantly in herpes zoster-vaccinated patients, in a similar magnitude to healthy controls, while only two patients experienced a mild/moderate flare.

Regarding the immunogenicity and safety of SARS-CoV2 vaccination in patients with SLE, the SLR identified a significant number of studies ( online supplemental table S4.6 ). A meta-analysis, including 32 studies and 8269 patients in total, tested clinical effectiveness (ie, prevention from COVID-19), immunogenicity and safety, and found a pooled seropositivity rate 81.1% following various anti-SARS-CoV2 vaccine formulations (higher with mRNA vaccines), very rare severe adverse events (<1%), as well as a cumulative flare rate 5.5% 68 ; however, moderate or severe flares were reported only in 0%–2% of patients in all but one studies ( online supplemental table S4.6 ). Additionally, seven studies addressed the influence of concomitant or background immunosuppression on vaccine immunogenicity ( online supplemental table S4.7 ). As shown in these studies, concomitant use of MMF, RTX and possible GC was associated with lower patient ability to mount immune responses to SARS-CoV2 vaccination.

For the recent update of the EULAR recommendations for the management of SLE, we performed five different SLRs based on respective PICOs, to cover the most important aspects in the treatment of this challenging disease.

HCQ is the backbone treatment for all patients with SLE, while GC are still used in the majority of patients. The current SLR confirmed the beneficial effects of HCQ in lupus, ranging from prevention of infections or thrombosis to improved survival. Regarding retinal toxicity, although studies seem to converge to longer duration of use and higher cumulative dose as major risk factors for this complication, the actual rate of this complication had wide variation among studies, possibly in part due to different screening techniques used and definitions applied. We did not document other major safety signals. On the contrary, the current SLR confirmed the correlation of chronic GC use with multiple adverse outcomes in SLE (eg, susceptibility to infections, osteonecrosis, irreversible damage, among others). It should be noted that the recommended lowering of the maximum maintenance dose to 5 mg/day (instead of 7.5 mg/day) was not based on a randomised trial comparing the safety of these two different maintenance doses. Nevertheless, most observational studies that tested threshold daily prednisone doses in relation to adverse events pointed to the 5 mg/day, as well as to a stronger association with increasing doses (see table 1 ).

For the use of conventional and biologic immunosuppressive drugs in extrarenal SLE, the approved biologics anifrolumab and belimumab have proven efficacy in the form of high-quality RCTs with low RoB, compared with standard of care. Importantly, RCTs have become more elaborate in recent years, because in the anifrolumab studies, organ-specific endpoints, such as the CLASI and tender/swollen joint counts, were applied (belimumab studies had used SLEDAI and BILAG domains). RCTs are not available for conventional immunosuppressive agents in extrarenal SLE and are unlikely to be performed in the future due to the long experience with the everyday use of the drugs. Additionally, there are very few comparative studies between different immunosuppressive agents, (MTX, AZA, MMF, etc) all prior to the starting date of the current SLR.

Regarding the treatment of LN, equal efficacy of standard of care treatment, MMF and CYC, was again confirmed in additional comparative studies, mainly of low quality. More importantly, two high-quality RCTs with low RoB led to the approval of belimumab and voclosporin for the treatment of active LN. 4 5 These RCTs were the largest that have been performed in LN to date, and the BLISS-LN additionally used a novel response definition (PERR) and used an extended time-point at 2 years (all other RCTs of ‘induction’ therapies in LN have tested efficacy at 6 or 12 months). Post hoc analyses of both BLISS-LN and AURORA did not find a statistically significant benefit of any of the drugs in class 5 LN, but patients with this histologic class represented less than 20% of the study population in both studies; belimumab was also found to perform better in patients with baseline proteinuria less than 3 g/day.

For treatment targets of SLE, our SLR provided robust evidence for the positive association of remission and LLDAS with lower risk for multiple adverse outcomes, including damage ( table 4 ), flares, mortality and hospitalisation. Although the two states are comparable in terms of prognosis, data point towards slightly lower odds for damage accrual for remission over LLDAS; on the other hand, LLDAS is achieved more frequently than DORIS remission. The prognostic significance of both conditions has been tested in longitudinal cohorts of patients receiving routine care. Interestingly, a randomised trial has been designed to test whether a ‘treat-to-target’ approach aiming at remission or LLDAS confers additional benefit over standard of care. 69

Two randomised studies, CORTICOLUP and WIN-LUPUS, tested the discontinuation of prednisone (CORTICOLUP) and immunosuppressive agents (WIN-LUPUS) in extrarenal SLE and LN, respectively. 55 60 Although both studies found higher rates of relapse in patients that discontinued treatment, and withstanding their limitations (eg, CORTICOLUP was criticised for the abrupt—rather than more gradual—stopping of prednisone from 5 mg/day), they have opened the way for similar trials in SLE. A number of cohort studies have been reported with successful discontinuation, especially of GC, without an increased risk for flare in the majority of patients.

Some methodological considerations of our work merit explanation. Since high-quality studies are lacking for most organ manifestations of SLE, we adopted an inclusive approach during article screening and selection, in order to capture evidence from observational and non-controlled studies for topics where RCTs are absent or scarce. This led to inclusion of a large number of studies (n=439), many of which had limited contribution to the conclusions regarding drug efficacy for specific manifestations. This issue is particularly relevant for conventional immunosuppressive drugs, which are often used to treat extrarenal lupus manifestations, but lack support from randomised evidence. With improved trial design and approval of new drugs (mainly biologics), we anticipate that SLR for future updates of SLE recommendations will focus more on RCTs and high-quality observational studies with low RoB. Additionally, our SLR did not include the EMBASE database, and Medline was partially captured through PubMed. We acknowledge that this may have led to omission of some studies, nevertheless the multiple sources used for our SLR (PubMed, Cochrane, hand search of references of included studies) has reduced the possibility of leaving out significant studies.

In conclusion, the dedicated SLRs that supported the update of the EULAR recommendations for the management of SLE found high-quality data for the efficacy of biologic agents in treating the disease (anifrolumab and belimumab) and for the new treatment options in LN (RCT with low RoB for belimumab and voclosporin), but low-to-moderate quality concerning most other aspects of the disease. Additionally, treatment targets, such as remission and low disease activity, show a robust and consistent association with several favourable outcomes, supporting their establishment as the goal of therapy in SLE. Studies (some of them randomised) addressing the issue of treatment tapering in lupus patients in remission have also been published since the previous recommendations, following the paradigm of rheumatoid arthritis and spondylarthritis.

Ethics statements

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Ethics approval

Acknowledgments.

We wish to acknowledge the support of the EULAR Quality of Care Committee and express our sincere appreciation and gratitude to the EULAR Secretariat, especially Simona Lupatin, executive assistant and to Dora Togia for the outstanding organisation and coordination.

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1

Handling editor Kimme L Hyrich

X @george_bertsias

Contributors MK and AF drafted the manuscript, CBM, GB and DTB edited the manuscript, and AF provided the final version. AF acts as the guarantor responsible for the overall content of the manuscript.

Funding This study was supported by the European League Against Rheumatism (project number QoC015).

Competing interests AF reports honoraria and/or consulting fees from Lilly, Boehringer, Novartis, AbbVie, AstraZeneca, GSK, MSD, Pfizer, UCB, Amgen, Aenorasis, support for attending meetings from UCB. MK reports honoraria and/or consulting fees from GSK, participation in advisory boards from GSK, AstraZeneca, Amgen. GB reports grants from GSK, AstraZeneca, Pfizer, honoraria and/or consulting fees from Lilly, Aenorasis, Novartis, AstraZeneca, GSK, SOBI, Pfizer, participation in advisory boards from Novartis. DTB reports unrestricted investigational grants from GSK, honoraria and/or consulting fees from GSK, AstraZeneca, Pfizer. CBM declares no conflict of interest.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Physiological Adjustments to Stress Measures Following Massage Therapy: A Review of the Literature

Albert moraska, robin a pollini, karen boulanger, marissa z brooks, lesley teitlebaum.

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For reprints and all correspondence: Albert Moraska, University of Colorado at Denver and Health Sciences Center, School of Nursing, C288, Education 2 North 13120 east 19 th Ave. Aurora, CO 80045. E-mail: [email protected]

Corresponding author.

Received 2007 Sep 7; Accepted 2008 Apr 4; Issue date 2010 Dec.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/2.0/uk/ ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Use of massage therapy by the general public has increased substantially in recent years. In light of the popularity of massage therapy for stress reduction, a comprehensive review of the peer-reviewed literature is important to summarize the effectiveness of this modality on stress-reactive physiological measures. On-line databases were searched for articles relevant to both massage therapy and stress. Articles were included in this review if (i) the massage therapy account consisted of manipulation of soft tissues and was conducted by a trained therapist, and (ii) a dependent measure to evaluate physiological stress was reported. Hormonal and physical parameters are reviewed. A total of 25 studies met all inclusion criteria. A majority of studies employed a 20–30 min massage administered twice-weekly over 5 weeks with evaluations conducted pre-post an individual session (single treatment) or following a series of sessions (multiple treatments). Single treatment reductions in salivary cortisol and heart rate were consistently noted. A sustained reduction for these measures was not supported in the literature, although the single-treatment effect was repeatable within a study. To date, the research data is insufficient to make definitive statements regarding the multiple treatment effect of massage therapy on urinary cortisol or catecholamines, but some evidence for a positive effect on diastolic blood pressure has been documented. While significant improvement has been demonstrated following massage therapy, the general research body on this topic lacks the necessary scientific rigor to provide a definitive understanding of the effect massage therapy has on many physiological variables associated with stress.

Keywords: catecholamines, complementary medicine, cortisol, manipulative medicine

Introduction

Stress is the disruption in homeostasis caused by psychological experiences or physiological perturbations ( 1 ). Even so-called healthy living involves continual exposure to a variety of stressful experiences; however, the body addresses these in an allostatic manner thereby maintaining homeostasis. Physiological changes in response to a stressor such as epinephrine or cortisol production and release, prepare the individual to better cope with the situation. Minutes or hours following a stressful event the system usually returns to homeostasis. However, when the demands on the individual to manage the stressful experience exceed the resources available, acute stress may precipitate negative psychological and/or physical symptoms. Both severe stressors (e.g. major life events) and relatively minor stressors that occur on a frequent basis (e.g. daily hassles) have been associated with an increase in stress-related symptoms ( 2–5 ).

When stressful experiences become chronic, pathological consequences result and can contribute to physiological or psychological dysfunction including high blood pressure, cardiovascular disease, reduced immune function, thyroid disorders, alcoholism, diabetes, anorexia nervosa as well as depression and increased suicide attempts ( 6 , 7 ). In fact, in the United States the five leading causes of death have been linked to stress: heart disease, cancer, lung ailments, cirrhosis of the liver and suicide ( 8 ). Therefore, therapeutic techniques that reduce the harmful consequences of stress and facilitate effective coping mechanisms are essential to healthy living.

Complementary and alternative medicine (CAM) approaches to address health issues has become increasingly popular in recent years ( 9 , 10 ). It has been estimated that 36–42% of the US population use CAM modalities, with 5–11% specifically seeking massage therapy ( 9 , 11 ). Eisenberg et al . ( 9 ) estimated that 114 million visits to US-based massage therapists were made in 1997 exceeding those to all other CAM providers, with the exception of chiropractors. While reasons for seeking massage therapy are diverse, visits are frequently related to stress reduction. For example, wellness care (relaxation) accounted for 19% and anxiety reduction 5–9% of total visits to massage therapists ( 12 ).

The stress response is the body's reaction to any real or perceived threat and activates the sympathetic branch of the autonomic nervous system resulting in stimulation of the hypothalamus-pituitary-adrenal (HPA) axis ( 13 , 14 ). Subsequent to HPA activation is the production of a cascade of stress-associated hormones including epinephrine (adrenaline) and cortisol, which influence other physiological systems and enhance an individual's ability to address the stressor. This mechanism of action will increase heart rate and mobilize fuel stores in preparation for the perceived threat; however, under chronic stressful conditions the negative consequences described previously ensue. In contrast, massage therapy is believed to stimulate the parasympathetic branch of the autonomic nervous system. Activation of the parasympathetic nervous system facilitates the return to homeostasis after an emergency by reversing some of the physiological systems activated during the stress response. For example, an increase in parasympathetic tone would reduce heart rate and slow respiration, resulting in relaxation.

Massage therapy has been touted as an antidote for the symptoms of stress by the research community ( 15 ), massage professionals ( 16 ) and the lay public ( 17 ). In an effort to more thoroughly understand if massage therapy is effective in the management of the negative health consequences of stress, a synthesis of the available scientific literature is needed. The intent of this review is to provide a comprehensive, yet critical, evaluation of the peer-reviewed research investigating the relationship between massage therapy and physiological measures of stress. Physiological measures of stress including hormonal (cortisol, epinephrine and norepinephrine) as well as physical (heart rate and blood pressure) are reviewed; study limitations and areas for future research are also discussed.

Massage Definition and Inclusion Criteria

We define massage therapy to be the manipulation of soft tissues for the purpose of producing physiological effects on the vascular, muscular or nervous systems of the body. It has been reported that the effect of massage therapy is more robust when administered by trained therapists ( 18 ), therefore, only studies employing trained massage therapists are included in this review. Studies in which partners, parents or a relative were the primary source for massage are excluded. In addition, inclusion of a research study requires direct tissue manipulation, as such, studies including only touch therapies (e.g. gentle touch, therapeutic touch, acupressure and reflexology) are excluded. Given the limitations in application of massage therapy to infants and children, we chose to exclude studies involving these populations. Because massage therapy treatment of short duration, applied only to a localized body region, of short duration is believed to be effective, we chose to include those studies provided they met all other selection criteria.

Electronic Searches

Searches for research manuscripts included the following: MEDLINE, CINAHL, PsychINFO and the Massage Therapy Foundation database. In addition, the authors’ personal libraries and relevant citations from selected articles were reviewed. Keywords used for electronic searches included ‘stress’ in combination with each of the following terms: ‘massage’, ‘bodywork’, ‘physiotherapy’ and ‘manual therapy’.

Article Inclusion

Using the above search terms, a total of 1032 citations that were published by the end of 2006 were initially identified. Titles and abstracts from all 1032 citations were then reviewed for topical relevance; this process resulted in 122 unique citations that were more closely scrutinized. Review articles, Letters to the Editor, study summaries and non-research reports were excluded from further review. A total of 62 articles were subsequently read in their entirety with those articles selected for inclusion presenting dependent variables of stress that included the hormones cortisol, epinephrine, norepinephrine or physical measures of blood pressure (BP) and heart rate. Following that analysis, 25 articles were found to meet all inclusion criteria and were included in this report.

The intent of this synthesis was to assess the impact of massage therapy on physiological measures of stress, yet the published research had great variability in quality of study design and conduct. We therefore chose to review the literature that met our inclusion criteria described previously, rather than selecting articles based solely on strength of study criteria ( 19 , 20 ). Only those studies published in peer-reviewed journals and written in English language were reviewed.

Summary of Included Studies

A total of 25 studies met our inclusion criteria. Of those, 18 employed a randomized control trial (RCT) study design, two were conducted using a quasi-experimental design and five used a within-subjects design. Descriptions of the massage therapy interventions used were quite varied and ranged from a simplistic description of the session to a detailed presentation of techniques that could readily reproduce the treatment. The majority of the studies ( 22 ) administered massage therapy to subjects on a massage table, whereas three used chair massage. Duration of a massage session varied from 5 to 90 min, with over half (52%) of the studies using sessions lasting between 20 and 30 min. In many studies, the intervention consisted of 6–10 massage treatments, but research studies reported data following a single massage to as many as 22 sessions. Data collection following the first massage treatment session was the time point most frequently assessed. Given the breadth in descriptiveness of the techniques coupled with the subsequent variability of study results we chose to not provide comments on specific massage techniques. Study populations were varied and included sexually abused women ( 21 ), patients with eating disorders ( 22 , 23 ), pain conditions ( 24–26 ), hypertension ( 27 , 28 ), HIV positive diagnosis ( 29 ), cancer ( 30–32 ), post-operative patients ( 31 , 33 ), critical care patients ( 34 ), healthy adult populations ( 35–42 ) as well as specific disease states ( 43–45 ).

The hormone cortisol has become synonymous with ‘stress hormone’. Although circadian rhythm causes daily fluctuation for this variable, chronic stress will perpetually increase hypothalamic-pituitary-adrenocortical activity causing cortisol production to become elevated beyond normal levels. Multiple sampling sources have been evaluated for cortisol including saliva, urine and blood plasma. Studies that investigated the effects of massage therapy on these physiological measures are summarized in Table 1 .

Massage therapy and physiological measures of stress: Hormones

Abbreviations: n = Number of subjects; y = Years; NR = Not reported; RCT = Randomized control trial; W = Week, M = Month; ND = Not determined; E = Epinephrine; NE = Norepinephrine; P = Plasma sampling; S = Saliva sampling; U = Urine sampling.

↓ significant decrease; ↑ significant increase; ↔ no significant change; † P < 0.05; ‡ P < 0.01.

Salivary Cortisol

Saliva provides an easy, non-invasive means for assessing cortisol and is frequently reported in massage studies. While serum-free cortisol measures are the most reliable assessments for cortisol, salivary cortisol is accepted as an accurate window for this measure ( 46 ). Determination of a single-treatment effect of massage therapy is a commonly used experimental design in massage studies assessing salivary cortisol. Salivary cortisol evaluations are typically conducted at the first and final (typically 6th to 10th) massage sessions.

Of the nine studies reporting salivary cortisol at the first massage session, eight (89%) note a significant reduction immediately following massage therapy ( 22–25 , 27 , 29 , 40 , 41 ). It is unclear how long this reduction persists since a time-course has not been reported. Yet, in all of the studies when assessment of salivary cortisol is taken later in the study, this measure has returned to the baseline value. Thus, reductions in salivary cortisol may be short lived and multiple massage treatments do not appear to have a cumulative effect, although specific investigation into this has not been conducted. In the eight studies where salivary cortisol is assessed immediately pre-post the final massage improvement is less frequent with 63% of the studies now reporting a significant reduction ( 21 , 24 , 25 , 27 , 41 ). It is interesting that the one study that failed to find a reduction at the initial massage session reported a reduction at the final (eighth) session ( 21 ). The subject populations for studies reporting salivary cortisol are highly varied, which suggests that many groups may experience an immediate benefit from massage therapy for this variable; most study participants were, however, either healthy adults or experiencing chronic life stress. An example of the study design and findings for salivary cortisol is demonstrated in a study conducted by Lawler and Cameron ( 25 ) on migraine patients. In this study the authors assess cortisol before and after a 45 min massage following the first and sixth (final) massage sessions. Although the authors did not report cortisol data for the control group, they note a reduction in salivary cortisol from 6.25 to 3.86 nM following the first massage. At the sixth session they report similar pre- and post-massage values.

Urinary Cortisol

While saliva has been used to assess a single treatment change in cortisol following massage therapy, urine has been used more frequently to assess changes following multiple massage treatments. In massage studies an assessment is typically made at baseline and after 5 weeks of twice-weekly massage. Thus, this measure reflects the effect of multiple massage sessions over several weeks. With this method of assessment, three of nine published studies report a significant reduction in urinary cortisol following massage treatment ( 22 , 27 , 29 ). However, baseline differences between massage and control populations weaken the conclusion for two studies ( 22 , 27 ). In the third study where an effect was noted, massage therapy was administered on a daily basis for 22 consecutive days ( 29 ); in contrast, massage therapy given on three consecutive days was insufficient to establish an effect ( 33 ). The remaining studies all report no change in urinary cortisol ( 23 , 26 , 31 , 33 , 36 , 43 ).

Plasma Cortisol

No comprehensive studies were located that assessed plasma cortisol in subjects receiving massage therapy. One uncontrolled pilot study applied a ‘tactile massage’, in which the skeletal muscles were not manipulated to 11 subjects and reported reduced plasma cortisol compared to baseline after 10 weekly massage sessions in subjects with Type II diabetes ( 44 ).

Catecholamine

Psychological stress can increase sympathomedullar and sympathoneuronal nervous system activity ( 47 ). Epinephrine (adrenaline) is produced mainly from the adrenal medulla and reflects the subject's sympathomedullar activity. Norepinephrine (noradrenaline) is considered an indicator of sympathoneuronal activity as most of the circulating norepinephrine is released from sympathetic nerve endings. This hormonal defense reaction is aimed at mobilizing energy for the muscles and heart while reducing blood flow to the internal organs and the gastro-intestinal system. Whereas epinephrine output is mainly influenced by mental stress, norepinephrine is more responsive to physical activity ( 47 ). A decrease in either of these variables may indicate a physiological reduction in stress. Studies that explore the relationship between massage therapy and catecholamines are discussed subsequently and summarized in Table 1 .

Epinephrine and Norepinephrine

Seven studies report data on catecholamines following massage therapy, all of which determine levels of epinephrine and norepinephrine in urine samples at a similar periodicity as described for urinary cortisol ( 22 , 23 , 26 , 27 , 29 , 31 , 43 ). In six of the studies reporting epinephrine no change was noted, while one study reported an increase in urinary epinephrine in patients with Parkinson's Disease ( 43 ). Norepinephrine was also largely unaffected by massage therapy as no change in this variable was reported in five studies ( 22 , 26 , 27 , 29 , 31 ), while it increased in one report ( 23 ) and decreased in the remaining study ( 43 ). While the lack of an observed effect of massage therapy on catecholamines is striking, this may be due to the limited variability in study design. For instance, all of the studies originate from one research group and six use the same duration and frequency of massage treatment. In addition, only epinephrine and norepinephrine sampled from urine have been reported in the literature; no studies have reported the effect of massage therapy on plasma catecholamines.

Blood Pressure and Heart Rate

Increases in blood pressure, respiration and heart rate are all physiological manifestations of the sympathetic nervous system's response to stressful events. Stressful experiences in the workplace, for example, can raise BP and heart rate, which could subsequently contribute to cardiovascular disease. One argument is that massage therapy may ameliorate these symptoms of stress by promoting parasympathetic activity. Sixteen massage studies report data on BP or heart rate variables and are summarized in Table 2 .

Massage therapy and physiological measures of stress: Heart rate and blood pressure

Abbreviations: n = Number of subjects; y = Years; NA = Not available; RCT = Randomized control trial; W = Week; HR = Heart rate; SBP = Systolic blood pressure; DBP = Diastolic blood pressure.

↓ significant decrease; ↔ no significant change; † P < 0.05; ‡ P < 0.01; § P <0.001.

Blood Pressure

We identified eight studies that reported single-treatment effects of massage therapy on BP. Of these, three documented statistically significant reductions ( 35 , 37 , 42 ), four indicated no change ( 27 , 30 , 32 , 38 ) and one reported a reduction in mean arterial BP during, but not immediately after, massage ( 34 ). The collective body of literature reported participant systolic BP at baseline to be normal or mildly elevated, with the range between 117 and 144 mmHg. For the studies reporting statistical improvement in BP following a single massage session the change in systolic BP was relatively small (2–12 mmHg). In one study that strictly focused on BP, the authors noted that a single 30-min massage reduced systolic and diastolic BP by 4–8% ( 35 ). These effects were observed when massage therapy was directed to the back, neck and chest, whereas only systolic BP was reduced when massage therapy was to the legs, arms and face, suggesting that body region, rather than surface area may be an important consideration. In the three studies where diastolic BP was reduced, systolic BP also was reduced ( 35 , 37 , 42 ). While 50% of the studies reported no effect after a single massage session, this includes a broad group of studies in which great variability in subject health and massage duration complicates accurate analysis. For example, a single 90-min massage did not affect BP for healthy adults ( 38 ), however study participants entered massage treatment with normal systolic BP, thus the lack of an effect may be a desired finding.

Seven studies reported on changes in BP following multiple massage treatments or at a long-term follow-up after the final massage; their findings suggest a multiple-treatment effect of massage therapy on diastolic, but not systolic BP. In studies where eight or more massage sessions were administered over 3 or more weeks, subjects’ diastolic BP was reduced in four studies ( 27 , 30 , 35 ); this includes a study involving hypertensive participants. In the study of hypertensive patients, following 10 massage sessions a significant reduction in diastolic BP was noted when the subject was reclining, although they did not detect a reduction in BP following a single massage session unless the subject was in a sitting position during measurement ( 27 ). However, another study involving participants with hypertension reported a significant reduction in only systolic BP after 10 massage sessions ( 28 ). In general, the effect of multiple massage treatments on systolic BP appears to be less supported, while six studies report on this variable, only the one study noted previously reported a reduction in this measure ( 28 ). One small (11 subjects) within-subjects study did not find a change in systolic or diastolic BP ( 44 ) and a final study did not note a change in mean arterial BP ( 36 ). No studies reported an increase in BP following massage therapy.

Heart rate (HR) was reported in 11 studies on massage therapy with nine reporting data following a single treatment and three following multiple treatments. An effect of a single massage treatment was reported in five studies ( 24 , 25 , 38 , 39 , 42 ) with four reporting no change ( 28 , 30 , 32 , 34 ). The studies identifying significant significant change note small, but statistically significant reductions in HR of approximately 3–6 beats per minute (bpm) immediately following massage therapy. This effect does not appear to persist beyond the massage session. For example, a 5-min foot massage administered to critical care patients effected a statistically significant decrease in HR from 97.3 to 94.7 bpm during the massage, however, the reduction was not maintained when assessed 5 min post-massage ( 34 ). A longer massage treatment yields only slightly greater reductions in HR. Cowen et al . ( 38 ) found that a single 90-min Thai or Swedish massage significantly reduced HR among healthy subjects when assessed upon massage therapy completion (69.0 bpm to 63.4 bpm). Yet, the benefit may be repeatable as heart rate was reported to be reduced at each of six massage sessions for migraine sufferers, although the effect did not carry over to following sessions ( 25 ). In addition, a massage session that focused on myofascial trigger point therapy significantly reduced HR immediately after massage therapy ( 42 ). The authors also reported evidence indicating an increase in heart rate variability, which suggests the mechanism for reducing heart rate is by increasing parasympathetic activity. Although five studies (56%) reported a decrease in HR following a single massage, it is important to note that one did not have a comparison control group ( 25 ), which prevents clarity regarding whether the effect was the result of massage therapy or, more simply, resting quietly. Uncertainty exists for another study where the authors document a significant reduction in HR for burn patients, but also note a significant reduction for a ‘sit and relax’ control group ( 24 ). While individual effects on HR may vary, collectively, a small decrease in resting HR is frequently observed immediately following massage therapy and the duration of the massage does not appear to be a critical variable. Yet, the effect does not persist as HR measurements taken just minutes following massage therapy have been reported to return to pre-massage values.

Three studies assessed HR following multiple treatments ( 30 , 44 , 45 ); the two that report reductions in this variable were both small within-subjects studies ( 44 , 45 ) with a total of 15 subjects in the two studies.

Discussion and Conclusions

This report reviewed the literature on the effects of massage therapy at reducing physiological measures of stress, including hormonal (cortisol, epinephrine and norepinephrine) as well as physical (heart rate and blood pressure) variables. Published research in this field has evaluated massage therapy following single or multiple treatments. The single treatment measurement evaluated a dependent measure immediately prior to and following a massage session, whereas multiple-treatment effects were determined prior to the first massage and following a series of sessions that occur over successive days or weeks. Our review of the literature indicated that massage therapy may have a beneficial effect on several physiological variables, specifically salivary cortisol and heart rate, when assessed immediately pre-post massage, but is null or inconclusive for the multiple-treatment effect on physiological indices of stress.

A reduction in salivary cortisol was evident following a single massage treatment, yet salivary cortisol returns to initial values when assessed at a later time point, even if massage therapy was administered during the interim timeframe. The single-treatment effect, however, recurred as successive massage sessions also showed to be generally effective at lowering salivary cortisol. Reduction in HR was also documented immediately after massage therapy and while statistically significant, only modest reductions were reported. This effect on HR did not appear to persist for long after the massage session, but the reductions were again repeatable. It should be noted that a sizable percentage (44%) of the studies reporting HR did not detect a change in this variable. While several studies noted a reduction in BP from a single massage treatment, a greater number did not identify a significant change, although multiple-treatment effects on diastolic BP appeared to be more promising.

Hormonal variables associated with stress were largely unaffected by multiple massage treatments. Specifically, while as many as 10 massage sessions may have been administered between assessment time points, urinary measures of cortisol, epinephrine and norepinephrine were generally not affected by this treatment. However, the lack of an observed effect of massage therapy on these variables may be due to the limited variability in research study design as this variable has mostly been assessed in studies using a similar massage treatment regimen with assessment at comparable time points. No assessment of the catecholamines has been done in plasma samples with massage therapy.

Comparison of our findings with a meta-analysis conducted by Moyer et al . ( 48 ) in 2004 yielded a similar conclusion for reduction in heart rate following a single massage treatment. However, in their conclusion they did not detect a single massage session change in salivary cortisol, but did find a change for blood pressure, which contrast with our findings. In our review, we excluded studies where massage therapy was administered from a therapist without formal training as well as studies that were not published in a peer-reviewed journal. In addition, our search process yielded several studies that were not included in the Moyer et al . analysis. This variance in article inclusion likely accounts for much of the inferential differences between the reviews.

The findings that emerged from the present review, however, may say less about the true clinical effects of massage therapy on stress measures than they do about the current state of massage therapy research. In general, the studies we reviewed revealed a variety of methodological shortcomings. Although many of the studies were RCTs, several of those reports failed to include data from a control group for one or more of the selected outcome measures. Other studies using a RCT design showed statistically significant differences in outcome measures of interest between the intervention and control groups at baseline, but did not address the possible reasons for these differences (e.g. failure of the randomization process) or control for this difference in the analysis. Several studies presented results in a manner that made it difficult for the reviewers to even interpret the statistical findings. In addition, control groups in some studies were not always given an equivalent time for the control assignment such as reading, relaxation breathing or other quiet time activity. While RCTs are critical to determine the efficacy of massage therapy and other therapeutic interventions, it is equally critical that these trials be conducted with methodological rigor to ensure the validity and reliability of their results, and that these results be presented in a manner that can be clearly understood by the research community and massage therapy practitioners. Several of the studies we reviewed failed in this regard.

The studies meeting our inclusion criteria encompassed a wide variety of massage therapy interventions and an even more diverse group of subjects. The length, duration and treatment protocol were seldom justified by the study authors with regard to the specific needs of the treatment population and interventions ranged widely in both session and study duration. Subject populations ranged from healthy adults to pain patients to HIV-positive patients and victims of sexual abuse. Rarely did we find more than one study on one particular population; a healthy population was the most frequently studied. Furthermore, for those experiencing stress, most participants had been experiencing chronic stress associated with a condition they likely had for many years; populations experiencing acute stress were less frequently reported. All of these studies had relatively few participants with a range from 5 to 105 subjects (median = 30). There is no doubt that small clinical trials are important for providing proof of concept and justifying the pursuit of larger studies that can more definitively assess the effects of massage intervention on stress in a particular patient population. Unfortunately, to date, the research on massage therapy and stress has not progressed to demonstrate efficacy in a trial of sufficient size or methodological rigor to make definitive statements about its efficacy in reducing stress as measured by physiological variables in any particular patient population.

Future research efforts to examine the effectiveness of massage therapy in alleviating physiological symptoms of stress should employ methodological rigor and integrity so as to increase public and scientific confidence in the published results. Reports of statistical findings must be comprehensive and clearly presented. Massage therapy protocols should also be clearly documented for the purposes of scientific replication and differentiating the effectiveness of various interventions. Smaller studies should be conducted with an eye toward large RCTs that provide more definitive results on the effectiveness of massage therapy in alleviating stress. Ideally, these trials would test outcome measures that have clinical, not just statistical, significance; answer questions regarding efficacy of different massage therapy modalities; employ different modes of delivery (e.g. chair versus table); account for intertherapist variations and interactions between different massage therapy modalities; and thoroughly examine effects on different clinical and non-clinical populations. The findings that would emerge from these more meticulous and comprehensive research approaches would identify models that have the potential to yield more interpretable results, thus increasing confidence and validating the perceived benefits of massage therapy for stress management.

Conflict of interest: None declared.

Acknowledgements

The Massage Therapy Foundation provided financial support for this review article. The authors are especially grateful to G Hymel, A Pittas, J Balletto, A Low Choy and J Ryan for their assistance on this project.

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• Published: 23 October 2024

Gossypiboma with enterocutaneous fistula after cesarean section: a case report and review of the literature

• Leta Hinkosa Dinsa 1 ,
• Betel Bogale Workineh 1 &
• Chala Regassa Hunde 2  

Journal of Medical Case Reports volume  18 , Article number:  515 ( 2024 ) Cite this article

Metrics details

Introduction

Although precautions taken for surgical procedures are strict and effective in most operative theaters, the incidence of retained foreign bodies following surgery has a reported rate of 0.01–0.001%, of which gossypibomas make up 80% of cases.

Case presentation

A 42-year-old woman who was Oromo in ethnicity came to the hospital with symptoms of infection, including pus drainage from her lower abdominal incision, fever, chills, and weight loss. Tests indicated an intraabdominal mass consistent with a foreign body from a previous surgery. An exploratory laparotomy revealed a surgical pack causing intestinal perforations. The foreign body was removed, and the patient recovered well postoperatively.

Retained surgical items are serious problems of surgical operations that can result in morbidity and mortality. Therefore, it should be among the differential diagnoses of any abdominal pain in patients having a history of prior surgery.

Peer Review reports

A gossypiboma is a mass of cotton sponge accidentally left in a body cavity after a surgical procedure. It may not be possible to estimate the exact incidence of gossypiboma, owing to the reluctance to report any such case to avoid legal implications. Although precautions taken for surgical procedures are strict and effective in most operative theaters, the incidence of retained foreign bodies following surgery has a reported rate of 0.01–0.001%, of which gossypibomas make up 80% of cases [ 2 , 3 ]. They are most commonly diagnosed in the intraabdominal cavity. Other documented locations include the chest, extremities, central nervous system, and breast [ 4 ]. The reported incidence of gossypiboma after intraabdominal operations is 1 per 1000–1500. Most gossypibomas occur at intraabdominal operations, the majority from gynecological surgery but rarely from cesarean section [ 5 ].

It can be asymptomatic or can have variable presentations. When it is symptomatic, it will present with obstruction, peritonitis, adhesions, fistula, abscess formations, and erosion into the gastrointestinal tract to present as intestinal obstruction or even pass via the rectum [ 6 ]. The clinical presentation of a gossypiboma may include nonspecific symptoms, such as abdominal pain, nausea, vomiting, anorexia, constipation, and weight loss [ 5 ]. Complications of gossypiboma include bowel perforation, obstruction, peritonitis, adhesion, abscess, fistula, and migration of the surgical sponge into the bowel [ 7 ].

We report here a case who presented with a history of pus discharging through the umbilicus for 9 months. She revealed a history of cesarean section 11 months prior.

A 42-year-old woman who is Oromo in ethnicity came to the hospital with a concerning issue. She had undergone an emergency hysterectomy due to a ruptured uterus from obstructed labor at Wolegga University referral hospital, Nekemte, Ethiopia, in the past and was now experiencing pus drainage from her lower abdominal incision, accompanied by a foul smell. Additionally, she had been dealing with fever, chills, rigors, lower abdominal pain, loss of appetite, and weight loss for the past 5 months.

Despite her vital signs being within normal ranges, a physical examination revealed offensive pus drainage from the lower abdominal incision site and mild tenderness, without any palpable mass. Further tests showed signs of infection, including leukocytosis and low hemoglobin levels. Abdominal sonography indicated the presence of a complex intraabdominal mass consistent with a foreign body. As a result, an exploratory laparotomy was performed, during which a surgical pack from the previous hysterectomy was found to have caused adhesions and multiple perforations in the small intestine. The foreign body was removed, a part of the affected small intestine was excised, and the healthy sections were reconnected. Fortunately, the patient had an uneventful postoperative recovery.

On examination, she was in pain with the following vital signs: pulse rate of 118 bpm, blood pressure of 98/64 mmHg, and temperature of 37.5 °C. She had mild pale conjunctivae, anicteric sclera, and wet oral mucosa. Her chest was clear and resonant.

On the abdomen, there was a healed lower abdominal transverse wound, offensive pus draining through the umbilicus with fecal matter odor, mild lower abdominal tenderness, and a doughy-feeling left lower quadrant mass. Her complete blood count yield was leukocytosis of neutrophil predominance and hemoglobin of 8.9 mg/dl. The ultrasound finding was an ill-defined echo complex mass at the left lower quadrant area with an abscess.

Exploratory laparotomy was done at Arjo Primary Hospital, and a foreign body (surgical pack) left during previous CS was found causing severe inflammatory adhesion and multiple holes in the small intestine (Fig.  1 ). Gossypium with enterocutaneous fistula was the intraoperative diagnosis. About 2 m of small intestine with multiple fistula tracts was resected, and end-to-end ileo-ileal anastomosis was done (Fig.  2 ).

The removed surgical sponge at Jimma Arjo Primary Hospital, 2023 (surgical pack)

Resected small intestine with multiple fistula tracts at Jimma Arjo Primary Hospital, 2023

She had a smooth postoperative period and was discharged without any sequelae. On follow-up, she was seen as nutritionally improved and doing well.

The patient has no history of medical problems such as diabetes mellitus, hypertension, cardiac, or renal problems.

Here, we report the case of a rarely occurring gossypiboma following a cesarean section.

Gossypiboma can occur at almost any operative site; however, the intraperitoneal cavity is reported to be the most frequent site of occurrence, as we also observed in our patients. Its incidence is 1 in 100–5000 of all surgical procedures and 1 in 1000–1500 in all intraabdominal operations [ 8 ]. Blood loss of more than 500 ml, uncontrolled hemorrhage, emergency surgery, high body mass index, long operations, more than one subprocedure, more than one surgical team, change of operating surgeon, unexpected intraoperative findings, an unexpected change in surgical procedure, lack of surgical counts, and incorrect counts are some of the risk factors associated with an increased chance for unintentionally retained surgical items [ 1 , 8 ].

There are two types of pathophysiological foreign body reactions associated with gossypibomas. The first one is a fibrous aseptic inflammatory reaction and adhesion that encapsulates the gossypiboma in the omentum and surrounding organs. The second one is an exudative inflammatory reaction leading to an abscess or fistula formation. In our case, an enterocutaneous fistula developed to approximately 2 m of small intestine [ 4 , 9 ].

Clinical features in patients with gossypiboma are nonspecific and may present many decades after the surgery. A patient with previous abdominal surgery who presents later with abdominal pain, nausea, vomiting, fever, anorexia weight loss, a palpable mass, rectal bleeding or an altered bowel habit, and features of intestinal obstruction or malabsorption syndrome should be suspected to have abdominal gossypiboma [ 4 , 10 ]. The interval between the previous procedures and the present diagnosis of intraabdominal gossypiboma ranged from 2 months to 40 years. In our case, gossypiboma was diagnosed 11 months after the attributable operation [ 11 ].

The palpable mass in the abdomen may be confused with a soft tissue tumor according to its location [ 8 ]. Magnetic resonance imaging, ultrasound, and radiography have all been used to diagnose gossypiboma, but computed tomography scans have emerged as the most reliable. The ultrasound feature is usually a well-defined mass containing a wavy internal echogenic focus with a hypoechoic rim and a strong posterior shadow, as in our case [ 1 , 11 ].

Once diagnosed, gossypiboma can be removed using either open or laparoscopic surgery. Endoscopy is used to remove a foreign body that has transmurally migrated to the stomach or colon. [ 9 ]. Endoscopic and laparoscopic approaches may be successful; however, when there is the possibility of erosion or a fistula arising from a retained gauze pad, an “open” approach is usually required. Our case was complicated with severe inflammatory adhesion and multiple holes in the small intestine, so we used the open approach to remove the gossypiboma, resect 2 m of small intestine with multiple fistula tracts, and perform end-to-end ileo-ileal anastomosis. When the item is located early in the postoperative course, the minimally invasive surgical procedure appears to be the most successful [ 1 ].

Hence, we report a rare case of gossypiboma following a cesarean section conducted at Wolegga University referral hospital.

Care process improvement, standardized count protocols, deliberate wound exploration before closure, and resolving of count discrepancies are used as prevention strategies. Radiographic screening, and technological adjuncts where available, such as counting, detection devices, as well as multiple counting are also used [ 12 ]. To support manual counting, techniques using a radiofrequency wand and mat resulted in surgical sponge detection accuracy of 100% and 98.1%, respectively. In light of this, the body of evidence supported the application of technology with manual surgical counts to reduce unintentional retention of surgical items [ 13 ].

Limitations include the lack of complete laboratory investigations as well as the lack of clear patient photos, such as imaging photos.

As every case of gossypiboma is unique, it is a diagnostic challenge and has medico-legal implications. Despite its rarity, it has morbidity and mortality consequences. Therefore, for any patient presenting postoperatively with signs and symptoms of infection, pain, or palpable mass in the abdomen, the possibility of a retained foreign body should always be ruled out. To prevent gossypiboma, sponges are counted by hand before and after surgeries. The application of technology with manual surgical counts is also recommended.

Availability of data and materials

The datasets used are available from the corresponding author on request.

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Department of Midwifery, Wolegga University, Nekemte, Oromia Regional State, Ethiopia

Leta Hinkosa Dinsa & Betel Bogale Workineh

Department of Surgery, Wolegga University, Nekemte, Oromia Regional State, Ethiopia

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Leta Hinkosa Dinsa—Study design, execution, acquistion, data analysis, and interpretations. Betel Bogale Workineh—drafting and revising, Chala Regassa Hunde–Final approving of the case report.

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Correspondence to Leta Hinkosa Dinsa .

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Dinsa, L.H., Workineh, B.B. & Hunde, C.R. Gossypiboma with enterocutaneous fistula after cesarean section: a case report and review of the literature. J Med Case Reports 18 , 515 (2024). https://doi.org/10.1186/s13256-024-04783-x

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Received : 22 February 2024

Accepted : 08 August 2024

Published : 23 October 2024

DOI : https://doi.org/10.1186/s13256-024-04783-x

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