A scoping review of cohort studies assessing traditional Chinese medicine interventions

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Abstract

Backgrounds

Identifying topics and assessing the reporting quality of Traditional Chinese Medicine (TCM) cohort studies.

Methods

A scoping review of the literature was performed. A descriptive approach to summarize the core study characteristics was prepared, along with structured tables and figures to identify salient points of differences noted across studies. The reporting quality of TCM cohort studies was assessed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)-cohort checklist.

Results

A total of 199 TCM cohort studies were included. The largest number of TCM cohort studies was conducted in Mainland China (70.9%). The TCM cohort study was first published in 2003. The top three diseases studied were Acquired Immune Deficiency Syndrome (AIDS), Stroke, and Asthma. As for the intervention methods, Chinese herbal medicine formulas (60.3%), acupuncture (14.1%) and single herbs (12.6%) accounted for the majority, followed by moxibustion (4.0%) and qigong (2.0%). The overage sufficient reporting rate of included TCM cohort studies according to the STROBE-cohort checklist was 42.9%. Comparing with Chinese literature, the reporting rates of English literature in most items were higher.

Conclusion

For the application of cohort studies to inform the effects of TCM interventions, the interventions assessed and conditions studied were diverse, the reporting quality was unsatisfied.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12906-020-03150-9.

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Most cited references 14

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The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

Erik von Elm, Douglas G. Altman, Matthias Egger … (2008)

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles.18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies.A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies

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Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

Lawrence Blonde, Kamlesh Khunti, Stewart B Harris … (2018)

Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold standard” for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice. Funding : Sanofi US, Inc.

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The risk of bias in observational studies of exposures (ROBINS-E) tool: concerns arising from application to observational studies of exposures

Lisa Bero, Nicholas Chartres, Joanna Diong … (2018)

Background Systematic reviews, which assess the risk of bias in included studies, are increasingly used to develop environmental hazard assessments and public health guidelines. These research areas typically rely on evidence from human observational studies of exposures, yet there are currently no universally accepted standards for assessing risk of bias in such studies. The risk of bias in non-randomised studies of exposures (ROBINS-E) tool has been developed by building upon tools for risk of bias assessment of randomised trials, diagnostic test accuracy studies and observational studies of interventions. This paper reports our experience with the application of the ROBINS-E tool. Methods We applied ROBINS-E to 74 exposure studies (60 cohort studies, 14 case-control studies) in 3 areas: environmental risk, dietary exposure and drug harm. All investigators provided written feedback, and we documented verbal discussion of the tool. We inductively and iteratively classified the feedback into 7 themes based on commonalities and differences until all the feedback was accounted for in the themes. We present a description of each theme. Results We identified practical concerns with the premise that ROBINS-E is a structured comparison of the observational study being rated to the ‘ideal’ randomised controlled trial. ROBINS-E assesses 7 domains of bias, but relevant questions related to some critical sources of bias, such as exposure and funding source, are not assessed. ROBINS-E fails to discriminate between studies with a single risk of bias or multiple risks of bias. ROBINS-E is severely limited at determining whether confounders will bias study outcomes. The construct of co-exposures was difficult to distinguish from confounders. Applying ROBINS-E was time-consuming and confusing. Conclusions Our experience suggests that the ROBINS-E tool does not meet the need for an international standard for evaluating human observational studies for questions of harm relevant to public and environmental health. We propose that a simpler tool, based on empirical evidence of bias, would provide accurate measures of risk of bias and is more likely to meet the needs of the environmental and public health community.

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Author and article information

Contributors

Zhaoxiang Bian:

ORCID: http://orcid.org/0000-0001-6206-1958

bianzxiang@gmail.com

Journal

Journal ID (nlm-ta): BMC Complement Med Ther

Journal ID (iso-abbrev): BMC Complement Med Ther

Title: BMC Complementary Medicine and Therapies

Publisher: BioMed Central (London )

ISSN (Electronic): 2662-7671

Publication date (Electronic): 23 November 2020

Publication date PMC-release: 23 November 2020

Publication date Collection: 2020

Volume: 20

Electronic Location Identifier: 361

Affiliations

[1 ]GRID grid.221309.b, ISNI 0000 0004 1764 5980, Hong Kong Chinese Medicine Clinical Study Center, School of Chinese Medicine, , Hong Kong Baptist University, ; 3/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Hong Kong, SAR China

[2 ]Chinese EQUATOR Center, Hong Kong, SAR China

[3 ]GRID grid.411866.c, ISNI 0000 0000 8848 7685, Medical College of Acu-Moxi and Rehabilitation, , Guangzhou University of Chinese Medicine, ; Guangzhou, China

[4 ]Puning Traditional Chinese Medicine Hospital, Jieyang, China

[5 ]GRID grid.465583.9, ISNI 0000 0004 4671 245X, American Academy of Acupuncture and Oriental Medicine, ; Roseville, Minnesota USA

[6 ]GRID grid.10784.3a, ISNI 0000 0004 1937 0482, School of Chinese medicine, , The Chinese University of Hong Kong, ; Hong Kong, SAR China

Author information

Zhaoxiang Bian http://orcid.org/0000-0001-6206-1958

Article

Publisher ID: 3150

DOI: 10.1186/s12906-020-03150-9

PMC ID: 7684743

PubMed ID: 33228628

SO-VID: 300c299d-49ee-42a1-8997-aa0adabb9e75

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 23 April 2020

Date accepted : 9 November 2020

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Keywords: scoping review,cohort studies,traditional chinese medicine,reporting quality,evidence-based medicine

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Keywords: scoping review, cohort studies, traditional chinese medicine, reporting quality, evidence-based medicine

A scoping review of cohort studies assessing traditional Chinese medicine interventions

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Most cited references 14

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

The risk of bias in observational studies of exposures (ROBINS-E) tool: concerns arising from application to observational studies of exposures

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