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Rheumatology
Research
Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis
  1. Xin Pan1,
  2. Maria A Lopez-Olivo2,
  3. Juhee Song3,
  4. Gregory Pratt4,
  5. Maria E Suarez-Almazor2
  1. 1Department of Rheumatology, Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
  2. 2Department of General Internal Medicine, Rheumatology Section, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  3. 3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  4. 4Research Medical Library, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  1. Correspondence to Professor Maria E Suarez-Almazor; msalmazor{at}mdanderson.org

Abstract

Objectives We appraised the methodological and reporting quality of randomised controlled clinical trials (RCTs) evaluating the efficacy and safety of Chinese herbal medicine (CHM) in patients with rheumatoid arthritis (RA).

Design For this systematic review, electronic databases were searched from inception until June 2015. The search was limited to humans and non-case report studies, but was not limited by language, year of publication or type of publication. Two independent reviewers selected RCTs, evaluating CHM in RA (herbals and decoctions). Descriptive statistics were used to report on risk of bias and their adherence to reporting standards. Multivariable logistic regression analysis was performed to determine study characteristics associated with high or unclear risk of bias.

Results Out of 2342 unique citations, we selected 119 RCTs including 18 919 patients: 10 108 patients received CHM alone and 6550 received one of 11 treatment combinations. A high risk of bias was observed across all domains: 21% had a high risk for selection bias (11% from sequence generation and 30% from allocation concealment), 85% for performance bias, 89% for detection bias, 4% for attrition bias and 40% for reporting bias. In multivariable analysis, fewer authors were associated with selection bias (allocation concealment), performance bias and attrition bias, and earlier year of publication and funding source not reported or disclosed were associated with selection bias (sequence generation). Studies published in non-English language were associated with reporting bias. Poor adherence to recommended reporting standards (<60% of the studies not providing sufficient information) was observed in 11 of the 23 sections evaluated.

Limitations Study quality and data extraction were performed by one reviewer and cross-checked by a second reviewer. Translation to English was performed by one reviewer in 85% of the included studies.

Conclusions Studies evaluating CHM often fail to meet expected methodological criteria, and high-quality evidence is lacking.

  • Chinese herbal medicine
  • Quality of randomized controlled trials
  • Traditional Chinese medicine
  • Systematic review
  • Rheumatoid arthritis

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-013242

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    Footnotes

    • Twitter Follow Maria Suarez-Almazor @msalmazor

    • Contributors MES-A had full access to all of the data in the study and takes responsibility for the integrity and the accuracy of the data analysis. MES-A and MAL-O conceptualised and designed the study. GP and Geng were responsible for the search strategy. XP, Nayak and MAL-O were responsible for selection of the studies. XP, MAL-O contributed in quality appraisal and data extraction. JS, XP, MAL-O and MES-A analysed and interpreted the data. XP, MAL-O, JS and MES-A drafted the manuscript. XP, MAL-O, JS, GP and MES-A critically revised the manuscript for important intellectual content. MES-A provided administrative, technical or material support and supervised the study.

    • Funding The statistical analysis in this research (through the Biostatistics Resource Group) was supported in part by a Cancer Center Support Grant from the National Cancer Institute (P30CA016672) to the University of Texas MD Anderson Cancer Center.

    • Competing interests We have read and understood the BMJ Open policy on declaration of interests and declare the following interests: (1) MES-A was the recipient of a K24 career award from the National Institute for Musculoskeletal and Skin Disorders; (2) XP's work is supported by the Shanghai Municipal Education Commission and the Shanghai Shuguang Hospital, Shanghai University of TCM and (3) MAL-O is the recipient of a career award from the Rheumatology Research Foundation and has received a consulting fee from Complete HEOR Solutions outside the scope of the submitted work. All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.