Factors influencing the quality of clinical trials on traditional Chinese medicine— Qualitative interviews with trial auditors, clinicians and academic researchers

Journal article

Xue-yan Han, Xun Li, Ning Liang, Yuqian Yan, Ying Wang, Yutong Fei, Ying Zhang, Robinson, N. and Jian-Ping Liu (2019). Factors influencing the quality of clinical trials on traditional Chinese medicine— Qualitative interviews with trial auditors, clinicians and academic researchers. Complementary Therapies in Clinical Practice. 37, pp. 109-114. https://doi.org/10.1016/j.ctcp.2019.09.004
AuthorsXue-yan Han, Xun Li, Ning Liang, Yuqian Yan, Ying Wang, Yutong Fei, Ying Zhang, Robinson, N. and Jian-Ping Liu
Abstract

Background: As clinical trials evaluating the efficacy of traditional Chinese medicine (TCM) therapies have increased, several empirical studies have shown that the quality of TCM trials are generally low in terms of risk of bias. This qualitative study aimed to investigate the
factors influencing the quality of TCM clinical trials to provide strategic advice on trial quality improvement.
Methods: One focus group with clinical trial auditors (n=4) and six indepth semi-structured interviews with clinical research organization managers (n=2), lecturers and researchers in TCM academic institutions (n=2), a chief physician in a TCM oncology department and a PhD
candidate specialized in non-pharmaceutical TCM interventions were conducted. The interviews were audio-recorded, transcribed verbatim and thematically analyzed.
Results: Factors that influenced the quality of TCM clinical trials merged on the following 6 themes: trial design; trialists/ participants; trial conducting; TCM specified problems; trial monitoring, and finally societal influences. The lack of expertise and time inputs of the trialists were repeatedly mentioned. Methodological difficulties experienced when conducting TCM trials included calculating sample size, analyzing
the efficacy of TCM decoctions with multiple ingredients, blinding in trials investigating non-pharmaceutical TCM interventions were highlighted. Interviewees agreed that third-party monitoring can help improving trial quality and improved participant welfare and may accelerate recruiting processes and increase compliance; however more comprehensive regulations and funding requirements would be needed.
Conclusions: This study identified real-life issues influencing the quality of TCM clinical trials from design to reporting. In addition to mandatory training for TCM trial designers and coordinators, more effective
institutional oversight is required. Future studies should explore specific measures to address the methodological problems in TCM trials and explore how the quality of TCM trials can affect further evidence synthesis and clinical practice.

KeywordsTraditional Chinese Medicine (TCM); Clinical trial quality; Randomized Controlled Trials; Qualitative Research; Influencing factors
Year2019
JournalComplementary Therapies in Clinical Practice
Journal citation37, pp. 109-114
PublisherElsevier
ISSN1873-6947
Digital Object Identifier (DOI)https://doi.org/10.1016/j.ctcp.2019.09.004
Funder/ClientNational Natural Science Foundation of China
Ministry of Education of China
Publication dates
Online13 Sep 2019
PrintNov 2019
Publication process dates
Accepted13 Sep 2019
Deposited03 Oct 2019
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Women’s health and Chinese integrative medicine
Qu, F, Wang, FF, Robinson, N. and Hardiman, P (2017). Women’s health and Chinese integrative medicine. Journal of Zhejiang University: Science B. 18 (3), pp. 183-185. https://doi.org/10.1631/jzus.B17ed001
TRANSCUTANEOUS ELECTRICAL ACUPOINT STIMULATION IMPROVES THE OUTCOMES OF IN VITRO FERTILIZATION: A PROSPECTIVE, RANDOMIZED AND CONTROLLED STUDY
Qu, F, Wang, F-F, Wu, Y, Zhou, J, Robinson, N., Hardiman, P, Pan, J-X, He, Y-J, Zhu, Y-H, Wang, H-Z, Ye, X-Q, He, K-L, Cui, L, Zhao, H-L and Ye, Y-H (2017). TRANSCUTANEOUS ELECTRICAL ACUPOINT STIMULATION IMPROVES THE OUTCOMES OF IN VITRO FERTILIZATION: A PROSPECTIVE, RANDOMIZED AND CONTROLLED STUDY. Explore: The Journal of Science & Healing. 13 (5), pp. 306-312. https://doi.org/10.1016/j.explore.2017.06.004
The effects of acupuncture on polycystic ovary syndrome: A systematic review and meta-analysis
Qu, F., Yan, W., Hu, X-Y., Barry, J.A., Zhou, J., Wang, F-F., Ye, Y-H., Han, S-P., Li, R., Taw, M.B., Hardiman, P.J. and Robinson, N. (2016). The effects of acupuncture on polycystic ovary syndrome: A systematic review and meta-analysis. European Journal of Integrative Medicine. 8 (1), pp. 12-18. https://doi.org/10.1016/j.eujim.2016.02.001
The role of complementary and alternative medicine (CAM) in sexual and reproductive health
Qidwai, W, Wong, W, Nanji, K and Robinson, N. (2016). The role of complementary and alternative medicine (CAM) in sexual and reproductive health. European Journal of Integrative Medicine. 8 (1), pp. 1-3. https://doi.org/10.1016/j.eujim.2016.02.003
The Importance of Evidence for the Integration of Traditional and Complementary Medicine into Western Healthcare?
Robinson, N. (2016). The Importance of Evidence for the Integration of Traditional and Complementary Medicine into Western Healthcare? World Journal of Traditional Chinese Medicine. 2 (1), pp. 74 - 79. https://doi.org/10.15806/j.issn.2311-8571.2015.0029
Harmonising data collection from osteoarthritis studies to enable stratification: Recommendations on core data collection from an Arthritis Research UK clinical studies group
Kingsbury, SR, Corp, N, Watt, FE, Felson, DT, O'Neill, TW, Holt, CA, Jones, RK, Conaghan, PG, Arden, NK, Adams, J, Appleyard, I, Birrell, F, Blank, M, Callaghan, MJ, Cumming, J, Chapman, GJ, Halstead, J, Hamilton, DF, Hurley, M, Martin, K, Mason, DJ, Nuki, G, Redmond, AC, Reilly, K, Robinson, N., Roddy, E, Simpson, H, Smith, TO, Thomas, C, Thomas, E, Wilkinson, J and Wise, E (2016). Harmonising data collection from osteoarthritis studies to enable stratification: Recommendations on core data collection from an Arthritis Research UK clinical studies group. Rheumatology (United Kingdom). 55 (8), pp. 1394-1402. https://doi.org/10.1093/rheumatology/kew201
Introducing “Evidence for clinical practice” [Editorial]
Alper, BS, Malone-Moses, M, Manheimer, EW and Robinson, N. (2016). Introducing “Evidence for clinical practice” [Editorial]. European Journal of Integrative Medicine. 8 (3), pp. 147-149. https://doi.org/10.1016/j.eujim.2016.04.008
Pediatric integrative medicine needs research evidence to guide decision-making
Gardiner, P and Robinson, N. (2016). Pediatric integrative medicine needs research evidence to guide decision-making. European Journal of Integrative Medicine. 8 (2), pp. 79 - 80. https://doi.org/10.1016/j.eujim.2016.03.015
Bromelain and Cardiovascular Risk Factors in Diabetes: An Exploratory Randomized, Placebo Controlled, Double Blind Clinical Trial
Ley, C., NI, Q, Liao, X, Gao, H-L and Robinson, N. (2016). Bromelain and Cardiovascular Risk Factors in Diabetes: An Exploratory Randomized, Placebo Controlled, Double Blind Clinical Trial. Chinese Journal of Integrative Medicine. 22 (10), pp. 728-737. https://doi.org/10.1007/s11655-016-2521-2
General Practitioners’ use of and attitudes to acupuncture in relation to the UK’s National Institute for Health and Care Excellence (NICE) clinical guidelines—A pilot study
Czarnawska-Iliev, I and Robinson, N. (2016). General Practitioners’ use of and attitudes to acupuncture in relation to the UK’s National Institute for Health and Care Excellence (NICE) clinical guidelines—A pilot study. European Journal of Integrative Medicine. 8 (4). https://doi.org/10.1016/j.eujim.2016.07.004
Evidence is in the Eye of the Beholder: The case of the 2016 draft NICE Guidelines for Low Back Pain [editorial]
Hopper Koppelman, M, Bovey, M and Robinson, N. (2016). Evidence is in the Eye of the Beholder: The case of the 2016 draft NICE Guidelines for Low Back Pain [editorial]. European Journal of Integrative Medicine. 8 (4).
Common mistakes when using plant names and how to avoid them
Dauncey, EA, Irving, J, Allkin, R and Robinson, N. (2016). Common mistakes when using plant names and how to avoid them. European Journal of Integrative Medicine. 8 (5), pp. 597-601. https://doi.org/10.1016/j.eujim.2016.09.005
Integrating acupuncture: are there positive health outcomes for women?
Robinson, N. (2016). Integrating acupuncture: are there positive health outcomes for women? Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology). 18 (3), pp. 233-238. https://doi.org/10.1631/jzus.B1600260
Is traditional Chinese medicine recommended in Western medicine clinicalpractice guidelines in China? A systematic analysis.
Ren, J, Xun, Li, Sun,, J, Han, M, Yang, G-Y., Li, W-Y., Robinson, N. and Lewith, G. (2015). Is traditional Chinese medicine recommended in Western medicine clinicalpractice guidelines in China? A systematic analysis. BMJ Open. 5 (6), pp. e006572-e006572. https://doi.org/10.1136/bmjopen-2014-006572
Traditional Chinese Medicine - challenges for research
Robinson, N. (2015). Traditional Chinese Medicine - challenges for research. in: McCarthy, P.W. and Langweiler, M. (ed.) Methodologies for Effectively Assessing Complementary and Alternative Medicine (CAM) London Singing Dragon.
Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study
Trevelyan, EG, Turner, WA, Summerfield-Mann, L and Robinson, N. (2015). Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study. Trials. 16, p. 158. https://doi.org/10.1186/s13063-015-0668-3
The politics of integrative medicine: The case of CAM
Saks, M and Robinson, N. (2015). The politics of integrative medicine: The case of CAM. European Journal of Integrative Medicine. 7 (6), pp. 557-560. https://doi.org/10.1016/j.eujim.2015.11.019
GAP: From sound design to practical implementation in clinical trials for traditional chinese medicine
Shang, H, Zhang, B, Bian, Z, Li, Y, Clarke, M and Robinson, N (2014). GAP: From sound design to practical implementation in clinical trials for traditional chinese medicine. Evidence-based Complementary and Alternative Medicine. 2014, pp. 1-2. https://doi.org/10.1155/2014/560838
The quest for modernisation of traditional Chinese medicine
Xu, Q, Bauer, R, Hendry, BM, Fan, TP, Zhao, Z, Duez, P, Simmonds, MSJ, Witt, CM, Lu, A, Robinson, N, Guo, DA and Hylands, PJ (2013). The quest for modernisation of traditional Chinese medicine. BMC Complementary and Alternative Medicine. 13 (1), pp. 132-. https://doi.org/10.1186/1472-6882-13-132
A systematic review of experimental and clinical acupuncture in chemotherapy-induced peripheral neuropathy.
Franconi, G, Manni, L, Schröder, S, Marchetti, P and Robinson, N. (2013). A systematic review of experimental and clinical acupuncture in chemotherapy-induced peripheral neuropathy. Evidence-Based Complementary and Alternative Medicine (eCAM). 2013, p. 516916. https://doi.org/10.1155/2013/516916
The evidence for Shiatsu: A systematic review of Shiatsu and acupressure
Robinson, N, Lorenc, A and Liao, X (2011). The evidence for Shiatsu: A systematic review of Shiatsu and acupressure. BMC Complementary and Alternative Medicine. 11 (1), pp. 88-. https://doi.org/10.1186/1472-6882-11-88
The RCCM 2009 survey: Mapping doctoral and postdoctoral CAM research in the United Kingdom
Robinson, N and Lewith, G (2011). The RCCM 2009 survey: Mapping doctoral and postdoctoral CAM research in the United Kingdom. Evidence-based Complementary and Alternative Medicine. 2011, pp. 1-4. https://doi.org/10.1093/ecam/nep184
How parents choose to use CAM: A systematic review of theoretical models
Lorenc, A, Ilan-Clarke, Y, Robinson, N and Blair, M (2009). How parents choose to use CAM: A systematic review of theoretical models. BMC Complementary and Alternative Medicine. 9 (1), pp. 9-. https://doi.org/10.1186/1472-6882-9-9