Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2006, Vol. 4 ›› Issue (2): 120-129.doi: 10.3736/jcim20060204

• Review • Previous Articles     Next Articles

Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅰ: Clinical trial design and methodology

Zhao-xiang Bian1, You-ping Li2, David Moher3, Simon Dagenais3, Liang Liu1, Tai-xiang Wu2, Jiang-xia Miao4, Andrew K.L. Kwan1, Lisa Song1   

  1. 1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
    2. Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    3. Chalmers Research Group, Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    4. School of Chinese Medicine, Chinese University of Hong Kong, Hong Kong SAR, China
  • Online:2006-03-20 Published:2006-03-15


To discuss the quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) with respect to design and methodology, and provide suggestions for further improvement in future clinical trials.


A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i.e. herb preparation form and quality control of herbs).


The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6%) trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6%) trials. Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4% mentioned allocation concealment. The vast majority (86.8%) of trials were open-label, while only 13.2% used blinding. Almost half (45.5%) administered the CHM intervention as a tea or decoction. Only one trial (0.6%) reported a sample size calculation, and a single trial (0.6%) discussed quality control of the CHM intervention.


The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area. Recommendations: (1) Investigator conducting RCTs should have formal training about clinical trial design; (2) A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3) Conducting pilot studies prior to RCTs may help improve their design; (4) Registration of clinical trials and publishing their protocols prior to enrolment may reduce publication bias and solicit peer reviews of the proposed design; (5) Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.

Key words: Randomized controlled trial, Chinese herbal medicine, Methodology, Quality assessment

CLC Number: 

  • R-3

Table 1

Included Cochrane Library systematic reviews about Chinese herbal medicine"

Table 2

Excluded Cochrane Library systematic reviews about Chinese herbal medicine"

Table 3

Checklist of RCTs with Chinese herbal medicine"

Table 4

Basic characteristics of included RCTs"

Figure 1

Flow chart of design of clinical trial"

[1] Moher D, Soeken K, Sampson M , et al. Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine[J]. BMC Pediatr, 2002,2(1):3
[2] Linde K, ter Riet G, Hondras M , et al.Systematic reviews of complementary therapies—an annotated bibliography. Part 2: Herbal medicine[J].BMC Complement Altern Med, 2001, 1(): 5
[3] Liu JP, Kjaergard LL, Gluud C . Misuse of randomization: a review of Chinese randomized trials of herbal medicines for chronic hepatitis B[J]. Am J Chin Med, 2002,30(1):173-176
[4] Linde K, Jonas WB, Melchart D , et al. The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture[J]. Int J Epidemiol, 2001,30(3):526-531
[5] Sackett DL, Straus SE, Richardson WS, et al.Evidence-based medicine: how to practice and teach EBM( 2nd ed) [M].London: Churchill Livingstone , 1997,( 2nd ed):
[6] Schultz KF, Chalmers I, Hayes RJ , et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995,273(5):408-412
[7] Moher D, Pham B, Jones A , et al. Does quality of reports of randomized trials affect estimates of intervention efficacy reported in meta-analyses?[J]. Lancet, 1998,352(9128):609-613
[8] Moher D . CONSORT: an evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials[J]. JAMA, 1998,279(18):1489-1491
[9] Moher D, Cook DJ, Jadad AR , et al.Assessing the quality of reports of randomized trials: implications for the conduct of meta-analyses[J].Health Technol Assess, 1999, 3(12):i- iv, 1-98
[10] Altman DG, Schulz KF, Moher D , et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration[J]. Ann Intern Med, 2001,134(8):663-694
pmid: 11304107
[11] Chang ZQ, Chang XY . Clinical observation of integrated traditional Chinese and western medicine in treatment of diabetes[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 1998,18(11):674-676
[12] Schulz KF, Grimes DA . Sample size calculations in randomized trials: mandatory and mystical[J]. Lancet, 2005,365(9467):1348-1353
doi: 10.1016/S0140-6736(05)61034-3 pmid: 15823387
[13] Friedman LM, Furberg CD, DeMets DL.Fundamentals of clinical trials( 3rd ed) [M].New York: Spring Verlag , 1998,( 3rd ed):
[14] Freiman JA, Chalmers TC, Smith H Jr , et al. The importance of beta, the type Ⅱ error and sample size in the design and interpretation of the randomized control trial. Survey of 71 “negative” trials[J]. N Engl J Med, 1978,299(13):690-694
[15] Moher D, Dulberg CS, Wells GA . Statistical power, sample size, and their reporting in randomized controlled trials[J]. JAMA, 1994,272(2):122-124
doi: 10.1097/00008506-199501000-00018 pmid: 8015121
[16] Montenegro R, Needleman I, Moles D , et al. Quality of RCTs in periodontology—a systematic review[J]. J Dent Res, 2002,81(12):866-870
doi: 10.1063/1.1648631 pmid: 12454104
[17] Harrison JE . Clinical trials in orthodontics Ⅱ: assessment of the quality of reporting of clinical trials published in three orthodontic journals between 1989 and 1998[J]. J Orthod, 2003,30(4):309-315
[18] Schulz KF, Grimes DA . Unequal group sizes in randomized trials: guarding against guessing[J]. Lancet, 2002,359(9310):966-970
doi: 10.1016/S0140-6736(02)08029-7 pmid: 11918933
[19] Schulz KF. Grimes DA . Generation of allocation sequences in randomized trials: chance, not choice[J]. Lancet, 2002,359(9305):515-519
doi: 10.1016/S0140-6736(02)07683-3 pmid: 11853818
[20] .[ OTHER].Kjaergard LL, Villumsen J, Gluud C . Quality of randomized clinical trials affects estimates of intervention efficacy. 7th Annual Cochrane Colloquium Abstracts. Rome: 1999.
[21] Juni P, Altman D, Egger M . Systematic review in health care: Assessing the quality of controlled trials[J]. BMJ, 2001,323(7303):42-46
doi: 10.1136/bmj.323.7303.42 pmid: 11440947
[22] Schulz KF, Grimes DA . Allocation concealment in randomized trials: defending against deciphering[J]. Lancet, 2002,359(9306):614-618
doi: 10.1016/S0140-6736(02)07750-4 pmid: 11867132
[23] Schulz KF . Assessing allocation concealment and blinding in randomized controlled trials: Why bother?[J]. ACP J Club, 2000,132(2):A11-A12
doi: 10.2746/042516405774479979 pmid: 10750446
[24] Schulz KF, Grimes DA . Blinding in randomized trials: hiding who got what[J]. Lancet, 2002,359(9307):697-700
doi: 10.1016/S0140-6736(02)07816-9 pmid: 11879884
[25] Kaptchuk TJ . Intentional ignorance: a history of blind assessment and placebo controls in medicine[J]. Bull Hist Med, 1998,72(3):389-433
doi: 10.1353/bhm.1998.0159 pmid: 9780448
[26] Latronico N, Botteri M, Minelli C , et al. Quality of reporting of randomized controlled trials in the intensive care literature. A systematic analysis of papers published in Intensive Care Medicine over 26 years[J]. Intensive Care Med, 2002,28(9):1316-1323
[27] De Angelis, Drazen JM, Frizelle FA , et al. Clinical Trial Registration: A statement from the International Committee of Medical Journal Editors[J]. Croat Med J, 2004,45(5):531-532
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[4] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[5] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[6] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[7] Fabiana de Almeida Andrade, Caio Fabio Schlechta Portella. Research methods in complementary and alternative medicine: An integrative review. Journal of Integrative Medicine, 2018, 16(1): 6-13.
[8] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[9] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[10] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[11] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[12] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[13] Tom Fleischer, Tung-Ti Chang, Hung-Rong Yen. Post-hematopoietic stem cell transplantation in patients with hematologic disorders: Chinese herbal medicine for an unmet need. Journal of Integrative Medicine, 2016, 14(5): 322-335.
[14] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[15] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
Full text



[1] Xue-mei Liu, Qi-fu Huang, Yun-ling Zhang, Jin-li Lou, Hong-sheng Liu, Hong Zheng. Effects of Tribulus terrestris L. saponion on apoptosis of cortical neurons induced by hypoxia-reoxygenation in rats. Journal of Chinese Integrative Medicine, 2008, 6(1): 45-50
[2] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[3] A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H22 cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[4] Bing Hu , Hong-mei An , Ke-ping Shen , Qin Du. Senescence-inducing effects of Chinese herbal medicine Tenglong Buzhong Decoction on human colon carcinoma LS-174-T cells and the mechanism. Journal of Chinese Integrative Medicine, 2010, 8(11): 1048-1052
[5] Ya-bing Zhou, Jian-er Yu, Jie Wu, Li Bai, Li-li Huo, Xin-guang Zhang, Li-qing Li . Effects of Chinese herbal medicine Bushen Gubiao Recipe on toll-like receptor 4 and CD4 +CD25 +foxp3 +regulatory T cells in mice with recurrent respiratory tract infections. Journal of Chinese Integrative Medicine, 2010, 8(11): 1053-1059
[6] Chan Chen, Yong-mei Meng , Peng Zhang, Juan Wang, Hui-hui Zhao, Shu-zhen Guo , Wei Wang. Diagnosis and treatment rule of traditional Chinese medicine for syndrome factors of chronic congestive heart failure: a study based on Shannon entropy method. Journal of Chinese Integrative Medicine, 2010, 8(11): 1080-1084
[7] Liang-ping Hu , Xiao-lei Bao, Xue Guan. Statistical inference and experimental design of univariate qualitative data of single-group design. Journal of Chinese Integrative Medicine, 2010, 8(11): 1085-1089
[8] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100
[9] Pedro Saganha João, Doenitz Christoph, Greten Tobias, Efferth Thomas, J. Greten Henry. Qigong therapy for physiotherapists suffering from burnout: a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(11): 1233-1239
[10] Veena Sharma , Pracheta Janmeda , Ritu Paliwal , Shatruhan Sharma. Antihepatotoxic activity of Euphorbia neriifolia extract against N-nitrosodiethylamine-induced hepatocarcinogenesis in mice. Journal of Chinese Integrative Medicine, 2012, 10(11): 1303-1309