quality of randomized controlled trials in Chinese herbal medicine

March 18, 2006

Zhong Xi Yi Jie He Xue Bao. 2006 Mar;4(2):120-9.Related Articles, Links

[improving the quality of randomized controlled trials in Chinese herbal

medicine, part I: clinical trial design and methodology.]

[Article in Chinese]

Bian ZX, Li YP, Moher D, Dagenais S, Liu L, Wu TX, Miao JX, Kwan AK, Song L.

School of , Hong Kong Baptist University, Hong Kong SAR,

China;E-mail:bzxiang.

Objective: 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.

Methods: 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). Results:

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. Conclusion: 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.

PMID: 16529686 [PubMed - in process]

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