RCTs

[Guest guest]

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

Song L

 

[improving the quality of randomized controlled trials in Chinese herbal

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

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

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.

 

 

 

 

Oakland, CA 94609

 

 

-

snakeoil.works

Saturday, March 18, 2006 9:59 AM

Re: Looking for acupuncturist in Philadelphia

 

 

Cara Frank is there. She's on this list.

 

ann

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