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Table 3 Details of identified issues specific to TCM pilot trials

From: Pilot and feasibility trials in traditional Chinese medicine: a literature review of current practice

Issues specific to TCM pilot trials

Authors’ statements

Reference

Blinding; intervention

“in this study JWSYS [Jia-Wey Shiau-Yau San] was given in powder form and Premelle in tablet form. The question arises as to whether the women receiving JWSYS were aware that they were taking an established traditional Chinese herbal remedy. Since the trial was not a blind one and the improvement in the symptoms of these women could be due to an expectancy/placebo effect, given the cultural milieu”

Chen [12]

Randomization and blinding; intervention

“treatment with the complementary therapies of CM [Chinese medicine] had to be agreed by the patients or their families, thus randomly assigning the patients to the ST [standard treatment] or CH [Chinese herbs] by a completely blind method was difficult”

“there was no fixed CM formula”

Lee [27]

Comparison and effect estimate

“in addition, there is no standard treatment for AD [atopic dermatitis] based on evidence-based medicine that could be used for comparison. Therefore, it is very difficult to rate an intervention compared to a standard herbal medicine”

Choi 2012 [58]

Blinding

“although the shape and color of the placebo were similar to Yueju, the smells of Yueju and placebo were not exactly identical, which may lead to the plausible incomplete blind treatment to patients.

Wu [51]

Intervention and bias control

“the current study cannot exclude the possible effects of HAT [herbal acupuncture therapy] on other factors, such as basic herbal regimens, proper acupuncture selection, and long-term therapeutic courses involved in the response of IDH [Intradialytic hypotension]”

Tsai [47]