Problems lowering the study quality in traditional medicine, introspection from an example of meta-analysis of acupuncture

Abstract

Background: Most randomized controlled trials (RCTs) of traditional medicine (such as traditional Chinese medicine (TCM), psychotherapy or behavioral therapy, and dietary interventions, etc.) have reported that they could not provide convincing evidence to support the efficacy because of the low quality of their studies. Here, we aimed to determine the underlying problems of the study quality using standards of evidence-based medicine (EBM) to evaluate the efficacy of traditional medicine. Methods: We conducted an example of meta-analysis to evaluate the efficacy of acupuncture, a classical treatment of TCM, for treatment of intracerebral hemorrhage (ICH). The quality of the included studies was evaluated by using a Jadad score. Results: A total of 24 Chinese RCTs that enrolled 1815 patients with ICH were included. Although the results suggested that acupuncture had good efficacy for relief of neurological deficits and improvement of the activities of daily living despite the high heterogeneity of the included studies, the low quality of the included literature reduced the worthiness of the evidence. Two systematic problems (lack of blinding and allocation concealment and high heterogeneity) and one non-systematic problem (lack of reports on adverse events and follow-up) of the TCM studies were found in this illustrational meta-analysis. We believed that other interventions of traditional medicine also suffer from these problems. Conclusions: Non-systematic problems can be improved by perfecting the experimental design, educating the researcher, and improving the reporting system. However, systematic problems are derived from the characteristics of traditional medicine that are difficult to be corrected. We propose that adoption of objective indexes might be a better solution to improve the systematic problems of traditional medicine. We summarized the problems and the underlying solutions, which may contribute to improve the study quality of systematic review in traditional medicine, strictly complying with the principles of EBM.

Verification of the Efficacy and Safety of Qi‐Replenishing Chinese Medicine in Treating Prediabetes: A Meta‐Analysis and Literature Review

“…In fact, the safety of traditional medicines also requires rigorous verification, which is similar to the use of Western medicine. As our previous study indicated that “lack of reporting of adverse events and follow-up” has been a primary nonsystematic problem encountered in several TCM studies [ 13 ], based on the results of the present study, we suggest that the adverse events of TCM cannot be ignored.…”

“…Currently, there is an increasing focus on the adverse events of traditional medicines. Although several clinicians practicing TCM traditionally believe that TCM treatments have no or few adverse effects [ 13 , 29 ], several reports have emphasized that adverse events do occur in TCM treatments. For instance, Ng et al reported on the adverse events of aristolochic acids in several herbal medicines [ 30 ].…”

“…The quality of studies of alternative therapy, including TCM, is always questioned due to the flaws in the experimental design [ 13 , 29 , 31 ]. To obtain convincing evidence, we selected only those trials whose Jadad scores were ≥4.…”

“…To obtain convincing evidence, we selected only those trials whose Jadad scores were ≥4. Randomization, control, and blinding (or using objective indices [ 13 ]) were designed in the involved studies. Furthermore, in some trials, the experiment was designed using “T + C vs. C + P (T: therapy of traditional medicine; C: conventional treatments; P: placebo), which has been described in our previous studies [ 13 , 29 , 31 ].…”

“…On the other hand, “holistic concept” and “syndrome differentiation” are two basic principles in TCM [ 13 ]. “Syndrome differentiation” requires that the herbs and other therapies be selected according to the TCM syndrome.…”