Table 4.
Common Defects of Study Design and Reporting Quality Among Current RCTs
| Items | Limitations | Potential Negative Consequences |
|---|---|---|
| Study design | Lack of appropriate sample size estimation | Diminishment of credibility of the results; reduction in likelihood of finding an effect of the treatment |
| Lack of sham-/placebo- acupuncture as parallel control in trials comparing acupuncture with Western medications | Potential bias and uncertainty on the placebo effects of acupuncture | |
| Without appropriate statistics (ie intention-to-treat analysis, etc) for data of those withdrawal/dropout patients | Increased risk of an overestimation/underestimation of the efficacy of acupuncture or Western medications | |
| Lack of follow-ups | Unable to evaluate medium- and long- term effects/safety of acupuncture | |
| Objective indices (ie, polysomnography, actigraphy, etc) is seldom used in PMI studies | (i) Unable to understand the effects of acupuncture on sleep architecture (ii) A biased judgement or even a question on acupuncture’s real efficacy due to a mismatch between the subjective and objective sleep-wake duration |
|
| No discussion of the effects of acupuncture responding to specific/each TCM syndrome pattern (all TCM syndrome patterns are mixed for efficacy assessment) | Difficult to judge the real therapeutic effect of acupuncture | |
| Reporting quality | Lack of reports on if or how allocation concealment and blinding of patients/outcome assessments are performed | Inadequate blinding is associated with an exaggeration of the estimated efficacy |
| Lack of description and in-depth analysis of the specific causes of withdrawal/dropout | Unable to understand patient’s compliance and acceptance of acupuncture, placebo or Western medications | |
| Protocols and/or registration Information are not always available | Greatly weakens the reliability of the evidence | |
| Incomplete descriptions of needling details and/or treatment regimen, as well as acupuncturists’ background | (i) Poor reproducibility of the trial results (ii) Hinder the clinical promotion of effective acupuncture prescription |