Issues of design and statistical analysis in controlled clinical acupuncture trials: an analysis of English‐language reports from Western journals

Abstract

Objective To investigate major methods of design and statistical analysis in controlled clinical acupuncture trials published in the West during the past six years (2003–2009) and, based on this analysis, to provide recommendations that address methodological issues and challenges in clinical acupuncture research. Method PubMed was searched for acupuncture RCTs published in Western journals in English between 2003 and 2009. The keyword used was acupuncture. Results One hundred and eight qualified reports of acupuncture trials that included more than 30 symptoms/conditions were identified, analyzed, and grouped into efficacy (explanatory), effectiveness (pragmatically beneficial) and other (unspecified) studies. All were randomized controlled clinical trials (RCTs). In spite of significant improvement in the quality of acupuncture RCTs in the last 30 years, these reports show that some methodological issues and shortcomings in design and analysis remain. Moreover, the quality of the efficacy studies was not superior to that of the other types of studies. Research design and reporting problems include unclear patient criteria and inadequate practitioner eligibility, inadequate randomization and blinding, deficiencies in the selection of controls, and improper outcome measurements. Problems in statistical analysis included insufficient sample sizes and power calculations, inadequate handling of missing data and multiple comparisons, and inefficient methods for dealing with repeated-measure and cluster data, baseline value adjustment, and confounding issues. Conclusion Despite recent advancements in acupuncture research, acupuncture RCTs can be improved, and more rigorous research methods should be carefully considered.

Acupuncture for dysphagia after chemoradiation in head and neck cancer: Rationale and design of a randomized, sham-controlled trial

“…Sham intervention ideally should mimic the procedure of acupuncture without eliciting therapeutic effects[48]. However, it has been suggested that sham acupuncture needling also evokes physiological responses that are similar to real acupuncture needling, and this may explain why effect sizes in many sham controlled studies are small[45, 46, 70, 71]. For this reason, some have argued that using non-invasive acupuncture needles as sham control is a better approach than the minimally invasive needling approach we are employing[71, 72].…”

“…However, it has been suggested that sham acupuncture needling also evokes physiological responses that are similar to real acupuncture needling, and this may explain why effect sizes in many sham controlled studies are small[45, 46, 70, 71]. For this reason, some have argued that using non-invasive acupuncture needles as sham control is a better approach than the minimally invasive needling approach we are employing[71, 72]. Because of the smaller needle diameter, softer needle body, and very shallow insertion we are employing in this study, we believe the stimulation will be quite minimal, and perhaps even less strong than non-insertive controls that often apply significant surface pressure.…”

The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial

“…Some papers have reported that acupuncture has no significant differencescompared to sham acupuncture [12-14]. To confirm the efficacy of EA for severe chronic functional constipation, we chose a commonly used sham method as described in western journals as the control group - superficial insertion at non-acupuncture points [15] with no current output using an EA simulator. We used an EA apparatus which has the metal wire removed, giving an identical visual appearance to the real one.…”

Acupuncture Pain Research: Quantitative and Qualitative

“…5. In addition to a comprehensive and rigorous methodological design, appropriate methods of statistical analysis are also necessary [86,87].…”