Methodological concerns when designing trials for the efficacy of acupuncture for the treatment of pain

Abstract

The aim of all clinical research must surely be to assess an intervention or process or relationship between variables, ultimately in order to be able to improve clinical practice and healthcare for patients/consumers. As such, evidence gathered must have external validity (generalisability)52 and it must be relevant to clinical practice. It can be seen therefore that research into acupuncture for pain relief is an inherently difficult task, which requires much sensitivity and careful planning in order to minimise error when drawing conclusions. The researcher needs to adequately address problems such as sample size, blinding, randomisation and appropriate use of control and treatment. It is also most important to be able to clarify that the placebo (if used) is credible to the patient. The field of acupuncture has been overwhelmed with hundreds of sub-standard trials and much doubt still surrounds the issue of efficacy. Few good quality rigorous trials exist to support the use of acupuncture for pain relief in general21. It has also been noted that the question of long-term efficacy has not been assessed by the many trials29 and this needs to be addressed prior to its acceptance. Further well conducted rigorous trials are therefore needed, utilising the lessons learnt through the substantial number of previous trials, in order to adequately assess the efficacy of acupuncture for painful conditions. Such trials must therefore: • Utilise a placebo control • Be randomised and stratified • Ensure patient blinding • Use self completed outcome measures and blinded assessors • Have sufficient and well validated outcome measures • Check credibility of treatment • Have a well defined entry criteria which includes a single condition only • Have a long term follow up • Enrol sufficient subjects, the number to be determined by a power calculation • Provide adequate acupuncture treatment as would be found in clinical practice • Be group comparative so as to negate any carry-over effects In this way good quality trials can be undertaken which will yield reliable results and therefore add meaningful data to the body of knowledge appertaining to the effectiveness of acupuncture.