The use of placebo controls in acupuncture trials has been an international concern for many years. We discussed some common problems in placebo controls and introduced four kinds of control methods (sham acupuncture, non-points acupuncture, minimal acupuncture and non-specific sites acupuncture). For sham acupuncture, non-points acupuncture and non-specific sites acupuncture, patients who have received acupuncture are liable to doubt the intervention they are taking. Minimal acupuncture has better reliability but is limited to use in many diseases for its physiological effect. Needling on some special parts of the body, for example, head and back side of the body, can make balance among factors as reliability, physiological effect and feasibility. This paper recommends a control method needling special parts according to the tradiontional acupuncture theory, which provides references for acupuncture clinical trials.
Objective To assess the effectiveness and safety of various types of acupuncture in the treatment of mammary dysplasia. Methods We searched The Cochrane Library, CENTRAL, MEDLINE (1966 to 2004), EMBASE (1980 to 2004), CBM (1975 to 2004), CNKI (1997 to 2004) and reference lists, databases of ongoing trials and relevent academic conference proceedings. Results Five studies involving 534 women ranging from 78 to 180 met the inclusion criteria. The recovery rates of two groups in one study showed acupuncture was statistically superior to Rupixiao (RR 9.00, 95%CI 2.29 to 35.43; RR 8.04, 95%CI 2.20 to 32.02), six good improvement rates (including groups analysis) indicated that there was no significant difference between acupuncture and other therapies. None of the studies reported incidence of adverse reaction. Conclusions Overall, there is no conclusive evidence for acupuncture in the treatment of mammary dysplasia because the quality of included studies and amount of evidence are both poor and insufficient. There is an urgent need for larger, well-designed randomised controlled trials to assess the effectiveness and adverse-effect of acupuncture.
ObjectiveSham acupuncture control is a commonly employed method to assess the specific effects of acupuncture in clinical trials. However, due to the absence of specific reporting standards, the reporting quality of sham acupuncture in these trials is low. In order to standardize the reporting of sham acupuncture and improve the reporting quality of sham acupuncture, our project team has developed SHam Acupuncture REporting guidelines and a checklist in clinical trials (SHARE). MethodsThe development process included four parts: we conducted literature research to form initial items of sham acupuncture reporting; two rounds of Delphi surveys were carried out to evaluate the reporting necessity of these initial items; two expert consensus meetings were held to further discuss and agree upon the Delphi results and approve the SHARE checklist; a pilot testing was conducted to assess the feasibility and practicality of the list and make necessary revisions to generate the final SHARE checklist. ResultsThe SHARE checklist consisted of 10 categories with 19 items. The requirements for reporting sham acupuncture primarily focused on sham acupuncture detailed information as well as relevant background factors. ConclusionThe SHARE serves as specialized reporting guidelines for sham acupuncture that offers clear guidance on comprehensive and concise reporting of sham acupuncture.