Assessing blinding in randomised controlled trials of acupuncture: challenges and recommendations.

The revision of CONSORT guidelines for reporting blinding in randomised controlled trials is the subject of controversy and criticism. To determine whether the criticism is justified, in this short communication paper we discuss the problems encountered in the methodology of the assessment of blinding, and the reporting of blinding in randomised controlled trials and the standards of reporting on blinding with reference to their usage in clinical trials of acupuncture for chronic pain. To conclude we recommend two simple guidelines: the development of sound clinical protocols that anticipate potential difficulties and reinforce overall internal validity, and secondly. the accurate reporting of the methodologies used to ensure a clear view of blinding procedures.