Adverse event reporting in acupuncture clinical trials focusing on pain

Abstract

Objectives: To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the Consolidated Standards of Reporting Trials (CONSORT) in 2001, the quality of published RCTs has improved. To improve reporting on adverse events, CONSORT expanded the section on harms (adverse events) in 2004. This paper evaluates whether the updated harms guidelines have been implemented in RCTs evaluating acupuncture for pain relief.

Methods: Systematic searches were conducted using the following databases: MEDLINE, Allied & Complementary Medicine, Cumulative Index to Nursing & Allied Health Literature, and All EBM Reviews. Each database was searched from 2005 through 2008, corresponding to the availability of the updated harms guideline.

Results: Ten studies met the inclusion criteria of this review. Six of the 10 studies mentioned or discussed adverse events. Four of the 6 studies did not detail how adverse events were collected. Only 2 studies discussed how adverse events were assessed.

Discussion: On the basis of our findings, acupuncture clinical trials for pain reduction have yet to comprehensively meet CONSORT's guidelines for adverse event reporting. Acupuncture is commonly used by patients experiencing pain and although typically viewed as a benign and minimally invasive therapy, serious adverse events have been reported in the literature. To effectively and comprehensively document and understand these events, routine reporting according to CONSORT's harms guidelines should become the norm. Both science and patients are served by accurately evaluating the safety of acupuncture for patient populations experiencing pain.