Adverse Event Reporting in Acupuncture Clinical Trials Focusing on Pain

This systematic review examined the quality of adverse event reporting in randomized clinical trials of acupuncture focused on pain reduction, specifically analyzing adherence to the CONSORT (Consolidated Standards of Reporting Trials) guidelines published in 2004. The investigators conducted systematic searches of medical databases (MEDLINE, Allied & Complementary Medicine, CINAHL, and All EBM Reviews) to identify studies published between 2005 and 2008 — a period corresponding to the availability of the updated guidelines on adverse event reporting.

Of the 10 studies meeting inclusion criteria, only 6 mentioned or discussed adverse events, and only 2 provided detailed descriptions of how those events were assessed and collected. The studies analyzed acupuncture for various painful conditions, including chronic low back pain, fibromyalgia, knee osteoarthritis, shoulder pain, and pelvic pain. Quality assessment using the CONSORT checklist showed that studies met on average 17 of the 22 recommended items, with scores ranging from 14 to 21.

The most commonly reported adverse events included pain at the needle insertion site, observed in 5 of the 10 studies, with significant differences between true and sham acupuncture groups. Mild hematoma or ecchymosis was reported in some studies, as were nausea, a sense of relaxation, or post-treatment fatigue. Serious adverse events were rare, including one case of pulmonary embolism and one myocardial infarction with death, both deemed unrelated to acupuncture treatment.

A concerning finding was that only one study specifically defined what constituted a serious adverse event, and most studies did not detail how adverse events were collected or assessed. Different collection methods were used, including checklists, direct questioning, and spontaneous report, but many studies did not specify their method. This methodological variability compromises the ability to compare safety data across different studies.

The analysis revealed that none of the studies fully met the CONSORT guideline recommendations for adverse event reporting. Specifically, all studies failed to report who, how, and why certain adverse events were selected for reporting. Only two studies provided adequate descriptions of how adverse events were monitored and collected, although the majority (7 of 10) adequately reported participant withdrawals by treatment group.

The authors stress that, although acupuncture is commonly perceived as a benign and minimally invasive therapy, serious adverse events have been documented in the literature, including pneumothorax, hematoma, dizziness, and syncope. Inadequate reporting of adverse events in clinical trials compromises both patient safety and the quality of scientific evidence available to guide clinical practice.

This study also discusses the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, developed in 2001 as a specific extension of CONSORT for acupuncture trials. Although STRICTA provides detailed guidance on how to report acupuncture interventions, its adoption has been limited, having been implemented by only 5 journals specializing in complementary and alternative medicine.