Insufficient reporting of adverse effects in acupuncture trials

This cross-sectional meta-epidemiological study investigated the patient-reported acupuncture-related adverse events (A-AEs) in acupuncture randomised controlled trials (RCTs). All RCTs were included that used acupuncture as the intervention group to obtain the efficacy and/or safety of acupuncture therapy and that based the acupuncture therapy on Traditional Medicine theory.

The researchers assessed

• (1) the general characteristics of acupuncture RCTs;
• (2) the general characteristics of PROs;
• (3) the reporting scores of PROs by the Extension of Consolidated Standards of Reporting Trials of Patient-Reported Outcomes (CONSORT PRO Extension);
• (4) the general characteristic of A-AEs; (5) the incidence of A-AEs.

They included 476 RCTs; 296 (62.2%) used PROs as study outcomes, 272 (57.1%) reported safety outcomes. The Visual Analogue Scale (149, 23.7%) and the Pittsburgh Sleep Quality Index (42, 6.7%) were the most common PROs reported. The reporting of PROs was incomplete, with sufficiently reporting scores ranging from 2.7% to 97.6% across the CONSORT PRO Extension.

164 studies reported A-AEs, of which 141 reported specific details. The OR for the incidence of AEs in the acupuncture group compared to the control group was 1.434 (95% CI 1.148 to 1.793). The researchers identified 1277 reports of A-AEs, predominantly tissue injury (eg, haematoma, bleeding), irritation (eg, pain, post-acupuncture discomfort), with no reports of serious A-AEs. The reporting of A-AEs lacked details on the acquisition methods (15.5%), occurrence time (5.5%), A-AEs’ treatment (18.1%) and A-AEs’ recovery (19.7%). Studies that reported funding, registry information, acupuncturist qualifications and non-significant primary outcomes were associated with the A-AEs’ reporting, and the difference was statistically significant (p≤0.05).

The authors concluded that their study found that the reporting of PROs and A-AEs was insufficient in acupuncture RCTs. Future studies should clarify the clinical significance of using PROs as outcomes and report AEs comprehensively to provide patients with sufficient information on the benefits and harms of acupuncture treatments.

If you have followed my blog for any length of time, you will have seen numerous studies that show how poor the reporting of AEs is in trials of acupuncture and other forms of so-called alternative medicine (SCAM). This is not just regrettable, it is unethical, dangerous and amounts to scientific misconduct.

Based on such flawed evidence SCAM promoters claim that their treatments are quite safe. But because of the very inadequate reporting this assumption might well be wrong. Thus consumers are systematically being misled into making wrong, and in a worst case scenaario fatal, therapeutic decisions.

Imagine what scandal it would generate, if we found that studies of pharmaceuticals were systematically hiding AEs by simply not monitoring and reporting them!