Patient-reported outcomes and acupuncture-related adverse events are overlooked in acupuncture randomised controlled trials: a cross-sectional meta-epidemiological study.

Abstract

Objectives: To investigate the patient-reported outcomes (PROs) and acupuncture-related adverse events (A-AEs) in acupuncture randomised controlled trials (RCTs).

Design: Cross-sectional meta-epidemiological study.

Data sources: We comprehensively searched for eligible studies between 1 January 2014 and 1 May 2024, in MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang Data and VIP Database.

Eligibility criteria: RCTs that used acupuncture as the intervention group to obtain the efficacy and/or safety of acupuncture therapy. Acupuncture therapy should be based on Traditional Medicine theory.

Main outcome measures: We 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.

Results: We included 476 studies in this study. 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, and we found that 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). We identified 1277 reports of A-AEs in eligible studies, 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).

Conclusion: This 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.