Methodological rigor in acupuncture randomized controlled trials (RCTs) requires adequate consideration of demographic factors that influence treatment outcomes. However, researchers frequently neglect sex/gender and race/ethnicity, despite increasing evidence of their impact on treatment responses. This study systematically examines how acupuncture RCTs consider and report sex/gender and race/ethnicity. We systematically searched seven databases (MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang, and VIP). Two authors jointly performed study screening and eligibility assessment, and any disagreements were resolved by a senior reviewer (YDe). We included RCTs of acupuncture published between 1 January 2014 and 31 May 2025. Two authors independently extracted data and evaluated the reporting and analysis of sex/gender and race/ethnicity using 27 predefined items. In total, 567 studies were included. Reporting of sex information increased over time but remained incomplete. Among English-language studies that used sex- or gender-related terminology (n = 180), only 42.8% (77/180) correctly distinguished between the terms "sex" and "gender". Although 73.8% of studies (418/567) reported participants’ sex distribution, very few examined its association with treatment efficacy, and only 5.3% (30/567) reported any information on race or ethnicity. Furthermore, only two studies examined the intersectional effects of sex and race, and none considered nonbinary gender categories. Acupuncture RCTs show substantial deficiencies in reporting and analyzing sex/gender and race/ethnicity. Inconsistent terminology and limited analytical integration reduce evidence generalizability and clinical applicability. Researchers should adopt standardized reporting frameworks and systematically incorporate these variables as key analytical factors to improve rigor and equity. Open Science Framework (Registration ID: 10.17605/OSF.IO/6SXE5).
Lin et al. (2026) studied this question.