Research methodology in acupuncture and moxibustion for managing primary dysmenorrhea: A scoping review.

BACKGROUND: Acupuncture and moxibustion have promising effects in managing primary dysmenorrhea. However, some evidence from clinical trials remains controversial due to methodological flaws in study designs that involve acupuncture and its related modalities and require urgent attention and dialogue. METHODS: Allied and Complementary Medicine Database (AMED), Cochrane Library, Excerpta Medica database (EMBASE), PubMed, Web of Sciences, Chinese Biological Medicine (CBM), China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), and Wanfang database were searched from their inception to July 2021. Data were extracted based on the types of study design, primary outcome measures, adverse events (AEs), and participants' subjective views. RESULTS: Most studies (n = 282, 93 %) were published in Chinese and 21 (7 %) in English. Among these, there were 209 (69 %) randomized controlled trials (RCTs), 39 (13 %) non-randomized controlled trials (nRCTs), 30 (10 %) case-series reports, 15 (5 %) cohort studies, and 10 (3 %) case reports. The most frequent reported outcome was pain, followed by emotion, sleeping quality, quality of life, skin temperature, changes in brain function, uterine and ovarian blood flow, and reproductive endocrine level. AEs were reported in 37 studies with mild events, and all recovered without actions taken; 31 trials reported no AEs; 235 failed to report any AEs. One RCT found that the satisfaction rate of the intervention group was statistically significantly higher than the control group. CONCLUSION: Clinical studies on acupuncture and its related modalities face methodological challenges and require urgent attention. RCT with blinding and sham control might be the gold standard trial design. However, it may not be the most suitable research method for these modalities. We recommend using pragmatic RCTs in this field, where trial protocol registration on the trial registry platforms and detailed safety reporting should be mandatory.

Efficacy and Safety of Acupuncture and or Moxibustion for Managing Primary Dysmenorrhea: A Systematic Review and Meta-Analysis.

Acupuncture and moxibustion have been accepted as add-on options for primary dysmenorrhea (PD); however, the clinical evidence is still inadequate. We searched AMED, CENTRAL, EMBASE, PubMed, Web of Science, CBM, CNKI, VIP, Wangfang database, ANZCTR, ClinicalTrials.gov, and the WHO ICTRP, from their inception to February 2021. The pooled analysis of 13 RCTs with 675 participants for VAS showed that acupuncture and moxibustion were more effective in managing PD than the control group with the MD of -1.93 (95% CI [-2.80, -1.06] and -2.67 (95% CI [-4.96, -0.38]). With the CMSS, seven studies with 487 participants showed that these modalities were more effective than the control group with the MD of -7.58 (95% CI [-10.97, -4.19]) and -3.78 (95% CI [-6.90, -0.66]). The findings indicated that acupuncture and moxibustion could relieve pain effectively and has fewer adverse events (AEs) in managing PD.