PMID- 35998757 OWN - NLM STAT- MEDLINE DCOM- 20221216 LR - 20221221 IS - 1873-6963 (Electronic) IS - 0965-2299 (Linking) VI - 71 DP - 2022 Dec TI - Research methodology in acupuncture and moxibustion for managing primary dysmenorrhea: A scoping review. PG - 102874 LID - S0965-2299(22)00076-0 [pii] LID - 10.1016/j.ctim.2022.102874 [doi] AB - 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. CI - Copyright (c) 2022 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Liu, Weiting AU - Liu W AD - School of Nursing and Midwifery, Edith Cowan University, Perth, Australia. Electronic address: weitingl@our.ecu.edu.au. FAU - Wang, Carol Chunfeng AU - Wang CC AD - School of Nursing, Midwifery, Health Sciences & Physiotherapy, The University of Notre Dame Australia, Perth, Australia. FAU - Lee, Khui Hung AU - Lee KH AD - School of Science, Edith Cowan University, Perth, Australia. FAU - Ma, Xiaopeng AU - Ma X AD - Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China. FAU - Kang, Timothy Leen AU - Kang TL AD - Institute of Chinese Acuology, Perth, Australia. LA - eng PT - Journal Article PT - Review DEP - 20220820 PL - Scotland TA - Complement Ther Med JT - Complementary therapies in medicine JID - 9308777 SB - IM MH - Female MH - Humans MH - Research Design MH - *Moxibustion/methods MH - *Acupuncture Therapy/methods MH - Quality of Life MH - China MH - Dysmenorrhea/drug therapy OTO - NOTNLM OT - Acupuncture OT - Clinical studies OT - Methodology OT - Moxibustion OT - Primary dysmenorrhea OT - Scoping review COIS- Declaration of Competing Interest The authors declared no potential conflicts of interest. EDAT- 2022/08/24 06:00 MHDA- 2022/12/15 06:00 CRDT- 2022/08/23 19:24 PHST- 2021/10/28 00:00 [received] PHST- 2022/07/20 00:00 [revised] PHST- 2022/08/19 00:00 [accepted] PHST- 2022/08/24 06:00 [pubmed] PHST- 2022/12/15 06:00 [medline] PHST- 2022/08/23 19:24 [entrez] AID - S0965-2299(22)00076-0 [pii] AID - 10.1016/j.ctim.2022.102874 [doi] PST - ppublish SO - Complement Ther Med. 2022 Dec;71:102874. doi: 10.1016/j.ctim.2022.102874. Epub 2022 Aug 20.