TY - JOUR
T1 - Research methodology in acupuncture and moxibustion for managing primary dysmenorrhea
T2 - A scoping review
AU - Liu, Weiting
AU - Wang, Carol Chunfeng
AU - Lee, Khui Hung
AU - Ma, Xiaopeng
AU - Kang, Timothy Leen
N1 - Funding Information:
This work was supported by the project on Edith Cowan University and Industry Collaboration Scholarship ( G1004906 ).
Publisher Copyright:
© 2022 The Authors
PY - 2022/12
Y1 - 2022/12
N2 - 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.
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.
KW - Acupuncture
KW - Clinical studies
KW - Methodology
KW - Moxibustion
KW - Primary dysmenorrhea
KW - Scoping review
UR - http://www.scopus.com/inward/record.url?scp=85136525836&partnerID=8YFLogxK
U2 - 10.1016/j.ctim.2022.102874
DO - 10.1016/j.ctim.2022.102874
M3 - Review article
C2 - 35998757
SN - 0965-2299
VL - 71
JO - Complementary Therapies in Medicine
JF - Complementary Therapies in Medicine
M1 - 102874
ER -