- Title
- Acupuncture for comorbid depression and insomnia in perimenopause : a feasibility patient-assessor-blinded, randomized, and sham-controlled clinical trial
- Creator
- Zhao, Fei; Zheng, Zhen; Fu, Qiang-Qiang; Conduit, Russell; Xu, Hong; Wang, Hui-ru; Huang, Yu-Ling; Jiang, Ting; Zhang, Wen-Jing; Kennedy, Gerard
- Date
- 2023
- Type
- Text; Journal article
- Identifier
- http://researchonline.federation.edu.au/vital/access/HandleResolver/1959.17/193426
- Identifier
- vital:18189
- Identifier
-
https://doi.org/10.3389/fpubh.2023.1120567
- Identifier
- ISSN:2296-2565 (ISSN)
- Abstract
- Background and objective: Whilst acupuncture is widely used for treating psychosomatic diseases, there is little high-quality evidence supporting its application in comorbid perimenopausal depression (PMD) and insomnia (PMI) which are common complaints during climacteric. This feasibility, patient-assessor-blinded, randomized, sham-controlled clinical trial addresses this gap by investigating the efficacy and safety of acupuncture on depressed mood and poor sleep in women with comorbid PMD and PMI. Methods: Seventy eligible participants were randomly assigned to either real-acupuncture (RA) or sham-acupuncture (SA) groups. Either RA or SA treatment were delivered in 17 sessions over 8 weeks. The primary outcomes for mood and sleep were changes on 17-items Hamilton Depression Rating Scale (HAM-D17) and Pittsburgh Sleep Quality Index (PSQI) scores, from baseline to 16-week follow-up. Secondary outcome measures involved anxiety symptoms, perimenopausal symptoms, quality of life, participants' experience of and satisfaction with the acupuncture treatment. Blood samples were taken to measure reproductive hormone levels. Intention-To-Treat and Per-Protocol analyses were conducted with linear mixed-effects models. The James' and Bang's blinding indices were used to assess the adequacy of blinding. Results: Sixty-five participants completed all treatment sessions, and 54 and 41 participants completed the eight- and 16-week follow-ups, respectively. At post-treatment and 8-week follow-up, the RA group showed a significantly greater reduction in PSQI scores than the SA group did; although the reduction of HAM-D17 scores in RA group was significant, the change was not statistically different from that of SA. There were no significant mean differences between baseline and 16-week follow-up in either HAM-D17 or PSQI in either group. There were no significant between-group differences in serum reproductive hormone levels. All treatments were tolerable and no serious adverse events were reported, and the blinding was successful. Conclusion: Acupuncture is safe and can contribute to clinically relevant improvements in comorbid PMD and PMI, with satisfactory short-and medium-term effects. Whether the anti-depressive benefit of acupuncture is specific or non-specific remains to be determined. No evidence was found for any longer-term benefit of acupuncture compared to sham at 16 weeks. Further research is required to elucidate mechanisms underlying the short to medium term effects of acupuncture. Copyright © 2023 Zhao, Zheng, Fu, Conduit, Xu, Wang, Huang, Jiang, Zhang and Kennedy.
- Publisher
- Frontiers Media S.A.
- Relation
- Frontiers in Public Health Vol. 11, no. (2023), p.
- Rights
- All metadata describing materials held in, or linked to, the repository is freely available under a CC0 licence
- Rights
- https://creativecommons.org/licenses/by/4.0/
- Rights
- Copyright © 2023 Zhao, Zheng, Fu, Conduit, Xu, Wang, Huang, Jiang, Zhang and Kennedy
- Rights
- Open Access
- Subject
- 4203 Health services and systems; 4206 Public health; Acupuncture; Clinical trial; Comorbid depression and insomnia; Depression; Hormone levels; Insomnia; Non-pharmacologic intervention; Perimenopause
- Full Text
- Reviewed
- Funder
- This work was sponsored by RMIT Research Stipend Scholarship, RMIT University, Australia, and University's Scientific Research Project, Shanghai Sanda University [2021zz02-yj] to F-YZ; and National Key R&D Program of China [2021YFC2501500], TCM Research Project, Shanghai Municipal Health Commission [2022CX007], and Shanghai Technical Superiority Project of “Preventive Treatment of Disease”, Shanghai Municipal Health Commission [ZY(2021-2023)-0104-02-GF-04] to W-JZ.
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