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The efficacy and safety of acupuncture for perimenopause symptom compared with different sham acupuncture control groups: A protocol of systematic review and meta-analysis.

ABSTRACT: BACKGROUND:Perimenopause is a period that every woman must go through, most people are more or less affected by perimenopausal symptoms, it to affect women's health, work, life, and economy. As acupuncture treatment is more and more increasing in perimenopausal symptoms, there have also been many clinical trials about it. But the results of the trials are inconsistent. Therefore, we will conduct a systematic review and meta-analysis of the safety and efficacy of perimenopausal symptoms treated with acupuncture. METHODS:The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. RCT study on different acupuncture interventions for perimenopausal symptoms will be searched in 8 databases (PubMed, EMBASE, the Cochrane Library, the web of science, CBM, CNKI, WAN FANG, and VIP). Besides, the search will also be performed on the clinical trial research platform if necessary. The primary outcome that will be extracted: the Flushes per 24?hours, the Frequency of hot flashes, the severity of hot flashes, the menopause-related symptom score, the treatment efficacy, the adverse event. Endnote software X8 will be used for study selection, STATA 13.0 and Review Manager software 5.3 will be used for analysis and synthesis. These studies selection, data extraction, and risk of bias assessment will be conducted by 2 independent reviewers. RESULTS:This study will provide the results: 1. the primary and secondary outcome indicators of different acupuncture intervention measures (traditional hand acupuncture, moxibustion, ear acupuncture, laser, acupressure points) for perimenopausal symptoms. 2. The effects of different control groups (medicine control, routine care, waiting, and sham acupuncture control) on the analysis results will be reported, especially the effects of different sham acupuncture control (invasive/noninvasive) on the analysis results. CONCLUSION:This systematic review and meta-analysis study hopes to provide useful evidence for better use of different types of acupuncture in treat perimenopausal symptoms and better design of control groups in related clinical trials. In addition, the research conclusion will be published in peer journals.OSF REGISTRATION NUMBER DOI 10.17605/OSF.IO/VZCKU Ethics and dissemination This conclusion of the study will be published in peer journals. The ethical approval is not required because there is no direct involvement of human.

SUBMITTER: He Q

PROVIDER: S-EPMC7478674 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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The efficacy and safety of acupuncture for perimenopause symptom compared with different sham acupuncture control groups: A protocol of systematic review and meta-analysis.

He Qiujun Q Ren Yajing Y Wang Yanqiu Y Zhang Feng F Zhang Sanyin S

Medicine 20200301 10

<h4>Background</h4>Perimenopause is a period that every woman must go through, most people are more or less affected by perimenopausal symptoms, it to affect women's health, work, life, and economy. As acupuncture treatment is more and more increasing in perimenopausal symptoms, there have also been many clinical trials about it. But the results of the trials are inconsistent. Therefore, we will conduct a systematic review and meta-analysis of the safety and efficacy of perimenopausal symptoms t ...[more]

PMID: 32150082

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Project description:BackgroundChronic urticaria (CU) is a refractory skin disease with long duration and a high recurrence rate. Acupuncture has been widely used for the treatment of CU in clinical practice in China. However, until now, there has been no appropriately designed randomized controlled trial (RCT) to provide explicit evidence about the effectiveness of acupuncture for the treatment of CU worldwide. Therefore, we plan to conduct a pilot study to explore its effectiveness and safety and determine the feasibility of studying acupuncture in a future, full-scale, RCT of CU.Methods/designThis randomized, sham-controlled, participant-blinded and assessor-blinded pilot trial is underway in China. A total of 60 participants with CU will be randomly assigned to two groups in a 1:1 ratio: one treated with real acupuncture and the other with sham acupuncture, for 10?sessions over 2?weeks. The experimental group will receive acupuncture on a fixed prescription of acupoints, whereas the control group will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The primary outcome will be the urticaria activity score (UAS). The secondary outcomes will include a visual analogue scale (VAS) score for itching intensity, the Dermatology Life Quality Index (DLQI), the Hamilton Depression Scale (HAMD), the Hamilton Anxiety Scale (HAMA), the humoral immunity index, serum total IgE, and adverse events. The UAS, VAS for itching and the DLQI will be conducted at baseline and at 1, 2, 3, and 4?weeks after randomization. The HAMD, HAMA, humoral immunity index, and serum total IgE will be assessed at baseline and at 2?weeks after randomization. Adverse events will be summarized at 1 week and 2 weeks after randomization.DiscussionThe pilot study mainly aims to investigate trial feasibility, and confirm basic information about its effects and safety. Results of this trial will help clarify whether the acupuncture treatment is beneficial for symptom improvement in patients with CU. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for CU.Trial registrationAcupuncture-Moxibustion Clinical Trial Registry, AMCTR-ICR-18000190 . Registered on 19 June 2018.

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The efficacy and safety of acupuncture for perimenopause symptom compared with different sham acupuncture control groups: A protocol of systematic review and meta-analysis.

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The efficacy and safety of acupuncture for perimenopause symptom compared with different sham acupuncture control groups: A protocol of systematic review and meta-analysis.

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