摘要
目的:总结分析针灸治疗围绝经期失眠的随机对照临床试验研究特征,评价其方法学质量与针刺干预措施的报告质量,为今后开展相关研究提供参考。方法:通过计算机检索6个中英文数据库,筛选以针灸疗法为主治疗围绝经期失眠的随机对照试验,提取其研究特征,运用Cochrane偏倚风险评估工具及针刺临床试验干预措施报告规范(STRICTA)对照检查清单进行评价。结果:共纳入文献92篇,其中针刺研究57篇(64.1%),耳穴疗法研究20篇(21.7%)。其诊断标准以教材和指南为主,结局指标以量表为主,研究多聚焦于针灸与其他疗法的优势比较。Cochrane偏倚风险评估结果发现,大部分研究在随机序列的生成(64.1%)、分配隐藏(19.6%)、受试者和干预提供者盲法(0%)、结局评价者盲法(15.2%)方面报告率较低。对照STRICTA条目发现,报告完整度分别为用针数量0篇、进针深度39篇(50.6%)、针具类型42篇(54.5%)、治疗场所信息0篇,治疗师背景4篇(5.2%)。结论:目前针灸治疗围绝经期失眠的随机对照试验的报道多见于国内,其方法学质量与针刺相关报告质量偏低,提示未来相关临床试验需进一步完善和规范试验设计与报告。
Objective:To summarize and analyze the characteristics of clinical randomized controlled trials(RCTs)on acupuncture and moxibustion for perimenopausal insomnia,evaluate their methodological quality and the quality of reporting on acupuncture interventions,and provide reference for future related research.Methods:Six Chinese and English databases were searched using computer retrieval.RCTs on acupuncture and moxibustion therapy for perimenopausal insomnia were screened.Their study characteristics were extracted,and Cochrane′s risk of bias assessment tool and the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA)checklist were used for evaluation.Results:A total of 92 articles were included,with 57 studies(64.1%)on acupuncture and 20 studies(21.7%)on auricular therapy.Diagnostic criteria were primarily based on textbooks and guidelines,and outcome measures primarily utilized scales.Many studies focused on comparing the advantages of acupuncture and moxibustion with other therapies.Cochrane′s risk of bias assessment found low reporting rates in random sequence generation(64.1%),allocation concealment(19.6%),blinding of participants and personnel(0%),and blinding of outcome assessors(15.2%).Comparing with STRICTA criteria,completeness of reporting was lacking in number of needles used(0%),depth of needling(50.6%reported),type of needles(54.5%reported),information on treatment setting(0%),and therapist background(5.2%reported).Conclusion:Currently,reports of RCTs on acupuncture and moxibustion for perimenopausal insomnia are predominantly from China,with generally low methodological quality and reporting quality related to acupuncture interventions,suggesting a need for future clinical trials to further improve and standardize their design and reporting.
作者
林小丁
陈丽萍
徐钰棋
李容
郑润晨
任玉兰
黄金珠
LIN Xiaoding;CHEN Liping;XU Yuqi;LI Rong;ZHENG Runchen;REN Yulan;HUANG Jinzhu(School of Acupuncture-Moxibustion and Tuina,Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China;School of Chinese Classics,Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China;School of Clinical Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China)
出处
《世界中医药》
CAS
北大核心
2024年第11期1667-1673,共7页
World Chinese Medicine
基金
国家自然科学基金青年科学基金项目(82004415)。
