Abstract：
BACKGROUND: An increasing number of women suffer from perimenopausal syndrome (PMS) and the global burden of this disease has been steadily rising. Acupoint application therapy and Chinese herbal medicine (CHM) are widely used as effective methods for treating PMS, but the efficacy was inconsistent and the evidence should be summarized by quantitively analysis.
OBJECTIVE: The purpose of this systematic review and meta-analysis was to evaluate the clinical efficacy and safety of the acupoint application combined with the CHM for the treatment of PMS.
METHODS: We searched eight databases from their inception to August 2022 to identify relevant studies. Only randomized controlled trials (RCTs) focusing on acupoint application combined with CHM for the treatment of PMS were included in this study. To assess the clinical efficacy and safety, meta-analysis was used to quantitively synthesize the effect estimates. Subgroup analysis, publication bias assessment and sensitivity analysis were also performed. We further assessed whether the included studies had reported on the purity and potency of the CHM used in their trials.
RESULTS: A total of 8 RCTs with 560 participants were included in the systematic review and meta-analysis, of which none of them included a description of an independent testing of purity or potency of the CHM product used. There were significant differences between the acupoint application combined with CHM and CHM alone in terms of Kupperman Menopausal Index (KMI) score (MD = -2.91, 95%CI: -3.91 to -1.91), total effective rate (RR = 1.22, 95% CI: 1.11-1.34), Pittsburgh Sleep Quality Interview (PSQI) score (MD = -2.86, 95% CI: -3.61 to -2.10) and reduction in the serum level of luteinizing hormone (LH) (MD = -2.52, 95% CI: -4.70 to -0.34), whereas there were no differences between the two groups regarding lowering serum level of follicle-stimulating hormone (FSH) (MD = -1.66, 95% CI: -3.98-0.67) and elevating serum level of oestradiol (E2) (MD = 2.41, 95% CI: -0.70-5.52). For the comparation between the acupoint application combined with CHM and western medicine (WM), the KMI score (MD = -6.80, 95%CI: -7.95 to -5.65) was substantially different, while the PSQI score (MD = -0.60, 95% CI: -1.88-0.68) was not substantially different. The total effective rate in the combined group (91.7%) was higher than the western medicine group (83.49%).
CONCLUSIONS: Acupoint application combined with CHM may enhance the efficacy and safety of patients with PMS. However, due to the lack of description of an independent testing of purity or potency of the CHM product used in the trials, as well as blinding of participants and investigators, these results should be interpreted with caution.
OBJECTIVE: The purpose of this systematic review and meta-analysis was to evaluate the clinical efficacy and safety of the acupoint application combined with the CHM for the treatment of PMS.
METHODS: We searched eight databases from their inception to August 2022 to identify relevant studies. Only randomized controlled trials (RCTs) focusing on acupoint application combined with CHM for the treatment of PMS were included in this study. To assess the clinical efficacy and safety, meta-analysis was used to quantitively synthesize the effect estimates. Subgroup analysis, publication bias assessment and sensitivity analysis were also performed. We further assessed whether the included studies had reported on the purity and potency of the CHM used in their trials.
RESULTS: A total of 8 RCTs with 560 participants were included in the systematic review and meta-analysis, of which none of them included a description of an independent testing of purity or potency of the CHM product used. There were significant differences between the acupoint application combined with CHM and CHM alone in terms of Kupperman Menopausal Index (KMI) score (MD = -2.91, 95%CI: -3.91 to -1.91), total effective rate (RR = 1.22, 95% CI: 1.11-1.34), Pittsburgh Sleep Quality Interview (PSQI) score (MD = -2.86, 95% CI: -3.61 to -2.10) and reduction in the serum level of luteinizing hormone (LH) (MD = -2.52, 95% CI: -4.70 to -0.34), whereas there were no differences between the two groups regarding lowering serum level of follicle-stimulating hormone (FSH) (MD = -1.66, 95% CI: -3.98-0.67) and elevating serum level of oestradiol (E2) (MD = 2.41, 95% CI: -0.70-5.52). For the comparation between the acupoint application combined with CHM and western medicine (WM), the KMI score (MD = -6.80, 95%CI: -7.95 to -5.65) was substantially different, while the PSQI score (MD = -0.60, 95% CI: -1.88-0.68) was not substantially different. The total effective rate in the combined group (91.7%) was higher than the western medicine group (83.49%).
CONCLUSIONS: Acupoint application combined with CHM may enhance the efficacy and safety of patients with PMS. However, due to the lack of description of an independent testing of purity or potency of the CHM product used in the trials, as well as blinding of participants and investigators, these results should be interpreted with caution.
摘要：
背景：越来越多的女性患有围绝经期综合征（PMS），并且这种疾病的全球负担一直在稳步上升。穴位贴敷疗法和中药(CHM)被广泛用作治疗PMS的有效方法,但疗效不一致,应通过定量分析总结证据.
目的：本系统评价和荟萃分析的目的是评价穴位贴敷联合CHM治疗PMS的临床疗效和安全性。
方法：我们搜索了从成立到2022年8月的8个数据库，以确定相关研究。本研究仅包括以穴位贴敷联合CHM治疗PMS的随机对照试验（RCT）。为了评估临床疗效和安全性，荟萃分析用于定量综合效果估计。亚组分析,我们还进行了发表偏倚评估和敏感性分析.我们进一步评估了纳入的研究是否报道了其试验中使用的CHM的纯度和效力。
结果：共有8个RCT，560名参与者被纳入系统评价和荟萃分析，其中没有一项包括对所用CHM产品的纯度或效力的独立测试的描述。穴位贴敷联合CHM与单纯CHM在Kupperman更年期指数(KMI)评分方面有显著性差异(MD=-2.91,95CI:-3.91~-1.91),总有效率(RR=1.22，95%CI：1.11至1.34)，匹兹堡睡眠质量访谈（PSQI）得分（MD=-2.86，95％CI：-3.61至-2.10）和血清黄体生成素（LH）水平降低（MD=-2.52，95％CI：-4.70至-0.34），而两组之间在降低血清促卵泡激素（FSH）水平（MD=-1.66，95％CI：-3.98至0.67）和升高血清雌二醇（E2）水平（MD=2.41，95％CI：-0.70至5.52）方面没有差异。为了比较穴位贴敷联合CHM和西药（WM）之间的差异，KMI评分（MD=-6.80，95CI：-7.95至-5.65）有很大不同，而PSQI评分(MD=-0.60,95%CI:-1.88~0.68)无实质差异。联合组总有效率(91.7%)高于西药组(83.49%)。
结论：穴位贴敷联合CHM可提高PMS患者的疗效和安全性。然而,由于缺乏对试验中使用的CHM产品的纯度或效力的独立测试的描述，以及对参与者和调查人员的致盲，这些结果应谨慎解释.
目的：本系统评价和荟萃分析的目的是评价穴位贴敷联合CHM治疗PMS的临床疗效和安全性。
方法：我们搜索了从成立到2022年8月的8个数据库，以确定相关研究。本研究仅包括以穴位贴敷联合CHM治疗PMS的随机对照试验（RCT）。为了评估临床疗效和安全性，荟萃分析用于定量综合效果估计。亚组分析,我们还进行了发表偏倚评估和敏感性分析.我们进一步评估了纳入的研究是否报道了其试验中使用的CHM的纯度和效力。
结果：共有8个RCT，560名参与者被纳入系统评价和荟萃分析，其中没有一项包括对所用CHM产品的纯度或效力的独立测试的描述。穴位贴敷联合CHM与单纯CHM在Kupperman更年期指数(KMI)评分方面有显著性差异(MD=-2.91,95CI:-3.91~-1.91),总有效率(RR=1.22，95%CI：1.11至1.34)，匹兹堡睡眠质量访谈（PSQI）得分（MD=-2.86，95％CI：-3.61至-2.10）和血清黄体生成素（LH）水平降低（MD=-2.52，95％CI：-4.70至-0.34），而两组之间在降低血清促卵泡激素（FSH）水平（MD=-1.66，95％CI：-3.98至0.67）和升高血清雌二醇（E2）水平（MD=2.41，95％CI：-0.70至5.52）方面没有差异。为了比较穴位贴敷联合CHM和西药（WM）之间的差异，KMI评分（MD=-6.80，95CI：-7.95至-5.65）有很大不同，而PSQI评分(MD=-0.60,95%CI:-1.88~0.68)无实质差异。联合组总有效率(91.7%)高于西药组(83.49%)。
结论：穴位贴敷联合CHM可提高PMS患者的疗效和安全性。然而,由于缺乏对试验中使用的CHM产品的纯度或效力的独立测试的描述，以及对参与者和调查人员的致盲，这些结果应谨慎解释.
