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英国医疗服务体系中更年期症状的中医治疗:是否有必要进行临床试验?

Chinese medicine treatment for menopausal symptoms in the UK health service: is a clinical trial warranted?

作者信息

Scheid Volker, Tuffrey Veronica, Weijburg Thomas, Bovey Mark, Ward Trina

机构信息

EASTmedicine, Faculty of Science and Technology, University of Westminster, 115 New Cavendish Street, London W1W 6UW, United Kingdom.

Faculty of Science and Technology, University of Westminster, 115 New Cavendish Street, London W1W 6UW, United Kingdom.

出版信息

Maturitas. 2015 Feb;80(2):179-86. doi: 10.1016/j.maturitas.2014.11.006. Epub 2014 Nov 20.

Abstract

OBJECTIVES

The aims of this pilot study were to evaluate treatment effects, ascertain safety and formulate best practice Chinese medicine protocols relevant for London women suffering from menopausal symptoms.

STUDY DESIGN

This clinical pilot study employed a case series design within a wider action-based research project. 117 perimenopausal women between 45 and 55 years of age recruited from the general population were treated for menopausal symptoms by six experienced practitioners of Chinese medicine at the Polyclinic of the University of Westminster. Practitioners were instructed to treat as near to their usual practice style as possible. This involved using Chinese herbal medicine and/or acupuncture along with dietary and lifestyle advice. A maximum of 12 treatments over 6 months was allowed per patient.

OUTCOME MEASURES

The menopause specific quality of life questionnaire (MenQoL), the Greene climacteric scale, and flushing diaries were used to evaluate treatment outcomes. Liver and kidney function tests were carried out at intake and after 1, 6 and 12 treatments to evaluate the safety particularly in relation to the use of herbal medicines.

RESULTS

Patients showed significant improvement across all domains measured by the MenQoL and Greene climacteric scales. Reduction on the MenQoL scale between first and last visit was from 4.31 to 3.27 (p<0.001) and on the Green climacteric scale from 21.01 to 13.00 (p<0.001). Study participants did not reliably complete their flushing diaries. No adverse events or abnormal liver or kidney function values were observed during the course of the study.

CONCLUSIONS

Further research that seeks to investigate the effects observed in more detail and to evaluate them against other forms of treatment and/or no-treatment controls is warranted. This could be achieved by way of a pragmatic randomized controlled trial that evaluated Chinese medicine against orthodox medical care.

摘要

目的

本试点研究的目的是评估治疗效果、确定安全性并制定适用于有更年期症状的伦敦女性的最佳中医治疗方案。

研究设计

本临床试点研究在一个更广泛的基于行动的研究项目中采用了病例系列设计。从普通人群中招募的117名45至55岁的围绝经期女性,由威斯敏斯特大学综合诊所的六位经验丰富的中医师治疗更年期症状。要求中医师尽可能按照他们通常的治疗方式进行治疗。这包括使用中药和/或针灸以及饮食和生活方式建议。每位患者在6个月内最多接受12次治疗。

观察指标

使用更年期特定生活质量问卷(MenQoL)、格林更年期量表和潮热日记来评估治疗效果。在入组时以及接受1次、6次和12次治疗后进行肝肾功能检查,以评估安全性,特别是与使用草药有关的安全性。

结果

患者在MenQoL和格林更年期量表测量的所有领域均显示出显著改善。MenQoL量表上首次就诊与最后就诊之间的降幅从4.31降至3.27(p<0.001),格林更年期量表上从21.01降至13.00(p<0.001)。研究参与者未可靠地完成他们的潮热日记。在研究过程中未观察到不良事件或肝肾功能异常值。

结论

有必要进行进一步的研究,以更详细地调查所观察到的效果,并将其与其他治疗形式和/或无治疗对照进行评估。这可以通过一项务实的随机对照试验来实现,该试验将中医与传统医疗护理进行比较。

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