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针刺治疗子宫内膜异位症相关疼痛的疗效:一项多中心随机单盲安慰剂对照试验。

Efficacy of acupuncture for endometriosis-associated pain: a multicenter randomized single-blind placebo-controlled trial.

机构信息

Institute of Obstetrics and Gynecology, Jiangxi University of Chinese Medicine, Jiangxi, People's Republic of China; Department of Gynecology, the Affiliated Hospital of Jiangxi University of Chinese Medicine, Jiangxi, People's Republic of China.

Reproductive Science, the Second Affiliated Hospital of Jiangxi University of Chinese Medicine, Jiangxi, People's Republic of China.

出版信息

Fertil Steril. 2023 May;119(5):815-823. doi: 10.1016/j.fertnstert.2023.01.034. Epub 2023 Jan 27.

DOI:10.1016/j.fertnstert.2023.01.034
PMID:36716811
Abstract

OBJECTIVE

To evaluate the efficacy and safety of acupuncture in the treatment of endometriosis-associated pain.

DESIGN

A multicenter, randomized, single-blind, placebo-controlled trial.

INSTITUTIONS

Four tertiary hospitals in Jiangxi and Hainan Provinces.

SUBJECTS

Women with endometriosis-associated pain aged between 20 and 40 years.

INTERVENTION

Subjects were assigned randomly to receive either acupuncture or sham acupuncture treatment for 12 weeks, starting one week before each expected menstruation and administered as a 30-minute session once per day, 3 times a week. During the menstruation period, acupuncture was administered daily when pelvic pain associated with endometriosis occurred. After acupuncture or sham acupuncture treatment, the subjects were followed for another 12 weeks.

MAIN OUTCOME MEASURES

Changes in maximum pain as assessed with the visual analog scale (VAS) for various pelvic pain, duration of dysmenorrhea, and scores on the Multidimensional Pain Inventory, Beck Depression Inventory, Profile of Mood States, and Endometriosis Health Profile from baseline to week 12 and week 24.

RESULTS

A total of 106 women were assigned randomly to the acupuncture and sham groups. In the acupuncture group, the reduction in the dysmenorrhea VAS score was significantly greater after treatment, but not at the end of the trial, compared to the sham group. The duration of pain was significantly shorter in the acupuncture group. All test scores were improved to a significantly greater extent in the acupuncture group than in the sham group at week 12 but not at week 24. Changes in nonmenstrual pelvic pain and dyspareunia VAS scores were not different between the groups. No severe adverse events or differences in adverse events were recorded.

CONCLUSION

Acupuncture is an effective and safe method of relieving dysmenorrhea, shortening the pain duration, and improving wellbeing and quality of life in women with endometriosis-associated pain, although its efficacy fades after treatment is discontinued.

CLINICAL TRIAL REGISTRATION NUMBER

NCT03125304.

摘要

目的

评估针灸治疗子宫内膜异位症相关疼痛的疗效和安全性。

设计

多中心、随机、单盲、安慰剂对照试验。

机构

江西省和海南省的四家三级医院。

受试者

年龄在 20 至 40 岁之间、患有子宫内膜异位症相关疼痛的女性。

干预措施

受试者随机分为接受针灸或假针灸治疗 12 周,从每次预期月经前一周开始,每周 3 次,每天 1 次,每次 30 分钟。在月经期,当与子宫内膜异位症相关的盆腔疼痛发生时,每天进行针灸治疗。针灸或假针灸治疗后,对受试者进行另外 12 周的随访。

主要观察指标

基线至 12 周和 24 周时,视觉模拟量表(VAS)评估的各种盆腔疼痛的最大疼痛变化、痛经持续时间以及多维疼痛量表、贝克抑郁量表、状态-特质焦虑量表和子宫内膜异位症健康量表的评分。

结果

共有 106 名女性被随机分配至针灸组和假针灸组。与假针灸组相比,针灸组治疗后痛经 VAS 评分的降低更为显著,但在试验结束时则不然。针灸组的疼痛持续时间明显缩短。与假针灸组相比,在 12 周时,针灸组的所有测试评分均有显著改善,但在 24 周时则不然。非经期盆腔疼痛和性交痛 VAS 评分的变化两组间无差异。未记录到严重不良事件或不良事件的差异。

结论

针灸是缓解子宫内膜异位症相关疼痛、缩短疼痛持续时间、改善女性幸福感和生活质量的有效且安全的方法,尽管其疗效在治疗停止后会消退。

临床试验注册号

NCT03125304。

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