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一项柳属植物提取物治疗原发性痛经的双盲对照交叉研究

A double-blind controlled crossover study to investigate the efficacy of salix extract on primary dysmenorrhea.

机构信息

Department of Midwifery, School of Nursing and Midwifery, Shahrekord University of Medical Sciences, Shahrekord, Iran.

Medical Plants Research Center, Shahrekord University of Medical Science, Shahrekord, Iran.

出版信息

Complement Ther Med. 2019 Jun;44:102-109. doi: 10.1016/j.ctim.2019.04.002. Epub 2019 Apr 5.

DOI:10.1016/j.ctim.2019.04.002
PMID:31126541
Abstract

OBJECTIVES

Primary dysmenorrhea in the absence of pelvic pathology is a common gynecologic disorder affecting the quality of life of women of reproductive age. This study evaluates the effect of salix extract on primary dysmenorrhea.

DESIGN

This study was a randomized crossover clinical trial.

SETTING

The study population included 96 female students with level two or three of primary dysmenorrhea: 48 students in the treatment group (sequence I) followed by control (sequence II) and 48 students in control group (sequence I) followed by treatment (sequence II).

INTERVENTIONS

The intervention was salix capsule (400 mg daily) and the active control was mefenamic acid capsule (750 mg daily) as.

MAIN OUTCOMES

Pain intensity, measured by the visual analog scale (VAS), amount of bleeding, and severity of dysmenorrhea symptoms were outcomes. Generalized estimating equations were used for data analysis.

RESULTS

The demographic and menstrual characteristics of the students were homogenous between the groups. The results showed that the students in mefenamic acid group had a significantly higher level of VAS than the students in the salix group over time (1.61 ± 0.06, P < 0.001). The estimated odds of the bleeding level in the salix and mefenamic acid group were not significantly different (P = 0.31). In average, 77.39%±16.18 of the students in salix group showed no symptoms followed by 22.18%±14.08 of the students who experienced mild symptoms. Averagely, 44.58%±20.16 of the students in the mefenamic acid group had mild symptoms followed by moderate symptoms (28.12%±15.29).

CONCLUSIONS

Salix extract significantly decreased dysmenorrhea in comparison to mefenamic acid, as the standard treatment of dysmenorrhea.

摘要

目的

原发性痛经在无盆腔病变的情况下是一种常见的妇科疾病,会影响育龄妇女的生活质量。本研究评估柳提取物对原发性痛经的影响。

设计

这是一项随机交叉临床试验。

设置

研究人群包括 96 名痛经程度为二级或三级的女性学生:48 名治疗组(序列 I)后为对照组(序列 II),48 名对照组(序列 I)后为治疗组(序列 II)。

干预措施

干预措施为柳胶囊(400mg/天),阳性对照为甲芬那酸胶囊(750mg/天)。

主要结局

疼痛强度采用视觉模拟评分(VAS),出血量和痛经症状严重程度为结局。使用广义估计方程进行数据分析。

结果

两组学生的人口统计学和月经特征均具有同质性。结果表明,随着时间的推移,甲芬那酸组学生的 VAS 评分明显高于柳组学生(1.61±0.06,P<0.001)。柳和甲芬那酸组的出血量水平估计比值无显著差异(P=0.31)。平均而言,77.39%±16.18%的柳组学生无明显症状,其次是 22.18%±14.08%的学生有轻度症状。平均而言,44.58%±20.16%的甲芬那酸组学生有轻度症状,其次是中度症状(28.12%±15.29%)。

结论

与作为痛经标准治疗的甲芬那酸相比,柳提取物可显著减轻痛经。

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