Mahdavian Mitra, Mirzaii Najmabadi Khadijeh, Hosseinzadeh Hossein, Mirzaeian Sara, Badiee Aval Shapour, Esmaeeli Habibollah
Department of Midwifery, Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of pharmacology, Faculty of pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
J Caring Sci. 2019 Sep 1;8(3):181-189. doi: 10.15171/jcs.2019.026. eCollection 2019 Sep.
Menopause is the transition from the reproductive phase of a woman to the non-reproductive. It may impair quality of life. The study aims to determine the effectiveness of mixed herbal medicines on menopause symptoms A randomized, triple-blind, clinical trial and placebo-controlled study on 120 peri-menopausal women aged 45-65 years for 12 weeks. All participants took herbal extracts drops orally daily and randomly allocated into four groups: placebo (C), A (250 mg chamomile, 30 mg fennel, 15 mg saffron), B (1000 mg, 120 mg, 60 mg), and D (500 mg, 60 mg, 30 mg). Primary outcome was the mean change in scores of the menopause rating scale that evaluates 11 symptoms. The median (IQR) physical score significantly reduced from 8.5(4) to 2(3), in psych score reduced from 12(4) to 2 (2) and in urogenital score reduced from 6.5(3) to 3(2) in group B. In group D physical score decreased from 12(6) to 8(4), in psychological score reduced from12 (3) to 8(4) and urogenital score reduced from 7.5 (3) to 8(3) at week 12. No significant differences in group A and C. With comparison the scores of physical, psych and urogenital domain of MRS questionnaire in 1th ,6th and 12th, no significant difference within group A and C were seen, but statistically significant difference was within group B (p<0.001) and D (p<0.001) in all weeks. The effect size was 0.92. A 12 weeks extracts treatment, there were significant improvement in physical, psychological and urogenital domains in group B.
更年期是女性从生殖阶段向非生殖阶段的过渡。它可能会损害生活质量。本研究旨在确定混合草药对更年期症状的有效性。这是一项针对120名年龄在45至65岁之间的围绝经期女性进行的为期12周的随机、三盲、临床试验及安慰剂对照研究。所有参与者每天口服草药提取物滴剂，并随机分为四组：安慰剂组（C组）、A组（250毫克洋甘菊、30毫克茴香、15毫克藏红花）、B组（1000毫克、120毫克、60毫克）和D组（500毫克、60毫克、30毫克）。主要结局是评估11种症状的更年期评定量表评分的平均变化。B组的身体评分中位数（四分位间距）从8.5（4）显著降至2（3），心理评分从12（4）降至2（2），泌尿生殖系统评分从6.5（3）降至3（2）。在第12周时，D组的身体评分从12（6）降至8（4），心理评分从12（3）降至8（4），泌尿生殖系统评分从7.5（3）降至8（3）。A组和C组无显著差异。比较MRS问卷在第1、6和12周时身体、心理和泌尿生殖系统领域的评分，A组和C组内未见显著差异，但B组（p<0.001）和D组（p<0.001）在所有周均有统计学显著差异。效应大小为0.92。经过12周的提取物治疗，B组在身体、心理和泌尿生殖系统领域有显著改善。
