Tandon Vishal R, Mahajan Annil, Sharma Sudhaa, Khajuria Vijay
Department of Pharmacology, GMC, Jammu, Jammu and Kashmir, India.
Department of Medicine and, Jammu, Jammu and Kashmir, India.
J Midlife Health. 2020 Jul-Sep;11(3):120-125. doi: 10.4103/jmh.JMH_130_20. Epub 2020 Sep 29.
The aim of this study is to compare the effect of clonazepam and nortryptiline on menopausal symptoms in above 40 years women.
A prospective, randomized, open-label comparative study was conducted in a tertiary care teaching hospital for 1 year. Patients were randomized into two groups. Both the groups had 60 patients, out of which Group A had 39 menopausal patients and Group B had 31 menopausal patients, respectively. Group 1 received tablet clonazepam 0.5 mg bed time orally daily. Group 2 received tablet nortryptiline 25 mg bed time orally daily. The primary efficacy end points were effect on menopausal symptoms evaluated by at 0, 4, and 8 weeks.
Mean age since menopause was 45 ± 4.06 years, and the mean number of years since menopause was 9.18 ± 7.59 years clonazepam and nortryptiline recorded statistically comparable effect with numerical superiority of nortryptiline both at 4 and 8 weeks on mean Menopausal Symptom Score, thereby indicating that both the drugs may have directly/indirectly improved the mean menopausal symptoms equally. Improvement in the clonazepam group was numerically and statistically more than nortryptiline group at 4 and 8 weeks on mean Vasomotor Symptom Score with < 0.01 in clonazepam group and < 0.05 in nortryptiline group both at 4 and 8 weeks. Both the drugs showed comparable results on psychosocial symptom score both at 4 and 8 weeks with numerical superiority in nortryptiline group. Clonazepam group showed more improvement on mean physical score than nortryptiline group numerically and statistically. Both the drugs showed comparable results on mean sexual symptom score at 4 weeks, but nortryptiline proved to be statistically better at 8 weeks < 0.01 versus < 0.05 in clonazepam group.
Clonazepam and nortryptiline recorded statistically comparable effect at 4 and 8 weeks on mean menopausal symptom. Both the drugs were equally safe and did not recorded any serious Adverse Drug Reaction (ADRs).
本研究旨在比较氯硝西泮和去甲替林对40岁以上女性更年期症状的影响。
在一家三级护理教学医院进行了一项为期1年的前瞻性、随机、开放标签的对照研究。患者被随机分为两组。两组各有60名患者，其中A组有39名更年期患者，B组有31名更年期患者。第1组每天睡前口服0.5毫克氯硝西泮片。第2组每天睡前口服25毫克去甲替林片。主要疗效终点是在0、4和8周时评估的对更年期症状的影响。
绝经后的平均年龄为45±4.06岁，绝经后的平均年数为9.18±7.59年。氯硝西泮和去甲替林在第4周和第8周时对平均更年期症状评分的影响在统计学上具有可比性，去甲替林在数值上更具优势，这表明两种药物可能直接或间接地同等程度地改善了平均更年期症状。在第4周和第8周时，氯硝西泮组的平均血管舒缩症状评分在数值上和统计学上均高于去甲替林组，氯硝西泮组在第4周和第8周时均<0.01，去甲替林组在第4周和第8周时均<0.05。两种药物在第4周和第8周时的心理社会症状评分结果具有可比性，去甲替林组在数值上更具优势。氯硝西泮组在平均身体评分上比去甲替林组在数值上和统计学上有更多改善。两种药物在第4周时的平均性症状评分结果具有可比性，但在第8周时，去甲替林在统计学上更优，氯硝西泮组为<0.05，而去甲替林组为<0.01。
氯硝西泮和去甲替林在第4周和第8周时对平均更年期症状的影响在统计学上具有可比性。两种药物同样安全，未记录到任何严重的药物不良反应（ADR）。
