مقایسه اثر ملیس با سیتالوپرام و دارونما در درمان اختلالات خواب زنان یائسه: کارآزمایی بالینی

Background: Different treatment used for resolving menopausal problems. Some studies assayed effectiveness of citalopram but it had some side effects and other studies about medicinal plants in Iran, including Melissa (combination of officinalis and foeniculum vulgare) showed improvement insomnia and anxiety. This study decided to assay effectiveness of this drug and comparison with placebo and citalopram in treatment of sleep disturbance of menopausal women. Methods: Sixty postmenopausal women suffering from sleep disturbances that referred to Yas hospital between 2011-2013 were recruited to this double blind controlled study with 8 weeks’ follow-up period. They were randomized in three groups of twenty patients each, group A: received Melissa 600 mg that made by traditional medical school, group B: received citalopram 20 mg from Arya company that increased to 30 mg after one week and group C: received placebo. The patients were evaluated by Pittsburgh Sleep Quality Index (PSQI) questionnaire before and after treatment, also we checked the side effects of every drugs. Study was dissertation of one of the author with code 22263. This research has been supported by Tehran University of Medical Sciences and Health Services Grant. This study was registered at Iranian Registry of Clinical Trials with code of IRCT2013072714174N1. Results: Pittsburgh sleep quality index improved significantly in all groups, there was significant differences between Melissa group and two other group, but there wasn’t significance difference between citalopram and placebo group, there was a trend in favor of Melissa versus citalopram and placebo. All of seven field of PSQI improved significantly in all groups that showed improvement of sleep quality in all field of sleep disturbance. Conclusion: Melissa (compound of officinalis and foeniculum vulgare) may be recommended for the treatment of sleep disturbances in postmenopausal women. Although further investigation with more cases is needed to find long-term results and compare with hormone therapy.