Effects of Viola odorata syrup on sleep quality in menopausal women: a randomized, triple-blind, controlled trial.

ABSTRACT

PURPOSE: The present study aimed to assess the effects of Viola odorata syrup on the sleep quality of postmenopausal women. METHODS: This triple-blinded randomized clinical trial was conducted on menopausal women presenting to the healthcare centers in Mashhad, Iran, in 2019. The participants were selected using simple random sampling. Participants received 5 ml syrup V. odorata or placebo twice a day for 1 month. Data were collected using the Pittsburgh Sleep Quality Index. The data were analyzed using SPSS version 25. RESULTS: The 118 eligible women enrolled in the study were divided into two groups of V. odorata syrup and placebo (n = 59 each). The analysis was conducted on only 84 menopausal women (42 in each group) due to exclusions. Exclusions consisted of 12 participants who withdrew from the study due to unwillingness to cooperate, 8 who had irregular consumption of the therapeutic syrup, 6 with inaccurate completion of the questionnaire, and 8 due to lack of accessibility. The two study groups were homogenous in terms of demographic characteristics. Before the intervention, no significant difference was observed in the mean PSQI score between the two groups (9.2 ± 2.9 vs. 8.4 ± 2.5) (P = 0.18). However, a significant difference was seen in the mean PSQI score between the two groups (4.9 ± 1.9 vs. 8.1 ± 2.1, P < 0.001) after the intervention. CONCLUSIONS: The findings of this study suggest that V. odorata syrup may be a useful therapeutic agent to improve the sleep quality of menopausal women. REGISTRATION CODE IRCT20180514039660N1.