The Effect of Combined Herbal Capsule on Constipation and Sexual Function of Postmenopausal Women with Chronic Constipation: A Triple Blind Randomized Controlled Trial

Abstract

Abstract Background: Menopause is a physiological period in women's life. Women experience hormonal changes, such as hot flashes, sexual dysfunction, vaginal dryness, sleep disorders, constipation, and so on. Considering the high prevalence of chronic constipation and sexual dysfunction in postmenopausal women, its effects on quality of life and health of individuals and increasing the tendency to use complementary medicine, especially traditional medicine, this study was conducted to determine the effect of combined herbal capsules on chronic constipation and sexual dysfunction in postmenopausal women. Methods: This randomized, controlled triple-blind clinical trial was conducted on 64 menopausal women aged 40-60 years with chronic constipation. Individuals were randomly assigned to two intervention group (combined herbal capsule) and control group (placebo). A combination herbal capsule containing clove plants, Pimpinella anisum and F.Vulgare, violet flowers, Terminalia chebula and Vitis vinifera, Senna leaves, Alhagi maurorum and Golqand. Constipation questionnaire (CQ) was completed before the intervention and then weekly, and the patient's assessment of constipation symptoms questionnaire (PAC-SYM) was completed before the intervention, two and four weeks after the intervention by the participants. The female sexual function questionnaire (FSFI) was completed before the intervention and four weeks after the intervention by the participants. ANCOVA repeated measure and ANCOVA with baseline adjustment, Mann-Whitney U, Friedman, Chi-square and independent t testS were used for data analysis. Results: There was no statistically significant difference between the two groups in terms of socio-demographic characteristics, constipation symptoms and the total mean score of sexual function and its sub-domains before the intervention (P>0.05). After the intervention, the average frequency of bowel movements in the intervention group was significantly higher than the control group (adjusted mean difference = 4.2; 95% confidence interval = 0.3 to 4.5). Also, the straining during defecation, the amount of stool, incomplete defecation, sensation of obstruction during defecation, and the need for manipulation to facilitate the removal of stools had a significant reduction in the combined herbal capsule group than the placebo group (P <0.001). The amount and consistency of defecation were also improved in both groups, but there was a significant difference in the healing in the combined herbal capsule group compared to the placebo group (P <0.001). The mean score of constipation symptoms in the intervention group was significantly decreased compared to the control group (adjusted mean difference was = -15.4; 95% confidence interval = -11.5 to- 19.29). Also, after the intervention, the total mean score of sexual function in the intervention group was significantly higher than the control group (adjusted mean difference: 8.7, 95% confidence interval = 6.6 to 10.8). Moreover, there was a significant difference in mean score of libido (0.9; 0.6 to 1.3), arousal (1.3; 0.9 to 1.6), moisture (1.5; 1.0 to 1.9), orgasm (1.6; 1.2 to 2.1), satisfaction (2.1; 1.6 to 2.6), and pain (1.5; 1.0 to 1.9) during intercourse between the two groups after the intervention (P<0.001). Conclusion: Based on the results of this study, the use of herbal capsules improves chronic constipation and sexual function in postmenopausal women.