Comparing Effect of Oral Contraceptive LD and Vitex Agnus in Improved Clinical and Paraclinical Parameters of Poly Cystic Ovarian Syndrome (PCOS): A Triple Blind Randomized Clinical Controlled Trial

Abstract

Abstract: Background: Polycystic ovarian syndrome is the most common hormonal disorder in reproductive-age women. This syndrome is associated with many complications for women, so treatment is necessary. Objectives: To evaluate the effects of combined oral contraceptives LD and Vitex Agnus on Improvement of clinical and paraclinical parameters of polycystic ovarian syndrome Material and methods: This triple-blind controlled trial was performed on 70 women aged 18-45 years with polycystic ovarian syndrome in Clinics of Alzahra and Taleghani hospitals and health centers in 2015 Tabriz, Iran through purposive sampling method. Women were divided into two groups of 35 persons by randomized blocking method. The first group received LD capsule (21 first capsules containing a LD tablet and 7 next capsules containing a placebo) and the second group received Vitex capsule (Each capsule contains two Vitex tablets), 1 times daily for three cycles of 28 days. Demographic and Fertility questionnaires were completed by subjects. Before and after 3 cycles free testosterones, DHEA-S (Dehydroepiandrosterone sulfate), Prolactin were assessed. After 3 cycles regulation of the mensural cycle length was assessed. Results: Socio-demographic and fertility characteristics in two groups were homogeneous before intervention. No significant statistical differences were between the LD and vitex Agnus groups three months after intervention in terms of normalization of menstrual cycle duration, means of free testosterones, DHEA-S, Prolactin serum levels, and side effects (P›0.05). Three months after intervention, the menstrual cycle duration of about 68.6% of the LD group members and 60% of the vitex Agnus group members became normal. The means of free testosterone serum in LD and vitex Agnus group (P=0.26 , P=0.50) and means of prolactin levels in LD and vitex Agnus group (P=0.56, P=0.54) had no differences three months after the intervention as compared to the time before intervention. The mean of DHEA-S serum level in both LD MD (CI 95%) = - 0.52; (-0.85 to -0.18) and vitex Agnus groups MD (CI 95%) = -0.60; (-0.79 to -0.40) decreased significantly three months after intervention as compared with the time before intervention. Conclusions: This study showed that LD and vitex Agnus were effective in normalization of menstrual cycle and reduction of DHEA-S, but they had no effect on free testosterone serum and prolactin levels. The effects of LD and vitex Agnus on normalization of menstrual cycle and means of prolactin, free testosterone, and DHEA-S serum levels in the women with PCO were similar. Therefore, vitex Agnus can be used rather than LD.