The Effects of Combined Low-Dose Oral Contraceptives and Vitex Agnus on the Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome: A Triple-Blind, Randomized, Controlled Clinical Trial

Abstract

Background: Polycystic ovarian syndrome (PCOS) is the most common hormonal disorder in reproductive-age women. This syndrome is associated with many complications, so treatment of the disorder is usually warranted. Objectives: To evaluate the effects of a combined low-dose oral contraceptive (LD) and Vitex agnus on the improvement of clinical and paraclinical parameters of PCOS. Methods: This triple-blind, controlled trial was performed in 2015 in 70 women aged 18-45 years with PCOS in the clinics of the Alzahra and Taleghani hospitals and at other health centers in Tabriz, Iran, using a purposive sampling method. The women were randomized to either the LD or Vitex agnus groups. Regulation of menstrual cycle length, free testostrone, DHEA-S (Dehydroepiandrosterone sulfate), prolactin levels were assessed both before and after three cycles. Results: The socio-demographic characteristics of the two groups were homogeneous before the intervention began. No significant statistical differences were identified between the LD and Vitex agnus groups three months after the intervention in terms of normalization of the menstrual cycle duration, means of free testostrone levels, DHEA-S, prolactin serum levels, and side effects. Three months after the intervention, the menstrual cycle duration in about 68.6% of the LD group members and 60% of the Vitex agnus group members became normal. The average levels of serum free testosterone and prolactin in both the LD and Vitex agnus groups had no differences three months after the intervention compared to prior to the intervention. The mean of the serum DHEA-S level in both the LD (Mean Difference (MD) = -0.52; [95% CI: -0.85 to -0.18]) and the Vitex agnus groups (MD = -0.60; [95% CI: -0.79 to -0.40]) decreased significantly three months after the intervention when compared with before the intervention. Conclusions: This study showed that LD and Vitex agnus were both effective in normalizing the menstrual cycle and reducing DHEAS, but they had no impact on the serum free testosterone or prolactin levels. The effects of LD and Vitex agnus on the normalization of the menstrual cycle and the means of serum prolactin, free testosterone, and DHEA-S levels in the women with PCOS were similar. Therefore, Vitex agnus can be used in place of LD.