Femicomfort in the Treatment of Premenstrual Syndromes: A Double-Blind, Randomized and Placebo Controlled Trial

Article excerpt

Objective: Premenstrual syndromes (PMS) affecting 20-40% of women of reproductive age. The aim of this double blind and placebo controlled trial was to investigate whether femicofort a supplement contains Vitamin B6, Vitamin E and evening primrose oil could relieve symptoms of PMS.

Method: This was a randomized and double blind clinical trial. The trial was conducted between November 2009 and April March 2010. Women aged 20 to 45 years with regular menstrual cycles and experience of PMS symptoms (According to the current diagnostic criteria proposed by the American College of Obstetrics and Gynecology) for at least 6 months were eligible for the study. Patients were randomized to receive femicomfort or placebo in a 1: 1 ratio using a computer-generated code. The assignments were kept in sealed, opaque envelopes until the point of analysis of data. In this doubleblind, patients were randomly assigned to receive capsule of femicomfort (Group A) or capsule placebo for two menstrual cycles (cycles 3 and 4). The primary outcome measure was the Daily Symptom Report, a checklist of 17 premenstrual symptoms rated from 0 to 4 according to their severity throughout the menstrual cycle. Secondary outcome measure was Hamilton Depression Rating Scale (17-item).

Results: Femicomfort at this dose was found to be effective in relieving symptoms of PMS. The difference between the femicomfort and placebo in the frequency of side effects was not significant.

Conclusion: The results of this study indicate the efficacy of femicomfort in the treatment of PMS.

Keywords: Oenothera biennis, Premenstrual syndrome, Vitamin B6, Vitamin E

Iran J Psychiatry 2010; 5:2:47-50

Premenstrual syndromes (PMS) are among the most common health problems reported by women, affecting 20-40% of women of reproductive age. Premenstrual dysphoric disorder (PMDD) is a severe subtype of PMS that occurs in 3-8% of women of reproductive age.(1) It is characterized by severe mood and behavioral changes. The hallmark of PMDD is its cyclical luteal-phase-related nature.(2) The etiology of the syndrome is multifactorial and not fully defined. Initially, a great role in the etiology was attributed to decreased levels of progesterone in the luteal phase. An American telephone survey suggested that up to 80% of self-medicating sufferers use complementary remedies.(3) It has been reported that herbal medicine and vitamin B6 and Vitamin E are useful in relieving PMS symptoms. Evening primrose (Oenothera biennis) is a commonly used alternative therapy for PMS and is a rich source of omega-6 essential fatty acids.(3) The aim of this double blind and placebo controlled trial was to investigate whether femicofort (a supplement) which contains Vitamin B6, Vitamin E and evening primrose oil could relieve PMS symptoms.

Materials and Methods

This was a randomized and double blind clinical trial. The trial was conducted between November 2009 and April March 2010.

Participants

Women aged 20 to 45 years with regular menstrual cycles and experience of PMS symptoms (According to the current diagnostic criteria proposed by the American College of Obstetrics and Gynecology) (4) for at least 6 months were eligible for the study. The exclusion criteria were as follows: pregnancy or lactation; menstrual cycle irregularity; unstable medical illness; seizure disorder within the past year; history of multiple drug reaction; menstrual cycle length shorter than 24 days or longer than 35 days; major psychiatric disorder; suicidal ideation or intent; use of psychoactive drugs, investigational drugs, or specific medication for PMS in the past two months and history of substance abuse in the previous 6 months.

The trial was performed in accordance with the Declaration of Helsinki and subsequent revisions.

Written informed consents were obtained from the participants. Patients were recruited through an advertisement; and written informed consent was obtained. …