Effects of a Herbal Formulation on Premenstrual Symptoms: A Randomized Controlled Trial

Abstract

Objective: To determine the efficacy and safety of a herbal formulation, Premenefa®, containing chasteberry (Vitex agnus castus), cramp bark (Viburnum opulus), vitamin E, bioflavonoids (vitamin P complex), borage oil, and flaxseed oil, in controlling premenstrual symptoms.Background: Although many women do not satisfy strict diagnostic criteria for premenstrual syndrome (PMS), they may still experience premenstrual symptoms. Regardless of whether a woman has specific symptoms or a symptom complex such as premenstrual syndrome, persistence of premenstrual symptoms in spite of standard treatment leads many of these women to unsupervised use of non-prescription products, increasingly herbal preparations. However, few randomized studies have assessed effectiveness and safety of herbal products.Methods: This study was a randomized, double-blind, placebo-controlled, crossover trial of a herbal preparation proposed to alleviate premenstrual symptoms (Premenefa®). Participants were randomized to start either on the herbal preparation or on placebo. Crossover occurred after three menstrual cycles. Seventy-four women completed six cycles, three each on formulation and placebo. The primary outcome variable was global scores for 15 premenstrual symptoms. Individual symptom scores were also recorded and analyzed.Results: Global premenstrual symptom scores were significantly lower in the formulation cycles than in the placebo cycles (p < 0.0001).The difference was observed from the first cycle and increased progressively from the first cycle to the third cycle. Of subjects who completed the study, 62, 78, and 85 percent experienced at least a 50 percent lower score while on the herbal preparation for cycles one, two, and three respectively (p = 0.002 for cycles one to two, cycles two to three non-significant). Twenty-three, 34, and 61 percent of subjects experienced at least a 70 percent lower score (p = 0.0614 for cycles one to two; p = 0.001 for cycles two to three). All individual symptom scores improved significantly in the treated cycles. For nine symptoms, the improvement was observed from the first cycle and progressed significantly through the second and third cycles.Conclusion: Premenefa® afforded significant relief of premenstrual symptoms and was well tolerated. This formulation represents a possible choice for women presenting with premenstrual symptoms.