Pomegranate seed oil in women with menopausal symptoms: a prospective randomized, placebo-controlled, double-blinded trial

Objective: The aim of this study was to investigate the potential effects of pomegranate seed oil (PGS) on menopausal symptoms. Methods: The prospective randomized, placebo-controlled, double-blinded trial was completed by 81 postmenopausal women, who received two daily doses of either 30 mg PGS containing 127 mu g of steroidal phytoestrogens per dose or a placebo for 12 weeks. The participants reported their number of hot flashes and completed the Menopause Rating Scale II at baseline and at weeks 4, 8, 12, and 24. At baseline and after 12 weeks, hormonal status was determined. Results: After 12 weeks of treatment, PGS reduced the number of hot flashes per day by 4.3 (38.7%), whereas placebo reduced it by 2.5 (25.6%). Both groups were significant compared with baseline, but the treated group was not significant compared with the placebo group (P = 0.17). After 24 weeks, the treated group showed a mean of 7.1 (interquartile range, 4.0) hot flashes per day compared with the placebo group with a mean of 8.8 (interquartile range, 5.0; P = 0.02). Although the overall sum score of the Menopause Rating Scale II parameters at week 12 decreased in the treated group from 16.0 to 9.0 at week 12 and in the placebo group from 18.0 to 14.5 (P = 0.08), the sum score of the vegetative somatic symptoms subgroup decreased strongly versus placebo (P < 0.03), attributable mainly to an improvement in sleeping disorders. PGS did not affect the hormone status, and no adverse effects were reported. Conclusions: In postmenopausal women, PGS does not significantly reduce hot flashes within a 12-week observation period, but further studies are needed to investigate the long-term effect.