In this study, 81 postmenopausal women completed a 12 week course of treatment in a prospective, randomized, placebo-controlled double-blinded trial. They received either two daily doses of either 30 mg of pomegranate seed oil (PGS) containing 127 mcg of steroidal phytoestrogens per dose or a placebo. The women reported their symptoms with a daily diary using the Menopause Rating Scale. This scale assessed heart discomfort, sleeping disorders, hot flashes, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, vaginal dryness, and joint and muscular discomfort. At baseline and after the 12 weeks, the forms were collected, although phone interviews were done at 4, 8 and 24 weeks. At the initial visit and after 12 weeks of treatment, blood tests were taken including estradiol, thyroid stimulating hormone, prolactin, follicle-stimulating hormone (FSH), luteinizing hormone (LH), testosterone and progesterone.
While 100 women completed the trial, 19 did not meet the criteria for postmenopause based on FSH levels therefore, data for 81 women were used to analyze the results.
After the 12 weeks of treatment, PGS reduced the number of hot flashes by 4.3 per day and the placebo reduced it by 2.5 per day. Both groups were significantly improved compared to prior to the PGS or the placebo, but the pomegranate group was not statistically significant compared to the placebo group. Interestingly though, 12 weeks after the treatment was stopped, the reduction of hot flashes was significantly different between the PGS and the placebo. The overall total score of the Menopause Rating Scale did decrease in the PGS group from 16.0 to 9.0 at week 12 and from 18.0 to 14.5 in the placebo group. In looking at just the somatic symptoms, the PGS group did have a stronger response that was attributed mainly to an improvement in sleep disorder issues. There was no effect of PGS on hormone levels.
Summary: The not so good news is that pomegranate seed oil in this dose, in this study, did reduce the frequency of hot flashes significantly, but so did the placebo. The better news is that when looking at the overall Menopause Rating Scale sum score, including the severity of hot flashes, there was a trend toward a reduction in menopausal symptoms compared with placebo, although it did not reach the level of significance. In addition, the frequency of sleeping disorders did decrease significantly with the pomegranate seed oil, and after 12 weeks, at the end of the treatment, the difference between PGS and placebo in the reduction of hot flashes was significant. It’s hard to understand the meaning of that, but there is some suggestion of some sustainable, lingering effect of the PGS. Other good news is that they studied it at all, and this is actually the first prospective randomized, placebo-controlled, double-blinded trial that has investigated the effects of pomegranate seed oil on hormone levels in women who are postmenopausal.
Reference
Auerbach L, Rakus J, Bauer C, et al. Pomegranate seed oil in women with menopausal symtpoms: a prospective randomized, placebo-controlled, double-blinded trial. Menopause 2012; 19(4):426-432
