To our knowledge this is the first report of the effect of flaxseed on PCOS. Findings suggest that flaxseed may have a profound impact on testosterone levels, and also may diminish symptoms associated with hyperandrogenism, such as hirsutism. The reductions in androgen levels observed in this case study far surpass those reported with any other dietary intervention conducted to date. For example, Holte and colleagues (1995)
reported a decrease of 36% in serum testosterone among (n=13) PCOS patients who participated in a weight reduction intervention and experienced a mean weight loss of 12.4 kg. An effect size of similar magnitude was observed by Kiddy and associates (1992)
who reported a 31% decrease in free testosterone levels over a 6–7 month period with a 1000 kcal low fat diet among (n=24) women with PCOS. An earlier study by Pasquali and colleagues (1989) reported comparable results during an 8-month period with a 1000–1500 kcal diet of a 36% decrease in testosterone levels in (n=20) women with PCOS. Further, our results which show significant declines in both free and total testosterone ranging from 70–89% are in clear contrast to those of Huber-Buchholz and associates (1999)
, who tested a diet and exercise weight management intervention (n=18) and observed a 21% decrease in free testosterone with a concomitant 10% increase in total testosterone. Thus, the data from this case study are intriguing since results suggest that the reductions in androgen levels afforded by flaxseed supplementation are roughly 2–4 fold higher than those reported with other dietary interventions conducted previously.
The reductions in androgen levels observed in this case study of PCOS also exceed those reported with flaxseed supplementations among men with either prostate cancer or abnormal prostatic biopsies. In a pilot study of flaxseed supplementation and concurrent dietary fat restriction among men with prostate cancer (n=25), Demark-Wahnefried and associates (2001)
found only a 15% decrease in testosterone levels; however this study was only conducted over a period averaging 34-days. Furthermore, no difference in testosterone levels was observed with flaxseed supplementation and dietary fat restriction in a study of men with abnormal prostatic biopsies (n=15) (Demark-Wahnefried et al, 2003). Thus, the magnitude of effect on androgen levels observed in this case study is fairly impressive, as is the accompanying self-report of diminished hirsutism (a troubling and prevalent symptom in this patient population).
Currently the standard of care treatment for women with PCOS ranges from lifestyle modification to pharmacological interventions. Lifestyle modifications are associated with diet, weight loss, and exercise programs. Pharmacological interventions include; antiandrogens (Spironolactone, Flutamide), insulin lower agents (Metformin and thiazolidinediones), and estrogen-progestin combination (Oral contraceptives). (Dronavalli et al, 2007
) While effective, such treatment is associated with substantial cost and may cause various side effects, such as irregular menstruation, gastrointestinal symptoms, weight gain, and increased insulin resistance. In contrast, the costs and side effects associated with flaxseed supplementation are minimal in comparison and primary relate to flaxseed’s laxative effect.
The limitations of this case study are clear, in that the data emanate from a sample of only one and from data collected at only two time points (baseline and follow-up). Furthermore, while we attempted to reduce variability in androgen assessments by performing phlebotomy during identical windows of time during the day, and by the same laboratory, the direct assays used to assess androgen levels, have been criticized for their unreliability, especially within ranges that fall below 300 ng/dl. (Rosner et al, 2007
). Finally, clinical symptoms of PCOS were not collected using a standardized protocol and validated instruments. Despite these limitations, the data are still compelling. Such data point to the need for further research in this area, to more thoroughly explore the effects of flaxseed supplementation on hormonal markers and clinical symptoms associated with PCOS.