The widely anticipated preliminary results of the Kronos Early Estrogen Prevention Study (KEEPS) were released last week, pouring light over the dark shadow cast by the Women’s Health Initiative (WHI.)
The four-year study tested the safety and efficacy of micronized (bioidentical) progesterone combined with either oral (traditional) estrogen (o-CEE) or transdermal (bioidentical) estrogen (t-E2) to treat symptoms of menopause in healthy women aged 42 to 58.
The preliminary results were discussed in-depth in a teleconference last Thursday. The lead researchers spoke to the impressive outcomes including reduced markers of disease and improved quality of life for menopausal women – a life without hot flashes, night sweats, fatigue and low libido.
BodyLogicMD, the largest national network of physicians specializing in bioidentical hormone replacement therapy (BHRT), expressed great enthusiasm for the study’s findings. Dr. Stephen Center, Medical Director of BodyLogicMD of San Diego explains, “I am very pleased to see that the KEEPS preliminary results appear to support what all board-certified and fellowship-trained anti-aging physicians have known for many years. That is, bioidentical hormones help women (and men) feel better, are safe, and can modify the aging process to improve quality of life.” Dr. Center is one among more than 50 physicians nationwide, who for ten years have helped men and women reclaim their health and quality of life through BHRT. Just the sheer number of happy patients suggests this is the future of medicine. Dr. Center continues, “I currently have 500 patients receiving bioidentical hormones along with another five to ten new patients every week who are beginning to start the evaluation and treatment process. I am using bioidentical hormones myself and with my family. I can say with great confidence that this form of treatment is one of the greatest advances in modern medicine in the last 50 years.”
The study tested not only traditional hormone therapy, but the often controversial bioidentical hormone therapy. The outcomes suggest that women suffering from menopause can alleviate many discomforts of this stage in life with hormone therapy. With the combination of progesterone and o-CEE, depression and anxiety was reduced and overall mood was improved. The combination using t-E2 and progesterone, did not impact mood, but was overwhelmingly effective in treating sexual dysfunction. Subjects taking the t-E2 combination therapy experienced increased lubrication, desire, arousal and orgasm and decreased pain during intercourse. The o-CEE combination yielded similar improvements in libido, but not as superior.
Women, who gave up pursuit of hormone therapy for fear of an increased risk of cancer, heart disease or stroke, can look forward to relief once again. The KEEPS study showed no affects – increased risk or reduced risk of cancers during the four-year study. The risk of heart disease was shown to be reduced; however with the small size of the study, this finding is not considered statistically significant.
Dr. Jennifer Landa, Chief Medical Officer of BodyLogicMD and Medical Director of BodyLogicMD of Orlando, explains the differences between this study and the WHI and why women can now make a very educated and informed decision for the betterment of their health. “One of the most important factors being overlooked in the reports is that this study compared the combination of traditional or bioidentical estrogens with micronized progesterone versus progestin, which is most commonly, used in hormone replacement therapy studies (including the WHI.) Progestin in combination with estrogen has been shown in studies to decrease “good” cholesterol (HDL), increase coronary vasospasm, raise blood pressure and cause many negative cardiovascular consequences. On the other hand, progesterone has been shown to have many positive effects on the cardiovascular system including decreasing LDL (“bad” cholesterol), Lp(a) and homocysteine (both independent markers for cardiovascular disease), decreasing blood pressure, decreasing coronary atherosclerosis and relaxing coronary arteries. All of these are positive effects on the cardiovascular system, whereas the opposite is true for progestin.”
“Multiple studies, including the WHI, have previously documented increased risk of breast cancer when estrogen is combined with various forms of progestin, such as medroxyprogesterone acetate. And, in the past, none of these trials were randomized, double blind, placebo controlled trials. KEEPS is a landmark study proving that the combination of estrogen and micronized (bioidentical) progesterone does not increase the risk of breast cancer.” -Jennifer Landa, M.D.
And, much like cardiovascular disease, cancer is no longer considered a risk when choosing hormone therapy. In fact, this study is the first to show no increased risk of breast and ovarian cancers with combined estrogen and progesterone, which may be largely due the use of bioidentical progesterone, rather than progestin. “The WHI showed dangerous increases in the risk of breast cancer when estrogen was combined with progestin, but not when estrogen was used alone,” recalls Dr. Landa. “The KEEPS study, in agreement with many studies of the recent past, shows no increase in breast cancer risk when combined with progesterone over a four-year time period. Multiple studies, including the WHI, have previously documented increased risk of breast cancer when estrogen is combined with various forms of progestin, such as medroxyprogesterone acetate. And, in the past, none of these trials were randomized, double blind, placebo controlled trials. KEEPS is a landmark study proving that the combination of estrogen and micronized (bioidentical) progesterone does not increase the risk of breast cancer.”
The results released last week are merely preliminary, but the story they tell this far will impact healthcare and, the lives of many women, forever. Stay tuned for the full publication of the KEEPS study results later this year.