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Cincinnati, Ohio and Washington, D.C., October 18, 2004 – New data from a pilot study conducted by Martin B. Scharf, Ph.D., founder of Tri-State Sleep Disorders Center in Cincinnati shows that a plant-derived synthetic conjugated estrogen called Cenestin® (synthetic conjugated estrogens, A) reduced the number of nocturnal hot flashes by nearly 80 percent. The study also found that women taking Cenestin experienced an improvement in sleep latency and total sleep time, falling asleep faster and sleeping for a longer period of time.
"When estrogen levels in a woman's body decrease, their difficulties with sleep increase," said Dr. Scharf, whose data was presented at the 15th Annual Meeting of the North American Menopause Society in Washington, D.C. "Not only does the menopausal woman have to deal with symptoms like hot flashes, but she also has to manage potential increased irritability, depression and loss of well-being resulting from poor sleep."
"This pilot study is encouraging because it showed that when menopausal women took an estrogen therapy like Cenestin, the number of night sweats and hot flashes they experienced was reduced and they seemed to sleep better," said Dr. Scharf.
More than 1.5 million women each year enter menopause in the United States alone(i). Sleep disruptions are common among menopausal women, with more than one third of menopausal/post-menopausal women reporting nocturnal hot flashes as a reason for sleep difficulty(ii).
Study Details
Dr. Scharf's pilot study examined the effect of Cenestin on sleep in post-menopausal women experiencing nocturnal diaphoresis (excessive sweating) and hot flashes. Dr. Scharf explained that Cenestin was chosen for the study since it is derived from plant sources; he felt that women may be more comfortable taking a plant-derived conjugated estrogen that is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes and night sweats) and vulvar and vaginal atrophy (vaginal itching and dryness) associated with menopause.
The pilot study enrolled 19 post-menopausal females between 45 and 60 years of age who experienced an average of two incidences of night sweats and/or hot flashes per night. The women, who were post-menopausal for at least six months, or two months if menopause was induced by the surgical removal of the uterus, received a baseline screening including a physical exam, medical and sleep history, and completed a two-week diary reporting sleep quality, sleepiness and hot flashes.
After a baseline of three nights taking placebo, participants were randomized to either 0.625 mg of Cenestin (n=9) or placebo (n=10) once daily for a six-week period. They were monitored at a sleep center at the start of the trial, and again during the final three days of treatment, using standard monitoring methods to track sleep stages, eye movement, total sleep time, wake time and the number of times they awoke during the night. Galvanic skin responses -- an electrical skin conductance from the palms, face or scalp -- measured sweat gland activity.
Results showed a 79 percent reduction (3.13 at baseline vs. 0.63 at completion; p=0.0477) in the number of hot flashes in the Cenestin group. The mean reduction in galvanic skin responses was also significant, with a 57 percent reduction for the group that received Cenestin (6.25 at baseline vs. 2.67 at completion; p=0.0073). It was noted that patients taking Cenestin had a noticeable clinically significant difference in several sleep monitoring methods, suggesting an improvement in overall sleep quality and supportive of previous conclusions showing the efficacy of hormone therapy in improving sleep efficiency and wakenings.
Important Information About Estrogens
Estrogen use that is unopposed by progestin is associated with an increased risk of endometrial cancer in postmenopausal women with intact uteri. Estrogens should not be used in women with undiagnosed abnormal genital bleeding, known or suspected breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis, thromboembolic disorders, active or recent arterial thromboembolic disease, or pregnancy. Estrogens should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis. Due to these risks, estrogen with or without progestins should be prescribed at the lowest effective dose for the shortest duration, consistent with treatment goals and risks for the individual woman; periodic clinical reevaluation of such therapy is also advised.
About the Tri-State Sleep Disorders Center
Tri-State Sleep Disorders Center, based in Cincinnati, Ohio, has been a leader in sleep disorder research and treatment efforts for over 20 years. Providing diagnostic and treatment services to thousands of people in Cincinnati and throughout the country, the state-of-the-art sleep clinic also conducts cutting-edge research in ailments such as insomnia, apnea, snoring, depression, narcolepsy, fibromyalgia and many others.
*For full prescribing information, visit www.cenestin.com.
Contact:
Georgianne Gaz
Tri-State Sleep Disorders Center
513-671-3101
i The North American Menopause Society, "Menopause Core Curriculum Study Guide." http://www.menopause.org/NR/rdonlyres/9E4D788A-5DD6-4FDB-8D02-2293F7760D7C/0/sga.pdf (Last Accessed September 10, 2004).
ii The National Sleep Foundation, "Women and Sleep." http://www.sleepfoundation.org/publications/women.cfm#5 (Last Accessed September 2, 2004).