LYCOS RETRIEVER
Endometriosis: Patients
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GnRH Antagonists in Expanded Phase II Clinical Trials for Endometriosis -- Enrollment of patients in the 6-month Phase IIb clinical trial with NBI-56418 is on track for randomization of the last subject expected during the 4th Quarter, 2007. -- An additional Phase IIb clinical trial with the new formulation tablet is anticipated to begin in early 1st Quarter 2008 utilizing clinical endpoints that incorporate recent guidance from the FDA.
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The initial study involved 76 cases of endometriosis, with 61 said to be effectively treated, a success rate of 80%, which is comparable to what was claimed with the more complex decoctions. In particular, of 63 patients with dysmenorrhea as the prominent symptom, 89% were relieved. The herb formula was able to "thin the blood" (reducing the abnormally high viscosity of the endometriosis patients) and reduce excess populations of immunoglobulins, C3 (complement protein), and CD-8 T-cells in peripheral blood. The herbs were taken for three months, and could be continued during menstruation. Pharmacological studies have shown that rhubarb and turtle shell inhibit autoimmune responses. A follow-up study (18) by the same research team was carried out with Nei Yi Wan #1, and reported the following year.
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Estrogen is commonly known as a stimulant to Endometriosis tissue. Birth control pills can prevent ovulation, and subsequent additional estrogen production. Birth control pills are progestin dominant. Progestins usually suppress estrogen's effect. However, birth control pills contain estrogen. For some patients, the estrogen in the pills may just be a trade-off for the suppression, and no benefit is gained.
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Medical therapy for treating endometriosis involves hormonal therapy. Progestins, combination estrogens/progestins, danazol, and gonadotropin-releasing hormone (GnRH) agonists are some of the medications used. Patients should not begin a regimen of danazol or GnRH agonists unless they are monitored by a gynecologist and have a laparoscopically confirmed diagnosis of endometriosis.
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Pain is the most common complaint for women with endometriosis, and it can significantly impair the quality of life. The pain experienced around menstruation can be so debilitating that up to 25% of women with the condition are incapacitated for 2 - 6 days of each month. In severe cases, regular activities may be curtailed for up to 2 weeks per month. Sleeping problems have been reported in 75% of patients, mostly due to pain.
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Dysmenorrhea: Secondary dysmenorrhea occurs twice as often in women with endometriosis as in controls.7 Pain frequently commences prior to menses. Endometriosis should be considered in a patient presenting with significant dysmenorrhea, and the patient should be started on empiric therapy.
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