TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

经前综合症患者的治疗评估

• 批准号: 3315733
• 负责人: ELLEN W FREEMAN
• 金额: $ 20.57万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-02-01 至 1988-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3315733
• 关键词: behavior test; behavioral medicine; dosage; drug adverse effect; female reproductive system disorder diagnosis; human subject; human therapy evaluation; patient care planning; placebos; premenstrual syndrome; progesterone; psychological stressor; sign /symptom; statistics /biometry; stress; vitamin therapy

The proposed project is an outgrowth of the rapidly growing demand for medical treatment of premenstrual symptoms from women who feel that these symptoms are incapacitating. A conservative estimate that premenstrual symptoms are severe in 10 percent of females of reproductive age in the U.S. means that the problem touches large numbers of women. Treatment is often at considerable expense and inconvenience; physicians lack diagnostic criteria and controlled evaluation of treatment responses. At this time, there are no scientific data that clearly support contentions of treatment effectiveness. The specific aims of the proposed project are to (1) evaluate the efficacy of pyridoxine (Vitamin B6) for relief of premenstrual symptoms; (2) evaluate the efficacy of progesterone for relief of premenstrual symptoms; (3) determine which symptoms or symptom clusters are most likely to respond to these treatments and the relationships of intensity and timing of symptoms with treatment responses; (4) identify patient groups that are appropriately and inappropriately treated with these medications; and (5) report the safety of these medications for the dosages and time period of the study. At least 264 women will enter the treatment sequence in a double-blind crossover design. Phase I compares pyridoxine and placebo and also serves as a "washout" of placebo response; Phase II compares progesterone and placebo; Phase III evaluates stability of improvement for six additional menstrual cycles. Specific menstrual symptoms, intensity and timing will be assessed prior to treatment, on Day 25 (+ or - 4) each menstrual cycle during the study with an evaluation of symptom factors also on Day 9 (+ or - 4). Measures are at 10 time points using objective self-assessment instruments, daily symptom recordings, physician and counselor ratings. Descriptive and multivariate statistical methods are employed. Information from the study will provide guidelines for medical management of premenstrual symptoms: e.g. whether pyridoxine and progesterone are more effective than placebo; which symptoms respond to these treatments. It will increase diagnostic information on the subgroups of syndromes within the broad range of premenstrual symptoms.

拟议中的项目是快速增长的对 对那些感到这些症状的妇女的经前症状的药物治疗 症状使人丧失能力。保守的估计是经前 在中国，10%的育龄女性症状严重 美国意味着这个问题涉及到大量的女性。治疗是 经常花费巨大的费用和不便；医生缺乏诊断 治疗反应的标准和受控评估。在这个时候， 没有科学数据明确支持治疗的争论。 有效性。 拟议项目的具体目标是：(1)评估疗效 使用吡哆醇(维生素B6)缓解经前症状；(2) 评价黄体酮缓解经前症状的疗效； (3)确定哪些症状或症状群最有可能做出反应 这些处理以及强度和时机的关系 症状和治疗反应；(4)确定符合以下条件的患者组 适当和不适当地使用这些药物的； 报告这些药物的剂量和时间段的安全性 这项研究。 至少有264名女性将以双盲方式进入治疗序列 跨界设计。第一阶段比较了吡哆醇和安慰剂，也提供了 作为安慰剂反应的“冲刷”；第二阶段比较了黄体酮和 安慰剂；第三阶段评估另外六个项目的改善稳定性 月经周期。具体的月经症状、强度和时间会 在每个月经周期的第25天(+或-4)治疗前进行评估 在对症状因素进行评估的研究期间，也在第9天(+或 -4)。使用客观自我评估在10个时间点进行衡量 仪器，每日症状记录，医生和咨询师评级。 研究采用描述性和多变量统计方法。 这项研究的信息将为医疗管理提供指导 经前症状：例如吡哆醇和黄体酮是否 比安慰剂更有效；这些治疗对哪些症状有反应。 它将增加关于证候亚群的诊断信息 在广泛的经前症状范围内。