TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

拟议的项目是对以下方面的需求迅速增长的产物： 医学治疗的经前症状的妇女谁觉得这些 症状使人丧失能力。 据保守估计， 10%的育龄女性症状严重， 美国这意味着这个问题涉及大量妇女。 治疗是 通常花费相当大的费用和不便;医生缺乏诊断 治疗反应的标准和对照评价。 在这个时候， 没有科学数据明确支持 有效性 建议项目的具体目标是：（1）评估 吡哆醇（维生素B6）用于缓解经前症状;（2） 评估孕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响应 这些治疗的强度和时间的关系， 症状与治疗反应;（4）确定 适当和不适当地使用这些药物治疗;和（5） 报告这些药物的剂量和时间段的安全性， 书房 至少有264名妇女将进入双盲治疗序列， 交叉设计 第一阶段比较吡哆醇和安慰剂， 作为安慰剂反应的“洗脱”; II期比较孕酮和 安慰剂; III期评价另外6个月的改善稳定性 月经周期 具体的月经症状，强度和时间将 在每个月经周期第25（+或- 4）天治疗前进行评估 研究期间，还在第9天（+或 - 4）。 在10个时间点使用客观自我评估进行测量 仪器，每日症状记录，医生和顾问评级。 采用描述性和多元统计方法。 这项研究的信息将为医疗管理提供指导方针 经前症状：例如，吡哆醇和孕酮是否 比安慰剂更有效;哪些症状对这些治疗有反应。 它将增加对症状亚组的诊断信息 属于经前症状的范围

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.