PROGRAM OVERVIEW
Endometriosis is an enigmatic condition that affects millions of women worldwide. It is defined as the presence of functioning, endometrial-like tissue outside the uterus, which often induces a chronic, inflammatory reaction. It is predominantly found in women of reproductive age, from all ethnic and social groups. The associated symptoms - dysmenorrhea, chronic pelvic pain, dyspareunia, pain on micturition/defaecation, and sub-fertility - impact on a woman’s general physical, mental and social well being.
The precise mechanisms responsible for pain in endometriosis are unclear, which explains why the treatment options are limited. Nonsteroidal antiflammatory drugs (NSAIDs) and oral contraceptives are frequently used as an initial (first line) treatment of dysmenorrhea and pelvic pain associated with endometriosis in the absence of sub-fertility. Pain from endometriosis that is not responsive to NSAIDs or oral contraceptives is treated with either laparoscopic surgery or (second-line) medical therapy such as GnRH agonists, danazol, or progestins. However, current medical therapies have marked side effects, such as the hypoestrogenic state induced by GnRH-agonists; breakthrough bleeding and mood changes from progestin use, and negative effects on lipids, deepening of the voice, and hirsutism from androgens. Treatment failure often results in the woman seeking a hysterectomy and removal of both ovaries, which is clearly unsatisfactory if she still wishes to conceive.
Rationale for a meeting to improve study design for endometriosis and pain clinical research:
The best available evidence suggests that all medical therapies are equally effective at relieving symptoms and that surgical treatment may be effective. However, the literature is difficult to interpret because the clinical definition and the entry criteria for clinical trials vary considerably and the instruments used to measure pain as an outcome are poorly validated. In addition, the data obtained using instruments such as categorical and visual analogues scales are not even analyzed or reported uniformly. For example, some researchers have calculated a composite score for the different types of pain (menstrual, non-menstrual and during intercourse), which makes little sense if the treatment’s primary effect is to stop menstruation. This composite score has not been validated and may not have clinical relevance. Even more importantly, a standard approach to the measurement of the patient’s improvement in pain after treatment has not been developed. The overall effects on health related quality of life (HRQoL) have largely been neglected and there have been few attempts to measure HRQoL using reliable instruments. The measurement of HRQoL is gradually being adopted by clinical researchers because it is now being increasingly recognized that traditional outcome measures, such as pain levels, may not adequately assess the patient’s experience or related aspects of health, which may be more important to the patient. The few studies that have measured HRQoL in endometriosis have used generic measures that may not be sensitive enough to assess changes in specific illnesses, as they were designed to measure health status across a variety of diseases. The only disease-specific instrument with established measurement properties that addresses the dimensions of HRQoL considered important to women with the disease, including pain, is the Endometriosis Health Profile-30 (EHP-30) developed by the University of Oxford.
