An investigantional clinical evaluation of efficacy of milnacipran compared with sodium oxybate in patients suffering with fibromyalgia

Abstract

Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. Although fibromyalgia is often considered an arthritis-related condition, it is not truly a form of arthritis (a disease of the joints) because it does not cause inflammation or damage to the joints, muscles, or other tissues. The aim of the study is to find the efficacy of the investigational product compared with sodium oxybate in patients suffering with fibromyalgia. The objective of the study is to study the quality of life of patients suffering with fibromyalgia to observe the therapeutic efficacy of the drug, and compare with the reference drug to record the adverse events if reported to present the thesis which increase and deepen knowledge of the life situation of subjects suffering with fibromyalgia. Disturbed sleep has a major impact on quality of life and is often a common symptom of many other chronic conditions, such as chronic pain and mood disorders. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Accordingly, the SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments. The improvements reflected in Version 2.0 of the SF-36; psychometric studies of assumptions underlying scale construction and scoring; how they have been translated in more than 50 countries as part of the International Quality of Life Assessment (IQOLA) Project; and studies of reliability and validity. Milnacipran 100mg once daily has a predominantly analgesic effect as evidenced by the significant clinical benefits. Higher dose was associated with higher pain reduction. The results from the study show that milnacipran led to statistically significant improvements in pain and other multiple symptoms of FM.