Biomaterial Database

A double-blind placebo controlled trial of fluoxetine in fibromyalgia. 1994

F Wolfe, and M A Cathey, and D J Hawley

Arthritis Research Center, St. Francis Research Institute, Wichita, KS 67214.

42 women were randomized to receive either placebo or fluoxetine at 20 mgs per day. Inter and intra group differences in clinical variables were evaluated after 3 and 6 weeks of treatment. Except for self rated anxiety which improved in the placebo treated group at 3 weeks, no differences between groups were noted. For those receiving fluoxetine both AIMS Anxiety (4.0 baseline vs. 3.3, p = 0.04) and Depression scores (2.6 baseline vs. 1.9, p = 0.03) improved at 3 weeks; however, improvement in the Beck Depression Scale did not reach significance (11.8 vs. 9.4, p = 0.34). At 6 weeks, both AIMS Depression (2.6 at baseline and 1.5 at 6 weeks, p = 0.03) and Beck Depression Scales (11.8 at baseline vs. 8.3 at 6 weeks, p = 0.04) showed improvement, as did sleep quality (9.6 vs. 7.6, p = 0.03). But no other variable had a significant change from baseline at either the 3 or 6 week point. Our data do not suggest that fluoxetine improves the signs and symptoms of fibromyalgia.

UI	MeSH Term	Description	Entries
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D010147	Pain Measurement	Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies.	Analgesia Tests,Analogue Pain Scale,Formalin Test,McGill Pain Questionnaire,Nociception Tests,Pain Assessment,Pain Intensity,Pain Severity,Tourniquet Pain Test,Visual Analogue Pain Scale,Analog Pain Scale,Assessment, Pain,McGill Pain Scale,Visual Analog Pain Scale,Analgesia Test,Analog Pain Scales,Analogue Pain Scales,Formalin Tests,Intensity, Pain,Measurement, Pain,Nociception Test,Pain Assessments,Pain Intensities,Pain Measurements,Pain Questionnaire, McGill,Pain Scale, Analog,Pain Scale, Analogue,Pain Scale, McGill,Pain Severities,Pain Test, Tourniquet,Questionnaire, McGill Pain,Scale, Analog Pain,Scale, Analogue Pain,Scale, McGill Pain,Severity, Pain,Test, Analgesia,Test, Formalin,Test, Nociception,Test, Tourniquet Pain,Tests, Nociception,Tourniquet Pain Tests
D011569	Psychiatric Status Rating Scales	Standardized procedures utilizing rating scales or interview schedules carried out by health personnel for evaluating the degree of mental illness.	Factor Construct Rating Scales (FCRS),Katz Adjustment Scales,Lorr's Inpatient Multidimensional Psychiatric Rating Scale,Wittenborn Scales,Edinburgh Postnatal Depression Scale,Mini International Neuropsychiatric Interview
D003863	Depression	Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders.	Depressive Symptoms,Emotional Depression,Depression, Emotional,Depressive Symptom,Symptom, Depressive
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D005356	Fibromyalgia	A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)	Diffuse Myofascial Pain Syndrome,Fibrositis,Rheumatism, Muscular,Fibromyalgia, Primary,Fibromyalgia, Secondary,Fibromyalgia-Fibromyositis Syndrome,Fibromyositis-Fibromyalgia Syndrome,Myofascial Pain Syndrome, Diffuse,Fibromyalgia Fibromyositis Syndrome,Fibromyalgia-Fibromyositis Syndromes,Fibromyalgias,Fibromyalgias, Primary,Fibromyalgias, Secondary,Fibromyositis Fibromyalgia Syndrome,Fibromyositis-Fibromyalgia Syndromes,Fibrositides,Muscular Rheumatism,Primary Fibromyalgia,Primary Fibromyalgias,Secondary Fibromyalgia,Secondary Fibromyalgias,Syndrome, Fibromyalgia-Fibromyositis,Syndrome, Fibromyositis-Fibromyalgia,Syndromes, Fibromyalgia-Fibromyositis,Syndromes, Fibromyositis-Fibromyalgia
D005473	Fluoxetine	The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.	Fluoxetin,Fluoxetine Hydrochloride,Lilly-110140,N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine,Prozac,Sarafem,Lilly 110140,Lilly110140
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328	Adult	A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available.	Adults