Alprazolam and Ibuprofen in the Treatment of Fibromyalgia-Report of a Double-Blind Placebo-Controlled Study

Abstract

Objectives: To compare the effectiveness of alprazolam versus placebo and also versus ibuprofen and an alprazolam-ibuprofen combination in the treatment of patients with fibromyalgia. Methods: Subjects who met Yunus et al.'s modified criteria for fibromyalgia and gave their informed consent participated in a 5-week double-blind clinical trial. No subject had a currently active major depression. Weekly evaluations included psychological assessments [Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Beck Depression Inventory], subjective measurements of pain, pain relief and physical activity level [visual analog scales], musculoskeletal examination for tender points, and an observer- and self-rated measurement of global improvement [Clinical Global Impressions scale]. Results: Analyses were conducted on 61 subjects who completed at least 1 week of treatment and on the subgroup of 45 study completers. Alprazolam- and ibuprofen-treated subjects tended to improve more in some pain-related symptoms, but not all differences were statistically significant nor was there a constant pattern of improvement. Alprazolam-treated subjects experienced sedation, drowsiness, fatigue and weakness more commonly than subjects not receiving this treatment. Gastrointestinal [GI] symptoms, headaches, irritability and insomnia were experienced by placebo-treated subjects at rates similar to those treated with active medication. GI symptoms were more serious in ibuprofen-treated subjects. Conclusions: Although these subjects with fibromyalgia syndrome obtained some benefit from alprazolam and ibuprofen, neither was consistently significantly superior to the other or to a placebo treatment. Little benefit was obtained from a combination of the two drugs. Variability in the course of the disorder limits generalizations that can be derived from this short-term clinical trial. Long-term studies are needed because of the chronic nature of this illness.

KEYWORDS:

• Fibromyalgia
• alprazolam
• ibuprofen