Non-steroidal antiinflammatory drugs are not very effective, even if commonly used, in primary fibromyalgia syndrome (PFS), whereas cyclobenzaprine (C) has proved to be quite useful. The aim of this open randomized study was to compare low-dose C alone or in combination with ibuprofen (I) in 32 female patients suffering from PFS. Fifteen patients were given C 10 mg, and 17 patients C 10 mg plus I 600 mg. All patients received the drugs orally at night and were evaluated at baseline and at days 5 and 10. Assessment of efficacy included the number of tender points (max. = 16), muscle tightness (score 1-5), sleep difficulty (score 1-10), pain intensity (visual analogue scale 0-10) and duration of morning stiffness (min). At the end of the study all symptoms were found to be improved to the same extent in both treatment groups. An exception was morning stiffness, which became significantly more reduced in the patients taking C plus I. No patient discontinued the trial owing to adverse side-effects. In conclusion, C and I given concomitantly at night proved to be safe and advantageous in relieving the discomfort of PFS in the short term
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