In a double-blind crossover study, the efficacy and tolerability of oral cyclobenzaprine administered in two different regimens were compared in 40 patients affected by primary fibromyalgia syndrome. The patients were randomly divided into two groups. Each group of 20 patients was treated for 15 days with either a single dose of 10 mg/day cyclobenzaprine at bedtime or 30 mg/day cyclobenzaprine in three equal doses daily. Following treatment there was a 15-day washout period before the groups were crossed over to the other treatment. Both regimens resulted in a significant decline in the number of tender points; significant improvements were also reported in the quality of sleep, anxiety, fatigue, irritable bowel syndrome and stiffness. There was no significant difference in efficacy between the two therapeutic regimens at any stage during the trial. The frequency of reported side-effects was significantly greater (P < 0.001) when patients received 30 mg/day cyclobenzaprine (26 patients, 84%) than when they received 10 mg/day (10 patients, 27%). A dose of 10 mg cyclobenzaprine at bedtime significantly improved the symptomatology of patients affected by primary fibromyalgia syndrome. The higher dose did not further reduce these symptoms but did result in a higher incidence of side-effects.
A double-blind study comparing the efficacy and tolerability of dothiepin with that of placebo in the treatment of primary fibromyalgia syndrome was carried out. Dothiepin was shown to improve significantly the condition of patients with primary fibromyalgia syndrome and there was a significant difference between dothiepin and placebo in all the clinical variables measured. Only mild and transient side-effects were reported. Further controlled studies are required to define the effects of dothiepin on fibromyalgia.
SUMMARY Thirty rheumatoid patients with persistent knee effusion were treated intra-articularly with rifamycin SV, 500 mg weekly, or with saline solution, 10 The intra-articular use of cytotoxic drugs has been limited because of local and general toxicity and has met with little success.4-"0 Early experiments demonstrated that rifamycin SV, a valuable antibiotic with a wide spectrum of antibacterial properties, inhibited the protein synthesis of bacterial cells by blocking DNA-dependent RNA polymerase. " We decided on the use of rifamycin SV in RA after observing that, when injected locally in experimental monoarthritic guinea-pigs, it markedly inhibited the uptake of labelled precursors of RNA and DNA by inflammatory cells and hyperplastic lining cells, with no histological evidence of cellular necrosis (Caruso I, unpublished).The data presented here are the results of local treatment of RA knee synovitis in a double-blind study in which rifamycin SV was compared with saline solution.'2 13 From these results we can conclude that rifamycin SV is a promising development in the field of local RA therapy.
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