[Diacereine: an original approach in the treatment of degenerative and/or extra-articular rheumatism].

71 patients with variously located osteoarthrosis or primary fibromyalgic syndrome were treated with oral diacereine (DAR). The case series was accumulated in successive periods and may be divided into three groups. An "open" test on DAR (100 mg/die for 4 weeks) was conducted on the first group of 31 arthrosis patients. On the second group of 20 other arthrosis patients a "double-blind, cross-over" test was carried out using DAR (100 mg/die) and naproxene (500 mg/die) both for 2 weeks. The third group of 20 patients with fibromyalgia was treated with DAR alone: 100 mg/die 5 days a week for 12 weeks. The efficacy of the treatment was judged on the basis of the following parameters: rest pain, pressure pain, pain on active and passive movement, and functional limitation. In the first group a positive therapeutic effect was noted in 20 cases (68.9%). There were side effects (moderate diarrhea) in 3 patients 2 of whom suspended treatment. In the second group, DAR and naproxene had an almost identical effect. However 7 patients (36.8%) expressed a preference for DAR, 9 (47.4%) expressed no preference and only 3 (15.8%) preferred naproxene. Side effects were encountered in 3 patients treated with naproxene (2 cases of epigastralgia and pyrosis and 1 case of dyspnea so marked as to require suspension of treatment) and in 3 treated with DAR (modest diarrhea). In the third group, a positive therapeutic effect was noted in 68.4% of the patients with fibromyalgia with a 15% incidence of side effects consisting of slight abdominal pain (diarrhea caused suspension of treatment in 1 case only). Blood chemical parameters were studied in all three groups and no alterations attributable to the treatment were found. The obtained result suggests that the new drug is effective and well tolerated in the envisaged indications.