A new medical approach to the treatment of osteoarthritis. Report of an open phase IV study with ademetionine (Gumbaral).
A non-controlled clinical phase IV trial was carried out involving 20,641 patients with osteoarthritis of the knee, the hip, and the spine and also with osteoarthritic polyarthritis of the fingers, who were treated with ademetionine tablets given in a fixed dosage schedule for eight weeks. No additional analgesic/antirheumatic treatment was allowed. Nevertheless, concomitant medication for other diseases was permissible. The efficacy was described as "very good" or "good" in 71 percent of cases, as "moderate" in 21 percent, and as "poor" in 9 percent of cases. The tolerance was assessed as very good or good in 87 percent, as moderate in 8 percent, and as poor in 5 percent of cases. The trial therapy was discontinued prematurely because of symptoms of intolerance in 5 percent of the patients and because of a lack of efficacy in 2.3 percent of cases.
Berger
R
R
Degussa Pharma Gruppe, Frankfurt am Main, Federal Republic of Germany.
Nowak
H
H
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D012436:S-Adenosylmethionine / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D012436:S-Adenosylmethionine