ABSTRACT
A double blind, placebo controlled trial examined the effects of folinic acid on the efficacy and toxicity of methotrexate in 27 patients with rheumatoid arthritis. Clinical and laboratory indices of disease activity worsened significantly in the 13 patients treated with folinic acid after four weeks of treatment, but not in the 14 patients treated with placebo. Exacerbation of rheumatoid arthritis led to withdrawal of the test drug in seven of the patients treated with folinic acid but in none of those treated with placebo. It is concluded that excerbation of rheumatoid arthritis is likely when folinic acid is given shortly after the weekly dose of methotrexate.
Subject(s)
Arthritis, Rheumatoid/chemically induced , Leucovorin/adverse effects , Methotrexate/adverse effects , Arthritis, Rheumatoid/drug therapy , Double-Blind Method , Drug Administration Schedule , Drug Therapy, Combination , Female , Humans , Leucovorin/administration & dosage , Leucovorin/therapeutic use , Male , Methotrexate/administration & dosage , Methotrexate/therapeutic use , Middle AgedSubject(s)
Anti-Infective Agents/therapeutic use , Anti-Ulcer Agents/therapeutic use , Antitrichomonal Agents/therapeutic use , Campylobacter Infections/drug therapy , Duodenal Ulcer/drug therapy , Helicobacter pylori , Organometallic Compounds/therapeutic use , Tinidazole/therapeutic use , Cimetidine/therapeutic use , Clinical Trials as Topic , Colloids , Duodenal Ulcer/microbiology , Humans , Treatment OutcomeABSTRACT
100 consecutive patients with both duodenal ulcer and Campylobacter pylori infection were followed up to see whether eradication of C pylori affected ulcer healing or relapse. Patients were randomly assigned to 8 weeks of treatment with cimetidine or colloidal bismuth subcitrate (CBS), with tinidazole or placebo being given concurrently from days 1 to 10, inclusive. Endoscopy, biopsy, and culture were done at entry, in weeks 10, 22, 34, and 62, and whenever symptoms recurred. There was no maintenance therapy. C pylori persisted in all of the cimetidine-treated patients and in 95% of those treated with cimetidine/tinidazole, but was eradicated in 27% of the CBS/placebo group and 70% of the CBS/tinidazole group. When C pylori persisted, 61% of duodenal ulcers healed and 84% relapsed. When C pylori was cleared 92% of ulcers healed (p less than 0.001) and only 21% relapsed during the 12 month follow-up period (p less than 0.0001).
