title: Double-blind, randomized, placebo-controlled study of three-month treatment with the combination of ofloxacin and roxithromycin in recent-onset reactive arthritis.
abstract: In a randomized, double-blind, placebo-controlled trial, 56 patients with recent-onset ReA [enteroarthritis, n = 47 (84%); uroarthritis, n = 9 (16%)] were randomly assigned to receive 200 mg ofloxacin and 150 mg roxithromycin twice daily (Combi, n = 26) or placebo (n = 30) for 3 months. Patients were assessed at entry, at 2 weeks, and at 1, 2, 3, 4, 5, and 6 months. The primary outcome measure was recovery from arthritis at 6 months, and secondary outcome measures were swollen and tender joint counts, Ritchie index, serum CRP level, erythrocyte sedimentation rate, and joint pain on a visual analogue scale at 6 months. After 6 months, 20 patients [77% (95% CI 56-91)] in Combi and 20 patients [67% (95% CI 47-83)] in placebo group had recovered from arthritis (p = 0.55), and all clinical and laboratory variables showed improvement with no statistically significant difference between groups. Adverse events were reported by 62% of the patients in the Combi versus 40% in the placebo group. In conclusion, outcome of ReA was good in both treatment groups. Three-month treatment with the combination of ofloxacin and roxithromycin had no advantage over placebo in patients with recent-onset ReA.
authors.affiliation: Department of Bacteriology and Immunology, Haartman Institute, University of Helsinki, Helsinki, Finland, antti.kuuliala@gmail.com.
authors.forename: Antti
authors.initials: A
authors.lastname: Kuuliala
authors.forename: Heikki
authors.initials: H
authors.lastname: Julkunen
authors.forename: Leena
authors.initials: L
authors.lastname: Paimela
authors.forename: Ritva
authors.initials: R
authors.lastname: Peltomaa
authors.forename: Hannu
authors.initials: H
authors.lastname: Kautiainen
authors.forename: Heikki
authors.initials: H
authors.lastname: Repo
authors.forename: Marjatta
authors.initials: M
authors.lastname: Leirisalo-Repo
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D016918:Arthritis, Reactive / Q000188:drug therapy*; D002169:Campylobacter Infections / Q000188:drug therapy; D002690:Chlamydia Infections / Q000188:drug therapy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D000091402:Prohibitins; D015575:Roxithromycin / Q000627:therapeutic use*; D012480:Salmonella Infections / Q000188:drug therapy; D012720:Severity of Illness Index; D016896:Treatment Outcome; D015009:Yersinia Infections / Q000188:drug therapy
chemical_list: D000900:Anti-Bacterial Agents; C000717331:PHB2 protein, human; D000091402:Prohibitins; D015575:Roxithromycin; D015242:Ofloxacin