title: Comparison of sulfasalazine and placebo in the treatment of reactive arthritis (Reiter's syndrome). A Department of Veterans Affairs Cooperative Study.
abstract: OBJECTIVE
  To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective in the treatment of reactive arthritis (ReA) that has been unresponsive to nonsteroidal antiinflammatory drug (NSAID) therapy.
  
  
  METHODS
  One hundred thirty-four patients with ReA who had failed to respond to NSAIDs were recruited from 19 clinics, randomized (double-blind) to receive either SSZ or placebo, and followed up for 36 weeks. The definition of treatment response was based on joint pain/tenderness and swelling scores and physician and patient global assessments.
  
  
  RESULTS
  Longitudinal analysis revealed improvement in the patients taking SSZ compared with those taking placebo, which appeared at 4 weeks and continued through the trial (P = 0.02). At the end of treatment, response rates were 62.3% for SSZ treatment compared with 47.7% for placebo treatment. The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints.
  
  
  CONCLUSIONS
  SSZ at a dosage of 2,000 mg/day is well tolerated and effective in patients with chronically active ReA.
authors.affiliation: VAMC, Salt Lake City, Utah, USA.
authors.forename: D O
authors.initials: DO
authors.lastname: Clegg
authors.forename: D J
authors.initials: DJ
authors.lastname: Reda
authors.forename: M H
authors.initials: MH
authors.lastname: Weisman
authors.forename: J J
authors.initials: JJ
authors.lastname: Cush
authors.forename: F B
authors.initials: FB
authors.lastname: Vasey
authors.forename: H R
authors.initials: HR
authors.lastname: Schumacher
authors.forename: E
authors.initials: E
authors.lastname: Budiman-Mak
authors.forename: D J
authors.initials: DJ
authors.lastname: Balestra
authors.forename: W D
authors.initials: WD
authors.lastname: Blackburn
authors.forename: G W
authors.initials: GW
authors.lastname: Cannon
authors.forename: R D
authors.initials: RD
authors.lastname: Inman
authors.forename: F P
authors.initials: FP
authors.lastname: Alepa
authors.forename: E
authors.initials: E
authors.lastname: Mejias
authors.forename: M R
authors.initials: MR
authors.lastname: Cohen
authors.forename: R
authors.initials: R
authors.lastname: Makkena
authors.forename: M L
authors.initials: ML
authors.lastname: Mahowald
authors.forename: J
authors.initials: J
authors.lastname: Higashida
authors.forename: S L
authors.initials: SL
authors.lastname: Silverman
authors.forename: N
authors.initials: N
authors.lastname: Parhami
authors.forename: J
authors.initials: J
authors.lastname: Buxbaum
authors.forename: C M
authors.initials: CM
authors.lastname: Haakenson
authors.forename: R H
authors.initials: RH
authors.lastname: Ward
authors.forename: B J
authors.initials: BJ
authors.lastname: Manaster
authors.forename: R J
authors.initials: RJ
authors.lastname: Anderson
authors.forename: W G
authors.initials: WG
authors.lastname: Henderson
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016918:Arthritis, Reactive / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010919:Placebos / Q000627:therapeutic use*; D000091402:Prohibitins; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D016312:Treatment Refusal
chemical_list: D000893:Anti-Inflammatory Agents; C000717331:PHB2 protein, human; D010919:Placebos; D000091402:Prohibitins; D012460:Sulfasalazine