title: Comparison of sulfasalazine and placebo in the treatment of ankylosing spondylitis. A Department of Veterans Affairs Cooperative Study.
abstract: OBJECTIVE
  To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective for the treatment of active ankylosing spondylitis (AS) that is not controlled with nonsteroidal antiinflammatory drug therapy.
  
  
  METHODS
  Two hundred sixty-four patients with AS were recruited from 15 clinics, randomized (double-blind) to SSZ or placebo treatment, and followed up for 36 weeks. Treatment response was based on morning stiffness, back pain, and physician and patient global assessments.
  
  
  RESULTS
  While longitudinal analysis revealed a trend favoring SSZ in the middle of treatment, no difference was seen at the end of treatment. Response rates were 38.2% for SSZ and 36.1% for placebo (P = 0.73). The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). AS patients with associated peripheral arthritis showed improvement that favored SSZ (P = 0.02). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints.
  
  
  CONCLUSIONS
  SSZ at a dosage of 2,000 mg/day does not seem to be more effective than placebo in the treatment of AS patients with chronic, longstanding disease. SSZ is well tolerated and may be more effective than placebo in the treatment of AS patients with peripheral joint involvement. This effect is more pronounced in treatment of the peripheral arthritis in this subgroup of AS patients.
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: W D
authors.initials: WD
authors.lastname: Blackburn
authors.forename: J J
authors.initials: JJ
authors.lastname: Cush
authors.forename: G W
authors.initials: GW
authors.lastname: Cannon
authors.forename: M L
authors.initials: ML
authors.lastname: Mahowald
authors.forename: H R
authors.initials: HR
authors.lastname: Schumacher
authors.forename: T
authors.initials: T
authors.lastname: Taylor
authors.forename: E
authors.initials: E
authors.lastname: Budiman-Mak
authors.forename: M R
authors.initials: MR
authors.lastname: Cohen
authors.forename: F B
authors.initials: FB
authors.lastname: Vasey
authors.forename: M E
authors.initials: ME
authors.lastname: Luggen
authors.forename: E
authors.initials: E
authors.lastname: Mejias
authors.forename: S L
authors.initials: SL
authors.lastname: Silverman
authors.forename: R
authors.initials: R
authors.lastname: Makkena
authors.forename: F P
authors.initials: FP
authors.lastname: Alepa
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: J R
authors.initials: JR
authors.lastname: Ward
authors.forename: W G
authors.initials: WG
authors.lastname: Henderson
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010349:Patient Compliance; D010919:Placebos / Q000627:therapeutic use*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D016312:Treatment Refusal
chemical_list: D000893:Anti-Inflammatory Agents; D010919:Placebos; D012460:Sulfasalazine