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. 2015 Jul 17;2015(7):CD010952. doi: 10.1002/14651858.CD010952.pub2

Dougados 1994.

Methods Design: RCT
Number of centres: NA
Treatment duration: 2 weeks
Flare design: Yes
Wash‐out period: Yes (2 days)
Time point of assessments: BL, 1 week, 2 weeks
Participants Inclusion criteria: 1. Having received NSAID daily for at least 1 month; 2. A 2‐day washout period for the concomitant NSAIDs; 3. A flare of the disease defined by the 2 following: pain evaluated on a VAS over 40, and increase in pain of at least 30% between screening and entry visit.
Exclusion criteria: 1. Peripheral articular disease (at least 2 inflamed joints at screening visit); 2. Inflammatory bowel disease; 3. Serious concomitant medical illness; 4. Judged to be in functional class IV according to the Steinbrocker criteria.
Classification: ESSG, Amor and modified New York criteria
Ximoprofen (5 mg):
Number of participants: 46
Number of completers: 41
Age (mean (SD)): 40 (10)
Male (%): 63
Symptom duration: NA
Disease duration (mean (SD)): 10 (8) years
HLA‐B27 positive (%): 80
Ximoprofen (10 mg):
Number of participants: 49
Number of completers: 46
Age (mean (SD)): 40 (10)
Male (%): 71
Symptom duration: NA
Disease duration (mean (SD)): 8 (7) years
HLA‐B27 positive (%): 67
Ximoprofen (20 mg):
Number of participants: 45
Number of completers: 41
Age (mean (SD)): 40 (13)
Male (%): 62
Symptom duration: NA
Disease duration (mean (SD)): 8 (8) years
HLA‐B27 positive (%): 76
Ximoprofen (30 mg):
Number of participants: 50
Number of completers: 44
Age (mean (SD)): 40 (12)
Male (%): 76
Symptom duration: NA
Disease duration (mean (SD)): 10 (8) years
HLA‐B27 positive (%): 84
Placebo:
Number of participants: 95
Number of completers: 71
Age (mean (SD)): 40 (11)
Male (%): 68
Symptom duration: NA
Disease duration (mean (SD)): 10 (8) years
HLA‐B27 positive (%): 75
Interventions Ximoprofen (5 mg) vs Ximoprofen (10 mg) vs Ximoprofen (20 mg) vs Ximoprofen (30 mg) vs Placebo
Co‐medication: NA
Outcomes Extracted outcomes:

  1. Pain on VAS

  2. Withdrawals due to adverse events

  3. Duration of morning stiffness

  4. Schober's test

  5. Pain relief ≥ 50%

  6. Number of any adverse events

  7. Number of adverse events per organ system
Notes In comparison 2 (NSAID vs NSAID dose) we chose to compare the smallest to the highest dose (Ximoprofen 5 mg vs Ximoprofen 30 mg).
In comparison 3 (NSAID vs Placebo) we chose to present data from the highest dose (Ximoprofen 30 mg).
Funding source: Supported in part by Laboratories Jacques LOGEAIS.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "This randomization was performed centrally by using the computer system. The allocated drug for the recruited patient was then sent to the investigator's office."
Allocation concealment (selection bias) Low risk "This randomization was performed centrally by using the computer system. The allocated drug for the recruited patient was then sent to the investigator's office."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "All these capsules (placebo or Ximoprofen) were undistinguishable."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk "double blind"; "Clinical assessment was made weekly by the same investigator for each patient."
Comment: Probably done, but no further information provided on blinding of the outcome assessor.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk "During the trial 42 patients withdrew (24 in the placebo group, 25%: 21 because of inefficacy, 1 because of toxicity, and 2 because of both toxicity and inefficacy; 5 in the 5 mg Ximoprofen group, 11%: 4 because of inefficacy and 1 because of toxicity; 3 in the 10 mg Ximoprofen group, 6%: all because of inefficacy; 4 in the 20 mg Ximoprofen group, 9%: 2 because of inefficacy, 1 because of both inefficacy and toxicity and 1 for a reason unrelated to treatment; 6 in the 30 mg Ximoprofen group, 12%: 4 because of inefficacy and 2 because of toxicity."
Selective reporting (reporting bias) Unclear risk Patient and physicians assessment of disease activity was assessed (see methods section), but not reported. All other outcomes that were assessed, were reported.
Other bias Low risk Sufficient power for primary efficacy hypothesis (sample size calculations). No other bias detected.