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

Nahir 1980.

Methods Design: RCT
Number of centres: 1
Treatment duration: 4 weeks
Flare design: No
Wash‐out period: Yes (7 days no anti‐inflammatory/analgesic medication)
Time point of assessments: Start of wash‐out, BL, 7, 14, 28 days
Participants Inclusion criteria: 1. Radiographic evidence of sacroiliitis and clinically active disease; 2. Demonstrated spinal pain; 3. Decreased range of motion of some part of the spine; 4. Increased ESR.
Exclusion criteria: 1. Hepatic, renal, or gastric disease; 2. Previous intolerance to indomethacin.
Classification: NA
Diclofenac (150 mg):
Number of participants: 31
Number of completers: 30
Age (mean): 37 (range 26 to 58)
Male (%): 97
Symptom duration: NA
Disease duration: 32% 1 to 5 years, and 68% > 5 years
HLA‐B27 positive (%): 77
Sulindac (600 mg):
Number of participants: 31
Number of completers: 31
Age (mean): 37 (range 20 to 57)
Male (%): 97
Symptom duration: NA
Disease duration: 42% 1‐5 years, and 58% > 5 years
HLA‐B27 positive (%): 90
Interventions Diclofenac (150 mg) vs Sulindac (600 mg)
Co‐medication: Not reported
Outcomes Extracted outcomes:

  1. Pain on VAS

  2. Withdrawals due to adverse events

  3. Duration of morning stiffness

  4. Severity of morning stiffness

  5. Chest expansion

  6. Schober's test

  7. Number of any adverse events

  8. Number of serious adverse events
Notes Funding source: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "…the patients were randomly assigned to diclofenac … or sulindac…"
No information is provided on sequence generation.
Allocation concealment (selection bias) Unclear risk No information provided on allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "…the patients were randomly assigned to diclofenac 50 mg thrice daily plus sulindac placebo twice daily or sulindac 200 mg thrice daily plus diclofenac placebo thrice daily."
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk "A double‐blind between‐patient comparison…"
No further information is provided on the blinding of outcome assessors
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcome data is available for > 95% of the study participants.
Selective reporting (reporting bias) Low risk All outcomes stated in the methods are reported.
Other bias Low risk No other bias was detected.