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. 2017 Aug 2;2017(8):CD012537. doi: 10.1002/14651858.CD012537.pub2

Moran 1979.

Methods Allocation: randomised
Blinding: double‐blind
Controlled: active comparator
Centre: single
Arm: 2 arms, cross‐over design; 4 weeks, followed by cross‐over and a further 4 weeks
Participants Inclusion criteria: children suffering from seronegative juvenile polyarthritis; disease sufficiently active to be considered in need of an anti‐inflammatory analgesic agent
Exclusion criteria: unstated
Baseline characteristics
N = 23
Age: 5 to 16 years; median 11 to 12 years
Gender: male (unstated); female (unstated)
Number randomised: intervention (23); control (23)
Number completed: intervention (22); control (20)
Setting and location: unstated
Interventions Intervention group (N = 23): naproxen 10 mg/kg/24 hrs given as a suspension in 2 divided doses
Control group (N = 23): aspirin soluble 80 mg/kg/day, divided into 4 doses
Study duration: 2 x 4 weeks
Outcomes Primary outcomes

  1. Functional grading

  2. Joint involvement

  3. Grip strength

  4. Walking time over 20 m

  5. Functional test

  6. Comparison with last visit to physician

  7. Laboratory tests (haemoglobin, full blood count, platelets, ESR, liver function tests, urea, urine analysis, stools for occult blood)


Secondary outcomes

  1. Side effects
Notes Sources of funding: unstated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "random allocation for either ... drug"
Allocation concealment (selection bias) Unclear risk Comment: Insufficient information
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "placebo suspension and tablets were given to make the study double‐blind"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "placebo suspension and tablets were given to make the study double‐blind"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: All participants were accounted for. Lost to follow‐up and withdrawals explained.
Selective reporting (reporting bias) Low risk Comment: All planned outcomes from the methods were reported in the results.
Size High risk Comment: Total participants = 23 (< 50 per treatment arm)
Other bias Low risk Comment: No other potential sources of bias found.