Skip to main content
. 2015 Jul 17;2015(7):CD010952. doi: 10.1002/14651858.CD010952.pub2

Ansell 1978.

Methods Design: Cross‐over study
Number of centres: NA
Treatment duration: Each treatment period was 4 weeks
Flare design: Yes
Wash‐out period: Yes (2 weeks, not between therapies)
Time point of assessments: BL, 4, 8 weeks
Participants Inclusion criteria: Radiographic evidence of sacroiliitis of at least grade 2 and clinically active symptoms.
Exclusion criteria:

  1. Suffering from significant renal, hepatic or cardiac disease, or diseases likely to be associated with sacroiliitis (e.g. psoriasis);

  2. History of untoward reaction to either drug;

  3. Peptic ulcer;

  4. Likely to become pregnant.


Classification: NA
All participants:
Number of participants: 25
Number of completers: NA
Age: range 25 to 69
Male (%): 92
Symptom duration: NA
Disease duration: NA
HLA‐B27 positive (%): NA
Interventions Naproxen (750 mg) vs Butacote (300 mg)
Co‐medication: NA
Outcomes Extracted outcomes:
1. Patient's global assessment of disease activity (BL not available, post‐treatment after 4 weeks (± SD)) (scale 0 to 3, higher is worse)
Naproxen 750 mg: 1.71 ± 0.73
Butacote 300 mg: 1.27 ± 0.33
2. ESR (BL (± SD), change after 4 weeks (± SD)) (in mm/hr, higher is worse)
Naproxen 750 mg: 26.31 ± 13.97, +2.17 ± 11.97
Butacote 300 mg: 28.82 ± 19.31, ‐3.54 ± 10.48
3. Tragus‐to‐wall distance (BL (± SD), change after 4 weeks (± SD)) (in cm, higher is worse, left side (no differences with right side))
Naproxen 750 mg: 15.07 ± 5.23, ‐0.16 ± 1.40
Butacote 300 mg: 15.23 ± 4.11, ‐1.14 ± 1.16
4. Schober's test (BL (± SD), change after 4 weeks (± SD)) (in cm, higher is better)
Naproxen 750 mg: 3.25 ± 2.07, +0.42 ± 0.89
Butacote 300 mg: 3.34 ± 1.84, +0.90 ± 2.42
Notes Results are not included in the meta‐analysis, because the number of patients in each treatment group was not available. Available results are described in this table.
Only results of first part of cross‐over trial are presented.
Funding source: Geigy Pharmaceuticals provided Butacote and placebo.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "For analysis patients were split into two groups". No information was provided on sequence generation.
Allocation concealment (selection bias) Unclear risk "For analysis patients were split into two groups". No information was provided on allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk "double‐blind, cross‐over study with double‐dummy technique". Probably done, but no further information was provided on blinding participants.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk "double‐blind". Probably done, but no further information was provided on blinding of outcome assessor.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information was provided on drop‐outs or missing data.
Selective reporting (reporting bias) Low risk All pre‐specified outcomes according to the methods section, are reported in the results section.
Other bias High risk Crossover design, possible carry‐over effect in Schober's test and ESR (not reported for other outcomes).