Palferman 1991.
Methods |
Design: RCT Number of centres: 2 Treatment duration: 3 months Flare design: No Wash‐out period: Yes (with Paracetamol as escape) Time point of assessments: BL, 1, 2, 3 months |
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Participants |
Inclusion criteria: 1. Over sixteen years of age; 2. Satisfied the Rome criteria for AS Exclusion criteria: 1. Pregnant; 2. Receiving concomitant treatment with hydantoins or sulphonamides; 3. Receiving prednisolone in excess of 7.5 mg daily; 4. History of indomethacin intolerance; 5. Renal or hepatic impairment. Classification: Rome criteria Nabumetone (2000 mg): Number of participants: 23 Number of completers: 14 Age (mean): 40 Male (%): 87 Symptom duration: NA Disease duration (mean): 13.7 years HLA‐B27 positive (%): NA Indomethacin (150 mg): Number of participants: 19 Number of completers: 10 Age (mean): 40 Male (%): 58 Symptom duration: NA Disease duration (mean): 14.64 years HLA‐B27 positive (%): NA |
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Interventions | Nabumetone (2000 mg) vs Indomethacin (150 mg) Co‐medication: Not reported |
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Outcomes |
Extracted outcomes:
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Notes | Funding source: Not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "…they were randomised to one of the two groups..." No information was provided on sequence generation. |
Allocation concealment (selection bias) | Unclear risk | No information was provided on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "…to one of the two groups and treatment started with either indomethacin 50 mg tds or nabumetone 1 g bd." No actions were undertaken to blind participants from their allocated treatment. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided on blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | "If a patient withdrew from the study prior to month three, the data from the last assessment was used." "Eighteen patients withdrew early, that is, before the three month assessment…" Although actions were undertaken to impute for missing data, the level of missing data was considerable in both groups. |
Selective reporting (reporting bias) | High risk | Spinal pain (on a 0 to 3 graded scale) was measured but not reported in the results. |
Other bias | High risk | There was some BL imbalance that was not adjusted for in the analyses. |