Simpson 1966.
Methods |
Design: Cross‐over study Number of centres: 1 Treatment duration: each treatment period was 4 weeks Flare design: No Wash‐out period: No Time pointof assessments: BL, 4, 8 weeks |
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Participants |
Inclusion criteria: 1. X‐ray evidence of involvement of sacroiliac joints, small joints of the hand were not involved; 2. Chest expansion had to be limited and morning stiffness present; 3. Latex test had to be negative; 4. Serum uric acid level not be in excess of 6.5 mg/100 mL; 5. Raised ESR. Exclusion criteria: None reported. Classification: NA Phenylbutazone (300 mg): Number of participants: 7 Number of completers: 6 Flufenamic acid (600 mg): Number of participants: 7 Number of completers: 7 All participants: Age (mean): males 35, females 51 Male (%): 79 Symptom duration: NA Disease duration: NA HLA‐B27 positive (%): NA |
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Interventions | Phenylbutazone (300 mg) vs Flufenamic acid (600 mg) Co‐medication: Not reported |
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Outcomes |
Extracted outcomes:
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Notes | For the outcome pain on Likert scale individual patient data that were presented in the paper were combined for the meta‐analysis to a mean and SD.Funding source: Not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "… and the order of administration was randomized." No information on sequence generation was provided. |
Allocation concealment (selection bias) | Unclear risk | No information was provided on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Matched capsules containing flufenamic acid 100 mg and phenylbutazone 50 mg were administered at the rate of six capsules per day." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was provided on blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The number of missing observations were low (extracted from table 1). |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods were reported in the results. |
Other bias | High risk | No information provided how statistical analyses were performed. Unable to determine BL characteristics imbalance. |