Lomen 1986 I.

Methods	Design: RCT Number of centres: 8 Treatment duration: 26 weeks Flare design: No Wash‐out period: Yes (at least 48 hours) Time point of assessments: BL, 2, 4, 6, 10, 14, 18, 22, 26 weeks
Participants	Inclusion criteria: 1. Age 18 to 60; 2. Definitive diagnosis of AS for which clinical and radiographic criteria include: a) pain and stiffness in the lumbar region for more than 3 months, b) major limitation of motion in the lumbar spine in all three planes, c) pain and stiffness in the thoracic region for more than 3 months, d) limitation of chest expansion, e) night pain, f) history or evidence of iritis or its sequelae, and g) bilateral sacroiliac disease on radiographic examination. Exclusion criteria: A serious adverse event during the first week of treatment. Classification: NA Flurbiprofen (150 to 300 mg): Number of participants: 30 Number of completers: 25 Age: NA Male (%): 87 Symptom duration: NA Disease duration: NA HLA‐B27 positive (%): NA Indomethacin (75 to 150 mg): Number of participants: 27 Number of completers: 22 Age: NA Male (%): 89 Symptom duration: NA Disease duration: NA HLA‐B27 positive (%): NA
Interventions	Flurbiprofen (150 to 300 mg) vs Indomethacin (75 to 150 mg) Co‐medication: All patients were given a daily diary card to record consumption of any non‐study drugs.
Outcomes	Extracted outcomes: 1. Pain on Likert scale (mean change after 26 weeks) (scale 0 to 6, higher is worse) Flurbiprofen 150 to 300 mg: ‐1.9 (N = 24) Indomethacin 75 to 150 mg: ‐1.8 (N = 21) 2. Withdrawals due to adverse events 3. Duration of morning stiffness (mean change after 26 weeks) (in hours, higher is worse) Flurbiprofen 150 to 300 mg: ‐6.21 (N = 25) Indomethacin 75 to 150 mg: ‐5.73 (N = 20) 4. Chest expansion (mean change after 26 weeks) (in cm, higher is better) Flurbiprofen 150 to 300 mg: +0.86 (N = 25) Indomethacin 75 to 150 mg: +1.40 (N = 21) 5. Occiput‐to‐wall distance (mean change after 26 weeks) (in cm, higher is worse) Flurbiprofen 150 to 300 mg: ‐2.2 (N = 19) Indomethacin 75 to 150 mg: ‐3.1 (N = 15) 6. Intermalleolar distance (mean change after 26 weeks) (in cm, higher is better) Flurbiprofen 150 to 300 mg: ‐1.8 (N = 25) Indomethacin 75 to 150 mg: ‐5.4 (N = 21) 7. Schober's test (mean change after 26 weeks) (in cm, higher is better) Flurbiprofen 150 to 300 mg: +0.9 (N = 25) Indomethacin 75 to 150 mg: +0.8 (N = 21) 8. Number of any adverse events 9. Number of adverse events per organ system
Notes	Outcomes that were not included in the meta‐analysis, because no measure of variance (SD, SE or CI) was reported for these outcomes: pain on Likert scale, duration of morning stiffness, chest expansion, occiput‐to‐wall distance, intermalleolar distance, Schober's test. Available results are described in this table. BL results were not available for any of the outcomes. Funding source: Not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Assignment to one of the two treatment groups was in accordance with a standardized randomization scheme."
Allocation concealment (selection bias)	Low risk	"Treatment was double‐blind, with patients receiving…in identically appearing bottles with attached decoding labels."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Treatment was double‐blind, with patients receiving…in identically appearing bottles with attached decoding labels."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"double‐blind", Comment: probably done, but no further information provided on blinding of outcome assessor.
Incomplete outcome data (attrition bias) All outcomes	High risk	"Patients were withdrawn before completing the first week if a serious adverse event occurred." "If symptoms did not subside after this time, the patient was withdrawn." "Patients who had normal values at baseline on any measure were excluded from the analyses." ; Comment: Several points in time at which the authors withdrew patients (how many?) for reasons with a high risk of attrition bias. Also unclear why some outcomes had less number of patients than those that completed the study.
Selective reporting (reporting bias)	Unclear risk	Pain during the day was assessed (see methods section), but not reported (see results section). All other outcomes that were assessed, were reported.
Other bias	Low risk	No other bias detected.