Carcassi 1990.

Methods	Design: RCT Number of centres: 1 Treatment duration: 12 weeks Flare design: No Wash‐out period: Yes (48 hours) Time point of assessments: BL, 2, 4, 8 and 12 weeks
Participants	Inclusion criteria: 1. Out‐patients only; 2. Age 18 to 75; 3. If female, post‐menopausal or surgically sterile; 4. Definite diagnosis of AS; 5. Active disease as defined by the presence of spinal and/or sacroiliac pain with an increased sedimentation rate and/or active involvement of one or more peripheral joints and/or morning stiffness; 6. Onset after 16 years of age. Exclusion criteria: 1. Acute or active metabolic, neurological, infectious, endocrine, or auto‐immune disease giving rise to arthritis; 2. Evidence of clinically significant, uncontrolled heart, lung, kidney, liver, endocrinological, neurological, gastrointestinal, or hypertensive disease; 3. History of significant upper gastrointestinal bleeding or documented gastric/duodenal ulcer during 5 years prior to study entry; 4. Abnormal pre‐treatment laboratory values that were considered clinically significant but not due to AS if such values were believed to influence the safety evaluations; 5. History of blood dyscrasia, significant psychiatric disorder, drug abuse or alcoholism, allergy to NSAIDs or history of malignancy (unless patient was free of malignant disease for at least 1 year and required no active treatment); 6. Patients receiving steroids, intra‐articular injections, immunosuppressive therapy or investigational drugs during 8 weeks prior to enrolment; 7. If all NSAIDs or analgesics were not discontinued for at least 48 hours prior to enrolment and if patient took salicylates or other NSAIDs or anti‐coagulants during the study. Classification: New York criteria Pirazolac (300 to 600 mg): Age (mean): 36.8 (range 18 to 72) Disease duration: 119 months (range 5 to 480) Indomethacin (25 to 50 mg): Age (mean): 40 (range 20 to 62) Disease duration: 126 months (range 6 to 600) All participants: Number of participants: 151 Number of completers: 119 Male (%): 85 Symptom duration: NA HLA‐B27 positive (%): NA
Interventions	Pirazolac (300 to 600 mg) vs Indomethacin (25 to 50 mg) Co‐medication: Continuation of any prior physical therapy regimen was required, patients were allowed to take vitamins and medications for control of permitted conditions, antacids were permitted only on a non‐chronic basis
Outcomes	Extracted outcomes: 1. Withdrawals due to adverse events (after 12 weeks) (in %) Pirazolac 300 to 600 mg: 20% Indomethacin 25 to 50 mg: 9% 2. Number of any adverse events (after 12 weeks) (""Only the adverse effects for which the severity and relationship to the study drug were known are included.") Pirazolac 300 to 600 mg: N = 14 Indomethacin 25 to 50 mg: N = 6 3. Number of adverse events per organ system (after 12 weeks) Pirazolac 300 to 600 mg: cardiovascular n = 1, gastro‐intestinal n = 6, neurologic n = 1, dermatologic n = 3 Indomethacin 25 to 50 mg: cardiovascular n = 0, gastro‐intestinal n = 3, neurologic n = 4, dermatologic n = 0
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. The outcomes Schober's test, occiput‐to‐wall distance, chest expansion and duration of morning stiffness were also reported, but could not be used due to presentation in graphs from which the data could not be extracted. Funding source: Not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Each patient was randomly assigned to either". Probably done, but no further information was provided on sequence generation.
Allocation concealment (selection bias)	Unclear risk	No information provided on allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"All drugs were supplied in an identical capsule form." "Those patients who were randomized to pirazolac had received placebo at times corresponding to the second daily dose of indomethacin, so that all patients took medication on a t.i.d. basis".
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"double‐blind". Probably done but no further information was provided on blinding of outcome assessors.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"There were no significant differences between the two treatment groups with regards to drop‐out rates (p=0.17)."
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes according to the methods section, are reported in the results section.
Other bias	Low risk	No other bias was detected.