Quijada‐Carrera 1996.

Methods	Randomised, double‐blind, placebo‐controlled, parallel‐group Single centre (ambulatory rheumatology clinic), Spain Duration screening and washout not reported, 8 weeks parallel‐group phase Analyses based on at least 3 weeks in study, and separately for ITT population. No imputation described Analgesics and NSAIDs discontinued 3 weeks before enrolment No stated minimum pain intensity
Participants	Tenoxicam: N = 32; pain baseline (0‐100) 65.9 (SD 27); disease duration 7.7 (SD 5) years Placebo: N = 32; pain baseline (0‐100) 66.5 (SD 19); disease duration 11.6 (SD 9.5) years Bromazepam: N = 33; pain baseline (0‐100) 63 (SD 19); disease duration 10.5 (SD 8.7) years Tenoxicam plus bromazepam: N = 37; pain baseline (0‐100) 58.6 (SD 20); disease duration 12.6 (SD 9.5) years The 4 study groups did not differ significantly with respect to age, sex, weight, height, education level, or work type. Except for duration of fibromyalgia symptoms, the clinical characteristics of participants at baseline were similar in the 4 treatment groups. The mean duration of disease symptoms was lower in the tenoxicam group than in the other 3 treatment groups Inclusion criteria: ACR 1990 criteria Exclusion criteria: "The following laboratory tests should be within normal limits: erythrocyte sedimentation rate, complete blood count, glucose, urea, uric acid, creatinine, creatinine phosphokinase, aldolase, lactic dehydrogenase, serum glutamic oxalate, serum glutamic pyruvic transaminase, alkaline phosphatase, rheumatoid factor, antinuclear antibodies, and thyroid‐stimulating hormone. Roentgenograms of cervical and lumbar spine, hands, knees and hips were also taken. For the purposes of the study fibromyalgia patients should not have more than two locations with degenerative radiographic signs. pregnant or lactating, had a previous history of hypersensitivity to NSAIDs or benzodiazepines, suffered from peptic ulceration, inflammatory joint diseases, connective tissue diseases, hematologic, muscular, neurologic, renal or infectious disorders"
Interventions	Tenoxicam 20 mg in the morning fixed and bromazepam placebo at bedtime Placebo in the morning and at bedtime Bromazepam 3 mg fixed at bedtime and placebo in the morning Tenoxicam 20 mg in the morning fixed and bromazepam placebo at bedtime Rescue and/or allowed medication: no information on rescue medication given; psychotropic drugs except bromazepam were not allowed
Outcomes	Pain: Pain (time period not reported) 0‐10 cm; only rates of 25% and more pain relief reported PGIC much or very much improved: global assessment of fibromyalgia; rates of markedly improved or asymptomatic reported Fatigue: not assessed Sleep problems: rates of marked improvement of sleep quality reported Adverse events (AEs): no information provided Health‐related Quality of life: not assessed Psychological distress: not assessed
Notes	Oxford Quality Score R = 1 DB = 1 W = 1 Total = 3/5 No conflicts of interest reported Funding source ‐ not reported; Roche Spain provided the study medication
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details reported
Allocation concealment (selection bias)	Unclear risk	No details reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No details reported
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Participant‐reported outcomes; participants were adequately blinded to intervention. Blinding of outcome assessors of safety not adequately described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Imputation using LOCF for efficacy data. ITT analysis
Selective reporting (reporting bias)	Low risk	Most secondary outcomes reported
Group similarity at baseline	Low risk	Similar at baseline
Sample size bias	High risk	Fewer than 50 participants per treatment arm