Mena 1977.
Methods |
Design: RCT Number of centres: NA Treatment duration: 6 weeks Flare design: Yes Wash‐out period: No Time point of assessments: BL, 2, 4, 6 weeks |
|
Participants |
Inclusion criteria: 1. At least two Rome clinical criteria of the disease; 2. Abnormal or ankylosed sacroiliac joints by radiographic criteria; 3. Suffering an exacerbation of their disease, defined as a clear increase in spinal or sacroiliac pain and one or more of the following: a) muscle spasm in the back, b) decreased range of motion of some part of the spine, c) elevation of the ESR. Exclusion criteria: 1. Age below 19 years; 2. Involvement of more than two peripheral joints not including the shoulders or hips; 3. Probability of pregnancy during the trial; 4. Hypersensitivity to the experimental drugs; 5. Other rheumatoid variants, positive rheumatoid factor or serious concomitant diseases. Classification: Rome criteria Flurbiprofen (150 to 200 mg): Number of participants: 12 Number of completers: 9 Age: NA Male (%): 75 Symptom duration: NA Disease duration: NA HLA‐B27 positive (%): "HLA‐B27 antigen was tested in 8 patients and only one was negative" Phenylbutazone (300 to 400 mg): Number of participants: 15 Number of completers: 13 Age: NA Male (%): 80 Symptom duration: NA Disease duration: NA HLA‐B27 positive (%): "HLA‐B27 antigen was tested in 8 patients and only one was negative" |
|
Interventions | Flurbiprofen (150 to 200 mg) vs Phenylbutazone (300 to 400 mg) Co‐medication: Co‐medication was allowed, but the use of any other analgesia or anti‐inflammatory drug was discouraged. |
|
Outcomes |
Extracted outcomes: 1. Pain on Likert scale (BL, mean change after 6 weeks) (scale 0 to 4, higher is worse) Flurbiprofen 150 to 200 mg: 2.3 (N = 12), ‐0.8 (N = 9) (P < 0.05 versus BL) Phenylbutazone 300 to 400 mg: 1.9 (N = 15), ‐0.7 (N = 13) (P < 0.05 versus BL) 2. Withdrawals due to adverse events 3. Duration of morning stiffness (BL, mean change after 6 weeks) (in hours, higher is worse) Flurbiprofen 150 to 200 mg: 4.6 (N = 12), ‐4.3 (N = 9) (P = not significant versus BL) Phenylbutazone 300 to 400 mg: 1.2 (N = 15), +0.5 (N = 13) (P = not significant versus BL) 4. ESR (BL, mean change after 6 weeks) (in mm/hr, higher is worse) Flurbiprofen 150 to 200 mg: 24.0 (N = 12), +5.6 (N = 9) (P = not significant versus BL) Phenylbutazone 300 to 400 mg: 28.0 (N = 15), ‐6.7 (N = 13) (P < 0.05 versus BL) 5. Chest expansion (BL, mean change after 6 weeks) (in cm, higher is better) Flurbiprofen 150 to 200 mg: 2.5 (N = 12), +0.5 (N = 9) (P < 0.05 versus BL) Phenylbutazone 300 to 400 mg: 3.2 (N = 15), +0.1 (N = 13) (P = not significant versus BL) 6. Occiput‐to‐wall distance (BL, mean change after 6 weeks) (in cm, higher is worse) Flurbiprofen 150 to 200 mg: 7.6 (N = 12), ‐1.1 (N = 9) (P < 0.05 versus BL) Phenylbutazone 300 to 400 mg: 6.6 (N = 15), ‐1.4 (N = 13) (P < 0.02 versus BL) 7. Schober's test (BL, mean change after 6 weeks) (in cm, higher is better) Flurbiprofen 150 to 200 mg: 12.3 (N = 12), +0.0 (N = 9) (P = not significant versus BL) Phenylbutazone 300 to 400 mg: 12.6 (N = 15), +0.5 (N = 13) (P < 0.05 versus BL) 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, ESR, occiput‐to‐wall distance, Schober's test. Available results are described in this table. Funding source: The Upjohn Company provided a grant to support this study. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Twelve patients were randomly assigned to a flurbiprofen group and 15 to a phenylbutazone group." No 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 | "The drugs were available in a blister package. Each blister contained one 50 mg tablet of flurbiprofen or one 100 mg tablet of phenylbutazone and a placebo tablet identical to the other drug." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The contents of the tablets were not known to the patient or the investigator." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition is equal and low (< 25%) in both groups. |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods were reported. |
Other bias | Low risk | No other bias was detected. |