Table 2.
Details of eight trials and two matched cohort studies used in meta-analysis of low dose prednisolone in treatment of rheumatoid arthritis
| Study | Equivalent dose of prednisolone | Length of treatment | No of patients taking steroids/ control | Reported major adverse effects (defined by authors) |
|---|---|---|---|---|
| Randomised trials v placebo | ||||
| Chamberlain 197611 | 3 or 5 mg | 2 years | 30/19 | Vertebral fracture in 1 v 1; no proved peptic ulcers |
| Harris 19835 | 5 mg | 6 months | 18/16 | Two fractures on steroid, no ocular changes; all patients subjected to lumbar spine films and ophthalmic examination |
| Stenberg 199243 | 3 mg | 3 months | 22/22 | None (only mild adverse effects, similar to placebo group) |
| Gestel 1995632 | 10 mg | 3 months | 20/20 | No fractures; all patients had lateral spine radiographs taken |
| Kirwan 19954 | 7.5 mg | 2 years | 61/67 | None (two cases of hypertension/weight gain on steroid, two with diabetes and hypertension, respectively, on placebo) |
| Randomised trials v aspirin | ||||
| Empire Rheumatism Council 195513 | 15 mg | 1 year* | 50/50 | Hypertension in 2 v 0 and indigestion in 1 v 5 caused drop out |
| Joint Committee 19542021 | 16 mg† | 2 years* | 30/32 | None (moon face or rubicundity in 11, depression in 5, euphoria in 4 v tinnitus in 11, deafness in 10, nausea, dyspepsia or anorexia in 13 reported in first year. Similar adverse effects in second year (one drop out on each drug, no fractures or cataract)) |
| Joint Committee 19592 | 10 mg‡ | 2 years* | 45/39 | Fractures in 2 v 1, psychosis in 2 v 0, ulcers in 3 v 0, infections in 4 v 3. All had spinal x rays. Several other complications described, most probably unrelated to trial drugs |
| Matched cohorts | ||||
| Saag 199453 | ⩽15 mg | >12 months | 112/112 | Survival type analysis; adverse events more common with steroid, see text |
| McDougall 199454 | 8 mg | 10 years | 122/122 | Fractures in 31 v 19, cataracts in 36 v 22, osteonecrosis in 5 v 2 |
*
Three year results not analysed because of too many drop outs,14 treatment not randomised,22 or too low adherence to randomised treatment.23
†
Average dose, all started with equivalent of 60 mg prednisolone.
‡
Average dose, all started with 20 mg.