Details of trials comparing the efficacy of NSAIDs with placebo for low back pain
|
First author (reference) | NSAIDs dose/frequency/duration (no of patients) | Reference treatment(s) (no of patients) |
Methods score | Results3-150 |
| Amlie20 | (i) piroxicam 20 mg capsules/twice d† first two days, one d next 5 days/7d (140) | (ii) placebo capsules (142) | 73 | (i) More pain relief than (ii) measured with visual analogue scale after 3 days. After 7 days no significant differences. (Side effects similar (i) 13% (ii) 17%) |
| Goldie32 | (i) indomethacin 25 mg capsules/three d/course of 50 capsules (25) | (ii) placebo capsules (25) | 62 | No of patients with complete relief of pain after 7 and 14 days (i) 7, 14 (ii) 9, 16. No significant differences. (Side effects comparable (i) 8 (ii) 5) |
| Weber33 | (i) piroxicam 20 mg capsules/40 mg d first two days, 20 mg d next 12 days/14d (120) | (ii) placebo capsules (94) | 59 | Reduction of pain in back and leg measured by visual analogue scales after 4 weeks the same in the two groups (data in graphs). No significant differences. (More side effects in (i) 22 than in (ii) 13) |
| Lacey36 | (i) piroxicam 10 mg capsules/four times d first two days, two times d next 12 days/14d (168) | (ii) placebo capsules (169) | 57 | Patient (%) improved after 1 week only in subgroups with initial moderate/severe pain (i) 82%/49% (ii) 53%/38%. No differences for subgroup with mild initial pain. Results after 2 weeks not reported (no data presented on side effects for subgroup with back pain; overall, including other musculoskeletal disorders, similar (i) 12% (ii) 9%) |
| Szpalski38 | (i) tenoxicam 20 mg i m injection on day one/+ 20 mg capsules 1 d for day 2 to 14 (+7 days bed rest) (37) | (ii) placebo injection + placebo capsules (+7 days bed rest) (36) | 55 | Mean pain intensity on VAS on day 1, 8 and 15 (i) 7.4, 1.9, 0.6 (ii) 7.1, 2.8, 0.8. (I) significantly better on day 8. Side effects: one patient in group (i) |
| Radin43 | (i) phenylbutazone 100 mg capsules/six d for two days, three d next 8 days (6) | (ii) placebo capsules | 48 | Group (i) improvement in motor weakness and painful straight leg raising. No results are reported for group (ii). Side effects reported in group (i) 3 |
| Berry22 | (i) naproxen sodium 275 mg capsules/2 times 2 capsules d/14d (37 in cross over design). (ii) diflunisal 250 mg capsules/2 times 2 capsules d/14 d (37 in cross over design) | (iii) placebo capsules (37 in cross over design) | 44 | Decrease in pain by VAS. Group (i) reduction in pain (ii) no change (iii) increase of pain. Data in graphs. Group (i) significantly better than (iii) and somewhat better than (ii). Side effects similar in the three groups (i) 18 (ii) 18 (iii) 16 |
| Weber47 | (i) phenylbutazone 200 mg capsules/2 times 2 capsules 3 times d for 3 days, 1 capsule 3 times d next 2 days (28) | (ii) placebo capsules (29) | 43 | No of patients reporting definite positive effect after intervention period (i) 14 (ii) 8. No significant differences. There were no side effects reported by the patients |
| Jacobs50 | (i) indomethacin 25 mg capsules/3 capsules d for 2 days, 4 capsules d next 5 days (25 with nerve root pain) and (30 without nerve root pain) | (ii) placebo capsules (25 with nerve root pain) and (30 without nerve root pain) | 33 | Group (i) significantly more effective than (ii) only in patient with nerve root pain (data in graphs). Number of side effects (i) 38 (ii) 23 |
| Basmajian21 | (i) diflunisal capsules 500 mg twice d (−), (ii) diflunisal capsules 500 mg + 5 mg cyclobenzaprine twice d (−) | (iii) placebo capsules twice d (−) | 30 | No of patients reporting marked improvement after 3, 4, and 7 days. (i) 10, 14, 24 (ii) 10, 14, 31 (iii) 10, 14, 20. Group (ii) significantly better after 4 days (based on total distribution). No other significant differences were found. No significant side effects were found |
↵3-150 Results of the most important outcome measures according to the authors of the study. p Values < 0.05 were taken as significant.† d = per day.