Summary of findings for the main comparison. NSAIDs compared to placebo in people with acute low back pain.
| NSAIDs compared to placebo in people with acute low back pain | ||||||
| Patient or population: adults (≥ 18 years of age) with acute low back pain Setting: primary and secondary care settings, mainly general practice and outpatient clinics Intervention: NSAIDs Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with NSAIDs | |||||
|
Pain intensity VAS (0 to 100; lower = better) Follow‐up: ≤ 3 weeks (range 7 to 15 days) |
The mean pain intensity in the placebo group ranged from 7.9 to 33.9 | The mean pain intensity in the NSAID group was 7.29 lower (10.98 lower to 3.61 lower) |
‐ | 815 (4 RCTs) | ⊕⊕⊕⊝ Moderatea | MID is 10 points on a 0 to 100 scale |
|
Disability RMDQ (0 to 24; lower = better) Follow‐up: ≤ 3 weeks (range 7 to 14 days) |
The mean disability in the placebo group ranged from 6.0 to 7.3 | The mean disability in the NSAID group was 2.02 lower (2.89 lower to 1.15 lower) |
‐ | 471 (2 RCTs) | ⊕⊕⊕⊕ High | MID is 2.4 points on a 0 to 24 scale |
|
Proportion of participants experiencing global improvement Various dichotomised Likert scales; lower = better Follow‐up ≤ 3 weeks (range 1 to 15 days) |
Study population | RR 1.40 (1.12 to 1.75) | 1201 (5 RCTs) | ⊕⊕⊝⊝ Low b,c | ||
| 367 per 1000 | 514 per 1000 (412 to 643) | |||||
|
Proportion of participants experiencing adverse events Follow‐up range 1 day to 12 weeks |
Study population | RR 0.86 (0.63 to 1.18) | 1394 (6 RCTs) | ⊕⊝⊝⊝ Very lowa,d,e,f | ||
| 111 per 1000 | 95 per 1000 (70 to 130) | |||||
|
Return to work (%) Follow‐up: 7 days |
Study population | RR 1.48 (0.98 to 2.23) |
266 (1 RCT) |
⊕⊝⊝⊝ Very lowa,g | ||
| 212 per 1000 | 314 per 1000 (208 to 473) |
|||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; VAS: visual analogue scale; RMDQ: Roland Morris Disability Questionnaire; RR: risk ratio; RCT: randomised controlled trial; MID: minimal important difference | ||||||
| GRADE Working Group grades of evidence High certainty. We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty. We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty. Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low certainty. We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded one level due to risk of bias. More than 25% of the included participants were from studies with a high risk of bias. bDowngraded one level due to inconsistency. There is moderate to substantial heterogeneity with an I² of 52% and a wide variance in point estimates across studies. cDowngraded one level due to indirectness. Two studies (three treatment arms) included a small percentage of participants with additional sciatic complaints (different population). NSAID tablets, capsules or intramuscular injections were used (different intervention). Treatment time and timing of outcome assessments ranged (differences in outcome), which could make the results less generalisable. dDowngraded one level due to inconsistency. On visual inspection, there is a wide variance in point estimates across studies. Follow‐up duration to measure and report adverse events varied greatly, and was probably too short in a few studies to adequately detect all adverse events. eDowngraded one level due to indirectness. Two studies (three treatment arms) included a small percentage of participants with additional sciatic complaints (different population). Most studies had a relatively short follow‐up time (ranging from 1 day to 2 to 3 weeks), except for one study (follow‐up time 12 weeks). Therefore, it is unclear if the follow‐up time frame was sufficient to measure and report all relevant outcomes regarding adverse events. fDowngraded one level due to imprecision. The total number of events was less than 300. gDowngraded two levels due to imprecision. Only one study was included in the comparison, with a total number of events far less than 300. The 95% CI includes both no effect and the threshold of appreciable benefit.