Summary of findings for the main comparison. Duloxetine for the treatment of painful diabetic neuropathy.
| Duloxetine for painful diabetic neuropathy | ||||||
| Patient or population: patients with painful neuropathy or chronic pain from diabetic peripheral neuropathy Settings: primary and secondary care Intervention: duloxetine | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Duloxetine | |||||
|
Number of patients with ≥ 50% improvement of pain at 12 weeks or less Duloxetine 60 mg daily 11‐point Likert score Follow‐up: 8 to 12 weeks |
257 per 1000 | 445 per 1000 (370 to 535) | RR 1.73 (1.44 to 2.08) | 908 (4 studies) | ⊕⊕⊕⊝ moderate1 | NNTB for ≥ 50% reduction in pain at 60 mg daily: 5 (95% CI 4 to 7) |
|
Mean improvement in pain at 12 weeks or less Duloxetine 60 mg daily 11‐point Likert score Scale from: 0 to 10 Follow‐up: 8 to 12 weeks |
The mean mean improvement in pain at 12 weeks or less ‐ duloxetine 60 mg daily in the control groups was ‐1.65 units | The mean mean improvement in pain at 12 weeks or less ‐ duloxetine 60 mg daily in the intervention groups was 0.96 lower (1.26 to 0.65 lower) | ‐ | 722 (4 studies) | ⊕⊕⊕⊝ moderate2 | |
|
Number of patients with ≥ 30% improvement in pain at 12 weeks or less Duloxetine 60 mg daily 11‐point Likert scale Follow‐up: 8 to 12 weeks |
411 per 1000 | 629 per 1000 (547 to 719) | RR 1.53 (1.33 to 1.75) | 799 (4 studies) | ⊕⊕⊕⊝ moderate1 | NNTB for ≥ 30% reduction in pain at 60 mg duloxetine daily: 5 (95% CI 3 to 7) |
|
Mean improvement in Patient Reported Global Impression of Change at 12 weeks or less Duloxetine 60 mg daily VAS Scale from: 0 to 10 Follow‐up: 8 to 12 weeks |
The mean mean improvement in patient reported global impression of improvement change at 12 weeks or less ‐ duloxetine 60 mg daily in the control groups was ‐3.06 units | The mean mean improvement in Patient Reported Global Impression of Improvement Change at 12 weeks or less ‐ duloxetine 60 mg daily in the intervention groups was 0.6 lower (0.77 to 0.44 lower) | ‐ | 1018 (5 studies) | ⊕⊕⊕⊝ moderate3 | |
|
Adverse event leading to cessation All neuropathic pain indications Duloxetine 60 mg daily |
56 per 1000 | 109 per 1000 (90 to 133) | RR 1.95 (1.6 to 2.37) | 4837 (14 studies) | ⊕⊕⊝⊝ low4 | NNTH for duloxetine 60 mg daily, all indications, and all adverse effects leading to cessation: 18 (95% CI 13 to 30) |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; RR: risk ratio; NNTB: number needed to treat for an additional beneficial outcome; NNTH: number needed to treat for an additional harmful outcome | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Four trials, all company sponsored and performed but all trials pre‐registered on ClinicalTrials.gov have been published. No publication bias detected. 2 Two of four studies by company. Effect in Rowbotham nonsignificant, contributing some heterogeneity. 3 Five studies but wide CIs in the independent studies. 4 Variable quality of adverse event collection.