Summary of findings 4. Any pharmacological agent versus placebo or any other pharmacological agent for treatment of Buerger's disease.
| Folic acid versus placebo for treatment of Buerger's disease | ||||||
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Patient or population: patients with Buerger's disease
Settings: community
Intervention: folic acid Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with folic acid | |||||
| Ulcer healing | see comment | ‐ | Ulcer healing was not appraised by the study in this comparison | |||
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Pain
VAS. Scale from: 0 to 10; higher score = more pain Follow‐up: 0, 2, 6 months |
Baseline | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝1 very low | ||
| The mean pain in the placebo group was 5.09 points | The mean pain in the intervention group was 1.17 higher (0.66 lower to 3.00 higher) | |||||
| 2 months | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝1 very low | |||
| The mean pain in the placebo group was 5.75 points | The mean pain in the intervention group was 0.3 lower (2.04 lower to 1.44 higher) | |||||
| 6 months | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝1 very low | |||
| The mean pain in the placebo group was 4.82 points | The mean pain in the intervention group was 1.36 lower (3.17 lower to 0.45 higher) | |||||
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Change in rate of amputation (Difference in number of amputations at start of treatment) Follow‐up: 2 and 6 months |
2 months | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝1 very low | No new cases of amputations two months after start of treatment | |
| see comment | ||||||
| 6 months | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝1 very low | No new cases of amputations six months after start of treatment | ||
| see comment | ||||||
| *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; RR: risk ratio; MD: mean difference; VAS: visual analogue scale | ||||||
| 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 | ||||||
1 participants without critical ischaemia, resulting in absence of amputations and no differences in pain score in both groups, one single small study ‐ downgraded by three levels