Summary of findings 3. ImmunoGuard versus placebo for reducing inflammation in familial Mediterranean fever.
| ImmunoGuard versus placebo for reducing inflammation in familial Mediterranean fever | ||||||
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Participant or population: people with familial Mediterranean fever
Settings: outpatient (Armenia)
Intervention: ImmunoGuard Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | ImmunoGuard | |||||
| Number of participants experiencing an attacka | Not reported. | |||||
| Duration of attacks | Not reported. | |||||
| Time between attacks | Not reported. |
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| Prevention of AA amyloidosis | Not reported. | |||||
| Adverse drug reactions | The study reported that no adverse effects were observed. | 23 (1 study) |
⊕⊕⊕⊝ Moderateb | — | ||
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Acute‐phase response Follow‐up: 1 month |
The mean ESR was 23.3 mm/hour in the placebo group. | Mean ESR was2.90 mm/hour lower in the ImmunoGuard group than the placebo group (10.86 mm/hour lower to 5.06 mm/hour higher). | — | 23 (1 study) | ⊕⊕⊕⊝ Moderateb | P = 0.48, no evidence of a difference. |
| The mean WBC count was 11.2 × 109/L in the placebo group. | Mean WBC count was 0.9 (109/L) lower in the ImmunoGuard group than the placebo group (4.66 lower to 2.86 higher). | — | P = 0.64, no evidence of a difference. | |||
| The mean CRP was 2.9 mg/L in the placebo group. | Mean CRP was 0.36 mg/L lower in the ImmunoGuard group than the placebo group (1.29 lower to 0.57 higher). | — | P = 0.45, no evidence of a difference. | |||
| *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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AA: amyloid A; CI: confidence interval; CRP: C‐reactive protein; ESR: erythrocyte sedimentation rate; WBC: white blood cell. | ||||||
| GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: 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 certainty: we are very uncertain about the estimate. | ||||||
aAttack definition: fever ≥ 38 °C, abdominal pain, chest pain, arthropathy, myalgia and erysipelas‐like erythema. bDowngraded one level for small sample size.