Summary of findings for the main comparison. Surgery (tonsillectomy with or without adenoidectomy) for children with periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis (PFAPA) syndrome.
| Surgery (tonsillectomy with or without adenoidectomy) for children with periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis (PFAPA) syndrome | ||||||
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Patient or population: children with PFAPA
Settings: Europe (Finland/Italy) in tertiary hospitals
Intervention: surgery (tonsillectomy with or without adenoidectomy) Comparison: no treatment (watchful waiting) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| No treatment (watchful waiting) | Surgery (tonsillectomy with or without adenoidectomy) | |||||
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Complete resolution of symptoms (proportion of patients with 'immediate and persistent resolution of symptoms' from the point of surgery/randomisation up to end of study follow‐up) |
Study population (average) | RR 4.38 (0.64 to 30.11) | 65 (2 studies) | ⊕⊕⊕⊝ moderate1 | The NNTB based on the study population risk was 1/(684‐156)*1000 = 1.89. 1 study followed up patients up to 6 months; another up to 18 months. |
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| 156 per 1000 | 684 per 1000 (100 to 1000) | |||||
| Medium risk population | ||||||
| 192 per 1000 | 841 per 1000 (123 to 1000) | |||||
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Complications of surgery (haemorrhage and days with pain) |
Both studies reported no complications from surgery. Days of pain not reported as an outcome. |
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Number of episodes of fever and associated symptoms (episodes per person per month) |
Mean 0.5 episode per person per month (1 episode every 2 months) | Mean 0.04 episode per person per month (1 episode every 25 months) | Rate ratio: 0.08 (0.05 to 0.13) | 65 (2 studies) | ⊕⊕⊕⊝ moderate1 | — |
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Severity of episodes (number of days with fever and the associated symptoms (per episode)) |
Mean 3.5 (range of 2 to 6) days per episode | Mean 1.7 (range of 2 to 4) days per episode | Mean difference: 1.8 days per episode | 39 (1 study) |
⊕⊕⊕⊝ moderate1 | Study reported statistical significance. Standard deviations were not reported in the study for average number of days per episode. |
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Use of corticosteroids (proportion of patients using corticosteroids) |
Study population (average) |
RR 0.58 (0.37 to 0.92) |
39 (1 study) |
⊕⊕⊝⊝ low1,2 | Review intended to report number of courses/patient, but these data were not available in the studies. | |
| 900 per 1000 | 522 per 1000 (333 to 828) | |||||
| Absence or time off school | None of the studies reported this | |||||
| Quality of life | None of the studies reported this | |||||
| *The basis for the assumed risk was the median risk in the control groups for "medium risk population" and for "study population", this was the average (i.e. total number of participants with events divided by total number of participants included in the meta‐analysis). 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; NNTB: number needed to treat to benefit; RR: risk ratio | ||||||
| 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. | ||||||
1We downgraded the certainty of the evidence by one level because of the small size of the studies and broad confidence intervals. There was also concern as to whether the treatment received by the control group reflects current practice. The criteria for recruitment of patients into one of the studies was not stringent and could have included patients who did not have PFAPA (Renko 2007). 2We had additional concerns about the applicability of this outcome. Measuring the proportion of patients who had received steroids might not reflect the potential harms from this alternative treatment, which increases with the number of courses used. The numbers used in our analysis were estimations from the percentages reported in the paper, with the assumption that all patients randomised were included in the analysis. However, it is possible that not all participants were included in the study's analysis (i.e. there was some loss of data). We therefore downgraded by an additional one level.