Summary of findings for the main comparison. Antibiotics compared to placebo for acute rhinosinusitis in adults.
Antbiotics compared to placebo for acute rhinosinusitis in adults | ||||||
Patient or population: acute rhinosinusitis in adults, whether clinically diagnosed or confirmed by imaging Settings: general practice (11 studies), otolaryngology outpatient clinics of university hospitals (2 studies), medical centre (1 study), unknown (2 studies) Intervention: antibiotics Comparison: placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Placebo | Antibiotics | |||||
Cure in adults with clinically diagnosed acute rhinosinusitis | 55 per 100 | 60 per 100 (56 to 65) | OR 1.25 (1.02 to 1.54) | 1687 (8 studies) | ⊕⊕⊕⊕ High | Combination of sinusitis‐like symptoms. Most frequently used clinical symptoms: nasal discharge, facial pain, and common cold or upper respiratory tract infection. NNTB 19 (95% CI 10 to 205) |
Cure in adults with acute rhinosinusitis confirmed by radiography1 | 51 per 100 |
62 per 100 (52 to 72) |
OR 1.57 (1.03 to 2.39) |
394 (3 studies) |
⊕⊕⊕⊝ Moderate2, 3 |
Clinical suspicion + radiography, using various criteria:
NNTB 10 (95% CI 5 to 136) |
Cure in adults with acute rhinosinusitis confirmed by computed tomography1,4 | 11 per 100 |
39 per 100 (18 to 64) |
OR 4.89 (1.75 to 13.72) |
127 (1 study) |
⊕⊕⊕⊝ Moderate5 | Clinical suspicion + computed tomography, using as a criterion presence of fluid level or total opacification in any sinus NNTB 4 (95% CI 2 to 15) |
Severity or duration of different clinical symptoms: resolution of purulent secretion | 60 per 100 | 70 per 100 (63 to 77) | OR 1.58 (1.13 to 2.22) | 660 (3 studies) | ⊕⊕⊕⊕ High | NNTB 10 (95% CI 6 to 35) |
Side effects: total | 15 per 100 | 28 per 100 (24 to 33) |
OR 2.21 (1.74 to 2.82) |
1816 (10 studies) | ⊕⊕⊕⊕ High | NNTH 8 (95% CI 6 to 12) |
Side effects: diarrhoea | 10 per 100 | 18 per 100 (13 to 24) |
Peto OR 2.00 (1.41 to 2.85) |
1210 (7 studies) | ⊕⊕⊕⊕ High | NNTH 13 (95% CI 8 to 29) |
Clinical failure | 11 per 100 | 6 per 100 (4 to 8) |
Peto OR 0.48 (0.36 to 0.63) |
2603 (12 studies) | ⊕⊕⊕⊕ High | NNTH 19 (95% CI 15 to 27) |
*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; NNTB: number needed to treat for an additional beneficial outcome; NNTH: number needed to treat for an additional harmful outcome; OR: odds ratio | ||||||
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. |
Only outcomes that could be pooled were presented.
1High heterogeneity (I² = 41%) for the outcome of cure in adults with acute rhinosinusitis confirmed by imaging led us to split the outcome into cure in adults with acute rhinosinusitis confirmed by radiography and cure in adults with acute rhinosinusitis confirmed by computed tomography. 2There was a high risk of blinding bias in Axelsson 1970. Blinding was not reported and was probably not applied. Placebo group participants did not receive tablets, only nose drops. It was not possible to blind sinus irrigation as an intervention. Only group 2 participants underwent radiological evaluation every second day. Group 3 participants received a longer course of tablets than group 4. For this reason, we downgraded the quality of evidence from high to moderate. Omitting this trial from the meta‐analysis did not substantially change the overall result; therefore, we did not downgrade the quality of the evidence further. 3Three trials reported cure in adults with acute rhinosinusitis confirmed by radiography, and confidence intervals were wide. We downgraded the quality of the evidence to moderate. 4Lindbaek 1996 and Lindbaek 1998 presented study results from two distinct groups (those with fluid level or total opacification in any sinus on computed tomography and those with only mucosal thickening on computed tomography, respectively). Consequently, the results of the two trials were very different (I² = 84%). We opted to report only the results from Lindbaek 1996 because the beneficial effect of antibiotics was clearly present only in this subgroup. 5Only one trial (N = 127) reported on cure in adults with acute rhinosinusitis confirmed by computed tomography. We downgraded the quality of the evidence to moderate because of the low number of participants despite this being a well‐conducted trial.