Lildholdt 1997.
Methods |
Allocation: prospective, randomised, blinded trial Design: parallel, multi‐phased trial. Patients in this comparison were from phase I of the study (after failing 1 month's initial medical treatment) |
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Participants |
Number: 34, out of 126 recruited into phase 1 of trial Age: > 18 years Gender: not indicated Setting: hospital otorhinolaryngology outpatient clinic or specialty private practice (Sweden) Eligibility criteria: bilateral nasal polyps confirmed by biopsy Exclusion criteria:
Baseline characteristics: symptom score, polyp size score, peak expiratory flow (PEF) index (nasal PEFR/oral PEFR), semi‐quantitative smell test |
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Interventions |
Intervention group: n = 18: snare polypectomy under local anaesthetic in addition to 400 µg topical budesonide daily Comparator group: n = 16: single intramuscular injection of betamethasone in addition to 400 µg topical budesonide daily Use of additional interventions: phase 1 of trial: double‐blind, placebo‐controlled treatment with 2 different doses of topical budesonide (200 µg, n = 44; or 400 µg, n = 40) or placebo (n = 42) |
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Outcomes | Primary outcome: symptom scores (blocked nose, runny nose, sneezing) at 12 months Secondary outcomes: symptom scores (blocked nose, runny nose, sneezing) at 1, 3, 6 and 9 months; polyp scores, PEFR index and smell tests at 1, 3, 6, 9 and 12 months | |
Declaration of interest | Not indicated | |
Source of funding | Astra Draco | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation is not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants cannot be blinded to surgery Not possible to blind assessor to surgical versus medical participants on endoscopy |
Incomplete outcome data (attrition bias) All outcomes | High risk | Unclear how many of the 34 patients randomised into surgical versus medical treatments were available at 12 months. However, this is likely to be high risk as only about 60% of the overall trial participants were available |
Selective reporting (reporting bias) | High risk | The outcomes for phase 2 of the trial (medical versus surgical subgroups) are not reported separately so outcomes cannot be assessed and data were insufficient for meta‐analysis |
Other bias | Low risk | — |