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. 2014 Dec 1;2014(12):CD006991. doi: 10.1002/14651858.CD006991.pub2

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)
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:
  • recent steroid treatment (sustained release within 3 months, systemic within 2 months or topical within 1 month), pregnancy or acute purulent sinusitis

  • "Treatment success" after 4 weeks of medical treatment in phase 1 as judged by improvement in at least 3 of the following assessments: investigator's assessment of polyp size; patient's overall assessment of polyposis; patient's assessment of sense of smell; patient's overall assessment of treatment efficacy; PEF index improvement (of at least 10%)


Baseline characteristics: symptom score, polyp size score, peak expiratory flow (PEF) index (nasal PEFR/oral PEFR), semi‐quantitative smell test
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)
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