Ghabanchi 2009.
Methods | Study design: RCT Conducted in Iran Number of centres: 1 Recruitment period: unclear Funding source: Shiraz University of Medical Sciences |
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Participants | Inclusion criteria: not specified Exclusion criteria: not specified Group A: randomised 9; analysed 9 Group B: randomised 11; analysed 11 |
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Interventions | Group A: prednisolone 5 mg mucoadhesive tablet, twice daily for 2 weeks Group B: triamcinolone acetonide 0.1% paste, 3 times daily for 2 weeks |
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Outcomes | Clinical score (5‐grade score), adverse effects Quote: "Every variable (pain, atrophy, ulceration and interference in daily life) was evaluated independently by the same experienced clinician at 2–6 follow ups (the first one 48 hours after the beginning of treatment)." |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not feasible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data. All randomised participants included in result analysis. |
Selective reporting (reporting bias) | High risk | Comment: ≥ 1 outcomes of interest were reported incompletely (standard deviations were missing) so they could not be entered in a meta‐analysis. Data on adverse effects were not reported clearly (quote: "many patients dislike the bitter taste of topical prednisolone mucoadhesive tablet"). |
Other bias | Low risk | No other sources of bias identified. |