Amirchaghmaghi 2016.
Methods | Study design: RCT Conducted in Iran Number of centres: 1 Recruitment period: October 2012 to June 2013 Funding source: supported by Vice Chancellory of Mashhadd University of Medical Sciences |
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Participants | Inclusion criteria: people with clinical signs of erosive‐atrophic OLP which was confirmed by clinical and histopathological examination Exclusion criteria: pregnancy; breastfeeding; current use of anticoagulants or antiplatelet agents; current orthodontic treatment; history of gastric ulcers, duodenal ulcers, gallstones, hepatic diseases, any existing malignancy or viral infection in mouth; receiving any topical treatment for OLP in the past 2 weeks or any systemic treatment for OLP in the past 4 weeks; use of azathioprine, ciclosporin or receiving PUVA, UVA or UVB in the last month; history of allergy to corticosteroids or curcumin Group A: randomised 12; analysed 12 Group B: randomised 8; analysed 8 |
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Interventions | Group A: 1 dexamethasone mouthwash 0.5 mg 3 times daily + 1 nystatin (100,000 units) suspension 3 times daily + 4 curcumin tablets (500 mg) twice daily for 4 weeks Group B: 1 dexamethasone mouthwash 0.5 mg 3 times daily + 1 nystatin (100,000 units) suspension 3 times daily + 4 placebo tablets twice daily for 4 weeks |
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Outcomes | Pain (VAS), clinical score (Thongprasom), complete resolution, adverse effects Measured at baseline, 14 days and 28 days |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed using a computer‐generated random number table." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was performed using a computer‐generated random number table. Study medication tablets with 95% curcominoids (Samilabs Limited, Bangalore, India) and identical placebo tablets (containing lactose) were prepackaged by a university pharmacist in identical containers. During treatment, both of the practitioners and the patients were unaware of medications they were using." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "During treatment, both of [sic] the practitioners and the patients were unaware of medications they were using." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "During treatment, both of [sic] the practitioners and the patients were unaware of medications they were using." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data. All randomised participants included in the result analysis. |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |