Liu 2013.
Methods | Study design: RCT Conducted in West China Number of centres: 1 (Hospital of Stomatology, Sichuan University) Recruitment period: April 2011 to May 2012 Funding source: unspecified |
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Participants | Inclusion criteria: erosive OLP determined clinically and pathologically, aged 18–60 years; single erosive lesion; erosive area 100 mm²; disease process duration < 2 months; normal physical examination results before medication (including complete blood cell count, blood glucose test, renal and hepatic clinical chemistry examination, blood pressure examination, ultrasonic examination of abdomen, chest x‐ray and electrocardiogram) Exclusion criteria: > 1 site of erosion (e.g. people with bilateral erosions); hypertension (stage 2), cardiovascular disease, blood disease, or other systemic diseases; other oral mucosal diseases; immunotherapy within 3 months or other topical or systemic treatment of OLP within 1 week of the start of the study; lichenoid reaction caused by amalgam fillings or certain drugs; pregnancy or intention of pregnancy; breastfeeding; use of steroid hormone‐based contraceptives recently; refusal to follow the doctor's advice or to complete the follow‐up review Group A: randomised 30; analysed 29 Group B: randomised 31; analysed 30 |
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Interventions | Group A: betamethasone compound 1.4 mg (betamethasone dipropionate 5 mg + betamethasone disodium phosphate 2 mg/mL), intralesional injection, once weekly for 2 weeks Group B: triamcinolone acetonide 8 mg, intralesional injection, once weekly for 2 weeks |
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Outcomes | Pain (VAS), size of erosive area, relapse rate, adverse effects | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were assigned randomly to the experimental and control groups using a computer‐generated random number list." |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "All injections were performed by the same researcher, who was the only researcher aware of which participants received which medication." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: participants (self‐assessed, pain was primary outcome) were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing data balanced in numbers across intervention groups (1 in each) and not likely to have a clinically relevant impact on the intervention effect estimate. Unlikely to have introduced bias. |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |