Kaushal 2001

Methods	Location: India. Number of centres: One. Funding source: Not stated. Recruitment period: August 1997 to March 1999.
Participants	Inclusion: Adults who developed oral mucositis after radiotherapy for histologically proven squamous cell carcinoma of head and neck. Exclusion: Patients with early head and neck cancer suitable for brachytherapy, those on palliative radiotherapy, had previous radiotherapy of chemotherapy, those with concurrent chemotherapy or those with distant metastases. 120 randomised and completed.
Interventions	Gr A (n = 60) Human placental extract (Placentrex) 2 ml IM, 5 times weekly for 3 weeks. Gr B (n = 60) Disprin™ gargle, 1 tablet in a cup of water, 3 times daily 0.5 mg/ml betamethasone oral drops, 8 drops 3 times daily. Both groups received Betadine™ antiseptic mouthwashes three times daily.
Outcomes	Progression of mucositis to grade 3, improvement in dysphasia, decrease in pain (data not used). All evaluated 2 times weekly, but unclear over what time period. Interruption of radiotherapy due to severe radiation reactions. To include the data we included the patients who did not get worse with the mucositis improved outcome.
Notes	No power calculation reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Quote: "randomised" ‐ no details given.
Allocation concealment?	Unclear risk	No information given.
Blinding of participants/carers?	High risk	Comment: Interventions given differently.
Blinding of outcome assessors?	High risk	Not mentioned.
Incomplete outcome data addressed?	Low risk	All randomised patients included in analysis. 0% drop‐outs.
Free of selective reporting?	Unclear risk	Planned outcomes described and reported.
Free of other bias?	Unclear risk	Placentrex given for 3 weeks ‐ ?duration of control group treatment.