Kawaguchi 2007.

Methods	Randomised, controlled, open‐label trial parallel‐group design Intention‐to‐treat analysis: yes
Participants	The trial was conducted in 12 university hospitals in Japan. 150 participants randomly assigned to prednisolone group (66) or prednisolone and valaciclovir group (84). All participants received treatment within 7 days of onset of Bell's palsy. Age range: > 15 years. The mean age in the valaciclovir plus prednisolone group was 54.5 (SD 17.3) and 58% of these participants were women. In the prednisolone group the mean age was 47.0 (SD 18.6) and 62% were women. Inclusion criteria Patients with Bell's palsy treated within 7 days of onset, no other initial treatment Exclusion criteria Ramsay‐Hunt‐Syndrom Contraindications for treatment with prednisolone or valaciclovir Severe diabetes mellitus Psychologic disease Pregnancy Peptic ulcer Connective tissue disease Renal dysfunction
Interventions	Participants received either 20 mg prednisolone 3 times daily for 5 days, then 10 mg 3 times daily for 2 days, then 10 mg daily for 2 days plus valaciclovir 500 mg twice daily for 5 days or prednisolone (the same regimen) alone
Outcomes	Virological examination for anti‐herpes simplex virus and anti‐varicella zoster virus antibodies Detection of herpes simplex virus and herpes zoster virus reactivation Facial movement and recovery measured using the Yanagihara rating scale (Yanagihara 1977), defined as a score of ≥ 36 Follow‐up for 6 months at 1 and 2 weeks after treatment and then at 1, 2, 3, 4, 5, and 6 months after treatment Frequency of incomplete recovery at end of the study and adverse events. Final outcomes reported at 6 months
Funding	Partly funded by a Grant‐in‐Aid for Scientific Research, Ministry of Education, Science and Culture, Japan
Conflicts of interest	No information given
Date conducted	October 2002 to January 2005
Notes	Multicentre: 12 university hospitals
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients were randomly assigned to one of the treatment groups by simple randomisation." Comment: the method of generating the random sequence is not described
Allocation concealment (selection bias)	High risk	Not used; when participants were entered into the trial, the allocation envelope contained the name of the treatment group
Blinding of participants?	High risk	Not done
Blinding of assessors?	High risk	Not done
Incomplete outcome data?	Low risk	Numbers of participants who did not complete clearly documented: 10% were lost to follow‐up
Selective outcome reporting?	High risk	Frequency of incomplete recovery at end of the study and adverse events not reported in the paper
Other sources of bias?	Low risk	No other potential sources of bias identified