Balfour 2007a.
Methods | Double‐blinded RCT. Study start and end dates (November 2007 to February 2010) obtained from Clinicaltrials.gov | |
Participants | 23 students (aged over 15 years) with symptoms of infectious mononucleosis for two weeks or less. Setting unclear. Of patients included in data analysis 12 were male and 9 female. Maximum age of participants was 24 years | |
Interventions | Valomaciclovir 2 g orally twice daily for 21 days, versus placebo | |
Outcomes | Number of participants with improvement in clinical symptoms and reductions in viral burden from baseline, number of participants who experienced adverse events | |
Notes | Unpublished study: data obtained from conference slides supplied by author and information on Clinicaltrials.gov | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 23 participants were enrolled, however 21 were included in data analysis. 2 participants were excluded; 1 due to not having a primary EBV infection and 1 as they had an adverse event on day 11. In reporting of SF12 questionnaires there are data missing from one of the placebo patients ‐ no details are given on why this might be the case |
Selective reporting (reporting bias) | High risk | Clinical exam/symptom scores not individually reported; only reported as composite score of 10 parameters |
Other bias | High risk | Unpublished trial, not peer reviewed Supported by an investigator‐initiated grant from Epiphany Biosciences |