Simon 2003.
Methods | Double‐blinded 3‐arm pilot RCT. Start and end dates not stated | |
Participants | 45 children (aged 2 to 18) with symptoms of infectious mononucleosis for 1 week or less. Clinic setting. 25 male participants and 20 female participants included | |
Interventions | 1. Valacyclovir 20 mg/kg tds for 14 days and placebo A OD for 5 days 2. Valacyclovir 20 mg/kg tds for 14 days plus prednisolone 1 mg/kg/day for 5 days 3. Placebo B tds for 14 days plus placebo A OD for 5 days |
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Outcomes | Sore throat, stomach ache, fatigue, swollen glands, headache, vomiting, rash, loss of appetite, nausea, sweats, chills, swollen eyes, runny nose, cough, and feeling bad were scored as either absent (0), mild (1), moderate (2), or severe (3) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "An independent pharmacy was in charge of random group assignment, medicine dispersement, and dosing". Unclear how randomisation was performed |
Allocation concealment (selection bias) | Low risk | "An independent pharmacy was in charge of random group assignment, medicine dispersement, and dosing" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | States "double blind" but does not elaborate further |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | States "double blind" but does not elaborate further |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Patients that did not complete the study or had a missing result on day 20 had their last observation carried forward to day 20 prior to any analysis". Incomplete data in 1 of the results tables |
Selective reporting (reporting bias) | High risk | Individual symptom scores were not all reported, but reported as composite scores: "selected score", "feeling bad score", "fatigue score" and "total score" |
Other bias | High risk | Study funding source and conflicts of interest not stated. However, 2 authors were from a drug company. |