Colin 2000.
Methods | Multicentre, randomised, double‐masked study that was conducted in France between 1 July 1994 and 16 October 1995. | |
Participants | Immunocompetent patients aged 18 years or older with herpes zoster ophthalmicus, diagnosed within 72 hours of skin eruption, were eligible for this study. People with other pre‐existing ocular disorders, renal failure, immune dysfunction, or diseases necessitating cytotoxic or immunosuppressive treatment, liver failure, or intolerance or hypersensitivity to acyclovir were ineligible. Women of childbearing age who were not using effective contraceptions or who were pregnant or breast‐feeding were excluded. |
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Interventions | Participants were randomly allocated to either valacyclovir (1 g three times daily for 7 days) or acyclovir (800 mg five times daily for 7 days), the other tablets of the five‐times daily regime were substituted with placebo tablets. | |
Outcomes | The aim was to compare efficacy and safety of valacyclovir and acyclovir. Ocular symptoms, ocular movement, pupil diameter and reflexes, conjunctivae, sclera and episclera, cornea, anterior chamber, ocular tension, and retina were investigated. The ophthalmic examination focused on the frequency, severity and duration of ocular complications. Participants assessed ocular pain severity on a 4‐point scale (0 to 3) and on a visual analogue scale. Sensorineural disorders and healing of skin lesions were assessed at each visit. Tolerance was assessed on the basis of adverse effects and changes in laboratory parameters on days 1 (inclusion) and 7. | |
Notes | The study was supported by Glaxo Wellcome, France. There was no declaration of interest among the primary researchers. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sufficient information is not given by the authors. |
Allocation concealment (selection bias) | Unclear risk | Sufficient information is not given by the authors. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Sufficient information is not given by the authors. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Sufficient information is not given by the authors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants withdrawing informed consent is explained in detail. |
Selective reporting (reporting bias) | Low risk | Reported outcomes of the two abstracts and the main publication did not differ. |
Other bias | Unclear risk | Some of the study authors were sponsored by the pharmaceutical company marketing valacyclovir and it is unclear whether a conflict of interest exists. |