Land 1994.
Methods |
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Participants | Inclusion criteria
Exclusion criteria: NS |
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Interventions |
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Outcomes |
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Notes | Retrospective analysis of data collected in prospective RCT (double‐blinded and placebo controlled) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study reports randomisation of patients, however, procedure was not described |
Allocation concealment (selection bias) | Unclear risk | One of the authors (HS) of the study (although not involved in the patients' care) received the "randomisation code". This author was responsible for collecting all information about study. Study reports that the physicians in charge and the patients were not informed about the initial treatment. No information was provided regarding randomisation methodology |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study reported the use of double blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reported complete follow‐up, no information regarding the conduct of analyses based on the intention‐to‐treat principle |
Selective reporting (reporting bias) | Low risk | The study protocol is not separately available but the published report includes all expected outcomes |
Other bias | High risk | Funding: Two authors employees of 1) Shaman Pharmaceuticals (San Carlos, CA) and 2) The Lipsome Company Inc (Princeton, NJ) |