2002
DOI: 10.1677/joe.0.1750545
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Endocrinology trial design: adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults

Abstract: We have evaluated the reporting of withdrawals due to adverse effects and specific adverse effects in randomised controlled trials of recombinant human GH in adults. A systematic review was carried out of randomised controlled trials of the clinical effectiveness of recombinant human GH in adults with GH deficiency in relation to impact on quality of life. Trials were identified from searching electronic databases, bibliographies of related articles and consulting experts. There was reporting of withdrawals du… Show more

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Cited by 17 publications
(9 citation statements)
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References 22 publications
(67 reference statements)
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“…Consequently, dosages were reduced, resulting in fewer adverse effects and a much improved safety profile (137)(138)(139)(140)(141)(142)(143)(144)(145)(146)(147)(148).…”
Section: Side Effects and Risks Associated With Gh Therapymentioning
confidence: 99%
“…Consequently, dosages were reduced, resulting in fewer adverse effects and a much improved safety profile (137)(138)(139)(140)(141)(142)(143)(144)(145)(146)(147)(148).…”
Section: Side Effects and Risks Associated With Gh Therapymentioning
confidence: 99%
“…The characteristics of the patients and treatment received are shown in Table 1. Blinding of patient or physician may have been undermined in those trials using higher doses of GH (Table 1), which caused side-effects (Bryant et al ., 2002). The reporting quality of most of the trials was poor, with serious omissions when describing study design.…”
Section: Resultsmentioning
confidence: 99%
“…Although described as 'double blind', most studies did not describe the status of treating physicians or observers. Blinding of patient or physician may have been undermined in those trials using higher doses of GH (Table 1), which caused side-effects (Bryant et al ., 2002). Follow-up was complete, or near complete, with any drop-outs accounted for.…”
Section: Resultsmentioning
confidence: 99%
“…The lengths of treatment and of washout periods have also varied, and some studies have been placebo controlled, whilst others have been open label and liable to a 'placebo effect'. Even with placebo-controlled trials, the side-effects of GH treatment potentially negate the effects of blinding, by revealing whether the subject is receiving GH or placebo (10). This may result in bias on the part of the observer and of the subjects, who are likely to be aware of the hypothesis being tested.…”
Section: Introductionmentioning
confidence: 99%