Ginkgo Biloba Research Today is a free monthly online journal that collates and summarizes the latest research about Ginkgo Biloba, including details on ginkgo biloba, herbal remedies, side effects, benefits. | ||||||||
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The Hawthorne Effect: a randomised, controlled trial.McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, Fisher P
ABSTRACT: BACKGROUND: The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. METHODS: Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation) or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months). Our primary outcomes were cognitive functioning (ADAS-Cog) and participant and carer-rated quality of life (QOL-AD). RESULTS: We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT), with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n=140; mean difference = 2.018; 95%CI -3.914, -0.121; p=0.037 favouring the intensive follow-up group), and on participant-rated quality of life score (n=142; mean difference =-1.382; 95%CI -2.642, -0.122; p=0.032 favouring minimal follow-up group). There was no significant difference on carer quality of life. CONCLUSION: We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048. Published 4 July 2007 in BMC Med Res Methodol, 7(1): 30.
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