Age, sex, disease severity, and disease duration difference in placebo response: implications from a meta-analysis of diabetes mellitus

The placebo response in patients with diabetes mellitus is very common. A systematic evaluation needs to be updated with the current evidence about the placebo response in diabetes mellitus and the associated factors in clinical trials of anti-diabetic medicine. Literature research was conducted in...

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Bibliographic Details
Published in:	BMC medicine 2020-11, Vol.18 (1), p.322-322, Article 322
Main Authors:	Lin, Chu, Cai, Xiaoling, Yang, Wenjia, Lv, Fang, Nie, Lin, Ji, Linong
Format:	Article
Language:	eng
Subjects:	Age Age (Psychology) Age differences (Psychology) Age Factors Bias Care and treatment Clinical trials Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - epidemiology FDA approval Female Glucose Glycated Hemoglobin A - analysis HbA1c Hemoglobin Humans Male Medical research Medicine, Experimental Meta-analysis Patients Placebo Effect Placebo response Psychological aspects Regression analysis Regression models Severity of Illness Index Sex Sex differences (Psychology) Sex Factors Software packages Subgroups Type 1 diabetes mellitus Type 2 diabetes mellitus Weight Weight reduction
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Summary:	The placebo response in patients with diabetes mellitus is very common. A systematic evaluation needs to be updated with the current evidence about the placebo response in diabetes mellitus and the associated factors in clinical trials of anti-diabetic medicine. Literature research was conducted in Medline, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for studies published between the date of inception and June 2019. Randomized placebo-controlled trials conducted in type 1and type 2 diabetes mellitus (T1DM/T2DM) were included. Random-effects model and meta-regression analysis were accordingly used. This meta-analysis was registered in PROSPERO as CRD42014009373. Significantly weight elevation (effect size (ES) = 0.33 kg, 95% CI, 0.03 to 0.61 kg) was observed in patients with placebo treatments in T1DM subgroup while significantly HbA1c reduction (ES = - 0.12%, 95% CI, - 0.16 to - 0.07%) and weight reduction (ES = - 0.40 kg, 95% CI, - 0.50 to - 0.29 kg) were observed in patients with placebo treatments in T2DM subgroup. Greater HbA1c reduction was observed in patients with injectable placebo treatments (ES = - 0.22%, 95% CI, - 0.32 to - 0.11%) versus oral types (ES = - 0.09%, 95% CI, - 0.14 to - 0.04%) in T2DM (P = 0.03). Older age (β = - 0.01, 95% CI, - 0.02 to - 0.01, P
ISSN:	1741-7015 1741-7015