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Lin C, Cai X, Yang W, et al. Age, sex, disease severity, and disease duration difference in placebo response: implications from a meta-analysis of diabetes mellitus. BMC Med. 2020;18(1):322doi: 10.1186/s12916-020-01787-4.
Lin, C., Cai, X., Yang, W., Lv, F., Nie, L., & Ji, L. (2020). Age, sex, disease severity, and disease duration difference in placebo response: implications from a meta-analysis of diabetes mellitus. BMC medicine, 18(1), 322. https://doi.org/10.1186/s12916-020-01787-4
Lin, Chu, et al. "Age, sex, disease severity, and disease duration difference in placebo response: implications from a meta-analysis of diabetes mellitus." BMC medicine vol. 18,1 (2020): 322. doi: https://doi.org/10.1186/s12916-020-01787-4
Lin C, Cai X, Yang W, Lv F, Nie L, Ji L. Age, sex, disease severity, and disease duration difference in placebo response: implications from a meta-analysis of diabetes mellitus. BMC Med. 2020 Nov 16;18(1):322. doi: 10.1186/s12916-020-01787-4. PMID: 33190640; PMCID: PMC7667845.
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BMC Med. 2020 Nov 16;18(1):322. doi: 10.1186/s12916-020-01787-4.

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

BMC medicine

Chu Lin, Xiaoling Cai, Wenjia Yang, Fang Lv, Lin Nie, Linong Ji

Affiliations

  1. Department of Endocrinology and Metabolism, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
  2. Department of Endocrinology and Metabolism, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. [email protected].
  3. Department of Endocrinology and Metabolism, Beijing Airport Hospital, Beijing, China.
  4. Department of Endocrinology and Metabolism, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. [email protected].

PMID: 33190640 PMCID: PMC7667845 DOI: 10.1186/s12916-020-01787-4

Abstract

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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 < 0.01) and longer diabetes duration (β = - 0.02, 95% CI, - 0.03 to - 0.21 × 10

CONCLUSION: The placebo response in diabetes mellitus was systematically outlined. Age, sex, disease severity (indirectly reflected by baseline BMI and baseline HbA1c), and disease duration were associated with placebo response in diabetes mellitus. The association between baseline BMI, baseline HbA1c, and placebo response may be the result of regression to the mean.

Keywords: HbA1c; Placebo response; Type 1 diabetes mellitus; Type 2 diabetes mellitus; Weight

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