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| |  Clinical Evidence Is Not Strong for Using Metformin to Treat Obesity in Children: Presented at ECO By Shazia Qureshi AMSTERDAM, Netherlands -- May 11, 2009 -- Even though metformin is commonly used in the treatment of childhood obesity, the clinical evidence of its benefit is not strong, researchers reported here at the 17th European Congress on Obesity (ECO). While the study found modest and effective short-term reductions in body mass index (BMI) and insulin resistance when metformin was given to obese, nondiabetic children and adolescents in 5 clinical trials, researchers suggested that larger, long-term studies are needed. Lead author Min Hae Park, Non-Communicable Disease Epidemiology Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom, presented the results of this systematic review in a poster on May 8, noting that "metformin is perhaps the most commonly used drug in paediatric obesity, but clinical use has preceded evidence for benefit." The study was a systematic review of clinical trials of metformin treatment in children and adolescents who were obese but did not have diabetes. Only double-blind, randomised, placebo-controlled trials with a follow-up of at least 6 months that were published before December 2008 were included. For a study to be included, the subjects had to be aged 19 years or younger and have obesity, but not diabetes, known monogenic or genetic syndromes predisposing to obesity, polycystic ovary syndrome, or other chronic health problems. The researchers found 5 studies that met the inclusion criteria. In total there were 365 participants randomised and 320 who completed the trials. The dropout rates were 11% among metformin patients and 16% of placebo patients. The researchers found that all subjects showed hyperinsulinaemia or insulin resistance, and were predominantly from ethnic minority groups known to have a higher risk of metabolic complications. Park did a meta-analysis of data on trial completers using a random-effects model. In each study, the patient group treated with metformin showed greater a reduction in BMI than the group taking placebo (weighted mean difference range, 0.79-2.73 kg/m2). The meta-analysis across all 5 studies showed that the reduction in BMI with metformin treatment was 1.42 kg/m2 (95% confidence interval [CI], 0.83-2.02 kg/m2) greater than with placebo (I2 = 56.2%; P = .058). Metformin treatment lowered the homeostasis model assessment of insulin resistance (HOMA-IR) score by 2.01 (95% CI 0.75 to 3.26) more than placebo did (I2 = 49.5%, P = 0.138). Park said that the effect size for both BMI and HOMA-IR was unadjusted, and not based on intention-to-treat analyses. In addition, she found no evidence for treatment effects of metformin versus placebo on fasting insulin, fasting glucose, high-density lipoprotein cholesterol, triglyceride levels, or blood pressure. Gastrointestinal problems were more commonly reported in the groups receiving metformin than in placebo groups (risk difference 10%-15%). While "metformin may be moderately efficacious in reducing BMI and insulin resistance in the short term among obese hyperinsulinaemic children and adolescents, larger long-term studies across different populations are needed to establish the role of metformin as therapy for obesity in young people," concluded Park. Funding for this study was provided by the Economic and Social Research Council UK.
[Presentation title: Metformin for Obesity in Children and Adolescents: A Systematic Review. Abstract T5:PO.158]
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