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Lifestyle modification with drug treatment achieves most weight loss,
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     The best results in weight loss are achieved when drug treatment is used as an adjunct to a comprehensive programme of diet modification, exercise, and behaviour therapy, a new US study shows.

    The randomised one year trial involved 180 women and 44 men between the ages of 18 and 65 whose body mass index was between 30 and 45 (New England Journal of Medicine 2005;353:2111-20). At the beginning of the study the participants were asked to keep to their usual eating and activity habits. Later they were prescribed a balanced deficit diet giving about 5 MJ to 6.3 MJ of energy a day. In this diet about 15% of their energy derived from proteins, 30% or less from fats, and the remainder from carbohydrates. All participants were encouraged to walk 30 minutes a day most days of the week.

    The participants were randomly assigned to one of four treatment groups:

    Sibutramine (a serotonin and noradrenaline reuptake inhibitor that seems to modify internal signals controlling hunger) alone—the drug, at doses up to 15 mg, was given on eight brief visits to a primary healthcare provider over the study period, at which the participants also received a pamphlet containing tips for healthy eating and activity and general encouragement.

    Lifestyle modification alone—participants attended 90 minute group meetings once a week, led by trained psychologists, that dealt with lifestyle, exercise, attitudes, relationships, and nutrition, and they were given weekly homework assignments that included keeping daily records of food and energy intake and physical activity.

    Combined treatment—the combination of slightly modified versions of the treatments in the first two groups.

    Sibutramine and brief therapy—participants received sibutramine and met a healthcare provider for 10-15 minutes per session on the same schedule as those receiving sibutramine alone and were also given two treatment manuals and completed homework assignments, which included food intake and activity records that were reviewed during their visits with the providers.

    The researchers found that participants in the combined treatment group lost significantly more weight at the end of the study than those in the other three groups (P<0.001). The mean loss in the combined treatment group was 12.1 (SD 9.8) kg, roughly double that in the sibutramine alone group (5 (7.4) kg) and the lifestyle modification group (6.7 (7.9) kg). Participants receiving sibutramine and brief therapy lost 7.5 (8) kg.

    The authors wrote, "Nearly twice as many subjects in the combined therapy group as in the monotherapy groups lost 10% or more of their initial weight, a prespecified benchmark for success . . . subjects treated by lifestyle modification alone had significantly greater weight loss than those who received sibutramine alone during the first 18 weeks."

    The authors could not identify the components of the group lifestyle modification that, when combined with sibutramine, contributed most to the increased weight loss, but they noted that "keeping daily food-intake records during the first 18 weeks correlated positively with weight loss at all assessments." Participants in the combined treatment group who were in the top third of record keeping lost 18.1 (9.8) kg, whereas those in the bottom third lost 7.7 (7.5) kg (P=0.04).

    An accompanying editorial said, "In 2005, a majority of adult Americans are overweight or obese, putting millions of them at increased risk for serious medical conditions, including cardiovascular disease, type 2 diabetes mellitus, and certain forms of cancer. In obesity, a weight loss of 5% to 10% can significantly improve risk factors for obesity-related diseases and delay or prevent type 2 diabetes in persons at high risk."(Quebec David Spurgeon)