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Combination Therapy Improves Weight Loss
GASTROENTEROLOGY NEWS continued
apy. About 16,000 people in North America are diagnosed with the disease and about 13,000 deaths occur due to the disease each year. Fifty-six patients from 12 institutions entered the International Cancer of the Esophagus Trial (ICE-T). Thirty were treated with the tri-modality regimen and 26 were randomized to receive surgery alone. Patients randomized to triple therapy were treated first with 5-fluorouracil 1000 mg/m2 for 4 days while also receiving cisplatin 1000 mg/m2.
They also received radiation therapy at 50.4 Gray in 1.8 Gray fractions over 5 weeks. Three to 8 weeks following completion of radiation, the patients went to surgery. After 6 years, median survival for those who received all 3 treatments was 4.5 years. The median survival for those receiving surgery was 1.8 years. Patients who received the more intense treatment spent an average of 10 days in hospital after surgery compared with 11.5 days for those
who had surgery alone. There were two deaths, both occurring in the surgery-only group. “We can now tell patients that there is a curative possibility for patients with esophageal cancer,” said Dr. Mark Krasna, Professor of Surgery at the University of Maryland School of Medicine. “Even though there were a small number of patients in this trial,” Krasna said, “the stark differences in the results show that giving chemotherapy, radiation, and surgery works best.”
Combination Therapy Improves Weight Loss
tice is likely to limit therapeutic benefits,” Dr. Wadden and co-authors note. In the 1-year trial, 224 obese adults were randomly assigned to one of the following therapy approaches: to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in 8 visits of 10 to 15 minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestylemodification counseling (ie, combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in 8 visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen. At 1 year, subjects who received combined therapy lost a mean (⫾SD) of 12.1 ⫾ 9.8 kg, whereas those receiving sibutramine alone who lost 5.0 ⫾ 7.4 kg, those treated by lifestyle modification alone lost 6.7 ⫾ 7.9 kg, and those receiving sibutramine plus brief therapy lost 7.5 ⫾ 8.0 kg (P ⬍ .001). In addition, participants in the combined-therapy group who frequently recorded their food intake lost more weight than those who did
so infrequently (18.1 ⫾ 9.8 kg vs 7.7 ⫾ 7.5 kg, P ⫽ .04). The researchers state that the group given sibutramine plus brief therapy was included to determine whether practitioners might provide effective lifestyle counseling during a limited number of visits of 10 to 15 minutes each, aimed at simulating patterns of primary care practice. They found that participants in this group lost significantly more weight at week 18 than did those who received sibutramine alone. “Thus, it appears that practitioners may be able to provide brief, effective weight-loss counseling. However, the superiority of this approach faded after week 18, when the frequency of visits was reduced,” the authors point out. “The combination of medication and group lifestyle modification resulted in more weight loss than either medication or lifestyle modification alone,” the authors state. “The results underscore the importance of prescribing weight-loss medications in combination with, rather than in lieu of, lifestyle modification.” For more details, see The New England Journal of Medicine 2005; 353:2111–2120.
A
dding behavioral therapy to treatment with sibutramine significantly improves weight loss, as compared with that achieved by drug therapy alone, according to research reported in The New England Journal of Medicine. A study team led by Thomas A. Wadden, PhD, Professor of Psychology in the Department of Psychiatry at the University of Pennsylvania School of Medicine and director of the school’s weight and eating disorders program, compared the relative efficacies at 1 year of using weight-loss medication (sibutramine) alone, lifestyle modification alone, or a combination of sibutramine and lifestyle modification. Sibutramine produces its therapeutic effects by norepinephrine, serotonin, and dopamine reuptake inhibition. It is 1 of 2 medications, including orlistat, that are currently approved by FDA for the induction and maintenance of weight loss. “Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This prac-
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apy. About 16,000 people in North America are diagnosed with the disease and about 13,000 deaths occur due to the disease each year. Fifty-six patients from 12 institutions entered the International Cancer of the Esophagus Trial (ICE-T). Thirty were treated with the tri-modality regimen and 26 were randomized to receive surgery alone. Patients randomized to triple therapy were treated first with 5-fluorouracil 1000 mg/m2 for 4 days while also receiving cisplatin 1000 mg/m2.
They also received radiation therapy at 50.4 Gray in 1.8 Gray fractions over 5 weeks. Three to 8 weeks following completion of radiation, the patients went to surgery. After 6 years, median survival for those who received all 3 treatments was 4.5 years. The median survival for those receiving surgery was 1.8 years. Patients who received the more intense treatment spent an average of 10 days in hospital after surgery compared with 11.5 days for those
who had surgery alone. There were two deaths, both occurring in the surgery-only group. “We can now tell patients that there is a curative possibility for patients with esophageal cancer,” said Dr. Mark Krasna, Professor of Surgery at the University of Maryland School of Medicine. “Even though there were a small number of patients in this trial,” Krasna said, “the stark differences in the results show that giving chemotherapy, radiation, and surgery works best.”
Combination Therapy Improves Weight Loss
tice is likely to limit therapeutic benefits,” Dr. Wadden and co-authors note. In the 1-year trial, 224 obese adults were randomly assigned to one of the following therapy approaches: to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in 8 visits of 10 to 15 minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestylemodification counseling (ie, combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in 8 visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen. At 1 year, subjects who received combined therapy lost a mean (⫾SD) of 12.1 ⫾ 9.8 kg, whereas those receiving sibutramine alone who lost 5.0 ⫾ 7.4 kg, those treated by lifestyle modification alone lost 6.7 ⫾ 7.9 kg, and those receiving sibutramine plus brief therapy lost 7.5 ⫾ 8.0 kg (P ⬍ .001). In addition, participants in the combined-therapy group who frequently recorded their food intake lost more weight than those who did
so infrequently (18.1 ⫾ 9.8 kg vs 7.7 ⫾ 7.5 kg, P ⫽ .04). The researchers state that the group given sibutramine plus brief therapy was included to determine whether practitioners might provide effective lifestyle counseling during a limited number of visits of 10 to 15 minutes each, aimed at simulating patterns of primary care practice. They found that participants in this group lost significantly more weight at week 18 than did those who received sibutramine alone. “Thus, it appears that practitioners may be able to provide brief, effective weight-loss counseling. However, the superiority of this approach faded after week 18, when the frequency of visits was reduced,” the authors point out. “The combination of medication and group lifestyle modification resulted in more weight loss than either medication or lifestyle modification alone,” the authors state. “The results underscore the importance of prescribing weight-loss medications in combination with, rather than in lieu of, lifestyle modification.” For more details, see The New England Journal of Medicine 2005; 353:2111–2120.
A
dding behavioral therapy to treatment with sibutramine significantly improves weight loss, as compared with that achieved by drug therapy alone, according to research reported in The New England Journal of Medicine. A study team led by Thomas A. Wadden, PhD, Professor of Psychology in the Department of Psychiatry at the University of Pennsylvania School of Medicine and director of the school’s weight and eating disorders program, compared the relative efficacies at 1 year of using weight-loss medication (sibutramine) alone, lifestyle modification alone, or a combination of sibutramine and lifestyle modification. Sibutramine produces its therapeutic effects by norepinephrine, serotonin, and dopamine reuptake inhibition. It is 1 of 2 medications, including orlistat, that are currently approved by FDA for the induction and maintenance of weight loss. “Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This prac-
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