OBJECTIVE: To evaluate the cost-effectiveness and safety of two distinct low calorie diets (LCD). DESIGN: Prospective controlled study. METHODS:67 obese patients [body mass index (BMI) 40 kg/m2] were included in two study groups. Group A: 26 patients followed a 458 kcal diet given in three meals for 1 month. Group B: 41 patients followed a 800 kcal diet for 3 months and with outpatient control. MEASUREMENTS: Anthropometric, cardiovascular risk and nutritional profile changes were evaluated, as well as total direct and indirect costs, and the incidence of complications. RESULTS: No significant initial differences were observed between the two study groups. Eighty-six point two per cent of the patients completed the therapy correctly. After treatment a significant decrease was observed in the following variables for both groups, but no differences were detected between Groups A and B: mean weight loss (A= 9.28 kg, B= 8.7 kg), ponderal loss percentage (A/B= 7.2/6.8%), glycemia (A/B= 18.6/12.1 mg/dl), systolic blood pressure (SBP) (A/B= 11.8/6.5 mmHg), diastolic blood pressure (DBP) (A/B 5.9/6.8 mmHg), and final insulin-resistance (IR) index (A= 4.4, B= 4.3). Group A had the highest drop in total cholesterol (37.7 vs 8.1 mg/dl) and triglycerides (54.4 vs 2.5 mg/dl). No changes were observed in ureic acid, renal function and serum albumin. Thirty-six patients (55.3%) suffered trivial complications associated to the VLCD (16.9% gastrointestinal, 20% anxiety), with no differences between groups. Group A patients were on sick leave due to asthenia, and two patients in this group had serious complications (transient ischemic attack and atrial fibrillation). The total cost of Group A treatment was 3018.9 against 582.6 euros for Group B. CONCLUSIONS: The 3-month 800 kcal/day VLCD was more cost-effective and safer than the 1-month 458 kcal/day diet.
RCT Entities:
OBJECTIVE: To evaluate the cost-effectiveness and safety of two distinct low calorie diets (LCD). DESIGN: Prospective controlled study. METHODS: 67 obesepatients [body mass index (BMI) 40 kg/m2] were included in two study groups. Group A: 26 patients followed a 458 kcal diet given in three meals for 1 month. Group B: 41 patients followed a 800 kcal diet for 3 months and with outpatient control. MEASUREMENTS: Anthropometric, cardiovascular risk and nutritional profile changes were evaluated, as well as total direct and indirect costs, and the incidence of complications. RESULTS: No significant initial differences were observed between the two study groups. Eighty-six point two per cent of the patients completed the therapy correctly. After treatment a significant decrease was observed in the following variables for both groups, but no differences were detected between Groups A and B: mean weight loss (A= 9.28 kg, B= 8.7 kg), ponderal loss percentage (A/B= 7.2/6.8%), glycemia (A/B= 18.6/12.1 mg/dl), systolic blood pressure (SBP) (A/B= 11.8/6.5 mmHg), diastolic blood pressure (DBP) (A/B 5.9/6.8 mmHg), and final insulin-resistance (IR) index (A= 4.4, B= 4.3). Group A had the highest drop in total cholesterol (37.7 vs 8.1 mg/dl) and triglycerides (54.4 vs 2.5 mg/dl). No changes were observed in ureic acid, renal function and serum albumin. Thirty-six patients (55.3%) suffered trivial complications associated to the VLCD (16.9% gastrointestinal, 20% anxiety), with no differences between groups. Group A patients were on sick leave due to asthenia, and two patients in this group had serious complications (transient ischemic attack and atrial fibrillation). The total cost of Group A treatment was 3018.9 against 582.6 euros for Group B. CONCLUSIONS: The 3-month 800 kcal/day VLCD was more cost-effective and safer than the 1-month 458 kcal/day diet.
Authors: Maria Raitakari; Thomas Ilvonen; Markku Ahotupa; Terho Lehtimäki; Aimo Harmoinen; Pauli Suominen; Juhani Elo; Jaakko Hartiala; Olli T Raitakari Journal: Arterioscler Thromb Vasc Biol Date: 2003-12-01 Impact factor: 8.311