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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
[Effectiveness and safety of Very Low Calory Diets in obese patients]
M Sáez Belló1, C Segarra Villalba, E Gras Colomer
1Servicio de Farmacia. Hospital Univesitario Dr. Peset. Valencia.. saez_marbel@gva.es.
Purpose:
To evaluate effectiveness, safety and adherence of Very Low Calory Diet (VLCD) in patients with obesity.
Methods:
Observational prospective descriptive study. Patients with BMI >30 kg/m2 who started VLCD were included. We arranged 3 pharmacotherapeutical consultations, picking up the variables: age, sex, BMI, side effects and number of VLCD cycles. We defined effectiveness as weight loss in absolute and relative terms and weight loss rate (kg/week); safety as incidence and severity of side effects by the Pharmacovigilance Spanish System (SEFV); and adherence by a SMAQ adapted questionnaire.
Results:
29 women and 15 men were included, with a mean of 42 years. 5 patients did not complete the follow-up. Effectiveness: weight loss average was 7kg (IQR 9,5 a 5,3) and relative of 6,7%, (p < 0.0005). The weight loss rate was 1,2kg per week (IQR 1,6 a 0,9).
Safety:
33% of the patients described side effects. All of them were mild (37% constipation, 16% dizziness, 12% anxiety, 5% headache, 2% gases y 2% epigastrical pain). ADHERENCE: 84% of the patients were adherent by the SMAQ adapted questionnaire: 74% in the first cycle and 92% in the following ones. The relation between the number of cycles and the adherence did not get statistical differences (p = 0,1127).
Conclusions:
Effectiveness and adherence to the treatment could improve in obese patients by setting interdisciplinary measures in the daily clinical practice.
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