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Efficacy of intensive multitherapy for patients with type 2 diabetes mellitus: a randomized controlled trial
Menard J, Payette H, Baillargeon J, Maheux P, Lepage S, Tessier D, Ardilouze J
Canadian Medical Association Journal [Journal de l'Association Medicale Canadienne] 2005 Dec 6;173(12):1457-1463
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: National guidelines for managing diabetes set standards for care. We sought to determine whether a 1-year intensive multitherapy program resulted in greater goal attainment than usual care among patients with poorly controlled type 2 diabetes mellitus. METHODS: We identified patients with poorly controlled type 2 diabetes receiving outpatient care in the community or at our hospital. Patients 30 to 70 years of age with a hemoglobin A1c concentration of 8% or greater were randomly assigned to receive intensive multitherapy (n = 36) or usual care (n = 36). RESULTS: The average hemoglobin A1c concentration at entry was 9.1% (standard deviation (SD) 1%) in the intensive therapy group and 9.3% (SD 1%) in the usual therapy group. By 12 months, a higher proportion of patients in the intensive therapy group than in the control group had achieved Canadian Diabetes Association (CDA) goals for hemoglobin A1c concentrations (goal 7.0%: 35% versus 8%), diastolic blood pressure (goal < 80 mmHg: 64% versus 37%), low-density lipoprotein cholesterol (LDL-C) levels (goal < 2.5 mmol/L: 53% versus 20%) and triglyceride levels (goal < 1.5 mmol/L: 44% versus 14%). There were no significant differences between the 2 groups in attaining the targets for fasting plasma glucose levels, systolic blood pressure or total cholesterol:high-density lipoprotein cholesterol ratio. None of the patients reached all CDA treatment goals. By 18 months, differences in goal attainment were no longer evident between the 2 groups, except for LDL-C levels. Quality of life, as measured by a specific questionnaire, increased in both groups, with a greater increase in the intensive therapy group (13% (SD 10%) versus 6% (SD 13%), p < 0.003). INTERPRETATION: Intensive multitherapy for patients with poorly controlled type 2 diabetes is successful in helping patients meet most of the goals set by a national diabetes association. However, 6 months after intensive therapy stopped and patients returned to usual care, the benefits had vanished.

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