Journal Club Alcohol, Other Drugs, and Health: Current Evidence November-December, 2015

Featured Article Effects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Type 2 Diabetes: A 2-Year Randomized, Controlled Trial. Gepner Y, et al. Ann Intern Med. 2015;163(8):569–579.

Study Objectives “To assess cardiometabolic effects of initiating moderate alcohol intake in persons with [type-2 diabetes mellitus] and whether the type of wine matters.”

4 Study Design Randomized trial among 224 participants in Israel. Participants had no alcohol use at baseline and well-controlled type-2 diabetes mellitus (T2DM). Randomization to three arms: –150 mL of mineral water, white wine, or red wine with dinner for 2 years.

5 Assessing Validity of an Article about Therapy Are the results valid? What are the results? How can I apply the results to patient care?

Are the Results Valid? Were patients randomized? Was randomization concealed? Were patients analyzed in the groups to which they were randomized? Were patients in the treatment and control groups similar with respect to known prognostic variables?

Are the Results Valid? (cont‘d) Were patients aware of group allocation? Were clinicians aware of group allocation? Were outcome assessors aware of group allocation? Was follow-up complete?

Were patients randomized? Yes.

Was randomization concealed? Not stated.

Were patients analyzed in the groups to which they were randomized? Yes.

Were the patients in the treatment and control groups similar? Mostly. –There were more men in the red wine group: 77%, compared with 65% in both the white wine and water groups.

Were patients aware of group allocation? Yes, patients were aware of group allocation based on beverage.

Were clinicians aware of group allocation? Not stated.

Were outcome assessors aware of group allocation? Not stated.

Was follow-up complete? Not quite. –Of the 224 participants, 94% had follow-up data at 1 year and 87% at 2 years.

What Are the Results? How large was the treatment effect? How precise was the estimate of the treatment effect?

How large and precise was the treatment effect? HDL cholesterol levels increased by 2mg/dL more in the red wine (but not white) group than in the water group (95% Cl, 0.04 to 0.06 mmol/L [1.6 to 2.2 mg/dL]; P< 0.001). The white wine (but not red) group had a decrease in fasting plasma glucose that was 17mg/dL larger than the water group (Cl, —1.60 to —0.3 mmol/L [—28.9 to —5.5 mg/dL]; P = 0.004). Decreases in glucose with wine were only significant among the 1 in 3 participants who were slow alcohol metabolizer homozygotes. –FPG level was mmol/L ( -3.8 mg/dL) versus 0.82 mmol/L (14.8 mg/dL; P = 0.043), HOMA-IR score was -1.4 versus 0.3 (P = 0.012), and HbAlc level was 0.1% versus 0.6% (P = 0.024).

How Can I Apply the Results to Patient Care? Were the study patients similar to the patients in my practice? Were all clinically important outcomes considered? Are the likely treatment benefits worth the potential harm and costs?

Were the study patients similar to those in my practice? The trial was conducted in Israel among people consuming a Mediterranean diet. Men and women aged 40 to 75 years with T2DM. Exclusion criteria were: –more than 1 alcoholic drink per week; –personal or family history of addiction, smoking, stroke, or myocardial infarction; –major surgery within the past 3 months; –using more than 2 insulin injections per day or an insulin pump; –triglyceride level >4.52 mmol/L (400 mg/dL), hemoglobin A1c (HbA1c) level <6.4% or ≥10%; –women with first-degree relatives with breast cancer; –pregnant women.

Were all clinically important outcomes considered? These results are insufficient to support any recommendation to start drinking for health reasons.

Are the likely treatment benefits worth the potential harm and costs? Costs were not reported, nor was there evidence of a therapeutic benefit from alcohol consumption.