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.

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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.”

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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.

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Assessing Validity of an Article about Therapy

• Are the results valid?

• What are the results?

• How can I apply the results to patient care?

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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?

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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?

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Were patients randomized?

• Yes.

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Was randomization concealed?

• Not stated.

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Were patients analyzed in the groups to which they were

randomized?

• Yes.

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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.

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Were patients aware of group allocation?

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

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Were clinicians aware of group allocation?

• Not stated.

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Were outcome assessors aware of group allocation?

• Not stated.

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Was follow-up complete?

• Not quite.– Of the 224 participants, 94% had

follow-up data at 1 year and 87% at 2 years.

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What Are the Results?

• How large was the treatment effect?

• How precise was the estimate of the treatment effect?

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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 -0.21 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).

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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?

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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.

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Were all clinically important outcomes considered?

• These results are insufficient to support any recommendation to start drinking for health reasons.

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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.