1 Journal Club Alcohol, Other Drugs, and Health: Current Evidence September–October 2015

2 Featured Article Randomized Controlled Intervention of the Effects of Alcohol on Blood Pressure in Premenopausal Women. Mori TA, et al. Hypertension. 2015;66(3):517–523.

3 Study Objective To examine the effects of the administration of alcohol on premenopausal women’s blood pressure.

4 Study Design Randomized controlled trial using a cross-over design in 24 normotensive pre-menopausal women (all of whom had at baseline an average alcohol consumption of 2–3 standard drinks in a day). Following a run-in phase, participants were divided into two groups based on reported average consumption: Participants consuming < 200 g alcohol in a week were administered: –100 ml/day of red wine on 4 days per week (an average of 46 g/week of alcohol, about 0.5 drinks per day), –200 ml/day of red wine daily (average of 146 g/week of alcohol, about 1.5–2 drinks/day), –and then similar amounts of dealcoholized red wine consecutively over three 4-week periods. Participants consuming > 200 g alcohol in a week were administered: –100 ml/day of red wine daily (an average of 73 g/week of alcohol, about one drink per day), –300 ml/day of red wine daily (218 g/week of alcohol, about 2–3 drinks/day), –and then similar amounts of dealcoholized red wine consecutively over three 4-week periods.

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

6 Are the Results Valid? Did the investigators demonstrate similarity in all known determinants of outcomes? Did they adjust for differences in the analysis? Were exposed patients equally likely to be identified in the two groups? Were the outcomes measured in the same way in the groups being compared? Was follow-up sufficiently complete?

7 Did the investigators demonstrate similarity in all known determinants of outcomes? Researchers used a cross-over design in which participants serve as their own control.

8 Did they adjust for differences in the analysis? No, a cross-over design was used in this 12 week trial with each participant serving as her own control.

99 Were exposed patients equally likely to be identified in the groups? Yes.

10 Were the outcomes measured in the same way in the groups being compared? Yes.

11 Was follow-up sufficiently complete? Yes. All 24 participants completed the study.

12 What are the Results? How strong is the association between exposure and outcomes? How precise is the estimate of the risk?

How strong is the association between exposure and outcome? How precise is the estimate of the risk? 13 There was a 2±0.6 mm Hg increase in blood pressure among women consuming an average of 2-3 standard drinks per day.

14 How Can I Apply the Results to Patient Care? Were the study patients similar to the patients in my practice? Was the duration of follow-up adequate? What was the magnitude of the risk? Should I attempt to stop the exposure?

15 Were the study patients similar to the patients in my practice? The participants were healthy, premenopausal, non-smoking women, aged years who consumed 2-3 drinks per day. –“They had a body mass index <30 kg/m2 and no history of hypertension, dyslipidaemia, diabetes mellitus, liver disease, or coronary, cerebrovascular or peripheral vascular disease, and were free of clinical evidence of vascular disease on examination. They were not taking any medications, including aspirin, nonsteroidal anti-inflammatory drugs, or the oral contraceptive pill.”

16 Was the duration of follow-up adequate? No. –Alcohol consumption patterns often persist for years. The three 4-week study periods provide information about the short term impact of alcohol exposure on blood pressure, yet leave important questions about chronic exposure unanswered.

17 What was the magnitude of the risk? “Awake systolic and diastolic BP were 2.3/1.3 mm Hg higher in women who consumed 146–218 g alcohol/wk (≈2–3 standard drinks/day) as red wine for 4 weeks when compared with a similar period when only dealcoholized red wine was consumed. There was no effect of lower level alcohol intake (42–73 g alcohol/week; ≈0.5–1 standard drink/d) to lower BP.”

18 Should I attempt to stop the exposure? This is the first study to demonstrate that alcohol consumption elevates blood pressure among premenopausal women. Clinicians should advise their patients of the cardiovascular risks associated with alcohol consumption.