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Ethanol Should Be Subjected to a Randomized Controlled Trial

      To the Editor:
      The meta-analysis by Huang et al
      • Huang C.
      • Zhan J.
      • Liu Y.-J.
      • Li D.-J.
      • Wang S.-Q.
      • He Q.-Q.
      Association between alcohol consumption and risk of cardiovascular disease and all-cause mortality in patients with hypertension: a meta-analysis of prospective cohort studies.
      in the September 2014 issue of Mayo Clinic Proceedings revealed an association between low to moderate ethanol consumption and reduced risk of cardiovascular disease and all-cause mortality (ACM) in hypertensive patients. This study adds additional observational evidence to support the hypothesis that there is a J-shaped curve for ACM vs ethanol consumption, with minimum ACM observed in persons with a low-level long-term ethanol intake of about 10 g/d (about 1 standard serving or drink). This well-designed study reinforces previous epidemiological data suggesting similar benefits of low levels of ethanol consumption in other populations. What is needed is a large prospective randomized controlled trial comparing ethanol vs placebo to provide the high-quality evidence needed for physicians to prescribe low-dose ethanol for patients who could benefit.
      Ethanol has been consumed by humans for millennia, and at high doses it can cause well-known adverse effects, such as hepatitis and cirrhosis. Ethanol abuse can lead to addiction and devastating consequences for at-risk individuals. However, many individuals have no propensity for abuse of ethanol or experiencing any other serious adverse effects of a single serving per day. By the age of 40 years, when cardiovascular disease begins to become a major cause of death, most people know whether they have a tendency to abuse ethanol. With latent and overt alcoholics excluded from randomization, a study could be conducted using capsules of ethanol vs placebo capsules of water (to preserve blinding). If taken in the evening with food, effects on driving accidents should be minimized or eliminated.
      If the benefits found in this meta-analysis were associated with any pharmaceutical, there would be great excitement about its potential widespread use, and a phase 3 clinical trial would have been conducted long ago. It is time to obtain definitive proof of the alleged benefits of low-dose ethanol consumption or to disprove them in a randomized controlled trial.

      Reference

        • Huang C.
        • Zhan J.
        • Liu Y.-J.
        • Li D.-J.
        • Wang S.-Q.
        • He Q.-Q.
        Association between alcohol consumption and risk of cardiovascular disease and all-cause mortality in patients with hypertension: a meta-analysis of prospective cohort studies.
        Mayo Clin Proc. 2014; 89: 1201-1210

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