DLM: Alcohol (2001)


Hein HO, Suadicani P, Gyntelberg F. Alcohol consumption, serum low density lipoprotein cholesterol concentration, and risk of ischaemic heart disease: six year follow up in the Copenhagen Study. BMJ. 1996;312:736-741.

Worksheet created prior to Spring 2004 using earlier ADA research analysis template.
Study Design:
non-randomized trial with concurrent or historical controlsPopulation based descriptive study
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:
Inclusion Criteria:
Exclusion Criteria:
1. history of acute MI, angina, stroke or intermittent claudication
Description of Study Protocol:
he Copenhagen male study was set up in 1970 with men from 14 large work sites in Copenhagen. Sample of 6125 men 40-59 years of age1971-72 information obtained about alcohol intake. 1985-86, survivors from the 1970 study were traced through the Danish central population register and 4505 survivors from the original cohort were invited to participate in this study. Morbidity and mortality followed between 1985-86 and Dec 31, 1991.
Data Collection Summary:
Data collected: 1. weekly alcohol use 2. smoking history 3. physical exam 4. physical activity 5. social class 6. serum lipids 7. EKG 8. Blood pressure 9. BMI Outcome measures: Incidence of ischemic heart disease over a 6-yr follow-up
Description of Actual Data Sample:
2826 men, 53-74 years of age without history of ischemic heart disease 172 (6.1%) had a first ischaemic heart disease event
Summary of Results:
There was an overall inverse association between alcohol intake and risk of ischaemic heart disease In men with a ­ concentration of LDL cholesterol (>5.25 mmol/L) cumulative incidence rates of ischemic heart disease were 16.4% for abstainers, 8.7% for those who drank 1-21 beverages/wk, 4.4% for those who drank >22 beverages/wk Using abstainers as reference and after adjustment for confounders, corresponding RR were 0.4(95% CI, 0.2 to 1.0) (P<0.05) and 0.2 (95% CI, 0.1 to 0.8)(P<0.01). In men with LDL cholesterol <3.63 mmol/L, use of alcohol was not associated with risk In middle-aged and elderly men, the inverse association between alcohol consumption and risk of ischaemic heart disease is highly dependent on the concentration of LDL cholesterol.
Author Conclusion:
The type of alcohol used was asked during data collection. HDL cholesterol was significantly ­ in alcohol users compared to abstainers (medians, 2.5 and 97.5 percentiles) 1.33 mmol/L (0.81 and 2.22) vs. 1.20 (0.76 and 1.98) (P<0.001). Dietary intake was not assessed. In the abstainers, there was a significantly ­ proportion of men with Type 2 diabetes mellitus, and decreased¯ HDL cholesterol. A causal effect between alcohol use and HDL cholesterol can not be made from this observational study.
Funding Source:
Government: Grants from the Danish Medical Research Council
University/Hospital: Grants from King Christian X's Foundation, the Danish Heart Foundation, and the Else and Mogens Wedell-Wedellsborg Foundation.
Reviewer Comments:
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) ???
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? ???
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) ???
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? ???
  2.2. Were criteria applied equally to all study groups? ???
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) ???
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? ???
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) ???
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? ???
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? ???
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? ???
5. Was blinding used to prevent introduction of bias? ???
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? ???
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) ???
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? ???
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? ???
  5.5. In diagnostic study, were test results blinded to patient history and other test results? ???
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? ???
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? ???
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? ???
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? ???
  6.6. Were extra or unplanned treatments described? ???
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? ???
  6.8. In diagnostic study, were details of test administration and replication sufficient? ???
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? ???
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? ???
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? ???
  7.5. Was the measurement of effect at an appropriate level of precision? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? ???
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? ???
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes