1. www.aodhealth.org1 Journal Club Alcohol, Other Drugs, and Health: Current Evidence July-August 2007

2. www.aodhealth.org2 Featured Article Smoking, alcohol consumption, and Raynaud’s phenomenon in middle age Suter LG, et al. Am J Med. 2007;120(3):264–271.

3. www.aodhealth.org3 Study Objective To determine whether… smoking and drinking are associated with Raynaud’s phenomenon

4. www.aodhealth.org4 Study Design Data came from the community-based Framingham Heart Study Offspring Cohort. Subjects included 1602 men and 1840 women who were white and had a mean age of about 62 years. Researchers used a validated survey to classify Raynaud’s status. Analyses were adjusted for key confounders (e.g., cardiovascular disease, body mass index).

5. www.aodhealth.org5 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. www.aodhealth.org6 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. www.aodhealth.org7 Did the investigators demonstrate similarity in all known determinants of outcomes? Did they adjust for differences in the analysis? Subjects were excluded if they used occupational vibrational tools. Most subjects were free of any connective tissue disease. The following covariates associated with Raynaud’s or smoking and alcohol use were measured and adjusted for: –Age and Body Mass Index –Use of Antihypertensive Medications –Cardiovascular Disease –Menopausal and Hormonal Status Antinuclear antibody (ANA) testing was not performed.

8. www.aodhealth.org8 Were exposed patients equally likely to be identified in the two groups?  All subjects received similar surveillance for the exposures of interest (smoking and drinking).

9. www.aodhealth.org9 Were the outcomes measured in the same way in the groups being compared?  All subjects received similar surveillance for the outcome of interest (Raynaud’s phenomenon).  The study was not blinded. –The large number of variables and outcomes measured in this cohort makes bias due to lack of blinding unlikely.

10. www.aodhealth.org10 Was follow-up sufficiently complete? Histories of the exposures and the outcome were measured simultaneously, precluding a cause-effect determination. No information on the length of the exposures was presented.

11. www.aodhealth.org11 What are the Results? How strong is the association between exposure and outcomes? How precise is the estimate of the risk?

12. www.aodhealth.org12 What are the Results? Approximately 6% of women and 4% of men had Raynaud’s phenomenon. Regular smoking in the past 12 months, versus not smoking, was significantly associated with an increased risk of Raynaud’s in men (odds ratio [OR], 2.59) but not in women. Moderate drinking, versus not drinking,* was significantly associated with a decreased risk in men (OR, 0.51) but not in women. *Not drinking is about <2 drinks per week; moderate drinking is ≥2 to ≤7 drinks per week for women and ≥2 to ≤14 drinks for men

13. www.aodhealth.org13 What are the Results? (cont.) However, drinking red wine (≈1 glass or more per week), versus no red-wine drinking, appeared to… –lower risk for both men (OR, 0.30) and women (OR, 0.59). Heavier drinking, versus not drinking, was associated with... –increased risk in women (OR, 1.69) but not in men. *Heavier drinking is >7 drinks per week for women and >14 drinks for men.

14. www.aodhealth.org14 How strong is the association between exposure and outcome? BehaviorAdjusted Odds Ratios and 95% Confidence Intervals Regular smokingWomen: NA* Men: 2.59 (1.11-6.04) Moderate drinkingWomen: 0.89 (0.57-1.40) Men: 0.51 (0.29-0.89) Heavier drinkingWomen: 1.69 (1.02-2.82) Men: 0.85 (0.42-1.70) Wine drinkingWomen: 0.59 (0.36-0.96) Men: 0.30 (0.15-0.62) *There was no association between smoking and Raynaud’s among women in bivariate analyses; therefore, in multivariable analyses involving women, only drinking was included.

15. www.aodhealth.org15 How precise is the estimate of the risk? The confidence intervals are fairly wide because of the low prevalence of the disorder among the general population.

16. www.aodhealth.org16 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?

17. www.aodhealth.org17 Were the study patients similar to the patients in my practice? Subjects were white, in their early 60’s, and had a mean BMI close to 30. 12%-13% currently smoked. 31%-40% were abstinent from alcohol. 14%-15% met criteria for heavy drinking. 14%-32% had a history of cardiovascular disease.

18. www.aodhealth.org18 Was the duration of follow-up adequate? Histories of the exposures and the outcome were assessed simultaneously. The timing of the exposure in relation to the development of the outcome was not presented.

19. www.aodhealth.org19 What was the magnitude of the risk? In men, the adjusted odds ratio for smoking (2.59) is substantial. In men and women, the protective effect of moderate wine consumption (adjusted ORs, 0.3- 0.6) is also notable.

20. www.aodhealth.org20 Should I attempt to stop the exposure? According to these data, Raynaud’s can be added to the list of adverse effects of… –smoking in men and –heavier alcohol consumption in women. Also, a lower risk of Raynaud’s can be added to the list of potential benefits of moderate wine consumption for both men and women. However, this study does not support a role for alcohol consumption in general to decrease Raynaud’s risk.