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Multivitamin Supplementation and Cataract A Case-Control Study

Multivitamin Supplementation and Cataract A Case-Control Study. ASMPH 2012 Group 6 Abad, Imperial, Javate, Palma, Uy R, Valencia. Introduction. Age-related cataract - Leading cause of blindness ~17 million (Congdon, 2001)

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Multivitamin Supplementation and Cataract A Case-Control Study

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  1. Multivitamin Supplementation and CataractA Case-Control Study ASMPH 2012 Group 6 Abad, Imperial, Javate, Palma, Uy R, Valencia

  2. Introduction • Age-related cataract - • Leading cause of blindness • ~17 million (Congdon, 2001) • 500,000 of the population is blind, of these 62% (310,000) is due to cataract (Philippine Information Agency)

  3. Significance of the Study • Evaluating advertising claims for multivitamins • Finding a modifiable preventive factor for cataract • Delay onset by 10 years  reduce need for surgery by half (Congdon, 2001) • Focusing on the elderly: An ever-increasing, undervalued population

  4. Review of Related Literature Oxidative Insult  Cataract Formation (Head, 2001) A Possible Protective Role? Antioxidants: Vitamins A, C, E Riboflavin – Glutathione Reduction Possibly Vitamin B5, Folate, Selenium

  5. Review of Related Literature:A Role for Multivitamins? YEA • OR =0.84 (AREDS, 2006) • OR= 0.83 (Clinical Study Group, 2008) • OR = 0.6 (Kuzniarz, 2001) NAY • (AREDS, 2001) • (Gritz, et al., 2001) • (West, 2000) • (Seddon, 2007

  6. Conceptual Framework

  7. Objectives • General • To determine if multivitamin intake among ophthalmologic patients in the Philippines is a protective factor in the development of cataracts • Specific 1. To determine the proportion of patients with cataract who take and do not take multivitamins 2. To determine the proportion of patients without cataract who take and do not take multivitamins 3. To determine if there is an association between multivitamin intake and cataract development controlling for the effect of the following: age, group, sex, level of education, smoking profile, and body mass index (BMI).

  8. Research Design: Case Control

  9. Description of Study Population • Two private ophthalmologic clinics (Manila and Cabanatuan) and OPD of a public hospital in Manila • Case - any patient aged 55 years old and above, who had been diagnosed by a doctor to have cataract in at least one eye • Control - a patient aged 55 years old and above, who had no cataract in any eye based on doctor’s diagnosis.

  10. Variables: Operational Definition and Categories • Independent Variable - Multivitamin Intake (+) Multivitamin Intake: regular or frequent intake of any multivitamin supplement for at least 10 years prior to diagnosis or consultation (-) Multivitamin Intake: inconsistent/infrequent or no intake of any multivitamin supplement for at least 10 years prior to diagnosis or consultation

  11. Variables: Operational Definition and Categories • Dependent Variable: Cataract • Having a diagnosis of a cataract in either or both eyes of the patient, assessed by an ophthalmologist via a slit lamp examination or other diagnostic tools for cataract detection

  12. Variables: Operational Definition and Categories • Potential Confounding Variables • Age • Sex • Educational Attainment • Smoking • Body Mass Index

  13. Sample Size Estimation • Epi Info™ Version 3.5.1 • Assumptions: • 90% level of confidence • 80% power • 2:3 ratio between the two groups • 50% expected frequency of exposure in the not ill group • 0.6 odds ratio • Computed: 260 cases and 174 controls • Actual: 260 cases and 187 controls

  14. Sampling Design • Quota sampling • Identification of Cases (with cataract) and controls (without cataract) through interview • Validation through medical records (if necessary)

  15. Data Collection Tool • Primary Data • Query (Face to face interview) • Multiple interviewers - standardized interview behavior • Secondary Data (for validation) • Medical records of participants

  16. Potential Biases and Methods to Minimize them • Selection Bias - caution in making generalizations • Source of subjects • Non-response • Information bias • Recall bias - sufficient probing during interview • Hawthorne effect - blinding • Confounding - stratified analysis

  17. Data Processing and Statistical Analysis • Completeness and consistency of interview sheets • Verification if necessary • Double encoding • Analysis • cOR at 95% and Pearson's chi square value • Stratified analysis - Mantel Haenszel value • Multiple Logistic Regression • Wald test

  18. Ethical Considerations • Informed consent • Interview form sheets coded only by the research team members • Possible commercial value

  19. Limitations of the Study • Time constraints • Readjustment of sample size

  20. Results

  21. Distribution of cases and controls of cataract according to intake of multi-vitamins from two private ophthalmologic clinics in Manila and Cabanatuan, and an outpatient department of a public hospital in Manila • 260 cases: 61.4% multivitamin users • 187 controls: 55.5% multivitamin users

  22. Results • Odds ratio: .27 (90% CI = 0.93 – 1.75) -> not significant • Therefore, multivitamins not protective of cataract development • Stratified analysis for confounders: none of the variables can be considered a confounder

  23. Distribution and stratified analysis of cases and controls according to age, sex, educational attainment, smoking status, and BMI

  24. Distribution and stratified analysis of cases and controls according to age, sex, educational attainment, smoking status, and BMI

  25. Results • Logistic regression: assessment of the effects of multivitamin intake, age, sex, education, smoking status, and BMI on the development of cataract • Only age showed a significant contribution

  26. Table 4. Logistic Regression Analysis of the Effect of Multivitamin Intake, Age, Sex, Education, Smoking Status, and BMI on the Development of Cataract

  27. Discussion of Results

  28. Discussion of Results • multivitamins intake may not have a protective effect from cataract • Studies with similar results: • Gritz and colleagues randomized controlled trials • Excellent reference • Age- Related Eye Disease Study • May be due to unbalanced diets

  29. Discussion of Results • Stratified analysis • level of education: elementary level gave a statistically significant confidence interval -> low level of education increased the odds of developing cataract with multivitamin intake • may be due to inadequate knowledge on health, lack of proper diet or improper intake of multivitamins

  30. Discussion of Results • Why the rest are not confounders? • recall bias: sole contributory factor for these results • first, overestimation or underestimation of data reporting • second, false information was given • Logistic regression: aging is significant and contributory to the development of cataract • Aging is the primary risk factor while age, sex, smoking status and BMI are contributory risk factors

  31. Discussion of Results • One must be careful about multivitamins and their claims; practice vigilance • Not prudent for one to rely solely on multivitamins for health promotion and disease prevention

  32. Conclusions • Multivitamin supplementation does not confer protection against the development of cataract among ophthalmologic patients in the study. • Stratified analysis of the data reveals that none of the different variables considered, which include age group, sex, level or education, smoking status, and BMI proved to be a confounder.

  33. Recommendations • Recommendation for a cohort study • future investigations regarding the protective influence of multivitamin supplementation • Recommendation for a randomized controlled trial • Standardizing the multivitamins being taken as well as the frequency of consumption • Daily nutritional intake must be noted • Categorizing the participants into the different cataract kinds

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