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- 1. CRISBERT I. CUALTEROS, M.D. Department of Family and Community Medicine Perpetual Succour Hospital
- Gerald Holtmann, M.D., Nicholas J. Talley, M.D., Ph.D., Tobias Liebregts, M.D.,
- Birgit Adam, M.D., and Christopher Parow, M.D.
- New England Journal of Medicine
- February 23,2006; 354: page 832-840
3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. A positive response: improvement by at least one grade 15. 16. 17. 18. 19.
- Improved symptom-severity scores on the LDQ from baseline in all four study groups.
- Itopride was significantly superior to placebo during the testing of the global hypothesis
- Placebo and itopride given at 50 mg TID was not significant (P 0.07)
- Placebo & itopride at 100 mg TID &
- at 200 mg TID were both significant (P 0.05)
- Testing of all planned hypotheses for response rates to patients global assessment of efficacy showed significant result
- There was a significant association between the dose of itopride and the response rate
- The global hypothesis on the response rates according to the severity of pain and fullness yielded a significant discrimination between itopride & placebo
21. Holtmann G et al. N Engl J Med 2006;354:832-840 Response Rates Based on Patients' Global Assessment of Efficacy 22.
- NDI quality-of life scores were better among patients treated with active medication than placebo.
- The NDI quality-of-life score improved by a mean of 13.2+/-19.4 with placebo and by 18.0+/-21.9 with itopride (P = 0.02).
- However, differences between the various doses of itopride tested were not statistically significant.
23. Primary Outcome Variables among 523 Patients 24. 25. 26.