1. The Impact of Lifestyle Modification on the Health-Related Quality of Life of Patients With Reflux Esophagitis Receiving Treatment With a Proton Pump Inhibitor Department of GASTROENTNROLOGY R1 조주희 1 Yoshikazu Kinoshita, MD, PhD1, Kiyoshi Ashida, MD, PhD2, Hiroto Miwa, MD, PhD, FACG3 and Michio Hongo, MD, PhD Am J Gastroenterol MAY 2009; 104:1106 – 1111

2. INTRODUCTION 2

3.  Reflux esophagitis (RE) is one of the most common disorders treated in general practice. 10 – 20 % of Western society 2.5 – 6.7 % of Asian populations  Lifestyle modification - beneficial for many patients with RE - an important component of their day-to-day management  Almost all physicians recommended lifestyle changes such as improved diet, weight loss, and head elevation in bed, to the majority of their patients with RE 3

4. Background  There are very few data from randomized clinical trials to support the view that lifestyle advice improves symptoms.  REQUEST (re-assessment of quality of life on reflux esophagitis treatment) –To determine the baseline characteristics and HRQOL of Patients with RE –To evaluate the effect of a short course of antisecretory therapy with the proton pump inhibitor (PPI) lansoprazole on HRQOL 4

5. Methods 5

6. Patients and treatment  Total of 1,809 hospitals and clinics across Japan  May 2005 - February 2006  Patients –newly diagnosed RE –relapse of RE following previous anti-secretory therapy –those who agreed to switch to lansoprazole from their current medication for RE  mucosal break prior to the study  Endoscopic findings : according to the Los Angeles classification with the Japanese modification (8,9)  Patients were treated with lansoprazole : 15 – 30 mg / day for 8 weeks 6

7. Health-related quality of life and symptoms 7  HRQOL was assessed –Self-administer questionnaire using the Japanese version of the 8-item Short-Form Health Survey (SF-8) –RE-specific HRQOL questionnaire → after 4 and 8 weeks of treatment with lansoprazole  A score of 50 is the mean for the Japanese general population across the eight domains and two summary scores : higher scores indicate a better HRQOL

8. The SF-8™ Health Survey

9. RE-specific HRQOL questionnaire  grade “ difficulty in daily life” → “daily life” domain “ dissatisfaction with limitation in eating amount ” → domain of “eating” “ dissatisfaction with avoiding favorite food” → domain of “eating” “ dissatisfaction with disturbances in falling asleep” →”sleep”domain “ dissatisfaction with interrupted sleep ” →”sleep”domain  5-point Likert scale 5 : not at all / 4 : slightly / 3 :moderately / 2 : quite a lot / 1 : extremely  The mean score of these three domains was defined as the RE-specific summary (RES) score  The score for each domain and the RES score ranged from 1 to 5 (higher scores indicating a better HRQOL ) 9

10. Assessment of lifestyle modification Physicians were asked to report whether they advised their patients regarding lifestyle modification during the treatment period in three specific categories: – advised new lifestyle modification at the start of lansoprazol treatment – advised to continue the lifestyle previously advised – no lifestyle modification was advised 10

11. Results 11

12. Patient characteristics 12 Group A : 40.8 % Group B : 33.3 % Group C : 25.9 %

13. 13 Changes in health-related quality of life 5.7 ± 8.14.3 ± 7.54.0± 7.6

14. 14

15. 15 At week 8, the changes in HRQOL scores from baseline were significantly greater in Group A than in the other groups irrespective of sex, age, baseline severity of typical symptoms, or initial dose of LPZ.

16. 16 Details of lifestyle modification

17. Conclusions 17