Effects of the New Prokinetic Agent DA-9701 Formulated With Corydalis Tuber and Pharbitis Seed in Patients With Minimal Change Esophagitis: A Bicenter, Randomized, Double Blind, Placebo-controlled Studyopen access
- Authors
- Park, Chan Hyuk; Kim, Hyun-Soo; Lee, Sang Kil
- Issue Date
- Jul-2014
- Publisher
- KOREAN SOC NEUROGASTROENTEROLOGY & MOTILITY
- Keywords
- DA-9701; Minimal change esophagitis; Motilitone; Non-erosive reflux disease
- Citation
- JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY, v.20, no.3, pp.338 - 346
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY
- Volume
- 20
- Number
- 3
- Start Page
- 338
- End Page
- 346
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/159629
- DOI
- 10.5056/jnm14019
- ISSN
- 2093-0879
- Abstract
- Background/Aims DA-9701 (Motilitone) is a new prokinetic agent formulated with Corydalis Tuber and Pharbitis Seed. We assessed the efficacy of DA-9701 in symptomatic patients with minimal change esophagitis. Methods Patients with minimal change esophagitis presenting with reflux or dyspeptic symptoms were randomly assigned to receive either DA-9701 30 mg or placebo t.i.d. (means 3 times a day). After 4 weeks of treatment, the primary efficacy end point determined by changes of the Nepean dyspepsia index questionnaire-Korean version (NDI-K) symptom scores, was analyzed. Results Forty-two and 39 patients were assigned to the treatment and control groups, respectively. After 4 weeks, NDI-K symptom scores were reduced from 35.4 to 13.5 (P < 0.001) and from 43.0 to 27.7 (P < 0.001) in the treatment and the control groups, respectively. However, changes in the symptom scores did not differ between the 2 groups (P = 0.741). Although the quality of life scores were significantly improved after 4 weeks in both groups, changes in the quality of life score between the baseline value and that at 4 weeks did not differ between the 2 groups. The reflux symptom score was significantly improved in the treatment group compared to the placebo group in patients aged 65 years or older (P = 0.035). Conclusions Although NDI-K symptom scores and quality of life scores were improved after 4 weeks of treatment compared with baseline values in patients with minimal change esophagitis, DA-9701 did not improve the symptom scores or quality of life scores compared with the placebo.
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