Randomised clinical trial: efficacy of the addition of a prokinetic, mosapride citrate, to omeprazole in the treatment of patients with non-erosive reflux disease - a double-blind, placebo-controlled study.
BACKGROUND
Proton pump inhibitors (PPIs) are less effective in non-erosive reflux disease (NERD) patients than in reflux oesophagitis patients. Whether the addition of prokinetics to PPIs improves NERD patients' symptoms remains unknown.


OBJECTIVE
To evaluate the efficacy of mosapride in NERD patients when used with PPI.


METHODS
A total of 200 NERD patients were randomised to one of two arms: omeprazole (10 mg once daily) plus mosapride citrate (5 mg three times a day) (treatment arm) and omeprazole plus placebo (placebo arm). The primary endpoint was the rate of responders [visual analogue scale (VAS) was zero or <1 cm] after 4 weeks of treatment. The secondary endpoints were changes in the VAS score and the safety profile.


RESULTS
There was no significant difference between the rates of responders in both arms in intent-to-treat (ITT) and per-protocol (PP) analysis. The change in the VAS score in treatment arm was significantly better than placebo arm in PP analysis (-4.0 ± 0.2 and -3.3 ± 0.2, mean ± S.E.M.) (N.S. in ITT analysis). The rate of adverse events was similar in both groups.


CONCLUSIONS
The addition of mosapride to omeprazole was not more effective than omeprazole alone.
Hyogo College of Medicine, Nishinomiya, Japan. miwahgi@hyo-med.ac.jp
H
H
Miwa
K
K
Inoue
K
K
Ashida
T
T
Kogawa
A
A
Nagahara
S
S
Yoshida
N
N
Tano
Y
Y
Yamazaki
T
T
Wada
D
D
Asaoka
T
T
Fujita
J
J
Tanaka
T
T
Shimatani
N
N
Manabe
T
T
Oshima
K
K
Haruma
T
T
Azuma
T
T
Yokoyama
D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001549:Benzamides / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage*; D009853:Omeprazole / Q000008:administration & dosage; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D011788:Quality of Life; D012720:Severity of Illness Index; D013223:Statistics as Topic; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D001549:Benzamides; D005765:Gastrointestinal Agents; D009025:Morpholines; D054328:Proton Pump Inhibitors; C062720:mosapride; D009853:Omeprazole