Mosapride as an adjunct to lansoprazole for symptom relief of reflux oesophagitis

Yao Chun Hsu, Tzeng Huey Yang, Wei Lun Hsu, Huei Tang Wu, Yang Chih Cheng, Ming Feng Chiang, Chaur Shine Wang, Hwai Jeng Lin

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

AIMS To investigate if mosapride, a prokinetic agent, was an effective adjunct to acid suppression in improving the symptoms of reflux oesophagitis. METHODS Patients (n = 96) with reflux oesophagitis were randomly assigned to either mosapride (5 mg three times daily) or placebo for 4 weeks. Symptom severity was assessed by a validated questionnaire at enrolment, 4 and 8 weeks after medication. The primary outcome for the first 4 weeks was decrease in symptom scores. After a 3 day washout period, patients initially allocated to mosapride crossed over to placebo and vice versa for the next 4 weeks. The outcome of the second phase was maintenance of symptom control. All patients received lansoprazole (30 mg once daily) throughout study. RESULTS The decreased symptom score after 4 weeks of treatment with lansoprazole and mosapride (n = 50) was 13.42 ± 1.16 (mean ± SEM), similar to that of lansoprazole plus placebo (10.85 ± 1.03, n = 46), with an insignificant difference of 2.57 (95% CI -0.53, 5.67, P = 0.103). However, a sub-group analysis for patients with pre-treatment scores of >18 points (n = 48) revealed that lansoprazole plus mosapride achieved a greater reduction of symptom score than lansoprazole plus placebo (18.22 ± 1.91 vs. 12.88 ± 1.65; mean difference of 5.34, 95% CI 0.28, 10.40, P = 0.039). In the second phase, there was no difference between lansoprazole with mosapride or placebo in maintaining symptom control (39/44 or 86.64% vs. 41/50 or 82%, P = 0.401). Subgroup analysis for those with substantial residual symptoms revealed similar results. CONCLUSION Compared with placebo, mosapride generally does not provide additional benefit to a standard dose of lansoprazole in patients with reflux oesophagitis, except possibly in the subgroup of severely symptomatic patients.

Original languageEnglish
Pages (from-to)171-179
Number of pages9
JournalBritish Journal of Clinical Pharmacology
Volume70
Issue number2
DOIs
Publication statusPublished - Aug 2010
Externally publishedYes

Fingerprint

Lansoprazole
Peptic Esophagitis
Placebos
mosapride
Maintenance
Acids
Therapeutics

Keywords

  • gastro-oesophageal reflux disease
  • lansoprazole
  • mosapride
  • reflux oesophagitis
  • therapeutic effectiveness

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

Cite this

Mosapride as an adjunct to lansoprazole for symptom relief of reflux oesophagitis. / Hsu, Yao Chun; Yang, Tzeng Huey; Hsu, Wei Lun; Wu, Huei Tang; Cheng, Yang Chih; Chiang, Ming Feng; Wang, Chaur Shine; Lin, Hwai Jeng.

In: British Journal of Clinical Pharmacology, Vol. 70, No. 2, 08.2010, p. 171-179.

Research output: Contribution to journalArticle

Hsu, Yao Chun ; Yang, Tzeng Huey ; Hsu, Wei Lun ; Wu, Huei Tang ; Cheng, Yang Chih ; Chiang, Ming Feng ; Wang, Chaur Shine ; Lin, Hwai Jeng. / Mosapride as an adjunct to lansoprazole for symptom relief of reflux oesophagitis. In: British Journal of Clinical Pharmacology. 2010 ; Vol. 70, No. 2. pp. 171-179.
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abstract = "AIMS To investigate if mosapride, a prokinetic agent, was an effective adjunct to acid suppression in improving the symptoms of reflux oesophagitis. METHODS Patients (n = 96) with reflux oesophagitis were randomly assigned to either mosapride (5 mg three times daily) or placebo for 4 weeks. Symptom severity was assessed by a validated questionnaire at enrolment, 4 and 8 weeks after medication. The primary outcome for the first 4 weeks was decrease in symptom scores. After a 3 day washout period, patients initially allocated to mosapride crossed over to placebo and vice versa for the next 4 weeks. The outcome of the second phase was maintenance of symptom control. All patients received lansoprazole (30 mg once daily) throughout study. RESULTS The decreased symptom score after 4 weeks of treatment with lansoprazole and mosapride (n = 50) was 13.42 ± 1.16 (mean ± SEM), similar to that of lansoprazole plus placebo (10.85 ± 1.03, n = 46), with an insignificant difference of 2.57 (95{\%} CI -0.53, 5.67, P = 0.103). However, a sub-group analysis for patients with pre-treatment scores of >18 points (n = 48) revealed that lansoprazole plus mosapride achieved a greater reduction of symptom score than lansoprazole plus placebo (18.22 ± 1.91 vs. 12.88 ± 1.65; mean difference of 5.34, 95{\%} CI 0.28, 10.40, P = 0.039). In the second phase, there was no difference between lansoprazole with mosapride or placebo in maintaining symptom control (39/44 or 86.64{\%} vs. 41/50 or 82{\%}, P = 0.401). Subgroup analysis for those with substantial residual symptoms revealed similar results. CONCLUSION Compared with placebo, mosapride generally does not provide additional benefit to a standard dose of lansoprazole in patients with reflux oesophagitis, except possibly in the subgroup of severely symptomatic patients.",
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AU - Yang, Tzeng Huey

AU - Hsu, Wei Lun

AU - Wu, Huei Tang

AU - Cheng, Yang Chih

AU - Chiang, Ming Feng

AU - Wang, Chaur Shine

AU - Lin, Hwai Jeng

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N2 - AIMS To investigate if mosapride, a prokinetic agent, was an effective adjunct to acid suppression in improving the symptoms of reflux oesophagitis. METHODS Patients (n = 96) with reflux oesophagitis were randomly assigned to either mosapride (5 mg three times daily) or placebo for 4 weeks. Symptom severity was assessed by a validated questionnaire at enrolment, 4 and 8 weeks after medication. The primary outcome for the first 4 weeks was decrease in symptom scores. After a 3 day washout period, patients initially allocated to mosapride crossed over to placebo and vice versa for the next 4 weeks. The outcome of the second phase was maintenance of symptom control. All patients received lansoprazole (30 mg once daily) throughout study. RESULTS The decreased symptom score after 4 weeks of treatment with lansoprazole and mosapride (n = 50) was 13.42 ± 1.16 (mean ± SEM), similar to that of lansoprazole plus placebo (10.85 ± 1.03, n = 46), with an insignificant difference of 2.57 (95% CI -0.53, 5.67, P = 0.103). However, a sub-group analysis for patients with pre-treatment scores of >18 points (n = 48) revealed that lansoprazole plus mosapride achieved a greater reduction of symptom score than lansoprazole plus placebo (18.22 ± 1.91 vs. 12.88 ± 1.65; mean difference of 5.34, 95% CI 0.28, 10.40, P = 0.039). In the second phase, there was no difference between lansoprazole with mosapride or placebo in maintaining symptom control (39/44 or 86.64% vs. 41/50 or 82%, P = 0.401). Subgroup analysis for those with substantial residual symptoms revealed similar results. CONCLUSION Compared with placebo, mosapride generally does not provide additional benefit to a standard dose of lansoprazole in patients with reflux oesophagitis, except possibly in the subgroup of severely symptomatic patients.

AB - AIMS To investigate if mosapride, a prokinetic agent, was an effective adjunct to acid suppression in improving the symptoms of reflux oesophagitis. METHODS Patients (n = 96) with reflux oesophagitis were randomly assigned to either mosapride (5 mg three times daily) or placebo for 4 weeks. Symptom severity was assessed by a validated questionnaire at enrolment, 4 and 8 weeks after medication. The primary outcome for the first 4 weeks was decrease in symptom scores. After a 3 day washout period, patients initially allocated to mosapride crossed over to placebo and vice versa for the next 4 weeks. The outcome of the second phase was maintenance of symptom control. All patients received lansoprazole (30 mg once daily) throughout study. RESULTS The decreased symptom score after 4 weeks of treatment with lansoprazole and mosapride (n = 50) was 13.42 ± 1.16 (mean ± SEM), similar to that of lansoprazole plus placebo (10.85 ± 1.03, n = 46), with an insignificant difference of 2.57 (95% CI -0.53, 5.67, P = 0.103). However, a sub-group analysis for patients with pre-treatment scores of >18 points (n = 48) revealed that lansoprazole plus mosapride achieved a greater reduction of symptom score than lansoprazole plus placebo (18.22 ± 1.91 vs. 12.88 ± 1.65; mean difference of 5.34, 95% CI 0.28, 10.40, P = 0.039). In the second phase, there was no difference between lansoprazole with mosapride or placebo in maintaining symptom control (39/44 or 86.64% vs. 41/50 or 82%, P = 0.401). Subgroup analysis for those with substantial residual symptoms revealed similar results. CONCLUSION Compared with placebo, mosapride generally does not provide additional benefit to a standard dose of lansoprazole in patients with reflux oesophagitis, except possibly in the subgroup of severely symptomatic patients.

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