Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)

Abstract

BackgroundIn Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms.MethodsThis was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients ≥ 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] ≥ 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS ≤ 2). UMIN clinical trial registration number: UMIN000005399.ResultsOf 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events.ConclusionsThe favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy.Trial registrationUMIN000005399.

ACG and CAG Clinical Guideline: Management of Dyspepsia

“…Follow up was from 4 to 52 weeks and there was a trend towards PPI being more eff ective than prokinetic therapy (RR=0.78; 0.60-1.02, P =0.06) ( Appendix 2 : Appendix Figure 9 ) but this did not achieve statistical significance. Two trials ( 57,62 ) showed PPI therapy was superior and one ( 66 ) reported no diff erence.…”

“…Th ere were no randomized studies comparing prokinetic therapy with placebo. Th ere were three trials ( 57,62,66 ) that compared PPI with prokinetic therapy in 680 dyspepsia patients. Follow up was from 4 to 52 weeks and there was a trend towards PPI being more eff ective than prokinetic therapy (RR=0.78; 0.60-1.02, P =0.06) ( Appendix 2 : Appendix Figure 9 ) but this did not achieve statistical significance.…”

Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

“…Hsu et al 8 reported that the efficacy of PPI was similar to prokinetics in patients with FD according to the Rome III criteria after 2 weeks of treatment. In another study of 23 The co-administration of PPI and prokinetics is commonly prescribed for patients with FD and is frequently recommended by clinical guidelines, although the efficacy has been questioned. The present study documented that combining DA-9701 with PPI provided no additional amelioration of dyspeptic symptoms compared with PPI or prokinetics alone.…”

Effect of pantoprazole and Helicobacter pylori therapy on uninvestigated dyspeptic patients

“…The main treatments for these two symptoms are PPIs (9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25). If heartburn, acid regurgitation, and other symptoms that suggest gastroesophageal reflux disease had not been excluded from the dyspepsia symptoms, PPI treatment could have been more effective (24).…”

“…The GOS score has been validated in patients with dyspepsia (12,13), and has previously been used in clinical studies of patients with dyspepsia to assess symptoms and treatment success (14)(15)(16)(17)(18)(19)(20). The GOS score measures the severity of the eight symptoms noted above using a 7-point Likert scale, which is defined as follows: 1=no complaint and no symptoms; 2=a minimal complaint that can be ignored easily and without effort; 3=a mild complaint that can be ignored with effort; 4=a moderate complaint that cannot be ignored, but does not influence daily activities; 5=a moderately severe complaint that cannot be ignored and occasionally limits daily activities; 6=a severe complaint that cannot be ignored and often limits concentration on daily activities; and 7=a very severe complaint that cannot be ignored, markedly limits daily activities, and often requires rest.…”