Journal Article | Gastroenterology

November 29, 2020



Introduction

 

            A great proportion of emergency room cases is due to gastrointestinal symptoms such as abdominal pain, nausea, and vomiting. It is a challenge for clinicians to treat patients that exhibit these symptoms when no organic disease is present. Majority of healthcare expenditure in the Philippines is out of pocket. It would be costly to make frequent trips to the emergency room only to alleviate such symptoms.

 

            A study done in 2011 by Kinoshita and Chiba explored the therapeutic effects of famotidine on chronic symptomatic gastritis. Management of these patients differs in several parts of the world. In Japan, where the study was conducted, patients with chronic upper abdominal symptoms were diagnosed with chronic symptomatic gastritis without histologic or endoscopic evidence. They are given mucoprotective agents (rebapamide) which offer some relief.1

 

 In western countries, the abovementioned patients are diagnosed with functional dyspepsia (FD) as defined by the Rome III criteria. To be considered with this diagnosis, they should be reporting at least 1 of the following 4 typical symptoms: epigastralgia, epigastric burning, postprandial epigastric fullness, and early satiation, for over 6 months after the presence of organic disease has been ruled out. 2-4

 

Relevance

 

In Japan, the entity of chronic symptomatic gastritis includes a wider range of patients than functional dyspepsia; thus, patients with non-typical symptoms such as nausea and shorter symptom duration may be diagnosed symptomatically with chronic gastritis. The potential of famotidine is explored in terms of treating chronic symptomatic gastritis as it has been deemed effective for FD.

 

Objective

 

            The study aimed to determine whether patients with chronic symptomatic gastritis had a therapeutic response to famotidine similar to that in patients with FD.

 

Highlights

 

Patients and Methods

 

            The study enrolled 10,311 patients with a diagnosis chronic symptomatic gastritis in a multicenter, prospective single-arm open-label post-marketing study. Endoscopic, pathological, or laboratory tests to confirm the presence of histological gastritis or the absence of organic abdominal diseases were not required for enrollment.

 

Patients enrolled in this study were those with uninvestigated functional gastroduodenal disorders, including weak reflux symptoms, regardless of the symptom duration defined in the Rome III criteria with no intake of histamine 2 receptor antagonists or proton pump inhibitors for 2 weeks. A total of 8,640 have responded appropriately.

 

 

Study Protocol

 

            Daily administration of famotidine (20 mg) was given to the patients for 4 weeks. They were tasked to keep a diary of their abdominal symptoms. The face scale was used to assess the intensity of three symptoms (heartburn, epigastralgia, and epigastric fullness). For the evaluation of abdominal symptomrelated QOL impairment, an Izumo scale, a self-reporting questionnaire was used before administration and 2 and 4 weeks after the beginning of famotidine treatment.

 

Results

 

            Three subgroups of patients were created: patients with chronic symptomatic gastritis, patients with FD like symptoms, and patients with functional dyspepsia. About 32% or 2,750 patients out of 8,640 underwent endoscopy. Of these, 2,595 were found to have no organic disease. A total of 155 patients were revealed to be positive for organic disease.

 

Around 2,402 out of those who showed no organic disease had at least 1 of the 4 abdominal symptoms required for the diagnosis of FD (later diagnosed with FD-like symptoms without organic disease). However, of these patients, only 343 had experienced symptoms for more than 6 months and were finally diagnosed with FD according to the Rome III criteria.

 

Effects of Famotidine on Patients with Chronic Symptomatic Gastritis

 

            Of the patients diagnosed with chronic symptomatic gastritis, 67.5% (5,710) did not undergo an endoscopic examination; thus, the presence of organic disease was not completely ruled out.

 

Approximately 5% (155) out of those who underwent endoscopy were found to have an organic disease such as peptic ulcer and gastric cancer. The chief complaints of upper gastrointestinal (GI) symptoms were ranked in order of epigastralgia (68.0%), epigastric fullness (67.5%), and heartburn (48.2%), though all 3 were concomitant in many. The duration of symptoms in over 80% of the patients with upper GI symptoms was less than 6 months.

 

            After the beginning of famotidine administration, the intensity score for each symptom decreased rapidly. After famotidine administration, quality of life (QOL) was improved remarkably along with symptom resolution. There was no marked difference in the relieving effects of famotidine among the 3 types of symptoms, though epigastric fullness tended to be relieved more slowly.

 

Effects of famotidine on patients with FD-like symptoms and without organic disease

 

            Out of the 2,595 patients who showed no evidence of organic disease, 2,402 complained of epigastric fullness or epigastralgia. Patients with FD-like symptoms and without organic disease are those who had symptoms that had lasted less than 6 months.

           

            Soon after administration of famotidine began, the intensity scores of epigastric fullness and epigastralgia decreased rapidly. Similarly, their related QOL impairment, were attenuated, though the therapeutic effect seemed to be stronger for epigastralgia.

 

Effects of famotidine on patients with FD

 

            Three hundred and forty three patients who had epigastralgia and/or epigastric fullness that had lasted for over 6 months with the absence of organic disease were diagnosed to have functional dyspepsia. At enrollment, 65.3% of these patients reported epigastralgia and 75.5% reported epigastric fullness, while 40.8% had both. These symptoms were resolved after the 4 week famotidine administration, and their scores were reduced as well as their QOL impairment.

 

There was no significant difference regarding the effect of famotidine between epigastralgia and epigastric fullness, though the effect on epigastralgia was faster.

 

Famotidine induced remission

 

            Symptomatic remission was defined as a score of 0 (asymptomatic) for the symptoms on the face scales. Remission of QOL impairment required 2 factors in regard to the Izumo scale, a score of less than 2 (slightly bothered) for each specific question, and a total score of 3 or less for the 3 subscale (heartburn, epigastralgia, epigastric fullness).

 

            After 4 weeks of administration, famotidine caused symptomatic remission in over 60% of the patients and improved QOL to a remission state in over 90%. Remission rates evaluated by the Izumo scale for the endoscopically examined and unexamined groups were 76.5% and 75.7% respectively. Remission rates for FD-like patients and patients with organic disease were 76.72 and 72.83%, respectively,

 

            Patient background factors and baseline Izumo scale scores were explored as potential influencing factors for remission rates. Analyses revealed that depression, anxiety, stress, nonsteroidal anti-inflammatory drug (NSAID) use, and baseline Izumo scale scores (abdominal symptoms, heartburn, epigastralgia, and epigastric fullness) were influential factors for the remission rates.

 

Conclusion

 

            Famotidine is effective to relieve abdominal symptoms and improve QOL, not only in patients with Rome III-defined FD, but also in those with chronic symptomatic gastritis.

 

References:

 

  • Miwa H, Osada T, Nagahara A, Ohkusa T, Hojo M, Tomita T, et al. Effect of a gastro-protective agent, rebamipide, on symptom improvement in patients with functional dyspepsia: a double- blind placebo-controlled study in Japan. J Gastroenterol Hepatol. 2006;21:1826–31.
  • Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GNJ. Functional gastroduodenal disorders. Gut. 1999;45(Suppl 2):II37–42.
  • Tack J, Tally NJ, Camilleri M, Holtman G, Hu P, Malagelada JR, et al. Functional gastroduodenal disorders. Gastroenterology. 2006;130:1466–79.
  • Tack J, Tally NJ. Gastroduodenal disorders. Am J Gastroenterol. 2010;105:757–63.  
  • Fauci, Braunwald et al. Harrison’s Internal Medicine 17th edition.
  • Yoshikazu Kinoshita and Tsutomu Chiba. Therapeutic effects of famotidine on chronic symptomatic gastritis: subgroup analysis from future study. J Gastroenterol. 2011.

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