The Efficacy of Helicobacter Pylori Eradication Therapy with HpSA Test in Dyspeptic Patients of A Family Practice Polyclinic
......................................................................................................................... Ferit Erdogan¹, U. Güney Ozer Ergün², Nafiz Bozdemir², Refik Burgut³, Fatih Köksal⁴, Macit Sandikci⁵

1 Department of Family Medicine University of Baskent, Adana,
2 Department of Family Medicine and
3 Department of Biostatistics and
4 Department of Microbiology and
5 Department of Gastroenterology, Medical Faculty University of Cukurova, Adana, Turkey

Correspondence:
A. F. Erdogan,
Baskent University, Faculty of Medicine
Department of Family Medicine
Mah. Serinevler 39. Sok. No:6, 01250,
Yuregir, Adana, Turkey
Tel: +90 322 3272727
Fax: + 90 322 3271276
E-mail: feriterdogan1@hotmail.com , aferdoga@baskent-adn.edu.tr

ABSTRACT Aims: To assess the prevalence of Helicobacter pylori in dyspeptic and non-dyspeptic patients, via the HpSA test, to show short term effects of triple eradication therapy on clinical and bacteriological recovery. Material and Methods: One hundred dyspeptic patients and 49 patients complaining of other problems were included in the study. The patients were selected from a family practice polyclinic. H. pylori infection was detected with the Helicobacter pylori stool antigen (HpSA) test. Patients who were positive for H. pylori were treated with a triple eradication therapy (lansoprazole 2*30 mg,amoxicillin 2*1 g and clarithromycin 2*500 mg for two weeks). Patients who tested negative for H. Pylori were treated with lansoprazole 1*30 mg for four weeks. All dyspeptic patients were recalled to be controlled after six weeks. A 5-point Likert scale was used to assess the pre therapy and post therapy symptoms. The test was repeated for patients who received eradication therapy. Results: While the incidence of H. pylori amongst dyspeptic patients was 60%, the rate was 34.7% in non-dyspeptic patients. The H. pylori incidence rate amongst dyspeptic patients was significantly high (p=0.005). H. pylori risk in dyspeptic patients increased 2.94 fold. This increase was statistically significant (p=0.006). Following therapy, both groups showed a statistically-significant reduction in symptom scores. The success rate of the eradication therapy was 80.5% (per protocol). When all patients receiving eradication therapy were considered, the success rate was 58.9% (intention-to-treat). Conclusion: H. pylori infection is prevalent amongst dyspeptic patients. H. pylori infection should be taken into consideration during the treatment of dyspeptic patients. The use of the stool antigen test is effective in diagnosis and treatment of H. pylori infection. Key words: Family practice, dyspepsia, Helicobacter pylori, stool antigen test.

Dyspepsia is a prevalent health problem with a relatively high incidence rate¹. The annual prevalence of dyspepsia in Western countries is 25% and dyspepsia constitutes 2-5% of all primary level consultations. It is a basic cause for morbidity and economic loss. Furthermore, it seriously affects the quality of life of patients².

Understanding of the etiology of gastrointestinal illnesses has improved during the last 20 years³. Warren and Marshall cultured H. pylori culture and identified a link with gastritis and stomach ulcers in 1982⁴. In the following years, epidemiological studies linked some strains of this bacterium with a slightly increased lifetime risk of stomach cancer and MALT lymphoma³. Dyspeptic patients show a significantly higher rate of H. pylori incidence than the general population⁵.

The Maastricht II Consensus Report by the Europe Helicobacter study group advises that the diagnosis and treatment of H. pylori should be carried out at a primary level. The Maastricht II-III Consensus Report advises the use of PPI based amoxicillin (A) and clarithromycin (C) or metronidazole (M). The report also advises the use of the Helicobacter pylori stool antigen test (HPSA) and urea breath tests in diagnosis and treatment of H. pylori^6,7.

The aim of the present study was to assess the prevalence of H. pylori in dyspeptic and non-dyspeptic patients and to show the short-term effects of eradication therapy and acid suppression.

Patients were selected from the Yalim Erez Family Practice Polyclinic affiliated to the Faculty of Medicine at Cukurova University, Turkey. 100 patients with dyspeptic complaints and 49 patients with other complaints were included in the study consecutively. Patients who agreed to participate in the study were informed about the aim and method of study and subsequently the written consent of patients was obtained.

The selection criteria for dyspeptic patients were as follows: patients aged 18 years and above; patients who have had dyspeptic complaints for a month or more; patients who did not have alarming symptoms (newly-onset dyspepsia in people over 45, dysphagia, unexplained weight loss etc.); patients who did not have a history of gastroesophageal reflux, irritable bowel syndrome, cholelithiasis or dominant symptoms; patients who had not undergone stomach surgery; patients who were not pregnant or breast feeding; patients who did not have complaints while using analgesics or aspirin; patients who did not use antibiotics, bismuth, or proton pump inhibitor (PPI) during the previous two weeks; patients who did not have a serious illness.

The criteria for patients who did not have dyspeptic complaints were as follows: patients aged 18 years and above and patients who did not have dyspeptic complaints.
Questionnaires were completed via face-to-face interviews in both groups of patients. Pre treatment dyspeptic symptoms (epigastric pain, discomfort, early satiety, fullness, bloating, nausea) were assessed using a five-point Likert scale:
1- No problem
2- Minor problem (patient is able to ignore symptoms)
3- Moderate problem (symptoms cannot be ignored and it affects daily activities)
4- Serious problem (prevents patients from concentrating on daily activities)
5- Major problem (seriously affects daily activities and/or causes need for rest)

Stool samples were taken from patients and stored at -20 oC. The samples were tested with Platinum HpSA test (Meridian Diagnostic Inc.) for H. pylori twice a week at the Faculty of Medicine/Department of Microbiology, Cukurova University. Optical density was assessed as follows: in 450 mg <0.140 is negative, a value between 0.140 and 0.159 is susceptible and >0.160 is positive.

Triple ((lansoprazole 30 mg 2*1, amoxicillin 1 g 2*1 and clarithromycin 500 mg 2*1) (LAC) eradication therapy was administered for 14 days to dyspeptic patients who were positive for H. pylori. Lansoprazole 30 mg 1*1 was administered to dyspeptic patients who were negative for H. pylori. Patients who were not dyspeptic did not receive any kind of therapy.

After six weeks from the beginning of therapy both positive and negative patient groups were called to control. Dyspeptic symptoms during the post treatment period were scored with the Likert scale. The HpSA test was repeated for patients who were positive for H. pylori and received eradication therapy.

Data was analyzed using Statistical Package for Social Sciences (SPSS) 11.0 software. Statistical evaluation included chi square test, ANOVA and logistic regression.

One hundred dyspeptic patients were included in the study. 49 patients complaining about other problems were selected as the non dyspeptic group. The patients were selected from a family practice polyclinic. The age of dyspeptic patients ranged between 18 and 67 (average 34.52 ± 13.023). The age of the control group patients was varying between 18 and 74 (average 40.08 ±14.167). The duration of dyspeptic complaints ranged between 1 to 480 months (average 63.09 ± 74.04 months).

A flowchart of the study process is shown in Figure 1.

The prevalence of H. pylori in both groups is shown in Table 1. While the prevalence of H. pylori was 60% in dyspeptic patients and 34.7% in non-dyspeptic patients. The prevalence of H. pylori was significantly higher in dyspeptic patients. (p=0.005)

The increase of risk in dyspeptic patients is shown comparatively, based on logistic regression modeling (Table 2). The risk was 2.94 times higher in dyspeptic patients. This variation between the two groups is statistically significant. (p=0.06)

The symptom scores of both the group of patients who received eradication therapy and patients who received PPI are shown in Table 3. The post treatment decrease of symptom scores in both groups was statistically significant.

Of the 60 dyspeptic patients who were positive for H. pylori, 56 patients underwent eradication therapy (2 patients were excluded for pregnancy and 2 patients did not consent to the therapy). 41 patients completed the study in the H.pylori (+) group. (4 patients were excluded for side effects, 2 patients were excluded because they did not use the medicine as prescribed and 9 patients were excluded because they did not participate in controls).

Of the patients who were negative for H. pylori and received PPI for 4 weeks, 32 patients followed the controls.

The results of the HpSA test after eradication therapy are shown in Table 4. The success of the eradication therapy was assessed as 80.5% (33/41) per protocol. When all patients who received eradication therapy were considered, the success rate of the eradication therapy was 58.9% (33/56) -intention-to-treat.

The prevalence of H. pylori was significantly higher in dyspeptic patients when compared with the non-dyspeptic group. (Tables 1 and 2)

A previous study on the prevalence of H. pylori in both dyspeptic patients and the general population was conducted in eight European countries. That study found that the prevalence of H. pylori ranged between 25% and 85% in dyspeptic patients and between 15% and 70% in the general population⁵.

The results of the present study support the findings of the above mentioned study. Koçak et al. found 61% prevalence of H. pylori in 80 patients of a gastroenterology polyclinic who had dyspeptic complaints⁸. The present study found similar rates amongst dyspeptic patients. A study conducted in Istanbul on the prevalence of H. pylori using the HpSA test in patients who were susceptible to H. pylori infection, reported a rate of 36.6%⁹. This is lower than the rate found in the present study.

The higher prevalence of H. pylori indicates that there may be some relationship between dyspeptic illnesses and this bacterium. The results of the present study are similar to those within the literature.

A significant improvement in symptoms was observed in both the eradication therapy and PPI therapy groups. (Table 3) A study in Turkey on symptoms of H. pylori eradication therapy in non-ulcer dyspeptic patients found significant short term recovery based on total symptom scores¹⁰.

Many polyclinic and multi-centered studies have reported a success rate of A and K therapy combined with PPI of between 80% and 95%^11-14. Meta-analysis of 112 studies found the eradication rate ranged between 71.9% and 83.3%¹². The Maastricht II Consensus Report advises the triple regimes of C and A or M combined with PPI as the premium option, but recent studies assert that the success of eradication is less than 80%, due to C or M resistance of PPI based regimes^15-17. A meta-analysis in 1997 assessed the success rate with LAC as 84.4%. This meta analysis found a steady decrease in eradication rates. In 2004, the eradication rate was assessed as 55.3%¹⁸. The eradication rate of the present study is 80.5%, which is similar to other studies of LAC. The use of HpSA is assessed as an effective tool to evaluate diagnosis and treatment of H. pylori infection at the primary level. Although the HpSA testing was conducted by the department of microbiology in the present study, the necessary equipment is easily obtained and there is no need to submit samples to a specialist testing facility. These features show the efficacy and ease of the test.

Dyspeptic patients present a significantly higher incidence of H. pylori than the general population. Underlying results of dyspepsia are related to H. pylori. H.pylori eradication should be taken into consideration in dyspepsia. HpSA is a noninvasive and practical test suitable for use at the primary level.

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