‘Test and treat’ policy in dyspepsia: time for a reappraisal

Abstract

The ‘test and treat’ policy is the recommended way to eradicate Helicobacter pylori in young patients with uninvestigated dyspepsia if the prevalence of H. pylori is high. India is considered to have a high prevalence of H. pylori. This observational study was conducted in order to discover the prevalence of H. pylori disease in uninvestigated dyspeptic patients, based on stool antigen test and immunoglobulin M (IgM) antibodies in the sera in order to ascertain the role of the ‘test and treat’ policy in this geographical area. Fifty patients (age <55 years) with uninvestigated dyspepsia presenting to surgery out-patient department of a tertiary teaching hospital in northern India were included in the study. Fifty healthy controls were also included. Dyspeptic patients with alarm symptoms were excluded from the study. Patients and controls were tested for IgM antibodies in their sera and H. pylori antigen in their stools. The positivity of the IgM antibody and H. pylori antigen in stools of the cases was 16% and 8%, respectively, while only 4% IgM positivity was found in the controls' samples. This study highlights the low prevalence of H. pylori in dyspeptic Indian patients. This indicates that initial proton pump therapy may be a better option than the ‘test and treat’ policy for young patients with uninvestigated dyspepsia.

Introduction

The diagnosis of Helicobacter pylori infection remains a subject of interest and culture is still the method with the highest level of standardization for confirming infection. The status of this bacterium has been suggested as a means of selecting young dyspeptic patients for gastroscopy, the rationale being the small endoscopic yield in H. pylori negative patients.¹ As endoscopy is invasive, poorly accepted and costly, the National Institute for Clinical Excellence (NICE) recommends that all dyspeptic patients without alarm symptoms, irrespective of age, should be managed initially with full-dose proton pump inhibitor (PPI) for one month. If they relapse, they should be offered the ‘test and treat’ option for H. pylori along with the recommendation to use expensive but more accurate non-invasive breath and stool antigen tests instead of blood serology.^2,3 The ‘test and treat’ option cures patients with peptic ulceration and reduces the need for endoscopy without increasing the risk of missing neoplasia.² Other guidelines recommend eradication for those with gastro-oesophageal reflux disease (GORD) who are likely to require long-term PPI therapy because the profound acid suppression may accelerate the progression of H. pylori-induced atrophic gastritis, thereby increasing the potential risk of cancer.⁴ The ‘test and treat’ strategy for H. pylori in patients under the age of 50–55 years with dyspepsia who do not have any ‘alarm’ symptoms evaluated via endoscopy is increasingly being adopted in populations with infection rates higher than 10% of the general population.⁵ This study was conducted in a cohort of uninvestigated dyspeptic patients in order to ascertain the effectiveness of the ‘test and treat’ policy in this geographical area.

Materials and methods

This prospective study was conducted in the Departments of Microbiology and Surgery, University College of Medical Sciences (UCMS), Delhi, and the Guru Teg Bahadur Hospital (GTBH), a tertiary care hospital in east Delhi.

Fifty patients with uninvestigated dyspepsia (January–June 2011) were included along with 50 controls (26 healthy volunteers; 24 asymptomatic relatives of patients). Written informed consent was obtained from all participants.

Dyspepsia was defined as a combination of upper gut symptoms (epigastric pain, burning, fullness, nausea, vomiting and belching). Patients were excluded if they had any of the following: alarm symptoms; were aged over 55 years with new onset symptoms; a family history of gastric cancer; suffered unintended weight loss; gastrointestinal bleeding; progressive dysphagia; odynophagia; unexplained iron deficiency anaemia; persistent vomiting; a palpable mass; lymphadenopathy; or jaundice.

Sera were tested for immunoglobulin M (IgM) antibodies against H. pylori using Calbiotech Helicobacter pylori IgM ELISA Kit (Calbiotech Inc., Spring Valley, CA, USA). Stool samples were tested for H. pylori antigen by using IMMUNOCARD STAT!^R HPSA^R TEST PROCEDURE (Meridian Bioscience Inc., Cincinnati, OH, USA), a rapid lateral flow immunoassay for H. pylori antigen.

Results

The sociodemographic profile of the study population is shown in Table 1. Females predominated and the maximum number of cases was found in the 31–45 year age group.

Table 1

Demographic profile of the study group (n = 100)

	Cases (n = 50)		Healthy controls (n = 26)		Asymptomatic relatives of cases (n = 24)
Age group (y)	Male	Female	Male	Female	Male	Female	Total
≤15	2	1	1	1	0	1	6
16–30	3	4	2	2	1	2	14
31–45	11	14	4	9	6	8	52
46–55	6	9	3	4	1	5	28
Total	22	28	10	16	8	16	100

IgM antibodies against H. pylori were demonstrable in the sera of eight (16%) and two (8.3%) of the patients and the asymptomatic relatives, respectively; none of the healthy controls showed the presence of IgM antibodies. On the other hand, the H. pylori antigen in stools was present only in four (8%) of the 50 patients and was not present in any of the controls or the asymptomatic relatives (Table 2).

Table 2

Serological findings of the study group (n = 100)

	Cases (n = 50)		Healthy controls (n = 26)		Asymptomatic relatives of cases (n = 24)
Serological assay	n	%	n	%	n	%	Total
Calbiotech Helicobacter pylori IgM ELISA in serum	8	16	0	0	2	8.3	10 (10%)
IMMUNOCARD STAT^R HPSA^R H. pylori antigen in stools	4	8	0	0	0	0	4 (4%)

Discussion

The ‘test and treat’ policy for H. pylori is an attractive alternative strategy to conventional therapy for the initial management of patients with uncomplicated dyspepsia. However, the disparity between the high prevalence of infection and the occurrence of this clinically important disease has led researchers to suggest that, apart from gastritis, H. pylori may not play a major role in the aetiological findings of the pathology of the upper gastrointestinal system.⁶

Esophagogastroduodenoscopy should be the gold standard for diagnosing pathological features rather than H. pylori infection. Antibody testing has the advantages of simplicity, low cost and utility for epidemiological studies. Fecal antigen testing is a highly reliable method for confirming the eradication of H. pylori infection.⁷

The extremely low IgM antibodies and fecal antigen positivity seen in our study reflect the low prevalence of acute/recent infection in our scenario, which is further substantiated by the fact that a majority of cases (80%) were aged between 30–55 years when the infection (mostly acquired during childhood) became chronic. In such cases, demonstration of IgG antibodies would probably be a better indicator of H. pylori infection. However, the persistence of IgG antibodies decreases its utility in the diagnosis of active disease. Studies suggest that adult responses are very transient as most would have been colonized by H. pylori for decades and a low percentage of IgM incident rate indicates the chronic condition of the subjects studied, whether or not an acute infection existed.⁸ On the other hand, a high IgG antibody count is an indicator of a high prevalence of infection in populations from developing countries where 50% are infected by the age of five and infection rates as high as 90% have been reported in early adulthood. Two of the asymptomatic relatives of our cases had IgM antibodies. The patients who were related to them were also positive for IgM antibodies and had stool antigen for H. pylori. Epidemiological studies have documented the impact of low socioeconomic conditions, crowding and interfamilial spread on the acquisition of H. pylori infection.⁹

There is uncertainty about the role of H. pylori in GORD. A lower prevalence of H. pylori among patients with GORD than among those without the disease has been attributed to the tendency of H. pylori infection to reduce gastric acid secretion with advancing age.¹⁰ Geographical location is an important determinant as the prevalence of H. pylori in GORD is lower in countries with a high prevalence of H. pylori in the general population. The reason for this is unclear but may be related to dietary or genetic factors.

Conclusion

Treatment regimens for H. pylori eradication in India may not be effective due to the common occurrence of gastrointestinal infections and antibiotic misuse. The organism is well adapted to humans, with persistent infection and low-level disease, suggesting that for the most part it has a commensal rather than pathogenic relationship with man. This study highlights the low prevalence of H. pylori in dyspeptic Indian patients. This indicates that initial proton pump therapy may be a better option than the ‘test and treat’ policy for young patients with uninvestigated dyspepsia.

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