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doi:10.1111/jgh.12178

GASTROENTEROLOGY

Prevalence of Helicobacter pylori infection and the effect of

its eradication on symptoms of functional dyspepsia in
Kashmir, India
Jaswinder Singh Sodhi, Gul Javid, Showkat Ali Zargar, Syed Tufail, Altaf Shah, Bashir Ahmad Khan,
Ghulam Nabi Yattoo, Ghulam Mohamad Gulzar, Mushtaq Ahmad Khan, Mohd Iqbal Lone, Riyaz u Saif,
Shaheena Parveen and Abid Shoukat
Department of Gastroenterology, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, Kashmir, India

Key words
functional dyspepsia, gastritis, H. pylori,
symptoms, triple therapy.
Accepted for publication 8 January 2013.
Correspondence
Dr Jaswinder Singh Sodhi, Department of
Gastroenterology, Sher-i-Kashmir Institute of
Medical Sciences, Srinagar, Kashmir 190011,
India. Email: [email protected]
Conflict of interest: The authors have no
potential conflict of interest.

Abstract
Background and Aim: Epidemiology of Helicobacter pylori infection has regional variation. Effect of eradication of H. pylori on symptoms of functional dyspepsia is uncertain,
and the data in Asian scenario are scanty. The study aimed to see H. pylori positivity rate
in patients of functional dyspepsia and the effect of its eradication on symptoms.
Methods: Randomized, double-blind, placebo-controlled study was the study design
used. Patients of functional dyspepsia defined as per Rome 2 criteria were tested for
H. pylori infection by rapid urease test and gastric biopsy. H. pylori-positive patients were
randomly allocated to triple therapy (20 mg of omeprazole, 500 mg of clarithromycin, and
1000 mg of amoxicillin orally two times daily) and omeperazole plus identical placebo for
2 weeks. Symptoms were assessed with the weekly Likert scale.
Results: H. pylori positivity rate in functional dyspepsia was 1160/2000 (58%). At 6
weeks, the eradication rate for H. pylori in triple therapy and placebo group was (181/259
[69.8%] and 13/260 [5.0%], P = 0.001), respectively. On intention-to-treat analysis, the
symptom resolution at 1 month was (157/259 [60.7%] and 136/260 [52.3%], P = 0.38),
respectively. At 12 months, H. pylori eradication and healing of gastritis in triple therapy
and placebo group were (116/174 [66.7%] and 12/180 [6.7%], P = 0.001) and (132/174
[75.9%] and 11/180 [6.1%], P = 0.001), respectively. On intension to treat, the resolution
of symptoms in triple therapy and placebo group was (95/217 [43.7%] and 72/195 [36.9%],
P = 0.13).
Conclusion: There is high H. pylori positivity rate in patients of functional dyspepsia. The
eradication of H. pylori does not resolve the symptoms despite healing of gastritis.

Introduction
Functional dyspepsia (FD) is defined as persistent or recurrent
abdominal pain or discomfort centered in the upper abdomen in
patients who have no definite organic or biochemical explanation
for their symptoms like gastroesophageal reflux disease, acid
peptic disease, pancreaticobiliary disease, and malignancy.1 It is
generally chronic and causes impaired quality of life, and the cost
of treatment is high. The etiology of FD is unknown, but various
factors are implicated like gastric acid hypersecretion, gastroduodenal motility disorder, disturbances of visceral perception,
as well as Helicobacter pylori infection.2
The epidemiology of H. pylori varies from region to region with
different epidemiology in Asian population compared with West.
H. pylori infection is present in 3060% of patients with FD in
Western countries,3,4 while exposure to H. pylori occurs early in
India and the prevalence in patients with dyspepsia is 65%.5 If
808

H. pylori-related gastritis is the cause of pain or discomfort, then

eradication of H. pylori and resolution of gastritis should cause
resolution of symptoms in FD. In the West, number of studies as
well as meta-analysis has been conducted to see the effect of
eradication of H. pylori on symptoms of FD. The results have been
equivocal.6,7 The studies in India have been scarce. Keeping in
view the scarce data in India and the varied epidemiology of
H. pylori in Asian population, we conducted a double-blind,
placebo-controlled study to see positivity rate of H. pylori infection among Kashmiri population with FD and to see the effect of
eradication of H. pylori on symptoms of FD.

Material and methods

This randomized, placebo-controlled, double blind study was hospital based and conducted in Department of Gastroenterology at
Sher-i-Kashmir Institute of Medical Sciences (SKIMS), Srinagar,

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Kashmir, India between August 2006 to January 2009. All the

patients gave informed written consent, and the approval was
given by the ethics committee of SKIMS.
Subject population. Patients of FD with H. pylori positivity
were taken up for the study. FD was defined as per Rome 2 criteria
that includes at least 12 weeks (which need not to be consecutive)
within the preceding 12 months of persistent or recurrent pain or
discomfort (abdominal fullness, early satiety, bloating, nausea)
centered in the upper abdomen, with no evidence of organic
disease that could explain the symptoms like reflux esophagitis,
peptic ulcer, or erosive gastritis, and no evidence that the dyspepsia
is exclusively relieved by defecation or associated with the onset
of a change in stool frequency or stool form, that is, irritable bowel
syndrome (IBS).8
Exclusion criteria. Patients with age < 18 years, pregnant
ladies, and patients taking H2 receptor antagonists, proton pump
inhibitors (PPI), or prokinetics 2 weeks before run-in period and
during the 7-day run-in period were not included in the study.
Study design. Patients with dyspepsia were screened on outpatient department basis to rule out any systemic disease. These
patients were subjected to upper gastro-intestinal (GI) endoscopy
and ultrasound abdomen to rule out any cause for dyspepsia.
Patients with normal upper GI endoscopy were subjected to gastric
biopsies. Four biopsy specimens, two each from antrum and
corpus along greater curvature, were obtained for histology and for
H. pylori identification. Additional two biopsies, one each from
antrum and corpus, were obtained for rapid urease test (RUT) for
screening of H. pylori.
At pre-entry, two test results for H. pylori had to be positive, one
by RUT and the other by identification of H. pylori by histology.
Solution-based RUT was done by putting biopsy specimen into a
plastic tube containing urea-rich medium with pH sensitive dye.
The color change from yellow to pink was observed for a period of
30 min. Gastric biopsy was stained with hematoxylin and eosin,
and Giemsa stain, and the severity of gastritis was graded according to the Houston modification of the Sydney system.9 The histopathological examination was done by a senior pathologist who
was unaware of patients treatment assignment.
Run-in period. Patients who were H. pylori-positive were
given diary cards that included pamphlets containing description
of symptoms and severity (Likert scale grading) in local language
(Urdu), as well as in English, because majority of our native
population can read and write in local language (Urdu). These
symptoms were explained to the patient on first visit by the doctor
and then advised to apply this at home and write on pamphlets kept
in a diary, and submit the same during next follow-up visit.
Patients noted their symptoms for 1 week before enrollment.
Patients who had at least 3 days of at least moderate dyspepsia
were included in the study. No drug was given during the run-in
period.
This was followed by randomization according to computergenerated randomization test (1:1) to receive either triple therapy
(TT) with twice-daily treatments, with 20 mg of omeperazole (Cap

H pylori therapy in functional dyspepsia

Omez, Dr Reddys Lab, Hyderabad, India), amoxycillin, 1000 mg

(Wymox, Wyeth Lederle, Mumbai, India), and 500 mg of
clarithromycin claribid, Pfizer, Mumbai, India) for 14 days, or
twice-daily treatment with omeperazole 20 mg and identical
appearing placebo. Neither the investigator nor the patients were
aware of treatment assignments. The drugs were dispensed by a
senior technologist in endoscopy lab.
Follow-up. The patients were followed up 1, 3, 6, 9, and 12
months after cessation of treatment. Diary cards (filled out the
week before each visit) were collected at each visit.
EGD and gastric biopsy for H. pylori and histopathology were
performed 6 weeks and at 12 months to look for eradication of
H. pylori and healing of gastritis, and development of any other
endoscopic abnormality like esophagitis, and gastric or duodenal
ulcer.
Assessment of dyspepsia. Symptoms of dyspepsia were
assessed with diary cards using the validated seven-point Likert
scale. Likert scales assess the severity of symptoms ranging from
none to very severe, as shown below.10
Score Severity: none (0), minimal (1), mild (2), moderate (3),
moderately severe (4), severe (5), very severe (6). Treatment
success was defined as score of 0 or 1
Statistical analysis. Keeping in view high seroprevelence
of H. pylori in adult population in Indian subcontinent, we analyzed 556 patients that gave this study a power of greater than
90%, with an alpha error of 5%. Data were analyzed on intentionto-treat and on per-protocol analysis. Students t-test was used to
compare the mean values of continuous variables, and chi-square
tests were used to analyze categorical values. Patients who
reported on the diary card no more than minimal dyspeptic symptoms (score of 0 or1) during any of the 7 days before each visits
were considered to be a treatment success.

Results
We screened 2640 patients of FD. Six hundred and forty (23.2%)
had IBS overlapping with FD and were excluded, while 2000
patients had FD only, which included 1240 (62%) patients who
had epigastric discomfort and the remaining 760 (38%) had epigastric pain. One thousand one hundred sixty patients (58%) were
positive for H. pylori on the basis of histology and RUT test, out of
which 556 (47.9%) patients with moderate-to-severe symptoms
consented to participate in this study. The remaining 604 patients
had either mild dyspepsia or they did not give consent to participate in the trial and were excluded.
Among 556 patients, 280 were randomly allocated to TT (TT
group), and 276 were allocated to identical placebo (placebo
group). Two hundred and fifty-nine (259) patients in TT group and
260 in placebo group were included for intention-to-treat analysis
as 21 patients in TT group and 16 patients in placebo group had no
data available, as these patients did not report to the hospital for
taking drugs. Two groups were matched with respect to age, sex,
smoking, severity of symptoms, and type of symptoms. Baseline
characteristic features of the studied subjects are shown in Table 1.

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Table 1 Baseline characteristics of patients of FD treated with triple

therapy and equivalent placebo
Parameters

Age (years)
Mean
Range
Males, n (%)
Rural (n %)
Smoker, Yes/No, n (%)
Symptom severity, n (%)
Moderate
Severe
Symptoms
Pain upper abdomen
Abdominal discomfort
Duration of FD (months)
Median (range)

Treatment group
(n = 259)

Placebo group
(n = 260)

46
2565
76 (29.3)
189 (73)
85 (33)

43
2068
93 (35.7)
182 (70)
52 (20)

217 (84)
42 (16.2)

223 (85.7)
36 (13.8)

139 (53.6)
120 (46.23)
120 (46.33)

164 (63)
96 (36.9)
96 (36.9)

Adverse drug reaction. The main side-effect reported was

diarrhea and crampy abdominal pain in TT group and dry mouth,
nausea, and headache in placebo group.

Discussion

14 (436)

6 (314)

FD, functional dyspepsia.

Over a period of 1 year, 85 patients in the TT group and 80 in

placebo group were excluded because of unavailability of data
after randomization because of loss of follow-up. (Fig. 1).
Fifteen patients on follow-up had emergency admission in hospital because of severe pain upper abdomen that included nine
patients in TT group and six in placebo group. In TT group, on
further evaluation, one patient had dilated pancreatic duct with
stones in it, and two patients had sludge-related acute pancreatitis.
In other six patients, no cause for pain could be found. In (other)
six patients in placebo group, one patient had biliary ascariasis,
while in other five patients, no cause for severe pain could
be ascertained. All these 15 patients were excluded from final
analysis.

H. pylori status and resolution of symptoms. At 6

weeks, the eradication rate of H. pylori by intention-to-treat analysis in TT and placebo group was (181/259 [69.9%] and 13/260
[5.0%], P = 0.001), respectively. At 4 weeks, the resolution of
symptoms in TT and placebo group was (157/259 [60.6%] and
[136/260 (52.3%)], P = 0.38), respectively.
At 1 year, the eradication of H. pylori in TT group and placebo
group was (116/174 [66.6%] and12/180 [6.6%], P = 0.001),
respectively. On intention-to-treat analysis, at 1 year, the symptom
resolution in TT and placebo group was (95/217 [43.7%] and
72/195 [36.9%], P = 0.13), while as per protocol analysis, it was
(95/174 [54.6%] and 72/180 [40%], P = 0.35), respectively
(Table 3).
The difference in mean (standard deviation) symptom score
between TT and placebo group at 1, 3, 6, 9, and 12 months was not
significant (Table 2). In TT group, there was no difference in
symptom resolution in patients where H. pylori was eradicated,
70/116 (60.3%), compared with those where H. pylori was not
eradicated, 25/58 (43.1%) (P > 0.05).
810

Healing of gastritis. With intention-to-treat analysis, at 6

weeks, healing of gastritis in TT and placebo group was (94/259
[36.3%] and 13/260 [5%], P = 0.001), while at 1 year, it was
(132/174 [75.9%] and 11/180 [6.2%], P = 0.001), respectively. At
1 year, none of the patient in TT group developed duodenal or
gastric ulcer, while two patients in placebo group had evidence of
erosive duodenitis.

The present study tested the hypothesis that if H. pylori-related

gastritis is the cause of pain or discomfort in FD, then eradication
of H. pylori and resolution of gastritis should cause resolution of
symptoms. Our results indicated that resolution of gastritis and
eradication of H. pylori were not associated with relief of FD
thereby indicating that factors other than gastritis and H. pylori are
involved in the pathogenesis of FD.
Despite eradication of H. pylori and healing of gastritis in TT
group compared with placebo group, there was no significant
difference in resolution of symptoms, which was (43.7% and
36.9%, P = 0.13) on intention-to-treat and (54.6% and 40%,
P = 0.35) on per-protocol analysis during the 12 months of
follow-up (Table 3). In TT group, there was no difference in
symptom resolution in patients where H. pylori was eradicated,
70/116 (60.3%), compared with those where H. pylori was not
eradicated, 25/58 (43.1%) P > 0.05.
The symptom resolution in TT group was almost similar to
placebo group that could be due to long duration of symptoms in
TT group compared with placebo group, which was median
(range) (14 [336] and 6 [314]) months, respectively. The longer
duration of symptoms in TT group could be the reason for
decreased response to treatment. In a previous study by McColl
et al., the treatment and duration of symptoms were independently
related to resolution of symptoms in a multivariate analysis. The
percentage of patients with resolution of symptoms decreased with
increased duration of symptoms.11
Previous studies are mainly from the Western countries. Loren
et al. conducted a meta-analysis of randomized, controlled trials to
assess the effect of eradication therapy for H. pylori on symptoms
of FD. This meta-analysis provides little support for the use of
H. pylori eradication therapy in patients with FD.12 Talley analyzed 16 published studies. Eight among them reported that antiH. pylori therapy was efficacious, and eight failed to detect a
statistically significant benefit.6
In India, the trials for effect of H. pylori eradication in FD are
limited. Because the epidemiology of H. pylori varies from region
to region, the response to eradication therapy may also vary in
Asian setting. In the only study from India that examined the role
of eradication in FD, H. pylori eradication therapy was superior to
sucralfate in providing symptom relief (81% vs 33%) that lasted
for about 12 weeks.13 Upendra et al. evaluated the role of antiH. pylori therapy in FD and found symptomatic relief. However,
the study had limitations because of less number of patients and
follow-up of only 3 months.14

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H pylori therapy in functional dyspepsia

Functional dyspepsia with IBS

n = 2640
640 Excluded (IBS)
Functional dyspepsia (FD)
( n = 2000)

Functional dyspepsia+ H. pylori +ive

1160 (58%)

(Both RUT and

gastric biopsy positive)

Functional dyspepsia with moderate-to-severe dyspepsia

n = 556 (47.9%)

Randomization

Triple therapy ( n = 280)

Placebo ( n = 276)

Patients excluded n = 21

Patients excluded n = 16

Did not participate

n = 259
Included with intention to treat

Did not participate

n = 260
Included with intention to treat

Excluded at 1 year
n = 85

Excluded at 1 year
n = 80

Loss of follow-up33
Continued PPI use43
Wrong diagnosis- 9

Figure 1 Algorithm showing number of

patients included in the study, randomization
and their numbers according to the intention
to treat and per protocol. FD, functional dyspepsia; IBS, irritable bowel syndrome; RUT,
rapid urease test.

Loss of follow-up59
Continued PPI use15
Wrong diagnosis - 6

Follow-up
12 months
(n = 174)
Included as per-protocol analysis

Follow-up
12 months
(n = 180)
Included as per-protocol analysis

Table 2 Mean (standard deviation) symptom severity score at base

line and during 7 days run-in period before each clinical visit

Table 3 Main study outcome of patients after treatment with triple

therapy or placebo

Duration

Triple therapy

Placebo

P value

Variables

Baseline
1 month
3 months
6 months
9 months
12 months

3.4
1.6
1.5
1.6
1.5
1.6

3.2
1.9
1.7
2.0
1.8
1.9

0.8
0.17
0.18
0.07
0.33
0.30

(1.0)
(1.2)
(1.1)
(1.1)
(1.4)
(1.4)

(1.1)
(1.3)
(1.3)
(1.3)
(1.4)
(1.5)

In our study (23.2%), patients had IBS overlapping with FD. In

population-based studies, the estimated prevalence of IBS among
dyspeptic subjects ranges between 13% and 29%, while the prevalence of FD among IBS subjects ranges between 29% and

Resolution of symptoms
4 weeks (%)
1 year (%)
Eradication of Helicobacter pylori
6 weeks (%)
1 year (%)
Healing of gastritis
6 weeks (%)
1 year (%)

Triple therapy
group

Placebo
group

P value

60.6
43.7

52.3
36.9

0.38
0.13

69.9
66.6

5.0
6.6

0.001
0.001

36.3
75.9

5
6.2

0.001
0.001

Resolution of symptom: No pain or mild pain/discomfort (score of 0 or

1.) in upper abdomen over 7 days before 12-month visit.

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JS Sodhi et al.

87%.1517 In Asia, the figures are similar. In a population-based

study from Mumbai, India, the prevalence of dyspepsia was 30%,
while among subjects with IBS, the prevalence of dyspepsia was
58%.18 Similarly, the prevalence of IBS among subjects with dyspepsia at 14% was greater than in the general population where
it was 7.5%.19
We demonstrated a 58% H. pylori positivity rate in patients of
FD. Previous studies have reported 5060% prevalence of
H. pylori infection in FD in contrast with 2050% of asymptomatic individuals in the Western world.3,4,15 The prevalence of
H. pylori infection in our study was more in patients living in rural
areas compared with urban areas (69% and 46.8%, P = 0.002),
respectively. Both these observation can be explained by the fact
that the major risk factor for infection is the socioeconomic status
of the family.
We used TT in the form of omeperazole 20 mg, amoxicillin
1000 mg, and clarithromycin 500 mg twice a day for a period of 2
weeks. Previous studies have shown an eradication rate of about
90% for H. pylori infection at 4 weeks with this regimen.20 Our
study showed eradication of H. pylori infection in 66.6% of
patients in the TT group. This eradication rate was low compared
with previous studies with clarithromycin and amoxicillin that
could be due to resistance to antibiotics. The frequency of resistance to macrolides varies from country to country. In Asia, these
antibiotics are frequently used, which could be one of the reasons
for low eradication rate because of development of resistance to
these drugs.21
Data on H. pylori eradication rate in Indian patients are available from several clinical trials. Many of these trials used a single
test (RUT) to determine clearance of H. pylori infection. When
rigorous criteria (i.e. a combination of negative urease test, negative histology, and negative urea breath test) were applied, as in a
prospective trial from Northern India, the eradication rate was
considerably lower.21
The strength of our study was that a large number of patients of
FD were enrolled, and patients had a long-term follow-up of 12
months. FD was defined as per Rome 2 criteria based on predominant symptoms into two subgroups, that is, pain upper abdomen or
discomfort upper abdomen, characterized by abdominal fullness,
early satiety, bloating, or nausea, and the time course was at least
12 weeks (not consecutive) over a period of 12 months. Although
Rome 2 criteria for FD excluded patients with predominant heartburn and IBS, it has some limitations over Rome 3 criteria for FD.
The subgroups as per Rome 2 criteria are on the basis of predominant symptoms. The term predominant is still not defined, and
also, it has remained unsettled whether discomfort is a mild variant
of pain or a separate symptom complex. Moreover, discomfort
comprises number of different non-painful symptoms that include
upper abdominal fullness, early satiety, bloating, nausea, epigastric burning, belching, and vomiting. This type of subgroup classification shows instability in their categorization over a period of
time. In Rome 3 criteria, symptoms are considered to originate 6
months prior to diagnosis and are active for 3 months. This time
period is less restrictive compared with Rome 2 criteria. Rome 3
criteria decreased the number of symptoms to four specific symptoms that include post-prandial fullness, early satiation, epigastric
pain, and epigastric burning, and subgrouped them into two
groups, that is, meal-related symptoms (post-prandial distress syndrome) and meal-unrelated (epigatric pain syndrome) that corre812

late with pathophysiological mechanisms of FD rather than single

predominant symptom that is used in Rome 2 criteria.2224 In this
study, recruitment of patients started in year 2006 when Rome 2
criteria were still being used for research purpose and Rome 3
criteria were being introduced.
The overall loss to follow-up in this study was 92/519 (17.8%),
of which 33 (12.8%) where in treatment group and 59 (21.4%) in
placebo group, which is a limiting factor in this study. Majority of
patients were lost to follow-up in winter season (November to
March) and belonged to rural hilly areas (189/259 [73%] in treatment group and 182/260 [70%] in placebo group [Table 1]). This
could have been the main reason for high dropout rate; during
winter season, because of heavy snow fall, there are poor road
links and poor transport facilities. Furthermore, there had been no
telephonic connectivity with these patients to ascertain the actual
reasons for not coming for follow-up.
Loss to follow-up with subsequent missing data can affect the
results of the trial whether done by intention-to-treat or by perprotocol analysis, and can introduce bias especially if the characteristics of population lost to follow-up differ between two
randomized groups, although in our study, the baseline characteristics of these patients in terms of age, sex, geographic region,
smoking pattern, severity, and type of symptoms were almost
similar with patients who continued follow-up.
A dropout rate of 5% or lower is usually of little concern,
whereas loss of 20% or more may have bias on the study
outcome. Despite the previous facts, it is possible that patients in
treatment group who were lost to follow-up had improvement in
their symptoms, lost interest in the study, and did not report.
Those who persisted with symptoms continued to follow-up and
thereby caused effective treatment to appear ineffective, or vice
versa may be true if patient did not improve or adverse effects
of drugs led to dropout, and only those who responded continued follow-up, thereby causing ineffective treatment to appear
effective.
In this study, patients who were lost to follow-up, their last
symptom scores before they dropped out were not included in
per-protocol analysis (last value carried forward). However, previous studies have shown that such inclusion reduces the strength
of study and gives biased results of the treatment effects. The ideal
solution to prevent the bias would have been to keep the dropout
rate minimum.25,26
In this study, patients underwent upper GI endoscopy three
times: one at baseline and the other two endoscopies at 6 weeks
and 12 months to look for healing of gastritis and eradication of
H. pylori. Assessment of resolution of gastritis was possible only
by taking gastric biopsy on endoscopy. Urea breath test is an ideal,
non-invasive test to look for eradication of H. pylori with high
sensitivity and specificity. We could not use this test because it is
expensive and most of the time non available for our patient
population, so we relied on subjecting these patients to endoscopy
that had a dual advantage of taking biopsy to look for resolution of
gastritis as well as to look for eradication of H. pylori. We used
combination of RUT and histology (hematoxylin and eosin stain,
and Giemsa stain) to look for identification of H. pylori that has a
sensitivity of 8998% and specificity of 9398%,27 although it has
limitations: no cultures for H. pylori were taken, H. pylori may not
be uniformly distributed, and gastric biopsy may be negative
despite the presence of H. pylori in gastric mucosa.

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JS Sodhi et al.

Omeperazole was used in both TT group as well as in placebo

group, although it is known to reduce the sensitivity of endoscopybased tests for detection of H. pylori because of proximal shift of
H. pylori toward cardia.28 However, in this study, we had discontinued PPIs 3 weeks before enrollment of patients, and also, no PPI
was given following TT for a period of 1 year. Repeat EGD and
endoscopic H. pylori testing was done at 6 weeks and at 1 year
without PPI therapy.
This study concludes with the message that there is high
prevalence of H. pylori in patients of non-ulcer dyspepsia, and
despite its eradication and healing of gastritis, there is no significant symptom resolution. The cause of their pain needs further
evaluation.

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