1. International Presentation Dr Muhammad Sayedul Arefin

2. WELCOME

3. Title
Efficacy of Helicobacter pylori eradication in Helicobacter pylori positive functional dyspepsia patients- A Double-blind, Randomized, Placebo-controlled Trial

4. Guide
Professor Dr Md Hasan Masud Professor, Department of Gastroenterology BSMMU

5. Introduction Dyspepsia is a common disorder
Functional dyspepsia – most predominant cause of dyspepsia; when organic causes are excluded; 8.3 % at community level in Bangladesh
H.pylori causes dyspeptic symptoms by mechanisms other than producing any macroscopic lesion in gastroduodenal mucosa
Prevalence of H.pylori is 39-87% among functional dyspepsia world wide

6. Rationale of the study
Patients with FD - normal life expectancy but markedly reduced the quality of life; emotional distress and impaired vitality
Though the initial RCT evidences were conflicting, H.pylori eradication in FD
Symptom improvement in 40% patients
NNT – 8
Significant improvement of quality of life

7. Hypothesis
Eradication of H. pylori improves the symptoms of H. pylori positive functional dyspepsia patients

8. Aims and Objectives General Objectives
To see whether the eradication of H. pylori improves the dyspeptic symptoms of ‘H. pylori positive FD’ patients
To measure the dyspepsia status of the patients 2 months after completion of anti H.pylori therapy
To measure the dyspepsia status in control group 2 months after completion of placebo therapy

9. Aims and Objectives General Objectives ( contd…)
To compare the dyspepsia status between H. pylori eradicated and non-eradicated groups 2 months after completion of therapy  
Specific Objective
To see the efficacy of Levofloxacin, Amoxicillin & Omeprazole based triple therapy

10. Materials and Methods Study design : Double blind parallel group
randomized placebo controlled trial
Place of study : Department of Gastroenterology,
BSMMU
Period of study : March 2016 to March 2017
Study population : Functional dyspepsia patients visiting
Gastroenterology OPD of BSMMU

11. Selection Criteria Inclusion criteria 18-55 years of age
FD Patients diagnosed on the basis of ROME III criteria who were positive for H. pylori
Exclusion criteria
Underlying PUD
Dyspepsia with alarm features
Abnormal abdominal USG e.g. hepatosplenomegaly, ascites, gall stone disease, chronic pancreatitis

12. Selection Criteria Exclusion criteria
Pt. on drugs that may cause dyspepsia e.g. NSAID, iron, digoxin
Previous GI surgery
Predominant reflux symptoms
Pregnancy
Abnormalities in blood tests (anemia, raised ESR, abnormal thyroid function test, abnormal transaminase values )
Signs of other diseases that may cause dyspepsia like symptoms (e.g. malignancies , celiac disease, IHD, DM, thyroid diseases)
Recent GI infection

13. Operational Definition
Dyspepsia : symptoms arising from gastroduodenal region consisting of epigastric pain, postprandial fullness, early satiation, anorexia, belching, nausea and vomiting, upper abdominal bloating, and even heartburn and regurgitation
Functional dyspepsia : Bangla Validated Version of Enhanced Asian ROME III Questionnaires (EAR3-Q) for Diagnosis of Functional Gastrointestinal disorders
Detection of Helicobacter pylori infection : Urea Breath Test

14. Sample Size Sample size, Sample size calculation for clinical trial:
P1= Experimental group response (from a previous study)
= 21% patients of experimental group had symptomatic improvement of dyspepsia after H. pylori eradication (McColl et al., 1998)
P2 = control group response (from a previous study)
= 7% patients of control group had symptomatic improvement of dyspepsia after H.pylori eradication (McColl et al., 1998)
Zα =Z-value (two tail) of SND at a given level of significance
= 1.96 (at 5% level of significance)
Zβ = Z-value (one tail) at a given power
= 1.28(at 90% power, when β=0.1)
120 patients (60 patients in each group) were intended for inclusion into the study

15. Statistical Analysis
Continuous variables were expressed as mean with standard deviation and categorical variables as count with percentage
Categorical data were assessed by Chi-square test
Unpaired t-test was used to compare the age distribution of the patients
Multi variate analysis was done to see any association between different variables and resolution of dyspepsia

16. Ethical Consideration
Informed consent was obtained from each patient before study enrollment
The study protocol was approved by the Institutional Review Board (IRB) of Bangabandhu Sheikh Mujib Medical University(BSMMU)

17. Method Dyspeptic patient visiting Gastroenterology OPD
Organic causes of dyspepsia excluded
FD – on the basis of Bangla validated version of ROME III
UBT repeated after 2 months, Dyspepsia reassessed
Randomly assigned to Group A(2 wks anti H.pylori) & Group B (placebo)
UBT to diagnose H.pylori. Finally H.pylori +ve FD were included
Statistical Analysis

18. Results and Observations

19. Dyspepsia Resolved (n=8) Dyspepsia Resolved (n=13)
Randomised Patients
(n= 59)
Lost to F/UP
n=12
Group A
Anti H.p therapy (LAO)
n=30
Group B
Placebo therapy
n=29
Lost to F/UP n=7
Completed
n=17
Completed
n=23
Dyspepsia Resolved (n=8)
47.1%
Dyspepsia Resolved (n=13)
56.5%

20. Demographic variables
Distribution of the patients by age, sex, monthly income, smoking & duration of symptoms (n=40)
Demographic variables
Group A (n=23)
Group B (n=17)
P value n %
Age (years)
Mean±SD
34.05±7.06
31.64±9.44
0.360ns
Range (min-max)
25-50
20-55
Sex
Male 8
34.8 7
41.2
0.679ns
Female 15
65.2 10
58.8
Monthly income (Tk)
<10,000 9
39.1
10,000-30,000 12
52.2
0.282ns
>30,000 2
8.7
0.0
Smoking status
Smoker 5
21.7 4
23.5
0.837ns
Non smoker 19
82.6 13
76.5
Duration of symptoms
Upto 6 months
17.4 3
17.6
6-12 months 6
35.3
0.998ns
>12 months 11
47.8
47.1

21. Comparison between two groups based on resolution of dyspepsia
Symptom resolution n
Symptom resolution rate (%)
Group A (n-23) 13
56.5
Group B (n-17) 8
47.1
P value
0.554ns

22. H.pylori eradication rate 2 months after therapy

23. Comparison between H.pylori eradicated and non-eradicated patients irrespective of allocated treatment regimen (drug/placebo)
Symptom resolution
Eradication group
(n=20)
Non eradication group
P value n %
Resolved 10
50.0 5
25.0
0.102ns
Not resolved 15
75.0

24. Variables F value P value
Multivariate Analysis showing association of co-variates with resolution of dyspesia
Variables
F value
P value
Age
0.298
0.20
Sex
0.064
0.80
Monthly income
0.097
0.75
Smoking status
0.041
0.84
Duration of symptoms
5.057
0.03

25. Conclusion
There is no relationship between H.pylori eradication (by LAO regimen) and resolution of dyspeptic symptoms in patients with functional dyspepsia
H.pylori eradication therapy does not improve dyspeptic symptoms in our clinical setting
A more potent Anti Hp regimen in comparison to LAO should be sought

26. Limitation Small sample size Short study period Single center study
FD - not assessed by any validated symptom scoring scale
Large number patients (19/59, 32.2%) lost to follow-up
H.pylori eradication rate was high (23.5%) in placebo group - may be due to false -ve UBT

27. Recommendations Multi-center study with large sample size
Further study with prolong duration and multiple follow ups
More potent anti H.pylori regimen
Close monitoring to get a flawless UBT report

28. Thank You