|Year : 2016 | Volume
| Issue : 4 | Page : 1079-1084
Impact of Helicobacter pylori eradication on the quality of life among patients with functional dyspepsia attending the Munshaat Sultan Family Health Center, Menoufia University Hospitals
Taghreed M Farahat, Mahmoud A Kora, Hala M Shaheen, Aml A Salama, Fatma A Abdel Gawad MSc, MBBCh
Faculty of Medicine, Menoufia University,Shebin el Kom, Egypt
|Date of Submission||11-Dec-2014|
|Date of Acceptance||02-May-2015|
|Date of Web Publication||21-Mar-2017|
Fatma A Abdel Gawad
Faculty of Medicine, Menoufia University, Shebin el Kom, 32511
Source of Support: None, Conflict of Interest: None
To assess the impact of Helicobacter pylori (Hp) eradication on the patient's quality of life.
Functional dyspepsia (FD) is a common clinical problem that is seldom life-threatening, but impairs health-related quality of life. It was found that Hp gastritis was present in 30–60% of patients with FD.
Patients and methods
This study was carried out on 318 patients (18–55 years old) who fulfilled the ROME III diagnostic criteria for FD. They attended the Munshaat Sultan Family Health Center, Menouf district, Menoufia, Egypt, during the period from January 2013 to January 2014. Patients were invited to complete a baseline quality of life in patients with reflux and dyspepsia questionnaire (QOLRAD), and were classified as Hp+ and Hp− by Hp stool antigen testing. Hp+ patients received a 1-week course of Hp eradication. Hp+ and Hp− patients received a 4-week course of proton pump inhibitors (PPIs), prokinetics, and lifestyle modification, followed by on-demand therapy (PPIs, prokinetics) and lifestyle modification for 6 months. Reassessment of the patient's quality of life using the QOLRAD questionnaire by the two groups was performed 6 weeks and 6 months from the start of the treatment.
Out of 318 patients with FD attended Munshaat Sultan Family Health Center a006Ed fulfilled ROME III criteria the percentage of Hp was 41.8%. QOLRAD were significantly lower in Hp+ than Hp− patients (P < 0.001). There was a highly statistically significant improvement in QOLRAD and dyspeptic symptoms 6 weeks and 6 months after the intervention among Hp+ and Hp− patients (P < 0.001)
In patients with FD, Hp eradication in infected patients and PPIs and prokinetics in Hp− patients reversed low QOL scores and improved global QOL during the 6-month follow-up period. Thus, we recommend the test and treat strategy for Hp for the management of patients with FD attending primary care clinics.
Keywords: eradication, functional dyspepsia, Helicobacter pylori, prokinetics, quality of life
|How to cite this article:|
Farahat TM, Kora MA, Shaheen HM, Salama AA, Abdel Gawad FA. Impact of Helicobacter pylori eradication on the quality of life among patients with functional dyspepsia attending the Munshaat Sultan Family Health Center, Menoufia University Hospitals. Menoufia Med J 2016;29:1079-84
|How to cite this URL:|
Farahat TM, Kora MA, Shaheen HM, Salama AA, Abdel Gawad FA. Impact of Helicobacter pylori eradication on the quality of life among patients with functional dyspepsia attending the Munshaat Sultan Family Health Center, Menoufia University Hospitals. Menoufia Med J [serial online] 2016 [cited 2020 Feb 27];29:1079-84. Available from: http://www.mmj.eg.net/text.asp?2016/29/4/1079/202528
| Introduction|| |
Functional dyspepsia (FD), which is one of the most common GI disorders encountered in clinical practice, is defined by the Rome III criteria as the presence of chronic dyspeptic symptoms for 3 months, with onset at least 6 months before diagnosis, and the absence of any structural abnormality (determined by upper GI endoscopy), metabolic cause, or systemic cause explaining the symptoms .
Unfortunately, the etiology of FD remains largely unknown, different factors being involved, and no definite and effective treatment is currently available for all these patients . The discovery of Helicobacter pylori (Hp) in the 1980s triggered the expectation that dyspeptic symptoms could be caused by such a persistent infection in the stomach .
Although FD is not a fatal disease, it is associated with considerable impairment in quality of life  and thus also an unfavorable economic effect because of frequent consumption of drugs and taking days off because of the symptoms .
There are a number of outpatient studies suggesting that FD impairs health-related quality of life in patients, and seems to affect all major variables of quality of life, namely, mental, social, and physical functioning .
As infection with Hp is the main cause of peptic ulcer disease , ROME III recommended eradication of Hp in all infected patients with nonulcer dyspepsia diagnosed at upper endoscopy, also suggesting noninvasive testing, followed by Hp eradication (test and treat) in the absence of alarming symptoms .
| Objectives|| |
To assess the impact of Hp eradication on the patient's quality of life.
| Patients and Methods|| |
This prospective, parallel-group trial was conducted on a calculated sample (according to the prevalence of FD and population size in the age group 18–55 years) with 80% power. The sample included 288 patients, which was increased to 318 patients to factor in dropouts. Patients aged (18–55 years) and who fulfilled the ROME III  diagnostic criteria for FD were recruited from among patients who attended the Munshaat Sultan Family Health Center, Menouf district, Menoufia Goverorate, during the period of the study from 1 January 2013 to the end of January 2014. The study was approved by the Ethical Committee of the Faculty of Medicine, Menoufia University, and informed consent was obtained from all participants.
The exclusion criteria were as follows: age at least 55 years, patients with a family history of gastrointestinal cancers, patients with peptic ulcer diagnosed by upper GIT endoscopy, patients with a history of NSAIDs intake, uncooperative patients, pregnant women, and patients who had undergone Hp eradication at least 2 weeks ago.
Methods of the study
At the beginning of the study, all patients were evaluated using a predesigned questionnaire that was administered by a face-to-face interview. This questionnaire was translated into the Arabic language and was accepted after validation. The questionnaire included three sections. The first section focused on the basic evaluation of the patients including personal history such as name, age, residence, and socioeconomic status according to El-Gilany et al. (using seven domains: Occupation, Education, Family domain, Economic domain, Family possessions domain, Home sanitation domain, and Healthcare domain). Patients were classified into very low, low, middle, and high socioeconomic levels depending on the quartiles of the calculated score.
The second section included the ROME III questionnaire for the diagnosis of FD. The third section included quality of life in patients, which was assessed using the Reflux and Dyspepsia questionnaire (QOLRAD) . It contains 25 items combined into five dimensions: emotional distress, sleep disturbance, vitality, food/drink problems, and physical/social functioning.
Hp stool antigens were tested in all patients. The analyses were carried out using International immune – Diagnostics Microwell ELISA Helicobacter pylori antigen kit reagents.
All patients received pantoprazole 40 mg once daily, domperidone 10 mg premeal three times daily, and lifestyle modification (avoidance of any spicy, fatty food, coffee, chocolate, smoking, etc.) until the results of the Hp stool antigen test were obtained. Hp− patients completed a 4-week course of this regimen, whereas Hp+ patients received eradication therapy (pantoprazole 40 mg twice daily for 2 weeks, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily for 1 week) besides this regimen. This was followed by on-demand pantoprazole 40 mg, domeridone 10 mg, and lifestyle modification for 6 months.
Follow-up of the patients was performed 6 weeks and 6 months after the start of treatment using the same QOL questionnaire; stool antigen was repeated for Hp+ patients at 6 weeks whereas resistant cases were referred to an internal medicine specialist.
Data were collected, tabulated, and analysed statistically using an IBM personal computer with statistical package for the social science (SPSS, version 20; SPSS Inc., Chicago, Illinois, USA). The c2-test was used for the analysis of qualitative variables. t-Test for comparison of two independent normally distributed quantitative variables, paired t-test for comparison of two dependent normally distributed quantitative variables. Effect size describes the magnitude of the difference between two groups, calculated by the difference in the means between two groups and dividing that number by their combined (pooled) standard deviation. A 'small' effect size is 0.20, a 'medium' effect size is 0.50, and a 'large' effect size is 0.80 .
A P value greater than 0.05 was considered nonsignificant (NS), a P value lower than 0.05 was considered significant (S), and a P value lower than 0.001 was considered highly significant (HS)
| Results|| |
A total of 318 patients with FD (133 Hp+ and 185 Hp−) [Figure 1] were included in this study; their mean age was 36.3 ± 10.9, 52.8% were women, 47.8% had received education higher than the secondary level, 41.2% were professional and semiprofessional workers, 77% were married, and 84% were non smokers. There was a statistically significant difference between Hp+ patients and Hp− patients only in terms of sex (P < 0.05) ([Table 1]).
|Table 1 Comparison between Helicobacter pylori-positive and Helicobacter pylori-negative patients in sociodemographic characteristics|
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The isolated domains and the mean score of QOLRAD were significantly lower among Hp+ than Hp− patients (P < 0.001) ([Table 2]).
|Table 2 Baseline quality of life in patients with reflux and functional dyspepsia (mean±SD)|
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Of 318 patients with FD enrolled in this study, the FD symptoms improved in 267 patients and 51 patients were referred, yielding a total response rate of 84% [Figure 2]. Hp infection persisted in 33 patients after Hp eradication [Figure 3].
|Figure 2: The total response rate of the studied patients 6 weeks after intervention.|
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|Figure 3: The response rate in Helicobacter pylori (Hp) positive patients after Hp eradication.|
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There was a highly statistically significant improvement in QOLRAD and its isolated domains 6 weeks and 6 months after the intervention among Hp+ and Hp− patients (P < 0.001). In Hp+ patients, there was a statistically insignificant difference in QOLRAD and its isolated domains (sleep disturbance, food/drink problems, physical/social functioning) 6 weeks and 6 months from the intervention (P > 0.05). However, the vitality domain was statistically significantly lower 6 months than 6 weeks after the intervention and (P < 0.05). In Hp− patients, QOLRAD and its isolated domains were statistically significantly lower at 6 months than 6 weeks after the intervention (P < 0.05) ([Table 3]).
|Table 3 Quality of life in patients with reflux and functional dyspepsia before and (6 weeks and 6 months) after the intervention in both Helicobacter pylori-positive and Helicobacter pylori negative-patients|
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The short-term effect size was 2.14 in Hp+ patients and 1.9 in Hp− patients, whereas the long-term effect size was 1.9 and 1.1 in Hp+ patients and Hp− patients, respectively ([Table 4]).
|Table 4 Effect size of Helicobacter pylori eradication and prokinetics treatment on the quality of life of patients with functional dyspepsia|
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| Discussion|| |
The role of Hp in the pathogenesis of FD has been explored extensively. Hp may cause inflammation and dysmotility, probably initiates visceral hypersensitivity, and alters acid secretion . Eradication of Hp in patients with FD continues to be a matter of debate . Many studies have shown that Hp eradication resulted in longer-term symptom improvement in the FD patient group than in the placebo group .
This study was carried out on 318 patients who attended the Munshaat Sultan Family Health Center and fulfilled the ROME III diagnostic criteria for FD. Hp infection as a factor of FD was detected by Hp stool antigen in 133 patients (41.8%). This is similar to the result reported by Buzas , who reported a prevalence of Hp among Hungarian patients with FD of 50.7%. In a study carried out in Malaysia, Abdul Aziz et al.  found that 23.5% of patients tested positive and 76.5% tested negative for the urea breath test, whereas Dube et al. found that the prevalence of Hp was 87% in a South African population. Mohammad et al.  reported that the prevalence of Hp infection in Egyptian school children was 72.38%. A cross-sectional study carried on Egyptian patients reported that Hp antibodies were found in 55.6% of HCV-infected patients versus 39.4% of the healthy controls . In a study of dyspeptic patients in primary care facilities in Canada, 30% of patients were positive for Hp infection .
In terms of the sociodemographic characteristics of the patients studied, the mean age (SD) was 36.3 (10.9) years. There was a statistically significant difference (P < 0.05) between Hp+ and Hp− FD patients in sex, where Hp+ was more common in women (59.4%) whereas men were more likely to be Hp− (51.9%). This sex difference was reported in Hungary to be nonstatistically significant .
The results of the present study suggested that the baseline QOL (total and the five domains) was impaired in patients with FD and there was a highly statistically significant difference (P < 0.001) between Hp+ and Hp− patients.
Buzas  used another disease-specific instrument (the Functional Digestive Disorders Quality of Life) and reported that it was not possible to distinguish patients with and without H pylori infection on the basis of QOL data.
In the study of Aro et al. , in patients with FD, a clinically meaningful (≥5 point) and statistically significant reduction in health-related quality of life were found in all SF-36 domains, except for role emotional, compared with nondyspeptics.
Out of 318 patients who received FD treatment in this study, dyspeptic symptoms improved in 84% of patients and 16% were referred for endoscopy. Also, Hp eradication showed a highly statistically significant effect (P < 0.001).
Santacroce and Anand  reported that the links between Hp and nonulcer dyspepsia are debatable; however, some patients with nonulcer dyspepsia benefit from eradication. Patients with symptoms have a higher eradication rate than patients with nonulcer dyspepsia disease.
Meta-analysis in patients with FD found that Hp eradication therapy is associated with improvement in dyspeptic symptoms in patients with FD, which is consistently found in Asian, European, and American populations .
In a review article of Rokkas , Hp eradication indeed conferred significant benefits to primary care patients with FD. However, the cost-effectiveness of Hp eradication in FD varies geographically. It seems that the overall response is much better in regions where Hp is highly prevalent and this is where it may be most cost-effective. Thus, patients with FD in Asia would benefit from treatment for Hp infection, with an increased chance of symptom resolution of as much as 3.6-fold to 13-fold following its eradication .
Abdul Aziz et al.  found that both the HP and the non-HP-related dyspepsia groups showed a statistically significant decrease in the post-treatment scores following treatment with eradication and empirical therapy, respectively.
The European consensus report  on the management of Hp infection recommends eradication of Hp in individuals with FD after a full investigation. Meta-analyses in patients with FD have found that eradication was associated with a minor improvement in dyspeptic symptoms .
In the present study, there was a statistically significant improvement in QOL and its five domains (emotional distress, sleep disturbance, vitality, food/drink problems, and physical social functioning) after 6 weeks of treatment and after 6 months of on-demand maintenance therapy in both Hp+ and Hp− FD patients (P < 0.001). The effect size was large after short-term therapy and during maintenance treatment in both HP+ and Hp− patients, but it was higher in Hp+ than Hp− patients. However, the on-demand maintenance treatment did not contribute toward the 6-month improvement in QOL. In Hp+ patients, there was a statistically insignificant difference in QOLRAD and its isolated domains (sleep disturbance, food/drink problems, physical/social functioning) between 6 weeks and 6 months after intervention (P > 0.05), whereas the vitality domain was statistically significantly lower at 6 months than 6 weeks after the intervention (P < 0.05). In Hp− patients, QOLRAD and its isolated domains were statistically significantly lower 6 months than 6 weeks after the intervention (P < 0.05).
Buzas  reported that prokinetics and Hp eradication was associated with significant improvements in short-term and long-term QOL; on-demand maintenance treatment did not contribute toward the 1-year improvement in QOL. The effect size was large after short-term therapy and small during maintenance treatment .
| Conclusion and Recommendations|| |
Eradication of Hp infection in infected patients, proton pump inhibitors, and prokinetics treatment in uninfected patients reversed low QOL scores and improved global QOL during 6 weeks and 6 months of the follow-up period, whereas the on-demand maintenance treatment did not contribute toward the 6-month improvement in QOL. Thus, we recommend the test and treat strategy for Hp for the management of patients with FD attending primary care clinics.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Lee H, Jung HK, Huh KC. Current status of functional dyspepsia in Korea. Korean J Intern Med 2014; 29
Tack J, Talley NJ, Camilleri M, Holtmann G, Hu PJ, Malagelada JR, et al.
Functional gastroduodenal disorders. Gastroenterology, 2006; 130
Moayyedi P, Soo S, Deeks J, Delaney B, Harris A, Innes M, et al.
Eradication of Helicobacter pylori
for non-ulcer dyspepsia. Cochrane Database Syst Rev 2005; CD002096.
Ghoshal UC, Singh R, Chang FY, Hou X, Wong BC, Kachintorn U, Functional Dyspepsia Consensus Team of the Asian Neurogastroenterology and Motility Association and the Asian Pacific Association of Gastroenterology. Epidemiology of uninvestigated and functional dyspepsia in Asia: facts and fiction. J Neurogastroenterol Motil, 2011; 17
Yazdanpanah K, Moghimi N, Yousefinejad V, Ghaderi E, Azizi A, Nazem SF. Dyspepsia prevalence in general population aged over 20 in the west part of Iran. J Pak Med Assoc 2012; 62
Welén K, Faresjö A, Faresjö T. Functional dyspepsia affects women more than men in daily life: a case–control study in primary care. Gend Med 2008; 5
Moayyedi P, Soo S, Deeks J, Delaney B, Harris A, Innes M, et al
. Eradication of Helicobacter pylori for non-ulcer dyspepsia (Review). The Cochrane Collaboration, the Cochrane Library 2006; 19
Zullo A, Hassan C, De Francesco V, Repici A, Manta R, Tomao S, et al. Helicobacter pylori
and functional dyspepsia: an unsolved issue? World J Gastroenterol, 2014; 20
Bestene JA. Visceral sensitivity and functional dyspepsia: or much more than this? Rev Col Gastroenterol, 2010; 25
El-Gilany A, El-Wehady A, El-Wasify M. Updating and validation of the socioeconomic status scale for health research in Egypt. East Mediterr Health J 2012; 18
Kulich KR, Wiklund I, Junghard O. Factor structure of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire evaluated in patients with heartburn predominant reflux disease. Qual Life Res 2003; 12
Cohen J. Statistical power analysis for the behavioral sciences
ed. Hillsdale, NJ: Erlbaum; 1988.
O'Morain C. Role of Helicobacter pylori
in functional dyspepsia. World J Gastroenterol 2006; 12
Mazzoleni LE, Guilherme B, Sander GE, Mazzoleni F, Uchoa DM, De Bona LR et al.
The role of Helicobacter pylori
infection in functional dyspepsia. Arch Intern Med 2011; 171
Harvey RF, Lane JA, Nair P, Egger M, Harvey I, Donovan J, Murray L Clinical trial: prolonged beneficial effect of Helicobacter pylori
eradication on dyspepsia consultations – The Bristol Helicobacter Project. Aliment Pharmacol Ther 2010; 32
Buzás GM. Quality of life in patients with functional dyspepsia: short- and long-term effect of Helicobacter pylori
eradication with pantoprazole, amoxicillin, and clarithromycin or cisapride therapy: a prospective, parallel-group study. Curr Ther Res Clin Exp 2006; 67
Abdul Aziz AF, Hamzah Z, Tong SF, Nadeson S, Wan Puteh SE. Helicobacter pylori
related dyspepsia: prevalence and treatment outcomes at University Kebangsaan Malaysia-Primary Care Centre. Asia Pac Fam Med 2009; 8
Dube C, Nkosi TC, Clarke AM, Mkwetshana N, Green E, Ndip RN. Helicobacter pylori
antigenemia in an asymptomatic population of Eastern Cape Province, South Africa: public health implications. Rev Environ Health; 2009; 24
Mohammad MA, Hussein L, Coward A, Jackson SJ. Prevalence of Helicobacter pylori
infection among Egyptian children: impact of social background and effect on growth. Public Health Nutr, 2008; 11
El-Masry S, El-Shahat M, Badra G, Aboel-Nour MF, Lotfy M. Helicobacter pylori
and hepatitis C virus coinfection in Egyptian patients. J Glob Infect Dis 2010; 2
Jung HK, Na YJ, Moon IH. Changes of Helicobacter pylori
-positive peptic ulcer disease: based on data from a general hospital. Korean J Gastrointest Endosc 2006; 32
Aro P, Talley NJ, Agréus L, Johansson SE, Bolling-Sternevald E, Storskrubb T, Ronkainen J Functional dyspepsia impairs quality of life in the adult population. Aliment Pharmacol Ther 2011; 33
Santacroce L, Anand BS. Helicobacter pylori infection treatment and management. 2014. Available from: http://emedicine.medscape.com
. [Last accessed on 2014 Nov 24].
Zhao B, Zhao J, Cheng WF, Shi WJ, Liu W, Pan XL, Zhang G ×. Efficacy of Helicobacter pylori
eradication therapy on functional dyspepsia: a meta-analysis of randomized controlled studies with 12-month follow-up. J Clin Gastroenterol 2014; 48
Rokkas T. The role of Helicobacter pylori
infection in functional dyspepsia. Arch Intern Med J 2012; 25
Malfertheiner P, Mégraud F, O'Morain C, Hungin AP, Jones R, Axon A, et al
. European Helicobacter Pylori
Study Group (EHPSG). Current concepts in the management of Helicobacter pylori
infection – The Maastricht 2-2000 Consensus Report. Aliment Pharmacol Ther 2002; 16
Laine L, Schoenfeld P, Fennerty MB. Therapy for Helicobacter pylori
in patients with nonulcer dyspepsia. A meta-analysis of randomized, controlled trials. Ann Intern Med 2001; 134
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]