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Helicobacter pylori related dyspepsia: prevalence and treatment outcomes at University Kebangsaan Malaysia-Primary Care Centre

Helicobacter pylori related dyspepsia: prevalence and treatment outcomes at University Kebangsaan... Background: Optimum management of dyspepsia in primary care is a debatable subject. Testing for Helicobacter pylori (HP) has been recommended in primary care as this strategy will cure most underlying peptic ulcer disease and prevent future gastro duodenal disease. Methods: A total of 98 patients completed Modified Glasgow Dyspepsia Severity Score Questionnaire (MGDSSQ) at initial presentation before undergoing the Carbon Urea Breath Test (UBT) for HP. Those with positive UBT received Eradication Therapy with oral Omeprazole 20 mg twice daily, Clarithromycin 500 mg daily and Amoxycillin 500 mg twice daily for one week followed by Omeprazole to be completed for another 4 to 6 weeks. Those with negative UBT received empirical treatment with oral Omeprazole 20 mg twice daily for 4 to 6 weeks. Patients were assessed again using the MGDSSQ at the completion of treatment and one month after stopping treatment. Results: The prevalence of dyspepsia at Universiti Kebangsaan Malaysia-Primary Care Centre was 1.12% (124/11037), out of which 23.5% (23/98) was due to HP. Post treatment assessment in both HP (95.7%, 22/23) and non HP-related dyspepsia (86.7%, 65/75) groups showed complete or almost complete resolution of dyspepsia. Only about 4.3% (1/23) in the HP related dyspepsia and 13.3% (10/75) in the non HP group required endoscopy. Conclusion: The prevalence of dyspepsia due to HP in this primary care centre was 23.5%. Detection of HP related dyspepsia yielded good treatment outcomes (95.7%). Background One of the challenges in treating dyspepsia for primary Dyspepsia is described as chronic or recurrent pain or dis- care physicians is to determine the optimal treatment for comfort in the upper abdomen. The prevalence of dyspep- the patient presenting with new onset or previously unin- sia in western countries is approximately 25% which vestigated dyspeptic symptoms [3]. accounts for 2–5% of primary care consultations [1,2]. Page 1 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 Dyspepsia could be due to several causes such as peptic The Maastricht 2–2000 guidelines and primary care guide- ulcer disease, reflux disease, drugs (especially Non-Steroi- lines for the management of HP infection recommend a dal Anti-Inflammatory Drugs, NSAIDs) and idiopathic. test-and-treat approach without endoscopy for adult Symptoms commonly overlap, making diagnosis diffi- patients under 45 years presenting in primary care with cult. Gastro-oesophageal reflux disease (GORD) presents persistent dyspepsia [8,9]. with predominant or frequent (more than once a week) heartburn or acid regurgitation [4]. Hence, it is often dif- However, there is much more limited evidence on the test ficult to distinguish between dyspepsia and GORD in the and treat approach in Malaysia. uninvestigated patient who presents with upper gastroin- testinal symptoms in primary care. The United States National Institutes of Health (NIH) [10] recommends the carbon labelled urea breath test Almost one third of patients presenting with dyspepsia in (UBT) as the best diagnostic approach because of its primary care have peptic ulcer disease. In patients under- intrinsic operational advantages. Sensitivities of greater going endoscopy for peptic ulcer disease, detection and than 90% and specificities approaching 100% [10] make eradication of Helicobacter pylori (HP) has demonstrated UBT the gold standard for diagnosis of active HP disease a potential cure for patients presenting with dyspepsia. [8,11]. To prevent a false negative result, the UBT should Kurata and colleagues in their study noted that there is a not be administered within four weeks of proton pump significantly higher prevalence of peptic ulcer disease in inhibitor (PPI), bismuth or antibiotic therapy [12]. dyspeptic patients who test positive for HP compared to those who do not [5]. Early endoscopy may be theoreti- However, the test and treat approach is not currently prac- cally desirable for all patients but this is currently not tised at primary care level in Malaysia. Apart from private practical [2]. Moreover, it is an invasive procedure, costly diagnostic laboratories, only Universiti Kebangsaan and causes discomfort to the patient. Malaysia Medical Centre (UKMMC) has this facility. This test is not available in any of the government-funded hos- Immediate referral for endoscopy is recommended for pitals across Malaysia. patients on regular NSAIDs and those with alarm symp- toms such as weight loss, bleeding, anaemia, dysphagia, The management of dyspepsia is an important issue for jaundice and palpable mass [6]. The recommendation of both primary care physicians and specialists as the initial endoscopy in older patients is made because of concerns approach may dictate both patient outcome and future over the risk of underlying malignancy with increasing age consumption of health care resources. This study aims to [7]. determine the prevalence of HP related dyspepsia and treatment outcomes among patients attending the UKM To date, the main options for the treatment of younger Primary Care Centre, a university funded primary care patients with uninvestigated dyspepsia without alarming clinic. The extension of this service to the primary care features include the following [7]: facility from the UKMMC will facilitate the initiation of eradication at primary care level, hence limiting endos- (1) Empirical H -receptor antagonist therapy; copy for cases resistant to treatment. The study also aims to demonstrate the improvement of symptoms of dyspep- (2) Empirical proton pump inhibitor (PPI) therapy sia in both groups of HP positive and negative patients after appropriate treatment. (3) HP testing and treatment of positive cases (HP test and treat) followed by acid suppression if the patient Methods remains symptomatic This cross-sectional study was conducted at UKM Primary Care Centre, a teaching primary care centre located in an (4) Early endoscopy alone urban area south of Kuala Lumpur. The study was con- ducted over a period of six months (January to June (5) Early endoscopy with biopsy for HP and treatment 2005). All new and 'follow-up' patients who attended if positive UKM Primary Care Centre during the study period were screened for symptoms suggestive of dyspepsia and subse- (6) Acid suppression followed by endoscopy and quently managed by the research team. Patients who were biopsy if the patient returns symptomatic; or 18 to 50 years old and had symptoms of dyspepsia for at least four weeks were included in the study. Those (7) HP test and treat with endoscopy if the patient excluded from the study were patients who had associated remains symptomatic alarm symptoms (i.e. anaemia, dysphagia, gastrointesti- nal bleeding, jaundice, lymphadenopathy, palpable mass, Page 2 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 significant weight loss), patients on NSAIDs, anticoagu- intervals (10, 20, 30 minutes) into the respective cham- lant and steroid drugs, patients previously diagnosed, or bers. The filled chambers were transported for analysis had undergone surgery for gastroenterological or hepato- either immediately or within one week. UBT positive indi- biliary disease, patients previously on eradication regimes cates HP-related dyspepsia while UBT negative indicates for HP infection, patients with previously positive finding Non-HP-related dyspepsia on endoscopy for other gastric pathologies, patients with Ethical approval family history of gastric cancer and patients who were pregnant. This study obtained ethical approval from the Medical Research Center, Faculty of Medicine, Universiti Kebang- The nature of the dyspepsia was assessed by determining saan Malaysia (#FF-179-2004). the most predominant symptoms experienced by the patients. This involved a researcher interviewing the Data analysis patients and asking them what they considered to be their The data was analyzed using SPSS™ (Statistical Program most troublesome and frequent symptoms (i.e. epigastric for Social Sciences) software program version 11.5. Pear- pain, bloating, nausea, burping/belching, heartburn, sour son's Chi square was used for detection of differences in taste or halitosis). The patients were then asked to fill a categorical variables between the two groups (HP and self-administered questionnaire regarding severity of dys- Non HP). Mann Whitney's test was used for analysis of peptic symptoms using the Modified or Abbreviated Glas- non-normally distributed data. The paired t-test was used gow Dyspepsia Severity Score. Patients with language to assess the mean scores pre and post treatment. The problems were referred to either a researcher or the para- unpaired t -test used to assess the relation between quan- medical staff who were pre-trained for the period of study. titative and qualitative variables. All tests were done using a priori level of significance of 0.05. The patients were then subjected to Urea Breath Test (GRAF Medical System) using carbon urea following Sample size the method described in the UBT study tool. Specimens Using the Epidinfo programme and a prevalence range of were sent for analysis as soon as possible or not more than 30 to 40% at 95% confidence interval, the calculated sam- one week. Patients were reviewed and informed about the ple size required was 92 patients. result and if the breath test result was positive, the patients received a regime of: oral Omeprazole 20 mg twice daily, Results Amoxycillin 500 mg twice daily & Clarithromycin 500 mg Over the six month period of the study, a total of 124 daily for one week patients presented with dyspepsia, making the prevalence of dyspepsia in adult patients attending PPP-HUKM This regime was chosen as it has been proven to achieve 1.12% (124/11037). Further analysis on dyspeptic partic- consistent eradication of rates greater than 90%. (Based ipants (98/124) recruited into this study, 23.5% (23/98) on Malaysian Academy of Medicine Consensus on Man- tested positive for urea breath test (HP-related dyspepsia) agement of Peptic Ulcer Disease [13]) and 76.5% (75/98) tested negative for urea breath test (Non HP-related dyspepsia). Instruments Modified Glasgow Dyspepsia Severity Score Both the HP and non HP-related dyspepsia groups This tool consists of an abbreviated version of the original showed statistically significant decline in the post treat- Glasgow Dyspepsia Severity Dyspepsia Score [14], which ment scores following treatment with eradication and has been shown to be a valid, responsive and reproducible empirical therapy respectively. (Table 1) means of assessing the severity of dyspepsia to allow measurement of symptoms over a one-month period. Post eradication assessment of those with HP-related dys- pepsia demonstrated 95.7% (22/23) complete or almost Carbon Urea Breath Test (UBT) complete resolution of dyspepsia symptoms (score 0–1), A period of fasting before the test was not mandatory but whereas only 1 (4.3%) continued to experience dyspepsia timing in relation to the last meal was at least two hours (score more than 1). In the Non HP- related dyspepsia before testing. Ingestion of carbonated drinks before the group, 13.3% (10/75) did not respond to treatment, with procedure was not allowed. Patients were instructed to a mean score of 4.5. There were a higher proportion of take a deep breath and to count from 1 to 5 while blowing patients in the non-HP group who required further endos- into the chamber bag slowly. Patients were given a drink copy compared with the HP-related dyspepsia group containing the substrate (75 mg IRIS carbon urea, GRAF (13.3% vs. 4.3%). (Table 2) Medical Systems) and orange juice in a 3/4 glass of water. The patients were instructed to blow at indicated time Page 3 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 Table 1: Paired t-test in symptoms score decline pre and post treatment in HP and Non-HP related dyspepsia Symptom score Mean (SD) Group N Pre Treatment Post Treatment Score Decline 95% Confidence Interval HP 23 8.43 ± 1.56 0.87 ± 1.01 7.57 ± 1.59 6.88 ± 8.25 * Non HP 75 7.00 ± 1.52 1.05 ± 1.43 5.95 ± 1.92 5.20 ± 6.39 *p = 0.0008, p = 0.0008 Our study also recorded the individual's predominant Discussion Since HP was first cultured by Warren and Marshall in symptom to ensure that definition of dyspepsia, (which is 1983, much has been learned about its clinical aspects pain or discomfort at centre upper abdomen), is strictly and its epidemiology. Knowledge of the epidemiology of followed and to exclude patients who presented with this infection comes mainly from prevalence studies. heartburn (gastro-oesophageal reflux disease, GORD) as a Investigation of the incidence of HP infection has been predominant symptom. limited due to difficulties in identifying the case at the onset. In general HP infection is more frequent in devel- This study has shown that the treatment response was oping countries than in developed nations. In developed good with most of the respondents achieved complete or countries, HP infection is acquired at fairly constant rate almost complete resolution of dyspepsia symptoms. The of 2–6% per year with prevalence 20–40% in adults [15]. use of symptomatic response to HP eradication therapy as Malaysian data shows that the prevalence of HP infection a marker of post treatment status has been evaluated by varies widely from 11 to 70% with an average of 35 to McColl (1998) who concluded that complete resolution 40%. The highest rate were seen among the indigenous of dyspeptic symptoms is a powerful predictor of eradica- natives (54 to 65.3%) in east coast of Sabah, East Malaysia tion of HP infection in ulcer patients. However, persist- [16]. ence of symptoms is a weak predictor of persisting infection; hence patients with persisting dyspepsia must The overall prevalence of HP- related dyspepsia below the have their HP status rechecked to guide further manage- age of 50 years old found in this study was 22.5% (23/98). ment [14]. This was supported in this study by the endos- This is at the lower end of the range in the study by KL copy findings of the participants who were referred for Goh where the overall prevalence of HP ranged from 26.4 persistent symptoms. Eleven (11.2%) of them were to 55.0% in various parts of Malaysia, covering the Penin- referred; 10 (13.3%) were from the non HP-related dys- sular as well as East Malaysia [16]. pepsia group and only one (3.3%) from the HP-related dyspepsia group. Four of them did not turn up and the The decline in the prevalence of HP infection seen in this results of the other seven were traced. study may reflect the steady improvement of our socioe- conomic conditions resulting in decreased transmission Post treatment review of the HP and non HP related dys- as living conditions and hygiene improved [16]. Moreo- peptic patients who had persistent symptoms, tissue biop- ver, the setting for this study was done in an urban based sies taken via endoscopy tested negative for HP infection. primary care clinic with the majority of the population Persistence of symptoms was found to be due to pan gas- from the lower to upper middle income groups. tritis, reflux oesophagitis and mild gastritis. Our study showed that a small number of patients required referral for endoscopy (1/23, 4.3%) when using Table 2: Treatment outcomes in patients presenting with the UBT as an initial approach in young patients with dys- dyspepsia pepsia without alarm symptoms. This was similar to find- ENDOSCOPY ings of other studies [2,8,10,11]. No Yes Although the test and treat strategy showed encouraging HP 95.7% (22/23) 4.3% (1/23) results, we do note that there are limitations to our study. Non HP 86.7% (65/75) 3.3% (10/75) The results obtained only reflected findings from a single urban based primary care centre. It does not reflect the Total 88.8% (87/98) 11.2% (11/98) overall population of primary care attendees which are Page 4 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 6. Bytzer P, Hansen JM, Schaffalitzky de Muckadell OB: Empirical H largely based in the suburban and rural areas. Further [SUB 2] Blocker Therapy or Prompt Endoscopy in Manage- multicentred studies looking into the cost effectiveness of ment Of Dyspepsia. Lancet 1994, 343(8901):. testing for HP using the UBT should be done. 7. American Gastroenterological Association Medical Position Statement: Evaluation of Dyspepsia. Gastroenterology 2005, 129:1753-1755. Conclusion 8. Malfertheiner P, Mégraud F, O'Morain C, Hungin APS, Jones R, Axon A, Graham DY, Tytgat G, The European Helicobacter Pylori Study Based on this study, the prevalence of HP related dyspep- Group (EHPSG): Current concepts in the management of H. sia among adult patients attending a primary care centre is Pylori infection. The Maastricht 2–2000 Concensus Report. 23.5% using the UBT. The treatment response using erad- Alimentary Pharmacology & Therapeutics 2002, 16:167-80. 9. Arent NL, Jacob T, Van Zwet, Anton A, Poul MO, Gotz JM, Werf G ication regime (with Omeprazole, Calrithromycin and Van de, Reenders K, Sluiter W, Kleibeuker J: Approach to treat- Amoxycillin for one week) showed encouraging response ment of Dyspepsia in Primary Care: A Randomized Trial with only 4.3% (1/23) requiring endoscopy. Comparing "Test and Treat " with prompt Endoscopy. Archives Internal Medicine 2003, 163(13):1606-1612. 10. NIH Consensus Development Panel on Helicobacter Pylori UBT should be an option for detection of HP related dys- in Peptic Ulcer Disease. JAMA 1994, 272(1):65-69. 11. Talley NJ, Axon A, Bytzer P, et al.: Management of uninvestigated pepsia in primary care setting based on its non invasive, and functional dyspepsia and working party report for the high patient acceptance and highly sensitive features. World Congress of Gasteroenterology 1998. Alimentary Phar- macology & Therapeutics 1998, 13:1135-48. 12. Lam SK, Talley NJ: Report for the 1997 Asia Pacific. Consensus Competing interests Guidelines on the management of H. pylori. Journal Gasteroen- The authors declare that they have no competing interests. terology & Hepatology 1998, 13:1-2. 13. Malaysian Academy of Medicine Consensus on Management of Peptic Ulcer Disease 1996 [http://www.acadmed.org.my]. Authors' contributions 14. McColl KEL, El-Nujumi A, Murray LS, El-omar EM, Dickson A, Kelman AFAA participated in the design and coordination and AW, Hilditch TE: Assessment of symptomatic response as pre- dictor of Helicobacter pylori status following eradication drafted the manuscript. therapy in patients with ulcer. Gut 1998, 42(5):618-620. 15. Rolan A, Giancaspero R: Long term reinfection rate and the ZH conceived the study, carried out the clinical trial, per- course of duodenal ulcer disease after eradication of Helico- bacter pylori in a developing countries. American Journal of Gas- formed the statistical analysis and helped to draft the teroenterology 2000, 95:50-56. manuscript. 16. Goh KL, Parasakhti N: The racial cohort phenomenon; seroep- idemiology of helicobacter pylori infection in a multiracial South East Asia country. European Journal of Gasteroenterology & NS participated in the design, coordinated and performed Hepatology 2001, 13:177-18. the Endoscopy studies. SEWP and TSF participated in the design of the study and statistical analysis. All authors read and approved the final manuscript. Acknowledgements We wish to thank Dean and Director of UKM Medical Centre for permis- sion to publish and all the staffs of UKMMC Primary Care Centre and the Endoscopy Unit for participating in this study We would also like to thank the original authors of the Modified or Abbre- viated Glasgow Dyspepsia Severity Score (McColl and colleagues) for the use of this instrument during this study. References Publish with Bio Med Central and every 1. Talley NJ, Vakil NB, Moayyedi P: American Gastroenterological scientist can read your work free of charge Association Technical Review: Evaluation of Dyspepsia. Gas- teroenterology 2005, 129:1756-1780. "BioMed Central will be the most significant development for 2. Talley NJ: Management guidelines for the millennium. Gut disseminating the results of biomedical researc h in our lifetime." 2002, 50(Suppl IV):iv72-78. Sir Paul Nurse, Cancer Research UK 3. Sander JO, Veldhuyzen Van Zanten , Flook Nl, Chiba N, Armstrong D, Barlum A, Bourdette : An evidence based approach to the Your research papers will be: management of untreated dyspepsia in era of HP. CMAJ 2000, available free of charge to the entire biomedical community 162(90120):. 4. Talley NJ: Dyspepsia and heartburn: a clinical challenge. Ali- peer reviewed and published immediately upon acceptance mentary Pharmacology & Therapeutics 1997, 11(suppl 2):1-8. cited in PubMed and archived on PubMed Central 5. Kurata JH, Nogawa AN, Chen YK, Parker CE: Dyspepsia in pri- mary care: perceived causes, reason for improvement and yours — you keep the copyright satisfaction with care. Journal of Family Practice 1997, 44:281-8. BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 5 of 5 (page number not for citation purposes) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Asia Pacific Family Medicine Springer Journals

Helicobacter pylori related dyspepsia: prevalence and treatment outcomes at University Kebangsaan Malaysia-Primary Care Centre

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Springer Journals
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Copyright © 2009 by Aziz et al; licensee BioMed Central Ltd.
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Medicine & Public Health; General Practice / Family Medicine; Primary Care Medicine
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1447-056X
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10.1186/1447-056X-8-4
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19435494
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Abstract

Background: Optimum management of dyspepsia in primary care is a debatable subject. Testing for Helicobacter pylori (HP) has been recommended in primary care as this strategy will cure most underlying peptic ulcer disease and prevent future gastro duodenal disease. Methods: A total of 98 patients completed Modified Glasgow Dyspepsia Severity Score Questionnaire (MGDSSQ) at initial presentation before undergoing the Carbon Urea Breath Test (UBT) for HP. Those with positive UBT received Eradication Therapy with oral Omeprazole 20 mg twice daily, Clarithromycin 500 mg daily and Amoxycillin 500 mg twice daily for one week followed by Omeprazole to be completed for another 4 to 6 weeks. Those with negative UBT received empirical treatment with oral Omeprazole 20 mg twice daily for 4 to 6 weeks. Patients were assessed again using the MGDSSQ at the completion of treatment and one month after stopping treatment. Results: The prevalence of dyspepsia at Universiti Kebangsaan Malaysia-Primary Care Centre was 1.12% (124/11037), out of which 23.5% (23/98) was due to HP. Post treatment assessment in both HP (95.7%, 22/23) and non HP-related dyspepsia (86.7%, 65/75) groups showed complete or almost complete resolution of dyspepsia. Only about 4.3% (1/23) in the HP related dyspepsia and 13.3% (10/75) in the non HP group required endoscopy. Conclusion: The prevalence of dyspepsia due to HP in this primary care centre was 23.5%. Detection of HP related dyspepsia yielded good treatment outcomes (95.7%). Background One of the challenges in treating dyspepsia for primary Dyspepsia is described as chronic or recurrent pain or dis- care physicians is to determine the optimal treatment for comfort in the upper abdomen. The prevalence of dyspep- the patient presenting with new onset or previously unin- sia in western countries is approximately 25% which vestigated dyspeptic symptoms [3]. accounts for 2–5% of primary care consultations [1,2]. Page 1 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 Dyspepsia could be due to several causes such as peptic The Maastricht 2–2000 guidelines and primary care guide- ulcer disease, reflux disease, drugs (especially Non-Steroi- lines for the management of HP infection recommend a dal Anti-Inflammatory Drugs, NSAIDs) and idiopathic. test-and-treat approach without endoscopy for adult Symptoms commonly overlap, making diagnosis diffi- patients under 45 years presenting in primary care with cult. Gastro-oesophageal reflux disease (GORD) presents persistent dyspepsia [8,9]. with predominant or frequent (more than once a week) heartburn or acid regurgitation [4]. Hence, it is often dif- However, there is much more limited evidence on the test ficult to distinguish between dyspepsia and GORD in the and treat approach in Malaysia. uninvestigated patient who presents with upper gastroin- testinal symptoms in primary care. The United States National Institutes of Health (NIH) [10] recommends the carbon labelled urea breath test Almost one third of patients presenting with dyspepsia in (UBT) as the best diagnostic approach because of its primary care have peptic ulcer disease. In patients under- intrinsic operational advantages. Sensitivities of greater going endoscopy for peptic ulcer disease, detection and than 90% and specificities approaching 100% [10] make eradication of Helicobacter pylori (HP) has demonstrated UBT the gold standard for diagnosis of active HP disease a potential cure for patients presenting with dyspepsia. [8,11]. To prevent a false negative result, the UBT should Kurata and colleagues in their study noted that there is a not be administered within four weeks of proton pump significantly higher prevalence of peptic ulcer disease in inhibitor (PPI), bismuth or antibiotic therapy [12]. dyspeptic patients who test positive for HP compared to those who do not [5]. Early endoscopy may be theoreti- However, the test and treat approach is not currently prac- cally desirable for all patients but this is currently not tised at primary care level in Malaysia. Apart from private practical [2]. Moreover, it is an invasive procedure, costly diagnostic laboratories, only Universiti Kebangsaan and causes discomfort to the patient. Malaysia Medical Centre (UKMMC) has this facility. This test is not available in any of the government-funded hos- Immediate referral for endoscopy is recommended for pitals across Malaysia. patients on regular NSAIDs and those with alarm symp- toms such as weight loss, bleeding, anaemia, dysphagia, The management of dyspepsia is an important issue for jaundice and palpable mass [6]. The recommendation of both primary care physicians and specialists as the initial endoscopy in older patients is made because of concerns approach may dictate both patient outcome and future over the risk of underlying malignancy with increasing age consumption of health care resources. This study aims to [7]. determine the prevalence of HP related dyspepsia and treatment outcomes among patients attending the UKM To date, the main options for the treatment of younger Primary Care Centre, a university funded primary care patients with uninvestigated dyspepsia without alarming clinic. The extension of this service to the primary care features include the following [7]: facility from the UKMMC will facilitate the initiation of eradication at primary care level, hence limiting endos- (1) Empirical H -receptor antagonist therapy; copy for cases resistant to treatment. The study also aims to demonstrate the improvement of symptoms of dyspep- (2) Empirical proton pump inhibitor (PPI) therapy sia in both groups of HP positive and negative patients after appropriate treatment. (3) HP testing and treatment of positive cases (HP test and treat) followed by acid suppression if the patient Methods remains symptomatic This cross-sectional study was conducted at UKM Primary Care Centre, a teaching primary care centre located in an (4) Early endoscopy alone urban area south of Kuala Lumpur. The study was con- ducted over a period of six months (January to June (5) Early endoscopy with biopsy for HP and treatment 2005). All new and 'follow-up' patients who attended if positive UKM Primary Care Centre during the study period were screened for symptoms suggestive of dyspepsia and subse- (6) Acid suppression followed by endoscopy and quently managed by the research team. Patients who were biopsy if the patient returns symptomatic; or 18 to 50 years old and had symptoms of dyspepsia for at least four weeks were included in the study. Those (7) HP test and treat with endoscopy if the patient excluded from the study were patients who had associated remains symptomatic alarm symptoms (i.e. anaemia, dysphagia, gastrointesti- nal bleeding, jaundice, lymphadenopathy, palpable mass, Page 2 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 significant weight loss), patients on NSAIDs, anticoagu- intervals (10, 20, 30 minutes) into the respective cham- lant and steroid drugs, patients previously diagnosed, or bers. The filled chambers were transported for analysis had undergone surgery for gastroenterological or hepato- either immediately or within one week. UBT positive indi- biliary disease, patients previously on eradication regimes cates HP-related dyspepsia while UBT negative indicates for HP infection, patients with previously positive finding Non-HP-related dyspepsia on endoscopy for other gastric pathologies, patients with Ethical approval family history of gastric cancer and patients who were pregnant. This study obtained ethical approval from the Medical Research Center, Faculty of Medicine, Universiti Kebang- The nature of the dyspepsia was assessed by determining saan Malaysia (#FF-179-2004). the most predominant symptoms experienced by the patients. This involved a researcher interviewing the Data analysis patients and asking them what they considered to be their The data was analyzed using SPSS™ (Statistical Program most troublesome and frequent symptoms (i.e. epigastric for Social Sciences) software program version 11.5. Pear- pain, bloating, nausea, burping/belching, heartburn, sour son's Chi square was used for detection of differences in taste or halitosis). The patients were then asked to fill a categorical variables between the two groups (HP and self-administered questionnaire regarding severity of dys- Non HP). Mann Whitney's test was used for analysis of peptic symptoms using the Modified or Abbreviated Glas- non-normally distributed data. The paired t-test was used gow Dyspepsia Severity Score. Patients with language to assess the mean scores pre and post treatment. The problems were referred to either a researcher or the para- unpaired t -test used to assess the relation between quan- medical staff who were pre-trained for the period of study. titative and qualitative variables. All tests were done using a priori level of significance of 0.05. The patients were then subjected to Urea Breath Test (GRAF Medical System) using carbon urea following Sample size the method described in the UBT study tool. Specimens Using the Epidinfo programme and a prevalence range of were sent for analysis as soon as possible or not more than 30 to 40% at 95% confidence interval, the calculated sam- one week. Patients were reviewed and informed about the ple size required was 92 patients. result and if the breath test result was positive, the patients received a regime of: oral Omeprazole 20 mg twice daily, Results Amoxycillin 500 mg twice daily & Clarithromycin 500 mg Over the six month period of the study, a total of 124 daily for one week patients presented with dyspepsia, making the prevalence of dyspepsia in adult patients attending PPP-HUKM This regime was chosen as it has been proven to achieve 1.12% (124/11037). Further analysis on dyspeptic partic- consistent eradication of rates greater than 90%. (Based ipants (98/124) recruited into this study, 23.5% (23/98) on Malaysian Academy of Medicine Consensus on Man- tested positive for urea breath test (HP-related dyspepsia) agement of Peptic Ulcer Disease [13]) and 76.5% (75/98) tested negative for urea breath test (Non HP-related dyspepsia). Instruments Modified Glasgow Dyspepsia Severity Score Both the HP and non HP-related dyspepsia groups This tool consists of an abbreviated version of the original showed statistically significant decline in the post treat- Glasgow Dyspepsia Severity Dyspepsia Score [14], which ment scores following treatment with eradication and has been shown to be a valid, responsive and reproducible empirical therapy respectively. (Table 1) means of assessing the severity of dyspepsia to allow measurement of symptoms over a one-month period. Post eradication assessment of those with HP-related dys- pepsia demonstrated 95.7% (22/23) complete or almost Carbon Urea Breath Test (UBT) complete resolution of dyspepsia symptoms (score 0–1), A period of fasting before the test was not mandatory but whereas only 1 (4.3%) continued to experience dyspepsia timing in relation to the last meal was at least two hours (score more than 1). In the Non HP- related dyspepsia before testing. Ingestion of carbonated drinks before the group, 13.3% (10/75) did not respond to treatment, with procedure was not allowed. Patients were instructed to a mean score of 4.5. There were a higher proportion of take a deep breath and to count from 1 to 5 while blowing patients in the non-HP group who required further endos- into the chamber bag slowly. Patients were given a drink copy compared with the HP-related dyspepsia group containing the substrate (75 mg IRIS carbon urea, GRAF (13.3% vs. 4.3%). (Table 2) Medical Systems) and orange juice in a 3/4 glass of water. The patients were instructed to blow at indicated time Page 3 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 Table 1: Paired t-test in symptoms score decline pre and post treatment in HP and Non-HP related dyspepsia Symptom score Mean (SD) Group N Pre Treatment Post Treatment Score Decline 95% Confidence Interval HP 23 8.43 ± 1.56 0.87 ± 1.01 7.57 ± 1.59 6.88 ± 8.25 * Non HP 75 7.00 ± 1.52 1.05 ± 1.43 5.95 ± 1.92 5.20 ± 6.39 *p = 0.0008, p = 0.0008 Our study also recorded the individual's predominant Discussion Since HP was first cultured by Warren and Marshall in symptom to ensure that definition of dyspepsia, (which is 1983, much has been learned about its clinical aspects pain or discomfort at centre upper abdomen), is strictly and its epidemiology. Knowledge of the epidemiology of followed and to exclude patients who presented with this infection comes mainly from prevalence studies. heartburn (gastro-oesophageal reflux disease, GORD) as a Investigation of the incidence of HP infection has been predominant symptom. limited due to difficulties in identifying the case at the onset. In general HP infection is more frequent in devel- This study has shown that the treatment response was oping countries than in developed nations. In developed good with most of the respondents achieved complete or countries, HP infection is acquired at fairly constant rate almost complete resolution of dyspepsia symptoms. The of 2–6% per year with prevalence 20–40% in adults [15]. use of symptomatic response to HP eradication therapy as Malaysian data shows that the prevalence of HP infection a marker of post treatment status has been evaluated by varies widely from 11 to 70% with an average of 35 to McColl (1998) who concluded that complete resolution 40%. The highest rate were seen among the indigenous of dyspeptic symptoms is a powerful predictor of eradica- natives (54 to 65.3%) in east coast of Sabah, East Malaysia tion of HP infection in ulcer patients. However, persist- [16]. ence of symptoms is a weak predictor of persisting infection; hence patients with persisting dyspepsia must The overall prevalence of HP- related dyspepsia below the have their HP status rechecked to guide further manage- age of 50 years old found in this study was 22.5% (23/98). ment [14]. This was supported in this study by the endos- This is at the lower end of the range in the study by KL copy findings of the participants who were referred for Goh where the overall prevalence of HP ranged from 26.4 persistent symptoms. Eleven (11.2%) of them were to 55.0% in various parts of Malaysia, covering the Penin- referred; 10 (13.3%) were from the non HP-related dys- sular as well as East Malaysia [16]. pepsia group and only one (3.3%) from the HP-related dyspepsia group. Four of them did not turn up and the The decline in the prevalence of HP infection seen in this results of the other seven were traced. study may reflect the steady improvement of our socioe- conomic conditions resulting in decreased transmission Post treatment review of the HP and non HP related dys- as living conditions and hygiene improved [16]. Moreo- peptic patients who had persistent symptoms, tissue biop- ver, the setting for this study was done in an urban based sies taken via endoscopy tested negative for HP infection. primary care clinic with the majority of the population Persistence of symptoms was found to be due to pan gas- from the lower to upper middle income groups. tritis, reflux oesophagitis and mild gastritis. Our study showed that a small number of patients required referral for endoscopy (1/23, 4.3%) when using Table 2: Treatment outcomes in patients presenting with the UBT as an initial approach in young patients with dys- dyspepsia pepsia without alarm symptoms. This was similar to find- ENDOSCOPY ings of other studies [2,8,10,11]. No Yes Although the test and treat strategy showed encouraging HP 95.7% (22/23) 4.3% (1/23) results, we do note that there are limitations to our study. Non HP 86.7% (65/75) 3.3% (10/75) The results obtained only reflected findings from a single urban based primary care centre. It does not reflect the Total 88.8% (87/98) 11.2% (11/98) overall population of primary care attendees which are Page 4 of 5 (page number not for citation purposes) Asia Pacific Family Medicine 2009, 8:4 http://www.apfmj.com/content/8/1/4 6. Bytzer P, Hansen JM, Schaffalitzky de Muckadell OB: Empirical H largely based in the suburban and rural areas. Further [SUB 2] Blocker Therapy or Prompt Endoscopy in Manage- multicentred studies looking into the cost effectiveness of ment Of Dyspepsia. Lancet 1994, 343(8901):. testing for HP using the UBT should be done. 7. American Gastroenterological Association Medical Position Statement: Evaluation of Dyspepsia. Gastroenterology 2005, 129:1753-1755. Conclusion 8. Malfertheiner P, Mégraud F, O'Morain C, Hungin APS, Jones R, Axon A, Graham DY, Tytgat G, The European Helicobacter Pylori Study Based on this study, the prevalence of HP related dyspep- Group (EHPSG): Current concepts in the management of H. sia among adult patients attending a primary care centre is Pylori infection. The Maastricht 2–2000 Concensus Report. 23.5% using the UBT. The treatment response using erad- Alimentary Pharmacology & Therapeutics 2002, 16:167-80. 9. Arent NL, Jacob T, Van Zwet, Anton A, Poul MO, Gotz JM, Werf G ication regime (with Omeprazole, Calrithromycin and Van de, Reenders K, Sluiter W, Kleibeuker J: Approach to treat- Amoxycillin for one week) showed encouraging response ment of Dyspepsia in Primary Care: A Randomized Trial with only 4.3% (1/23) requiring endoscopy. Comparing "Test and Treat " with prompt Endoscopy. Archives Internal Medicine 2003, 163(13):1606-1612. 10. NIH Consensus Development Panel on Helicobacter Pylori UBT should be an option for detection of HP related dys- in Peptic Ulcer Disease. JAMA 1994, 272(1):65-69. 11. Talley NJ, Axon A, Bytzer P, et al.: Management of uninvestigated pepsia in primary care setting based on its non invasive, and functional dyspepsia and working party report for the high patient acceptance and highly sensitive features. World Congress of Gasteroenterology 1998. Alimentary Phar- macology & Therapeutics 1998, 13:1135-48. 12. Lam SK, Talley NJ: Report for the 1997 Asia Pacific. Consensus Competing interests Guidelines on the management of H. pylori. Journal Gasteroen- The authors declare that they have no competing interests. terology & Hepatology 1998, 13:1-2. 13. Malaysian Academy of Medicine Consensus on Management of Peptic Ulcer Disease 1996 [http://www.acadmed.org.my]. Authors' contributions 14. McColl KEL, El-Nujumi A, Murray LS, El-omar EM, Dickson A, Kelman AFAA participated in the design and coordination and AW, Hilditch TE: Assessment of symptomatic response as pre- dictor of Helicobacter pylori status following eradication drafted the manuscript. therapy in patients with ulcer. Gut 1998, 42(5):618-620. 15. Rolan A, Giancaspero R: Long term reinfection rate and the ZH conceived the study, carried out the clinical trial, per- course of duodenal ulcer disease after eradication of Helico- bacter pylori in a developing countries. American Journal of Gas- formed the statistical analysis and helped to draft the teroenterology 2000, 95:50-56. manuscript. 16. Goh KL, Parasakhti N: The racial cohort phenomenon; seroep- idemiology of helicobacter pylori infection in a multiracial South East Asia country. European Journal of Gasteroenterology & NS participated in the design, coordinated and performed Hepatology 2001, 13:177-18. the Endoscopy studies. SEWP and TSF participated in the design of the study and statistical analysis. All authors read and approved the final manuscript. Acknowledgements We wish to thank Dean and Director of UKM Medical Centre for permis- sion to publish and all the staffs of UKMMC Primary Care Centre and the Endoscopy Unit for participating in this study We would also like to thank the original authors of the Modified or Abbre- viated Glasgow Dyspepsia Severity Score (McColl and colleagues) for the use of this instrument during this study. References Publish with Bio Med Central and every 1. Talley NJ, Vakil NB, Moayyedi P: American Gastroenterological scientist can read your work free of charge Association Technical Review: Evaluation of Dyspepsia. Gas- teroenterology 2005, 129:1756-1780. "BioMed Central will be the most significant development for 2. Talley NJ: Management guidelines for the millennium. Gut disseminating the results of biomedical researc h in our lifetime." 2002, 50(Suppl IV):iv72-78. Sir Paul Nurse, Cancer Research UK 3. Sander JO, Veldhuyzen Van Zanten , Flook Nl, Chiba N, Armstrong D, Barlum A, Bourdette : An evidence based approach to the Your research papers will be: management of untreated dyspepsia in era of HP. CMAJ 2000, available free of charge to the entire biomedical community 162(90120):. 4. Talley NJ: Dyspepsia and heartburn: a clinical challenge. Ali- peer reviewed and published immediately upon acceptance mentary Pharmacology & Therapeutics 1997, 11(suppl 2):1-8. cited in PubMed and archived on PubMed Central 5. Kurata JH, Nogawa AN, Chen YK, Parker CE: Dyspepsia in pri- mary care: perceived causes, reason for improvement and yours — you keep the copyright satisfaction with care. Journal of Family Practice 1997, 44:281-8. BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 5 of 5 (page number not for citation purposes)

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Asia Pacific Family MedicineSpringer Journals

Published: May 12, 2009

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