Cost-effectiveness of alginic acid in combination with proton pump inhibitor for the treatment of gastroesophageal reflux disease in systemic sclerosis patients.

BACKGROUND: Systemic sclerosis (SSc) patients often become refractory to proton pump inhibitors (PPI)-a standard treatment for gastroesophageal reflux disease (GERD)-and intolerant to PPI in combination with domperidone. PPI with alginic acid is an alternative treatment option, but alginic acid is costly. OBJECTIVES: We compared the costs and effectiveness of alginic acid plus PPI versus standard treatments (PPI with/without antacids as needed and lifestyle modifications) for GERD in SSc patients unsuitable for, or intolerant to, domperidone. METHODS: An economic evaluation using the Markov model was conducted among SSc patients aged between 40 and 65 years with GERD, having a partial or non-response to 4 weeks of standard-dose omeprazole (40 mg/day) and being unsuitable for or intolerant to domperidone. Using a societal perspective, we computed the incremental cost-effectiveness ratios (ICERs) in terms of Thai baht (THB) per quality-adjusted life-year (QALY) between a combination of alginic acid plus PPI and standard treatment for GERD. The lifetime time horizon was used. RESULTS: The ICER for alginic acid plus PPI versus standard treatments was 377 101 THB/QALY. According to the one-way sensitivity analysis, the cost of alginic acid was the most impactful parameter. If the market prices of alginic acid plus PPI were reduced by 61%, this treatment option would become cost-effective at the willingness-to-pay threshold of 160 000 THB/QALY (34.68 THB/USD data on 25 May 2023). Furthermore, if alginic acid were included in the public health insurance program, the national budget would be increased by 66 313 THB per patient, resulting in an overall budget increase of 5 106 101 to 8 885 942 THB compared with the standard treatment. CONCLUSIONS: Alginic acid plus PPI does not represent good value for money compared with the standard treatment among such SSc patients in Thailand unless its price is reduced significantly.

Incidence and Predictors of an Abnormal Liver Function Test Among 674 Systemic Sclerosis Patients: A Cohort Study.

Background: Abnormal liver function tests (LFTs) can indicate cirrhosis or liver cancer leading to mortality among systemic sclerosis (SSc) patients. No recent studies have investigated the clinical predictors of an abnormal LFT in SSc. We aimed to determine the incidence of abnormal LFT (including from hepatitis and cholestasis) and to identify its clinical predictors in SSc patients. Methods: An historical cohort was conducted on 674 adult SSc patients who attended the Scleroderma Clinic, Khon Kaen University, between January 2012 and November 2019 and who underwent routine screening for LFT. A Cox regression was used to analyze the clinical predictors of abnormal LFT. Results: Four hundred and thirty cases, representing 4190 person-years, had abnormal LFTs (viz, from hepatitis, cholestasis, and cholestatic hepatitis) for an incidence rate of 10.2 per 100 person-years. The respective incidence of hepatitis, cholestasis, and cholestatic hepatitis was 20.5, 12.9, and 20.4 per 100 person-years. The respective median first-time detection of hepatitis, cholestasis, and cholestatic hepatitis was 3.0, 5.9, and 2.8 years, and none had signs or symptoms suggestive of liver disease. According to the Cox regression analysis, the predictors of an abnormal LFT in SSc were elderly onset of SSc (hazard ratio (HR) 1.02), alcoholic drinking (HR 1.74), high modified Rodnan Skin Score (mRSS) (HR 1.03), edematous skin (HR 2.94), Raynaud's phenomenon (HR 1.39), hyperCKaemia (HR 1.88), and methotrexate use (HR 1.55). In contrast, current sildenafil treatment (HR 0.63) and high serum albumin (HR 0.70) were protective factors. Conclusion: Occult hepatitis, cholestasis, and cholestatic hepatitis can be detected in SSc patients using LFT screening, especially in cases of early disease onset. The long-term outcome is uncertain, and more longitudinal research is required.

Prevalence and associated factors of small intestinal bacterial overgrowth among systemic sclerosis patients.

BACKGROUND: Small intestinal bacterial overgrowth (SIBO) results in nutrient malabsorption and malnutrition, thereby increasing the morbidity and mortality in systemic sclerosis (SSc) patients. OBJECTIVES: To evaluate the prevalence and associated factors of SIBO in SSc patients. METHOD: A cross-sectional study was conducted between July 2015 and January 2016 in SSc patients over 18, using the glucose H2 /CH4 breath test to evaluate SIBO. RESULTS: Eighty-nine SSc patients (30 male and 59 female) underwent the glucose H2 /CH4 breath test. The mean age was 54.4. Twelve participants were positive for the glucose H2 /CH4 breath test, yielding a SIBO prevalence of 13.5% (95% CI 7.2-22.4) among SSc patients. A multivariate analysis revealed that duration of disease >5 years was significantly associated with SIBO (adjusted odds ratio 9.38; 95% CI 1.09-80.47). CONCLUSION: The prevalence of SIBO, using the glucose H2 /CH4 breath test, is not common among Thai SSc patients. However, a positive result was associated with longer duration of disease.

Impact of Fecal Hb Levels on Advanced Neoplasia Detection and the Diagnostic Miss Rate For Colorectal Cancer Screening in High-Risk vs. Average-Risk Subjects: a Multi-Center Study.

OBJECTIVES: The Asia-Pacific Colorectal Screening (APCS) scoring system was developed to identify high-risk subjects for advanced neoplasia. However, the appropriate fecal immunochemical test (FIT) cutoff for high-risk population may be different from that of average-risk population. We aimed to evaluate the FIT performance at different cutoffs in high-risk subjects undergoing colorectal cancer (CRC) screening. METHODS: We prospectively enrolled asymptomatic subjects aged 50-75 years. Using the APCS score, subjects were stratified into either the average-risk or high-risk groups. All subjects were tested with one-time quantitative FIT and underwent colonoscopy. We compared the FIT performance for advanced neoplasia between two groups using different cutoffs (5 (FIT5), 10 (FIT10), 20 (FIT20), 30 (FIT30), and 40 (FIT40) µg Hb/g feces). RESULTS: Overall, 1,713 subjects were recruited, and 1,222 (71.3%) and 491 (28.7%) were classified as average-risk and high-risk, respectively. Advanced neoplasia was detected in 90 (7.4%) of the average-risk subjects and 65 (13.2%) of the high-risk subjects. In the high-risk group, by decreasing the cutoff from FIT40 to FIT5, the sensitivity increased by 33.8 percentage points with decreased specificity by 11 percentage points. In the average-risk group, the sensitivity increased by 20 percentage points with decreased specificity by 9.6 percentage points. At the lowest cutoff (FIT5), the number of needed colonoscopies to find one advanced neoplasia was 2.8 and 6.1 for the high-risk and average-risk groups, respectively. CONCLUSIONS: Using an appropriate FIT cutoff for CRC screening in high-risk subjects could improve CRC screening performance and reduce the unnecessary colonoscopies. To maintain high sensitivity and specificity for advanced neoplasia, the optimal cutoff FIT in the high-risk subjects should be lower than that in the average-risk subjects.

Outcomes of a Randomized Controlled Trial Comparing Modified High Dose Omeprazole and Amoxicillin Triple Therapy with Standard Triple Therapy for Helicobacter Pylori Eradication

Background: Helicobacter pylori (H. pylori) infection is related to peptic ulcer diseases and gastric cancer and eradication of H. pylori should be expected to decrease the risk of their development. Factors affecting H. pylori eradication are antibiotic resistance, CYP2C19 genotypes, drug regimen and patient compliance. Increment of omeprazole and amoxicillin dosage in clarithromycin-containing triple therapy regimen may overcome these problems and may be a better choice than the conventional clarithromycin-containing triple therapy regimen. Objective: To compare the eradication rates with modified triple therapy (MTT) and standard triple therapy (STT) as first-line treatment. Materials and Methods: The study was an open label, multicenter, randomized controlled trial. A total of 170 patients infected with H. pylori diagnosed by rapid urease test were randomly assigned into 2 groups. The first was treated with a 14-day MTT (20 mg omeprazole t.i.d., 500 mg amoxicillin t.i.d., and 500 mg clarithromycin b.i.d.) and the second with a 14-day STT (20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., and 500 mg clarithromycin b.i.d.). H. pylori eradication was evaluated by 14C-urea breath test. CYP2C19 genotypes, clarithromycin resistance, side effects and patient compliance were also recorded. Results: There were 85 patients in each group. The H. pylori eradication rate in the MTT group was 84.7% by ITT analysis and 91.1% by PP analysis, compared to the STT group values of 76.5% and 87.8% (p = 0.18 and 0.51), respectively. CYP2C19 genotypes and patient compliance were similar in both groups. Prevalence of clarithromycin resistance was 7.0%. Side effects were all mild with no significant differences between the twogroups. Conclusions: MTT is not superior to STT. From this study, MTT may not be recommended as the first-line treatment for H. pylori infection in Thailand because eradication rates proved to be less than 90% by ITT analysis.

The Optimal Cut-Off Level of The Fecal Immunochemical Test For Colorectal Cancer Screening in a Country with Limited Colonoscopy Resources: A Multi-Center Study from Thailand

Background: Selecting the cut-off point for the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening programs is of prime importance. The balance between the test performance for detecting advanced neoplasia and the available colonoscopy resources should be considered. We aimed to identify the optimal cut-off of FIT for advanced neoplasia in order to minimize colonoscopy burden. Methods: We conducted a multi-center study in 6 hospitals from diverse regions of Thailand. Asymptomatic participants, aged 50-75 years, were tested with one-time quantitative FIT (OC-SENSOR, Eiken Chemical Co.,Ltd., Tokyo, Japan) and all participants underwent colonoscopy. We assessed test performance in detecting advanced neoplasia (advanced adenoma and CRC) and measured the burden of colonoscopy with different cut-offs [25 (FIT25), 50 (FIT50), 100 (FIT100), 150 (FIT150), and 200 (FIT200)ng/ml]. Results: Among 1,479 participants, advanced neoplasia and CRC were found in 137 (9.3%) and 14 (0.9%), respectively. From FIT25 to FIT200, the positivity rate decreased from 18% to 4.9%. For advanced neoplasia, an increased cut-off decreased sensitivity from 42.3% to 16.8% but increased specificity from 84.2% to 96.3%. The increased cut-off increased the positive predictive value (PPV) from 21.5% to 31.5%. However, all cut-off points provided a high negative predictive value (NPV) (>90%). For CRC, the miss rate for FIT25 to FIT 150 was the same (n=3, 21%), whereas that with FIT200 increased to 35% (n=5). Conclusions: In a country with limited-colonoscopy resources, using FIT150 may be preferred because it offers both high PPV and NPV for advanced neoplasia detection. It could also decrease colonoscopy workload, while maintaining a CRC miss rate similar to those with lower cut-offs.

Three Human Gnathostomiasis Cases in Thailand with Molecular Identification of Causative Parasite Species.

Human gnathostomiasis is one of the important food-borne parasitic zoonoses. The disease is caused by a spirurid roundworm of the genus Gnathostoma. Here, we describe three parasitological confirmed cases of human gnathostomiasis, caused by Gnathostoma spinigerum, in a hospital in Thailand during 2004-2012. Clinical characteristics, treatment, and outcome of cases were revealed. Parasites were accidentally recovered from patients and morphologically identified as Gnathostoma species. Confirmed diagnosis and identification of causative parasite species was made by DNA extraction of the recovered worms, followed by a polymerase chain reaction (PCR) of the second internal transcribed spacer region (ITS2) of DNA and the partial cytochrome c oxidase subunit 1 (cox-1) gene. Sequences corresponding to ITS2 and cox-1 were similar to G. spinigerum. To our knowledge, this study represents the first molecular confirmation that recovered G. spinigerum is a causative agent of human infection in Thailand.

Cost utility analysis of endoscopic biliary stent in unresectable hilar cholangiocarcinoma: decision analytic modeling approach.

BACKGROUND/AIMS: Endoscopic biliary drainage using metal and plastic stent in unresectable hilar cholangiocarcinoma (HCA) is widely used but little is known about their cost-effectiveness. This study evaluated the cost-utility of endoscopic metal and plastic stent drainage in unresectable complex, Bismuth type II-IV, HCA patients. METHODOLOGY: Decision analytic model, Markov model, was used to evaluate cost and quality-adjusted life year (QALY) of endoscopic biliary drainage in unresectable HCA. Costs of treatment and utilities of each Markov state were retrieved from hospital charges and unresectable HCA patients from tertiary care hospital in Thailand, respectively. Transition probabilities were derived from international literature. Base case analyses and sensitivity analyses were performed. RESULTS: Under the base-case analysis, metal stent is more effective but more expensive than plastic stent. An incremental cost per additional QALY gained is 192,650 baht (US$ 6,318). From probabilistic sensitivity analysis, at the willingness to pay threshold of one and three times GDP per capita or 158,000 baht (US$ 5,182) and 474,000 baht (US$ 15,546), the probability of metal stent being cost-effective is 26.4% and 99.8%, respectively. CONCLUSIONS: Based on the WHO recommendation regarding the cost-effectiveness threshold criteria, endoscopic metal stent drainage is cost-effective compared to plastic stent in unresectable complex HCA.

Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma.

Hilar cholangiocarcinoma (HCCA) is one of the most common types of hepatobiliary cancers reported in the world including Asia-Pacific region. Early HCCA may be completely asymptomatic. When significant hilar obstruction develops, the patient presents with jaundice, pale stools, dark urine, pruritus, abdominal pain, and sometimes fever. Because no single test can establish the definite diagnosis then, a combination of many investigations such as tumor markers, tissue acquisition, computed tomography scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography, endoscopic ultrasonography/intraductal ultrasonography, and advanced cholangioscopy is required. Surgery is the only curative treatment. Unfortunately, the majority of HCCA has a poor prognosis due to their advanced stage on presentation. Although there is no survival advantage, inoperable HCCA managed by palliative drainage may benefit from symptomatic improvement. Currently, there are three techniques of biliary drainage which include endoscopic, percutaneous, and surgical approaches. For nonsurgical approaches, stent is the most preferred device and there are two types of stents i.e. plastic and metal. Type of stent and number of stent for HCCA biliary drainage are subjected to debate because the decision is made under many grounds i.e. volume of liver drainage, life expectancy, expertise of the facility, etc. Recently, radio-frequency ablation and photodynamic therapy are promising techniques that may extend drainage patency. Through a review in the literature and regional data, the Asia-Pacific Working Group for hepatobiliary cancers has developed statements to assist clinicians in diagnosing and managing of HCCA. After voting anonymously using modified Delphi method, all final statements were determined for the level of evidence quality and strength of recommendation.

Hospitalized incidence and outcomes of upper gastrointestinal bleeding in Thailand.

BACKGROUND: Upper gastrointestinal bleeding (UGIB) is a common emergency gastrointestinal problem which has substantial mortality and health care resources use. The nationwide basic information on UGIB is not available in Thailand. OBJECTIVE: To identify the hospitalized incidence, outcomes and hospitalization cost of patients who presented with UGIB in Thailand. MATERIAL AND METHOD: Information on illness of in-patients from hospitals nationwide was retrieved from three major health schemes database in fiscal year 2010. RESULTS: The hospitalized incidence rate of UGIB was 166.3 admissions per 100,000 populations and the hospitalized incidence rate of non-variceal upper gastrointestinal bleeding (NVUGIB) and variceal bleeding were 152.9 and 13.5 admissions per 100,000 populations respectively. Endoscopic procedure was undertaken in 27.6% of NVUGIB admissions and 80.7% of variceal bleeding admissions. The in-hospital mortality rate, hospitalization cost and length of stay were higher in variceal bleeding patients compared with NVUGIB patients. CONCLUSION: UGIB is an important emergency gastrointestinal problem which has significant mortality and substantial health care resources consumption.

PCR-RFLP and antimicrobial susceptibility profiles of Helicobacter pylori isolated from antrum and corpus of dyspeptic patients in Thailand.

The study determined the genetic heterogeneity of Helicobacter pylori isolates from antrum and corpus of the same dyspeptic patients in a Thai population and determined the relationship between the antimicrobial susceptibility (AS) profile (antibiogram) and PCR-restriction fragment length polymorphism (PCR-RFLP) pattern. One hundred and nineteen H. pylori isolates comprising 7 single and 56 paired antrum and corpus isolates obtained by gastric biopsy from 160 dyspeptic patients were analyzed. For PCR-RFLP, the 820 bp amplicon of ureC was digested with Sau3AI and HhaI, which revealed 16 (A-Q) and 19 (a- s) different PCR-RFLP patterns after Sau3AI and HhaI digestion, respectively. Combination of the restriction enzyme digestion patterns resulted in 35 distinct RFLP types. Among the 56 paired isolates, 47 were infected with H. pylori having the same AS and PCR-RFLP profiles, 7 with different AS profiles but the same PCR-RFLP profiles and 2 with different PCR-RFLP profiles but the same AS profiles. No patient was infected with H. pylori different in both PCR-RFLP and AS profiles. The results indicate that the majority of the paired H. pylori isolates displayed identical AS profile and PCR-RFLP patterns suggesting that most patients were infected with a single strain. Some patients could have been infected with single strains that were different in the AS profiles.

Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial.

BACKGROUND: Endoscopic biliary stent drainage is effective in the palliative treatment of patients with hilar cholangiocarcinoma (HCA). However, no randomized controlled trial comparing the efficacy of the self-expandable metal stent (SEMS) and the plastic stent (PS) in patients with unresectable complex HCA is available. OBJECTIVE: To compare the successful drainage rates of endoscopic SEMSs and PSs. DESIGN: A single-center, open-label randomized controlled trial. SETTING: University hospital in KhonKaen, Thailand. PATIENTS: One hundred eight patients with unresectable complex, Bismuth type II-IV HCA. INTERVENTIONS: Endoscopic retrograde cholangiography with unilateral SEMS or PS insertion. MAIN OUTCOME MEASUREMENTS: Successful drainage rate. LIMITATIONS: Diagnosis of HCA was made by clinical presentations, imaging studies, and clinical outcome during follow-up. RESULTS: One hundred eight patients were randomly allocated to the SEMS and PS groups. Intention-to-treat analysis revealed that the successful drainage rate in the SEMS group was higher than in the PS group (70.4% vs 46.3%, P = .011). The median survival times were 126 and 49 days, respectively, in the SEMS and PS groups. The overall survival rates of the patients in both groups were statistically different by log-rank test (P = .002). CONCLUSIONS: Endoscopic biliary drainage with the SEMS provides better adequacy of drainage and longer survival compared with the PS in patients with unresectable complex HCA.

Antimicrobial susceptibility of Helicobacter pylori isolated from gastric biopsies in dyspeptic patients.

The objective of this study was to evaluate the prevalence of antimicrobial resistance in Helicobacter pylori isolated from the antrum and corpus of dyspeptic patients in Khon Kaen, Thailand, and to compare the antimicrobial susceptibility patterns of H. pylori isolated from the antrum and corpus in individual patients. Antimicrobial susceptibility was determined by disk diffusion, studying susceptibility to metronidazole, clarithromycin, amoxicillin, erythromycin, ciprofloxacin, and tetracycline. The H. pylori resistant rate to at least one of the six antimicrobial agents tested was 37%. The resistance rates were 30.2% for metronidazole, 9.2% for ciprofloxacin, 5% for clarithromycin, 2.4% for amoxicillin, and 1.7% for erythromycin and tetracycline. Single, double, and more than double antimicrobial resistances were found in 27.7, 6.7 and 2.5%, respectively. Antimicrobial susceptibility testing revealed 11 antibiotypes. The most common antimicrobial susceptibility pattern found was sensitivity to 6 antimicrobial agents (63%). H. pylori antimicrobial resistance in specimens isolated from the antrum and corpus were nearly equivalent, 37.3% (22/59) and 36.7% (22/60), respectively. Most of the H. pylori specimens isolated from the antrum and corpus in individual patients were identical (87.7%).

Prevalence of Helicobacter pylori vacA, cagA, cagE, iceA and babA2 genotypes in Thai dyspeptic patients.

OBJECTIVES: To investigate the prevalence of the vacA, cagA, cagE, iceA, and babA2 genotypes in Helicobacter pylori strains isolated from Thai dyspeptic patients, and to determine whether any correlation exists between these genotypes and clinical manifestations. METHODS: Helicobacter pylori was examined in 112 patients (62 with non-ulcer dyspepsia (gastritis), 34 with peptic ulcer disease, and 16 with gastric cancer (GCA)), detected by culture or direct detection from gastric biopsies. Allelic variants of the vacA, cagA, cagE, iceA, and babA2 genotypes were identified by using the polymerase chain reaction. RESULTS: The positive rates for the vacAs1, vacAs2, cagA, cagE, iceA1, iceA2, and babA2 genes in H. pylori of dyspeptic patients were 100%, 0%, 98.2%, 88.4%, 45.5%, 33.1%, and 92%, respectively. The allelic variant vacAs1m1 was more prevalent (58%) than vacAs1m2 (42%). The cagA and cagE genes were commonly found together (87.5%). The most predominant genotypes were vacAs1m1, cagA, cagE, iceA1, and babA2. The various genes alone or in combination had no statistically significant association with the clinical outcomes (p>0.05). CONCLUSION: Neither single gene nor combination of vacA, cagA, cagE, iceA, and babA2 genes was significantly helpful in predicting the clinical outcome of H. pylori infection in Thai patients. The high prevalence of these genes in H. pylori isolated from Thai patient groups suggests that H. pylori strains are geographically dependent.

The endoscopic-pathologic findings in intestinal capillariais: a case report.

A 27-year-old Thai man presented with chronic watery diarrhea for 2 years. The diagnosis of capillariasis was made by enteroscopy after negative repeated stool tests. Here, the authors reported the first case of abnormal endoscopic finding of intestinal capillariasis. It showed segmental erythematous and swelling of proximal jejunal mucosa with an area of superficial erosion covered by exudates. The parasitic eggs were identified in jejunal content and worms were identified in jejunal mucosa. He was successfully treated with albendazole.

Sensitivity and specificity of an in-house rapid urease test for detecting Helicobacter pylori infection on gastric biopsy.

We developed an in-house rapid urease test (iRUT) and evaluated the efficacy and the agreement of the iRUT and the cRUT compared with culture and histology for the detection of H. pylori infection. Five iRUT media were tested with H. pylori isolates and other bacteria. The most suitable iRUT medium was further evaluated for detection of H. pylori infection. Gastric biopsies from 120 patients were diagnosed by culture, iRUT, cRUT and histology. The results of the iRUT and cRUT were read at 30 minutes, 1 hour and up to 24 hours. A true positive result was either the culture or both the RUT (cRUT or iRUT) and the histological examination being positive. The sensitivity and specificity of the iRUT result at 30 minutes, 1 hour and up to 24 hours were 77.1% and 100%, 77.6% and 100%, and 94.1% and 94.2%, respectively. Values for the same parameters of cRUT were 87.5% and 100%, 89.8% and 100%, and 100% and 94.2%, respectively. The agreement between the iRUT and cRUT was very good (kappa values > or = 0.82). Our results indicate that the iRUT is a-sensitive, specific and cost effective test. It can be appropriately applied for detecting H. pylori infection in gastric biopsy specimens.

Outward migration of Gnathostoma spinigerum in interferon alpha treated hepatitis C patient.

After the first dose injection of pegylated interferon alpha-2b (Peg-IFN alpha-2b) to a HCV infected Thai woman, she developed cyclic painful swelling nodules on right upper quadrant of abdomen and right anterior lower chest wall. The nodules subsided spontaneously within 1-2 days but were recurrent after every Peg-IFN alpha-2b injection. She also experienced acute urticaria. After nine months of therapy, an immature male of G. spinigerum migrated out from the skin nodule shortly after a Peg-IFN alpha-2b injection as scheduled. The worm showed a head-bulb bearing 8 transverse rows of spines which indicated immature stage. It had well defined four pairs of caudal papillae on posterior body part which were used to identify male gender. Painful migratory swelling and urticaria disappeared after the parasite was removed. She was continually treated and had sustained both virological and biochemical responses to HCV treatment. This case demonstrates that the outward migration of G. spinigerum may be stimulated by the injection of Peg-IFN alpha-2b.

Enzyme-linked immunosorbent assay for serodiagnosis of Helicobacter pylori in dyspeptic patients and volunteer blood donors.

Helicobacter pylori, an important etiological agent in the development of gastritis, peptic ulcer and gastric carcinoma, can be detected by the enzyme-linked immunosorbent assay (ELISA). Our objectives were: (1) to evaluate the efficacy of a commercial ELISA kit (Pyloriset EIA-G III) in sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for diagnosis of H. pylori infection in Thai dyspeptic patients in Khon Kaen Thailand; and (2) to examine the seroprevalence of H. pylori among blood donors at Srinagarind Hospital's Blood Bank, Khon Kaen University, by the commercial ELISA. Gastric biopsies obtained from 137 dyspeptic patients were diagnosed by culture, rapid urease test (RUT) and histology. Serum samples from the same dyspeptic patients and 100 healthy blood donors were assayed using the commercial ELISA. H. pylori infection in dyspeptic patients was considered positive when the culture or both RUT and histology were positive. Using a cut-off value at a titer of 20 U/ml (as recommended by the manufacturer), we found the commercial ELISA kit had a sensitivity of 93.3%, specificity of 75.3%, PPV of 74.7%, NPV of 93.5% and accuracy of 83.2%. The overall H. pylori seroprevalence in the healthy blood donors was 57%. Of the 100 healthy blood donors, 39 (60.9%) of the males and 18 (50.0%) of the females were seropositive.

Detection of H. pylori in dyspeptic patients and correlation with clinical outcomes.

The objectives of this study were to evaluate the methods used to diagnose Helicobacter pylon infection in gastric biopsies, and to evaluate the correlation between H. pylori infection and clinical outcomes. Gastric biopsies, obtained from 210 patients, were evaluated for H. pylori by culture, a commercial rapid urease test (RUT, Pronto Dry) and histological examination. A true positive result was either the culture or both the RUT and histological examination were positive. The results showed a H. pylori infection rate of 44.3% (93/210). The sensitivities, specificities, positive predictive values and negative predictive values were 88.2, 100, 100, and 91.4 % by the culture; 95.7, 98.3, 97.8, and 96.6% by RUT; and 96.8, 59.8, 59.8, and 65.7% by histological examination, respectively. The prevalences of H. pylori in non-ulcer dyspepsia (NUD), peptic ulcer dyspepsia (PUD) and gastric cancer (GCA) patients were 41.2, 57.9 and 70.6%, respectively. The chi-squared-test showed that GCA patients were significantly more frequent infected with H. pylori than NUD patients (p<0.05). Our study indicates that the RUT method was highly sensitive, specific and appropriate for routine clinical use.