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Ten day triple therapy with ranitidine bismuth citrate (RBC), amoxicillin and clarithromycin in the eradication of H. pylori
Esophageal, Gastric, and Duodenal Disorders A317
April 1998 Group B (~-+SE, 56-+5.1 yrs). CONCLUSIONS: 1) Lack of symptom improvement post-PD is strongly associated with poor esophageal emptying. 2) In contrast, 31% of patients with near total resolution of symptoms continue to show poor esophageal emptying. 3) As a group, these patients are older, suggesting a possible disturbance in visceral sensation. 4) Serial barium esophagrams to assess esophageal emptying may help better guide future therapy in patients with achalasia. S y m p t o m Improvement (%) < 50 < 50 Barium Drainage 50-90 Improvement
(%)
50-90
m nffil7
91-100 GroupA
n ffi 8
N
Test
nffi5 GroupB •
91-100
nffil6 • G1295 A NOVEL "ANTIGEN" ASSAY BASED ON STOOL SPECIMEN FOR THE DETECTION AND THE FOLLOW-UP OF H E L I C O B A C T E R P Y L O R I . PRELIMINARY REPORT. D Vaira., M Menegatti, C Acciardi, F Landi, C Ricci, B Massardi, F Mucci, M Miglioli. 1st Medical Clinic, Bologna, Italy. The aims of the present study were 1- to assess the reliability of a newly deloped assay for detection of H pylori infection in stools, HpSA (Premier Platinum HpSA, Meridien Diagnostics, Inc, River Hills Drive, Cincinnati, OH, USA) compared to standardized techniques as Giemsa, rapid urease test and culture, in antrum and in corpus and 13C UBT; 2- to evaluate the usability of HpSA in determining H pylori status after treatment. METHODS: In the last five weeks, stool specimens from 65 consecutive patients (M/F: 37128; age range 22-82 years, mean 52 years) referred to our Clinic for upper gastrointestinal endoscopy (no previous assumption of anti H pylori treatment or of any antibiotic therapy over the last 4 months as well as gastric resection) were tested. At endoscopy antral (A)(n=2) and corpus (C) (n=2) biopsies were taken for histology (Hematoxilin & Eosin and Giemsa stain), culture (A:n=l; C: n=l), CLO test (A:n=l; C: n=l). Patients also undergo 13C UBT. H pylori status was determined by the concordance 3 out of 4 tests positive. H pylori positive patients have been followed up after four weeks stopping eradication treatment. A second endoscopy with similar sampling as above was performed plus 13C UBT and HpSA. The HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for detection of H pylori antigens in human stools; the cut-off for the test, defined as Optical Density at 450nm, was 0.130. RESULTS: Table 1 shows the results according to the different tests performed.
HP + ve HP - ve
Clo A 43 22
Clo C 43 22
Col [ Col A IC 40 40 25 25
Methods: 42 patients with acute upper gastrointestinal bleeding (41 duedenal ulcer, 1 gastric ulcer) were prospectively studied. All patient had bled within the previous 24 hours and were undergoing diagnostic/therapeutic endoscopy and all had blood in the upper gastrointestinal tract. None were taking proton pump inhibitors prior to the bleed. The following tests were performed: a. Rapid urease test from a single antral biopsy b. Rapid urease test from a corpus biopsy c. Histology from the antrum d. Histology from the corpus and e. Serology (validated ELISA). The gold standard for a positive test was a combination of 2 positive tests from different categories (i.e. RUT+histology, RUT+ serology, serology+histology). Results: 42 patients were studied. 28 patients were positive for H pylori using the gold standard described above (67%). Of these 28 patients 7 (25%) were negative by the antral rapid urease test and 8 were negative by the corpus rapid urease test (28%, n.s.). Three of 28 patients were negative by antra/histology (11%) and 7 were negative by corpus histology (25%,p < 0.05). The positive and negative predictive values for tests are shown below:
Giemsa I Giemsa HpSA 13CUBT A IC 30 rain 43 [ 43 44 43 22 [ 22 21 22 m
The sensitivity and specificity of the HpSA stool test were: 98% and 96% respectively Interestingly although six patients only were at the moment available at the follow-up assessment, in the three eradicated patients the antingen from the stools (HpSA) has completely disappeared. On the other hand in three non eradicated patients, the antigen was found at value similar to the pre treatment base line. CONCLUSION: the HpSA stool assessment was found to be extremely sensitive and specific for H pylori diagnosis, and it seems promising for monitoring H pylori determination after treatment. • G1296 DIAGNOSTIC TESTS FOR H . P Y L O R I INFECTION IN ACUTE UPPER GASTROINTESTINAL HEMORRHAGE. N Vakil, AF Cutler, C Breitkreutz, A Affi, N Bethge. Univ. of Wisconsin, Milwaukee, WI. Sinai Hospital Detroit, MI, Krankenhaus Neukolln, Berlin, Germany. Rapid urease tests are frequently negative in patients with acute gastrointestinal hemorrhage but the cause is unknown. We have shown previously that blood accelerates the urease reaction and does not result in false negative urease tests in vitro. The aim of this study was to determine (a) the predictive value of diagnostic tests for H. pylori in acute upper gastrointestinal bleeding and (b) to test the hypothesis that false negative rapid urease tests are caused by a pH dependent autolysis of H. pylori due to blood in the antrum. In this case corpus biopsies would be more reliable.
Serology Histology Corpus Histology Antrum Rapid Urease test Corpus Rapid Urease test Antrum
Positive Predictive Value (%) 84 86 96 100 100
Negative Predictive Value (%) 100 53 81 58 67
Conclusions: (1) A combination of the rapid urease test and serology provides the best yield for the diagnosis of H pylori infection. (2) If the rapid urease test is negative a serologic test should always be performed. (3) Tests performed in the corpus are not more sensitive than tests in the antrum in gastrointestinal bleeding. This argues against a mechanism based on selective autolysis in the gastric antrum. G1297 TEN DAY TRIPLE THERAPY WITH RANITIDINE BISMUTH CITRATE (RBC), AMOXICILLIN AND CLARITHROMYCIN IN THE ERADICATION OF H . P Y L O R L N. Vakil AF Cutler. University of Wisconsin, Milwaukee WI, Sinai Hospital, Wayne State University, Detroit MI. Triple therapies have been shown to have high cure rates in H. pylori infection. Fourteen-day therapy with ranitidine bismuth citrate, amoxicillin and clarithromycin has been shown to have a high H. pylori eradication rate ( > 90%) and has the advantage of being a simple, twice daily regimen. The aim of this study was to determine the H. pylori eradication rate of a ranitidine bismuth citrate based triple regimen of shorter duration (10 days). Shorter durations of therapy, if effective, could enhance compliance and reduce costs. Method: Dyspepic patients who had a positive baseline 13 C Urea breath test and either a positive antral rapid urease test or positive IgG serology were studied. Treatment consisted of Ranitidine bismuth citrate 400 mg, clarithromycin 500 mg and amoxicillin 1 gram all given bid for 10 days. Eradication was determined 4 weeks or more after completion of therapy by the 13C urea breath test (enrichment < 2.4%). Results are expressed for modified intent to treat (all patients who took more than 1 dose of the drug) and per protocol (major protocol violators excluded). Results: 74 patients (30 males and 44 females) with a mean age of 47 -+ 2 yr. were enrolled. Two patients withdrew after randomization without having taken any medication and are not included in the analysis. 61 patients completed the protocol and 9 patients did not return for follow-up, 1 breath test is pending. Treatment was well tolerated with only 1 patient discontinuing therapy after a single dose of medication. Forty seven of 61 patients had successful eradication of H. pyloti and the per protocol eradication rate was 77% (95% confidence intervals=65-87%). Modified intent to treat eradication rate was 66% (95% confidence intervals=54-77%). Conclusions: Ten day, twice daily therapy with Ranitidine bismuth citrate, amoxicillin and clarithromycin is effective in eradication of H. pylori. Fourteen day therapy may be preferable because of the higher eradication rates. Funded by Glaxo-Wellcome
April 1998 Group B (~-+SE, 56-+5.1 yrs). CONCLUSIONS: 1) Lack of symptom improvement post-PD is strongly associated with poor esophageal emptying. 2) In contrast, 31% of patients with near total resolution of symptoms continue to show poor esophageal emptying. 3) As a group, these patients are older, suggesting a possible disturbance in visceral sensation. 4) Serial barium esophagrams to assess esophageal emptying may help better guide future therapy in patients with achalasia. S y m p t o m Improvement (%) < 50 < 50 Barium Drainage 50-90 Improvement
(%)
50-90
m nffil7
91-100 GroupA
n ffi 8
N
Test
nffi5 GroupB •
91-100
nffil6 • G1295 A NOVEL "ANTIGEN" ASSAY BASED ON STOOL SPECIMEN FOR THE DETECTION AND THE FOLLOW-UP OF H E L I C O B A C T E R P Y L O R I . PRELIMINARY REPORT. D Vaira., M Menegatti, C Acciardi, F Landi, C Ricci, B Massardi, F Mucci, M Miglioli. 1st Medical Clinic, Bologna, Italy. The aims of the present study were 1- to assess the reliability of a newly deloped assay for detection of H pylori infection in stools, HpSA (Premier Platinum HpSA, Meridien Diagnostics, Inc, River Hills Drive, Cincinnati, OH, USA) compared to standardized techniques as Giemsa, rapid urease test and culture, in antrum and in corpus and 13C UBT; 2- to evaluate the usability of HpSA in determining H pylori status after treatment. METHODS: In the last five weeks, stool specimens from 65 consecutive patients (M/F: 37128; age range 22-82 years, mean 52 years) referred to our Clinic for upper gastrointestinal endoscopy (no previous assumption of anti H pylori treatment or of any antibiotic therapy over the last 4 months as well as gastric resection) were tested. At endoscopy antral (A)(n=2) and corpus (C) (n=2) biopsies were taken for histology (Hematoxilin & Eosin and Giemsa stain), culture (A:n=l; C: n=l), CLO test (A:n=l; C: n=l). Patients also undergo 13C UBT. H pylori status was determined by the concordance 3 out of 4 tests positive. H pylori positive patients have been followed up after four weeks stopping eradication treatment. A second endoscopy with similar sampling as above was performed plus 13C UBT and HpSA. The HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for detection of H pylori antigens in human stools; the cut-off for the test, defined as Optical Density at 450nm, was 0.130. RESULTS: Table 1 shows the results according to the different tests performed.
HP + ve HP - ve
Clo A 43 22
Clo C 43 22
Col [ Col A IC 40 40 25 25
Methods: 42 patients with acute upper gastrointestinal bleeding (41 duedenal ulcer, 1 gastric ulcer) were prospectively studied. All patient had bled within the previous 24 hours and were undergoing diagnostic/therapeutic endoscopy and all had blood in the upper gastrointestinal tract. None were taking proton pump inhibitors prior to the bleed. The following tests were performed: a. Rapid urease test from a single antral biopsy b. Rapid urease test from a corpus biopsy c. Histology from the antrum d. Histology from the corpus and e. Serology (validated ELISA). The gold standard for a positive test was a combination of 2 positive tests from different categories (i.e. RUT+histology, RUT+ serology, serology+histology). Results: 42 patients were studied. 28 patients were positive for H pylori using the gold standard described above (67%). Of these 28 patients 7 (25%) were negative by the antral rapid urease test and 8 were negative by the corpus rapid urease test (28%, n.s.). Three of 28 patients were negative by antra/histology (11%) and 7 were negative by corpus histology (25%,p < 0.05). The positive and negative predictive values for tests are shown below:
Giemsa I Giemsa HpSA 13CUBT A IC 30 rain 43 [ 43 44 43 22 [ 22 21 22 m
The sensitivity and specificity of the HpSA stool test were: 98% and 96% respectively Interestingly although six patients only were at the moment available at the follow-up assessment, in the three eradicated patients the antingen from the stools (HpSA) has completely disappeared. On the other hand in three non eradicated patients, the antigen was found at value similar to the pre treatment base line. CONCLUSION: the HpSA stool assessment was found to be extremely sensitive and specific for H pylori diagnosis, and it seems promising for monitoring H pylori determination after treatment. • G1296 DIAGNOSTIC TESTS FOR H . P Y L O R I INFECTION IN ACUTE UPPER GASTROINTESTINAL HEMORRHAGE. N Vakil, AF Cutler, C Breitkreutz, A Affi, N Bethge. Univ. of Wisconsin, Milwaukee, WI. Sinai Hospital Detroit, MI, Krankenhaus Neukolln, Berlin, Germany. Rapid urease tests are frequently negative in patients with acute gastrointestinal hemorrhage but the cause is unknown. We have shown previously that blood accelerates the urease reaction and does not result in false negative urease tests in vitro. The aim of this study was to determine (a) the predictive value of diagnostic tests for H. pylori in acute upper gastrointestinal bleeding and (b) to test the hypothesis that false negative rapid urease tests are caused by a pH dependent autolysis of H. pylori due to blood in the antrum. In this case corpus biopsies would be more reliable.
Serology Histology Corpus Histology Antrum Rapid Urease test Corpus Rapid Urease test Antrum
Positive Predictive Value (%) 84 86 96 100 100
Negative Predictive Value (%) 100 53 81 58 67
Conclusions: (1) A combination of the rapid urease test and serology provides the best yield for the diagnosis of H pylori infection. (2) If the rapid urease test is negative a serologic test should always be performed. (3) Tests performed in the corpus are not more sensitive than tests in the antrum in gastrointestinal bleeding. This argues against a mechanism based on selective autolysis in the gastric antrum. G1297 TEN DAY TRIPLE THERAPY WITH RANITIDINE BISMUTH CITRATE (RBC), AMOXICILLIN AND CLARITHROMYCIN IN THE ERADICATION OF H . P Y L O R L N. Vakil AF Cutler. University of Wisconsin, Milwaukee WI, Sinai Hospital, Wayne State University, Detroit MI. Triple therapies have been shown to have high cure rates in H. pylori infection. Fourteen-day therapy with ranitidine bismuth citrate, amoxicillin and clarithromycin has been shown to have a high H. pylori eradication rate ( > 90%) and has the advantage of being a simple, twice daily regimen. The aim of this study was to determine the H. pylori eradication rate of a ranitidine bismuth citrate based triple regimen of shorter duration (10 days). Shorter durations of therapy, if effective, could enhance compliance and reduce costs. Method: Dyspepic patients who had a positive baseline 13 C Urea breath test and either a positive antral rapid urease test or positive IgG serology were studied. Treatment consisted of Ranitidine bismuth citrate 400 mg, clarithromycin 500 mg and amoxicillin 1 gram all given bid for 10 days. Eradication was determined 4 weeks or more after completion of therapy by the 13C urea breath test (enrichment < 2.4%). Results are expressed for modified intent to treat (all patients who took more than 1 dose of the drug) and per protocol (major protocol violators excluded). Results: 74 patients (30 males and 44 females) with a mean age of 47 -+ 2 yr. were enrolled. Two patients withdrew after randomization without having taken any medication and are not included in the analysis. 61 patients completed the protocol and 9 patients did not return for follow-up, 1 breath test is pending. Treatment was well tolerated with only 1 patient discontinuing therapy after a single dose of medication. Forty seven of 61 patients had successful eradication of H. pyloti and the per protocol eradication rate was 77% (95% confidence intervals=65-87%). Modified intent to treat eradication rate was 66% (95% confidence intervals=54-77%). Conclusions: Ten day, twice daily therapy with Ranitidine bismuth citrate, amoxicillin and clarithromycin is effective in eradication of H. pylori. Fourteen day therapy may be preferable because of the higher eradication rates. Funded by Glaxo-Wellcome