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Ranitidine bismuth citrate plus clarithromycin is effective in the eradication of Helicobacter pylori and prevention of duodenal ulcer relapse
A190
AGA
ABSTRACTS
GASTROENTEROLOGY,
pHMETRY FOLLOW-UP AFTER ENDOSCOPI C PNEUMATIC DILATATION FOR ACHALASIA. J. PEREZ DE LA SERNA, A. RUIZ DE LE(~N, C. SEVILLA MANTILLA, C. TAXONERA, M. DfAZRUBIO. Gastroenterology Service. HOSPITAL UNIVERSITARIO SAN CARLOS. MADRID. SPAIN. Treatment of achalasia by pneumatic dilatation (PD) reduces lower esophageal sphincter pressure (LESP) which can cause gastroesophageal reflux (GER). The aim of the study was: try to determine and compare the incidence of GER by distal esophageal pH monitoring in two periods of time, one after 3 months and the other one one year later, in order to find out if there are any differences and if there is a need to repeat the tes t in the follow-up of these patients. We have studied 32 achalasic patients (14 M, 18 F) after PD with excellent (El or good (G) resuRs (21 E, 11 G). A gastroscope and an esophagea! manometry were done on all patients before the procedure. A gastroscope, esophageal manometry and 24 H esophageal pH monitoring were done after 3 (Group II, and i 2 months later (Grout II). Results: Group I, 14 patients (40.6%) had a pathologic pH result, been symptomatic six out of them. Two patients had grade II and III esophagitis, respectively. Two other patients with mild heartburn had a normal pH result. Group II, 18 patients (56.2%) had a pathologic pH result, 4 of which (12.5%) symptomatic. The other 4 symptomatic patients had a normal pH result. There were no patients with endoscopic esophagitis in this group (group I patients with esophagitis have healed after treatment). The rate of LESP reduction of both groups in regard to the pre-dilatation values showed no difference. There were statisticallly significant differences between boths groups in respect to the total and greater than 5 rain. number of reflux episodes, and the percentage of time with pH < 4 during the supine period (p<0.05). Eight patients (25%) of Group I turned to pathologic results in the next control without reflux symptoms. On the contrary, five patients showed opposite results (from pathologic to normal). Conclusion.- 1 ) 24 H esophageal pH monitoring is useful in controlling achalasic patients after dilatation, because there is a discrepancy between symptoms and pH results~ 2) Premature controls can lead to! an erroneous diagnosis of patients that will develop reflux. 3) Probably the best time to do the pHmetry would be in around one year, in order: to identify most of the pathological results, except in patients with[ severe symptoms. 24 HOUR AMBULATORY
PREVALENCE OF HELICOBACTER PYLORI INFECTION IN SCHOOL. CHILDREN IN COUNTRIES WITH HIGH AND LOW SOClO-ECONOMIC STATUS AND DIFFERENT TRENDS IN INCIDENCE OF GASTRIC CANCER. F. Pern, M. Peelers, Y. Ghoos, B. Geypens, F. Lawson, S, Dote, B. Maes, A. Andriulli, V. Annese, P. Rutgeerts. University of Leuven. B-3000 Belgium, Cotonou. Benin, Bangalore, India and San Giovanni Rotondo. Italy. Chronic infection with Heltcobacwr pylori (Hp) is associated with a higher incidence of atrophic gastritis and possibly with gastric cancer. Aim: To study the prevalence of Hp infection in school children in 4 different countries with variable socioeconomic conditions and differing trends in incidence of gastric cancer Methods: The non-invasive and safe 13C-urea breath test was used to determine the Hp status of 1106 at random children aged between 5 and 19 years (7 age classes) and without any abdominal complaints. Results: Overall infection rate was 4.2% in Belgium, 28.9% in Italy, 80'.6% in Benin and 84.6% in India (Chi2: p<0.001). Only between India and Benin there was no significant difference. The figure gives the prevalences per age class (%). In three countries a fall in the IIp prevalet~ce in the second age class was found. 10~ so,,
.-~
I N D I A (n ffi 2 1 4 )
/.," .ff
/~.-' ""
-,.,/
~ 20,
~ ITALY
BENIN
(n = 721
24 HOUR pHMETRY PATTERN AFTER ENDOSCOPIC PNEUMATIC DILATATION FOR ACHALASIA. J. P~REZ DE LA SERNA, A. RUIZ DE LEON, C. SEVILLA MANTILLA C. TAXONERA, G. LC)PEZ-NAVA, M. DJAZ-RUBIO. Gastroenterology Service. HOSPITAL UNIVERSITARIO SAN CARLOS. MADRID. SPAIN, The AIM of the study was to evaluate the gastroesophageal reflux (GER) pattern using 24 H ambulatory pH metry in patients with achalasia after endoscopic pneumatic dilatation (PD) (RIGIFLEX, Microvasive). METHODS: In the last 6 years it has been performed 136 PD into 120 patients (p) (1.3 PD/p). From the 107 patients with excellent (E) or good (G) outcome (89.16%) it has been exc.luded : 5 P-becaus e of perforation during the procedure (3.6%), 14 p. which refuse or didn't come for further evaluation and 10 p. not yet evaluated. Then, we have studied 77 p (35 M, 42 F), (51 E, 25 G), mean age 49 (range 8-83) y. old. An esophageal manometry, upper endoscopy and 24 H pHmetry was performed between 1 and 6 months after PD (mean 3,02 0.8). RESULTS: 35 p (45.4%) had a pathological pHmetry, 19 p (24.6%) suffered heartburn, 14 of which with GER on pHmetry and 2 out of them had grade II and III esophagitis, respectively. 5 p. without pathological GER presented some peristalsis after PD; only one with pathological GER. We found 5 patterns of GER on pHmetry after PD: I) GER ur)der physiologic limits. II) High number of reflux episodes of normal duration (2 p, 2.6%). Ill) Episodes of long duration in the daytime period (9 p, 11.6%) (median 33, range 22-55). IV) Episodes of long duration in the supine period (14 p, 18.2%) (median 69, range 34240). 1 p with grade II esophagitis. V) Episodes of long duration in the day-time and supine period (10 p, 12.9%) (day-time period median 28.5, range 22-219; supine period median 92, range 20-239). 1 p with grade III esophagitis. CONCLUSION: Pathological GER is frequent after PD when studied by 24 H esophageal pH monitoring. It highlights the long duration of episodes, mainly during the supine period which can be related to the disturbed peristalsis, There is a poor correlation between symptoms,, endoscopy and 24 H pH results.
RANITIDINE BISMUTH CITRATE PLUS CLARITHROMYCIN IS EFFECTIVE IN THE ERADICATION OF HELICOBACTER PYLORI AND PREVENTION OF DUODENAL ULCER RELAPSE. WL. Peterson, SJ. Sontug, AA. Ciociola, DL. Sykes, DJ. MeSorley, DD. Webb and the H. pylori Ulcer Group. Univ. of Texas VA Medical Center, Dallas TX, VA Medical Center, Hines IL, Glaxo Inc., RTP NC. Ranitidine bismuth citrate is a novel compound with antisecretory, cyroprotective and antibelienbacter properties. The purpose of this factorialdesigned, multicenter, randomized, double-blind, placebo-controlled study was to compare the combination of ranitidine bismuth citrate (RBC) and clarithromycin (CLAR) to RBC alone, and CLAR alone, in the eradication of Helicobact~r pylori (Hp), healing of the duodenal ulcer (DU), and prevention of DU relapse. 136 Hp infected patients with an active DU were ~rcated with either RBC 4g0mg b.i.d, for four weeks plus CLAR 500rag t.Ld. for two weeks, RBC 400rag b.i.d, for four weeks plus placebo (PLC) t.i.d, for two weeks, PLC b.i.d. for four weeks plus CLAR 50grog t.i.d, for two weeks, or PLC b.i.d, for four weeks plus PLC t.i.d, for two weeks. Only patients with baseline positive culture, or positive histology, and rapid urease test (CLO) were considered Hp infected. Only patients with healed ulcers at the end of the four week treatment period were eligible to be entered into the 6 month post-treatment observation period, (ie, 84 of 136 patients). Of those 84 patients, 76 had an endoscopy performed at 1, 3 and 6 months posttrcatment and were evaluated for ulcer relapse. Patients whose ulcers were unhealed at the end of the 4 week treatment period or who did not wish to continue were dropped from the study, and given alternative therapy (ie,: 52 of 136 patients). Hp was considered eradicated if at least two ofthree tests performed 4 weeks posttreatment were negative. Any positive test classified the patient as infected. A single negative test classified the patient as unevaluable A total of 67 patients were evaluable for Hp eradication. Treatment Hp Eradication 6 Month Ulcer Relapse % (no. vatients~ % (95CI) RBC+CLAR 82% (14/17)* 20% (2.2-37.8) RBC 400rag bid 0% (0/20) 84% (67.9-100) CLAR 50grog lid 38% (8/21) 41% (21.4-60.6) PLC 0% (0/9) 87% (62.9-111) * p<0.009 as compared to all other therapies Conclusion: These results demonstrate that RBC 400mg b.i.d, when taken with CLAR 500rag t.i.d, is highly effective therapy for eradication of Hp, healing duodenal ulcers and prevention of duodenal ulcer relapse.
Methods:
Results:
8.5;10.5
10.5-12.5
12.5- 14.5
14.5-16.5
No. 4
at
In = 3421
40~
4.5-6.5 6.5"-8.5
VoI. IO8,
t6.5 - 18.5
C__onclusien: This multicenter study investigating the actual Helicobacter pylori status in an at random school population showed a good correlation between the prevalence of Hp infection and the socio-eennomic conditions. The highest prevalenoss were found in the countries (India, Benin) with low socio-economic status. Possibly this can be related to the rising incidence of gastric cancer in these 'regions.
AGA
ABSTRACTS
GASTROENTEROLOGY,
pHMETRY FOLLOW-UP AFTER ENDOSCOPI C PNEUMATIC DILATATION FOR ACHALASIA. J. PEREZ DE LA SERNA, A. RUIZ DE LE(~N, C. SEVILLA MANTILLA, C. TAXONERA, M. DfAZRUBIO. Gastroenterology Service. HOSPITAL UNIVERSITARIO SAN CARLOS. MADRID. SPAIN. Treatment of achalasia by pneumatic dilatation (PD) reduces lower esophageal sphincter pressure (LESP) which can cause gastroesophageal reflux (GER). The aim of the study was: try to determine and compare the incidence of GER by distal esophageal pH monitoring in two periods of time, one after 3 months and the other one one year later, in order to find out if there are any differences and if there is a need to repeat the tes t in the follow-up of these patients. We have studied 32 achalasic patients (14 M, 18 F) after PD with excellent (El or good (G) resuRs (21 E, 11 G). A gastroscope and an esophagea! manometry were done on all patients before the procedure. A gastroscope, esophageal manometry and 24 H esophageal pH monitoring were done after 3 (Group II, and i 2 months later (Grout II). Results: Group I, 14 patients (40.6%) had a pathologic pH result, been symptomatic six out of them. Two patients had grade II and III esophagitis, respectively. Two other patients with mild heartburn had a normal pH result. Group II, 18 patients (56.2%) had a pathologic pH result, 4 of which (12.5%) symptomatic. The other 4 symptomatic patients had a normal pH result. There were no patients with endoscopic esophagitis in this group (group I patients with esophagitis have healed after treatment). The rate of LESP reduction of both groups in regard to the pre-dilatation values showed no difference. There were statisticallly significant differences between boths groups in respect to the total and greater than 5 rain. number of reflux episodes, and the percentage of time with pH < 4 during the supine period (p<0.05). Eight patients (25%) of Group I turned to pathologic results in the next control without reflux symptoms. On the contrary, five patients showed opposite results (from pathologic to normal). Conclusion.- 1 ) 24 H esophageal pH monitoring is useful in controlling achalasic patients after dilatation, because there is a discrepancy between symptoms and pH results~ 2) Premature controls can lead to! an erroneous diagnosis of patients that will develop reflux. 3) Probably the best time to do the pHmetry would be in around one year, in order: to identify most of the pathological results, except in patients with[ severe symptoms. 24 HOUR AMBULATORY
PREVALENCE OF HELICOBACTER PYLORI INFECTION IN SCHOOL. CHILDREN IN COUNTRIES WITH HIGH AND LOW SOClO-ECONOMIC STATUS AND DIFFERENT TRENDS IN INCIDENCE OF GASTRIC CANCER. F. Pern, M. Peelers, Y. Ghoos, B. Geypens, F. Lawson, S, Dote, B. Maes, A. Andriulli, V. Annese, P. Rutgeerts. University of Leuven. B-3000 Belgium, Cotonou. Benin, Bangalore, India and San Giovanni Rotondo. Italy. Chronic infection with Heltcobacwr pylori (Hp) is associated with a higher incidence of atrophic gastritis and possibly with gastric cancer. Aim: To study the prevalence of Hp infection in school children in 4 different countries with variable socioeconomic conditions and differing trends in incidence of gastric cancer Methods: The non-invasive and safe 13C-urea breath test was used to determine the Hp status of 1106 at random children aged between 5 and 19 years (7 age classes) and without any abdominal complaints. Results: Overall infection rate was 4.2% in Belgium, 28.9% in Italy, 80'.6% in Benin and 84.6% in India (Chi2: p<0.001). Only between India and Benin there was no significant difference. The figure gives the prevalences per age class (%). In three countries a fall in the IIp prevalet~ce in the second age class was found. 10~ so,,
.-~
I N D I A (n ffi 2 1 4 )
/.," .ff
/~.-' ""
-,.,/
~ 20,
~ ITALY
BENIN
(n = 721
24 HOUR pHMETRY PATTERN AFTER ENDOSCOPIC PNEUMATIC DILATATION FOR ACHALASIA. J. P~REZ DE LA SERNA, A. RUIZ DE LEON, C. SEVILLA MANTILLA C. TAXONERA, G. LC)PEZ-NAVA, M. DJAZ-RUBIO. Gastroenterology Service. HOSPITAL UNIVERSITARIO SAN CARLOS. MADRID. SPAIN, The AIM of the study was to evaluate the gastroesophageal reflux (GER) pattern using 24 H ambulatory pH metry in patients with achalasia after endoscopic pneumatic dilatation (PD) (RIGIFLEX, Microvasive). METHODS: In the last 6 years it has been performed 136 PD into 120 patients (p) (1.3 PD/p). From the 107 patients with excellent (E) or good (G) outcome (89.16%) it has been exc.luded : 5 P-becaus e of perforation during the procedure (3.6%), 14 p. which refuse or didn't come for further evaluation and 10 p. not yet evaluated. Then, we have studied 77 p (35 M, 42 F), (51 E, 25 G), mean age 49 (range 8-83) y. old. An esophageal manometry, upper endoscopy and 24 H pHmetry was performed between 1 and 6 months after PD (mean 3,02 0.8). RESULTS: 35 p (45.4%) had a pathological pHmetry, 19 p (24.6%) suffered heartburn, 14 of which with GER on pHmetry and 2 out of them had grade II and III esophagitis, respectively. 5 p. without pathological GER presented some peristalsis after PD; only one with pathological GER. We found 5 patterns of GER on pHmetry after PD: I) GER ur)der physiologic limits. II) High number of reflux episodes of normal duration (2 p, 2.6%). Ill) Episodes of long duration in the daytime period (9 p, 11.6%) (median 33, range 22-55). IV) Episodes of long duration in the supine period (14 p, 18.2%) (median 69, range 34240). 1 p with grade II esophagitis. V) Episodes of long duration in the day-time and supine period (10 p, 12.9%) (day-time period median 28.5, range 22-219; supine period median 92, range 20-239). 1 p with grade III esophagitis. CONCLUSION: Pathological GER is frequent after PD when studied by 24 H esophageal pH monitoring. It highlights the long duration of episodes, mainly during the supine period which can be related to the disturbed peristalsis, There is a poor correlation between symptoms,, endoscopy and 24 H pH results.
RANITIDINE BISMUTH CITRATE PLUS CLARITHROMYCIN IS EFFECTIVE IN THE ERADICATION OF HELICOBACTER PYLORI AND PREVENTION OF DUODENAL ULCER RELAPSE. WL. Peterson, SJ. Sontug, AA. Ciociola, DL. Sykes, DJ. MeSorley, DD. Webb and the H. pylori Ulcer Group. Univ. of Texas VA Medical Center, Dallas TX, VA Medical Center, Hines IL, Glaxo Inc., RTP NC. Ranitidine bismuth citrate is a novel compound with antisecretory, cyroprotective and antibelienbacter properties. The purpose of this factorialdesigned, multicenter, randomized, double-blind, placebo-controlled study was to compare the combination of ranitidine bismuth citrate (RBC) and clarithromycin (CLAR) to RBC alone, and CLAR alone, in the eradication of Helicobact~r pylori (Hp), healing of the duodenal ulcer (DU), and prevention of DU relapse. 136 Hp infected patients with an active DU were ~rcated with either RBC 4g0mg b.i.d, for four weeks plus CLAR 500rag t.Ld. for two weeks, RBC 400rag b.i.d, for four weeks plus placebo (PLC) t.i.d, for two weeks, PLC b.i.d. for four weeks plus CLAR 50grog t.i.d, for two weeks, or PLC b.i.d, for four weeks plus PLC t.i.d, for two weeks. Only patients with baseline positive culture, or positive histology, and rapid urease test (CLO) were considered Hp infected. Only patients with healed ulcers at the end of the four week treatment period were eligible to be entered into the 6 month post-treatment observation period, (ie, 84 of 136 patients). Of those 84 patients, 76 had an endoscopy performed at 1, 3 and 6 months posttrcatment and were evaluated for ulcer relapse. Patients whose ulcers were unhealed at the end of the 4 week treatment period or who did not wish to continue were dropped from the study, and given alternative therapy (ie,: 52 of 136 patients). Hp was considered eradicated if at least two ofthree tests performed 4 weeks posttreatment were negative. Any positive test classified the patient as infected. A single negative test classified the patient as unevaluable A total of 67 patients were evaluable for Hp eradication. Treatment Hp Eradication 6 Month Ulcer Relapse % (no. vatients~ % (95CI) RBC+CLAR 82% (14/17)* 20% (2.2-37.8) RBC 400rag bid 0% (0/20) 84% (67.9-100) CLAR 50grog lid 38% (8/21) 41% (21.4-60.6) PLC 0% (0/9) 87% (62.9-111) * p<0.009 as compared to all other therapies Conclusion: These results demonstrate that RBC 400mg b.i.d, when taken with CLAR 500rag t.i.d, is highly effective therapy for eradication of Hp, healing duodenal ulcers and prevention of duodenal ulcer relapse.
Methods:
Results:
8.5;10.5
10.5-12.5
12.5- 14.5
14.5-16.5
No. 4
at
In = 3421
40~
4.5-6.5 6.5"-8.5
VoI. IO8,
t6.5 - 18.5
C__onclusien: This multicenter study investigating the actual Helicobacter pylori status in an at random school population showed a good correlation between the prevalence of Hp infection and the socio-eennomic conditions. The highest prevalenoss were found in the countries (India, Benin) with low socio-economic status. Possibly this can be related to the rising incidence of gastric cancer in these 'regions.