OBES SURG (2011) 21:1377–1381 DOI 10.1007/s11695-010-0254-4
CLINICAL RESEARCH
Helicobacter pylori Eradication Therapy in Obese Patients Undergoing Gastric Bypass Surgery—Fourteen Days Superior to Seven Days? Rute Maria Cerqueira & M. Conceição Manso & Manuel R. Correia & Carolina D. Fernandes & Hélder Vilar & Mário Nora & Paulo Martins
Published online: 14 September 2010 # Springer Science+Business Media, LLC 2010
Abstract Background The high prevalence of Helicobacter pylori (HP) in our obese population undergoing Roux-en-Y bypass gastric surgery (69.4%) and the concern that it may exacerbate postoperative foregut symptoms and increase gastric cancer risk led us to adopt a policy of HP systematic eradication in this group of patients. Our aim, in obese patients undergoing bypass gastric surgery, was to compare effectivity of 7- and 14-days clarithromycin-based triple therapy as the first-line treatment for HP eradication. Methods Three hundred seventy-three patients [mean age 41.2±10.3 years; 313 women (83.9%)] were HP positive This work was partially presented in the XIII World Congress—IFSO 2008—Surgery of Obesity—Multidisciplinary Approach of the Severe Obesity Buenos Aires, September 24–27, 2008 R. M. Cerqueira : M. R. Correia : C. D. Fernandes : H. Vilar Gastroenterology, S. Sebastião Hospital, Santa Maria Feira, Portugal M. C. Manso Biostastistics, Faculty of Health Sciences, University Fernando Pessoa, Porto, Portugal M. C. Manso REQUIMTE-UP, Porto, Portugal M. Nora : P. Martins Surgery, S. Sebastião Hospital, Santa Maria Feira, Portugal R. M. Cerqueira (*) Serviço de Gastrenterologia, Hospital S. Sebastião, R Dr. Cândido Pinho, 4520-271 Santa Maria Feira, Portugal e-mail:
[email protected]
determined by histology or urea breath test. In 2005, 94 patients (Group A) were treated with a 7-days triple therapy— proton pump inhibitor (PPI) b.i.d., clarithromycin (CL) 500 mg b.i.d., and amoxicillin (AMX) 1,000 mg b.i.d. Since 2006, 279 patients (Group B) were treated with a similar 14days drug regimen—PPI b.i.d., CL 500 mg b.i.d., and AMX 1,000 mg b.i.d. Posttreatment HP status was assessed by C13 urea breath test 4–6 weeks after the end of therapy. Results The eradication rates were 67.0% (Group A) and 79.9% (Group B). The eradication rate achieved with 14-days triple therapy was significantly higher than with 7-days triple therapy (OR=1.96; 95% CI: 1.16–3.30; p=0.016). Conclusions A 14-days triple therapy is more effective than 7-days triple therapy suggesting this regimen should be the first-line therapy for HP eradication in Portuguese obese patients undergoing bypass gastric surgery. Keywords Bariatric surgery . Obesity . Helicobacter pylori infection
Introduction In western countries, obesity is a rising epidemic and one of the major health problems in these societies. Surgery is the most effective long-term treatment for sustained weight loss and improvement of obesityassociated co-morbidities [1]. Due to long lasting weight impact and the high rate of diabetes mellitus resolution, Roux-en-Y gastric bypass (RYGB) is the most commonly bariatric surgery performed in our hospital. The most recent guidelines strongly recommend performing upper gastro-intestinal endoscopy (UGIE) before RYGB [2]. These recommendations were further supported by the
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evidence that abnormal UGIE findings are frequent in asymptomatic obese people undergoing preoperative RYGB evaluation [3–6] and that the gastrointestinal lesions are associated with Helicobacter pylori (HP) [3], a major etiological factor for chronic gastritis, peptic ulcer and, more importantly, gastric cancer [7–9]. Portugal has a high rate of HP infection prevalence (between 80% and 90% in people aged above 30 years) [10] and is one of the European Union leading countries in gastric cancer incidence [11]. HP infection also seems to have the potential to cause or aggravate foregut symptoms post RYGB [12] and to predispose to marginal ulcer post-RYGB [13, 14], even in the absence of ongoing gastric remnant infection [14]. A recent study also showed that HP infection remains in the excluded stomach for many years and its association with the severity of gastritis suggest that it can play a major role in mucosal change progression increasing even more the gastric cancer risk in patients submitted to RYGB [15]. Taking into consideration that the gastric remnant can be endoscopically examined only by double-balloon enteroscopy [15], a high skilled technique not widely available, and that excluded stomach gastric cancer has been reported [16, 17] the routine use of preoperative UGIE and HP screening and treatment appears justified in our population, a high gastric cancer prevalence one [11]. So, the high prevalence of HP infection in our obese population undergoing RYGB (69.4%), the concern that it may exacerbate postoperative foregut symptoms and increase the incidence of postoperative marginal ulcers and, more importantly, the risk of late diagnosis of severe disease due to technical difficulties of gastric remnant examination led us to adopt a policy of systematic HP screening and eradication in this group of patients. Our aim, in obese patients undergoing RYGB, was to compare the effectivity of 7- and 14-days clarithromycinbased triple therapy as the first-line treatment for HP eradication.
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From January to December 2005, 94 patients (Group A) were treated according to the Maastrich III guidelines 7-days triple therapy [18]—proton pump inhibitor (PPI) b.i.d., clarithromycin (CL) 500 mg b.i.d., and amoxicillin (AMX) 1,000 mg b.i.d.. Upon verification of an eradication rate far below the minimum recommended 80% rate, it was decided to extend the treatment duration from 7 to 14 days. Since January 2006 until April 2008, 279 patients (Group B) were treated with a similar 14-days drug regimen—PPI b.i.d., CL 500 mg b.i.d., and AMX 1,000 mg b.i.d. Posttreatment HP status was assessed by C13 urea breath test (Helico-test, Isomed, Madrid, Spain) 4–6 weeks after the end of therapy. To perform this test, 75 mg of C13 urea was used and citric acid was used as test meal. Retrospective analysis was made of a prospectively maintained data base recording demographic data (age, gender), endoscopic data, and HP therapy (drugs and duration). Statistical Analysis Statistical analyses were performed with SPSS® Statistics 17.0. Descriptive and inferential analyses were conducted to study the effectivity of two treatment therapies for HP eradication. Quantitative data were expressed as mean± standard deviation, median values, and corresponding 25th and 75th centiles, as well as the minimum and maximum values. Confidence intervals were also calculated. Comparisons of mean age between groups regarding gender, therapy, and eradication were performed with a three-way full factorial analysis of variance (ANOVA), after verification of normality and of homogeneity of variances for the dependent variable. Counts and percentages were reported for categorical variables. Confidence intervals for proportions of endoscopic diagnosis were calculated. When comparing proportions, the z test was used. When studying the association between nominal variables, chi-square tests were used, and OR calculated. Whenever statistical tests have been applied, the considered level of significance was α=0.05.
Patients and Methods After institutional review board approval, a retrospective electronic medical record review was performed. The study cohort consisted of HP-positive 312 patients consecutively scheduled for RYGB. All patients had a body mass index≥40 kg/m2 or≥35 kg/m2 with co-morbidities. HP colonization was assessed by histological examination of corpus and antrum gastric mucosa: two samples of each gastric segment were fixed in formalin, embedded in paraffin, and stained by hematoxilin and eosin and modified Giemsa. The results were reported as present or absent.
Results Table 1 summarizes demographic patient data. The patients had a mean age of 41.2 (±SD 10.3) years, 313 (83.9%) were female, 94 patients (Group A) were treated during 7 days while 279 (74.8%) were treated with a 14 days similar drug regimen. A three-way full factorial analysis using age as dependent variable and gender, therapy, and eradication as independent factors, showed that age only differs significantly regarding therapy group (F=5.062, p=0.025), being the mean age of patients in group A lower than the ones of
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Table 1 Description of the age (mean±standard deviation, 95% confidence interval for the mean, median and first, and third quartiles, minimum and maximum) of all patients, as well as by gender and therapy treatment group. Counts (n) and respective percentage (%) are presented for each group n (%)
All patients Gender Therapy Eradication *
Age of the patient (years)
Male Female A-7 days B-14 days No Yes
373 60 313 94 279 86 283
(100) (16.1) (83.9) (25.2) (74.8) (23.3) (76.7)
Mean (±SD)
95% CI
41.2 (±10.3) 40.5 (±11.4) 41.4 (±10.1) 39.0a (±10.1) 41.9b (±10.2) 40.6 (±10.9) 41.4 (±9.9)
40.2–42.3 37.6–43.4 40.2–42.5 36.9–41.1 40.7–43.1 38.3–43.0 40.2–42.6
Median (P25–P75)
Min–max
41 (33.8–50) 39 (32–49.5) 41 (34–50) 38 (32–45.8) 41(34–50) 40 (31.8–50.5) 41 (33–49)
19–69 19–66 19–69 19–63 19–69 19–61 19–69
p*
0.263 0.025 0.353
ANOVA
a,b
Different letters stand for significant differences
those in group B. The two other factors alone (gender and eradication), the factor interaction two-by-two or the three at the same time did not show significant differences for the mean age of the participants (p>0.261 for all comparisons). Therefore, the mean age of the patients included in both therapy treatment groups were found to be similar regarding gender and eradication distribution. Seventeen percent of group A patients were male and 15.8% of group B patients were also male, which did not differ significantly (χ2 =0.299, 1df, p=0.585). Table 2 describes the age of patients by therapy treatment group, and within that, by eradication status. Eradication rates were 67.0% (Group A) and 79.9% (Group B). Significant association was found (χ2 =5.832, 1df, p=0.016, n=373) between therapy and eradication (Fig. 1), being the 14-days treatment therapy associated with a higher rate of HP eradication (79.9; Table 2). The OR is 1.96 (95% CI: 1.17– 3.30), indicating that the 14-days treatment therapy increased the odds of eradication by 96%. As shown in Table 3, endoscopic lesions were found in 52.5% of the patients, and results of endoscopic diagnosis in both therapy groups did not show to be significantly different (p
