Miscellaneous Therapy Is Successful for H. Pylori Eradication
Miscellaneous Therapy Is Successful for H. Pylori Eradication
This was a pilot, open, prospective study for the treatment of patients with infection by H pylori. It was performed from June 2010 to December 2011 in the Digestive Endoscopy Department of Hospital Universitario Fundación Santa Fe de Bogotá, Colombia. The protocol was approved by the Ethics Committee of the same institution. Each patient received a complete explanation of the protocol and gave informed consent to participate in the study
Patients with the following criteria were included: (i) Age 18 to 70 years; (ii) Confirmed H. pylori infection, diagnosed by rapid urease test and histology; (iii) Symptoms of acid-peptic disease; (iv) Mental status permitting the understanding of the protocol.
Exclusion criteria: (i) A history of allergies to any of the medications to be used; (ii) Previously failed treatment of H. pylori eradication; (iii) Serious systemic disease, pregnancy or lactation; (iv) History of oesophageal or gastric surgery; (v) Concomitant use of PPIs or PPI use in the previous two weeks; (vi) Current intake of different antibiotics or antibiotic use in the two weeks previous to the beginning of study; (vii) MALT lymphoma.
Patients who met inclusion criteria were treated with the following regimen (Figure 1): first 5 days (Lansoprazole 30 mg, b.d., amoxicillin 1 g, b.d., metronidazole 500 mg, t.d.s.); days 6 to 10 (Lansoprazole 30 mg, q.d.s. and metronidazole 500 mg, t.d.s.); days 11 to 15 (Lansoprazole 30 mg, b.d., clarithromycin 500 mg, b.d. and metronidazole 500 mg t.d.s.). Patients received a written chart with the scheme and with instructions about the correct administration of therapy.
(Enlarge Image)
Figure 1.
Miscellaneous therapy for a duration of 15 days.
A complete clinical history was obtained from each patient. On enrolment, a diagnostic upper endoscopy was performed using an Olympus CV-180 Evis Exera II gastroscope. The endoscopic findings were classified as follicular gastritis, diffuse antral gastritis, gastric ulcer and duodenal ulcer. During pre- and posttreatment endoscopies, biopsies were taken using a jumbo biopsy forceps as follows: Antral and fundic samples were taken for rapid urease test. These tissues were immersed in a solution with urea at 10% for 20 s and considered positive if a variation from yellow to red could be observed. Four biopsies from gastric antrum and four biopsies from gastric body were obtained for histological examination and H. pylori detection by haematoxylin and eosin and Giemsa. Biopsies were taken from areas with no apparent atrophy or intestinal metaplasia. A follow-up endoscopy to evaluate eradication was performed at least 4 weeks posttreatment following the same protocol as the index endoscopy. Eradication of H. pylori was considered successful when both the rapid urease test and histology were negative.
A questionnaire was completed to record the intake of the medications and the development of adverse effects. These parameters were evaluated at least 4 weeks after the completion of the treatment. Adequate adherence was registered if the intake of the medication was greater than 90%. Patients were informed of the importance of strict adherence to the antibiotic schedule, and possible adverse effects related to the treatment were explained.
An analysis by protocol was performed (PP) in which data were evaluated from patients who were 100% compliant with the treatment. The outcome variable was calculated as the percentage of H. pylori infection eradication, determined 4 weeks after completion of treatment. The requirement to define successful eradication in a 15-day miscellaneous treatment was defined on the basis of a curation rate ≥95% (95% IC). Incidence of adverse effects was considered a nominal variable (present or absent). Following the recommendations of Hsu et al., we calculated a sample size of about 120 patients, which permitted us to obtain a confident estimate of outcome associated with a confidence interval of 95%.
Methods
This was a pilot, open, prospective study for the treatment of patients with infection by H pylori. It was performed from June 2010 to December 2011 in the Digestive Endoscopy Department of Hospital Universitario Fundación Santa Fe de Bogotá, Colombia. The protocol was approved by the Ethics Committee of the same institution. Each patient received a complete explanation of the protocol and gave informed consent to participate in the study
Eligibility Criteria
Patients with the following criteria were included: (i) Age 18 to 70 years; (ii) Confirmed H. pylori infection, diagnosed by rapid urease test and histology; (iii) Symptoms of acid-peptic disease; (iv) Mental status permitting the understanding of the protocol.
Exclusion criteria: (i) A history of allergies to any of the medications to be used; (ii) Previously failed treatment of H. pylori eradication; (iii) Serious systemic disease, pregnancy or lactation; (iv) History of oesophageal or gastric surgery; (v) Concomitant use of PPIs or PPI use in the previous two weeks; (vi) Current intake of different antibiotics or antibiotic use in the two weeks previous to the beginning of study; (vii) MALT lymphoma.
Therapeutic Regimen
Patients who met inclusion criteria were treated with the following regimen (Figure 1): first 5 days (Lansoprazole 30 mg, b.d., amoxicillin 1 g, b.d., metronidazole 500 mg, t.d.s.); days 6 to 10 (Lansoprazole 30 mg, q.d.s. and metronidazole 500 mg, t.d.s.); days 11 to 15 (Lansoprazole 30 mg, b.d., clarithromycin 500 mg, b.d. and metronidazole 500 mg t.d.s.). Patients received a written chart with the scheme and with instructions about the correct administration of therapy.
(Enlarge Image)
Figure 1.
Miscellaneous therapy for a duration of 15 days.
Clinical Data
A complete clinical history was obtained from each patient. On enrolment, a diagnostic upper endoscopy was performed using an Olympus CV-180 Evis Exera II gastroscope. The endoscopic findings were classified as follicular gastritis, diffuse antral gastritis, gastric ulcer and duodenal ulcer. During pre- and posttreatment endoscopies, biopsies were taken using a jumbo biopsy forceps as follows: Antral and fundic samples were taken for rapid urease test. These tissues were immersed in a solution with urea at 10% for 20 s and considered positive if a variation from yellow to red could be observed. Four biopsies from gastric antrum and four biopsies from gastric body were obtained for histological examination and H. pylori detection by haematoxylin and eosin and Giemsa. Biopsies were taken from areas with no apparent atrophy or intestinal metaplasia. A follow-up endoscopy to evaluate eradication was performed at least 4 weeks posttreatment following the same protocol as the index endoscopy. Eradication of H. pylori was considered successful when both the rapid urease test and histology were negative.
Adverse Effects and Compliance
A questionnaire was completed to record the intake of the medications and the development of adverse effects. These parameters were evaluated at least 4 weeks after the completion of the treatment. Adequate adherence was registered if the intake of the medication was greater than 90%. Patients were informed of the importance of strict adherence to the antibiotic schedule, and possible adverse effects related to the treatment were explained.
Statistical Analysis
An analysis by protocol was performed (PP) in which data were evaluated from patients who were 100% compliant with the treatment. The outcome variable was calculated as the percentage of H. pylori infection eradication, determined 4 weeks after completion of treatment. The requirement to define successful eradication in a 15-day miscellaneous treatment was defined on the basis of a curation rate ≥95% (95% IC). Incidence of adverse effects was considered a nominal variable (present or absent). Following the recommendations of Hsu et al., we calculated a sample size of about 120 patients, which permitted us to obtain a confident estimate of outcome associated with a confidence interval of 95%.
