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Lack of almagate interference in breath test results for Helicobacter pylori diagnosis (Almatest study).
Pons, C, Varas, M, Gisbert, JP, Barenys, M, Pajuelo, F, Fernández, FJ
Gastroenterologia y hepatologia. 2021;(9):628-636
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Abstract
OBJECTIVE The 13C-urea breath test (UBT) is the most widely used non-invasive diagnostic test for Helicobacter pylori. Debate continues to surround the possible interference of antacid intake on its result. This study aims to confirm the non-interference of almagate in the determination of H. pylori by UBT. PATIENTS AND METHODS Observational, multicentre study in adult patients treated with almagate in whom a UBT (TAUKIT®) was indicated. When the UBT result was negative, use of almagate was stopped for 30 days and the UBT was repeated. When the result was positive, no further determinations were made. The primary endpoint was the percentage of patients who, having had a negative result in the first breath test, were positive in the second after having stopped taking almagate (UBT false negatives, possibly attributable to almagate). RESULTS Of the 167 evaluable patients, 59% were female, average age was 49 and 97% had gastrointestinal symptoms. The result of the first UBT was negative in 71% of cases. Of these, in the second UBT test after stopping the almagate, the negative result was confirmed in 97.5%. Out of the total number of cases evaluated, the rate of false negatives was 1.8%. CONCLUSIONS Taking almagate has minimal or no interference in the result of UBT for the diagnosis of H. pylori infection. It can therefore be used in the weeks prior to a UBT.
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Phytomedicine-based and Quadruple Therapies in Helicobacter pylori Infection: A Comparative, Randomized Trial.
Asif, HM, Zaidi, SF, Sugiyama, T, Akhtar, N, Usmanghani, K
Alternative therapies in health and medicine. 2015;:33-9
Abstract
CONTEXT Helicobacter pylori (H pylori) is strongly associated with the development of gastritis, duodenal and gastric ulcers, gastric mucosa-associated lymphoid tissue (MALT) lymphomas and gastric carcinoma. Emerging antibiotic resistance and patients' poor compliance with modern therapies have resulted in increasing eradication failure. OBJECTIVES The current trial was conducted to evaluate the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H pylori infection and relief of its associated symptoms in Pakistan. DESIGN The study was a randomized, controlled, multicenter clinical trial. Setting • The study was conducted in high-risk areas of Pakistan, including at Shifa-Ul-Mulk Memorial Hospital in Karachi, at Bahawalpur Victoria Hospital in Bahawalpur, and at Nawaz Salik Hospital in Rawalpindi. PARTICIPANTS The study enrolled 210 patients who tested positive for H pylori, 118 males and 92 females. INTERVENTION Participants were divided into 2 groups according to treatment regimens. One group of participants received quadruple therapy-20 mg of omeprazole, 1g of amoxicillin, 500 mg of metronidazole, and 400 mg of bismuth compound-that was prescribed for 7 d, and another group received an alternate, phytomedicine-based, quadruple formulation-500 mg of Pylorex Plus-that was prescribed for 15 d. OUTCOME MEASURES The eradication rate for H pylori was the primary outcome measure. Eradication was considered to be achieved on the basis of a negative C-urea breath test (UBT) and a negative stool antigen test for H pylori (HpSAg) at 4 wk after the end of treatment. The secondary outcome measure was the improvement in the clinical features as assessed by dyspepsia scores. RESULTS In an intention-to-treat (ITT) analysis, the study found that H pylori was eradicated in 56 of the 90 participants in the quadruple therapy group who completed the study (62.2%) and in 48 of the 86 participants in the Pylorex Plus group who completed the study (55.8%). Therefore, Pylorex Plus had an eradication rate comparable with quadruple therapy. However, Pylorex Plus had significantly reduced gastrointestinal (GI) symptoms at the second wk and at 1 mo after treatment, both for participants in whom H pylori was eradicated and for those in whom it was not eradicated. The quadruple therapy group also showed reduced GI symptoms at the second wk and at 1 mo after treatment, but that result occurred only for those participants in whom H pylori was eradicated, and no significant improvement was observed for participants in whom it was not eradicated. CONCLUSIONS Current quadruple and alternate therapies yielded poor eradication rates (<70%), but the latter produced marked symptomatic improvement, both for participants in whom H pylori was eradicated and for those in whom it was not eradicated, pointing out its potential use with patients with functional dyspepsia (FD) who are both positive and negative for H pylori.
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Probiotics for standard triple Helicobacter pylori eradication: a randomized, double-blind, placebo-controlled trial.
Hauser, G, Salkic, N, Vukelic, K, JajacKnez, A, Stimac, D
Medicine. 2015;(17):e685
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Abstract
The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P < 0.001). Additionally, presence and intensity of epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, rash, and diarrhea were monitored over the study period. At 15 days postinclusion, probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P < 0.001).Adding probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.
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Do probiotics improve eradication response to Helicobacter pylori on standard triple or sequential therapy?
Dajani, AI, Abu Hammour, AM, Yang, DH, Chung, PC, Nounou, MA, Yuan, KY, Zakaria, MA, Schi, HS
Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association. 2013;(3):113-20
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Abstract
BACKGROUND The standard triple therapy for the eradication of Helicobacter pylori consists of a combination of a proton pump inhibitor at a standard dose together with two antibiotics (amoxicillin 1000 mg plus either clarithromycin 500 mg or metronidazole 400 mg) all given twice daily for a period of 7-14 days. Recent reports have shown a dramatic decline in the rate of H. pylori eradication utilizing standard triple therapy from 95% down to 70-80%. AIMS Our study was designed to evaluate the effect of adding a probiotic as an adjuvant to common regimens used for H. pylori eradication. MATERIALS AND METHODS An open label randomized observational clinical study was designed to test three different regimens of H. pylori eradication treatment: Standard triple therapy with a concomitant probiotic added at the same time (n = 100), starting the probiotic for 2 weeks before initiating standard triple therapy along with the probiotic (n = 95), and the third regimen consists of the probiotic given concomitantly to sequential treatment (n = 76). The three arms were compared to a control group of patients treated with the traditional standard triple therapy (n = 106). RESULTS The eradication rate for the traditional standard therapy was 68.9%, and adding the probiotic "Bifidus infantis" to triple therapy, led to a successful rate of eradication of 83% (P < 0.001). Pre-treatment with 2 weeks of B. infantis before adding it to standard triple therapy increased the success rate of eradication to 90.5%. Similar improvement in eradication rate was noted when B. infantis was added as an adjuvant to the sequential therapy leading to an eradication rate of 90.8%. CONCLUSION Adding B. infantis as an adjuvant to several therapeutic regimens commonly used for the eradication of H. pylori infection significantly improves the cure rates.
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[A multicenter study of Chinese patent medicine wenweishu/yangweishu in the treatment of Helicobacter pylori positive patients with chronic gastritis and peptic ulcer].
, , Hu, FL
Zhonghua yi xue za zhi. 2010;(2):75-8
Abstract
OBJECTIVE To evaluate the efficacy of Chinese patent medicine wenweishu /yangweishu in the treatment of Helicobacter pylori (H. pylori) positive patients with chronic gastritis and peptic ulcer. METHODS A randomized, controlled and multicenter trial was conducted in 642 H. pylori positive patients with chronic gastritis or peptic ulcer. They were randomized to three groups: PCM group (n = 222, pantoprazole 40 mg twice a day, clarithromycin 500 mg twice a day, metronidazole 400 mg twice a day, for 7 days); PCM plus wenweishu group (n = 196); and PCM plus yangweishu group (n = 224). (14)C breath test was performed 4 weeks after therapy. For the patients with gastric ulcer, ulcer healing was determined by endoscopy after therapy. RESULTS Intention-to-treat H. pylori eradication rate for PCM group, PCM plus wenweishu group, and PCM plus yangweishu group were 57.2% (127/222), 62.2% (122/196), 60.3% (135/224), respectively (P = 0.295, 0.512). Per-protocol H. pylori eradication rates were 62.3% (127/204), 70.1% (122/174), 65.2% (135/207), respectively (P = 0.108, 0.532).Per-protocol analysis gastric ulcer healing rate were 61.9% (13/21) 100.0% (18/18), 86.4% (19/22) respectively. The healing rate in PCM plus wenweishu groups was statistically significantly higher than the rate in PCM group (P = 0.004). The rates of symptom relief in PCM plus wenweishu groups and PCM plus yangweishu were statistically significantly higher than the rate in PCM group (both P < 0.01). Side-effects were rare and comparable between groups. CONCLUSION Although PCM combined with wenweishu or yangweishu in the treatment of H. pylori positive patients with chronic gastritis and peptic ulcer can not reach a significantly higher eradication rate, it can increase the rates of both gastric ulcer healing and symptom relief.
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Quadruple therapy for initial eradication of Helicobacter pylori in peptic ulcer: comparison with triple therapy.
Pai, CG, Thomas, CP, Biswas, A, Rao, S, Ramnarayan, K
Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology. 2003;(3):85-7
Abstract
BACKGROUND Quadruple therapy appears to be more effective than standard triple therapy in the management of patients with Helicobacter pylori infection who harbor drug-resistant organisms. No data are available on the relative efficacies of triple and quadruple drug regimens from India. METHODS Consecutive patients with peptic ulcer and H. pylori infection were randomized to receive lansoprazole 30 mg twice daily along with either amoxycillin (500 mg four times daily) and clarithromycin (500 mg twice a day) (Group A), or tri-potassium dicitrato bismuthate (120 mg four times daily), metronidazole (400 mg thrice daily) and tetracycline (500 mg 4 times daily) (Group B) for 10 days. Presence of H. pylori infection was looked for using an in-house urease test and histology before starting treatment, and 30 days after completion of treatment. RESULTS Twenty-nine of 35 patients in Group A and 24 of 33 in Group B had eradication of infection (82.8% and 72.7% by intention-to-treat analysis, and 87.9% and 85.7% by per protocol analysis, respectively; p = ns). Side-effects occurred in 4 (12%) and 5 (18%) patients in Groups A and B, respectively (p = ns); discontinuation of drugs was required in two patients in group B. CONCLUSIONS Quadruple therapy for initial treatment of H. pylori infection does not offer any advantage over standard triple therapy in Indian patients.