Bismuth-Based Triple Therapy with Bismuth Subcitrate, Metronidazole and Tetracycline in the Eradication ofHelicobacter pylori: A Randomised, Placebo Controlled, Double-Blind Study

OBJECTIVE: To determine the rate ofHelicobacter pylorieradication following bismuth-based triple therapy with colloidal bismuth subcitrate, tetracycline hydrochloride and metronidazole.PATIENTS AND METHODS: One hundred and eleven patients were randomly assigned, in a two to one ratio, to colloidal bismuth subcitrate 120 mg qid plus metronidazole 250 mg qid plus tetracycline 500 mg qid (Gastrostat), or matching placebo tablets and capsules for 14 days. Presence or absence ofH pyloriwas documented by histology at entry and at least 28 days after treatment. Patients had dyspeptic symptoms with or without a history of peptic ulcer. Patients with any previous attempt(s) at eradication ofH pylori, who used bismuth, antibiotics, H2 receptor antagonists or proton pump inhibitors in the previous four weeks were excluded.RESULTS: Fifty-three of 59 (90%) patients on bismuth-based treatment and only one of 35 (3%) on placebo achieved eradication by per protocol analysis. Fifty-three of 65 (82%) patients on bismuth-based treatment achieved eradication, while only two of 34 (5%) achieved eradication on placebo by intention to treat analysis. Eradication rates for bismuth-based treatment across sites ranged from 83% to 100%. Only two patients in the bismuth-based treatment group (4%) and one in the placebo group (3%) discontinued treatment because of adverse events.CONCLUSIONS: Colloidal bismuth subcitrate plus metronidazole plus tetracycline, given in the doses studied for 14 days, is safe and highly effective againstH pyloriinfection and would be appropriate as a first-line therapy for eradication.

Download Full-text

Prospective randomized comparison of ranitidine bismuth citrate (RBC) versus colloidal bismuth subcitrate (denol)-based triple therapy for the treatment of H. pylori infection

Gastroenterology ◽

10.1016/s0016-5085(98)80774-9 ◽

1998 ◽

Vol 114 ◽

pp. A190

Author(s):

NNS Kung ◽

JY Sung ◽

WF Yuen ◽

TH Li ◽

PW Ng ◽

...

Keyword(s):

Triple Therapy ◽

Colloidal Bismuth Subcitrate ◽

Bismuth Citrate ◽

Bismuth Subcitrate ◽

H Pylori ◽

Colloidal Bismuth

Download Full-text

Influence of metronidazole resistance on efficacy of quadruple therapy for Helicobacter pylori eradication

Gut ◽

10.1136/gut.42.2.166 ◽

1998 ◽

Vol 42 (2) ◽

pp. 166-169 ◽

Cited By ~ 61

Author(s):

R W M van der Hulst ◽

A van der Ende ◽

A Homan ◽

P Roorda ◽

J Dankert ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Quadruple Therapy ◽

Colloidal Bismuth Subcitrate ◽

Intention To Treat ◽

Group I ◽

Bismuth Subcitrate ◽

Metronidazole Resistance ◽

Group Ii ◽

H Pylori

Background—Metronidazole-containing eradication therapies are less effective for metronidazole resistantHelicobacter pylori. Although early data suggested improvement of the efficacy of bismuth triple therapy after the addition of acid suppressives, these findings were based on studies with small numbers of patients, incomplete post-eradication follow up, or omission of pretreatment susceptibility testing.Aims—To study the efficacy of quadruple therapy in the Amsterdam area, where the efficacy of bismuth triple therapy has been proved to be affected by metronidazole resistance.Patients and methods—Eighty two consecutive dyspeptic H pylori positive patients with either metronidazole susceptible (group I) or metronidazole resistant H pylori strains (group II) received quadruple therapy for one week: omeprazole 20 mg twice daily; colloidal bismuth subcitrate 120 mg four times a day; tetracycline 500 mg four times a day; metronidazole 500 mg three times a day. Susceptibility to metronidazole was determined by the E-test.Results—Intention to treat analysis showed thatH pylori infection had been cured in 42/43 patients (98%) in group I and 32/39 patients (82%) in group II (p = 0.02).Conclusion—The efficacy of quadruple therapy is significantly impaired in patients infected with metronidazole resistant H pylori. Therefore a non-metronidazole-containing regimen should preferably be used in areas known to have a high prevalence of pretreatment metronidazole resistance.

Download Full-text

Standard Triple Therapy versus Sequential Therapy inHelicobacter pyloriEradication: A Double-Blind, Randomized, and Controlled Trial

Gastroenterology Research and Practice ◽

10.1155/2015/818043 ◽

2015 ◽

Vol 2015 ◽

pp. 1-5 ◽

Cited By ~ 3

Author(s):

Jaime Natan Eisig ◽

Tomás Navarro-Rodriguez ◽

Ana Cristina Sá Teixeira ◽

Fernando Marcuz Silva ◽

Rejane Mattar ◽

...

Keyword(s):

Triple Therapy ◽

Controlled Trial ◽

Sequential Therapy ◽

Rapid Urease Test ◽

Double Blind ◽

Intention To Treat ◽

Standard Triple Therapy ◽

Urease Test ◽

H Pylori ◽

Triple Treatment

Aim. To compare 10-day standard triple therapy versus sequential therapy as first-line treatment in patients infected withH. pylori.Methods. One hundredH. pyloripositive patients (diagnosed by rapid urease test and histology), with average age of 47.2, M/F = 28/72, were randomized to receive either standard triple treatment (TT) as follows: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 g, b.i.d. for ten days, or sequential treatment (ST) as follows: lansoprazole 30 mg, amoxicillin and placebo 1.0 g b.i.d for the first five days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg b.i.d, for the remaining five days. Eradication rates were determined 60 days after treatment by urease, histology, or13C-urea breath test.Results. In intention to treat (ITT) analysis, the rate ofH. pylorieradication in the TT and ST groups was the same for both regimens as follows: 86% (43/50), 95% CI 93,3 to 73.4%. In Per protocol (PP) analysis, the rate ofH. pylorieradication in the TT and ST groups was 87.8% (43/49), 95% CI 94,5 to 75.3% and 89.6% (43/48), 95% CI 95,8 to 77.3%, respectively.Conclusions. In Brazil, standard triple therapy is as equally effective as sequential therapy in eradicatingHelicobacter pyloripatients. This study was registered under Clinical Trials with numberISRCTN62400496.

Download Full-text

Bismuth-Based Quadruple Therapy with Bismuth Subcitrate, Metronidazole, Tetracycline and Omeprazole in the Eradication ofHelicobacter pylori

Canadian Journal of Gastroenterology ◽

10.1155/2001/305756 ◽

2001 ◽

Vol 15 (9) ◽

pp. 581-585 ◽

Cited By ~ 19

Author(s):

Raymond Lahaie ◽

Alain Farley ◽

Chrystian Dallaire ◽

André Archambault ◽

Carlo A Fallone ◽

...

Keyword(s):

Eradication Rate ◽

Previous Attempt ◽

Colloidal Bismuth Subcitrate ◽

Minimal Inhibitory Concentrations ◽

Bismuth Subcitrate ◽

Antiulcer Drugs ◽

Resistant Strains ◽

H Pylori ◽

Irritable Bowel ◽

Intent To Treat

BACKGROUND: A previous study showed that 14 days of qid bismuth-based triple therapy with tetracycline 500 mg, metronidazole 250 mg and colloidal bismuth subcitrate 120 mg resulted in excellentHelicobacter pylorieradication rates (89.5%). The present study looked at a shorter treatment period by adding omeprazole and by reducing the dose of tetracycline.METHODS: One hundred sixty-one patients withH pyloriconfirmed by histology and13carbon urea breath test were included in the study. They were treated for seven days with bismuth subcitrate 120 mg plus metronidazole 250 mg plus tetracycline 250 mg qid plus omeprazole 20 mg bid (OBMT). Patients were 18 to 75 years of age and had dyspepsia with or without a history of peptic ulcer. Patients with irritable bowel syndrome, active ulcer or previous attempt at eradication, or those who had used antibiotics or antiulcer drugs in the previous 30 days were excluded. Eradication was determined by two13carbon urea breath tests done one and three months, respectively, after treatment. Strains with minimal inhibitory concentrations of 8 µg/mL or higher were considered to be resistant to metronidazole.RESULTS: The overall per protocol eradication rate was 84% - 89.5% in metronidazole-sensitive and 70.8% in metronidazole-resistant strains. Modified intent-to-treat analysis resulted in a 80% eradication rate - 82.5% in metronidazole-sensitive and 66.7% in metronidazole-resistant strains. Only one patient discontinued treatment because of adverse events.CONCLUSIONS: The OBMT regimen used in this study is safe and effective against metronidazole-sensitiveH pyloristrains.

Download Full-text

The efficacy, safety, and tolerability of levofloxacin quadruple therapy for helicobacter pylori eradication: a randomized, double-blind clinical trial

10.21203/rs.3.rs-53307/v1 ◽

2020 ◽

Author(s):

Fariborz Mansour-Ghanaei ◽

Behnam Masihypour ◽

Mohammad Fathalipour ◽

Soheil Hassanipour ◽

Homayoon Sokhanvar ◽

...

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Alternative Therapy ◽

Double Blind ◽

Intention To Treat ◽

Bismuth Subcitrate ◽

Double Blind Clinical Trial ◽

End Of Treatment ◽

H Pylori ◽

To Receive

Abstract BackgroundThe incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori.MethodsIn a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention.ResultsAccording to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively compared to the BPAL- 10 regimen 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6%) and BPAL-10 (36.7%) groups.ConclusionAlthough the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). This trial was retrospectively registered on July 10, 2015.

Download Full-text

The Efficacy, Safety, And Tolerability of Levofloxacin Quadruple Therapy For Helicobacter Pylori Eradication: A Randomized, Double-Blind Clinical Trial

10.21203/rs.3.rs-53307/v2 ◽

2021 ◽

Author(s):

Fariborz Mansour-Ghanaei ◽

Behnam Masihypour ◽

Mohammad Fathalipour ◽

Soheil Hassanipour ◽

Homayoon Sokhanvar ◽

...

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Alternative Therapy ◽

Double Blind ◽

Intention To Treat ◽

Bismuth Subcitrate ◽

Double Blind Clinical Trial ◽

End Of Treatment ◽

H Pylori ◽

To Receive

Abstract The incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1 % (95 % CI: 39.3-57.8) and 47.6 % (95 % CI: 39.7-58.4), respectively compared to the BPAL- 10 regimen 62.7 % (95 % CI: 53.6-72.8) and 62.4 % (95 % CI: 55.1-72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6 %) and BPAL-10 (36.7 %) groups. Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).

Download Full-text

Survey of anaemia andHelicobacter pyloriinfection in adolescent girls in Suihua, China and enhancement of iron intervention effects byH. pylorieradication

British Journal Of Nutrition ◽

10.1017/s0007114511005666 ◽

2011 ◽

Vol 108 (2) ◽

pp. 357-362 ◽

Cited By ~ 25

Author(s):

Wei Xia ◽

Xin Zhang ◽

Jiajia Wang ◽

Caihong Sun ◽

Lijie Wu

Keyword(s):

Adolescent Girls ◽

Intervention Group ◽

Fe Deficiency ◽

Control Group ◽

Colloidal Bismuth Subcitrate ◽

Bismuth Subcitrate ◽

H Pylori ◽

And Control ◽

The Relationship ◽

Colloidal Bismuth

In the present study, we investigated the prevalence of anaemia and Fe deficiency anaemia (IDA) and explored the relationship betweenHelicobacter pyloriinfection and IDA in adolescent girls. A total of 1037 adolescent girls from Suihua, China were enrolled. Hb, serum ferritin (SF), serum transferrin receptor (sTfR) and serum IgG antibodies toH. pyloriwere measured. Participants with IDA and co-existingH. pyloriinfection (n80) who had an intake of >25 mg/d of Fe were assigned randomly to the intervention and control groups. Patients in the intervention group were administered a 12-week course of oral EDTA–Na–Fe (60 mg Fe/dose, three times a week) and a 2-week course of colloidal bismuth subcitrate, amoxicillin and metronidazole. Subjects in the control group were administered EDTA–Na–Fe alone. Hb, SF and sTfR were reassessed 3 months after the 12-week regimen ended. Prevalence of anaemia, Fe deficiency (defined as SF < 12·0 μg/l), IDA andH. pyloriinfection in the population of 1037 was 19·5, 40·4, 17·1 and 31·2 %, respectively. The prevalence ofH. pyloriinfection in the IDA group was 46·9 %, while the non-anaemic group had 28·1 % prevalence. A significant increase in Hb and SF and a decrease in sTfR value were found in the intervention group and theH. pylori-negative group. Findings suggest that IDA is still one of the prominent problems in adolescent girls. There is an association betweenH. pyloriinfection and IDA. Treatment ofH. pyloriinfection is associated with a more rapid response to oral Fe therapy.

Download Full-text