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

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).

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

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.

Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in Chinese patients with atrial fibrillation

Vascular ◽  
2013 ◽  
Vol 22 (4) ◽  
pp. 252-258 ◽  
Author(s):  
Lizheng Mao ◽  
Chengyan Li ◽  
Tao Li ◽  
Kunxiong Yuan
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Safety Concern ◽  
Hazard Ratio ◽  
Chinese Patients ◽  
Systemic Embolism ◽  
Double Blind ◽  
Warfarin Group ◽  
Double Blind Clinical Trial ◽  
To Receive

This study assessed the effects and safety of rivaroxaban versus warfarin in Chinese patients with atrial fibrillation. In this double-blind clinical trial, a total of 353 consecutive patients with atrial fibrillation who were at risk of stroke or systemic embolism were enrolled to receive either rivaroxaban or warfarin. The primary effect endpoint occurred in five patients in the rivaroxaban group (2.29% per year) and in seven patients in the warfarin group (2.91% per year) (hazard ratio with warfarin, 0.76, 95% CI, 0.64–0.91; p = 0.03). Major and non-major clinically relevant bleeding occurred in 38 patients (14.3% per year) in the rivaroxaban group and in 36 patients (13.7% per year) in the warfarin group (hazard ratio rivaroxaban versus warfarin, 1.07; 95% CI, 0.93–1.14; p = 0.39). Adverse events were similar between these two arms ( p > 0.05). In conclusion, oral administration of rivaroxaban reduced the risk of stroke or systemic embolism without significantly increasing the safety concern.

scholarly journals Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial

2021 ◽  
Author(s):  
Marco Aurélio Fornazieri ◽  
Henrique Kazuo Lima Kubo ◽  
Lisandra Coneglian de Farias ◽  
Adriano Morita Fernandes da Silva ◽  
Ellen Cristine Duarte Garcia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Tranexamic Acid ◽  
Postoperative Bleeding ◽  
Group Versus ◽  
Double Blind ◽  
Randomized Controlled ◽  
Bleeding Volume ◽  
Double Blind Clinical Trial ◽  
To Receive

Abstract Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.

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

2000 ◽  
Vol 14 (7) ◽  
pp. 599-602 ◽  
Author(s):  
Sander Veldhuyzen van Zanten ◽  
Alain Farley ◽  
Norman Marcon ◽  
Raymond Lahaie ◽  
André Archambault ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Previous Attempt ◽  
Double Blind Study ◽  
Double Blind ◽  
Colloidal Bismuth Subcitrate ◽  
Intention To Treat ◽  
First Line Therapy ◽  
Bismuth Subcitrate ◽  
H Pylori ◽  
Colloidal Bismuth

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.

scholarly journals Efficacy of two dosing schemes of a liquid containing ivy leaves dry extract EA 575 versus placebo in the treatment of acute bronchitis in adults

2019 ◽  
Vol 5 (4) ◽  
pp. 00019-2019 ◽  
Author(s):  
Axel Schaefer ◽  
Fanny Ludwig ◽  
Bruno M. Giannetti ◽  
Michael Bulitta ◽  
Anja Wacker
Keyword(s):  
Clinical Trial ◽  
Acute Bronchitis ◽  
Acute Cough ◽  
Observational Period ◽  
Double Blind ◽  
Dry Extract ◽  
Double Blind Clinical Trial ◽  
Efficacy Outcome ◽  
End Of Treatment ◽  
Verbal Category

IntroductionThe results of a clinical trial published in 2016 showed the efficacy of ivy leaves dry extract EA 575 versus placebo in the treatment of patients suffering from acute cough. A clinical trial with a very similar design was conducted to not only show the reproducibility of former results but also to investigate an alternative dosing scheme.MethodsThis randomised, placebo-controlled, multicentre, double-blind clinical trial was conducted to assess the efficacy and safety of a liquid containing EA 575 in the treatment of acute bronchitis. A total of 209 patients were treated with a liquid containing EA 575 as an active investigational medicinal product (verum) either two (7.5 mL) or three (5 mL) times a day or placebo in the respective dosing scheme for 1 week, with a total observational period of 2 weeks. The primary efficacy outcome was a change in Bronchitis Severity Score (BSS) of the pooled placebo and pooled verum groups between visits 1 and 5. Additional secondary parameters were assessed, including, for example, change in cough severity as assessed by a visual analogue scale (VAS) and the Verbal Category Descriptive (VCD) score.ResultsSuperiority of verum over placebo was during and at the end of treatment, as measured by BSS. No significant differences between the dosing schemes were observed. VCD scores and VAS measurements also showed the superiority of verum over placebo.ConclusionThe existing data on the clinical efficacy of EA 575 were confirmed. Furthermore, a new dosing scheme was shown to be noninferior to the currently used scheme while maintaining the safety and tolerability of the well-established cough liquid containing EA 575.

scholarly journals Comparison of Levofloxacin-Based, 10-day Sequential Therapy with 14-day Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial

2018 ◽  
Vol 10 (4) ◽  
pp. 242-248 ◽  
Author(s):  
Eskandar Hajiani ◽  
Pezhman Alavinejad ◽  
Nahid Avandi ◽  
Abdol Rahim Masjedizadeh ◽  
Ali Akbar Shayesteh
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Eradication Rate ◽  
Therapy Group ◽  
Sequential Therapy ◽  
Quadruple Therapy ◽  
Group A ◽  
H Pylori ◽  
Group B ◽  
To Receive

BACKGROUND Considering the importance of Helicobacter pylori (H. pylori) eradication, this clinical trial was designed to prospectively evaluate the efficacy of levofloxacin-based, sequential therapy in comparison with quadruple therapy for eradicating H. pylori. METHODS Overall 156 patients with dyspepsia and H. pylori infection were included in this study and were randomly allocated to either 10-day sequential therapy group (group A) to receive pantoprazole (40 mg twice daily), amoxicillin (1 gr twice daily), levofloxacin (500 mg twice daily), and tinidazole (500 mg twice daily) (PALT) or 14-day quadruple therapy group (group B) to receive pantoprazole, clarithromycin, bismuth subcitrate, and amoxicillin (PABC). At the end of the study the eradication rate in each group was assessed by urea breath test (UBT). RESULTS Age range of the participants was 18-65 years (average 36.9 years) and 50% of them (78 patients) were men. 78 patients were allocated to group A and 78 patients to groupe B. After antibiotic therapy, all the patients received acid suppression therapy with Proton Pump Inhibitor (PPI) for 4 weeks and then the eradication rate was confirmed by UBT (Heli FAN plus 13C, Germany). Before performing UBT, all the participants were requested to halt consumption of PPI for at least 1 week. During the treatment there was not any major complication but in group A (sequential therapy), two patients complained of minor complications including musculoskeletal pain. None of the patients in group B had any complaint or side effect. The rate of H. pylori eradication in group A was 78.2% (61 patients) while this rate in group B was 83.3% (65 patients) with no significant difference between the two groups (p = 0.42). In subgroup analysis, the rate of eradication among men in group A and B were 76.9% and 89.7%, respectively (p = 0.22) while the eradication rate among women were 79.4% and 76.9%, respectively (p = 1.00). CONCLUSION It seems that levofloxacin base sequential therapy does not have any advantage in comparison with quadruple regimen and until finding any more effective short course therapy for H. Pylori eradication; we encourage quadruple regimen to be used as the first line therapy.

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

Gut ◽  
1998 ◽  
Vol 42 (2) ◽  
pp. 166-169 ◽  
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.

scholarly journals Comparing the Effect of Two Low-dose and High-dose Four-drug Regimens of Furazolidone in Eradicating Helicobacter Pylori

2021 ◽  
Vol 13 (2) ◽  
pp. 131-138
Author(s):  
Mohammad Reza Seyedmajidi ◽  
Seyed Ashkan Hosseini ◽  
Jamshid Vafaeimanesh
Keyword(s):  
Helicobacter Pylori ◽  
Dose Group ◽  
Low Dose ◽  
Good Choice ◽  
Response To Treatment ◽  
High Dose ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Drug Regimens ◽  
H Pylori

BACKGROUND Antibiotic resistance is a major cause of Helicobacter pylori (H. pylori) treatment failures. The increased resistance to clarithromycin and metronidazole has reduced the ability of this therapeutic regimen and prompted researchers to look for other drugs. One of the antibiotics of interest in this regard is furazolidone because of its low drug resistance. The aim of this study is compare two-drug regimens including low-dose and high-dose furazolidone in the treatment of H. pylori. METHODS This study is a clinical trial in which the studied subjects were categorized into two groups. The first group underwent treatment with amoxicillin 1000 mg-BD, furazolidone 100 mg-BD, omeprazole 20 mg-BD, and bismuth subcitrate 240 mg-BD for two weeks (low-dose OFAB). The second group received furazolidone 200 mg-BD (high-dose OFAB). Then eight weeks after completion of the treatment, they were examined in terms of eradication via the UBT test. RESULTS 85 participants completed the study in each group. The response to treatment was 76% and 83% in the low and high-dose groups, respectively, based on intention to treat analysis. Based on per protocol analysis the response to treatment was 78% and 84%, respectively, if excluded patients had completed their protocol and had response to treatment, and 72% and 79%, respectively, if excluded patients had completed their protocol and did not have response to treatment (p = 0.298). In the low-dose and high-dose groups, 16.5% and 24.7% of the participants suffered the complications of treatment with furazolidone (p = 0.18), respectively. Three patients in the high-dose group and one in the low-dose group did not complete the treatment because of the medication’s bad taste (p = 0.03). CONCLUSION Low doses of furazolidone had a comparable therapeutic effect compared with high doses, but patients experienced significantly lower levels of bad taste, which was a major cause of reluctance to continue treatment. Therefore, we think four-drug low-dose furazolidone treatment is a good choice in eradicating H. pylori.

scholarly journals Sequential, concomitant and hybrid first-line therapies for Helicobacter pylori eradication: a prospective randomized study

2014 ◽  
Vol 63 (5) ◽  
pp. 748-752 ◽  
Author(s):  
Vincenzo De Francesco ◽  
Cesare Hassan ◽  
Lorenzo Ridola ◽  
Floriana Giorgio ◽  
Enzo Ierardi ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Randomized Study ◽  
Sequential Therapy ◽  
Concomitant Therapy ◽  
First Line ◽  
Helicobacter Pylori Eradication ◽  
Intention To Treat ◽  
H Pylori ◽  
To Receive ◽  
Treat Analysis

Helicobacter pylori eradication remains a challenge for physicians. Sequential, concomitant and the hybrid regimens have been proposed as novel, more effective therapies. We compare the efficacy of these therapies. Dyspeptic patients referred for upper endoscopy with H. pylori infection were enrolled. Patients were randomized to receive: (a) sequential therapy – 20 mg omeprazole and 1 g amoxicillin for 5 days, followed by 20 mg omeprazole, 500 mg clarithromycin and 500 mg tinidazole for the successive 5 days; (b) concomitant therapy – 20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for either 5 days (5 day concomitant) or 14 days (14 day concomitant); or (c) hybrid therapy – 20 mg omeprazole and 1 g amoxicillin for 7 days, followed by 20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for the successive 7 days. All drugs were given twice daily. Bacterial eradication was checked by using a [13C]urea breath test. In ‘intention-to-treat’ analysis, sequential therapy achieved the highest eradication rate, which was higher than that of 5 day concomitant therapy (90  vs 78.1 %; P = 0.02). The success rate did not statistically differ among the sequential and either 14 day concomitant (90  vs 86.3 %; P = not significant) or hybrid therapies (90  vs 82.7 %; P = not significant). The 10 day sequential, 14 day concomitant and 14 day hybrid therapies, but not the 5 day concomitant regimen, achieved similarly high eradication rates. The lower therapeutic cost coupled with the lower number of tablets needed would favour the sequential therapy as the first-line H. pylori treatment in clinical practice.

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