Published July 30, 2023 | Version https://impactfactor.org/PDF/IJPCR/15/IJPCR,Vol15,Issue7,Article35.pdf
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A Randomized Comparative Study of Levofloxacin Based Triple Therapy with Standard Triple Therapy for Helicobacter Pylori Eradication

  • 1. Associate Professor, Department of Pharmacology, Darbhanga Medical College and Hospital, Laheriasarai, Darbhanga, Bihar, India
  • 2. Professor and HOD, Department of Pharmacology, Darbhanga Medical College and Hospital, Laheriasarai, Darbhanga, Bihar, India
  • 3. PG, Department of Pharmacology, Darbhanga Medical College and Hospital, Laheriasarai, Darbhanga, Bihar, India

Description

Background: The isolation of Helicobacter pylori has opened the floodgates to a new era of discovery and understanding of gastro-duodenal pathology and heralded a revolution in the thinking about the pathophysiology and the treatment of PUD in particular. Preliminary data on triple therapies including either levofloxacin or azithromycin have shown positive results and suggest that these compounds could be promising for Helicobacter pylori treatment. As more is learnt about the organism and the disease process, it is hoped that a simple and an effective cure will be discovered. Aim: Comparison of levofloxacin-based triple therapy with standard triple therapy for helicobacter pylori eradication. Methods and Materials: The study was conducted in 72 patients attending the OPD of Gastroenterology. Patients were randomized according to a computer-generated randomization schedule, to receive a 7 days treatment with either Esomeprazole 20mg, Levofloxacin 500mg and Azithromycin 500mg, once daily (ELA) or Esomeprazole 20mg, Clarithromycin 500mg and Amoxicillin 1g twice daily (ECA). Esomeprazole was given 30 minutes prior to breakfast and dinner, whilst the antibiotics were taken together immediately after meals. The use of alcohol was discouraged during the study period. All the patients were continued with esomeprazole 20mg once daily for the next 3 weeks, followed by a drug-free period of 1 week. Within a week following completion of the 7 days study medications, patients came for the end-of-treatment assessment. Results: Twenty-nine (85.3%) patients in the ELA group, 33(94.3%) patients in the ECA group experienced an improvement in the severity of the symptoms, whereas 5(14.7%) patients in the ELA group and 2(5.7%) patients in the ECA group felt that the symptoms were unresolved or even worsened. In the ELA group, the lesions were completely healed in 21(61.76%) cases as compared to 27(77.1%) cases in the ECA group (X2=2.32, p=0.127). Helicobacter pylori infection was eradicated in 23(67.6%) cases, in the ELA group, whereas the eradication rate with the ECA group was 77.1% (27 cases) (X2=0.779, p=0.377). Conclusion: The present study demonstrates that once daily levofloxacin plus azithromycin-based triple therapy achieves Helicobacter pylori eradication rate comparable to that of the standard, twice daily triple therapy. Patient compliance, drug tolerability and side effects profile were almost the same in the two treatment groups. Hence levofloxacin-based triple therapies may represent a promising, alternative therapeutic option in the first-line therapy for Helicobacter pylori infection.

 

 

Abstract (English)

Background: The isolation of Helicobacter pylori has opened the floodgates to a new era of discovery and understanding of gastro-duodenal pathology and heralded a revolution in the thinking about the pathophysiology and the treatment of PUD in particular. Preliminary data on triple therapies including either levofloxacin or azithromycin have shown positive results and suggest that these compounds could be promising for Helicobacter pylori treatment. As more is learnt about the organism and the disease process, it is hoped that a simple and an effective cure will be discovered. Aim: Comparison of levofloxacin-based triple therapy with standard triple therapy for helicobacter pylori eradication. Methods and Materials: The study was conducted in 72 patients attending the OPD of Gastroenterology. Patients were randomized according to a computer-generated randomization schedule, to receive a 7 days treatment with either Esomeprazole 20mg, Levofloxacin 500mg and Azithromycin 500mg, once daily (ELA) or Esomeprazole 20mg, Clarithromycin 500mg and Amoxicillin 1g twice daily (ECA). Esomeprazole was given 30 minutes prior to breakfast and dinner, whilst the antibiotics were taken together immediately after meals. The use of alcohol was discouraged during the study period. All the patients were continued with esomeprazole 20mg once daily for the next 3 weeks, followed by a drug-free period of 1 week. Within a week following completion of the 7 days study medications, patients came for the end-of-treatment assessment. Results: Twenty-nine (85.3%) patients in the ELA group, 33(94.3%) patients in the ECA group experienced an improvement in the severity of the symptoms, whereas 5(14.7%) patients in the ELA group and 2(5.7%) patients in the ECA group felt that the symptoms were unresolved or even worsened. In the ELA group, the lesions were completely healed in 21(61.76%) cases as compared to 27(77.1%) cases in the ECA group (X2=2.32, p=0.127). Helicobacter pylori infection was eradicated in 23(67.6%) cases, in the ELA group, whereas the eradication rate with the ECA group was 77.1% (27 cases) (X2=0.779, p=0.377). Conclusion: The present study demonstrates that once daily levofloxacin plus azithromycin-based triple therapy achieves Helicobacter pylori eradication rate comparable to that of the standard, twice daily triple therapy. Patient compliance, drug tolerability and side effects profile were almost the same in the two treatment groups. Hence levofloxacin-based triple therapies may represent a promising, alternative therapeutic option in the first-line therapy for Helicobacter pylori infection.

 

 

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Dates

Accepted
2023-05-30

References

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