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Published on: March 7, 2025
Enhanced H. pylori Treatment Using a β-Cyclodextrin-Propolis Complex: A Randomized Clinical Trial
Aisa Mehri1, Shabnam Pourmoslemi1, Alireza Khalilian2
1Department of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran, umsha.ac.ir.
A novel beta-cyclodextrin-propolis complex shows promise as a natural adjunctive therapy for Helicobacter pylori infection, improving eradication rates and symptom relief with minimal side effects.
Area of Science:
- Natural Product Chemistry
- Clinical Microbiology
- Pharmacology
Background:
- Helicobacter pylori infection presents a significant global health challenge, exacerbated by antibiotic resistance and treatment side effects.
- Propolis, a natural resin, possesses antimicrobial and anti-inflammatory properties but is limited by poor solubility and bioavailability.
- A beta-cyclodextrin-propolis complex was developed to enhance propolis delivery and efficacy for H. pylori infections.
Purpose of the Study:
- To evaluate the therapeutic efficacy of a beta-cyclodextrin-propolis complex as an adjunct to standard quadruple therapy for H. pylori eradication.
- To assess the impact of the complex on gastrointestinal symptom resolution and patient outcomes.
- To characterize the physical and release properties of the beta-cyclodextrin-propolis complex.
Main Methods:
- A double-blind, randomized clinical trial involving biopsy-confirmed H. pylori patients.
- Participants received standard quadruple therapy with omeprazole, plus either the beta-cyclodextrin-propolis complex (250 mg/day) or placebo for 2 months.
- Outcomes were measured via fecal antigen tests and symptom questionnaires; complex characterization included FESEM, FTIR, and drug release studies.
Main Results:
- The beta-cyclodextrin-propolis complex exhibited successful formation and sustained propolis release.
- A higher proportion of patients receiving the complex achieved negative H. pylori antigen tests and symptom resolution (57.1%) compared to placebo (41.6%).
- Adverse effects were mild and comparable between the treatment and control groups.
Conclusions:
- The beta-cyclodextrin-propolis complex demonstrates potential as an effective natural adjunct for H. pylori treatment.
- This complex may improve eradication rates and alleviate gastrointestinal symptoms associated with H. pylori infection.
- Further research into natural adjuncts like this complex is warranted given rising antibiotic resistance.
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