Gastroenterology · Medical Literature
Enhanced H. pylori Treatment Using a β-Cyclodextrin-Propolis Complex: A Randomized Clinical Trial.
Abstract
Helicobacter pylori infection poses a significant global health burden, with rising antibiotic resistance and treatment-related side effects highlighting the need for adjunctive therapies. Propolis, a natural resin with known antimicrobial and anti-inflammatory properties, suffers from poor solubility and bioavailability. This study evaluated a β-cyclodextrin-propolis complex designed to enhance delivery and therapeutic efficacy in H. pylori-infected patients. In a double-blind, randomized clinical trial at Hamadan University of Medical Sciences, biopsy-confirmed H. pylori patients received standard quadruple therapy plus omeprazole. The treatment group (n = 28) also received 250 mg/day of the β-cyclodextrin-propolis complex for 2 months; the control group (n = 12) received placebo capsules. Outcomes were assessed using fecal antigen tests and gastrointestinal symptom questionnaires 2 months posttreatment. Characterization of the complex was performed using FESEM, FTIR, and drug release profiling in PBS (pH 7.4). The complex demonstrated a successful formation and a sustained propolis release profile. Clinically, 57.1% of treated patients achieved negative antigen tests and symptom resolution, compared with 41.6% in the control group. Adverse effects were mild and comparable between groups. These findings suggest that the β-cyclodextrin-propolis complex may serve as an effective natural adjunct to standard H. pylori treatment, offering potential benefits in eradication rates and symptom relief. Iranian Registry of Clinical Trials (IRCT): 20230503058065N1.
Clinical relevance
Does adjunctive oral β-cyclodextrin-propolis complex (250 mg/day for 2 months) added to standard quadruple H. pylori therapy improve eradication rates and gastrointestinal symptom burden compared with quadruple therapy plus placebo in biopsy-confirmed H. pylori-infected patients? __SNAPSHOT__ {"studyDesign":"Double-blind, randomized clinical trial","setting":"Hamadan University of Medical Sciences, Iran (single academic center)","sampleSize":"n=40 total (intervention: n=28, control: n=12); highly unequal allocation ratio","population":"Adults with biopsy-confirmed H. pylori infection; additional eligibility and exclusion criteria not reported in abstract","intervention":"Standard quadruple therapy plus omeprazole AND β-cyclodextrin-propolis complex 250 mg/day orally for 2 months","comparator":"Standard quadruple therapy plus omeprazole AND matched placebo capsules for 2 months","primaryOutcome":"H. pylori eradication rate by fecal antigen test 2 months post-treatment; gastrointestinal symptom scores by questionnaire (secondary or co-primary — not explicitly distinguished in abstract)","followUp":"2 months post-treatment assessment (total duration including treatment: approximately 4 months; treatment duration confirmed as 2 months)","fundingSource":"Not reported"}
Key findings
The abstract reports that 57.1% (16/28) of patients in the intervention group achieved a negative fecal antigen test (H. pylori eradication) at 2 months post-treatment. The eradication rate for the control group and between-group comparative statistics (risk difference, relative risk, odds ratio, confidence intervals, and p-values) are not reported in the available abstract. Accordingly, no NNT can be calculated from the data provided. Gastrointestinal symptom questionnaire results are referenced but specific scores, effect sizes, and statistical results for this outcome are not reported in the abstract. The β-cyclodextrin-propolis complex was physicochemically characterized (FESEM, FTIR, drug release profiling in PBS at pH 7.4) and demonstrated successful complex formation and sustained propolis release. Adverse event data are not reported in the available abstract.
Practice implications
Based solely on the available abstract, this study cannot establish whether the β-cyclodextrin-propolis complex significantly improves H. pylori eradication rates over standard quadruple therapy alone. The 57.1% eradication rate in the treatment group is notably lower than the ≥90% target recommended by consensus guidelines (e.g., Maastricht VI) and is below rates typically achieved by well-administered bismuth-based quadruple therapy in clinical practice, raising the possibility that the background eradication regimen used was suboptimal, that the patient population had high antibiotic resistance rates, or that the fecal antigen test was performed before adequate post-treatment clearance of antigen. Without the control group eradication rate, confidence intervals, or a p-value, no causal inference is possible. The study does not report which patients were excluded, antibiotic susceptibility profiles, prior treatment history, or compliance rates — all critical determinants of generalizability. The formulation work (FESEM, FTIR, drug release profiling) is supportive of the plausibility of the delivery system, but physicochemical characterization does not substitute for clinical efficacy data. Results cannot be applied to routine clinical practice on the basis of this abstract alone. NOTE: This summary is based on the abstract only; the full text may contain additional data including the control group eradication rate, comparative statistics, symptom outcomes, and safety data that would substantially alter interpretation. __LIMITATIONS__ Very small sample size (n=40 total) with substantially unequal allocation (28:12), severely underpowering the study and increasing risk of type II error,Only an abstract is available; key comparative efficacy data (control group eradication rate, between-group statistics, confidence intervals, p-values) are not reported or are truncated,Highly unequal randomization ratio (roughly 2.3:1) is unexplained and non-standard, potentially introducing allocation bias or suggesting post-hoc group modification,Single-center design at one Iranian academic institution limits generalizability to other geographic regions and resistance patterns,The specific antibiotic regimen comprising 'standard quadruple therapy' is not defined in the abstract, precluding assessment of regimen quality or adequacy,Antibiotic susceptibility testing results are not reported; baseline resistance rates are unknown and represent a major confounder,Fecal antigen test for eradication confirmation without concurrent urea breath test or biopsy-based confirmation may reduce diagnostic specificity,Gastrointestinal symptom questionnaire is referenced but not validated or named, preventing assessment of patient-reported outcome instrument quality,Adverse event profile and safety data are entirely absent from the abstract,Funding source is not reported, preventing assessment of financial conflict of interest,No long-term follow-up beyond 2 months post-treatment; re-infection and relapse rates are unknown,Propolis composition is geographically variable; the specific Iranian propolis source, standardization, and active component quantification are not reported in the abstract __BOTTOM_LINE_CATEGORY__ not_ready_for_clinical_application __BOTTOM_LINE__ This small, single-center, double-blind RCT (n=40) reports a 57.1% H. pylori eradication rate with adjunctive β-cyclodextrin-propolis complex added to quadruple therapy, but provides no comparative control group eradication rate or inferential statistics in the available abstract, making efficacy conclusions impossible. The observed eradication rate is below accepted clinical benchmarks regardless of group assignment, and the substantially unequal allocation ratio and minimal sample size are major methodological concerns. This formulation represents an early-phase clinical investigation requiring adequately powered, comparative trials with pre-specified endpoints before any practice consideration is warranted.