Efficacy and safety of a medical device versus placebo in the early treatment of patients with symptoms of urinary tract infection: a randomized controlled trial.
García-Larrosa A et al.
Clinical Microbiology 2016, 5:1
Background:
The objective of the study was to analyze the efficacy and safety of a medical device containing reticulated gelatin with hibiscus and propolis (RGHP) in the early treatment of patients with symptoms of urinary tract infection (UTI).
Methods:
A double-blind, placebo-controlled trial was carried out in 60 patients who were randomized (1:1) to RGHP or placebo twice daily for 5 days. Follow-up was 11 days. Results: The risk ratio of patients who needed antibiotic treatment was lower in the RGHP group (RR, 0.3; 95% CI, 0.09 to 0.98). RGHP provided greater symptom relief than placebo (mean adjusted change in the global symptom score from baseline: -5.27 vs. 0.40; p<0.001). Adverse events were reported by 6.67% and 3.33% of patients (RGHP and placebo, respectively, p=0.5).
Conclusions:
RGHP was more effective than placebo in improving UTI symptoms and reduced the need for rescue antibiotic treatment.
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