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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Population
88 female patients over 18 years old with lower UTI
Methods
clinical trial, patients randomly assigned to control (antibiotics and placebo) or intervention (antibiotics plus 100 IU vitamin E daily), 3-day course of cefixime, then vitamin E for six months
Blinding
Open-label
Duration
six months
Funding
Unclear

Background and objective

Recurrent uncomplicated cystitis is highly prevalent among women. Antioxidants are often used as adjunctive therapy in urinary tract infections (UTIs) to counteract oxidative stress and restore a healthy urinary environment. This study aimed to evaluate the effect of vitamin E on the treatment and prevention of recurrent lower UTIs in women.

Materials and methods

This clinical trial included 88 female patients over 18 years old with lower UTI who were referred to the infectious diseases clinic at Vali-Asr Hospital in Birjand. Patients were initially assessed 3-5 days after starting antibiotics, and then at 3 and 6 month intervals for urinary symptoms and UTI recurrence. Patients were randomly assigned into one of the following groups: control group receiving antibiotics and a placebo, and the intervention group receiving antibiotics along with 100 IU of vitamin E daily. After completing a 3-day course of cefixime (400 mg/day), the intervention group continued vitamin E supplementation for six months. Data analysis was performed using SPSS version 19, with statistical significance set at P < 0.05.

Results

The mean age of the patients was 45.48 ± 14.23 years. After 3 days, the intervention group showed a significant improvement in urinary frequency and dysuria compared to the control group (P < 0.05), while improvement in urgency did not significantly differ between groups (P = 0.43). At 3 and 6 month intervals, UTI recurrence was significantly lower in the intervention group (P < 0.001; effect size = 0.52 and 0.69, respectively). Additionally, the average duration of recovery was significantly faster in the intervention group compared to the control group (P = 0.002).

Conclusion

Supplementing women with lower UTI with 100 IU of vitamin E daily to the antibiotic regimen significantly reduces recovery time, improves urinary symptoms (frequency and dysuria), and lowers UTI recurrence rates. However, further randomized clinical trials with large sample size are recommended to confirm these findings.

Trial registration

Iranian Registry of Clinical Trials Identifier: IRCT20210617051604N1 (July 11, 2021).

Research Insights

  • After 3 days, the intervention group showed a significant improvement in urinary frequency and dysuria compared to the control group (P < 0.05)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 IU daily
  • After 3 days, the intervention group showed a significant improvement in urinary frequency and dysuria compared to the control group (P < 0.05)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 IU daily
  • At 3 and 6 month intervals, UTI recurrence was significantly lower in the intervention group (P < 0.001; effect size = 0.52 and 0.69, respectively).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    100 IU daily
  • Additionally, the average duration of recovery was significantly faster in the intervention group compared to the control group (P = 0.002).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 IU daily
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