ABSTRACT
The natural clinoptilolite material is an inorganic crystal mineral called zeolite. It has been extensively studied and used in industrial applications and veterinary and human medicine due to positive effects on health. Limited data is available in the scientific literature about its effects on the levels of physiologically relevant minerals in the human organism. Accordingly, we performed a comprehensive and controlled monitoring of the relevant mineral and contaminants levels in human subjects supplemented with a certified clinoptilolite material within three clinical trials with different supplementation regimens. Effects of a registered and certified clinoptilolite material PMA-zeolite on selected mineral and metal levels were determined by standard biochemical methods and inductively coupled plasma mass spectrometry (ICP-MS) in the blood of subjects enrolled in three clinical trials: short-term (28 days, Mineral Metabolism and selected Blood Parameters study MMBP), medium-term (12 weeks, Morbus Crohn study), and long-term (4 years, Osteoporosis TOP study) supplementation. Lower concentrations were observed for copper (Cu) in patients with osteoporosis, which normalized again in the long-term supplementation trial, whereas sodium (Na) and calcium (Ca) levels diminished below the reference values in patients with osteoporosis. In the short- and long-term supplementation trials, increased levels of lead (Pb) were observed in PMA-zeolite-supplemented subjects, which decreased in the continued long-term supplementation trial. Increased levels of aluminum (Al) or Pb attributable to eventual leakage from the material into the bloodstream were not detected 1 h after intake in the short-term supplementation trial. Nickel (Ni) and Al were statistically significantly decreased upon long-term 4-year supplementation within the long-term supplementation trial, and arsenic (As) was statistically significantly decreased upon 12-weeks supplementation in the medium-term trial. Alterations in the measured levels for Na and Ca, as well as for Pb, in the long-term trial are probably attributable to the bone remodeling process. Checking the balance of the minerals Cu, Ca, and Na after 1 year of supplementation might be prescribed for PMA-supplemented patients with osteoporosis. Clinical Trial Registration: [https://clinicaltrials.gov], identifiers [NCT03901989, NCT05178719, NCT04370535, NCT04607018].
ABSTRACT
BACKGROUND AND OBJECTIVES: Energy-based treatments have been found to be a promising treatment modality for improving stress urinary incontinence (SUI) symptoms. This prospective two-center study was designed to evaluate the efficacy of fractional-pixel CO2 laser for the treatment of SUI. STUDY DESIGN/MATERIALS AND METHODS: Eighty-five women with SUI symptoms as per the cough stress test and validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), were treated intravaginally with Pixel-CO2 laser. Two treatment sessions were performed with a 1-month interval. Safety and treatment tolerance were assessed by the visual analog scale (VAS) immediately and at 1 week after each laser treatment. Associations of age and body mass index (BMI) with the ICIQ-UI-SF score were statistically assessed by the Jonckheere-Terpstra test. RESULTS: The ICIQ-UI-SF score was 12.0 at baseline, 7.0, after the first treatment, and 3.5 after the second treatment (P = 0.001). For women with BMI (25.0-29.9), the ICIQ-UI-SF score was 9.0 at the baseline, 6.0 after 1 month, and 5.0 at the 6 months follow-up visit (P = 0.04). For women with BMI ≥ 30.0, the ICIQ-UI-SF score was reduced from 14.0 to 8.0 1 month after the baseline and 5.0 at the 6-month follow-up visit (P = 0.001). SUI severity evaluation at baseline showed that 27.1% of women had mild, 24.7% had moderate, 45.9% had severe, and 2.4% had very severe SUI symptoms. SUI severity scores were significantly reduced, with 45.8% of women with no SUI symptoms, 18.8% with mild, 20.8% with moderate, and 14.6% with severe SUI symptoms at the 6-month follow-up. The patient's evaluation of VAS after the first treatment was 1.0-1.5 (0-10) and 0.0 1 week after the second treatment. CONCLUSION: Fractional-pixel CO2 laser is safe and effective for treating SUI. No adverse event or significant pain was reported during or after the procedure. Its safety and efficacy are clearly demonstrated. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.
