Lih-Lian Chen1, Yuh-Chiang Shen2, Chih-Chun Ke3, Zuha Imtiyaz4, Hui-I Chen4, Chin-Hsien Chang5, Mei-Hsien Lee6. 1. PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan. 2. PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; National Taipei University of Nursing and Health Sciences, 365 Mingde Road, Taipei 11219, Taiwan; National Research Institute of Chinese Medicine, Ministry of Health and Welfare, 155-1 Linong Street, Sec. 2, Taipei 11221, Taiwan. 3. Department of Urology, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan. 4. PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan. 5. Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan; Department of Cosmetic Science, Chang Gung University of Science and Technology, 261 Wenhua 1st road, Taoyuan City 33303, Taiwan. 6. PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Center for Reproductive Medicine & Sciences, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan. Electronic address: lmh@tmu.edu.tw.
Abstract
BACKGROUND: Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study. MATERIALS AND METHODS: In this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with aplacebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test. RESULTS: In total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60). CONCLUSIONS: Compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.
RCT Entities:
BACKGROUND: Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study. MATERIALS AND METHODS: In this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test. RESULTS: In total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60). CONCLUSIONS: Compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.
Authors: Łukasz Zapała; Kajetan Juszczak; Przemysław Adamczyk; Jan Adamowicz; Aleksander Ślusarczyk; Tomasz Kluz; Marcin Misiek; Artur Rogowski; Magdalena Emilia Grzybowska; Klaudia Stangel-Wójcikiewicz; Mikołaj Piotr Zaborowski; Ewa Poleszak; Piotr Radziszewski; Andrzej Wróbel Journal: Front Mol Biosci Date: 2022-06-21