Efficacy of cinnamon patch treatment for alleviating symptoms of overactive bladder: A double-blind,randomized, placebo-controlled trial |
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| Affiliation: | 1. PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan;2. Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan;3. National Taipei University of Nursing and Health Sciences, 365 Mingde Road, Taipei 11219, Taiwan;4. National Research Institute of Chinese Medicine, Ministry of Health and Welfare, 155-1 Linong Street, Sec. 2, Taipei 11221, Taiwan;5. Department of Urology, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan;6. Department of Cosmetic Science, Chang Gung University of Science and Technology, 261 Wenhua 1st road, Taoyuan City 33303, Taiwan;7. Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan;8. Center for Reproductive Medicine & Sciences, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan;1. Faculty of Medicine, Université Laval, Québec, Québec, Canada;2. Department of Obstetrics, Gynecology, Reproductive Sciences, Rutgers, New Brunswick, NJ;3. Division of Urology, Department of Surgery, Faculty of Medicine and Health Sciences, Centre Hospitalier Universitaire de Sherbrooke and Centre de Recherche du CHUS, Sherbrooke, Québec, Canada;4. Division of Urology, Department of Surgery, Faculty of Medicine, CHU de Québec-Université Laval, Québec, Québec, Canada;1. College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China;2. Ocean College, Zhoushan Campus, Zhejiang University, Zhoushan 316021, China;3. Zhejiang Center for Medical Device Evaluation, Hangzhou 310009, China.;4. Department of Pharmacy, Zhejiang Cancer Hospital, Hangzhou 310022, China;1. Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy;2. Samnium Medical Soc. Cooperative, 82100 Benevento, Italy;3. Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy;4. Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy;5. Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy;6. Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 213/D, 41121 Modena, Italy;7. B Natural R&D Unit, via Gran Sasso 33, 20011 Corbetta (MI), Italy;8. International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China;1. National Research Institute of Chinese Medicine, Ministry of Health and Welfare, Taipei, Taiwan, ROC;2. Program for Neural Regenerative Medicine, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan, ROC;3. Brain Research Center, National Yang-Ming University, Taipei, Taiwan, ROC;4. Department of Life Sciences and Institute of Genome Sciences, National Yang-Ming University, Taipei, Taiwan, ROC;5. Biophotonics Interdisciplinary Research Center, National Yang-Ming University, Taipei, Taiwan, ROC;6. School of Chinese Pharmaceutical Sciences and Chinese Medicine Resources, College of Biopharmaceutical and Food Sciences, China Medical University, Taichung, Taiwan, ROC;7. Medical Research Center, Cardinal Tien Hospital, Hsintien, New Taipei City, Taiwan, ROC;8. Graduate Institute of Physiology & Department of Physiology and Biophysics, National Defense Medical Center, Taipei, Taiwan, ROC;9. Department of Biotechnology and Animal Science, National Ilan University, Ilan, Taiwan, ROC;1. Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan 8174673461, Iran;2. Cardiac Rehabilitation Research center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan 8174673461, Iran;3. Department of Pharmaceutical Sciences, Bhimtal, Kumaun University, Nainital - 263 002, Uttarakhand, India;4. Lake Erie College of Osteopathic Medicine, Bradenton, FL 34211, United States;5. Halal Research Center of Islamic republic of Iran, Food and Drug Administration, Tehran 1415845371, Iran;6. Nutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah 6718874414, Iran;7. Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah 6718874414, Iran;8. R.R.College of Pharmacy, Bangaluru 090 560, Karnataka, India |
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| Abstract: | 
BackgroundCurrent 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 MethodsIn 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.ResultsIn 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).ConclusionsCompared 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. |
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