Evaluation of the Effects of Food Containing Epilobium angustifolium Extract on Quality of Life Related to Nocturia Urination Using the N-QOL Questionnaire: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
- 1 Toyo Shinyaku Co., Ltd., Saga, Japan
- 2 Toyo Shinyaku Co., Ltd., Saga, Japan
- 3 Toyo Shinyaku Co., Ltd., Saga, Japan
- 4 Toyo Shinyaku Co., Ltd., Saga, Japan
- 5 Toyo Shinyaku Co., Ltd., Saga, Japan
- 6 Toyo Shinyaku Co., Ltd., Saga, Japan
- 7 Toyo Shinyaku Co., Ltd., Saga, Japan
- 8 Toyo Shinyaku Co., Ltd., Saga, Japan
- 9 Toyo Shinyaku Co., Ltd., Saga, Japan
- 10 Medical Corporation Chidori-kai Ishibashi Orthopedic Clinic, Saga, Japan
Abstract
Background: Nocturia, characterized by waking during the night to urinate, is a common condition that significantly impacts quality of life (QOL) by disrupting sleep and reducing daytime vitality. Epilobium angustifolium , a medicinal plant, has shown potential in improving nocturia-related symptoms due to its active constituent, oenothein B, which possesses anti-inflammatory and antioxidant properties. This study aimed to evaluate the effects of Epilobium angustifolium extract on nocturia-related QOL using the Nocturia Quality of Life Questionnaire (N-QOL). Methods : We conducted a 9-week, randomized, double-blind, placebo-controlled, parallel-group trial involving healthy adults with frequent urination and self-perceived sleep disturbances. The participants were randomly assigned to receive either tablet containing Epilobium angustifolium extract providing 15 mg/day of oenothein B or a placebo for 8 weeks. The primary outcome was the N-QOL score, assessed at baseline, and at 4 and 8 weeks. Results: A total of 47 participants completed the study and were included in the analysis. The active group showed significantly greater improvements in the N-QOL total score and Sleep/Energy score compared to the placebo group at both 4 and 8 weeks. No significant differences were observed to the Bother/Concern score or Overall Health Perception. No adverse events related to the study food were reported. Conclusions : The intake of Epilobium angustifolium extract providing 15 mg/day of oenothein B significantly improved the nocturia-related QOL, particularly in the domains of sleep and energy, in adults with frequent urination tendencies and sleep complaints. These findings suggest that Epilobium angustifolium extract may serve as a practical and safe approach to managing nocturia-related QOL.
- van Kerrebroeck, P., Abrams, P., Chaikin, D., Donovan, J., Fonda, D., Jackson, S., et al . (2002) The Standardisation of Terminology in Nocturia: Report from the Standardisation Sub-Committee of the International Continence Society. Neurourology and Urodyna mics , 21, 179-183. https://doi.org/10.1002/nau.10053
- Kupelian, V., Wei, J.T., O’Leary, M.P., Norgaard, J.P., Rosen, R.C. and McKinlay, J.B. (2012) Nocturia and Quality of Life: Results from the Boston Area Community Health Survey. European Urology , 61, 78-84. https://doi.org/10.1016/j.eururo.2011.05.065
- Abraham, L., Hareendran, A., Mills, I.W., Martin, M.L., Abrams, P., Drake, M.J., et al . (2004) Development and Validation of a Quality-of-Life Measure for Men with Nocturia. Urology , 63, 481-486. https://doi.org/10.1016/j.urology.2003.10.019
- The Japanese Continence Society and The Japanese Urological Association (2020) Clinical Guidelines for Nocturia. 2nd Edition, Rich Hill Medical Inc.
- Gratzke, C., Bachmann, A., Descazeaud, A., Drake, M.J., Madersbacher, S., Mamoulakis, C., et al . (2015) EAU Guidelines on the Assessment of Non-Neurogenic Male Lower Urinary Tract Symptoms Including Benign Prostatic Obstruction. European Urology , 67, 1099-1109. https://doi.org/10.1016/j.eururo.2014.12.038
- Schepetkin, I.A., Ramstead, A.G., Kirpotina, L.N., Voyich, J.M., Jutila, M.A. and Quinn, M.T. (2016) Therapeutic Potential of Polyphenols from Epilobium Angustifolium (Fireweed). Phytotherapy Research , 30, 1287-1297. https://doi.org/10.1002/ptr.5648
- Matsuoka, N., Onizuka, S., Ogami, T., Takashima, S.I., Kamiya, T., Takagaki, K.Y., et al . (2023) The Effect of Food Containing Epilobium Angustifolium Extract on Quality of Life Related to Nocturnal Urination—A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study. Pharmacometrics , 104, 55-60.
- Buysse, D.J., Reynolds III, C.F., Monk, T.H., Berman, S.R. and Kupfer, D.J. (1989) The Pittsburgh Sleep Quality Index: A New Instrument for Psychiatric Practice and Research. Psychiatry Research , 28, 193-213.
- Wu, Y.H., Chueh, K.S., Chuang, S.M., Long, C.Y., Lu, J.H. and Juan, Y.S. (2021) Bladder Hyperactivity Induced by Oxidative Stress and Bladder Ischemia: A Review of Treatment Strategies with Antioxidants. International Journal of Molecular Sciences , 22, Article 6014. https://doi.org/10.3390/ijms22116014
- Dokumacioglu, E., Demiray, O., Dokumacioglu, A., Sahin, A., Sen, T.M. and Cankaya, S. (2018) Measuring Urinary 8-Hydroxy-2’-Deoxyguanosine and Malondialdehyde Levels in Women with Overactive Bladder. Investigative and Clinical Urology , 59, 252-256. https://doi.org/10.4111/icu.2018.59.4.252