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Planta Med 2019; 85(13): 1044-1053
DOI: 10.1055/a-0946-2280
Biological and Pharmacological Activity
Original Papers
Georg Thieme Verlag KG Stuttgart · New York

Cucurbita pepo–Rhus aromatica–Humulus lupulus Combination Reduces Overactive Bladder Symptoms in Women – A Noninterventional Study

Annett Gauruder-Burmester
1   Interdisciplinary Pelvic Floor Center (Interdisziplinäres Beckenbodenzentrum), Berlin, Germany
,
Stefan Heim
2   Omega Pharma Manufacturing GmbH & Co. KG, Herrenberg, Germany
,
Brigitte Patz
3   Brigitte Patz Medical Writing, Gäufelden, Germany
,
Stephanie Seibt
4   Analyze & Realize GmbH, Berlin, Germany
› Author Affiliations
Further Information

Publication History

received 26 February 2019
revised 23 May 2019

accepted 27 May 2019

Publication Date:
01 July 2019 (online)

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Abstract

This prospective, noninterventional, multicenter 12-wk study in women with overactive bladder investigated the effectiveness of Granu Fink femina, a herbal combination of seed oil from Uromedic pumpkin (cultivar of Cucurbita pepo), Rhus aromatica (fragrant sumach) bark extract, and Humulus lupulus (hop) cone extract in a clinical setting. Patients documented overactive bladder symptoms and quality of life using questionnaires as well as diaries recording day- and nighttime micturition frequencies, urine leakages during physical activity or at sneezing or coughing, and use of incontinence pads. The full analysis set included 117 women (age: 21 – 78 y). Urination frequency decreased significantly with improvement during daytime in 49, 71, and 77 (out of 99) patients and at night in 45, 63, and 70 (out of 100) patients after 1, 6, and 12 wk, respectively. The mean frequency of leakages and used pads decreased significantly from 0.9 leakages and 2.0 pads at baseline to 0.4 leakages and 1.4 pads after 12 wk. In all measured aspects of overactive bladder-related quality of life, (coping, concern, sleep, social), statistically significant improvement was reached after 1 wk, with further improvement at 6 and 12 wk. Ninety-nine percent of the physicians and 95.4% of the patients rated tolerability as “very good” or “good”. Treatment with Granu Fink femina progressively improved overactive bladder symptoms and related quality of life with significant improvements already after 1 wk. Based on these effects and the observed excellent tolerability profile, Granu Fink femina may be considered a valuable therapeutic option for overactive bladder.

Key words

overactive bladder - quality of life - Cucurbita pepo - Cucurbitaceae - Rhus aromatica - Anarcardiaceae - Humulus lupulus - Cannabaceae
 

  • References

  • 1 Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Kerrebroeck P, Victor A, Wein A. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21: 167-178
    CrossrefPubMedGoogle Scholar
  • 2 Shy M, Fletcher SG. Objective evaluation of overactive bladder: which surveys should I use?. Curr Bladder Dysfunct Rep 2013; 8: 45-50
    CrossrefPubMedGoogle Scholar
  • 3 Irwin D, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006; 50: 1306-1315
    CrossrefPubMedGoogle Scholar
  • 4 Stewart W, Van Rooyen J, Cundiff G, Abrams P, Herzog A, Corey R, Hunt T, Wein A. Prevalence and burden of overactive bladder in the United States. World J Urol 2003; 20: 327-336
    CrossrefPubMedGoogle Scholar
  • 5 Habermann T, Ghosh A. Mayo Clinic Internal Medicine Concise Textbook. CRC Press, Boca Raton: Mayo Clinic Scientific Press – Informa Healthcare; 2007
    Google Scholar
  • 6 Abrams P, Wein A. Introduction: overactive bladder and its treatments. BJUI Int 2000; 85: 1-2
    PubMedGoogle Scholar
  • 7 Tyagi S, Thomas C, Hayashi Y, Chancellor M. The Overactive Bladder: Epidemiology and Morbidity. Urol Clin North Am 2006; 33: 433-438
    CrossrefPubMedGoogle Scholar
  • 8 Jundt K, Peschers U, Friese K, Tunn R. Diagnostik der Reizblase bzw. überaktiven Blase. Der Drangsymptomatik auf der Spur. Gynäkologie + Geburtshilfe 2005; 4: 19-21
    PubMedGoogle Scholar
  • 9 Koelbl H. Die Reizblase in der gynäkologischen Praxis. J Urol Urogynäkol 2000; 7: 26-31
    PubMedGoogle Scholar
  • 10 Milsom I, Abrams P, Cardozo L, Roberts RG, Thüroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001; 87: 760-766
    CrossrefPubMedGoogle Scholar
  • 11 Robinson D, Toozs-Hobson P, Cardozo L. The effect of hormones on the lower urinary tract. Menopause Int 2013; 19: 155-162
    CrossrefPubMedGoogle Scholar
  • 12 Lenau H, Höxter G, Müller A, Maier-Lenz H. Wirksamkeit und Verträglichkeit von Cysto Fink® bei Patienten mit Reizblase und/oder Harninkontinenz. Therapiewoche 1984; 34: 6054-6059
    PubMedGoogle Scholar
  • 13 Schilcher H, Bauer H. Zur Plausibilität einer Phyto-„3er-Kombination“ zur Stärkung oder Kräftigung der Blasenfunktion. ÄfN 2003; 44: 485-489
    PubMedGoogle Scholar
  • 14 Muller C, Bracher F. Determination by GC-IT/MS of phytosterols in herbal medicinal products for the treatment of lower urinary tract symptoms and food products marketed in Europe. Planta Med 2015; 81: 613-620
    Article in Thieme ConnectPubMedGoogle Scholar
  • 15 Heim S, Seibt S, Stier H, Moré M. Uromedic® pumpkin seed derived Δ7-sterols, extract and oil inhibit 5α-reductases and bind to androgen receptor in vitro . Pharmacol Pharm 2018; 9: 193-207
    CrossrefPubMedGoogle Scholar
  • 16 Committee on Herbal Medicinal Products (HMPC). Assessment report on Cucurbita pepo L., semen EMA/HMPC/136022/2010 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_HMPC_assessment_report/2011/10/WC500116579.pdf Accessed April 10, 2019
    PubMedGoogle Scholar
  • 17 Orsavova J, Misurcova L, Ambrozova JV, Vicha R, Mlcek J. Fatty acids composition of vegetable oils and its contribution to dietary energy intake and dependence of cardiovascular mortality on dietary intake of fatty acids. Int J Mol Sci 2015; 16: 12871-12890
    CrossrefPubMedGoogle Scholar
  • 18 Zhang X, Ouyang JZ, Zhang YS, Tayalla B, Zhou XC, Zhou SW. Effect of the extracts of pumpkin seeds on the urodynamics of rabbits: an experimental study. J Tongji Med Univ 1994; 14: 235-238
    CrossrefPubMedGoogle Scholar
  • 19 Bach D. Placebokontrollierte Langzeittherapiestudie mit Kürbissamenextrakt bei BPH-bedingten Miktionsbeschwerden. Urologe 2000; 40: 437-443
    CrossrefPubMedGoogle Scholar
  • 20 Nishimura M, Ohkawara T, Sato H, Takeda H, Nishihira J. Pumpkin seed oil extracted from Cucurbita maxima improves urinary disorder in human overactive bladder. J Tradit Complement Med 2014; 4: 72-74
    CrossrefPubMedGoogle Scholar
  • 21 Borchert VE, Czyborra P, Fetscher C, Goepel M, Michel MC. Extracts from Rhois aromatica and Solidaginis virgaurea inhibit rat and human bladder contraction. Naunyn Schmiedebergs Arch Pharmacol 2004; 369: 281-286
    CrossrefPubMedGoogle Scholar
  • 22 Chakraborty A, Brantner A. Evaluation of biological activities of Rhus aromaticae extracts. Pharm Pharmacol Lett 2000; 2: 76-81
    PubMedGoogle Scholar
  • 23 ESCOP monographs. Lupuli flos – Hop strobile. European Scientific Cooperative on Phytotherapy. 2nd ed.. ed. Stuttgart: Thieme; 2003: 306-311
    Google Scholar
  • 24 Empagliflozin JM. Not just a glorified diuretic. Indian J Endocrinol Metab 2016; 20: 154-156
    CrossrefPubMedGoogle Scholar
  • 25 AWMF, Deutsche Gesellschaft für Gynäkologie und Geburtshilfe. Leitlinien, Empfehlungen, Stellungnahmen: Die überaktive Blase (ÜAB). AWMF online; 2010. Available at: https://www.awmf.org/leitlinien/detail/ll/015-007.html Accessed. April. 10. 2019
    Google Scholar
  • 26 Aaronson NK. Quality of life assessment in clinical trials: methodologic issues. Control Clin Trials 1989; 10: 195S-208S
    CrossrefPubMedGoogle Scholar
  • 27 Avery KN, Bosch JL, Gotoh M, Naughton M, Jackson S, Radley SC, Valiquette L, Batista J, Donovan JL. Questionnaires to assess urinary and anal incontinence: review and recommendations. J Urol 2007; 177: 39-49
    PubMedGoogle Scholar
  • 28 Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004; 23: 322-330
    CrossrefPubMedGoogle Scholar
  • 29 Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol 1996; 77: 805-812
    CrossrefPubMedGoogle Scholar
  • 30 Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 2002; 11: 563-574
    CrossrefPubMedGoogle Scholar
  • 31 Norton PA, MacDonald LD, Sedgwick PM, Stanton SL. Distress and delay associated with urinary incontinence, frequency, and urgency in women. BMJ 1988; 297: 1187-1189
    CrossrefPubMedGoogle Scholar
  • 32 Salamon H. Prüfung eines neuen Medikamentes zur Behandlung der Reizblase und allgemein gereizter Blasen mit rein funktionellen und organischen Blasenstörungen. Therapiewoche 1969; 19: 1187-1188
    PubMedGoogle Scholar
  • 33 Socha P. Ergebnisse einer neuen Behandlung gereizter Blasen und Enuresis mit Cysto-Kapseln. Dtsch Med J 1969; 20: 1-7
    PubMedGoogle Scholar
  • 34 Mohr H. Behandlung der Reizblase bei Frauen. Erfahrungen mit Cystokapseln Fink. MMW 1970; 112: 858-860
    PubMedGoogle Scholar
  • 35 Maurer H, Dreher E, Adam P, von Fischer B. Behandlung der sensorischen Urge-Symptomatik der Blase mit Cysto-Caps. Gynäkologische Rundschau 1979; 19: 108-110
    CrossrefPubMedGoogle Scholar
  • 36 Andersson KE. On the site and mechanism of action of beta3-adrenoceptor agonists in the bladder. Int Neurourol J 2017; 21: 6-11
    CrossrefPubMedGoogle Scholar
  • 37 Garely A, Kaufman J, Sand P, Smith N, Andoh M. Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther 2006; 28: 1935-1946
    CrossrefPubMedGoogle Scholar
  • 38 Armstrong RB, Dmochowski RR, Sand PK, Macdiarmid S. Safety and tolerability of extended-release oxybutynin once daily in urinary incontinence: combined results from two phase 4 controlled clinical trials. Int Urol Nephrol 2007; 39: 1069-1077
    CrossrefPubMedGoogle Scholar
  • 39 Benner JS, Nichol MB, Rovner ES, Jumadilova Z, Alvir J, Hussein M, Fanning K, Trocio JN, Brubaker L. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int 2010; 105: 1276-1282
    CrossrefPubMedGoogle Scholar
  • 40 Reynolds WS, McPheeters M, Blume J, Surawicz T, Worley K, Wang L, Hartmann K. Comparative effectiveness of anticholinergic therapy for overactive bladder in women: a systematic review and meta-analysis. Obstet Gynecol 2015; 125: 1423-1432
    CrossrefPubMedGoogle Scholar
  • 41 Chancellor MB, Yehoshua A, Waweru C, Globe D, Cheng IN, Campbell KL, Joshi M, Pulicharam R. Limitations of anticholinergic cycling in patients with overactive bladder (OAB) with urinary incontinence (UI): results from the CONsequences of Treatment Refractory Overactive bLadder (CONTROL) study. Int Urol Nephrol 2016; 48: 1029-1036
    CrossrefPubMedGoogle Scholar
  • 42 Sussman D, Yehoshua A, Kowalski J, Lee W, Kish J, Chaudhari S, Murray B. Adherence and persistence of mirabegron and anticholinergic therapies in patients with overactive bladder: a real-world claims data analysis. Int J Clin Pract 2017; 71: 3-4
    PubMedGoogle Scholar
  • 43 Hartmann KE, Mcpheeters ML, Biller DH, Ward RM, McKoy JN, Jerome RN, Micucci SR, Meints L, Fisher JA, Scott TA, Slaughter JC, Blume JD. Treatment of overactive bladder in women. Evid Rep Technol Assess (Full Rep) 2009; 187: 1-120
    PubMedGoogle Scholar
  • 44 Bristol Urological Institute. International Consultation on Incontinence Modular Questionnaire-ICIQ-OABqol Module; 2014. Available at: http://iciq.net/iciq-oabqol Accessed April 11, 2019
    PubMedGoogle Scholar
  • 45 Bristol Urological Institute. International Consultation on Incontinence Modular Questionnaire-ICIQ-OAB Module; 2014. Available at: http://iciq.net/iciq-oab Accessed April 10, 2019
    PubMedGoogle Scholar