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Clinical study of effectiveness and safety of CELcomplex® containing Cucurbita Pepo Seed extract and Flax and Casuarina on stress urinary incontinence in women.
J Tradit Complement Med 2019; 9(2):138-142JT

Abstract

Aim

The safety and effectiveness of a preparation containing a mix of Cucurbita Pepo Seed extract, Equisetum arvense and Linum usitatissimum - Flax A (CELcomplex®) on stress urinary incontinence (SUI) was evaluated in female patients recruited from 20 urological and gynaecological outpatient clinics in Slovakia.

Methods

A total of 86 women aged from 32 to 88 with SUI (grade 1 = 44, grade 2 = 42) were enrolled in the study and followed-up for six weeks (point 1) and twelve weeks (point 2). The primary outcome of the study was evaluated by changes in day-time and nocturnal urinary frequency (bathroom visits) and urinary incontinence episodes (leaks). Also, adverse events were quantified as well as the self-perceived effectiveness of the treatment. Research Ethics Board approval was obtained for this study.

Results

After 12 weeks of treatment there was a 30% (grade 1 SUI, p < 0.01), and 35% (grade 2 SUI, p < 0.01) improvement in urinary incontinence episodes, a 40% (grade 1 SUI, p < 0.01) and 26% (grade 2 SUI, p < 0.01) improvement in day-time urination frequency and 64% (grade 1 SUI, p < 0.01) and 54% (grade 2 SUI, p < 0.01) improvement in nocturnal urinary frequency. Reported side effects were: headache (3.5%), flatulence (4.1%) and gastrointestinal discomfort (3%). A total of 89.4 % of women in the study reported no side effects from this therapy and 97% acknowledged improvement of symptoms.

Conclusion

This clinical study demonstrated that a 12 week treatment with a mix of Cucurbita Pepo Seed extract, Equisetum arvense and Linum usitatissimum - Flax A (CELcomplex®) is highly effective on stress urinary incontinence (SUI) with minimum adverse events. Further studies may be needed in order to determine the effectiveness and efficacy of this phytotherapy in other populations.

Authors+Show Affiliations

Institute of Pharmacology and Clinical Pharmacology, Faculty of Medicine in Bratislava, Comenius University, Slovakia.Department of Pharmacology and Toxicology, Faculty of Pharmacy in Bratislava, Comenius University, Slovakia.Department of Pharmacology and Toxicology, Faculty of Pharmacy in Bratislava, Comenius University, Slovakia.Department of Pharmaceutical Sciences, College of Pharmacy Nova South Eastern University, USA.Department of Pharmacology and Toxicology, Faculty of Pharmacy in Bratislava, Comenius University, Slovakia. Department of Internal Medicine, Faculty of Medicine in Bratislava, Comenius University, Slovakia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30963048

Citation

Gažová, Andrea, et al. "Clinical Study of Effectiveness and Safety of CELcomplex® Containing Cucurbita Pepo Seed Extract and Flax and Casuarina On Stress Urinary Incontinence in Women." Journal of Traditional and Complementary Medicine, vol. 9, no. 2, 2019, pp. 138-142.
Gažová A, Valášková S, Žufková V, et al. Clinical study of effectiveness and safety of CELcomplex® containing Cucurbita Pepo Seed extract and Flax and Casuarina on stress urinary incontinence in women. J Tradit Complement Med. 2019;9(2):138-142.
Gažová, A., Valášková, S., Žufková, V., Castejon, A. M., & Kyselovič, J. (2019). Clinical study of effectiveness and safety of CELcomplex® containing Cucurbita Pepo Seed extract and Flax and Casuarina on stress urinary incontinence in women. Journal of Traditional and Complementary Medicine, 9(2), pp. 138-142. doi:10.1016/j.jtcme.2017.10.005.
Gažová A, et al. Clinical Study of Effectiveness and Safety of CELcomplex® Containing Cucurbita Pepo Seed Extract and Flax and Casuarina On Stress Urinary Incontinence in Women. J Tradit Complement Med. 2019;9(2):138-142. PubMed PMID: 30963048.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical study of effectiveness and safety of CELcomplex® containing Cucurbita Pepo Seed extract and Flax and Casuarina on stress urinary incontinence in women. AU - Gažová,Andrea, AU - Valášková,Simona, AU - Žufková,Viera, AU - Castejon,Ana M, AU - Kyselovič,Ján, Y1 - 2018/05/03/ PY - 2016/12/07/received PY - 2017/09/21/revised PY - 2017/10/06/accepted PY - 2019/4/10/entrez PY - 2019/4/10/pubmed PY - 2019/4/10/medline KW - Pumpkin seed KW - Stress urinary incontinence – SUI KW - Women SP - 138 EP - 142 JF - Journal of traditional and complementary medicine JO - J Tradit Complement Med VL - 9 IS - 2 N2 - Aim: The safety and effectiveness of a preparation containing a mix of Cucurbita Pepo Seed extract, Equisetum arvense and Linum usitatissimum - Flax A (CELcomplex®) on stress urinary incontinence (SUI) was evaluated in female patients recruited from 20 urological and gynaecological outpatient clinics in Slovakia. Methods: A total of 86 women aged from 32 to 88 with SUI (grade 1 = 44, grade 2 = 42) were enrolled in the study and followed-up for six weeks (point 1) and twelve weeks (point 2). The primary outcome of the study was evaluated by changes in day-time and nocturnal urinary frequency (bathroom visits) and urinary incontinence episodes (leaks). Also, adverse events were quantified as well as the self-perceived effectiveness of the treatment. Research Ethics Board approval was obtained for this study. Results: After 12 weeks of treatment there was a 30% (grade 1 SUI, p < 0.01), and 35% (grade 2 SUI, p < 0.01) improvement in urinary incontinence episodes, a 40% (grade 1 SUI, p < 0.01) and 26% (grade 2 SUI, p < 0.01) improvement in day-time urination frequency and 64% (grade 1 SUI, p < 0.01) and 54% (grade 2 SUI, p < 0.01) improvement in nocturnal urinary frequency. Reported side effects were: headache (3.5%), flatulence (4.1%) and gastrointestinal discomfort (3%). A total of 89.4 % of women in the study reported no side effects from this therapy and 97% acknowledged improvement of symptoms. Conclusion: This clinical study demonstrated that a 12 week treatment with a mix of Cucurbita Pepo Seed extract, Equisetum arvense and Linum usitatissimum - Flax A (CELcomplex®) is highly effective on stress urinary incontinence (SUI) with minimum adverse events. Further studies may be needed in order to determine the effectiveness and efficacy of this phytotherapy in other populations. SN - 2225-4110 UR - https://www.unboundmedicine.com/medline/citation/30963048/Clinical_study_of_effectiveness_and_safety_of_CELcomplex®_containing_Cucurbita_Pepo_Seed_extract_and_Flax_and_Casuarina_on_stress_urinary_incontinence_in_women L2 - https://linkinghub.elsevier.com/retrieve/pii/S2225-4110(17)30127-X DB - PRIME DP - Unbound Medicine ER -