Clinical study of effectiveness and safety of CELcomplex® containing Cucurbita Pepo Seed extract and Flax and Casuarina on stress urinary incontinence in women

10.1016/j.jtcme.2017.10.005

Andrea Gazová；Simona Valásková；Viera Zufková；Ana M. Castejon；Ján Kyselovic

Stress urinary incontinence - SUI ； Pumpkin seed ； Women

Journal of Traditional and Complementary Medicine

9卷2期（2019 / 04 / 01）

138 - 142

英文

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.

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