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Effects of EFLA®940 / Soybean Germ Extract combination on nocturia in an open clinical study

• EFLA®940 Pumpkin Seed Extract – Cucurbitae Sem extr.s.sicc
• Soybean germ extract

Study Summary

To investigate the efficacy and safety of a health food product containing EFLA®940 and soybean germ extract in the treatment of nocturia, an open clinical study was conducted in Japan on postmenopausal women suffering from stress incontinence.

Study design

Subjects: 39 postmenopausal women (aged 52-86 years) suffering from increased night urinary frequency. Study duration: 6 weeks.
Daily dosage: 875 mg EFLA®940 and 164 mg soybean germ extract (30% soyisoflavones) during weeks 1-2, 525 mg resp. 100 mg during the following weeks.
Participants were asked to record nocturnal and diurnal micturitions, incontinence episodes and subjective degree of satisfaction daily.
Efficacy was rated as one of four grades by the investigator. Statistical significance was determined by comparison of the mean values before (pre) and after dosing using paired t-test. Laboratory tests, vital signs and adverse events recording were analysed for safety and tolerance assessment.

Results

Frequency of Urination
The frequency of urination during night and daytime already markedly improved at week 1 of treatment. Night urinary frequency continuously improved thereafter until week 6, daytime values remained stable at the level reached at week 2.

Effects of EFLA®940 / Soybean Germ Extract combination on nocturia in an open clinical study

Results

There is a significant decrease of the key symptoms of overactive bladder syndrome and voiding symptoms, demonstrated by a decrease of the daily average frequency of urination, a decrease of the daily average frequency of urgency and a decrease of average frequency of nocturia. These decreases amount for each parameter at an average of 30% are shown graphically in the following way.

Incontinence Episodes

Frequency of incontinence markedly diminished continuously during the study period, in the group of 16 subjects who experienced episodes of incontinence during the observation period.

Subjective Improvement

EFLA®940/soybean germ extract combination improved patients’ subjective sleeping satisfaction.

Total Rate of Improvement

All the favorable effects quoted above were reflected by a high general improvement, as confirmed by the overall efficacy judged by the investigator based on all data.
Total improvement was rated for almost 75% of patients as “Markedly improved” and “Improved” after 6 weeks. In the subgroup of 33 subjects with 2 to 4 episodes of nocturia per night, the improvement rate was even higher (> 80%).

Safety

The study product demonstrated high safety and tolerance.

Conclusion

The present study demonstrated the beneficial effects of the food supplement containing a mixture of EFLA®940.
Pumpkin Seed Extract and soybean germ extract in postmenopausal women. The intake of the preparation quickly, continuously and significantly improved objective and subjective symptoms of women with urinary problems, resulting in an enhanced quality of life.

Reference:

Sogabe H, Terado T, 2001. Open clinical study of effects of pumpkin seed extract/ soybean germ extracts mixture containing processed food on nocturia. Jpn J Med Pharm Sci; 46(5): 727-37 – 07.07

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