Archives of gynecology and obstetrics · 2021
Effects of epigallocatechin gallate-enriched green tea extract capsules in uterine myomas: results of an observational study.
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Biro Rebekka, Richter Rolf, Ortiz Miriam, Sehouli Jalid, David Matthias
Аннотация
PURPOSE: The daily ingestion of green tea extract (GTE) capsules in women with oligo- or asymptomatic uterine myomas was monitored over 6 months with regard to their quality of life, myoma-associated complaints and side effects.
METHODS: The participants were interviewed and examined at the beginning of the study (T1) and then again after 6 months (T3). Quality of life was assessed using a SF-12 questionnaire while their myoma-associated complaints were ascertained by using a self-developed myoma symptom questionnaire. Changes in the size of the myomas were evaluated by vaginal sonography. Side effects after 3 months (T2) and 6 months were documented by systematic interviews.
RESULTS: Overall; 25 participants (median 45 years) have been enrolled. The analysis of the SF-12 questionnaire showed a significant improvement of the physical cumulative score of the SF-12 during the 6 month GTE capsule ingestion (T1: mean value (M) = 52.731; 95% confidence interval (KI95%): 49.791-55.671; T3: M = 55.862; KI95%%: 55.038-56.685; p = 0.019). However, the mental cumulative score of the SF-12 did not change significantly (p = 0.674). No significant correlation could be established between the capsule ingestion and changes in the symptom questionnaire, the laboratory parameters nor the myoma size. No relevant adverse side effects were reported.
CONCLUSION: Women who took GTE capsules showed a significant improvement in their physical cumulative score on the SF-12, but not in the global QoL score. Myoma size or other objective parameters did not change.
METHODS: The participants were interviewed and examined at the beginning of the study (T1) and then again after 6 months (T3). Quality of life was assessed using a SF-12 questionnaire while their myoma-associated complaints were ascertained by using a self-developed myoma symptom questionnaire. Changes in the size of the myomas were evaluated by vaginal sonography. Side effects after 3 months (T2) and 6 months were documented by systematic interviews.
RESULTS: Overall; 25 participants (median 45 years) have been enrolled. The analysis of the SF-12 questionnaire showed a significant improvement of the physical cumulative score of the SF-12 during the 6 month GTE capsule ingestion (T1: mean value (M) = 52.731; 95% confidence interval (KI95%): 49.791-55.671; T3: M = 55.862; KI95%%: 55.038-56.685; p = 0.019). However, the mental cumulative score of the SF-12 did not change significantly (p = 0.674). No significant correlation could be established between the capsule ingestion and changes in the symptom questionnaire, the laboratory parameters nor the myoma size. No relevant adverse side effects were reported.
CONCLUSION: Women who took GTE capsules showed a significant improvement in their physical cumulative score on the SF-12, but not in the global QoL score. Myoma size or other objective parameters did not change.