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Property:Results after intervention

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There were signifcantly (p<0.001) fewer urogenial symptoms (evaluted as maximum extent) in the enzyme-arm: enzyme-arm = 0.93 (0.52); placebo-arm = 1.38 (0.56). The treatment effect was observed from 1 week after start of radiation therapy until the last follow-up visit 5 month after intervention.  +
Significantly lower increase in Micronuclei in the Ginkgo arm (day 7: Mean=11.5, SD=2.4; day 90: Mean=2.9, SD=1.4) compared to placebo (day 7: Mean=17.1, SD=2.3; day 90: Mean=9.0, SD=1.3), p<0.01  +
Significantly lower increase in "clastogenic" factors in the Ginkgo arm (day 7: Mean=5.0, SD=2.9; day 90: Mean=1.9, SD=0.9) compared to placebo (day 7: Mean=10.5, SD=2.1; day 90: Mean=5.5, SD=1.2), p<0.05  +
No significant difference between the arms. Comparison between the Placebo and Intervention Arm: After Day 42: p = .75  +
No significant difference between the arms. Comparison between the Placebo and Intervention Arm: After Day 42: p = .81  +
No significant difference between the arms. Comparison between the Placebo and Intervention Arm: After Day 42: HADS A: p = .75, HADS D: p = .94  +
After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 39.1 (12.1), pentoxyfillin + placebo: 32.4 (20.8), vitamin E + placebo: 37.1 (15.5); placebos: 32.9 (18.5)  +
After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 73.0 (7.2), pentoxyfillin + placebo: 48.6 (35.9), vitamin E + placebo: 52.8 (29.4); placebos: 50.8 (23.9)  +
After 6 month, reduction in % (SD) in each case: Pentoxyfillin + vitamin E: 60.2 (10.7), pentoxyfillin + placebo: 39.1 (37.4), vitamin E + placebo: 40.0 (32.0); placebos: 42.6 (17.4) ANOVA: ns., trend of a signif. interaction with vitamin E  +
Overall: Significantly lower DPOAEs in placebo arm compared to ginkgo arm at a frequency of 8KHz, p=0.03 Significantly lower SNRs in placebo arm compared to Ginkgo arm at a frequency of 8KHz, p=0.04  +
FACT-HN35: After first round of chemoradiotherapy: significant improvement in guarana group for domains pain (p = 0.0133), social eating (p = 0.0227), swallowing (p = 0.0254), coughing (p = 0.0107), and weight loss (p = 0.012) After the fourth round of chemoradiotherapy: significantly worse in domain weight loss (p = 0.0074) and greater use of a nasogastric tube (p = 0.051), in addition to increased use of analgesics (p = 0.0253) in guarana group FACT Questionnaire: Comparison between intervention and placebo arm: trend toward worsening in the overall domain: p = .0054, significant worsening in the functional: p = .018 and symptoms domain: p = .0042 after the second cycle of chemotherapy; no significant differences, in any QOL domains, either for the guarana or placebo group, when the first measures were compared to the last assessments of each domain for each particular group EORTC-QOL C30: No improvement in symptoms in the three domains (functional, overall, and symptoms) in the guarana group compared to the placebo group No further information or statistical values given, domain specific results of the EORTC questionnaire only displayed in a graphic  +
Significant and clinically relevant improvement over time in both arms (reflexology: M= -0.70 [95% CI: -1.16, -0.24]; aromatherapy massage: M= -1.16 [95% CI: -1.15, -0.80]), but no sig. arm differences (M= 0.45 [95% CI: -0.12, 1.03]; p=NI).  +