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Property:Results after intervention

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D
Significant and clinically relevant improvement in both arms (reflex therapy: M= -1.44 [95%CI: -1.90, -0.97]; p= NI; aroma massage: M= -1.98 [95%CI: -2.49,-1.47]; p= NI), but no significant arm differences (M= 0.54 ([95%CI: -0.14, 1.22]; p= NI)  +
Arm A: 82% to 91% on the various scales, Arm B = 68% to 86% on the various scales. No significant arm differences  +
The most common answer to the question “What was the most important thing for you?” was “Relaxation and time for myself” in both arms  +
Mean difference 0.453 (SE = 0.323) in favor of aromatherapy, but this is significantly less than one point on the scale (p=0.046).  +
No statistically significant difference was found in this confirmative analysis between the enzyme-arm and the placebo-arm (p=0.317). Grade distributions as well as average scores were virtually identical.  +
The difference in average mucositis scores was based on a slightly earlier onset of mucositis in the enzyme-arm (p=0.041).  +
E
Using Friedman analysis, the score of diarrhea did not significantly increase throughout 4 weeks in patients receiving green tea (p<0.3)  +
The distinction in weight disappeared between the baseline and 6-week post-radiotherapy measurement  +
6 weeks after treatment, mucositis was found in 1 of the patients in the intervention compared with 10 patients in the placebo arm (Fisher’s exact chi-square test 16.2, p < 0.01)  +
F
Prevalence intervention vs. placebo: * acute (day 1) 47% vs. 58%, p=0.388, ns. * delayed day 2: 44.5% vs. 53%, p=0.508, ns. * delayed day 3: 47% vs. 50%, p<0.999, ns. Severity (Mean(SD)) intervention vs. placebo: * acute (day 1): 1.75(2.02) vs. 1.36(1.91), p=0.14, ns. * delayed day 2: 1.78(1.93) vs. 1.5(2.03), p=0.31, ns. * delayed day 3: 1.61(1.93) vs. 1.47(1.92), p=0.73, ns. Duration (Mean(SD)) intervention vs. placebo in h: * acute (day 1): 2.18(5.03) vs. 2.27(4.88), p=0.93, ns. * delayed day 2: 3.06(7.61) vs. 5.10(9.66), p=0.59, ns. * delayed day 3: 2.67(6.76) vs. 3.80(8.55), p=0.82, ns.  +
Prevalence intervention vs. placebo: * acute (day 1): 58% vs. 75%, p=0.070, ns. * delayed day 2: 75% vs. 81%, p=0.687, ns. * delayed day 3: 81% vs. 78%, p<0.999, ns. Severity (Mean(SD)): * acute (day 1): 1.47(2.18) vs. 0.94(1.77), p=0.14, ns. * delayed day 2: 1.03(1.89) vs. 0.83(1.84), p=0.72, ns. * delayed day 3: 0.80(1.83) vs. 0.92(1.86), p=0.78, ns.  +
6 months after Radiojodtherapy: Mean (SD; Range) for each: Change in Vitamin E Arm: No significant differences between from before to 6 months after radiojodtherapy. Change in Placebo Arm: Right submandibular gland: MSP: before radiojodtherapy: 28.73 (14.59; 0.4–67.11); 6 months after: 24.53 (10.91; 4.46–45.05); p = 0.039, sign. EF: before radiojodtherapy: 47.73 (16.65; 7.60–81.50); 6 months after: 43.02 (16.69; 15.18–76.32); p = 0.015, sign. Left parotid gland : EF: before radiojodtherapy: 58.14 (7.85; 44–73.67), 6 months after: 51.99 (21.12; 4.23–76.82); p = 0.035, sign. Otherwise: not significant -------------- Comparison Vitamin E (Vitamin E arm) vs. Placebo (placebo arm): Mean (SD; Range) from before to 6 months after radiojodtherapy Right parotid gland: FUR: Vitamin E: 0.39 (0.97; –2.88-0.97); Placebo: 0.09 (0.47; –0.84-1.06); p = 0.04, sign; otherwise not significant. Right submandibular gland: No significant differences. Left Parotid gland: EF: Vitamin E: 0.43 (9.48; –15.16-23.57); Placebo: 11.15 (22.49; –13.7-60.9); p = 0.04, sign.; otherwise not significant. Left submandibular gland: No significant differences. Number of Parotid glands with more than 15% decrease in EF: Vitamin E: 3/38 (7.9%), Placebo: 9/34 (26.5%); p = 0.035, sign.  +