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Property:Results after intervention

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Significant distribution differences between the arms Boswellia arm: more often with mild or moderate erythema (78% compared to 51% in base cream arm) Placebo arm: more often with intense erythema (49% compared to 22% in boswellia arm) Differences in grades of visual intensity of erythema were statistically significant Objective assessment, Computerized photo analysis: Significantly lower magenta color percentage in the boswellia arm (10.1%) compared to the placebo arm (13.3%) Higher proportion of patients treated with boswellia cream scored slight intensity of erythema compared to those of base cream arm (50.0% vs 23.0%) A lower fraction of boswellia cream arm patients scored visual intensity of erythema as intense compared to patients of the base cream arm (19.0% vs 48.6%)  +
Tendency towards lower incidence/expression of superficial skin symptoms in the boswellia group compared to the placebo group, p=0.066  +
'''Overall''' - No significant differences in incidence of SPT between intervention and control arm (no p-value reported) - Relative risks for recurrence and/or SPT not significant (no p-value reported)  +
'''Overall''' - No significant differences in 10-year survival rate between intervention and control arm (p=0.20) - Relative risk not significant (no p-value reported)  +
'''Overall''' - No significant differences in 10-year DFS rate between intervention and control arm (p=0.56) - Relative risks for DFS not significant (no p-value reported)  +
Sig. lower consumption in intervention than arm passive control (mean diff.= 39.59 mg Demerol; p= 0.015)  +
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After 6 months: Vitamin E 100mg: Increase EF right parotis (p < 0.01) and UI right submand. (p < 0.05) Vitamin E 200mg: Increase UI right parotis, both Submand. (p < 0.01) Vitamin E 300mg: Increase UF left parotis (p < 0.05) and right submand. (p < 0.01), increase UI in both submand. (p < 0.01) Usual Care: Decreasel UF in both parotis (p < 0.01) Rest: ns. All arms compared: UF: left submand.: p < 0.05 UI: right parotis: p < 0.05; both submand.: p < 0.01 ER: left parotis: p < 0.05  +
''Overall:'' Subgroupanalysis: low (<20 ng/mL (n=173)), middle (20-40 ng/mL (n=232)), or high (>40 ng/mL (n=5)) serum levels of 25(OH)D at baseline * In middle-baseline-level subgroup, 5-year relapse-free survival significantly higher in intervention arm than in placebo arm (85% vs. 71%; HR for relapse or death, 0.46; 95% CI, 0.24-0.86; p=.02) * In low-baseline-level subgroup no significant differences * In high-baseline-level subgroup no further analyses because of small number of patients * Overall survival was not significantly different between the arms in both the middle subgroup and the low subgroup Post hoc analysis: * Cumulative incidence of relapse was not significantly different * In the subgroup with middle baseline levels of 25(OH)D, the cumulative incidence of relapse was significantly lower in the intervention arm than in the placebo arm (subdistribution HR, 0.44; 95% CI, 0.21-0.89; p=.02) * No significant difference for the cumulative incidence of relapse in the low-baseline-level subgroup * Age adjusted analysis: hazard of relapse or death was significantly less in intervention arm compared with the placebo arm, with an adjusted HR of 0.66 (95% CI, 0.43-0.99; p=.048) but hazard of death was not significantly different * Analyses adjusted for stage I disease status did not show any significant differences * No ignificant associations for gender, age groups, body many index, site of cancer, disease stage and adenocarcinoma vs. nonadenocarcinoma  +