Property:Results after intervention
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A
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients +
NA +
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients +
NA +
Attia et al. (2008): Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate Cancer +
No significant differences in progression-free survival +
Attia et al. (2008): Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate Cancer +
NI +
Attia et al. (2008): Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate Cancer +
No significant differences in overall survival +
Attia et al. (2008): Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate Cancer +
NI +
Azizi et al. (2015): Efficacy of Topical and Systemic Vitamin E in Preventing Chemotherapy-induced Oral Mucositis +
Mean value
After 4th cycle
Intervention arm (paste): 2.9, intervention arm (tablets): 4.33, placebo arm: 4.86; p = 0.001 +
Azizi et al. (2015): Efficacy of Topical and Systemic Vitamin E in Preventing Chemotherapy-induced Oral Mucositis +
Number in % with grade 3-4
After 4th cycle
intervention arm (paste): 26.3, intervention arm (tablets): 43.7, placebo arm: 42.8; p = 0.01 +
B
Bairati et al. (2005): A Randomized Trial of Antioxidant Vitamins to Prevent Second Primary Cancers in Head and Neck Cancer Patients +
DFS for '''any supplementation''' beyond 3.5 years after randomization:
HR = 0.85 (95% CI: 0.48, 1.50), i.e. no significant difference between intervention and placebo arm
DFS for '''beta-carotene + Vit. E''' beyond 3.5 years after randomization:
HR = 1.11 (95% CI: 0.47, 2.61), i.e. no significant difference between intervention and placebo arm
DFS for '''only Vit. E''' beyond 3.5 years after randomization:
HR = 0.71 (95% CI: 0.33, 1.53), i.e. no significant difference between intervention and placebo arm +
Bairati et al. (2005): A Randomized Trial of Antioxidant Vitamins to Prevent Second Primary Cancers in Head and Neck Cancer Patients +
SPT for '''any supplementation''' beyond 3.5 years after randomization:
HR = 0.57 (95% CI: 0.31, 1.07), i.e. no significant difference between intervention and placebo arm
SPT for '''beta-carotene + Vit. E''' beyond 3.5 years after randomization:
HR = 1.11 (95% CI: 0.47, 2.61), i.e. no significant difference between intervention and placebo arm
SPT for '''only Vit. E''' beyond 3.5 years after randomization:
HR = 0.41 (95% CI: 0.16, 1.03), i.e. no significant difference between intervention and placebo arm
No influence of smoking status +
Bairati et al. (2005): Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients +
Local recurrence for '''any supplementation'''
HR = 1.37 (95% CI: 0.93, 2.02),i.e. no significant difference between intervention and placebo arm
Local recurrence for '''beta-carotene + Vit. E'''
HR = 1.56 (95% CI: 0.79, 3.07), i.e. no significant difference between intervention and placebo arm
Local recurrence for '''only Vit. E'''
HR = 1.29 (95% CI: 0.89, 2.08), i.e. no significant difference between intervention and placebo arm +
Bairati et al. (2005): Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients +
Side effects for '''any supplementation''' directly post-radiotherapy (T2):
''All sides'': OR = 0.77 (95% CI: 0.54, 1.09), i.e. no significant difference between intervention and placebo arm
''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences
Side effects for '''beta-carotene + Vit. E''' directly post-radiotherapy (T2):
''Total'': OR = 0.33 (95% CI: 0.17, 0.65), i.e. significant difference between intervention and placebo arm (lower risk for intervention arm)
''Larynx only'': OR = 0.42 (95% CI: 0.23, 0.77), i.e. significant difference between intervention and placebo arm (lower risk for intervention arm)
''Skin, mucosa, pharynx and esophagus'': no significant differences
Side effects for '''only Vit. E''' directly post-radiotherapy (T2):
''Total'': OR = 1.06 (95% CI: 0.70, 1.60), i.e. no significant difference between intervention and placebo arm
''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences
Side effects for '''any supplementation''' 1 month post-radiotherapy (T3):
''All sides'': OR = 1.11 (95% CI: 0.79, 1.55), i.e. no significant difference between intervention and placebo arm
''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences
Side effects for '''beta-carotene + Vit. E''' 1 month post-radiotherapy (T3):
''Total'': OR = 0.98 (95% CI: 0.52, 1.87), i.e. no significant difference between intervention and placebo arm
''Larynx only'': OR = 0.61 (95% CI: 0.32, 1.17), i.e. no significant difference between intervention and placebo arm
''Skin, mucosa, pharynx and esophagus'': no significant differences
Side effects for '''only Vit. E''' 1 month post-radiotherapy (T3):
''Total'': OR = 1.17 (95% CI: 0.78, 1.74), i.e. no significant difference between intervention and placebo arm
''Larynx, skin, mucosa, pharynx and esophagus'': no significant differences +
Bairati et al. (2005): Randomized Trial of Antioxidant Vitamins to Prevent Acute Adverse Effects of Radiation Therapy in Head and Neck Cancer Patients +
Mean difference (95% CI) between intervention and placebo arm for '''any supplementation''' 1 month post-radiotherapy (T3):
- EORTC QLQ-C30 sleep disturbance: 4.05 (0.37, 8.48); p = 0.07 (p = 0.02 for '''beta-carotene + Vit. E''' )
- EORTC QLQ-C30 diarrhea: -2.74 (-4.54, -0.93); p = 0.003)
- EORTC QLQ-C30 remaining scales: no significant differences
- HNQR: no significant differences
No reported results regarding '''only Vit. E''' +
Bairati et al. (2006): Antioxidant vitamins supplementation and mortality: a randomized trial in head and neck cancer patients +
'''Overall'''
Number of any cause deaths for ''any supplementation'':
- intervention arm n=102 vs. placebo arm n=77
- HR = 1.38 (95% CI: 1.03, 1.85), i.e. significant difference between intervention and placebo arm (higher risk for intervention arm)
Number of any cause deaths for ''beta-carotene + Vit. E'':
- intervention arm n=37 vs. placebo arm n=30
- HR = 1.31 (95% CI: 0.81, 2.11), i.e. no significant difference between intervention and placebo arm
Number of any cause deaths for ''only Vit. E'':
- intervention arm n=65 vs. placebo arm n=47
- HR = 1.43 (95% CI: 0.98, 2.07), i.e. no significant difference between intervention and placebo arm
No significant differences in other causes of cancer +
Barton et al. (1998): Prospective evaluation of vitamin E for hot flashes in breast cancer survivors +
Decrease Baseline to 4 weeks in %
Frequency of hot flashes per day:
Intervention arm: 25%, Placebo arm: 22%; p = 0.90 ns.
Correlation with baseline value: r = 0.12; p = 0.21 ns.
Daily hot flash score (frequency with average severity):
Intervention arm: 28%, Placebo arm: 20%; p = 0.68 ns.
Correlation with baseline value: r = 0.13; p = 0.18 ns.
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Crossover: Decrease 4 weeks to 8 weeks in %
Frequency of hot flashes per day:
Intervention arm: 0.04%, Placebo arm: 17%; p = 0.32 ns.
Daily hot flash score:
Intervention arm: 0.03%, Placebo arm: 25%; p = 0.24 ns.
Within-subject analysis: Significant differences in frequency and hot flash score between placebo and Vit. E (both p ≤ 0.05), approximately 1 less hot flash
Frequency differences between placebo and Vitamin E per week:
Intervention arm (Vitamin E first then Placebo): Week 1 vs. 5: p = 0.01; Week 2-4 vs. Week 6-9: p < 0.05, sign.
Placebo arm (Placebo first then Vitamin E): Week 1 vs. 5: p = 0.001; Week 2 vs. 6: p = 0.0004; Week 3 vs. 7: 0.003; Week 4 vs. 8: p = 0.07, sign.
Similar results for hot flash score
Question about patient preference in both arms:
Vit. E: 32%, Placebo: 29%, No preference: 38%. +
Barton et al. (2013): The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9 +
No difference between arms. +
Barton et al. (2013): The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9 +
No difference between arms. +
Barton et al. (2013): The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9 +
No difference between arms. +