| | Outcome topic | Results during intervention | Results after intervention | Overall RoB judgment |
|---|
| Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial | Selenium | Onset of mucositis after transplantation comparable in both selenium and placebo arm; p=0.81 | Overall: Cumulative incidence (grade 1-4) comparable in both selenium arm (83.8%) and placebo arm (81.1%); p=0.76; grade 3-4 mucositis significantly lower in selenium arm (10.8%) compared to placebo arm (35.1%); p=0.013 (grade 4: 2x in placebo arm, 0x in selenium arm)
Mean duration comparable (p=0.048), only duration of objective mucositis from grade 2 to 4 and back was significantly shorter in the selenium arm (3.6±1.84 days) than in the placebo arm (5.3±2.2 days); p=0.014 | high risk |
| Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer | Selenium | Significant difference for incidence of severe mucositis at week 3: selenium arm 9.8% vs. placebo arm 42.0% (p=0.017) | After 7 weeks no significant differences between the selenium arm and the placebo arm for:
- mean duration of oral mucositis (grade 1–4) (p=0.27)
- onset of oral mucosits (p =0.31)
- recovery (day after radiation completion (p=0.80)
- cumulative incidence of oral mucusitis (grade 1–4) (p=0.79)
Severe oral mucositis (grade 3 or 4) was seen in 25 patients in the selenium arm and in 20 patients in the placebo arm.
Addition: Development of oral mucositis in patients with selenium levels >65 mcg/l significantly delayed from baseline (p=0.04, no further explanation given) | high risk |
| Mansourian et al. (2015): The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancer | Curcumin | Significant difference between intervention vs. placebo arm in mean (SD):
intervention 3.7 (2.1) vs. placebo 7.9 (2.0); p < 0.001 | NA | some concerns |
| Mansourian et al. (2015): The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancer | Curcumin | Max. degree of mucositis (number (%) of patients):
- Grade 1: Intervention arm: 15 (78.9%), Placebo arm: 3 (16.7%)
- Grade 2: Intervention arm: 4 (21.1%), Placebo arm: 8 (44.4%)
- Grade 3: Intervention arm: 0 (0%), Placebo arm: 7 (38.9%)
- Grade 4: Intervention arm and Placebo arm: 0
- Difference between arms in distribution of grades: p < 0.001
- Time between T0 and onset of max. mucositis: no numbers given; p = 0.315
Incidence of max. mucositis (number (%)):
- 7 days: Intervention arm: 4 (21.1%), Placebo arm: 8 (44.4%)
- 14 days: Intervention arm: 6 (31.6%), Placebo arm: 4 (22.2%)
- 21 days: Intervention arm: 9 (47.4%), Placebo arm: 6 (33.3%)
| NA | some concerns |
| Mix et al. (2015): Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck | Selenium | NA | Overall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4) | some concerns |
