Example Queries III
What helps against mucositis in cancer?
| Topic | Results during intervention | Results after intervention | Overall RoB judgment | |
|---|---|---|---|---|
| Arbabi-kalati et al. (2012): Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: A double-blind randomized clinical trial | In week 2, 4 and 6 no statistically significant differences in mucositis intensity between arms;
in the 8th, 12th, 16th, and 20th week of chemotherapy there were statistically significant differences between both arms (p < 0.005) No statistically significant difference in the mucositis treatment period between both arms Increased drug effect with decreased mucositis intensity over increased time in the intervention arm (p < 0.005). | NI | ? | |
| Azizi et al. (2015): Efficacy of Topical and Systemic Vitamin E in Preventing Chemotherapy-induced Oral Mucositis | Number in % with grade 3-4
After 1st cycle intervention arm (paste): 7.6, intervention arm (tablets): 8.3, placebo arm: 7.6; p = ns After 2nd cycle intervention arm (paste): 11.5, intervention arm (tablets): 12.5, placebo arm: 15.3; p = ns After 3rd cycle intervention arm (paste): 21.7, intervention arm (tablets): 33.3, placebo arm: 31.8; p = 0.01 | 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 | ? | |
| Dörr et al. (2007): Efficacy of Wobe-Mugos E for Reduction of Oral Mucositis after Radiotherapy | NI | 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. | ? | |
| Dörr et al. (2007): Efficacy of Wobe-Mugos E for Reduction of Oral Mucositis after Radiotherapy | NI | The difference in average mucositis scores was based on a slightly earlier onset of mucositis in the enzyme-arm (p=0.041). | ? | |
| Ertekin et al. (2004): Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study | Intervention arm: Mucositis developed in 13 of 15 patients; Grade 1 mucositis was found in 8 patients and Grade 2 in 5 patients; Grade 3 and 4 was not developed; dose of radiotherapy for the patients in whom mucositis developed i was 3600 cGy (range 2400-4400)
Placebo arm: Grade 2 mucositis was developed in 4 patients and Grade 3 in 8 patients; Grade 4 mucositis did not occur in any patient; the median radiotherapy dose was 2000 cGy (range 1800-2800) Statistically significant differences were found in the week mucositis developed, in the severity of mucositis, and in the RT dose at which mucositis developed in favour of the intervention arm; mucositis began to appear in the second week at 1800 cGy; at the start of the third week and in the middle of the fourth week, it peaked and then began to lower; after 2400 cGy, the difference in the mucositis scores between the zinc and placebo groups was statistically significant and continued to be until 6 weeks after treatment | 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) | ? | |
| ... further results | ||||
| 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 | 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)
| high risk | |
| Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer | 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:
| high risk | |
| 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 | NA | Overall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4) | some concerns |