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) 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		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
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