Example Queries

What are the indications for taking selenium?

	Outcome name	Results during intervention	Overall RoB judgment
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients	Ejection fraction	After chemotherapy (8 days): significantly better cardiac ejection fraction in sodium selenite arm (mean(SD)= 63(6%)) vs. control arm (69(6%)); p <0.05	high risk
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients	Toxicity	After chemotherapy (8 days): significant less infections in sodium selenite arm (20%) compared to control arm (67%); p<0.05	high risk
Büntzel et al. (2010): Limited effects of selenium in the prevention of radiation-associated toxicities - results of a randomized study in head neck cancer patients	Toxicity	Maximum toxicity intervention vs. control arm: dysphagia 22.7% vs. 35.3%, ageusia 22.7% vs. 47.1%, xerostomia 22.7% vs. 23.5%, and stomatitis 36.4% vs. 23.5%; no significant differences; Significant mean difference between arms only for dysphagia at week 7: mean intervention arm 1.533 vs. control 2.167 (p=0.05)	some concerns
... further results

What are the side effects of cannabis?

	Side Effects / Interactions
Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial	No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83) No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83)
Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies	Overall 68% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=64 (32.2%), of which somnolence n=18 (9%), dizziness n=15 (7.5%), nausea n=10 (5%) 2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex) None of the deaths related to intervention Overall 64% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=41 (20.7%), of which somnolence n=6 (3%), dizziness n=6 (3%), nausea n=8 (4%) 2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex) None of the deaths related to intervention
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies	Part A Overall 60% at least one event, assessed as probably intervention-associated with frequency ≥ 5%: Total n=128, 31.7%, somnolence (n=42, 10.4%), nausea (n=21, 5.2%) and dizziness (n=21, 5.2%) Part B Overall 72% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=16, 15.5%; somnolence (n=6, 5.8%) More than twice as many patients in Sativex arm discontinued study due to side effects (n=14, 13.6% vs. n=6, 5.8%); no statistical comparison given) None of the deaths related to intervention Part A Overall 60% at least one event, assessed as probably intervention-associated with frequency ≥ 5%: Total n=128, 31.7%, somnolence (n=42, 10.4%), nausea (n=21, 5.2%) and dizziness (n=21, 5.2%) Part B Overall 62% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=12, 11.7%; somnolence n=0
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial	Moderate or severe cannabinoid-related side effects in intervention arm and placebo arm (31% vs. 7%, p=0.002): Significant differences for sedation (19% vs. 4%, p=0.002) and dizziness (10% vs. 1%, p=0.03) No differences for disorientation (p=0.5) and anxiety (p=1.00) No cannabinoid-related serious adverse events reported 83% of the participants preferred cannabis over placebo and 15% had a preference for placebo (p<0.001) Moderate or severe cannabinoid-related side effects in intervention arm and placebo arm (31% vs. 7%, p=0.002): Significant differences for sedation (19% vs. 4%, p=0.002) and dizziness (10% vs. 1%, p=0.03) No differences for disorientation (p=0.5) and anxiety (p=1.00) No cannabinoid-related serious adverse events reported 83% of the participants preferred cannabis over placebo and 15% had a preference for placebo (p<0.001)
Jatoi et al. (2002): Dronabinol Versus Megestrol Acetate Versus Combination Therapy for Cancer-Associated Anorexia: A North Central Cancer Treatment Group Study	Impotence in 18 % of men; vomiting; fluid retention; confused thinking; drowsiness; loss of coordination; inappropriate behavior Impotence in 4% of men; vomiting; fluid retention; confused thinking; drowsiness; loss of coordination; inappropriate behavior Impotence in 14% of men; vomiting; fluid retention; confused thinking; drowsiness; loss of coordination; inappropriate behavior
... further results

Does selenium help with mucositis?

	Outcome specification	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	Neutrophil and platelet engraftment time (the time point after transplantation at which a patient can maintain a sustained ANC of 4500 cells/mm3 and a sustained platelet count of at least 20 000/mm3 lasting 3 consecutive days without transfusions during hospital stay) NA Graft-versus-host disease is a condition where the donated stem cells (graft) attack the recipient's body (host) At 3 months Serum creatinine level and blood urea nitrogen test for renal function assessment and aspartate aminotransferase and alanine transaminase for liver function assessment, recorded daily NA Oral Mucositis Duration of fever	No difference between arms (p=0.32, p=0.87) NA NA NA NA NA Onset of mucositis after transplantation comparable in both selenium and placebo arm; p=0.81 Fever above 38.3°C in 72 patients (97.3%) during neutropenia; duration of fever comparable in both selenium and placebo arm ; p=0.98	NA No difference between selenium arm (26.92±6.26 days) and placebo arm (25.81±4.33 days); p=0.38 Overall: No difference between the arms; p= 0.35 No difference between the arms; p= 0.69 Overall: No difference between arms for increase in serum creatinine; p=0.31 or increase in aspartate aminotransferase and alanine transaminase: p=0.62 Significant difference in mean serum selenium level between two arms at 14 days after transplantation (8.34 mcg/dL in the selenium arm vs 7.36 mcg/dL in the placebo arm), p=0.018 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 NA	some concerns some concerns some concerns some concerns some concerns some concerns high risk some concerns
Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer	NA Inflammation of the oral mucosa (mucositis) due to radiotherapy	NA Significant difference for incidence of severe mucositis at week 3: selenium arm 9.8% vs. placebo arm 42.0% (p=0.017)	At the end of radiation (after 7 weeks) there was no difference in the mean serum selenium level between the selenium arm and placebo arm (p=0.24) Based on the selenium level before radiation, developing severe oral mucositis was statistically significant postponed in patients who had selenium levels ≥ 65 mcg/L (p=0.04) 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)	NA 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	Grade 3 or 4 Complete response rate (CR) NA NA Measured with EORTC C-30 Version 3 and EORTC QLQ - H&N35 Other treatment-associated side effects such as xerostomia, renal impairment, hearing dysfunction, and myelosuppression	NA NA NA NA No significant difference for the 7 weeks of intervention NA	Overall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4) Only one patient from the intervention arm did not reach CR and died After 12 months: No significant differences between arms After 12 months: No significant differences between arms No significant difference for week 6-8 post-treatment and Follow-up within a year Overall: Hearing dysfunction n=1 each in the intervention arm and placebo arm; elevated creatinine n=1 in the placebo arm; myelosuppression: anemia in the placebo arm n=1; leukopenia in the intervention arm n=3 and placebo arm n=2; dermatitis in the intervention arm n=2; dry mouth in the placebo arm n=2; dysgeusia in the intervention arm n=2, placebo arm n=1; odyno-/dysphagia in the intervention arm n=1, placebo arm n=2; oral/throat pain in the placebo arm n=2; mucus/sputum intervention arm n=3, placebo arm n=1	some concerns low risk low risk low risk some concerns some concerns

What is the optimal dosage of cannabis for the treatment of nausea?

	Outcome name	Outcome specification	Dosage and regime
Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial	Nausea	Nausea with questionnaire (no further information) + number of antiemetic drugs used
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial	CINV (Chemotherapy-Induced Nausea and Vomiting)	Self-reported "complete response" ("no vomiting", "no clinically significant nausea", defined as nausea <2 on a 10-point scale, and "no use of emergency medication") during the acute (0-24 h), delayed (24-120 h) and general phase (0-120 h) of chemotherapy with diary day -1 to 6 of each cycle)
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial	CINV (Chemotherapy-Induced Nausea and Vomiting)	Complete response, no vomiting or emergency medication 0-120h of chemotherapy
Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain	Nausea	Nausea
Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…)	Nausea	Measured daily