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List of results

Dias et al. (2015): The chemopreventive effect of Ginkgo biloba extract 761 against cisplatin ototoxicity: a pilot study + (CONTRA: * Not registered.)

Konmun et al. (2017): A phase II randomized double-blind placebo-controlled study of 6-gingerol as an anti-emetic in solid tumor patients receiving moderately to highly emetogenic chemotherapy + (Compliance of the study was 98.4% - 6-gingerol arm: 99.1% - placebo arm: 97.7%)
Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial + (Large sample according to power analysis, … Large sample according to power analysis, double-blinded, exact results could only be taken from the graph, no information on whether the arms differed in terms of pain perception at the beginning of the study, only the difference between A and B was considered at all time points, no development over timePRO* Ethics vote* Adequate randomization* Double blinding* Sample size according to power analysis* Low dropoutCONTRA* Except fatigue, no baseline values for investigated outcomes (e.g. pain), group differences possible * Multiple testing (no models over time)* Poor report quality (figures for endpoints can only be taken from graph)or endpoints can only be taken from graph))
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 + (Note: Chemotherapy compliance: 8x every 3 … Note: Chemotherapy compliance: 8x every 3 cycles of cisplatin, 6x 2 cycles, 2x 1 cycle, 1x, 1x no chemotherapyPRO:* Ethics approval obtained.* Participants were instructed to keep a diary of tablet intake.* Intent-to-treat analysis conducted.* Sample size calculation performed.* Measurement of selenium concentration at baseline (no group difference).* Comparability of groups at baseline established.CONTRA:* Very small sample size.* No indication of selenium deficiencies present.* Very superficial reporting, particularly in the results section, with little information on blinding.* No group comparison for number of chemotherapy/radiotherapy side effects or selenium concentration.py side effects or selenium concentration.)
Karp et al. (2012): Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597 + (Note: Interim analysis in October 2009 (46 … Note: Interim analysis in October 2009 (46% of endpoints reached with 1561 patients randomized), study was stopped by DMC on November 5, 2009 as a trend for a placebo arm benefit was found; June 2011 update with 54% of the endpointsPRO:* Prior testing of compliance in a 4-week phase and then testing every 3 months.* Stratification by demographic variables.* Power analysis conducted.* Intent-to-treat analysis performed.* Measurement of selenium concentration.* Very detailed presentation of data.CONTRA:* Participants could continue taking supplements containing ≤70 µg of selenium and others containing no selenium.* Subgroup analysis based on selenium concentration level but without significance values.* No mention of ethics approval.* Confusing description of DFS (disease-free survival).* Figure 2b describes OS (overall survival) in days (typographical error).* OS curves diverge significantly after approximately 7.5 years, but no explanation of these data is provided. no explanation of these data is provided.)
Brown et al. (2019): Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Body Composition among Patients with Advanced or Metastatic Colorectal Cancer: A Randomized Trial + (PRO * Ethics vote * Study protocol * Blind … PRO* Ethics vote* Study protocol* Blinding* Randomization* Pre/post level control of vitamin D (mean increase 25 (OH) D level over 1. 8 CTX cycles in intervention arm vs.placebo arm: mean difference 20.0 ng/mL; (95% CI: 14.7, 25.2); p<0.001)* High treatment adherence with regard to vitamin D3: median: 98%* Intention-to-treat analysisCONTRA* No indication of p-values for baseline differencesdication of p-values for baseline differences)
Minchom et al. (2014): An unblinded, randomised phase II study of platinum-based chemotherapy with vitamin B12 and folic acid supplementation in the treatment of lung cancer with plasma homocysteine blood levels as a biomarker of (...) + (PRO * Ethics vote * Precise observation o … PRO* Ethics vote * Precise observation of occurring side effects* Recording of patient compliance * Intention-to-treat analyses * Washout of previous vitamin intake taken into account * Adjustment of significance level due to multiple testing CONTRA: * No blinding * Not placebo controlled * Unclear randomization, as groups are not equal in size despite 1:1 distribution * Simultaneous offer of other supportive therapies whose influence is not considered in detail * Stage of cancer uncleardered in detail * Stage of cancer unclear)
Hajimohammadebrahim-Ketabforoush et al. (2019): Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical Trial + (PRO * Ethics vote; * Pre/post level contro … PRO* Ethics vote;* Pre/post level control of vitamin D (25 (OH) D level, mean (SD): Arm A: T0: 15.9 (3.8), T4: 22.5 (4.3), Arm B: T0:14.5 (3.6), T4: 13.7 (3.8); A vs. B: p<0.001)CONTRA* No power analysis* Unclear blinding* Descriptive differences regarding tumor pathology* Unclear randomization* Insufficient description of interventions in arm A and B* Unclear calculations (e.g. no information on control variables in the model)* Poor report qualityvariables in the model) * Poor report quality)
Lissoni et al. (2009): A Randomized Study of Chemotherapy versus Biochemotherapy with Chemotherapy plus Aloe arborescens in Patients with Metastatic Cancer + (PRO/CONTRA)
Lissoni et al. (1998): Biotherapy with the Pineal Immunomodulating Hormone Melatonin versus Melatonin plus Aloe vera in Untreatable Advanced Solid Neoplasms + (PRO/CONTRA)
Olsen et al. (2001): The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy + (PRO/CONTRA)
Su et al. (2004): Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms + (PRO/CONTRA ?)
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 + (PRO: * Ethical approval * Power analysis … PRO:* Ethical approval* Power analysis* Intent-to-treat analysis* Baseline comparability* Mention of drop-out comparison in the discussion, though no statistical values are providedCONTRA:* Lack of blinding control* No correction for multiple testing* Superficial and inadequate presentation of results: results are only shown graphically, with no mean/SD values available, lacking transparency* Very high drop-out rate, with 12 out of 15 participants in placebo arm who dropped out receiving Radiochemotherapy* Exact dosing from week 3 onward may vary for each participant* Apart from the primary endpoint, no specific timing provided for final comparisonsific timing provided for final comparisons)
Stratton et al. (2010): Oral Selenium Supplementation Has No Effect on Prostate- Specific Antigen Velocity in Men Undergoing Active Surveillance for Localized Prostate Cancer + (PRO: * Ethics approval obtained. * Partic … PRO:* Ethics approval obtained.* Participants were tested for 30 days to assess adherence to the intake protocol before randomization.* Only those with over 80% adherence were randomized.* Extensive prior questioning and recording of all medical factors related to potential selenium risk.* Detailed information on expected side effects provided.* Use of a "Data and Safety Monitoring Committee" to monitor protocols, side effects, etc.* Intent-to-treat analysis conducted.* Adequate and participant-adjusted analysis considering: Duration of participation in the study, Skin color, Baseline plasma selenium, Age, BMI, Nicotine consumption, PSA assay, Gleason score* Power analysis performed.* Arm comparability achieved except for BMI, which was adjusted in the analysis. CONTRA: * Participants could still take 50 μg of selenium outside of the study.* Unclear if baseline blood samples were taken before the test run of pill intake.* Baseline selenium differences between arms with p=0.07 were already close to significance.* The 800 μg selenium arm had a significantly higher descriptive level at 146 ng/mL compared to 128 ng/mL in the placebo arm.* Unclear randomization and blinding process.* Analysis of a subgroup from the 800 μg selenium arm resulted in very few participants.ium arm resulted in very few participants.)
Pace et al. (2003): Neuroprotective Effect of Vitamin E Supplementation in Patient Treated With Cisplatin Chemotherapy + (PRO: * Baseline vitamin E levels reported. … PRO:* Baseline vitamin E levels reported.CONTRA:* No blinding.* Small sample size without power analysis.* Very high dropout rate: 43%, with no information on distribution between arms.* No intention-to-treat analysis.* Poor reporting quality (e.g., no information on changes in vitamin E levels and compliance, possible selective reporting of endpoints).ossible selective reporting of endpoints).)
Azizi et al. (2015): Efficacy of Topical and Systemic Vitamin E in Preventing Chemotherapy-induced Oral Mucositis + (PRO: * Blinding of investigators. CONTRA: … PRO:* Blinding of investigators.CONTRA:* Unclear randomization.* No blinding of patients.* Small sample size without power analysis.* Very high dropout rate (after the fourth CTX cycle: Vitamin E paste: 27%, Vitamin E oral: 33%, Placebo: 46%).* No information on compliance.* Multiple testing without time-based models.* Poor reporting quality (e.g., no information on cancer types or stages, no standard deviations or 95% confidence intervals, no baseline values of the variables studied).baseline values of the variables studied).)
Kasseroller et al. (2003): Efficacy and tolerability of proteolytic enzymes as an anti-inflammatory agent in lymphoedema after axillary dissection due to mammary cancer + (PRO: * Detailed information on the baselin … PRO:* Detailed information on the baseline criteria* Intention-to-treat analysis* Double-blinded* Pill counting as control (compliance)CONTRA:* No information on ethics vote* No further information on drop-out/attrition* Statistical methods presented in a way that is difficult to understand * No statistically comprehensible substantiation of the results or group comparisons* Exclusion of test subjects with known intolerance: validity of side effects therefore limited*Apparent differences between groups compared to baseline with regard to previous cancer therapy and skin fold thickness* Outcome for assessment of success by doctor and patient not listed in study* Sparse description of randomisation, could be a quasi-randomisation ‘The patient number was allocated to the patient in uprising arithmetical order and the patient received the first box of matching medication’ived the first box of matching medication’)
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients + (PRO: * Detailed medical examination. * Com … PRO:* Detailed medical examination.* Comparability of values for measured endpoints given.CONTRA:* Very small sample size and no power analysis.* No blinding or placebo arm.* No mention of ethics approval.* Discrepancies between ejection fraction data in the abstract and table.* No inclusion or balancing based on participants' baseline values (very simple statistical calculation with high risk of bias).* Infection rate is significant in text but not indicated as significant in the table (p>0.05 but marked as "S" for significant).* Very superficial presentation of results.* Imprecise and insufficient description of side effects.* No statistical proof of arm comparability at baseline regarding demographic variables.* No information on the randomization process or possible drop-outs.* No indication of when follow-up on cardiac ejection fraction took place.* No age specification.* Although selenium serum measurement is mentioned, no data is provided.easurement is mentioned, no data is provided.)
Villani et al. (2016): Vitamin E neuroprotection against cisplatin ototoxicity: Preliminary results from a randomized, placebo-controlled trial + (PRO: * Double-blind design (patients/inves … PRO:* Double-blind design (patients/investigators).CONTRA:* Fewer patients than calculated in the power analysis (< 80 patients).* Very high dropout rate (Intervention arm: 76%; Placebo arm: 81%; reasons: discontinuation or insufficient cisplatin; participation in only one assessment, planned follow-up assessments could not take place due to further dropout (Intervention arm and Placebo arm: n = 8 each)).* No information on compliance.* No proper statistical comparison between the groups due to small sample size.* Poor reporting quality (e.g., no specific information on demographic variables such as cancer type, important numerical data missing, only imprecise graphics).* Due to the lack of demographic variables and the small sample size, the comparability of the groups through randomization cannot be assured.oups through randomization cannot be assured.)
Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (PRO: * Ethical approval * Intent-to-treat … PRO:* Ethical approval* Intent-to-treat analysis* Power analysisCONTRA:* Differences in treatment adherence* Some descriptive differences at baseline without p-values provided (e.g., pain duration)* Post-hoc analyses reveal confounding variables associated with higher mortality rates in intervention arms: high white blood cell count, low calcium, hemoglobin, and lymphocyte levels, raising doubts about group comparability.* In analyses of subjective pain perception, changes in opioid consumption were not controlled for.* Mostly one-dimensional pain parameters were considered.* Results in the text are reported unclearly, with some values missing or not precisely specified.* No information on cancer stage.* Poor reporting quality.* Correction for multiple comparison only for primary endpointsiple comparison only for primary endpoints)
Lichtmann et al. (2018): Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled Pain + (PRO: * Ethical approval * Intent-to-treat … PRO:* Ethical approval* Intent-to-treat analysis (primary endpoint)* Multiple testing controlled for endpoints pain and sleep disturbance* Arms comparable at baselineCONTRA:* No information on whether centers were comparable in patient treatment; particularly as “optimal” opioid treatment may vary by country.* No power analysis* No details provided on how randomization was conducted or how blinding was ensured* Correction for multiple testing only for primary endpointmultiple testing only for primary endpoint)
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 + (PRO: * Ethical approval * Intent-to-treat … PRO:* Ethical approval* Intent-to-treat analysis* Power analysis* Arms comparable at baselineCONTRA:* No information on whether centers were comparable in patient treatment; especially as “optimal” opioid treatment may vary from country to country.* Baseline data: cancer type not specified for 104 patients.* No control for multiple testing.* Reported results in the text are unclear.* No information on cancer stage.* No explanation of how randomization was conducted or how blinding was ensured.* Most comparisons are between the interventionarms and the placeboarm, but there are few comparisons between the interventionarms * No elaboration of the intent-to-treat analysis in the methodologyntent-to-treat analysis in the methodology)
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial + (PRO: * Ethical approval * Power analysis * … PRO:* Ethical approval* Power analysis* Daily contact with staff on days of administration* Structured assessment of side effects using a checklist* Adherence monitored through diary entries and capsule counts* McNemar’s test used to control for within-patient correlation* Control for order effects (p=0.29)* Comparability at baseline ensured by study designCONTRA:* Correction for multiple testing only for primary endpoints* 90% confidence interval (CI) (p=0.1) used for primary endpoints and 95% CI for secondary endpoints due to pilot study design (primary endpoint was also significant at 95%)* No differentiation of primary endpoint into acute or delayed responses, despite being listed in the methodology* Unclear presentation of when and how each endpoint is measured* Numerous interactions with pharmaceutical companies* Capsule dosing individualized, with no subgroup analyses for high vs. low doseso subgroup analyses for high vs. low doses)
Jatoi et al. (2002): Dronabinol Versus Megestrol Acetate Versus Combination Therapy for Cancer-Associated Anorexia: A North Central Cancer Treatment Group Study + (PRO: * Ethical approval * Stratified rando … PRO:* Ethical approval* Stratified randomization* Power analysis* Baseline comparabilityCONTRA:* Discrepancies in weight data reported by patients vs. doctors* No clear timeline for study completion, with varying median participation times across arms (dropouts due to consent withdrawal and/or side effects: 45%, 58%, and 41%; or death: 22%, 15%, and 26%)* Lack of a flowchart, making the timing of dropouts/attrition unclear* Only 45% completed questionnaires after one month; no details on intent-to-treat analysis, though tables suggest all randomized patients were included (dropouts were classified as "treatment failure")ts were classified as "treatment failure"))
Zalat et al. (2020): Evaluation of the cardioprotective effects of l-carnitine and silymarin in cancer patients receiving anthracycline-containing chemotherapy + (PRO: * Ethical approval * Study protocol * … PRO:* Ethical approval* Study protocol* Baseline comparisonCONTRA:* No blinding* Simple randomization: Even numbers assigned to carnitine and odd numbers to silymarin arm; unclear how the control group was randomized and no additional details on randomization* Statistical methods opaque: No group comparison despite planned ANOVA with group comparison* Unclear process for patient inclusion and unclear timing of randomization (patients were "recruited" after randomization); exclusion reasons in text differ from those in the figure* High risk of bias as 14 patients in the intervention groups dropped out due to non-compliance with the protocol and no ITT analysis was conducted* No information on adverse events* Change in silymarin arm over 6 months from 66.7 ± 0.045 to 68.56 ± 0.031 is highly significant (p = 0.003), despite a very small difference = 0.003), despite a very small difference)
Sun et al. (2016): A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy + (PRO: * Ethical approval available * Compar … PRO:* Ethical approval available* Comparability of groups regarding the degree of neurotoxicity ensured* Division into Full Analysis Set and Per Protocol Set* Evaluation of EEG by independent reviewers* Control across different hospitals* Transparent statistical analysis* Inclusion of a placebo control group* Large sample size* Prohibition of taking other medications during the studyCONTRA:* ITT Set unclear, only 225 instead of 239 were analyzed* No description of drop-out/attrition or reasons provided* No description of the sample (demographics, gender, age)* No reporting of variable dispersion (almost no confidence intervals)* Only t-tests used and no correction for alpha accumulation* Rounded p-values in the main text and no reporting of effect sizesmain text and no reporting of effect sizes)