Property:Additional Notes
This is a property of type Text.
H
Henning et al. (2015): Randomized Clinical Trial of Brewed Green and Black Tea in Men With Prostate Cancer Prior to Prostatectomy +
PRO:
* Ethics vote
* Group comparability is given
* Wash out and control of confounding factors: subjects were instructed to abstain from all teas and tea containing products (except the study tea) and not to consume any supplements or herbal therapies (i.e. lycopene, selenium, vitamin E, fish oil and saw palmetto).
* The polyphenon composition of the brewed tea (one sachet in 240 ml boiling water for 5 minutes) was determined by HPLC with electrochemical CoulArray detection.
* Power analysis
* Testing for normal distribution, consideration of the possibility of α-cumulation by multiple testing and adequate application of statistical methods
* Control of adherence to therapy (diary entries: Green tea arm =95%, Black tea arm=92%, Water-arm C= 93%)
CONTRA:
* Not blinded, but also rather difficult due to the different flavours of the teas
* Evaluation per-protocol (intention-to-treat would be better)
* Inconsistencies regarding arm size for PSA values (apparently not all analysed?, no information on missing data)
* High attrition
* Multiple endpoints, the overall false discovery rate was 10.8% +
Hershman et al. (2013): Randomized Double-Blind Placebo-Controlled Trial of Acetyl-L-Carnitine for the Prevention of Taxane-Induced Neuropathy in Women Undergoing Adjuvant Breast Cancer Therapy +
PRO:
* Ethical approval obtained.
* Exclusion of other medications: no other medications for the treatment of CIPN were allowed.
* Clinical relevance: a 5-point deterioration in the FACT-NTX score is stated to be clinically relevant.
* Power analysis conducted.
* Large sample size appropriate to the prior power analysis.
* Compliance measured: no difference between groups.
CONTRA:
* Patient awareness: patients were informed about the study's goal; symptom assessment is subjective and could be influenced by knowledge of the study's objectives.
* Lack of effect sizes: not reported.
* No laboratory values collected: lack of objective measures.
* No intention-to-treat analysis was performed. +
Hershman et al. (2018): Two-Year Trends of Taxane-Induced Neuropathy in Women Enrolled in a Randomized Trial of Acetyl-L Carnitine +
PRO:
* Ethical approval obtained.
* Randomization stratified by chemotherapy regimen and age.
* Exclusion of other medications for the treatment of CIPN.
* Analysis adjusted for baseline values and accounted for multiple factors.
* Baseline comparison conducted.
* Missing data on endpoints over time were comparable between arms.
* Detailed description of the study procedure.
* Endpoint not differentiated between sensory, motor, or autonomic neuropathy.
CONTRA:
* No effect sizes reported.
* No laboratory values collected (objective measures).
* No intention-to-treat analysis conducted. +
Hoopfer et al. (2015): Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapy +
? +
I
Inglis et al. (2020): Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT +
PRO:
* Ethics vote
* Comparability of the groups to the baseline
* Adherence controlled with tablets count at T1 and T2
CONTRA:
* Small sample size
* Lack of data for factors such as cancer stage that may have further influenced the effect of the intervention
* No indication of a power analysis
* No data on vitamin D levels at the end of the study
* Very low dose of vitamin D
* Simultaneous automatic calcium administration +
J
Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial +
PRO:
* Ethics approval obtained.
* Placebo-controlled and double-blind.
* Power analysis and adherence to sample size.
* Detailed protocol description.
* Measurement of selenium levels.
CONTRA:
* No compliance verification.
* No information on side effects or potential interactions with medications for mucositis prevention.
* Focus on small effects rather than clinically relevant ones and those corresponding to the predefined research question.
* Despite stating that previous studies show most stem cell transplant patients suffer from selenium deficiency, this was not tested or described here.
* Very few demographic variables provided.
* No verification of successful blinding.
* No information on whether participants could or did take other supplements. +
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 randomization
* Power analysis
* Baseline comparability
CONTRA:
* 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") +
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, 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 time
PRO
* Ethics vote
* Adequate randomization
* Double blinding
* Sample size according to power analysis
* Low dropout
CONTRA
* 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) +
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 analysis
* Power analysis
* Arms comparable at baseline
CONTRA:
* 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 methodology +
Jyothirmayi et al. (1996): Efficacy of Vitamin A in the Prevention of Locoregional Recurrence and Second Primaries in Head and Neck Cancer +
PRO:
* Double blinding
* High compliance rate (intervention: 89%, control: 86%)
* Intention-to-treat (dropout intervention: 12.5%, control: 16%)
CONTRA:
* No ethics vote reported
* No power analysis performed
* Partial descriptive group differences at Baseline (e.g. age: intervention: 56.3 vs. control: 58.2; stage III/IV: intervention: 18, control: 14)
* Hardly any correct statistical tests
*Poor report quality, e.g. no information on exact time period between radiotherapy/surgery and baseline +
K
Kadhim et al. (2021): Effect of Ginger Tea on Chemotherapy-Induced Nausea and Vomiting among Patients Attending the Oncology Teaching Hospital, Baghdad 2020 +
? +
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% 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 endpoints
PRO:
* 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. +
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 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’ +
Keshavarzi et al. (2019): The effect of vitamin D and E vaginal suppositories on tamoxifen-induced vaginal atrophy in women with breast cancer +
PRO:
* Ethics vote
* Triple blinding (patients, researchers, pathologists and analysts)
* Comparability of groups to baseline for characteristics
CONTRA:
* Under “Eligibility” inclusion of VMI≤51, but under “Procedure” inclusion of VMI≥52
* No indication of vitamin D or vitamin E levels
* No individual comparisons carried out in ANOVA, therefore unclear which arms actually differ
* No results for individual scales of the atrophy questionnaire
* No power analysis
* No correction for multiple testing +
Kessels et al. (2017): Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma A Randomized Clinical Trial +
PRO:
* Ethics vote
* Power analysis performed and criteria met
* 1 week wash-out of green tea before the start of the study
* Control of co-interventions (no further consumption of green tea, immunosuppressive medication)
* Control of adherence to therapy
CONTRA:
* No indication of demographic data. Comparability of the groups to the baseline? With such a small sample, randomisation may not be sufficient to ensure comparability
* Intent-to-treat analysis? Not serious due to low drop-out.
* Blinding could have been disturbed by side effects, but the outcomes are objective +
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% +
Kottschade et al. (2011): The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase 3 clinical trial +
PRO:
* Ethical approval obtained.
* Double-blinded.
* Intention-to-treat analysis conducted.
CONTRA:
* Fewer patients than calculated in the power analysis.
* High dropout rate during the study (immediately after randomization: A: Intervention, B: Placebo; A: 7%, B: 11%; further dropout during * the study, still part of ITT analysis: A: 35%, B: 42% due to treatment discontinuation (N = 29), side effects (N = 11), treatment change (N = 6), other medical problems (N = 6), death (N = 1), other reasons (N = 9)).
* Poor reporting quality (e.g., not all results reported as planned in the methods section, no information on compliance). +
Koyama et al. (2017): Intravenous Carnitine Administration in Addition to Parenteral Nutrition With Lipid Emulsion May Decrease the Inflammatory Reaction in Postoperative Surgical Patients +
PRO:
* Ethical approval obtained.
* Testing of variables for normal distribution.
* Reporting values adjusted for variable distribution.
* Good statistical methodology with adjusted corrections.
* Consideration of baseline values (ANCOVA).
CONTRA:
* At baseline: BMI, TLC, and ChE significantly higher in intervention arm (p < 0.05).
* Measurements of individual variables taken on different days.
* Unclear temporal definition of preoperative phase.
* 14 out of 16 participants had colorectal cancer, mostly stage I.
* Very brief data presentation.
* Very small sample size.
* Short intervention phase.
* BMI: significant preoperative difference between groups, with the difference on postoperative day 7 even larger but no longer significant.
* No reporting of significance values when no difference was found. +
Kraft et al. (2012): L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN) - a randomized multicentre trial +
PRO:
* Ethical approval for CARPAN protocol obtained.
* Registered as a clinical trial.
* Consideration of baseline values for carnitine.
* Critical evaluation of own results and reasons for findings.
* Power analysis conducted.
CONTRA:
* No clear categorization of dropout reasons into individual groups, and overall very high dropout rate, resulting in a small sample size (even though dropout was unavoidable due to disease stage), especially since power analysis required approximately 300 participants per group.
* No listing of questionnaire results.
* Baseline values not included as covariates.
* Although an intention-to-treat analysis was initially reported, no data was provided; imprecise description of applied analyses (where was what actually applied?) in the results section, with confusing reporting and statistically questionable procedures. +
L
Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer +
PRO:
* Ethics approval obtained.
* Power analysis conducted.
* Selenium levels measured at the beginning and end of radiotherapy.
* Adherence checked via self-report.
CONTRA:
* No intent-to-treat analysis conducted.
* Authors state baseline characteristics are comparable but do not provide statistical analysis.
* No explanation of how double-blinding was ensured.
* Unclear whose baseline values are reported—apparent discrepancy in patient numbers between intervention (34 patients evaluated) and placebo arm (37 patients' characteristics reported but only 33 evaluated according to flow diagram).
* Inconsistencies in patient numbers and dropout not clearly presented for the intervention arm.
* Small sample size.
* Selenium levels in the intervention arm were not significantly higher after supplementation compared to placebo, and selenium levels in the placebo arm increased during the study.
* Analyses in the results section are unclear and most are not reported in the methodology (post-hoc analyses).
* Results are presented without supporting tables or explanation of the analysis, making them difficult to interpret.
* Timeline of the study is unclear as it's uncertain when the values for "end of study" were taken—intervention was only 7 weeks but Kaplan-Meier curve is presented up to week 12. +