Property:Additional Notes
This is a property of type Text.
S
Sanaati et al. (2016): Effect of Ginger and Chamomile on Nausea and Vomiting Caused by Chemotherapy in Iranian Women with Breast Cancer +
* Vomiting severity mentioned as a target parameter in the report but not in the register
* High drop-out rate (n=20)
* Severity of CINV episodes not reported
* AEs not reported
* Tables partly incomprehensible
+
Shamsaei et al. (2017): The Vitamin E Preventive Effect on Taxol-Induced Neuropathy Among Patients With Breast Cancer: A Randomized Clinical Trial +
PRO:
* Ethical approval obtained.
* Adequate sample size according to power analysis.
CONTRA:
* Unclear blinding (only mentioned that the nurse distributing the medication is blinded).
* No information on compliance.
* Multiple testing.
* Poor reporting quality (e.g., no information on dropout, no information on important baseline characteristics). +
Sharp et al. (2009): A randomised, controlled trial of the psychological effects of reflexology in early breast cancer +
? +
Sharp et al. (2010): A randomised, controlled trial of the psychological effects of reflexology in early breast cancer +
''Additional Complementary and Alternative Medicine therapies''
assessed with CMQ (Complementary Therapies Questionnaire ) with no significant differences between all three arms at T1 (18 weeks post surgery) and T2 (24 weeks post surgery) +
Stauder et al. (1991): Strahlentherapeutische Nebenwirkungen bei Abdominalkrebspatienten und deren Reduktion durch hydrolytische Enzyme +
PRO:
* Randomised
CONTRA:
* No information on the gender of the patients
* According to the authors, the comparability of the arms was tested using the Mann-Whitney U test, the Wilcoxon test was used to test for significant differences between the symptom levels, the Mann-Whitney U test was used to test for significant differences between the treatment results and the ANOVA and LSD test were used for the descriptive presentation of the symptom progression. Unfortunately, these results and associated p-values are not presented in the study.
* No blinding
* No information on drop-out/attrition
* Survey of side effects clouded, as patients with known intolerance were excluded beforehand +
Stendell-Hollis et al. (2010): Green tea improves metabolic biomarkers, not weight or body composition: a pilot study in overweight breast cancer survivors +
PRO:
* Ethics vote
* Run-in period
* Control of treatment adherence (by using daily tea logs and participants had to return all used and unused tea bags to the clinic, compliance was very good with > 94% in both arms)
* Testing the flavour comparability of the teas (even if only with n=6)
* Control of general food intake via AFFQ and inclusion in analysis
* Testing for normal distribution of the data (baseline)
CONTRA:
* Overall small sample size
* High attrition
* Per-protocol analysis (intention-to-treat would be better) +
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 (…) +
PRO:
* Ethics vote
* Indication of the reliability of the measurement instruments
* Power analysis
* Intent-to-treat analysis (but see CONTRA)
* Very detailed description of the statistics
* Control for compliance and high compliance (44-60%), compliance with treatment was similar between arms (Cannabis extract 49%, THC 44%, and Placebo 60%; p > .15)
CONTRA:
* ITT only for tests between both intervention arm vs. placebo, tests between the 2 intervention arms with PP analysis
* Sample too small according to power analysis, recruitment was stopped after interim analysis due to lack of effects
* 84 patients had severe deviations from the protocol and/or took less than 90% of the intervention, had missing data on the primary endpoint, or had THC in serum at baseline
* Patients in PP analysis mostly male, older with better baseline scores for mood, nausea, daily food intake and QoL +
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.
* 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. +
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 ? +
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
* 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 study
CONTRA:
* 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 sizes +
T
Tan et al. (2018): Bromelain has significant clinical benefits after extraction of the third molar during chemotherapy in patients with hematologic tumor +
PRO:
* Ethics vote available
* Detailed specification of statistical parameters
CONTRA:
* Small number of study participants
* No information on drop-out or attrition: ‘If participants suffered from side effects, they stopped treatment and discontinued participation in the study.’
* The authors state that the study was double-blinded, but this is not possible due to the different treatment methods of the two arms
* Endpoint 4 not independent of endpoints 1, 2 and 3
* No correction for multiple testing (cumulative α-error possible)
* Unclear randomisation process (‘we randomly divided’) +
Toma et al. (2003): β-carotene supplementation in patients radically treated for stage I-II head and neck cancer: Results of a randomized trial +
PRO:
* Ethics vote
* Sufficiently large sample after power analysis
* Intention-to-treat analysis
* No baseline group differences
CONTRA:
* No blinding
* 3-year compliance at 68.7%, 40.2% discontinue beta-carotene treatment + compliance to treatment largely different among patients enrolled in different participating institutions
* Poor reporting quality, e.g. hardly any p-values reported +
U
Upadhyaya et al. (2017): Radioprotective effect of vitamin E on salivary glands after radioiodine therapy for differential thyroid cancer: A randomized-controlled trial +
PRO:
* Ethical approval obtained.
CONTRA:
* Single-blinded only.
* Small sample size without power analysis.
* No information on dropout.
* No control for multiple testing.
* No pairwise intergroup comparisons to determine the optimal dosage.
* No information on compliance.
* Poor reporting quality (e.g., no indication of how often vitamin E should be taken). +
Urashima et al. (2019): Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial +
PRO:
* Ethics vote
* Power analysis (duration about 7 years, if 80 per year and a total of 400 required)
* Intention to treat analysis (except for side effects)
* Adherence was asked at each visit, occasional calls from coordinator and review when a new pack was issued every 6 months
* If vitamin D supplementation was necessary, intervention was stopped, but subjects were followed up
* Note that subgroup analyses should be interpreted with caution due to multiple testing
* Follow-up rate 99.8%
CONTRA:
* Adherence self-report only
* 10% stopped intervention +
Uysal et al. (2016): Effects of foot massage applied in two different methods on symptom control in colorectal cancer patients: Randomised control trial +
* Power analysis, Bonferroni correction for multiple testing, active control
* CONTRA:
No mention of blinding, although this would have been possible with regard to classic foot massage vs. reflex therapy (note: subjective outcomes, placebo effect);
Reflex therapy received 30 min intervention, classic foot massage only 20 min (performance bias);
Reflex therapy was not carried out by trained therapists.
The arms already differed significantly from each other in the first week (baseline) on the EORTC QLQ C30 in the Global Health Scale (mean (SD): reflexology massage arm: 76.25 [9.85], classical massagel arm: 68.33 [5.72], control arm: 68.33 [11.34]; p=0.012). In addition, there are many more patients with stage III tumors in control arm (stage II/III: reflexology massage arm 10/10, classical massage arm 5/15 and control arm 3/17);
No information on the results of CR29 (reporting bias);
No information on effect sizes and clinical relevance ranges
+
V
Van Zandwijk et al. (2000): EUROSCAN, a Randomized Trial of Vitamin A and N-Acetylcysteine in Patients With Head and Neck Cancer or Lung Cancer +
PRO:
* Large sample according to power analysis
CONTRA:
* No blinding
* No p-values for baseline group differences -> at least descriptively partially different
* More treatment dropouts in vitamin A groups (vit. A: 26%/vit. A+NAC: 25% vs. NAC: 18%; p < 0.001)
* Very unclear reporting, only very few p-values reported overall +
Villani et al. (2016): Vitamin E neuroprotection against cisplatin ototoxicity: Preliminary results from a randomized, placebo-controlled trial +
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. +
PRO:
* Information on the tests used
CONTRA:
* No information on the ethics vote
* Hardly any demographic information and unclear randomisation process; comparability of the arms cannot be presented in a comprehensible manner
* Relatively small number of study participants
* No blinding
* No information on drop-out or attrition
* No baseline p-values given
* No information whether mono- or multicentre
* No information on the country and period of the study +
W
Williams et al. (1996): Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity +
? +
Wrbka et al. (1987): Unterstützung der Chemotherapie inoperabler Karzinome durch proteolytische Fermente +
PRO: -
CONTRA:
* Results almost unusable, no baseline values, graphs barely legible, many different cancer entities despite small sample, monocentric? etc.
* Only 16 patients in the evaluation of treatment success (even if this was unavoidable due to deaths)
* No statistical group comparisons carried out
* No information on the ethics vote +