Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting

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Article analysis
Students Name
University
Date

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Zhang, Lingyun, Xiujuan Qu, Yuee Teng, Jing Shi, Ping Yu, Tao Sun Jingyan Wang, Zhitu Zhu,
et al. 2017. "Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by
Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-
Controlled Phase III Trial (CLOG1302 study)." Journal of Clinical Oncology 35 (31): 3558-
3565.
1. Did the study ask a clearly focused question?
(Zhang, et al. 2017)Yes, the study question is clear and can be easily understood by the reader.
This both from the topic of the article and the summary of the purpose which is in the abstract.
The study was based on patients who had received highly emetogenic chemotherapy (HEC).
Thus the intervention given for this study is thalidomide which was uses in highly emetogenic
chemotherapy (HEC) to determine whether it reduced delayed nausea and vomiting. Randomized
control trials are used to measure the effectiveness of a medical intervention that is done on the
patient by having two groups, the general group which can sometimes be the placebo group and
the control group which is the one that is used to measure the effectiveness of the intervention1.
These type of studies are the best since they allow the researcher to compare two groups which
lead the researcher to conclude the effectiveness of the new clinical method or drug being tested.
In this case, the focus is determining whether thalidomide can be effectively used on reducing
nausea.
2. Was this a randomized controlled trial (RCT) and was it appropriately so?
This study is a placebo randomized control trial since it had two patient groups. Double-Blind,
Placebo-Controlled Phase III Trials are used for the trial of patients in different clinical settings
1 Hariton, Eduardo, and Joseph J. Locascio. 2018. "Randomised controlled trials—the gold standard for effectiveness research." BJOG,
p. 3.

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to determine if certain drugs are applicable to them or not. This means that two groups are used
as a placebo group and the control group. The role of the former is to receive drugs that have no
real effect so that the differences can be noted and analyzed in the control group2. Randomized
trials are the best since they are used to test the clinical effectiveness of different types of drugs
and thus the reason why this research was fit for the study. By being a randomized placebo trial,
the researchers were able to compare data from two groups of patients, one which was a placebo
and the other one which was a control group that was administered with thalidomide to
determine the effects that it has on the patient group. Through comparing the results from the
two groups the researcher is able to determine the effectiveness of the clinical intervention being
tasted3. Thus a randomized control trial is the best for this study since the participants are
randomly placed in the groups increasing the generalizability of the findings. In such case,
skewing and manipulation of the results are limited thus ensuring that the study yields the best
outcomes of the study.
3. Were participants appropriately allocated to intervention and control groups?
The patients were randomly assigned to the groups based on stratification using a computer-
generated sequence that ensured that both groups had an equal number of patients for the study.
This ensured true randomization in the ratio of 1:1. To balance the randomization easily, four
blocks were established and patients distributed across the blocks to increase monitoring and
assessment. The patient data was recorded from day one to five with short-term adverse events
being evaluated within day 1-5 while serious events were recorded and evaluated for a period of
up to 21 days. For this study two outcomes were considered, the primary outcome was a
complete response of the patient to vomiting without the use of any drugs and no emetic episodes
2 Chiodo, Gary T, Susan W Tolle, and Leslie Bevan. 2018. "Placebo-controlled trials." Western Journal of Medicine, p. 272
3 Gupta, Usha, and Menka Verma. 2013. "Placebo in clinical trials." Perspectives in Clinical Research, p. 643