Ethical Review

A study into the effectiveness of propolis as a treatment of oral mucositis in chemotherapy treated
children was conducted by the researchers T. Tomazevi and J. Jazbec. The criteria for eligibility in
the study included paediatric patients aged one to nineteen years, diagnosis of cancer and
commencement of chemotherapy. The exclusion criteria included allergy to propolis and pre-
diagnosed oral disease. The subjects were randomly assigned to propolis or placebo groups. The
study consisted of subjects brushing their teeth and then applying, using a micro tip applicator,
approximately 0.38g of propolis or placebo. A third party dentist investigated the condition of oral
mucositis daily and recorded the data. Before the study was conducted it was approved by the
Slovenian National Medical Ethics Committee and informed written consent was obtained from the
parents and caregivers of patients. The study was registered with ISRCTN number.
I believe this study was ethically sound in the way it treated subjects. It is right to seek ways to
improve patients wellbeing and ease symptoms caused by the treatment of a major illness. There
always exist harm in studies involving humans as subjects. In this study the researchers attempted to
minimize this. They did this by excluding those who could have allergic reactions from joining the
study and investigated what compounds propolis contained. The harm in this study was minor with
the majority of this from experiencing oral mucositis and preventing subjects from taking medicated
relief to ease symptoms. The researchers obtained informed written consent meaning parents
would have been aware of what their child was undergoing and had the right to withdraw at any
time.
The researchers stated in the article there was no conflict of interest to declare. Due to the fact this
study directly relates to relieving symptoms caused by chemotherapy there would have been
incentive for the researcher to falsify or manipulate some of the data. As a known disease in
modern society unearthing ways to treat symptoms, or in this case side effects of the cure, would
bring about financial benefits. The researchers stated that ten data points were excluded from the
results although valid reasons were given including subjects not following protocol and basic disease
deterioration. By explaining reasons why the data was discarded the researchers have ethically
justified their manipulation of the data. As this improves the accuracy of the trial.
In this study on the effects of propolis on oral mucositis the researcher did not participate in
unethical practises. They showed approval received from the hospital ethics board and parents. The
study did not force unnecessary tests on subjects and let them drop out if the subjects chose to do
so. They also gave adequate reasoning for the manipulation of results. For the above reasons this
study may be considered ethical.




Bibliography
Current Controlled Trials Ltd. (2012, July 11). The effect of propolis on chemotherapy induced oral
mucositis and bacteremia during oral mucositis. Retrieved 9 10, 2013, from Current Controlled Trial:
http://www.controlled-trials.com/ISRCTN47055000