A claim was made by a company (Heinz India Pvt Ltd.)
regarding their product "Complan" in advertisement shown in media,
according to which "Complan" increases the height of children. On
company website it is mentioned "Give your child the power of Complan
thrice a day and see him/her grow twice as fast" [1]. A reference is also
given there supporting the claim. After going through this study [2] I
found some issues that need to be critically analyzed to validate this
claim.
1. In the study, it is clearly mentioned that
subjects who were included in the study were "school children of 7-12
years of age in Coimbatore, India" [2]. But it seems that results are
generalized to all age group children in advertisement. In conclusion
section authors mentioned that "Encouraging findings from the present
study demonstrate the beneficial effect of health drink on growth in
children of 7-12 years" so it seems that authors were very clear about
the specific population of the study and generalizability of results to
specific population. But in the advertisement this fact was not shown
and results were generalized to all children, which is methodological
wrong and unethical.
2. In the "materials and methods" section it is
mentioned that children who were recruited in this study were from
"middle and low income families". In the results section it is mentioned
that "more importantly, it revealed sub-optimal food intake pattern by
children in all three groups". Therefore results of this study can not
be generalized to children of high socioeconomic class families and
children whose food intake is optimal. But the advertisement is
generalized to all children irrespective of there socioeconomic class
and nutritional status.
3. There were 58 dropouts from the study and they
were not included in the final analysis. Reasons for there dropouts were
not mentioned in the study. Characteristics of these subjects were not
compared to the subjects who remained in the study. Intention to treat
principle was not followed. This may insert bias in the observed
results. Ignoring the subjects who have withdrawn from study usually
introduces bias in the favor of the intervention [3].
4. Randomization process is not explained in detail.
In ‘materials and methods’ section it is mentioned that "schools were
randomly assigned to two treatment groups". This statement is not
sufficient to understand the randomization process.
5. This study was an open label study. No blinding
was done (or not reported in the study). In an unblinded study, there
are all chances of bias in the favor of treatment. This issue becomes
more important as the study is financially supported by the
manufacturers (Heinz India Pvt Ltd). Though authors did not report
conflict of interest or source of support in the published study. The
information regarding this source of support is taken from authors
profile available on internet [4].
6. In the advertisement on company website it is
mentioned that "Give your child the power of complan thrice a day and
see him/her grow twice as fast". In the study Complan was given twice a
day and in the advertisement thrice a day is mentioned, which is not
supported by this study [2].
After reading this study, two important ethical issues
have emerged first; the claims made by company are exaggerated and second,
results seem to be generalized to all children without any regard to the
study results. Methodological and ethical issues related to the study are;
not declaring conflict of interest and source of support by authors,
unclear randomization, not following intention to treat principle, and
blinding.
I believe there should be some regulation to
advertisements especially related to food, nutrition, drugs and cosmetics.
Central or state government should form a committee of experts for
analyzing these claims made by companies before they are shown in
advertisements. Only high quality research should be allowed to be quoted
by companies in these advertisements.
References
1. http://www.heinz.co.in/about-brand/complan-child-growth.aspx.
Accessed on October 17, 2010.
2. Vijayalakshmi P, Premakumari S, Haripriya S.
Supplementation of milk based health drink enriched with micro nutrients:
Part I Impact of growth and haemoglobin status of 7-12 year old children.
Indian J Nutr Dietet. 2008;45:449-65.
3. Greenhalgh T. How to read a paper: Assessing the
methodological quality of published papers. BMJ. 1997; 315:305.
4. http://www.pondiuni.edu.in/aaac/sch_dept_cent/foodscience/Foodscience/priya.fst.pdf.
Accessed on October 17, 2010.