Dear Editor,
Sivasankari et al.[1] described a study of nicotine replacement therapy and salivary cotinine levels in a sample of smokers. Their study was discussed extensively in eJournal Club India, and many disturbing observations emerged.[2]
The trial does not appear to have been registered with the Clinical Trials Registry of India. There is a striking difference in writing style between the first three paragraphs and the rest of the text; it appears that these three paragraphs may have been plagiarized from other sources, and this can easily be verified from online plagiarism checking tools.
Much of the rest of the text is deficient, contains errors, or makes no sense. As examples, the randomized controlled trial is described as a cross-sectional study. The stated period of study is different in different parts of the text. Details of randomization are not provided; the randomization must have failed because there are marked baseline differences between groups. There is variation in the stated sample size between abstract, text, and tables. The CONSORT (Consolidated Standards of Reporting Trials) diagram does not contain patient numbers. Two different Fagerstrom instruments are cited, and it is not clear to which instrument the reported Fagerstrom scores refer. The statistical analysis described is inconsistent between what was planned and what was performed; in any case, both are insufficient, given the study design. Confidence intervals are provided without a statement of the statistic that they describe; they are stated from higher to lower value instead of from lower to higher value; also, in places, they are stated as single numbers.
In many places, the phrasing, itself, is hard to understand, for example, what are “post-salivary cotinine levels?” What does “Figure 2: Comparison of mean pre and postcotinine gum” mean?
Many references are not appropriate to the text that was intended to be referenced. Last but not least, cotinine levels are of questionable value in patients who are receiving nicotine replacement, and so the very objective of the study is questionable.
In summary, we do not encourage readers to attach credence to the findings of this study.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
REFERENCES
- 1.Sivasankari T, Sankaran A, Murugappan S, Subramanyam V, Subramanian B, Reddy RJ, et al. Comparative evaluation of the efficacy of nicotine chewing gum and nicotine patches as nicotine replacement therapy using salivary cotinine levels as a biochemical validation measure. Indian J Psychiatry. 2023;65:635–40. doi: 10.4103/indianjpsychiatry.indianjpsychiatry_291_23. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Thakurdesai A, Ghosh A, Menon V, Sahoo S, Tripathi A, Harshe D, et al. Electronic journal clubs for capacity building: A case study in psychiatry as a model for medical disciplines in developing countries. Asian J Psychiatr. 2018;34:93–7. doi: 10.1016/j.ajp.2018.04.026. [DOI] [PubMed] [Google Scholar]