Comment on Bellapu, Dhanush, et al., sodium glucose co-transporter 2 inhibitors safety depending on their adverse drug reactions and glucose monitoring parameters in type 2 diabetes mellitus

Dear Editor, We have read with interest the research article titled “Sodium Glucose Co-Transporter 2 Inhibitors Safety Depending on Their Adverse Drug Reactions and Glucose Monitoring Parameters in Type 2 Diabetes Mellitus” authored by Bellapu et al.[1] The article designed as a “planned interventional comparative ponder,” is not consistent with established methodological guidelines. According to the CONSORT 2010 statement,[2] an interventional trial requires the active assignment of diagnostic or therapeutic interventions by investigators. Researchers merely observed the outcomes in patients already undergoing treatment. Hence, the study design more accurately corresponds to a descriptive observational study. Furthermore, since the investigation was conducted in 2023, consistency in reporting tense is necessary. Several methodological inconsistencies are evident throughout the study. A major concern lies in the reporting of sample size and duration, raising questions about data validity and external reproducibility. The abstract records 1726 patients enrolled between December 2021 and December 2022, while the results section describes 3456 patients recruited between January 2022 and January 2023. The STROBE guidelines[3] emphasize that transparent and consistent reporting of participants and timelines is critical for maintaining scientific credibility. The article does not mention obtaining approval from an Institutional Ethics Committee or hospital administration. Although the authors state that patients unwilling to participate were excluded, there is no clear mention of informed consent procedures, which represent an indispensable element of ethically conducted research. Additional issues are noted in the selection and description of patients. Data collection was performed on hospitalized patients, yet the reasons for admission were not reported. Reporting inconsistencies were also observed with HbA1c measurements, which were described variably as being performed thrice, every 6 months, or every 3 months in methodology and results section [Table 6], respectively.[1] The inclusion of a control group in this study was poorly justified, further weakening the validity of comparative claims. Moreover, results were unnecessarily duplicated in both tabular and graphical formats, with discrepancies in parameter values between them. Details of therapeutic regimens were sparse; while the terms “dual, triple, and quadruple therapy” were repeatedly used, the specific drug combinations and prior treatment histories were not reported. Although insulin use was mentioned, the proportion of patients receiving insulin was not revealed. Even if the Chi-square test revealed significant differences in adverse drug reactions (χ2 = 31.868, df = 3, P < 0.05), the authors concluded that both Canagliflozin and control groups were equally safe. Such conclusions, contradicting the statistical evidence, contravene CONSORT and ICMJE standards.[2,4] The methodology also states that renal function tests were conducted every four months; however, no related findings were reported. Adverse drug reactions in the control group were not systematically described, with only vague references to weight gain and hypoglycemia in the discussion section. Since patients were prescribed multiple oral antidiabetic drugs, attributing adverse events exclusively to SGLT2 inhibitors is scientifically unsound. The omission of demographic details further undermines interpretation, particularly regarding weight changes. Data reporting errors also weaken the study, including misreporting of FBS and PPBS values in Table 5 and a typographical error in Table 6, where HbA1c for the Canagliflozin group at day 180 was recorded as 50.5.[1] The use of FBS and PPBS values as safety indicators was inappropriate, as these parameters reflect efficacy. The discussion fails to adequately acknowledge the limitations of the study. The key issues such as sample size discrepancies, reporting biases, and lack of detailed treatment data were not addressed. According to the STROBE recommendations,[3] explicit recognition of study limitations is crucial for ensuring balanced interpretation and guiding future research directions. In conclusion, misclassification of study design, inadequate ethical reporting, inconsistent data presentation, flawed statistical interpretation, and absence of demographic details collectively reduce the reliability of its findings. Addressing these shortcomings would enhance the validity of the conclusions and strengthen their practical implications for both clinicians and researchers. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.