Critical review of drug promotional literature using the World Health Organization guidelines

Objective: Drug promotional literatures (DPLs) are used as a promotional tool to advertise new drugs entering the market to doctors. The objective of the present study is to evaluate the accuracy of DPLs by using the World Health Organization (WHO) criteria. Methods: An observational study was conducted from March to August 2014. The DPLs were collected from various departments at R.L. Jalappa Hospital and Research Centre attached to Sri Devaraj Urs Medical College, Kolar, India. The literature was evaluated based on 11 criteria laid down by the WHO. Findings: Two-hundred DPLs were evaluated. Cardiovascular drugs (34 [17%]) were promoted the most, followed by antidiabetic drugs (31 [15.5%]) and antimicrobial agents (29 [14.5%]). Single drug was promoted in 134 (67%) and fixed drug combination in 66 (33%) brochures. Manufacturer′s name was mentioned in 194 (97%), but their address was mentioned in 109 (54.5%) claims only. Drug cost was revealed only in 12 (6%) DPLs. Each ingredient′s generic name, brand name, and dosage form were mentioned in 197 (98%) brochures. Indication for use was stated in 193 (96.5%) claims. Contraindications, adverse effects, precautions, and drug interactions were listed in 68 (34.5%), 65 (32.5%), 65 (32.5%), and 58 (29%) advertisements. References were cited in 133 (66.5%) brochures. Only 63 (31.5%) literatures had relevant pictures of drugs being promoted and 59 (29.5%) had a graphical representation of pharmacological properties. A total of 131 (69%) DPLs followed 50% of the WHO criteria. Conclusion: Majority of DPLs satisfied only half of the WHO criteria for rational drug promotion and none of them fulfilled all the specified criteria. Incomplete or exaggerated information in DPLs may mislead and result in irrational prescription. Therefore, physicians should critically evaluate DPLs regarding updated scientific evidence required for quality patient care

Effect of Vitamin E and omega 3 fatty acids in type 2 diabetes mellitus patients

Diabetes mellitus (DM) and its complications have been implicated in hyperglycemia-induced oxidative stress. Antioxidants can improve glycemic control, lipid profile, and cognitive functions. We assessed the effect of Vitamin E and omega 3 fatty acids (OFA) on the above parameters. One hundred patients with type 2 DM receiving metformin 500 mg and glimepiride 1 mg were randomized to receive add-on therapy of Vitamin E 400 mg or OFA once daily for 12 weeks and the third group served as control. Fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c), body mass index (BMI), waist-hip ratio (WHR), lipid profile, and mini-mental state examination were done at baseline and 12 weeks. Eighty-seven patients completed the study. A significant reduction in FBS, PPBS, and HbA1c was observed in all the three groups at 12 weeks. There was significant reduction in total cholesterol and triglycerides (TG) in patients receiving either of the antioxidants and also significant reduction in low-density lipoprotein in patients receiving OFA at 12 weeks compared to baseline. BMI and WHR were significantly increased in control group. Intergroup analysis showed that in patients receiving Vitamin E and OFA, the reduction of FBS, PPBS, and HbA1c were similar. The patients receiving OFA had significant reduction in TG compared to control. There was no significant effect on cognitive function. Vitamin E and OFA had beneficial effects on lipid profile and anthropometric measurements; however, the glycemic control was similar to the patients in control group