The effect of diclofenac sodium given alone or in combination with paracetamol in ‎treatment of patients with type-2 diabetes mellitus‎

Abstract

Background: Type-2 diabetes mellitus (T2DM), is becoming an important health problem worldwide. Diabetes ‎mellitus may be associated with low grade chronic inflammation and oxidative stress; both of them could contribute to ‎its pathogenesis. The use of anti-inflammatory and/or antioxidant drugs, therefore, represents a promising attempt for ‎treatment and/or prevention of this disease.‎Objectives: To compare the effect of diclofenac sodium alone and when combined with paracetamol in type-2 diabetic ‎patients not achieving target HbA1c.‎Patients and Methods: Twenty four, type-2 diabetic patients consulting the Center for Diabetes and Endocrinology in ‎Maysan, south of Iraq, had managed to complete the 3 month period of the first part of this study after meeting a set of ‎inclusion criteria. Their HbA1c was more than 7% despite the continuous use of oral antihyperglycemic drugs. The ‎effect of diclofenac was compared with another group (n=21) that received paracetamol in addition to diclofenac ‎sodium. Blood samples were taken from before, one month and three months after the start of treatments for ‎measurement of HbA1c, C-reactive protein, C-peptide level and more frequently plasma glucose level ‎‎(fasting/random). Another sixty patients of similar inclusion criteria were also followed for three months but without ‎treatment and served as a control group.‎Results: The effect of one month treatment with diclofenac sodium alone or in combination with paracetamol resulted ‎respectively in a reduction in HbA1c by 9.4% and 11.4%, a reduction in CRP by 62.1% and 79.6%, an increase in C-‎peptide by 262.5% and 216%, a reduction in FPG by 11.2% and 18.1% and a reduction in RPG by 40.3% and 24.8% in ‎comparison to pre-treatment levels.‎The HOMA- ß C-peptide measured in a limited number of patients treated with diclofenac sodium or its combination ‎with paracetamol showed an increase by 405.3% and 330.6% three months after start of treatment for the two groups ‎respectively. The control, non- intervention group did not show significant changes in the levels of HbA1c over the ‎three-month period. ‎Conclusion: Diclofenac sodium 100mg SR capsule administered once daily for one month seems to be effective in ‎achieving a good glycemic control in patients not achieving target HbA1c. The addition of paracetamol to diclofenac did ‎not show a clear synergistic effect, despite paracetamol beneficial effect that had been shown in a previous study. ‎