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

Abstract EN

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.