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ABSTRACT
Rheumatoid arthritis (RA) is a systemic chronic inflammatory disease of unknown etiology that primarily targets synovial tissues and affecting both articular and extra-articular tissues. Boron shows important role in the pathogenicity and prognosis of RA, where reduced dietary boron content has been associated with RA. The present study was designed to to evaluate the safety of boron supplements when used in pharmacological doses as adjuvant with etanercept in treatment of RA patients. A double blind randomized placebo-controlled clinical trial with 60 days' treatment period was carried out during 8 months at Baghdad Teaching Hospital / (Medical City) Baghdad, Iraq. One hundred eleven patients maintained on Etanercept and other DMARDs with moderatesevere active RA were selected. Eighty RA patients were randomized into 3 groups to receive either 220 mg/day calcium fructoborate (CFB), 55 mg/day sodium tetraborate (NTB) in capsule dosage form (equivalent to 6 mg elemental Boron), or placebo (specially prepared for this purpose) once daily. Only 72 patients completed the study. Blood was obtained from each patient before and after 60 days, and utilized for the measurement of erythrocyte sedimentation rate (ESR), hemoglobin (Hb), white blood cells (WBC) count and platelets count, hepatic and renal functions. The results showed that boron supplements have no negative impact of the evaluated markers, and they demonstrated protective effects in certain occasions. In conclusion, both NTB and CFB showed relatively similar hematological, hepatic and renal safety profile when used as adjuvant in RA patients, with few predominance for CFB in this regard.
Keywords: Calcium fructoborate; Sodium tetraborate; Rheumatoid arthritis; Liver; Kidney.
INTRODUCTION
Boron, the mineral trace element, is an important micronutrient necessary for the growth and proliferation of many cells in all biological systems.1'2 The currently available evidence has not been yet recognized completely as an essential nutrient in animal cells,3 and more future data are required to support its vital role in this regard.4 Identification of many biological functions of boron as a regulator of many enzymes, membrane transporters and biochemical processes constitutes the basis of new drugs and nutraceuticals that include boron atom both as mineral and organic complex forms.5-7 Accordingly, as a dietary supplement boron containing formulas may enhance human health more than the normal foods do it.8 However, whether a supplement has medicinal...