Comparative Study of Femineral® and Floradix® in Women of Child-Bearing Age and Adolescent Girls with Iron Deficiency Anaemia

This double blind randomised trial compared the clinical efficacy of Femineral, a proprietary herbal preparation containing highly soluble iron compounds, minerals, and vitamins, with Floradix, the most popular iron supplement in Scandinavia for patients with iron deficiency anaemia (IDA). Fifty women of childbearing age and adolescent girls, all diagnosed with IDA, were randomised into two groups. One group (n = 26) was treated with Femineral (10 ml twice a day; 15 mg of iron supplement/day), while the second (n = 24) received Floradix (10 ml twice a day; 20 mg of iron supplement/day). The efficacy of 28 days of treatment in each group was evaluated by analysis of serum iron levels, blood haemoglobin and erythrocyte counts; by the mental performance of the patients on days one and 28; and by assessment of IDA symptoms, such as pale skin colour, fatigue, irritability, weakness, constipation, brittle nails, cold hands and feet, headache, blue tinge to sclera, and feeling of well being on days one, seven, 14 and 28. The Femineral group showed significant improvements in blood haemoglobin levels and red cell counts after 28 days, while the Floradix group did not. The 726 S. Babayan et al.: Sci Pharm. 2008; 76; 725–742. Femineral group showed better improvements in other IDA symptoms, such as impaired mental performance, pale skin colour, fatigue, irritability, weakness, constipation, brittle nails, cold hands and feet. Both groups showed significant improvements in serum iron levels at the end of the study. Such improvements correlate with the results of memory tests: the number of errors by both groups was significantly lower at the end of the study. There were no significant differences in memory tests between the two groups. Eight patients in the Floradix group and one in the Femineral group reported drowsiness. The Femineral group reported two other adverse events (nausea and vomiting). Femineral can be used safely in the treatment of iron deficiency anaemia. It is more efficient and safe than Floradix.