Abstract
Objective: To evaluate the efficacy and safety of ferrous gluconate, given orally thrice daily for three months, to pre-menopausal women with severe iron deficiency anaemia.
Method: A phase IV non randomized single arm open label drug trial was conducted at Gynaecology and Obstetrics Unit II in Abbasi Shaheed Hospital from Feb 2013 to March 2014, which is a 950 bedded public sector tertiary care hospital. Total fifty premenopausal women with documented severe iron deficiency anaemia, haemoglobin (Hb) between 6-8 g/dl were enrolled after taking written informed consent. Clinical evaluation and lab investigation for serum ferritin and haemoglobin levels were conducted at baseline and after completion of treatment. A standardized proforma for data collection was developed. Ferrous gluconate soft gelatin capsules were given as one capsule during or after the meal 3 times daily, for three months. All patients were evaluated four times during study first at the time of enrolment and after 30, 60, and 90 days for clinical efficacy and safety assessment.
Results: In our study all fifty premenopausal women completed iron treatment. Analysis of therapeutic efficacy parameters i.e. haemoglobin, and serum ferritin levels showed improvement that was statistically significant. By the end of treatment with oral ferrous gluconate, significant improvement in Hb levels was observed (7.574 +/- 0.559 g/dl vs 11.020 +/- 0.718, p<0.0001). Significant changes were noted in serum ferritin level (10.058 +/- 5.059 ng/ml vs 27.136 +/- 13.803, p<0.0001) after 3 months therapy. Ferrous gluconate proved to be safe in women with severe iron deficiency anaemia. The treated women did not exhibit any major side effect, only one serious side effect was reported (erythema nodosum). Mild self-limiting side effects including black discolouration of stool in 54% cases, nausea in 6%, constipation in 2% and diarrhoea in 2% was observed.
Conclusion: Oral ferrous gluconate treatment for severe iron deficiency anaemia is well tolerated and highly effective in premenopausal women.