The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency Anaemia
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 i...
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| Format: | Article |
| Language: | English |
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KARACHI MEDICAL AND DENTAL COLLEGE
2017-03-01
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| Series: | Annals of Abbasi Shaheed Hospital and Karachi Medical & Dental College |
| Subjects: | |
| Online Access: | https://www.annals-ashkmdc.org/index.php/ashkmdc/article/view/90 |
| _version_ | 1797364155366244352 |
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| author | Tazeen Fatima Munim Shaista Rashid |
| author_facet | Tazeen Fatima Munim Shaista Rashid |
| author_sort | Tazeen Fatima Munim |
| collection | DOAJ |
| description |
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 in- vestigation for serum ferritin and haemoglobin levels were conducted at baseline and after comple- tion 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 sta- tistically 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.
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| first_indexed | 2024-03-08T16:31:11Z |
| format | Article |
| id | doaj.art-5916cb8bb3a84fe69eb937bb4d24915d |
| institution | Directory Open Access Journal |
| issn | 1563-3241 |
| language | English |
| last_indexed | 2024-03-08T16:31:11Z |
| publishDate | 2017-03-01 |
| publisher | KARACHI MEDICAL AND DENTAL COLLEGE |
| record_format | Article |
| series | Annals of Abbasi Shaheed Hospital and Karachi Medical & Dental College |
| spelling | doaj.art-5916cb8bb3a84fe69eb937bb4d24915d2024-01-06T06:20:40ZengKARACHI MEDICAL AND DENTAL COLLEGEAnnals of Abbasi Shaheed Hospital and Karachi Medical & Dental College1563-32412017-03-0122110.58397/ashkmdc.v22i1.9078The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency AnaemiaTazeen Fatima MunimShaista Rashid 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 in- vestigation for serum ferritin and haemoglobin levels were conducted at baseline and after comple- tion 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 sta- tistically 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. https://www.annals-ashkmdc.org/index.php/ashkmdc/article/view/90Iron-deficiency anaemia, premenopausal, ferrous gluconate, haemoglobin, ferritin. |
| spellingShingle | Tazeen Fatima Munim Shaista Rashid The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency Anaemia Annals of Abbasi Shaheed Hospital and Karachi Medical & Dental College Iron-deficiency anaemia, premenopausal, ferrous gluconate, haemoglobin, ferritin. |
| title | The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency Anaemia |
| title_full | The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency Anaemia |
| title_fullStr | The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency Anaemia |
| title_full_unstemmed | The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency Anaemia |
| title_short | The Efficacy and Safety of Oral Ferrous Gluconate in Premenopausal Women with Severe Iron Deficiency Anaemia |
| title_sort | efficacy and safety of oral ferrous gluconate in premenopausal women with severe iron deficiency anaemia |
| topic | Iron-deficiency anaemia, premenopausal, ferrous gluconate, haemoglobin, ferritin. |
| url | https://www.annals-ashkmdc.org/index.php/ashkmdc/article/view/90 |
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