Efficacy of Medications in Anaemic Women of Reproductive Age

Background

Anaemia, a major public health problem continues to affect various age groups in many populations. It has become a global concern. According to Milman [1], the most common nutritional deficiency which causes anaemia in both developing as well as developed countries, is iron deficiency. As per the World Health Organization’s report, half of the total burden of anaemia was due to ID [2]. Similar to other disease burden, low income countries and underprivileged populations suffer the most [1]. Globally, the prevalence of anaemia among women of reproductive age was estimated to be around 29% [3]. Although the prevalence of anaemia has declined in India, still more than half of the women in 11 States and Union Territories were found to be anaemic in the national survey [4]. There is ignorance in the communities about anaemia, its causes, effects on health, essentialities of prevention and therapy. Iron deficiency anaemia (IDA) is a global public health problem and search for prevention and feasible therapy goes on.

Objective

Objective was to know the efficacy of Allopathic, Ayurvedic medication and nutritional advice on mild and moderate anaemia in women of reproductive age with no obvious disorders which could cause anaemia.

Material and Methods

Institute based study was done after approval of the ethics committee of the institute. Study subjects were women of 15 to 49 years of age who had reported to outpatient of obstetrics gynaecology with various disorders but not any which could be responsible for anaemia or chronic illnesses which could lead to anaemia. Volunteers, relatives or friends who accompanied the patients were also explained about the service oriented research and were included if they were willing and fitted into inclusion criteria. Most study subjects were patients (75%) No one who could be the study subject refused. Informed consent was taken before inclusion in study.

As per inclusion criteria thirteen hundred and thirty women, were enrolled screened for anaemia and 909(68.3%) women were anaemic (Hb less than 11 gm/ dl). 5(0.4%) with severe anaemia (haemoglobin less than 7 gms/dl and 904(67.9%) moderate & mild anaemia. Severely anaemic women, irrespective whether they were patients or volunteers were advised to go to specialists for further investigations and therapy. They were not part of the study. All 904 anaemic women with mild or moderate anaemia were also advised investigations which were not part of the study. However they were enrolled for the planned intervention. These 904 women were divided in 2 major groups Allopathic medication group A and Ayurvedic medicine group B, each subdivided divided into, group A Allopathic Medication, group An - Allopathic medication with nutritional advice, group B-Ayurvedic medication, and group Bn-Ayurvedic medication with nutritional advice. Of 904 anaemic women 226 were randomly put in group A, 226 group An, 226 group B 226 and group Bn 226. In group A, 35 women had Hb% between >7 to <8.9 gm/dl and 191 between >9 to <10.9 gm/ dl. In An, 42 had Hb% between >7 to < 8.9 gm/dl and 184 < 9 to >10.9 gm/dl. Under group B, 43 women had Hb between >7 to<8.9 gms/dl and 184 > 9 to <10.9 gm/dl. In group, Bn 47 women had Hb% between <7 to >8.9 gm/dl and 179 women between 9 to <10.9 gm/dl. So all the groups matched.

In all the women of group A, B, An and Bn, awareness was tried with the help of a booklet specially prepared for the study. Booklet had pictorial information about meaning of anaemia, its causes, symptoms, effects, prevention of anaemia and nutritional relationship with information about food items rich in iron and possible therapy. However food advocacy about nutrition with instructions to follow were given to only An and Bn groups. Women were called on 30th day and 60th day to check compliance to advocacy and medication. On 90thday, Hb% was rechecked with compliance to advocacy and medication. It was followed by compliance visits on 120th and 150th day about taking the medication and if any complaints. On 180th day Hb% was finally checked and recorded. Improvement if any was recorded. For qualitative assessment scale as per feeling of change was made under five grades on the basis of symptomatic response, deterioration, no change, little change, good & very good. At the initiation of study final inclusion criteria were decided knowing that some women might not take medication for 180 days. Those who did comply with consumption of medication for 85%, duration (for at least 165 days) were part of the study. For those who reported at 195 days also remained in the study and Hb was estimated. Hb was measured at the completion of planned duration. So +15 days of medication and reporting was included in compliance for inclusion in study.

Results

Under group A 226 women were enrolled for study, of which 36(15.93%) had Hb% between 7 to 7.9 gm/dl, 105(46.46%) 8 to 9.9 gm/dl & 85(37.61%) between 10 to 10.9 gm/dl. On 90th day of the 36 women with Hb% between 7 to 7.9 gm/dl, 13 did not report, only 23(64%) followed. All showed rise in Hb, 12(52.2%) to 8 to 9.9 gm/dl, 7(30.5%) to 10 to 10.9 gm/dl, and 4(17.4%) became non-anaemic. On 180th day, one more left the medication, 22(95.6%) reported for final check-up. and 19(86.4%) of them had become nonanaemic. So in group A of 36 women with Hb of 7 to 7.9 gms/dl, 22(61.11%) complied and 19(86.4%) of them became non-anaemic.

In the same group, A 105 women had Hb% between 8 to 9.9 gm/dl, of which 36 did not report (drop outs) and 69(65.8%) came for follow up. Around 90th day, 4(5.8%) had same Hb% and 60(87%) showed rise in Hb% to 10 to 10.9 gm/dl and 5(7.2%) had become non-anaemic. On 180th day 2 more did not report and 67(97.1%) came for final Hb check-up. Of them 64(95.2%) had become nonanaemic. 105 women 67(63.80%) complied and of them 95% had become nonanaemic.

In the same group 85 women had Hb% between 10 to 10.9 gm/dl, 52(61.2%) reported for follow up on 90th day, 25(48%) had no change in Hb% and 27(52%) became non- anaemic. On 180th day 51(98.0%) of 52 came for final check- up. One had Hb% between 10 to 10.9 gm/dl and 50(98%) had become non-anaemic. So total 51 of 85(60.71%) took medication and of them 98% became nonanaemic. Finally, of 140 women who followed, 22(15.7%) remained moderately anaemic and 118(84.2%) became mildly anaemic at 3 months.

On 180th day among moderately anaemic 133 women (95%) became non-anaemic, 7(5%) had become mildly anaemic and among mildly anaemic 4(3.4%) remained mildly anaemic and rest 114(96.6%) became non-anaemic. Compliance had no relation to economic class or age or education.

In the same group 2 women reported rash, 2 constipation 2 had diarrhoea, 3 had vomiting and 11 had pain in abdomen, a total of 16(7.07%) reported some side effects, which had no relation to economic class or age or education.

Under group An also 226 women were enrolled. Day one 41(18.5%) had Hb% between 7 to 7.9 gm/dl, 101(44.7%) between 8 to 9.9 gm/dl & 84(37.2%) between 10 to 10.9 gm/ dl. On 90th day of 41 women with Hb% between 7 to 7.9 gm/ dl, 12 did not report and 29(79%) came for follow up and all showed rise in Hb%, 17(59%) to 8 to 9.9 gm/dl, 9(31%) to 10 to 10.9 gm/dl and 3(10.3%) had become non-anaemic. On 180th day, 18(62%) of 29 women had become non-anaemic. So of 41 women with Hb 7 to 7.9% 29(70.73 %) complied and 18(62%) of them had become non-anaemic.

In the same group on day one, 101 women had Hb% between 8 to 9.9 gm/dl. Around 90th day, 38 did not report and 63(62.3%) came for follow up, 4(6.34%) had same Hb%, 51(80.9%) showed rise to 10 to 10.9gm/dl and 8(12.7%) became non anaemia. On 180th day one more did not report and 62(36.11%) came for final check-up, 57(92%) of them had become non-anaemic. So of 101 women with Hb between 8 to 9.9gm/dl, 62 (61.38%) complied and 92% of them had become non-anaemic.

In the same group on day one 84 women had Hb% between 10 to 10.9 gm/dl. Of which 34 did not return and 50(59.5%) came for follow up by 90th day. Over all 21(42%) of them had no change in Hb% and 29(58%) had become non-anaemic. On 180th day 49 women came for check-up and, 2(4%) had same Hb and 47(96%) became non-anaemic. So of 84 women with very mild anaemia, 49(59.52%) took therapy and 96% of them became non-anaemic. So under group An, on 180th day 140(61.9%) of 226 women came for final follow up, 29(20.7%) moderately anaemic and 111(79.3%) mildly anaemic. Overall 122(87%) women became non-anaemic. Among moderately anaemic women, 37.9% became mildly anaemic and 62.1% became non-anaemic. From mildly anaemic, women 6.3% remained mildly anaemic and 93.7% became non-anaemic. Compliance was irrespective to education or economic status.

In group, total 12(5.20 %) women out of 226 reported adverse reactions, 4 had rash, 3 vomiting and 5 had pain in abdomen at various stages of follow up with no relations to economic status or education.

Under group B 226 women were enrolled for study. On day one 44(19.46%) had Hb% between 7 to 7.9 gm/dl, 91(40.26%) between 8 to 9.9 gm/dl & 91(40.26%) 10 to 10.9 gm/dl. On 90th day of 44 women with Hb% between 7 to 7.9 gm/dl, 15 did not turn up and 29(66%) came for follow up, 14(48.3%) of them showed rise in Hb% to 8 to 9.9 gm/ dl, 8(27.6%) to 10 to 10.9 gm/dl and 7(24.2%) became non- anaemic. On 180th day, of the 44 women, 29(66%) came for final Hb and 17(58.6%) of them had become non-anaemic.

In the same group 90 women had Hb% between 8 to 9.9 gm/dl on day one. Of which 28 did not turn up and 62(68.2%) came for follow up. Around 90th day, 9(15%) had same Hb% and 46(74.2%) had Hb between 10 to 10.9gm/ dl and 7(10.3%) had become non-anaemic. On 180th day 2 more did not report and 60(66.66%) women reported for final Hb. Of which 53(88.4%) became non-anaemic. Final compliance was 66.66% and of them 88.8% had become non-anaemic. On day one 91 women had Hb% between 10 to 10.9 gm/dl of which 37 did not report and 54(59.4%) came for follow up by 90th day, 25(46.3%) had no change in Hb% and 29(54%) became non-anaemic. On 180th day 52(96.3%) came for check-up, one had same Hb% and 51(98%) had become non-anaemic. Overall of 91 women 96.3% became non-anaemic. Finally of 141 women who followed up, 180th day 63.12% were moderately anaemic and 36.87% were mildly anaemic. Among moderately anaemic women 41.4% became mildly anaemic and 58.6% became nonanaemic. From mildly anaemic 7.1% remained mildly anaemic and 92.9% had become nonanaemic. Total 85.8% had become non-anaemic & 14.2% mild anaemic.

Under group Bn also, 226 women were enrolled in the study. On day one 47(20.8%) had Hb% between 7 to 7.9 gm/ dl, 99(44%) between 8 to 9.9 gm/dl & 80(35.4%) between 10 to 10.9 gm/dl. Of 47 women with Hb% between 7 to 7.9 gm/dl, 22 did not report and 25(53.2%) came for follow up on 90th day, Of which 13(52%) women showed rise to 8 to 9.9 gm/dl, 8(32%) to 10 to 10.9 gm/dl and 4(16%) had become non-anaemic. On 180th day, one more woman didn’t report, 24 came for Hb check-up, 18(75%) of 24 had become non-anaemic. So of 47 women with Hb of 7 to 7.9 gm/dl, compliance was by 24(51.07%) and 75% of them had become non-anaemic. On day one 99 women had Hb% between 8 to 9.9 gm/dl, 38 of them did not report and 61(62%) came for follow up by 90th day, 4(7%) had same Hb% and 49(80.3%) showed rise in Hb% to 10 to 10.9 gm/dl and 8(13%) became non-anaemic. On 180th day 4 more did not report and 57(31.66%) finally came for Hb check-up, of which 51(89.5%) became non-anaemic. So of 99women in this group compliance was 63.33% (57). Of them 51(89.5%) became non-anaemic. On day one 80 women had Hb% between 10 to 10.9 gm/dl on 90th day, 18 did not report back and 62(78%) came for follow up. Of them 24(39%) had no change in Hb% and 38(61.3%) became non-anaemic. On 180th day 60(75.0%) came for final Hb check-up and 3 had Hb% between 10 to 10.9 gm/dl and 57(95%) had become non-anaemic. So of 80 women 75% complied and 95% of them became non-anaemic.

Finally of 141women of Bn group who followed, of 24(17.02%) with moderate anaemia, 25% became mildly anaemic and 75% became non-anaemic and of 117(82.9%) mildly anaemic. 7.7% remained mildly anaemic and 92.3% became nonanaemic. Overall of 141 anaemic women 89.4% became non-anaemic.

Of total 904 study subjects, 168(18.6%) were moderately anaemic & 736(81.41%) were mildly anaemic.

Overall 562(62.2%) women took medication for 6 months 104(61.90%) of moderately anaemic 72(69.23%) became non-anaemic & 32(30.8%) became mild anaemic & of 458(62.22%) mildly anaemic. 430(93.9%) became non- anaemic & 28(6.1%) remained mildly anaemic.

Subjective analysis revealed that of group A 18.57%, felt very good, 76.42% felt good, 4.28% had little change and 0.7% had no change. In group An 25 % felt very good, 62.14 % felt good, 10.7 % had little change and 2.14% had no change. In group B 20.56% felt very good, 65.24% felt good, 10.63 % had little change and 3.54% had no change. In group Bn 18.43% felt very good, 70.92 % felt good, 8.5% had little change and 2.12% had no change. No one said that there was a negative effect, though some did have side effects.

Discussion

Multiple causes and consequences of anaemia have been reported in developing countries. Globally, about 50% cases of anaemia are attributable to iron deficiency. A study was carried out in Abbottabad and the results showed that the most common type of anaemia was iron deficiency anaemia that affected 68% people, more common in women who did not have any disorder which could cause anaemia [5]. The present study findings also revealed that most women should not have become anaemic if they had enough iron intakes. Problem needs to be looked into and interventions designed according to population needs, doable and sustainable before treatment of 904 study subjects, 168(18.6%) were moderately anaemic and 736(81.41%) were mildly anaemic. Total 562(62.2%) women took medication for 6 months, 104(61.90% moderately anaemic and 458(62.22%) mildly anaemic. Finally from 104 moderately anaemic women, 72(69.23%) became non-anaemic and 32(30.8%) became mild anaemic. Of 458 mildly anaemic women, 430(93.9%) became non-anaemic and 28(6.1%) remained mildly anaemic.

Over all efficacy of medication in group A was 95%, in An 87%, in B 85.8% and in Bn 89.4%. Overall, 89.32% anaemic women became non-anaemic but not 100%. However they became mildly anaemic. Allopathic drug alone without nutritional advice had best efficacy. Ayurvedic drug with nutrition (Bn) had efficacy of 89.4% and only Ayurvedic drug (B) efficacy was 85.8%. No side effects were reported with ayurvedic medication. It had little more cost and was little less effective compared to allopathic drug, Ayurvedic medication was a good alternative which could be offered to those who refuse iron preparation due to side effects. Samal [6] also reported that ayurveda offers several formulations for the management of IDA. A systematic review was carried out to understand the role of Ayurvedic formulations for the management of IDA, be it by the response of most of the Ayurvedic formulations was better than Allopathic formulations and there was no untoward effect as observed with iron salts. Statistically significant results were obtained in favor of most of the Ayurvedic formulations in subjective and hematological parameters. It is essential that all attempts are made to prevent IDA, be it by Ayurvedic medication too [7, 8, 9, 10, 11, 12].

Correct nutritional information in their language should help a lot in consuming the right diet and to make a difference. Over all analysis of adherence and side effects of iron supplements revealed that adverse drug reactions were in those women who took allopathic medication (A and An) and the reasons of drop outs also. Pain abdomen was the most common adverse reaction, apart from vomiting and rash. None of the women who received the ayurvedic drugs had adverse effects and the cause of the drop outs was distaste and bigger size of tablet.

However it was revealed that allopathic medication alone without nutritional advocacy had better efficacy, 95%, than An group 87%. Food with iron might have affected iron absorption of drug and this aspect needs more studies [13, 14, 15, 16, 17, 18]. However in Ayurveda preparation it was not so. It could be synergy of contents of medication with food items. This aspect also needs more research. On subjective analysis there was no negative effect. The main risk factors for iron deficiency anaemia (IDA) are low intake of iron, poor absorption of iron from diets, high phytate or phenolic compounds or increased requirements during childhood and pregnancy. Present study revealed that if iron intake was increased, women could remain non-anaemic. Dietary modifications should range from primary prevention that involves a focus on a healthy diet which included iron. Good sources of iron, fruits, vegetables, whole grains, milk and milk products, lean meat, fish, dry beans, eggs, nuts have become too expensive for rural poor. For diet that can help in absorption of iron with good sources of vitamin C and non-haem iron, there is a need to expand the programs that are already working effective and efficient, for the whole population. Work should be done for creating awareness, ensuring they know what is essential for them and find means so that they can get their requirements [19, 20, 21].

However women have their beliefs too. Free medication was given still many women did not comply. Very few had side effects. For others reasons were not obvious. So socio behavioural research is also needed. However 100% did not become non-anaemic with iron. So something other than availability of iron is responsible and more research is needed about this aspect too [22, 23, 24, 25, 26, 27, 28].

Conclusion

Many women with supply of iron became nonanaemic. Allopathic as well as Ayurvedic medication were tolerated.

But compliance was a real issue. Few did not respond. This needs research. Food with iron with Allopathic medication reduced efficacy. In Ayurvedic medication it was not so. This also needs research.

Acknowledgement: We are grateful to department of Aayush, Government of India for the support to do the study.