INTRODUCTION:
Adolescence has been defined by the World Health Organization as the period of life spanning the ages between 10 to19 years. This is the formative period of life when the maximum amount of physical, psychological, and behavioral changes take place. This is a vulnerable period in the human life cycle for the development of nutritional anemia.[1,2]
Iron Deficiency is one of the most prevalent forms of malnutrition. Globally, 50% of anaemia is attributed to iron deficiency and accounts for around 841000 deaths annually worldwide.
Africa and Asia bear 71% of the global mortality burden, North America represents only 1.4 % of the totally morbidity and mortality associated with iron deficiency.[3]
Infants, children and adolescents are sometimes unable to maintain normal iron balance because of demands of body growth and lower dietary intake of iron. That is the reason why iron supplements are strongly recommended in adolescent age group especially those showing signs of iron deficiency anaemia in developing countries.[3]
Iron deficiency anaemia in adolescent age group is mainly because of negative iron balance in which the demands for iron exceed the body’s ability to absorb iron from the diet. This stage results from number of physiological mechanisms including blood loss, rapid growth spurts in adolescence and inadequate dietary iron intake.[4]
Food fads are not uncommon in adolescent age group which contributes to the problem.
Thus, dietary prevention of Iron deficiency anaemia include
1. To increase iron intake through food like green leafy vegetables, black dates, eggs etc.
2. Food fortification with iron; iron supplementation and by improved health services and sanitation.[4]
This study was conducted to study efficacy of Lecithin, homoeopathic preparation in management of iron deficiency anaemia in adolescent girls.
Lecithin is important in the vital processes of plant and animal organisms. Lecithin has a favourable influence upon the nutritive condition and especially upon the blood hence its use in anaemia and convalescence, neurasthenia and insomnia. Increases the number of red corpuscles and amount of haemoglobin. Excellent galactagog, renders milk more nourishing and increases quantity. Results in marked improvement in nutrition and general improvement. 5
Hence Lecithin was chosen as the drug for studying its efficacy in management of iron deficiency anaemia.
Aim:
To assess the efficacy of Lecithin, a homoeopathic preparation in cases of Iron Deficiency Anaemia in adolescent girls.
Objective:
Primary objective:
To evaluate and document the evidence-based efficacy and safety of the study drug in increasing blood haemoglobin level.
Secondary Objectives:
· To assess the efficacy of the study drug in relieving symptoms associated with anaemia.
· To assess the efficacy of the study drug in improving quality-of-life (QOL) in anaemic adolescent girls.
· To assess the improvement or changes, if any, in necessary investigations performed at the beginning and end of study especially Hb level.
Study Design: A Randomized Placebo Contorlled Study.
The duration of the study was 6 months.
Anaemic subjects without target organ damage attending the authors OPD were included in the study.
A total of 50 subjects were screened and included in the study.
Informed consent was obtained from parents of each study subject.
The study drug was dispensed duly labelled as per the Drugs and Cosmetic Act 1940 and rules 1945 from a reputed Homoeopathic Pharmacy. It was a randomized placebo controlled clinical trial wherein total 50 anaemic adolescent girls were selected for the study. From the 50 patients selected for the study 25 patients were selected randomly and were given the study drug in 3X potency form whereas remaining 25 patients were treated with placebo in the form of non-medicated tablets. It was a non-blind open study.
Diagnosis was mostly done clinically based upon haemogram report and iron levels. Patients from age group 12-18 yrs. and only girls were included in the study. The data has been collected by a structured interview session. 25patients randomly selected were administeredLecithin 3X homoeopathic preparation.
Case definition:
Iron Deficiency Anaemia was defined as a haemoglobin level less than 11g/dl in women with a serum iron level<50 µg/dl, accompanied by a serum ferritin level <30 ng/dl or a serum transferrin level>360 mg/dl.
Inclusion Criteria:
All cases which fit into case definition and showing Hb % between 8-11, reduced iron levels and reduced number of RBC’s.
Girls of 12-18 yrs. age group.
Exclusion Criteria:
Other types of anemia other than Iron deficieny anaemia.
Hb% less than 7
Thalassemias
Male patients.
Female patients less than 12 yrs and more than 18 yrs.of age.
Follow up chart was maintained to evaluate improvement in each case and is thus data of all cases is maintained.
Administration of Drug:
The potency selected was Lecithin 3X and repetition was strictly individualistic
Medicines were administered orally
Criteria for Assessment:
· Relief of symptoms
· Patient in general
· Hb%
· Iron levels.
For an effective evaluation and assessment, disease intensity was graded in every patient based on their presentation observed during case taking. After completion of the study, the post treatment disease scores were compared with the pre-treatment disease intensity scores and statistically evaluated.
Administration of Drug:
Drug Lecithin, potency 3X, was be purchased from a reputed Homoeopathic Pharmacy.
It was administered orally to the patients 3 tablets 3 times a day for 6 months.
Informed consent was taken from the parents before starting the study.
Criteria for Improvement:
The outcome measures were changes in the blood Hb levels at a timeline of three months and six months.
The effect size was considered as increasing of Hb level by a minimum of 2-3 g/Dl respectively.
Thus, cases where this increased Hb levels were observed were ascribed as ‘improved’ and the rest as ‘not improved’.
The study end‑point was increasing Hb levels following intervention.
The primary safety end‑point was any adverse event during the study in any of the groups.
The stopping guidelines was a marked deterioration of health condition and/or constant decrease in Hb levels among subjects in either group, constant progress of disease with appearance of complications, and adverse events (if any).
Follow-up:
The subjects were clinically assessed every week Investigations were done at baseline and after every 1 month of treatment or completion of the study period.
During the six-month trial, all data was measured and analyzed at entry, after three months, and after six months of the study by the outcome assessor.
Diet and Regimen:
All the participants were given additional instructions regarding the diet and regimen, keeping in mind their socioeconomic status and level of education. The usual measures includedinclusion of green leafy vegetables in diet, food items rich in iron etc. These additional measures were advised to all the participants to minimize bias.
The diet which was suggested to patients may have had a conjoint effect in increasing the blood Hb level along with the action of the study drugs but it cannot be generalised for all patients with Iron Deficiency Anaemia.
The following marks were given to the clinical features of cases-
Table 1-Scores before treatment-
|
3 |
|
|
Symptoms |
2 |
|
Iron level |
4 |
|
(if directly available and prominent) |
|
Table 2-Scores after treatment-
|
|
2 |
|
Amelioration of Symptoms |
1 |
|
Increased Iron Level |
3 |
The evaluation of cases of Iron Deficiency Anaemia is based on the disease intensity scores before treatment and after treatment. The cases with intensity scores 0 (after treatment) are considered as IMPROVED and the cases with ‘Same’ or ‘Increased’ intensity scores after treatment are considered as NOT IMPROVED.
Observation and Statistical Analysis:
A sample of 50 caseswas taken for this study. These cases were subjected to statistical study. The following tables reveal the observation and result of this study.
1. Age Distribution: The study was conducted on female patients between the age group 12-18 years.
2. Sex Distribution: Out of the 50 patients taken for study, all were female students.
Table-3:Distribution of Hb %
|
Hb % |
No. of Cases |
|
7-8 |
6 |
|
8-10 |
18 |
|
10-11 |
26 |
|
Total |
50 |
