RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

.

BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

1. Name of the Candidate : Mrs. CHITRA DEVI.MAnd Address First Year M.Sc Nursing,

Sushrutha College of Nursing, Bangalore-85.

2. Name of the Institution : Sushrutha College of Nursing, Bangalore-85.

3. Course of study : First Year M.Sc Nursing, And subject Medical and surgical Nursing

4. Date of Admission : 03.06.2009

5. Title of the Topic : A study to assess the effectiveness

of structured teaching programme

on knowledge regarding chelation therapy

among staff nurse’s in a selected

Hospitals, Bangalore.

6.0) BIREF RESUME OF THE INTENDED WORK:-

INTRODUCTION:-

“Your heart is your life line. So protect it from toxins to prevent

surgical intervention with new EDTA chelation therapy.”

-“Ambica gulati”-

The word chelation is derived from the Greek word chele that means claw

(like that of a scorpion or crab). The concept of chelation is based on the observation

that when a certain amino acid complex called EDTA (ethylene-diamine-tetra-acetic

acid) comes in contact with certain positively charged metals and other substances such

as lead, iron, copper, calcium, magnesium, zinc, plutonium and manganese, it grabs

them (hence the chele or claw), and removes them. Chelation therapy is the process of

removing from the body the undesirable ionic material by the infusion, or taking orally,

of an organic compound which has suitable chelating properties.

EDTA is a synthetic amino acid first used in the 1940's for treatment of heavy metal

poisoning. It is widely recognized as effective for that use as well as certain others,

including emergency treatment of hypercalcemia and the control of ventricular

arrhythmias associated with digitalis toxicity. Studies by the National Academy of

Sciences/National Research Council in the late 1960's indicated that EDTA was

considered possibly effective in the treatment of occlusive vascular disorders caused by

arteriosclerosis. EDTA grabs metallic cation such as Lead or Calcium from the body

and forms a stable compound that is then excreted from the system. The stability of this

bond is vital to success in chelation therapy. If the bond is weak, other chemicals can

break this bond to form their own compounds.

One way to think about the chelation process is to compare it to the way we

unclog our drains. We add a chemical to our drain. It dissolves the blockage.

The resulting compound is removed from the drain using the existing plumbing

system. Chelation process works in a similar manner on our body

Chelation therapy is widely used for the treatment of atherosclerosis and other chronic

degenerative diseases involving the circulatory system. It also has other benefits. Many

scientists suggest that the beneficial effect of chelation treatment is from the removal of

metallic catalysts that causes excessive free radical proliferation. This reduces the

oxidation of lipids, DNA, enzyme systems and lipoproteins. The chelation halts the bad

effects and initiates the body's healing process, often reversing the damage. It removes

the calcium and copper anions from the blood stream. The plaque lining the artery walls

are made porous and brittle. Eventually they may get dislodged. Even if only a

microscopic layer of the plaque is removed, it, along with a smoothening of the artery

wall due to the healing of the cells that line the arteries, can improve the blood flow to

the artery muscles substantially. This can prevent artery spasm and minimize or prevent

angina pain. Many patients who could not walk due to muscle pain or angina pain have

reported that they can walk without pain after chelation therapy.

Chelation therapy is used as a treatment for acute mercury, iron (including in cases

of thalassemia), arsenic, lead, uranium, plutonium and other forms oftoxic

metal poisoning. The chelating agent may administered intravenously, intramuscularly,

or orally, depending on the agent and the type of poisoning. [6]

One example of successful chelation therapy is the case of Harold McCluskey, a

nuclear worker who became badly contaminated with americium in 1976. He was

treated with diethylene triamine pentaacetic acid (DTPA) over many years, removing

41 MBq (1.1 mCi) of americium from his body. His death, 11 years later, was from

unrelated causes.

Several chelating agents are available, having different affinities for different metals.

Common chelating agents include:

Alpha lipoic acid  (ALA)

Aminophenoxyethane-tetraacetic acid  (BAPTA)

Deferasirox

Deferiprone

Deferoxamine

Diethylene triamine pentaacetic acid  (DTPA)

Dimercaprol  (BAL)

Dimercapto-propane sulfonate  (DMPS)

Dimercaptosuccinic acid  (DMSA)

Ethylenediamine tetraacetic acid (calcium disodium versante)  (CaNa2-EDTA)

Ethylene glycol tetraacetic acid (EGTA)

D-penicillamine

Heart disease

Some alternative medicine practitioners administer chelating agents, usually EDTA, to

patients withhardening of the arteries. The use of EDTA chelation therapy as a

treatment for coronary artery disease has not been shown to be effective and is not

approved by the U.S. Food and Drug Administration(FDA).[17] Several possible

mechanisms have been proposed, though none have been scientifically validated. The

procedure might leach calcium directly from the fatty plaques that block the arteries;

stimulate the release of a hormone that removes deposited calcium or lowers cholesterol

levels; or reduce oxidative stress on the blood vessel walls.[2] The US National Center

for Complementary and Alternative Medicine began conducting the Trial to Assess

Chelation Therapy (TACT) in 2003.[14] Patient enrollment was to be completed around

July 2009[2] with final completion around July 2010,[14] but enrollment in the trial

was suspended on September 26, 2008 for an investigation by OHRP after complaints

about ethical concerns such as inadequate informed consent.[18] The trial has been

criticized for lacking prior Phase I and II studies, and particularly because previous

controlled trials have not indicated benefits.[16] The American College for

Advancement in Medicine, a controversial organization created to promote chelation

therapy, has played a part in the adoption of the TACT clinical trial, which has led to

further criticism of the trial.[16] Atwood et al. have argued that methodological flaws

and lack ofprior probability make this trial "unethical, dangerous, pointless, and

wasteful."[16]

The American Heart Association states that there is "no scientific evidence to

demonstrate any benefit from this form of therapy" and that the "United States Food

and Drug Administration (FDA), the National Institutes of Health (NIH) and the

American College of Cardiology all agree with the American Heart Association" that

"there have been no adequate, controlled, published scientific studies using currently

approved scientific methodology to support this therapy for cardiovascular

disease."[17] Like other scientific commentators, they note that any improvement

among heart patients undergoing chelation therapy can be attributed to the placebo

effect and lifestyle changes discovered in conventional medicine but recommended by

chelationists; "quitting smoking, losing weight, eating more fruits and vegetables,

avoiding foods high in saturated fats and exercising regularly".[19] They note their

concern that patients could put off proven treatments for heart disease like drugs or

surgery.[19] A 2005 systematic reviewfound that controlled scientific studies did not

support chelation therapy for heart disease.[20] It found that very small trials and

uncontrolled descriptive studies have reported benefits while larger controlled studies

have found results no better than placebo.

6.1) NEED FOR THE STUDY:-

“Chelation therapy is a new hope for atherosclerosis patients and age

associated disease”

Chelation therapy is widely used for the treatment of atherosclerosis and other

chronic degenerative diseases involving the circulatory system. It also has other

benefits. Many scientists suggest that the beneficial effect of chelation treatment is from

the removal of metallic catalysts that causes excessive free radical proliferation. This

reduces the oxidation of lipids, DNA, enzyme systems and lipoproteins. The chelation

halts the bad effects and initiates the body's healing process, often reversing the

damage. It removes the calcium and copper anions from the blood stream. The plaque

lining the artery walls are made porous and brittle. Eventually they may get dislodged.

Even if only a microscopic layer of the plaque is removed, it, along with a smoothening

of the artery wall due to the healing of the cells that line the arteries, can improve the

blood flow to the artery muscles substantially. This can prevent artery spasm and

minimize or prevent angina pain. Many patients who could not walk due to muscle pain

or angina pain have reported that they can walk without pain after chelation therapy.

A review of treatment results from 2,870 patients in Brazil found significant

improvement in patients with heart disease or peripheral vascular disease who were

treated with chelation therapy. 76.9 percent of the heart patients treated reported

"marked improvement" and another 16.6 percent reported "good improvement". The

results were even better for the patients who were treated for peripheral vascular

disease. 91 percent showed "marked" improvement and 7.6 percent showed "good"

improvement. So, 96-98 percent of the patients treated reported improvement after

chelation therapy.

So, as an investigator i undertook a study to assess the of knowledge of staff

nurses regarding chelation therapy. This could help the staff nurses in improving their

knowledge regarding chelation therapy.

6.2. REVIEW OF LITERATURE: -

Mamtani M et al conducted study on Influence of iron chelators on

myocardial iron and cardiac function in transfusion-dependent thalassaemia: a

systematic review and meta-analysis. Iron chelators have dramatically prolonged

the life expectancy of patients with transfusion-dependent thalassaemia, but their

precise clinical benefit in reducing the myocardial iron burden and improving

cardiac function is unknown. This systematic review and meta-analysis included

published clinical trials that assessed the efficacy of iron chelators in regularly

transfused patients of thalassaemia major for two commonly reported outcomes -

myocardial iron content and left ventricular ejection fraction (LVEF). The meta-

analysis of 392 patients for myocardial iron content and 291 patients for LVEF

showed that (i) iron chelators reduced cardiac iron content by 23.9% (95%

confidence interval 17.3-29.8%); (ii) there was no significant difference between

the amount of iron reduced by deferoxamine and deferiprone (P = 0.9504); and (iii)

LVEF was not significantly influenced by iron chelators - summary Hedge's g 0.13

(95% confidence interval -0.10-0.36). A significant publication bias existed for

LVEF (Egger's P = 0.049) but not for myocardial iron (Egger's P = 0.871) ).The

results of this indicate that iron chelators significantly reduce myocardial iron

content. Further, the choice of deferoxamine versus deferiprone may rest on factors

other than their efficacy to reduce cardiac iron load

Aessopos A, et al conducted study on The heart in transfusion dependent

homozygous thalassaemia today--prediction, prevention and management. Cardiac

disease remains the major cause of death in thalassaemia major. This review deals

with the mechanisms involved in heart failure development, the peculiar clinical

presentation of congestive heart failure and provides guidelines for diagnosis and

management of the acute phase of cardiac failure. It emphasizes the need for

intensive medical--cardiac care and aggressive iron chelating management as, with

such approaches, today, the patients outcomes can be favourable in the long term.

It covers advances in the assessment of cardiac iron overload with the use of

magnetic resonance imaging and makes recommendations for preventing the onset

of cardiac problems by tailoring iron chelation therapy appropriate to the degree of

cardiac iron loading found.

Sullivan JL et al conducted study on [CurrenMore than 25 years ago, the

iron hypothesis proposed that a state of sustained iron depletion or mild iron

deficiency exerts a primary protective action against ischemic heart disease. Iron

depletion leads to a decreased availability of redox-active iron in vivo. The

amount of free iron available at sites of oxidative or inflammatory injury appears

to be a function of the stored iron level. Depletion of iron levels by phlebotomy,

systemic iron chelation treatment or dietary iron restriction reduce atherosclerotic

lesion size and increase plaque stability. In homozygous hemochromatosis there

is commonly a defect that inhibits iron retention in macrophages. This defect may

explain why atherosclerotic lesions appear to be less prevalent in this disorder.

Findings of the "FeAST" trial have been recently reported. The trial assessed the

potential benefit of mild iron reduction therapy in secondary prevention of

cardiovascular disease. It was therefore not a fully valid test of primary

prevention as postulated by the iron hypothesis. However, although no overall

statistically significant cardiovascular benefit was found, in the youngest quartile

at entry there were highly significant reductions in all cause mortality and in

combined death plus non-fatal myocardial infarction and stroke in association

with iron reduction therapy. The FeAST trial adds urgency to the initiation of

new studies to assess the impact of maintenance of complete iron depletion in the

primary prevention of cardiovascular disease

Barton JC. et al conducted study on Iron overload is characterized by excessive

iron deposition and consequent injury and dysfunction of the heart, liver, anterior

pituitary, pancreas, and joints. Because physiologic mechanisms to excrete iron are

very limited, patients with iron overload and its complications need safe, effective

therapy that is compatible with their coexisting medical conditions. The

availability of three licensed iron chelation drugs (one parenteral, two oral) and the

development and clinical investigation of other oral chelators represent new

opportunities to prevent or manage iron overload in patients with heritable types of

severe anemia, such as beta-thalassemia major and sickle cell disease, and for the

formulation of alternatives to phlebotomy therapy for patients with iron overload

associated with the HFE gene and other adult age-of-onset types of

hemochromatosis, African iron overload, and African-American iron overload.

Cohen AR. et al conducted study on New advances in iron chelation therapy.The

emergence of new chelators is likely to have a major impact on the treatment of

thalassemia major, sickle cell disease and other hematologic disorders for which

regular red cell transfusions are required either to correct severe anemia or to

prevent major complications of the underlying disease. In comparison with

deferoxamine, which requires prolonged parenteral infusion to achieve negative

iron balance, orally active chelators offer the promise of easier administration and

better compliance. Moreover, the availability of more than one iron chelator opens

up the possibility of combination therapy to target iron in specific organs and to

enhance overall iron excretion. Long-term studies, employing new technologies to

measure tissue iron, are required to determine whether the new chelators will be as

safe and effective as deferoxamine in maintaining control of iron stores and

preventing iron-induced cardiac disease, the major complication of transfusional

iron overload.

Arthur HM, . et al conducted study on The role of complementary and

alternative therapies in cardiac rehabilitation: a systematic evaluation. The design

and methods used for this study was conducted using complementary and

alternative medicine websites, Medline, Allied and Complementary Medicine,

CINAHL, Cochrane databases, EMBASE, SportDiscus, Clinical Evidence, and

Evidence-Based Practice to locate research-based scientific evidence related to the

use of complementary and alternative medicine in cardiac rehabilitation. Search

keywords included heart, cardiac, cardiovascular, coronary, myocardial and

rehabilitation, combined with particular therapies. Herbal/oral supplements were

not included in this evaluation. The result of this study shows : Some

complementary and alternative medicine therapies may be useful to patients by

themselves or coupled with traditional cardiac rehabilitation. Tai chi, as a

complement to existing exercise interventions, can be utilized for low and

intermediate risk patients. transcendental meditation may be used as a stress

reduction technique. There was insufficient evidence found for the use of

acupuncture or chelation therapy in cardiac rehabilitation or secondary prevention.

The study concludes some complementary and alternative medicine therapies hold

promise for patients in cardiac rehabilitation. Further research is essential,

however, in all areas of complementary and alternative medicine to confirm its

usefulness as an adjunct to cardiac rehabilitation.

Hershko C, . et al conducted study on Objectives and mechanism of iron

chelation therapy.Prevention of cardiac mortality is the most important beneficial

effect of iron chelation therapy. Unfortunately, compliance with the rigorous

requirements of daily subcutaneous deferoxamine (DFO) infusions is still a serious

limiting factor in treatment success. The development of orally effective iron

chelators such as deferiprone and ICL670 is intended to improve compliance.

Although total iron excretion with deferiprone is somewhat less than with DFO,

deferiprone may have a better cardioprotective effect than DFO due to

deferiprone's ability to penetrate cell membranes. Recent clinical studies indicate

that oral ICL670 treatment is well tolerated and is as effective as parenteral DFO

used at the standard dose of 40 mg/kg of body weight/day. Thus, for the patient

with transfusional iron overload in whom results of DFO treatment are

unsatisfactory, several orally effective agents are now available to avoid serious

organ damage. Finally, combined chelation treatment is emerging as a reasonable

alternative to chelator monotherapy. Combining a weak chelator that has a better

ability to penetrate cells with a stronger chelator that penetrates cells poorly but

has a more efficient urinary excretion may result in improved therapeutic effect

through iron shuttling between the two compounds. The efficacy of combined

chelation treatment is additive and offers an increased likelihood of success in

patients previously failing DFO or deferiprone monotherapy.

Kontoghiorghes GJ, et al conducted study on Advances in iron overload

therapies. prospects for effective use of deferiprone (L1), deferoxamine, the new

experimental chelators ICL670, GT56-252, L1NA11 and their combinations

Effective new therapies and mechanisms have been developed for the targeting and

prevention of iron overload and toxicity in thalassaemia and idiopathic

haemochromatosis patients. A new era in the development of chelating drugs

began with the introduction of deferiprone or L1, which as a monotherapy or in

combination with deferoxamine can be used universally for effective chelation

treatments, rapid iron removal, maintenance of low iron stores and prevention of

heart and other organ damage caused by iron overload. Several experimental iron

chelators such as deferasirox (4-[3,5-bis (2-hydroxyphenyl)-1,2,4-triazol-1-yl]-

benzoic acid) or ICL670, deferitrin (4,5-dihydro-2- (2,4-dihydroxyphenyl)-4-

methylthiazole-4 (S)-carboxylic acid) or GT56-252, 1-allyl-2-methyl-3-

hydroxypyrid-4-one or L1NAll and starch deferoxamine polymers have reached

different stages of clinical development. The lipophilic ICL670, which can only be

administered once daily is generally ineffective in causing negative iron balance

but is effective in reducing liver iron. It is suspected that it may increase iron

absorption and the redistribution of iron from the liver to the heart and other

organs. The experimental iron chelators do not appear to have significant

advantages in efficacy and toxicity by comparison to deferiprone, deferoxamine or

their combination. However, the prospect of combination therapies using

deferiprone, deferoxamine and new chelators will provide new mechanisms of

chelator interactions, which may lead to higher efficacy and lower toxicity by

comparison to monotherapies. A major disadvantage of the experimental chelators

is that even if they are approved for clinical use, they are unlikely to be as

inexpensive as deferiprone and become available to the vast majority of

thalassaemia patients, who live in developing countries.

Chagan L, . et al conducted study on Use of alternative pharmacotherapy in

management of cardiovascular diseases. The objective of this study was to review

use of alternative pharmacotherapy (AP) in patients with cardiovascular disease

(CVD) and significant drug interactions between AP and traditional CVD

medications.the study design used for this study was a literature search of

MEDLINE and the National Complementary and Alternative Medicine database

was done using these search terms: supplements, vitamins, garlic, fish oil, L-

arginine, soy, coenzyme Q10, herbs, phytosterols, chelation therapy, alternative

medicine, and CVD. English human clinical trials measuring surrogate and clinical

end points. The results of this study shows Antioxidants have not been

consistently proven beneficial in reducing cardiovascular mortality. Fish oils may

be beneficial in patients with hypertension and hypercholesterolemia, but

therapeutic doses need to be defined. Use of coenzyme Q10 in patients with heart

failure has not demonstrated consistent benefits. Garlic may lower blood pressure

and cholesterol levels, but also may increase bleeding, so its use in CVD patients

should be monitored. Clinical studies with small sample sizes have demonstrated

that L-arginine may be useful to prevent and treat CVD. The Food and Drug

Administration recommends 25 g/day of soy protein as part of a diet low in

saturated fats for cholesterol reduction. Plant sterols are recommended by the

American Heart Association and the National Cholesterol Education Program

Expert Panel as adjunct therapy to reduce low-density lipoprotein. No data support

use of chelation therapy. Some APs interact with common prescription CVD

medications (eg, gingko and ginseng with warfarin, St. John's Wort with digoxin).

The study concludes that the benefits of APs as part of the treatment for CVD are

controversial. Routine use is not recommended.

Ernst E. et al conducted study on Chelation therapy for coronary heart

disease: An overview of all clinical investigations. : The aim of this systematic

review was to summarize all the clinical evidence for or against the effectiveness

and efficacy of chelation therapy for coronary heart disease. The design and

methods used for this study was a thorough search strategy was implemented to

retrieve all clinical investigations regardless of whether they were controlled or

uncontrolled. The study results the most striking finding is the almost total lack of

convincing evidence for efficacy. Numerous case reports and case series were

found. The majority of these publications seem to indicate that chelation therapy is

effective. Only 2 controlled clinical trials were located. They provide no evidence

that chelation therapy is efficacious beyond a powerful placebo effect.the study

concludes that the given the potential of chelation therapy to cause severe adverse

effects, this treatment should now be considered obsolete.

Chagan L, et al conducted study on Use of alternative pharmacotherapy in

management of cardiovascular diseases.the objective of this study was to review

use of alternative pharmacotherapy (AP) in patients with cardiovascular disease

(CVD) and significant drug interactions between AP and traditional CVD

medications.the study design was a literature search of MEDLINE and the

National Complementary and Alternative Medicine database was done using these

search terms: supplements, vitamins, garlic, fish oil, L-arginine, soy, coenzyme

Q10, herbs, phytosterols, chelation therapy, alternative medicine, and CVD. The

methods used was English human clinical trials measuring surrogate and clinical

end points.the results of this study shows Antioxidants have not been consistently

proven beneficial in reducing cardiovascular mortality. Fish oils may be beneficial

in patients with hypertension and hypercholesterolemia, but therapeutic doses need

to be defined. Use of coenzyme Q10 in patients with heart failure has not

demonstrated consistent benefits. Garlic may lower blood pressure and cholesterol

levels, but also may increase bleeding, so its use in CVD patients should be

monitored. Clinical studies with small sample sizes have demonstrated that L-

arginine may be useful to prevent and treat CVD. The Food and Drug

Administration recommends 25 g/day of soy protein as part of a diet low in

saturated fats for cholesterol reduction. Plant sterols are recommended by the

American Heart Association and the National Cholesterol Education Program

Expert Panel as adjunct therapy to reduce low-density lipoprotein. No data support

use of chelation therapy. Some APs interact with common prescription CVD

medications (eg, gingko and ginseng with warfarin, St. John's Wort with

digoxin).The study conclude that the benefits of APs as part of the treatment for

CVD are controversial. Routine use is not recommended.

Lin MC, et al conducted study on State of complementary and alternative

medicine in cardiovascular, lung, and blood research: executive summary of a

workshop. The goal of this workshop was to enhance the exchange of information

and ideas between alternative medicine practitioners and scientists in

cardiovascular, lung, and blood research and to foster collaborative research

among these researchers. The workshop focused on 5 areas of research, including a

historical and cultural perspective of CAM, methodological issues in clinical trials,

herbal medicine, chelation therapy, mind/body (meditation) therapy, and

acupuncture. CAM has become widely used without rigorously proven efficacy

and safety. To protect the public, it was recommended that the fundamental

mechanistic research for these CAM approaches be vigorously pursued and that

any large-scale clinical trial be carefully executed to avoid any waste of resources

and any unnecessary risk. It was felt that standardization of botanical products and

procedure-based CAM intervention, such as acupuncture and meditation, is

essential for meaningful basic and clinical research. Although botanical products

properly consumed are perceived as generally safe, potential herb-drug interactions

are a major safety concern. Clearly, many challenges need to be addressed by the

scientific community before the public can be assured of the proper use of CAM.

Cooper GJ, et al conducted study on A copper(II)-selective chelator ameliorates

left-ventricular hypertrophy in type 2 diabetic patients: a randomised placebo-

controlled study.They performed a 12 month randomised placebo-controlled study

of the effects of treatment with the Cu(II)-selective chelator trientine

(triethylenetetramine dihydrochloride, 600 mg given orally twice daily) on LVH in

diabetic patients in an outpatient setting wherein participants, caregivers and those

assessing outcomes were blinded to group assignment. Using MRI, we measured

left ventricular variables at baseline, and at months 6 and 12. The change from

baseline in left ventricular mass indexed to body surface area (LVM(bsa)) was the

primary endpoint variable.The study results that Diabetic patients had LVH with

preserved ejection fraction at baseline. Trientine treatment decreased LVM(bsa) by

5.0 +/- 7.2 g/m(2) (mean +/- SD) at month 6 and by 10.6 +/- 7.6 g/m(2) at month

12 whereas LVM(bsa) was unchanged by placebo treatment. In a multiple-

regression model that explained ~75% of variation (R (2) = 0.748, p = 0.001),

cumulative urinary Cu excretion over 12 months was positively associated with

trientine-evoked decreases in LVM(bsa). The study concludes that Cu(II)-selective

chelation merits further exploration as a potential pharmacotherapy for diabetic

heart disease. Trial registration: Australian New Zealand Clinical Trials Registry

ACTRN 12609000053224 Funding: The Endocore Research Trust; Lottery Health

New Zealand; the Maurice and Phyllis Paykel Trust; the Foundation of Research,

Science and Technology (New Zealand); the Health Research Council of New

Zealand; the Ministry of Education (New Zealand) through the Maurice Wilkins

Centre for Molecular Biodiscovery; and the Protemix Corporation.

Quan H, et al conducted study on Opinions on chelation therapy in patients

undergoing coronary angiography: cross-sectional survey. The aim of the present

study was to document patients' opinions and beliefs about health care decision

making, physician and patient communication and relationships, and reasons for

using or not using chelation therapy as treatment for coronary artery disease. The

methods used were A mail survey was sent to patients who underwent coronary

angiography between 1998 and 2000 in Alberta. Information was collected on self-

reported reasons for chelation therapy use, sociodemographic characteristics,

communication and relationships between patients and physicians, as well as

beliefs regarding surgery, medications and chelation therapy.the study results in of

the 780 patients who received surveys, 96 users and 264 nonusers of chelation

therapy completed questionnaires. Among the users, 20.8% believed that chelation

therapy could cure heart disease, 44.2% believed that it could relieve symptoms,

16.7% believed that it could have side effects and 58.4% believed that it could

increase quality of life. Users and nonusers were similar in their beliefs about

safety and benefits of heart surgery, but users of chelation therapy were less likely

than nonusers to believe that using conventional medications could prevent

worsening of heart disease (53.1% versus 67.4%), increase quality of life (74.0%

versus 85.2%) and give a feeling of control over heart disease (61.5% versus

77.7%).the study concludes that the many chelation therapy users appeared to

have negative views toward the benefits of conventional medications and positive

views toward the safety of chelation therapy. Users and nonusers of chelation

therapy had the same views toward the benefits and safety of heart surgery.

Leung AW, et al conducted study on Magnetic resonance imaging assessment of

cardiac and liver iron load in transfusion dependent patients.the aim of this study

was to study the prevalence of cardiac and liver iron overload and the relationship

of T2* measurement with various clinical and biochemical parameters.the results

shows Mean age of the study subjects was 19.9 years (range 8.8-32.3) and the

mean cardiac T2* was 23.4 +/- 13.8 msec. Fifty percent of the subjects had

abnormal cardiac T2* (below 20 msec). Cardiac T2* was not found to have any

correlation with serum ferritin or liver T2*. Liver T2* value was abnormal in 79%

of the subjects and it correlated inversely with both current and 12 months average

serum ferritin (r = -0.44, P = 0.003; r = -0.46, P = 0.002). Clinical parameters

including age, duration of transfusion, age starting iron chelation therapy, and ratio

between transfusion volume and desferrioxamine dosage were not correlated with

cardiac and liver T2*. The study conclude that iron overload in heart and liver is

common in our transfusion dependent patients. Liver T2* has inverse correlation

with serum ferritin. Cardiac T2* does not have any correlation with the various

clinical and biochemical parameters.

Gedik GK, et al conducted study on Evaluation of cardiovascular complications

with 99mTc tetrofosmin gated myocardial perfusion scintigraphy in patients with

thalassemia major. The objective of this study was Iron overload limits the life

expectancy of thalassaemic patients by causing cardiac toxicity. Iron also plays a

catalytic role in the pathogenesis of atherosclerosis. The aim of this study was to

evaluate the role of (99m)Tc Tetrofosmin gated myocardial perfusion scintigraphy

(GMPS) in the detection of cardiac dysfunction in patients with thalassemia

major.The materials and methods used was Forty two patients with homozygous

beta-thalassemia were enrolled in the study. Myocardial perfusion and wall motion

were analysed in all patients (mean age 17 +/- 5.28) and 34 age-matched controls

using GMPS. Clinical data, liver function tests, hemoglobin, ferritin, low density

lipoprotein (LDL) and cholesterol levels, and the total number and frequency of

transfusions were collected from patient records.The results shows 97.6 % and

78.5 % of patients had normal myocardial perfusion and wall motion respectively.

Nine out of 42 thalassaemic patients had abnormal left ventricular wall motion;

half of these had septal hypokinesia. No significant correlation was found between

the total number of transfusions, serum ferritin levels and left ventricular ejection

fraction (p = 0.442 and p = 1.00, respectively). Echocardiography revealed systolic

dysfunction in 5 out of 9 patients with wall motion abnormality. LDL was normal

in 38 out of 42 patients and cholesterol levels were normal in 37 out of 42 patients.

The study concludes Regional wall motion abnormalities can be seen in patients

with thalassemia major. This early damage is frequently located in the septum and

can be detected by GMPS. Serum ferritin levels and the number of blood

transfusions are inadequate as predictors of myocardial dysfunction

Tanner MA, et al conducted study on Combined chelation therapy in

thalassemia major for the treatment of severe myocardial siderosis with left

ventricular dysfunction.the methods used was T2* cardiovascular magnetic

resonance (CMR) was performed in 167 TM patients receiving standard

subcutaneous deferoxamine monotherapy, and 22 had severe myocardial siderosis

(T2* < 8 ms) with impaired left ventricular (LV) function. Fifteen of these patients

received combination therapy with subcutaneous deferoxamine and oral

deferiprone with CMR follow-up. The study results shows baseline, deferoxamine

was prescribed at 38 +/- 10.2 mg/kg for 5.3 days/week, and deferiprone at 73.9 +/-

4.0 mg/kg/day. All patients continued both deferiprone and deferoxamine for 12

months. There were no deaths or new cardiovascular complications. The

myocardial T2* improved (5.7 +/- 0.98 ms to 7.9 +/- 2.47 ms; p = 0.010), with

concomitant improvement in LV ejection fraction (51.2 +/- 10.9% to 65.6 +/-

6.7%; p < 0.001). Serum ferritin improved from 2057 (CV 7.6%) to 666 (CV

13.2%) microg/L (p < 0.001), and liver iron improved (liver T2*: 3.7 +/- 2.9 ms to

10.8 +/- 7.3 ms; p = 0.006). the study concludes that In patients with severe

myocardial siderosis and impaired LV function, combined chelation therapy with

subcutaneous deferoxamine and oral deferiprone reduces myocardial iron and

improves cardiac function. This treatment is considerably less onerous for the

patient than conventional high dose continuous subcutaneous or intravenous

deferoxamine monotherapy, and may be considered as an alternative. Very

prolonged tailored treatment with iron chelation is necessary to clear myocardial

iron, and alterations in chelation must be guided by repeated myocardial T2*

scans..

Ann Hematol. et al conducted study on Cardiovascular effects of splenomegaly

and splenectomy in beta-thalassemia Splenomegaly is common in beta-

thalassemia, bearing some particular hemodynamic features, while splenectomy is

an established therapeutic intervention in these patients. Their effects, however, on

systemic hemodynamics and thalassemia heart disease have not yet been assessed.

The study included 32 consecutive patients, 13 with thalassemia major (TM) and

19 with thalassemia intermedia (TI), aged 23.4+/-4.2 years, requiring splenectomy.

Assessment was performed before and 6 months after splenectomy and included

hematological profile and resting echocardiography; total blood volume was also

measured in 10 of 32 cases. Preoperative echocardiographic data were compared

with those of 34 controls. Preoperative left ventricular diameters and mass, cardiac

index, and systolic pulmonary artery pressure were all significantly higher in

patients compared to controls (p<0.001), but did not differ significantly between

TM and TI patients. Postoperatively, the mean hemoglobin level increased from

8.1+/-0.6 to 9.1+/-0.4 g/dl (p<0.001), total blood volume index declined from

2847+/-332 to 2310+/-276 ml/m(2) (p<0.001), blood transfusions were

discontinued in 80% of TI patients and mean 6-monthly transfusion requirements

in TM patients were reduced from 28+/-5 to 22+/-4 units (p<0.001). However,

cardiac parameters were not significantly modified. It seems that left ventricular

remodeling, high output state, and increased pulmonary artery pressure

characterize both TM and TI patients who require splenectomy. Although these

abnormalities remain unchanged after splenectomy, the removal of the spleen may

contribute to the prevention of further cardiac damage by ameliorating the patients'

hematological status and reducing their transfusion needs.

Porter JB. et al conducted study on A risk-benefit assessment of iron-chelation

therapy Iron overload caused by lifelong transfusion-dependent anaemias, such as

beta-thalassaemia major, usually results in lethal cardiac toxicity in the second

decade of life if not treated by iron chelation. There is no physiological mechanism

for excreting the excess iron accumulated from blood transfusions and, unlike

hereditary haemochromatosis, venesection is not an option. Therefore, chelation

therapy is the only way to remove excess iron. This must be removed while not

depriving cells of the essential iron needed for normal metabolism. Additionally,

the iron chelator must prevent iron from participating in the generation of harmful

free radicals. Parenteral chelation therapy with deferoxamine (desferrioxamine) is

well established as promoting negative iron balance, reversing cardiac toxicity, and

prolonging life expectancy well into the fourth decade of life and, most likely,

beyond. Unfortunately, poor compliance with the rigours of parenteral treatment in

a minority of patients limits its regular use, resulting in reduced life expectancy in

these patients. Use of deferoxamine in excessive dosages may result in growth

retardation, sensorineural ototoxicity and ocular toxicity, as well as bone

deformities. These effects can be largely avoided if the dosage is adjusted to take

account of the degree of iron overload (using the therapeutic index) and if the

mean daily dose does not exceed 40 mg/kg. Nevertheless, it is recommended that

patients be regularly monitored for such adverse effects. Deferiprone (L1; CP20) is

an orally absorbed bidentate hydroxypyridinone iron chelator that can induce

urinary iron excretion, promote negative iron balance and reduce hepatic iron

levels in some transfusion-dependent patients, particularly in those who are

markedly iron overloaded and have not received regular deferoxamine therapy.

The long term efficacy and toxicity of deferiprone are the subjects of some

controversy, and the published results of randomised controlled trials are awaited.

Preliminary results suggest that when currently recommended dosages of

deferiprone (75 mg/kg/day) are used, hepatic iron settles at levels that still put most

patients at an increased risk from iron overload. A number of adverse effects may

occur, and require cessation of therapy in up to 30% of patients. These effects

include arthritis, nausea and (most seriously) agranulocytosis in 0.6 to 4% of

patients. The risk of the latter complication means that frequent white blood cell

counts are mandatory for patients taking this drug. There remains an urgent need to

identify an orally active chelator regimen that is as effective as deferoxamine and

has an acceptable degree of tolerability.

Kontoghiorghes GJ. et al conducted study on Present status and future

prospects of oral iron chelation therapy in thalassaemia and other diseases.In the

last few years we have witnessed the emergence of oral chelation which is a new

form of therapy for transfusional iron-loaded patients in thalassaemia and other

refractory anaemias. The need for a cheap, non-toxic, orally effective iron chelator

is paramount because it could potentially save the lives of many thousands of

patients. At present, less than 10% of the patients requiring iron chelation therapy

worldwide receive the widely used chelating drug desferrioxamine (DF) because of

its high cost, oral inactivity and toxicity. The most promising oral iron chelator is

1, 2-dimethyl-3-hydroxypyrid-4-one (L1 or INN: Deferiprone), which has so far

been taken by over 450 patients in 15 countries, and in some cases daily for over 4

years with very promising results. L1 was shown at 50-100 mg/kg/day to be

effective in bringing patients to negative iron balance. It increases urinary iron

excretion, decreases serum ferritin levels and reduces liver iron in multi-transfused

iron-loaded patients. Toxic side effects were mainly encountered at high doses (80-

100 mg/kg/day) and include transient agranulocytosis (5 cases), transient

musculoskeletal and joint pains (10-20%), gastric intolerance (2-6%) and zinc

deficiency (1%). The incidence of these toxic side effects was reduced by using

lower doses of 50-75 mg/kg/day. The overall efficacy and toxicity of L1 is

comparable to that of DF in animals and humans. Further work is required for

identifying susceptible individuals to L1 toxicity, and also optimum dose protocols

of L1 which can maximise iron excretion and minimise the incidence of toxic side

effects.

PROBLEM STATEMENT: -

A study to assess the effectiveness of structured teaching programme on

knowledge regarding chelation therapy among staff nurse’s in a selected

hospitals, Bangalore.

6.3) OBJECTIVES: -

To assess the existing knowledge of staff nurse’s regarding

chelation therapy by conducting pretest.

To develop and implement the structured teaching programme on

chelation therapy and its importance.

To assess the effectiveness of structured teaching programme by

conducting post test.

To find out the association between pretest knowledge scores with

selected demographic variables.

6.4) RESEARCH HYPOTHESIS: -

H1 - There is a significant association between the demographic variables

and knowledge regarding chelation therapy.

H2 - There is no significant association between the demographic

variables and knowledge regarding chelation therapy.

RESEARCH VARIABLES: -

INDEPENDENT VARIABLES: - Structured teaching programme on chelation

therapy.

DEPENDENT VARIABLES: - Knowledge regarding chelation therapy among

staff nurses.

DEMOGRAPHIC VARIABLES: - Selected demographic variable such as age,

sex, education, years of experience, working experience in medical ward,

previous knowledge about chelation therapy.

6.5) OPERATIONAL DEFINITION: -

Assess: - It refers to evaluate the staff nurse’s knowledge on chelation therapy.

Effectiveness: - It refers to significant difference between the pretest and

post test knowledge scores of staff nurse’s on chelation therapy.

Structured teaching programme: - It is an education given by the investigator

for 45 to 60 minutes with the help of the A.V aids. It

includes definition,medical use,use in heart disease,different

chelating agents,benefits, chelation process and nursing

management.

Knowledge: - It refers to the level of understanding of staff nurse’s regarding

chelation therapy.

Chelation therapy: - Chelation therapy is a recognized treatment for heavy metal

(such as lead) poisoning. EDTA, injected into the blood, will bind the

metals and allow them to be removed from the body in the urine.

6.6) ASSUMPTIONS:-

Staff nurse’s posses some knowledge regarding chelation therapy.

Knowledge can be assessed with the help of knowledge questions.

6.7) DELIMITATIONS:-

The study is limited to the staff nurse’s.

PROJECTED OUTCOME: -

The ultimate goal of this study is reducing the number of atherosclerosis clients.

Structured teaching programme on chelation therapy helps to create awareness

among staff nurse’s regarding importance of chelation therapy to reduce the

incidence of atherosclerotic diseases.

7.0) MATERIAL AND METHODS: -

7.1) SOURCE OF DATA: - Staff nurse’s who are going to get the knowledge

will be the source of data.

7.2) METHODS OF COLLECTION OF DATA: - Self administered

questionnaire regarding chelation therapy.

7.2.1) RESEARCH DESIGN: -

QUASI EXPERIMENTAL RESEARCH DESIGN: - The design adopted for

the present study was represented as.

O1 - Knowledge test before administration of structured teaching

programme.

X - Structured teaching programme on chelation therapy.

O2 - knowledge test after administration of structured teaching programme.

7.2.2) RESEARCH APPROACH: -

A research approach tells the researches from where the data is to be collected ,

what to collect, how to collect and analyses, then it also suggests the possible

conclusions and helps the researcher in answering specific research is the most

accurate and efficient way possible.

{Rose Grippa and Gotenery Lucero 1994}

An evaluative research approach was used in order to assess the effectiveness of

structured teaching programme on chelation therapy.

7.2.3) SETTING: -

Setting is the physical location and condition in which data collection takes

place.

{Polit & Hungler 1999}

The study will be conducted in selected hospitals, Bangalore.

7.2.4) POPULATION: -

The population of present study is staff nurse’s working in a selected hospital,

Bangalore.

7.2.5) SAMPLE SIZE: -

The sample of the study consists of 50 staff nurses.

7.2.6) SAMPLING PROCEDURE: -

Simple Random sampling techniques procedure

7.2.7) CRITERIA FOR THE SAMPLING: -

INCLUSIVE CRITERIA: -

Staff nurse’s who are willing to participate in data collection.

Staff nurse’s who are available at the time of data collection.

All staff nurse’s (including male & female) working in that hospital.

EXCLUSIVE CRITERIA: -

Staff nurse’s who are not willing to participate in data collection.

Staff nurse’s who are not available at the time of data collection.

DATA COLLECTION TOOLS: -

Pretest and post test will be used to assess the knowledge of chelation therapy

among staff nurse’s. It consist of two parts; part I & part II

Part I: - Selected demographic variables such as age, sex, education, years of

experience, working experience in medical ward, previous Knowledge about

chelation therapy.

Part II: - Self administered questionnaire on chelation therapy.

DATA ANALYSIS METHOD: -

Data analysis will be through both descriptive and inferential statistic.

7.3) DOES THE STUDY REQUIRE ANY INTERVENTION TO BE

CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS

Yes the study will be conducted on staff nurses by imparting knowledge

through structured teaching programme.

7.4) HAS ETHICAL CLEARANCE BEEN OBTAINED FROM

YOURS INSTITUTION

Yes, prior permission will be obtained from the research committee of the

Sushrutha College of nursing, Bangalore.

8) LIST OF REFERENCE: -

1. ̂  "Hemochromatosis: Monitoring and Treatment". National Center on Birth Defects and Developmental Disabilities (NCBDDD). 2007-11-01. Retrieved 2008-03-29.

2. ^ a b c d "Questions and Answers: The NIH Trial of EDTA Chelation Therapy for Coronary Artery Disease". National Center for Complementary and Alternative Medicine (NCCAM). Retrieved 2007-11-11.

3. ̂  http://www.ftc.gov/os/1999/07/9623147c3881acamcmp.htm4. ̂  http://www.ftc.gov/os/1998/12/9623147agr.htm5. ̂  http://www.ftc.gov/os/1998/12/9623147att.htm6. ̂  Natural Standard Professional

Monograph. http://www.naturalstandard.com/monographs/monoframeset.asp?monograph=/monographs/alternativemodalities/chelation.asp%3Fprintversion%3Dtrue Accessed June 16, 2009.

7. ̂  Nash, R. A. (2005). Metals in medicine. Alternative Therapies in Health and Medicine , 11 (4), 18-25.

8. ̂  Bridges, S. (2006). The promise of chelation. Mothering , 54-61.9. ̂  Klotter, J. (2006). Chelation for autism. Townsend Letter: The Examiner of

Alternative Medicine , 30, p. 273.10. ̂  Bridges, S. (2006). The promise of chelation. Mothering , 54-61.11. ̂  Ernst E (2000). "Chelation therapy for coronary heart disease: An overview of

all clinical investigations". Am. Heart J. 140 (1): 139–41. doi:10.1067/mhj.2000.107548. PMID 10874275.

12.^ a b Weber W, Newmark S (2007). "Complementary and alternative medical therapies for attention-deficit/hyperactivity disorder and autism". Pediatr Clin North Am 54 (6): 983–1006. doi:10.1016/j.pcl.2007.09.006.PMID 18061787.

13. ̂  Natural Standard Bottom Line Drug Monograph: Chelation Therapy.http://www.naturalstandard.com/monographs/alternativemodalities/patient-chelation.asp?printversion=true?printversion=true. Accessed June 16, 2009.

14.^ a b c NCCAM.Trial to assess chelation therapy15. ̂  http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

16.^ a b c d e f Atwood KC, Woeckner E, Baratz RS, Sampson WI (2008). "Why the NIH Trial to Assess Chelation Therapy (TACT) should be abandoned". Medscape J Med 10 (5): 115. PMID 18596934.

17.^ a b "American Heart Association: Chelation Therapy". Retrieved 2008-04-03.18. ̂  "Government probes chelation-heart disease study". Washington Post (AP).

Retrieved A2008-09-26.19.^ a b c http://www.americanheart.org/presenter.jhtml?identifier=300084320. ̂  Seely DM, Wu P, Mills EJ (2005). "EDTA chelation therapy for

cardiovascular disease: a systematic review". BMC Cardiovasc Disord 5: 32. doi:10.1186/1471-2261-5-32. PMID 16262904.

21. ̂  Bernard S, Enayati A, Roger H, Binstock T, Redwood L (2002). "The role of mercury in the pathogenesis of autism" (PDF). Mol Psychiatry 7 (Suppl 2): S42–3. doi:10.1038/sj.mp.4001177. PMID 12142947.

22. ̂  Stokstad E (2008). "Stalled trial for autism highlights dilemma of alternative treatments". Science 321 (5887): 326.doi:10.1126/science.321.5887.326. PMID 18635766.

23. ̂  "Aspies For Freedom". Aspies For Freedom. Retrieved 2009-02-24.24. ̂  Immunization Safety Review Committee, Board on Health Promotion and

Disease Prevention, Institute of Medicine(2004). Immunization Safety Review: Vaccines and Autism. Washington, DC: The National Academies Press. ISBN 0- 309-53275-2.

25. ̂  Doja A, Roberts W (2006). "Immunizations and autism: a review of the literature". Can J Neurol Sci 33 (4): 341–6.PMID 17168158.

26. ̂  Thompson WW, Price C, Goodson B et al. (2007). "Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years". N Engl J Med 357 (13): 1281–92. doi:10.1056/NEJMoa071434. PMID 17898097.

27. ̂  Rutter M (2005). "Incidence of autism spectrum disorders: changes over time and their meaning". Acta Paediatr 94(1): 2–15. doi:10.1080/08035250410023124. PMID 15858952.

28. ̂  Blakeslee, Sandra (2004-05-19). "Panel Finds No Evidence To Tie Autism To Vaccines". New York Times. Retrieved 2008-02-01. "An examination of scientific studies worldwide has found no convincing evidence that vaccines cause autism, according to a committee of experts appointed by the Institute of Medicine."

29. ̂  Knudtson ML, Wyse DG, Galbraith PD, et al. (2002). "Chelation therapy for ischemic heart disease: a randomized controlled trial". JAMA 287 (4): 481–6. doi:10.1001/jama.287.4.481. PMID 11798370.

30. ̂  "American College for Advancement in Medicine, File No. 962 3147, Docket No. C-3882". Federal Trade Commission. Retrieved 2007-11-11.

31. ̂  "Medical Association Settles False Advertising Charges Over Promotion of 'Chelation Therapy'". Quackwatch.December 8, 1998. Retrieved 2007-11-11.

32. ̂  American College for Advancement in Medicine (August 14, 2002). "Physician Group Backs New NIH Chelation Therapy Study For Heart Disease". Press release. Retrieved 2007-11-11.

33. ̂  Succimer Chelation Improves Learning, Attention, and Arousal Regulation in Lead-Exposed Rats but Produces Lasting Cognitive Impairment in the Absence of Lead Exposure

34. ̂  Hazards of chelation therapy: Brown MJ, Willis T, Omalu B, Leiker R (2006). "Deaths resulting from

hypocalcemia after administration of edetate disodium: 2003–2005". Pediatrics 118 (2): e534–6. doi:10.1542/peds.2006-0858. PMID 16882789.

Baxter AJ, Krenzelok EP (2008). "Pediatric fatality secondary to EDTA chelation". Clin Toxicol (Phila) 46: 1083.doi:10.1080/15563650701261488. PMID 18949650.

9) SIGNATURE OF THE STUDENT: -

10) REMARK OF THE GUIDE: -

The topic is relevant and it helps to enhance the knowledge of staff

nurse regarding chelation therapy.

11) NAME & DESIGNATION OF GUIDE: - Mrs. RENUKA HEAD OF THE DEPARTMENT,

MEDICAL AND SURGICAL NURSING

11.1) GUIDE NAME & ADDRESS: - Mrs. RENUKA HEAD OF THE DEPARTMENT,

MEDICAL AND SURGICAL NURSING

SUSHRUTHA COLLAGE OF NURSING,

B.S.K 3RD STAGE BANGALORE-85.

11.1) SIGNATURE OF GUIDE:-

11.2) HEAD OF THE DEPARTMENT: - Mrs. RENUKA HEAD OF THE DEPARTMENT,

MEDICAL AND SURGICAL NURSING

11.3) SIGNATURE OF HOD:-

12.1) REMARK OF THE PRINCIPAL: -

12.2) SIGNATURE OF THE PRINCIPAL: -