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THEBENEFITS OF THE USE OF MISTLETOE (VISCUM ALBUM) IN HERBALPREPARATIONS

Tableof Contents

HISTORY OF MISTLETOE (VISCUM ALBUM) 4

LOCATION OF MISTLETOE (VISCUM ALBUM) (botanical information) 4

CHEMICAL CONSTITUENTS OF MISTLETOE (VISCUM ALBUM) (Pharmacology) 5

MEDICINAL QUALITIES OF MISTLETOE (VISCUM ALBUM) 5

CONTRA-INDICATIONS OF MISTLETOE (VISCUM ALBUM) 6

KNOWN HERBAL FORMULAS OF MISTLETOE (VISCUM ALBUM) 7

DOSAGE AND APPLICTAIONS OF MISTLETOE (VISCUM ALBUM) 7

PERSONAL EXPERIENCE 8

THEBENEFITS OF THE USE OF MISTLETOE (VISCUM ALBUM) IN HERBALPREPARATIONS

ABSTRACT

Thepaper has focused on the benefits of the use of mistletoe (Viscumalbum) in herbal preparations. Mistletoe is one of the naturalhealing methods that have been used in many decades in the treatmentof various diseases. As evidenced in the literature, Viscum album isused for cancer therapy, treatment of hypertension, hepatitis,degenerative inflammation of the joint, anxiety, as well as animmunostimulant. Mistletoe preparations have a number of biologicallyactive elements including lectins, glycoproteins, proteins andgalacturonans among others. Nevertheless, these elements depend withvarious factors such as the host tree as well as the season ofharvest.

Viscumalbum herbal preparations are available in many countries. Thesecombination products THMP, Crataegus, Allium Sativum in the Autriamarket Visci albi herba, Crataegi fructus and Melissae hera in theCzec Republic Visci herba and Tincture in the German market Visciherbae recentis intractum in the Poland market tincture and herbaltea in Slovenia whilst mixed preparations are available in theUnited Kingdom. In order to achieve the objective of the research,the researcher will focus on five public hospitals in Germany. Theparticipants will be medical practitioners who will be chosenrandomly from the entire population. The results and findings of thecurrent study will be significant in health institutions, practiceand research.

HISTORY OF MISTLETOE (VISCUMALBUM)

Forcenturies, mistletoe (Viscum album) has been employed in thepreparation of herbal medicines used in the treatment of variousdiseases including epilepsy, cancer, menopausal symptoms,infertility, asthma, nervous tension, dermatitis, as well ashypertension amongst others (Böhling et al. 2003 Christopher,2009). Concern in mistletoe started in the 1920s. During this time,Rudolf Steiner recommended it for treating cancer. Rudolf is knownfor the discovery of anthroposophical and anthroposophy medicine.Research on mistletoe treatment has been carried out since the year1980s. A wide array of diverse mistletoe preparations have beenmarketed by various German phyto-pharmacological suppliers includingABNOBA HEILMITTEL, NOVIPHARM, WELEDA, HELIXOR HEILMITTEL and MADAUSamongst others (Böhling et al. 2003). These providers offerdifferent products, for instance, WELEDA markets anthroposophicalamong other herbal extracts. In the current time, research onmistletoe has been carried out and it has proven beneficial in herbalpreparations for the treatment of various diseases including cancerand respiratory diseases.

LOCATION OF MISTLETOE (VISCUMALBUM) (botanical information)

Mistletoeis locally widespread in the United Kingdom. A survey carried outbetween the years 1993 and 1996 demonstrated that it is prevalent inapple orchard regions of the Welsh borders (Olsnes et al. 1982).Mistletoe invasion on host tree has been shown to harm them. In fact,huge invasions result in the death of the host tree, especiallyduring extended times of dry weather. Furthermore, mistletoe lessensthe productivity of host fruit trees and in order to mitigate this,it is cut out to impede its spread.

CHEMICAL CONSTITUENTS OFMISTLETOE (VISCUM ALBUM) (Pharmacology)

Thechemical constituent of mistletoe depends with various factorsincluding the host tree, extraction techniques, season, as well asparts used in the extraction. For instance, it has been shown thatgrowing mistletoe on apple tree produces the best pharmacologiceffect (Olsnes et al. 1982). The key elements of mistletoe encompasslectins (these are carbohydrate attached proteins) that encompassviscumin. Another element is polypeptides referred to as viscotoxins.These have a fundamental chemical structure known as thionis.Phenolic elements are also present in mistletoe and they encompasso-coumaric acid and digallic acid. These are found in form ofglycosides. Extracts of mistletoe are known to simulate macrophagecytotoxicity, amplify cytokine secretion, induce phagocytosis ofimmune cells, and improve the effects of cytotoxicity on numerouscell ranks in vitro (Christopher, 2009). Other elements found on theplant encompass alkaloids, viscotoxins, flavonoids, acids, andterpenoids. In a nutshell, the active chemical elements of mistletoeencompass lectin, alkaloids, polysacchrides, proteins, andglycoproteins.

MEDICINAL QUALITIES OFMISTLETOE (VISCUM ALBUM)

Mistletoeis known to have various medicinal qualities. The pharmacologicprofile of the plant has two key qualities and they encompassantitumor actions and modulating the immune system. It has been shownthat the activities of mistletoe depend with the dosage offered(Stirpe et al. 1982). For instance, when given at high quantities,it acts as an antineoplastic whilst when given at low quantities, itacts as an immunomodulator. Supporters of mistletoe in diseasetreatment and management argue that it enhances life quality, assistin reducing cancer as well as the rate of survivor, and makes theimmune system to become stronger (Stirpe et al. 1982). It has alsobeen used in the treatment of menopausal symptoms, infertility,asthma, nervous tension, and dermatitis. Most of these activities arebelieved to be supported by lectin as it stimulates macrophagecytotoxolog, amplifies the secretion of cytokine and inducephagocytosis.

CONTRA-INDICATIONS OFMISTLETOE (VISCUM ALBUM)

Mistletoecontains a combination of poisonous viscotoxins, proteins, andlectins. As compared to its fruits, the stems and leaves are moretoxic and the toxicity varies with the mistletoe host plant (Olsneset al. 1982). Mistletoe has been shown to have allergic reactions.This was evidenced from an individual who handled business mistletoetea and who developed allergic rhinitis (Milius, 2002). In anothercase, anaphylaxis developed after mistletoe was injected in a subject(Olsnes et al. 1982). It is a serious allergic reaction that occurswhen mistletoe allergic persons comes into contact with it. In thiscase, persons suffering from hypersensitivity or allergies shouldavoid using mistletoe or its elements.

Mistletoeshould not be used in patients suffering from organ dysfunction orwho have related diseases. As proposed by herbalists, mistletoeshould be avoided in n patients suffering from chronic progressiveillnesses including tuberculosis. Besides, close monitoring should bedone on individuals with heart diseases and who use mistletoe. Thereason behind this is that the herb may result in hypotension orhypertension (Böhling et al. 2003).

Mistletoeis also known to interact and interfere with subsistingimmunosuppressant and cardiac therapies. It is also opposed inpatients under the treatment of monamine oxidase (MAO) inhibitorsowing to the reason that it contains tyramine (Olsnes et al. 1982).Pregnant or lactating mothers should not use mistletoe as it ishypothesized to contain uterine stimulant activity.

KNOWN HERBAL FORMULAS OFMISTLETOE (VISCUM ALBUM)

C20H48O8(C20H32+ 8H2O)

CH3O3.OH

DOSAGE AND APPLICTAIONS OFMISTLETOE (VISCUM ALBUM)

Dosageand application of mistletoe depends with various factors such as thetechnique of preparation, host tree, as well as productstandardization to a certain element (Böhling et al. 2003). Besides,the amount of dosages given depends with the severity and kind ofillness being treated as well as personal patient conditions. Givingoverdose should be avoided as it may lead poisoning. In traditionaltimes, mistletoe leaves were used in making tea, which was then takenas recommended by herbalists. Tea is prepared by pouring cold waterinto one tablespoon (2.5 g) of chopped drug. The mixture should beleft for ten to twelve hours before straining. The recommended dosageis 1 to 2 cups ever day. Mistletoe is also taken in form of tincture.The recommended ratio is 1:5 which should be mixed with 45 percent ofalcohol. The dosage for this is 1-4 milliliters every day. Driedaqueous extract should be prepared in the ratio of 4:1 and the dosageis 100 to 250 mg every day.

Researchershave studied mistletoe in numerous injectable treatments includingsubcutaneous, intravenous, and intrapleural (Stirpe et al 1982).These have been provided by a healthcare giver in controlledsettings. At times, therapy entails two stages: the initiation stageand the maintenance stage. It is recommended that patients intendingto use mistletoe should seek advice from a qualified healthcarespecialist. Further research is however required considering thatthere exist numerous side impacts as well as drug interactions.

PERSONAL EXPERIENCE

Ihave had a personal experience with the herb. Sometimes back, Idecided to use Viscum album as a nervine for epilepsy. Based on theanecdotal evidence backing Viscum album as a nervine, I decided touse it together with other herbs to a friend who was suffering fromepilepsy. I used Dr Christopher’s Nerve Herbal Food Combinationformula to relieve my friend’s nervous tension. Since epilepsyaffects the nerves I used black cohosh (Actaea racemosa), cayenne(Capsicum annuum), hops flowers (Humuluslupulus),lobelia (Lobeliaerinus),skullcap (Scutellariagalericulata), valerian (Valerianaofficinalis),wood betony (Pediculariscanadensis),and mistletoe (PedicularisCanadensis)to feed, regulate, strengthen and regenerate his nerve system.Dr. John R. Christopher notes that “Misteloe […] will soothe,tone and quite the nerves,lessening cerebral excitement and influencing febrile condition.”(J.Christopher 387).

Grieve(2006) also notes that “Mistletoehas a reputation for curing epilepsy and other convulsive nervousdisorders.” I extracted the aforementioned herbs in a base of Pure VegetableGlycerin, Ethyl Alcohol (less than 5%) and distilled water. Afteradministering 15-30 drops of the extract between meals for a fewdays, the combination helped control attacks and had helpedmy friend to feel much better and have more quality of life.This is because the herbal formula I used helped feed/rebuild thespinal cord and revitalizethe motor nerve at the base of the skull (medulla area and uppercervical)which stopped the nerve cell disturbances that had been causingregular seizures.

PROPOSAL

Viscumalbum is a kind of mistletoe that has stimulated interest all throughhistory. It is indigenous in the European as well as southern andwestern Asian regions. Mistletoe is valued for its therapeutic andsupposed supernatural properties. It has been employed in thepreparation of herbal medicines used in the treatment of variousdiseases including epilepsy, cancer, menopausal symptoms,infertility, asthma, nervous tension, dermatitis, as well ashypertension amongst others (Ernst et al. 2003). In the Europeanregion, it is linked with Christmas and employed as a winterdecoration. Besides, some believe in kissing beneath clusters ofmistletoe. The plant is known to grow on various host trees. In theUnited Kingdom for instance, it grows on lime, apple, poplar,hawthorn, blackthorn, and willow. Mistletoe invasion on host tree hasbeen shown to harm them. In fact, huge invasions result in the deathof the host tree. Furthermore, mistletoe lessens the productivity ofhost fruit trees and in order to mitigate this, it is cut out toimpede its spread.

Awide array of diverse mistletoe preparations have been marketed byvarious German phyto-pharmacological suppliers who offer differentproducts including anthroposophical among other herbal extracts. Thechemical constituent of mistletoe depends with various factorsincluding the host tree, extraction techniques, season, as well asparts used in the extraction. The active chemical elements ofmistletoe encompass lectin, polysacchrides, proteins, andglycoproteins. Mistletoe is known to have various medicinalqualities. The pharmacologic profile of the plant has two keyqualities and they encompass antitumor actions and modulating theimmune system. Dosage of mistletoe depends with various factors suchas the technique of preparation, host tree, as well as productstandardization to a certain element. Contra-indications have alsobeen established related with the plant. For instance, it is said tocontain toxic elements the reason why dosage should be recommended bya healthcare specialist. It has been shown to have allergic reactionswhilst patients suffering from organ dysfunction should not use theherb.

Accordingto researches, mistletoe has various benefits most of which aremedicinal in nature (Stirpe et al. 1982). It has been evidenced to bebeneficial in the treatment of various conditions including cancer,hepatitis, and respiratory diseases amongst others. The current paperseeks to identify the benefits of the use of mistletoe in herbalpreparations. With reference to this, existing literature regardingthe topic will be identified and analyzed in order to compare pastresearches. This will be offered in the literature review section andit will assist in identifying gaps that exist concerning the benefitsof mistletoe.

Backgroundof the Study

Formany centuries, mistletoe has been employed in herbal preparationsfor the treatment of diverse conditions such as epilepsy, anxiety,high blood pressure, arthritis, as well as vertigo (Milius, 2002).During the start of the twentieth century, the plant was widely usedin the European continent for the treatment of cancer. It has turnedout t be a basis of great interest in some parts of the world. Forinstance, although it has been believed to be a “non-proventherapy” in Norway, it still remains as an accepted technique fortreatment. In the past five decades, a number of laboratories, humanand animal researches have been carried out on probable anti-cancerimpacts believed to be brought about by immune-stimulatory impacts ofmistletoe (Milius, 2002).

Inspite of its many uses, studies have shown that mistletoe is mosteffective for cancer therapy. Nevertheless, there exists inadequateclinical proof to regard it as a confirmed therapy for cancerpatients (Ernst et al. 2003). Reports on the toxic impacts ofmistletoe have been provided but they are not common. Variousinstitutes have provided information regarding the employment ofmistletoe in disease treatment. For instance, the National CancerInstitute (NCI) has offered an alternative and complementary druginformation synopsis and outline regarding the employment ofmistletoe in cancer therapy. To this end, it has provided variousinformation proofs concerning the effectiveness of the mistletoedrugs. To start with, the NCI has put forth that animal researcheshave produced mixed findings when mistletoe extracts have been usedto slow the growth of tumors (Ernst et al. 2003). Secondly, clinicaltrials that have been performed using mistletoe extracts or itselements have been inadequate for verifying its effectiveness in thetreatment and management of cancer in human beings. Lastly, somecountries such as the United States (US) do not sell mistletoe aswell as its berries considering that they have been proven to bepoisonous to humans (Watson, 2001).

Asaforementioned, mistletoe is not sold in the US. Nevertheless, in thepresent time, the U.S. Food and Drug Administration (FDA) haveoffered Investigational New Drug (IND) endorsement to research onmistletoe (Ernst et al. 2003). Mistletoe has been listed by theGerman Commission Monographs as an effective remedy for malignanttumors and in treating and managing degenerative inflammation of thejoints (Ernst et al. 2003). There are two key kinds of mistletoe,American and European. Although they contain the same proteinelements, they have been alleged to have diverse uses. For instance,American mistletoe is deemed to amplify blood pressure, induce smoothmuscles, and generate intestinal and uterine contractions. On theother hand, European mistletoe is deemed to act as a calmative andantispasmodic agent and lessen blood pressure. Nevertheless, thereexists diminutive research to validate these declarations. In thiscase, further research needs to be carried out to fill the existinggaps in past studies.

ResearchAims and Objectives

Thegeneral objective of the current research is to investigate thebenefits of the use of mistletoe (viscum album) in herbalpreparations. The specific objectives encompass:

  • To investigate the effectiveness of mistletoe in disease treatment

  • To explore the prevalence of the use of mistletoe plant and its elements.

  • To examine the side effects of the use of mistletoe in disease treatment and management.

ResearchQuestions

  • What are the benefits of the use of mistletoe (viscum album) in herbal preparations?

  • What is the effectiveness of mistletoe herbal preparations in the treatment of various diseases?

  • What is the prevalence of the use of mistletoe plant and its elements?

Significanceof the Study

Theresults and findings of the current study will have implications onhealth, practice and further research on the same topic. To startwith, health institutions will have a great understanding regardingthe benefits offered by mistletoe in herbal preparations. Asevidenced by review of literature, extensive research has beencarried out to investigate the effectiveness of mistletoe in thetreatment of various diseases including cancer, HIV, hepatitis, andstimulation of the immune system among others. The current researchadds up to this set of knowledge, which will be used by medicalpractitioners and professionals in their daily practice. In addition,the study will act as a platform of other further studies which willbe conducted in future.

Reviewof Literature

HerbalPreparations

Traditionally,herbal preparations are employed in various therapeutic areasincluding oncology and for cardiovascular disorders (EuropeanMedicines Agency, 2012). The manufacturing procedures used bringabout the differences in the preparations used. In the Europeancontinent, there are various mistletoe preparations obtainable forsubcutaneous and therapeutic use. According to research, combinationsproducts which contain herbal preparations exist in variouscountries. For instance, in Austria, THMP is sold as herbal tea usedfor treating mild cardiovascular and to stabilize blood pressure.Other preparations include Crataegus and Allium sativum are alsosold. In the United Kingdom, mixed preparations are available in themarket (Watson, 2001). In Germany, various herbal preparations are onthe market including Visci herba, expressed juice and extracts fromVisci herba, and tincture. In Lithuania, Viscum album is available inmuti element homoeopathic products, for instance, Visci albi which isprovided as injection solution. Viscum album is found in such hosttrees as Pinus, Malus, and Abies. In Poland, Visci herbae recentisintractum is sold (European Medicines Agency, 2012). The preparationhas been in the market for 30 years and it is sold as liquid dosage.It is used to treat arterial hypertension and close medicalsupervision should be offered during therapy. In Slovenia, tinctureand herbal tea are sold for the treatment of circulatory and cardiacdisorders. In Norway, Visci albi preparations are sold onprescription by a physician (European Medicines Agency, 2012). Theyare also employed in cosmetics but at very low concentrations.

Prevalenceof Use

Mistletoeis considered to be beneficial and has been used widely in manylocations in the treatment and therapy of various disease andconditions. Its employment in folk medicine has a lengthy history andsome groups such as the Druids consider mistletoe that grows on oakto be of better quality. Mistletoe plant together with its elements,which include lectin, alkaloids, polysacchrides, proteins, andglycoproteins have a great impact on the circulatory, immune andcardiac systems. Research has shown that mistletoe has a wide arrayof medicinal uses and they encompass astringent, antiseptic,diuretic, antispasmodic, and digestive (Newall et al. 1996). Besides,it has been used in the treatment of a wide range of conditionsencompassing ulcers, particular kinds of cancer, epilepsy,rheumatism, as well as high blood pressure amongst others. In spiteof the research carried out to investigate its anti-tumor impacts,studies are still in progress to establish its clinical functions. Insome countries such as Germany, mistletoe extracts including Helixorand Iscador are sold and employed as oncological medicines. In theUS, Mistletoe is not sold considering that is has been proven to bepoisonous to humans. In countries such as Germany, it has becomerecognized for its medicinal value. It has been used in treatment andtherapy of various diseases including respiratory problems,circulatory issues, and cancer, in particular lung cancer. It is usedas an unconventional treatment for cancer in Europe.

HerbalPreparations for Various Disease Treatments

Inthe European continent and in particular Germany, mistletoe has beenacknowledged for its herbal preparations. For instance, a currentresearch carried out in Germany demonstrated that 15 percent ofpatients suffering from lung cancer made use of mistletoepreparations (Loeper, 1999). This was aimed at supporting thetreatment of tumor. Whilst the frequencies for other kinds ofcancers are high, the frequency of usage indicates considerablenational dissimilarities. Rudolf Steiner, who founded anthroposophy,came up with the idea of treating cancer using mistletoe extracts. Hedid comparisons between cancer and the parasitic character of themistletoe plant and considered that cancer signifies a faltering ofthe spiritual defenses of the body. In the year 2001, public interestin US was stimulated after performer Suzanne Somers decided to makeuse of Iscador for her chemotherapy (Ernst &amp Steuer-Vogt, 2003).Somers was suffering from breast cancer and her decision followedradiotherapy and surgery as the treatment methods.

Mistletoeextracts have been investigated for various kinds of cancersencompassing breast, colorectal, bladder, cervical, liver, ovarian,lung, neck, and kidney cancers, in addition to leukemia and melanoma(Ernst &amp Steuer-Vogt, 2003). In a retrospective study carriedout on 991 patients who suffered from colorectal cancer, it wasevidenced that the use of mistletoe preparations considerablylessened the degree of return by 23 and 13 percent on patients withlymphnode positive condition and lymph node negative conditionrespectively (Newall et al. 1996). This deduction was made after thetreated group was compared with another group that did not receivetreatment. Furthermore, the likelihood of survival on the group thatreceived mistletoe treatment was 340 days more as compared to theuntreated one. In another randomized clinical investigation, 47patients suffering from breast cancer were studied (Newall et al.1996). They were put under mistletoe lectin with a dosage of half to1 ng/kg two times every week. The results showed that after the studperiod the patients had improved activity of T-lymphocytes as well asof the secondary blood natural killer cells. In another case, cancerpatients were given mistletoe preparations and observed for a certainperiod of time. The dosage ranged from half to 1 mg/kg taken on adaily basis. The results indicated amplification in T-helper cells,lymphocytes, natural killer cells, and cytokine release (Loeper,1999). The use of mistletoe in the therapy was also linked withenhanced quality life.

Theeffectiveness of mistletoe preparations in treating various kinds ofcancer is linked with its ability to eradicate cancer cells and toimprove the immune system by amplifying white blood cells (Grieve,2006). Besides, it lessens the side impacts of radiation therapy andchemotherapy and enhances life quality. Although various studies havebeen performed to address the uses of mistletoe preparations incancer treatment, these researches contain a number of weaknesses.This is the reason as to why some countries such as the US do notsell mistletoe for use. According to researchers, mistletoe fightsvarious cancers by stopping the formation of blood vessels whichassist in the growth of cancerous tumors. As a result, it has beencategorized as an anti-angiogenic and biological reaction modifier.

Inan initial study conducted in 1997, Viscum album was used in thetreatment of hepatitis (Loeper, 1999). Some of the patients whoreceived treatment attained total eradication of the virus.Nevertheless, the studies were poorly designed. Studies have alsoevidenced mistletoe extracts to be effective in stimulating theimmune system (Loeper, 1999). This is particularly in personssuffering from common colds. Human studies have shown that mistletoeslows down the growth of cells and amplifies the stability of DNA. Itoffsets the impacts of the medicines employed in suppressing theimmune system. Controlled trials and case series conducted in healthypersons and cancer patients respectively evidence the effectivenessof mistletoe extracts and its elements in stimulating the immunesystem. A number of healthy volunteers were provided with mistletoeextract for a period of eight weeks. The results indicated anincrease in secondary mononuclear cells.

Herbalcombinations that contained mistletoe extracts were evidenced todecrease the rate of blood pressure in adult patients suffering fromhypertensive. The dosage was offered for a period of three to fivemonths. Nevertheless, it was hard to deduce the impacts of mistletoeextracts alone considering that the treatment employed an herbalcombination. There also lacks controlled trials which assessmistletoe as an exclusive anti-hypertensive.

Sincethe start of the Aids pandemic, mistletoe has been used in thetreatment of patients suffering from HIV in the European region(Watson 2001). The treatment was founded on the immune-modulatoryimpacts of mistletoe. Treatment appeared to be tolerable whilstminimum side impacts were reported. Although mistletoe helps inreducing progression, it has been shown that mistletoe preparationsdo not demonstrate the same impacts. As a result, recommendations formistletoe can only be made after further research has been conducted.An exploratory trial was carried out to explore the impacts ofmistletoe on the function of the liver, decrease of inflammation andviral load, as well as preservation of quality of life (Olsnes et al.1982). However, minute impacts were evidenced. Recommendations forsuperior and well designed clinical studies are made with theintention of resolving the inconsistent information.

SideEffects of Mistletoe Preparations

Althoughmistletoe has been proven beneficial and used in herbal preparationssuch as anthroposophical, Helixor and Iscador for the treatment ofvarious diseases, it has been shown to have a number of side impacts.To start with, it is contraindicated in persons suffering fromchronic progressive infections such as tuberculosis, as well as thosewith protein hypersensitivity. In addition, it should not be used inpatients suffering from highly febrile, acute, and inflammatorydiseases. A number of reactions related with the herb preparationshave been reported including hyperemia (amplified blood in organs)and erythema (this is reddening of the skin) (Loeper, 1999).Mistletoe should not be used in persons with cardiovascular diseaseas this is linked with numerous adverse impacts. Iscador isassociated with grade three to four toxicities including generalmalaise, fever, anorexia, depressive moods, as well as swelling.However, discontinuation of the herb does not lead to any effectswhilst no death has been associated with the use of the herb.

Inanother study, mistletoe was linked with dermatologic adverseimpacts. These encompass vasculitis, indurations, urticaria, burningsensations, pruritus, and allergic reactions including delayedhypersensitivity (Watson, 2001). Mistletoe should be avoided inuncontrolled hyperthyroid persons. According to the producers ofNovipharm, mistletoe may result in the activation of the metabolismof the patient and over stimulation therefore deteriorating thecondition. Besides, it should be used with care in diabetic patientsas it has been linked with alterations of the insulin levels.

Methodology

Themethodology chapter provides the structure and design of theresearch. It offers information on the data collection methods,analysis, presentation, ethical concerns, as well as researchlimitations. In order to achieve the outlined objectives and answerthe research questions, the research needs to use appropriate design,effective data collection methods, sampling techniques, andinstruments. The construction and administration of the instrumentsalso need to be effective. For this research, both quantitative andqualitative methodology is used.

ResearchDesign

Researchdesign entails the research methodology and procedure used in astudy. For the purposes of achieving the objectives of the researchstudy, both secondary and primary research methods includingquantitative and qualitative research were used. The secondary datais gathered from existing literatures such as journals and scholarlyarticles. The primary data is obtained by conducting interviews andquestionnaires. The two research methods are very crucial inobtaining in-depth information that answers the research question.

Theresearcher will use questionnaires containing both open ended andclosed ended questions for the quantitative part. It is worth notingthat quantitative research is proven to provide maximum assuranceregarding the generation of significant contributions to the researchknowledge and practice. The reason to support this affirmation isthat quantitative research applies theories, hypothesis andmathematical models concerning the issue being investigated. Similarto the majority of researches, the current study uses thestructured-undistinguished questionnaires. They are preferred in thatthey comprise questions with similar wording besides being written ina similar way to all the target participants (Churchill 1995). Theresponses obtained from the participants together with the questionsare standardized. Standardizing responses and questions is importantin that it ensures the participants provide their responses tosimilar questions (Churchill 1995). Secondly, these types ofquestionnaires are easy to complete thus, the participants experienceno difficulties. Lastly, the process of analyzing and tabulating thedata gathered is also simple.

InstrumentsUsed

Theinvestigator has developed a number of instruments that will be usedin the research. These include the Information sheet, Demographicsheet, and Consent form. These are essential in ensuring success andeffectiveness of the research.

Theresearch will take a period of 3 months. In order to start thesurvey, the researcher will obtain permission from the management ofthe various public hospitals involved in the study. After obtainingpermission, the researcher will present the questionnaires to theparticipants, who would be selected randomly. After thequestionnaires have been filled, the respondents will be expected tosend them back to the researcher directly or through the hospitals’poster system. To guarantee the return rate, an envelope will beattached to each questionnaire.

Targetand Sampling Method

Theresearcher targets the public medical institutes in Germany. Theparticipants will be the medical professionals who will be selectedrandomly and equally from each hospital. Five hospitals will beinvolved in the research. The researcher will use simple randomsampling method to gather information from the participants. Simplerandom sampling is deemed to be an efficient method of selecting therequired sample from the whole population. A simple random sample isdefined as a sample or a division of persons selected from the wholepopulation (Aaker and Day 1990). The sampling method allowsindividuals to be selected at random and by chance. It allows personsto have similar likelihood of being selected at any phase of thesampling procedure. Simple random sampling has a number of advantagesover other sampling methods. For instance, it lessens the possibilityof human bias while selecting participants from the whole populationto take part in the research. Accordingly, it offers researchers witha sample which is representative of the entire population underinvestigation (Aaker and Day 1990). The sampling method enables theresearcher to make statistical inferences or generalizations from thepopulation sample considering that the chosen units for the sampleare selected using probabilistic techniques. Such statisticalinferences are believed to contain external validity.

SampleSize

Inthe current study, a sample size of 100 participants will be used.These participants, who are the medical professionals of the selectedpublic medical institutes, will be surveyed by representing them withthe questionnaires for completing with the purposes of meeting theaim of the research. The sample size will be obtained through thesimple random sampling method. The researcher chose to use thissampling method because it is free of classification error and theinformation collected is easy to interpret. The study is expected totake a survey period of 3 months.

PilotStudy

Pilotstudy is carried out to ensure that the aims and expectations of theresearcher with regards to the data to be gathered from theadministration of the questionnaires are achieved (Aaker and Day1990). According to Churchill (1995), pilot study is applied toassess the questions in the questionnaire along with their sequence.A pilot study requires the participants to be composed of aconsiderable fraction of the sample population (Aaker and Day 1990).Additionally, the participants involved in the pre-test should becomparable to the respondents involved in the actual study (Churchill1995). Churchill (1995) further argues that the pilot study should becarried as a process with two stages. The initial stage is conductedby personal interviews, without taking into consideration the methodto be used in data collecting during the actual study. This will helpthe researcher determine whether the participants are aware of whatis required of them, or if the questions are vague or not (Churchill1995). Personal interviews help the researcher identify the wordsthat ought to be changed, the questions that need to be improved, andthe order in which the questions should be arranged. In the secondstage, the pre-test should be carried out in the same way that theactual study will be conducted. The second stage is meant to revealthe potential problems of the survey method. It is important to notethat the responses provided in this stage should be tabulated andcoded. This will help in checking the conceptualization of theproblem in the study and the data analysis method required to counterit (Churchill 1995).

Priorto conducting the research, a pilot test would be conducted with theaim of evaluating feasibility, cost, statistical variability, andtime. This would allow the prediction of a suitable sample size anddevelop the study design. It is significant to ensure validity of thequestionnaire in order to obtain valid outcomes. This will beachieved by making sure that the questionnaire focus on the relevantand consistence questions, and applying a sample size that representthe population.

Forthe purposes of this study, a pilot study will conducted to check thewording, as well as the sequence of questions. This is so as todetermine whether the questionnaire will collect all the intendedinformation for the study. Additionally, the structure of thequestionnaire will also be taken into consideration. The commentsobtained from the respondents will be received and recorded. Theissues raised with regards to the structure of the questionnaire willbe discussed and rectified.

EthicalIssues

Anumber of ethical issues will be considered when designing andconducting the current research study. The first important thing willbe to obtain permission from the participants. Every individual has aright to choose whether or not to participate in the study (Churchill1995). The researcher will ensure that the decisions of theparticipants are respected. A full disclosure of what kind of studythis is, risks involved and the benefits involved will be revealed tothe participants to enhance their decisions in participating in thestudy. Participants will have an opportunity to ask questions withregards to the study. The confidentiality and privacy of theparticipants will be ensured. So as to ensure this, the participantswill not be required to write their names on the questionnaires. Theother important ethical issue considered in this study is respect forthe opinions put forth by the respondents. The findings presented inthe study will reflect the opinions of the respondents and not theresearchers. This study will also avoid plagiarism by recognizing thecontribution made by different researchers and theorists.

StatisticalTreatment of Data

Thequantitative data, obtained using the questionnaires, will beanalyzed using SPSS 16 for Windows. Data analysis will consist ofdifferent statistical tests and analyses. To begin with, descriptiveanalyses will be done to provide a description of the collected data.The process of analyzing data helps the researcher refine interviewquestions and probes, and focus on the responses that are the same asthose described by other participants.

Limitationsof the Study

Thefindings of this study will be limited to information collected fromthe sampled respondents. This limits the information available to theresearcher to help make their conclusions on the topic.

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