Vertigoheel - _double_blind_comparative Betahistine 2000

7/22/2019 Vertigoheel - _double_blind_comparative Betahistine 2000

1/6

QUALITY OF LIFE IN VERTIGO PATIENTS: A DOUBLE-BLIND COMPARATIVE STUDY OF A HOMEOPATHIC MEDICATION

Wolfgang Strasser, Michael Weiser

AbstractQuality-of-lifessuesandaccurateobser-vation of symptomscan be essentialinselecting.individually appropriate phar-maceuticaltherapyfor vertigo. .Forthisreason,the presentstudy comparestheeffectsof Vertigoheeland betahistine .notonly with regard to the frequency,dura-tion, and intensity of vertigo attacks butalso with regard to quality of life .inpatientswith vertigos of varying etiol-ogy.The double-blindstudy incliJdeda totalof II 9 patientsfrom IS practices.Treat-ment wasadministeredthree times dailyfor six weeksand consistedof either ISdrops of Vertigoheelor 6 mg of betahis-tine. Quality of life wasassessedbymeansof two psychometrictests,theSF-36HealthSurveyand a vertigo-spe-cific questionnaire.Quality of life mea-sured in terms of both physicaland psy-chologicalwell-being improvedsignificantly during therapy with Vertigo-heel,which provedto be equivalenttobetahistinetherapy.Keywords: Vertigoheel, betahistine,ver-tigo, clinical study,quality of life

2 @ BiologischeMedizin

Quality of ife inertigo PatientsA Double Blind Comparative Studyof a Homeopathic Medication

IntroductionNearly 10 of all patients seen by physi-cians in family practice name dizziness asone of the symptoms of their health prob-lem (1). Primary-care physicians oftenwonder whether an initial physical exami-nation and a few simple, common tests ofcoordination can adequately pinpoint thecause of this condition or whether thepatient will have to be referred to a spe-cialist for further examination. In mostcases, targeted tests of coordination canindeed determine the exact etiology andseverity of the vertigo. If needed, moreextensive examination may include nys-tagmus analysis, electronystagmography,or posturography (2).

A patient who fears sudden attacks of ver-tigo may avoid physical exertion and psy-chological stress and withdraw fromsocial activities. Because such avoidance isoften associated with depressive loss ofself-esteem that affects the patient s subse-quent behavior, therapeutic measures tar-get both the frequency and the severity ofthe attacks in order to improve thepatient s quality of life and thus his or hersubjectively perceived state of health.

The findings of various research groups,however, reveal that patients overall clin-ical pictures involve more than just theobjectively determined degree of severityof their vertigo. In the process of subjec-tive evaluation and care of individual ver-tigo patients, physicians repeatedly findthat even when they observe and docu-ment similar clinical conditions and func-tional limitations in patients, substantialdifferences are evident in these patientsbehavior and subjective perceptions ofhealth Depending on personality, life situ-ation, and individual values the burden of

suffering that the basic ailment imposeson individual vertigo patients varies sig-nificantly (3). Therefore, assessment of apatient s total situation must include notonly technologically measurable andquantifiable symptoms but also thepatient s subjective perception of theseverity of his or her illness as it impactsquality of life. This perspective hasreopened the discussion on a number ofpharmacological therapies, including notonly antivertigo drugs but also antihista-mines and hemorheological medications;increasingly, their therapeutic value isbeing considered from additional perspec-tives. This basic approach was given spe-cial consideration in the current clinicaltrial of Vertigo heel (drops) versus betahis-tine in patients with vertigos of varyingetiology.

...................................................................................COMMENTARY A randomized double-blind study by Weiseret al. comparing the efficacy of Vertigoheel. and betahistine was published in Arch Oto-

laryngol Head Neck 1998. While that first pa-per focussed on efficacy and tolerance of thetwo medications this second article adds theparameter of quality of life and is thereforemore than just an afterthought to the first.Taken together these two papers provide an ex-ample of evidence-based medicine. This proce-dure should become the accepted standard be-cause it demonstrates how quality control canbe implemented in biological medicine. The re-sults of this study by confirming the equiva-lence of the antihomotoxic medication and theallopathic drug in improving quality of lifealso document the cost effectiveness and lackof adverse effects of antihomotoxic therapy formild forms of vertigo.

Hartmut Heine Ph.D. ......................................................................


2/6

QUALITY OF LIFE IN VERTIGO PATIENTS: A DOUBLE.BLlND COMPARATIVE STUDY OF A HOMEOPATHIC MEDICATION

Question I :In general,wouldyousayyour healthis:Scale:excellent;ery good;good;fair; poorQuestion 2:Comparedto one year ago, how would you rateyou[ health in general now?Scale:much better now than one year ago;somewhatbetter now than one year ago;about the sameas one year ago;somewhatworsethan one yearago; muchworsethan one year ago.Question 3:The following questionsare about activities youmight do during a typical day.Doesyour healthnow limit you in these activities? If s howmuch?a, Vigorousactivities such as running,liftingheavy objects,participating in strenuous

sportsb. Moderateactivities, such as moving a table,

pushing a vacuum cleaner,bowling, or playinggolf

c. Lifting or carrying groceriesd. Climbingseveralflights of stairse. Climbing one flight of stairsf. Bending,kneeling,or stoopingg. Walking more t han a mileh. Walking several hundred yardsi. Walking one hundred yardsj. Bathing or dressingyourselfScale:yes,limited a lot; yes,.limited a little; no, notl imited at a llQuestion 4:Doring the past 4 weeks,haveyou had any ofthe following problemswith your work or otherregular daily activities as a result of your physi-cal health?

a . Cu t down on the a mount of t ime. yo u sp enton work or other activitiesb. Accomplishedlessthan you would likec. Were limited in the kind of work or other

activitiesd. Had difficulty performing the work or other

activities for example,it took extra effort)Scale:yes,noQuestion 5:During the past 4 weeks,haveyou had any ofthe following problems with your work or otherregular daily activities as a result of any emo-tionalproblems such as feeling depressedoranxious)?a. Cut down on the amount of time you spenton work. or other activitiesb. Accomplishedlessthan yoo would likec. Did work or activities lesscarefully thanusualScale:yes, noQuestion 6:During the past 4 weeks,to what extent hasyour physical health or emotional problems inter-fered with your normal social activities with. fam-ily, friends, neighbors,or circle of acquaintances?Scale:Not at all; slightly; moderately;quite a bit; ex-tremelyQuestfon 7:How muchbodily pain haveyou had during thepast 4 weeks?Scale:none;very mild; mild; moderate;severe;very se-vereQuestion 8:Duringthe past4 weeks,how.mochdid pain in-terferewith your normalwork includingbothwork outsidethe homeand housework)?

Tab.I: The SF-36 Health Surveyfor evaluating quality of life Germanversion).

Vertigoheel, manufactured by BiologischeHeilmittel Heel GmbH of Baden-Baden, isa homeopathic medication containing theingredients Ambra 6X, Cocculus 4X,Conium 3X, and Petroleum 8X. Severalstudies have confirmed the efficacy of thiscombination in treating vertigos of vary-ing etiology 4-6, 12). In the present study,the anti vertigo drug betahistine, an H3receptor antagonist, served as the refer-ence substance. This drug has been widelytested in clinical studies; available data onit are abundant and include direct com-parisons to other reference substances

antivertigo drugs, calcium antagonists,neuroleptics, and placebos) 7-11).

The results of the present study were firstpublished in 1998 in a paper that focussedon assessing the effects of Vertigo heel andbetahistine on the frequency, duration,and intensity of vertigo attacks and onlybriefly discussed the results of psychome-tric testing 12). For reasons mentionedabove, however, a more detailed investi-gation of patients subjective state ofhealth and the issue of quality of life is ofparticular interest. The purpose of the pre-

Scale:no t at a ll ; a l it tle bit; mod erately;quite a bit; ex -tremelyQuestion 9:Thesequestions are about how you feel and howthings havebeenwith you during the past 4weeks.For each question, pleasegive the one an-swer that comesclosest to the way you havebeenfeeling.How much of the time during thepast4 weekLa. Did you Jeel foi l of life?b. HaveyoU beenvery nervous?c. Have y ou felt so down in the dump s that

nothing could cheer you up?d. Have y ou felt ca lm a nd pe aceful?e. Did you have a lot of energy?f. Haveyou felt downhearted and depressed?g. Did you feel worn out:h. Haveyou beenhappy?I. Did you feel t ired?Scale:all of the time; most of the time; some o f thetime; a litt le of the time; none of the t imeQuestion 10:During the past 4 weeks,how much of the timehas your physicalhealth or emotional problemsinterfered with your social activities like visitingfriends, relatives, etc.)?Scale:all of the time; most of the time; some o f thetime; a little of the time; none of the timeQuestion How TRUEor FALSEs eachof the followingstatements for you?a. I seem to get sick a little easier than other

peopleb. I am as healthy as anybody I knowc. I expect my health to get worsed. My health is excellentScale:definitely true; mostly true; don t know; mostlyfalse; definitely false

sent paper is to convey the results of thestudy s psychometric assessments of qual-ity of life and to investigate this aspect ofthe performance of Vertigoheel andbetahistine in a direct comparison test.

Methods

Design of the StudyFor the purpose of daily comparison ofthe efficacy of Vertigo heel and beta his tineagainst vertigo over a treatment period ofsix weeks, the study was conceived as amulticentric, randomized, double-blind

@ Biologische Medizin 3


3/6

/QUALITY OF LIFE IN VERTIGO PATIENTS: A DOUBLE-BLIND COMPARATIVE STUDY OF A HOMEOPATHIC MEDICATION

Category I:direct symptoms of vertigoQuestion:How would you rate the severity of the fonowingsymptomsin any vertigo attacks you. had sinceyour last visit?a. rotating sensationb. swayingsensationc. sensationof being elevatedd. everything goesblacke. everything gets blurryf. general unsteadinessg. distUrbedcoordinationScale:nonexistent;slight;moderate;severe;very severeCategory 2:intensity of vertigo attacks duringspe-cific activitiesQuestiop:Sinceyourlast visit,howbadhaveyour attacksof vertigobeenwhenyoua. turnedyourhead?b. bentover?c. stoodup?d. laydown?Scale:no sensationof vertigo;verymild;moderate;e-vere;verysevere

Tab.2:Vertigo-specificquestionnaire for evaluating quality of life

clinical test comparing parallel groups.The double-dummy technique with corre-sponding placebos was implemented tomaintain the double-blind procedure fordetails, see 12. Each patient kept a dailyrecord of frequency, duration, and inten-sity of vertigo attacks and assessed theseprimary variables using a four or five-point rating system. To assess quality oflife, each patient completed the SF-36Health Survey and a vertigo-specific ques-tionnaire see Tables 1 and 2) on the firstand last days of treatment visits 1 and 6).

Patient DemographicsPatients with acute or chronic vertigos ofvarying etiology including Meniere s dis-ease and vasomotor disturbances) wereincluded in the study. Excluded, for exam-ple, were patients with vertigo caused byautonomic dysregulation, tumors, or con-sumption of caffeine, nicotine, or alcohol.Concomitant treatment with other anti-vertigo drugs was not permitted during

4 @ Biologische Medizin

Category 3:symptoms associated with vertigoQuestion:Sinceyour last visit, how often haveyou experbencedthe following symptomsin connectionwithattacks of vertigo?a. physicalweaknessand exhaustionb. diff iculty in seeingc. diff iculty in hearingd. t innituse. headachef. palpitationsg. trembling limbsh. gastrointestinal disturbancesi. nauseaj. a feeling of heavinessand pressurein yourheadk. an emptyfeeling in various body parts or or-

gansI. general mental exhaustionm. light-headednessn. difficulty in concentratingo. restlesssleep or insomniap. nervousnessq. fatiguer. forgetfulnesss. anxietyScale:never;seldom;sometimes;ften;veryoften

the study. The duration of treatment foreach patient was six weeks; the dosagewas 3x15 drops of Vertigo heel or 3x6 mgof betahistine per day for details, see 12.

The criteria targeted in assessing efficacywere:. frequency, duration, and intensity of

the vertigo attacks patient diaries)vertigo-specific symptoms vertigo-specific questionnaire)quality of life normed SF-36 question-naire)general efficacy ratings by patientsand physicians.

.Quality-of-Life Questionnaire

The SF-36 Health Survey is a generalinstrument for assessing health-relatedquality of life; it is not illness-specific 13).This psychometric test was originallydeveloped for use in English-speakingcountries, but meanwhile the normed

Category 4:limitations on. daily activitiesQuestion:How true is eachof the following statementsabout how you havebeensinceyour last visit?a. I was afraid of fallingb. I was afraid that my illMSSwould get worsec. I had trouble with fast movementsd. I had trouble driv ing or using public trans.

portation bus/traine. I had trouble get ting up from a lying posi-tionf. I had trouble standing up from a sitting posi-tiong. I had trouble. readingh. It was hard for me to climb stairsi. It was hard for me to go down..stairsj. It was hard for me to movearound in thedarkk. It was hard for me to leave the house/

apartmentI. It was h ard forme to look downm. It was hard for me to do houseworkScale:not true at al l; a l it tle bit true;moderately true;mostly true; very true

German version has also performed wellin terms of its scale structure and reliabil-ity in several series of tests on healthy andill individuals. The SF-36 questionnaireconsists of 11 questions and 36 subques-tions in these 8 categories: physical func-tioning, role-physical, bodily pain, generalhealth, vitality, social functioning, role-emotional, and mental health Table 1).

Where needed, scores for individual ques-tions were transposed so that high scoresuniformly reflected positive assessmentsof quality of life. Scores in each categorywere then totaled and converted into ascore on a scale of a to 100 convertedscore = 100 x [actual total score - lowestscore] / range). Thus a score of a corre-sponds to the lowest quality of life and ascore of 100 to the highest quality of life.For each of the two treatment groups,average values were calculated for thetotal score in each category at visit 1 andvisit 6 and for the difference between visit


4/6

QUALITY OF LIFE VERTIGO PATIENTS: A DOUBLE-BLIND COMPARATIVE STUDY OF A HOMEOPATHIC MEDICATION

CategoryI. Direct symptomsof vertigo2. Intensity of vertigo attacks

during specific activities3. Symptomsassociated

with vertigo4. limitationsondailyactivities

6 and visit 1. In this scoring system, posi-tive differences correspond to increases inquality of life. Mann-Whitney statisticsand the left boundaries of the 90 confi-dence interval served as standards of rele-vance for differences that appeared overthe course of treatment.

Vertigo-Specific QuestionnaireThis self-assessment questionnaire forevaluating the course of the illness con-sists of four categories of questions. Thefirst category deals with the severity orintensity of sensations contributing to ver-tigo, the second with activities that triggervertigo, the third with related symptoms,and the fourth with other physical and

49.7 62.2 + 12.5

emotional concomitant phenomena (Table2). Individual questions were scored from0 to 4, with 0 representing a total absenceand 4 great severity of the symptom inquestion. After transposing each individ-ual score (4 - original score), total scoreswere calculated for each category andconverted to a scale of 0 to 100 (convertedscore = [actual total score/highest possi-ble total score] x 100) for easier compari-son. In each treatment group, averagescores were calculated for each visit andfor the difference between final and initialstatus (visit 6 and visit 1). In this scoringsystem, positive differences correspond toimprovements in health. Here, too, Mann-Whitney statistics and the left boundaries

PhysicalHealth

BIB

B6 Bt B6 BI B6C D

Fig.I: TheinfluenceofVertigoheelandbetahistineon qualityof life (summarymeasure:hysicalhealth)in patientswith vertigo.VI = initial score(beginningof treatment);V6= final score(aftersixweeksof treatment);A = physicalunctioning;B = role-physical; = bodilypain;D = generalhealth.*Wilcoxon-Prattest (2-tailed;P


5/6

QUALITY OF LIFE IN VERTIGO PATIENTS: A DOUBLE BLlND COMPARATIVE STUDY OF A HOMEOPATHIC MEDICATION

improvement in quality of life was equiv-alent in the two groups (Figures 1 and 2).

Vertigo Specific QuestionnaireIn the psychometric test of vertigo symp-toms, significant improvement in all itemswas observed in both treatment groupsand corresponded to positive change inquality of life. For example, subjectivevertigo-related impairments (palpi tations,gastrointestinal symptoms, l ight-headed-ness, nervousness, or sleep disorders)decreased significantly under both treat-ment protocols, and the decreases wereequivalent in the two treatment groups(Table 3).

Evaluationof herapyAssessments of the efficacy of the thera-pies by both physicians and patients cor-roborated the results of the psychometrictests. A majority of the physicians andpatients rated the efficacy of therapy asvery good (= complete freedom fromsymptoms) or good (= obvious im-provement). According to the physicians'ratings, symptomatic improvement wasachieved in 94 of the Vertigo heelpatients and 83 of the betahistinepatients (for details, see (12) ).

iscussionThe purpose of this study was to comparethe efficacy of Vertigo heel (drops) to thatof betahistine in outpatients with vertigosof varying etiology during a six-weektreatment period. In addition to the pri-mary criteria (frequency, duration, andintensity of vertigo attacks) the study alsorecorded the effect of therapy on qualityof life as measured by the SF-36 HealthSurvey and a vertigo-specific question-naire. The anti vertigo drug beta his tineserved as a recognized reference sub-stance whose efficacy in suppressing typi-cal vertigo symptoms and improvingpatients' sense of well-being had alreadybeen documented by clinical studies (7, 8,11). In both treatment groups, significantand clinically relevant reductions in ver-tigo attacks occurred over the course ofthe six-week treatment period. Clinicallyrelevant reductions in subjective symp-toms were also apparent in both groups

6 @ BiologischeMedizin

Mental Health

818

86 81 866 81( D

Fig.2: The influence of Vertigoheel and betahistine on quality of life (summary measure:mental health) in patientswith vertigo. VI = initial score (beginning of treatment); V6 = final score (after six weeks of treatment);A = vital ity; B = role-emotional; C = social functioning; D = general mental heal th. Wilcoxon-Pratt test(2-tailed; P


6/6

QUALITY OF LIFE IN VERTIGO PATIENTS: A DOUBLE-BLIND COMPARATIVE STUDY OF A HOMEOPATHIC MEDICATION

belonging to Denollet s Type D ( dis-tressed personality ), which is character-ized by severe depression and social alien-ation, had a mortality rate four times thatof the patient group as a whole.

In summary, the results of the presentstudy demonstrate that treating vertigopatients with Vertigo heel produces obvi-ous improvement in both physical andmental health (as expressions of quality oflife) and that the effects of Vertigo heel arecomparable to those of betahistine. Fur-thermore, the safety of both forms of ther-apy is confirmed.References(I) KroenkeK,Arrington ME,MangelsdorffAD.The preva-

lence of symptomsin medical outpatients and the ade-quacy of therapy.Arch Intern Med 1990; 150: 1685-9

(2) StollW. Sinnvolle Diagnostik und Therapiedes Symp-toms Schwindel( Meaningful diagnosisand therapy ofsymptomatic vertigo ). DtschArztebl 1996; 93:A-460-4

(3) Hlatky MA.Patient preferencesand clinical guidelines.JAMA 1995; 273; 1219-20

(4) ClaussenCF.Der Schwindel und seine biologischeBehandlung mit Vertigoheel- Ergebnissevon klinisch

experimentellen Untersuchungen( Biological treatmentof vertigo with Vertigoheel: results of clinical experi-mental studies ). Bioi Med 1983; 12(6):531-2

(5) ClaussenCF,BergmannJ, Bertora G,ClaussenE. Kli-nisch-experimentelle Priifung und aquilibriometrischeMessungenzum Nachweisder therapeutischenWirk-samkeit eines homoopathischenArzneimittels bestehendaus Ambra, Cocculus,Conium und Petroleum bei derDiagnoseVertigo und Nausea( Clinical experimentaltesting and equilibriometry prove the therapeutic effi-cacy of a homeopathic medication consisting ofAmbra,Cocculus,Conium und Petroleum in casesofvertigo with nausea ).Arzneim-Forschl Drug Res 1984;34: 1791-8

(6) ZennerS, Borho B,MetelmannH. Schwindelund seineBeeinfluBbarkeit durch ein homoopathischesKombina-tionspraparat ( The effects of a homeopathic combina-tion medication on vertigo ). Erfahrungsheilkunde1991;40 (6);423-9

(7) Elbaz P.Flunarizine and betahistine. Twodifferenttherapeutic approaches in vertigo compared in adouble-blind study. Acta Octolaryngol Suppl 1988; 460;143-8

(8) FraysseB,BebearJP,Dubreuil C,et al. Betahistinedihydrochloride versus flunarizine. A double-blind studyon recurrent vertigo with or without cochlear syn-drome typical of Meniere sdisease.Abstract ActaOtolaryngol 1991; 490 (Suppl.): 1-10

(9) KluyskensP,lambert P,D Hooge D.TrimetazidineVersusBetahistine in VestibularVertigo. Double-blind Study.Drugs of Today 1990; 26 (Suppl 13): 13-22

(10) Canty P,Valentine J, Papworth SJ.Betahistine in peri-

pheral vertigo. A double-blind, placebo-controlled,cross-over study of Serc@versus placebo.J laryngolOtol 1981; 95: 687-92

II OosterveldWJ.Betahistine dihydrochloride in thetreatment of vertigo of peripheral vestibular origin. Adouble-bl ind placebo cont ro ll ed s tudy. J l aryngol O tol1984; 98: 37-41

(12) Weiser M,StrosserW, Klein P.Homeopathicvs Conven-tional Treatment of Vertigo - A RandomizedDouble-blind Controlled Clinical Study.Arch Otolaryngol HeadNeck Surg 1998; 124:879-85

(13) Ware JE,Kosinski M,Keller SD.SF-36PhysicalandMental Health SummaryScales:A User s Manual.TheHealth Institute, New England MedicalCenter,Boston,MassachusettsDecember, 1994

(14) Bullinger M, Kirchberger I,Ware J. Der deutscheSF-36Health Survey ( The German SF-36 Health Survey ).ZGesundheitswiss1995; 3: 21-36

(15) Denollet J, SysSU,Stroobant N,et al. Personality asindependent predictor of long-term mortality inpatients with coronary heart disease.lancet 1996;347: 417-21

Authors addressc/o Dr. Michael WeiserGleisslestr. 3477815 BiihlGermany

70002736/ E129 D- /2/2001 KK

@ BiologischeMedizin

Documents

Vertigoheel - _double_blind_comparative Betahistine 2000