Vertigoheel - Double - Blind - Comparative Betahistine 2000
Vertigoheel - Double - Blind - Comparative Betahistine 2000
Vertigoheel - Double - Blind - Comparative Betahistine 2000
OF LIFE
IN VERTIGO
PATIENTS:
A DOUBLE-BLIND
COMPARATIVE
STUDY
OF A HOMEOPATHIC
MEDICATION
that the basic ailment vertigo patients (3). Therefore, total situation
on individual
Quality-of-life issues and accurate observation of symptomscan be essentialin selecting.individually appropriate pharmaceuticaltherapy for vertigo. .Forthis reason,the present study comparesthe effects of Vertigo heeland betahistine .not only with regard to the frequency,duration, and intensity of vertigo attacks but also with regard to quality of life .in patients with vertigos of varying etiology. The double-blind study incliJdeda total of II 9 patients from IS practices.Treatment was administeredthree times daily for six weeks and consistedof either IS drops of Vertigoheelor 6 mg of betahistine. Quality of life was assessed by meansof two psychometrictests, the SF-36Health Surveyand a vertigo-specific questionnaire.Quality of life (measured in terms of both physical and psychologicalwell-being) improved significantly during therapy with Vertigoheel,which proved to be equivalent to betahistine therapy. Keywords: Vertigo heel, betahistine,vertigo, clinical study, quality of life
cians in family practice name dizziness one of the symptoms lem (1). Primary-care whether wonder physicians
quantifiable
perception perspective
coordination can adequately pinpoint cause of this condition or whether patient will have to be referred cialist for further examination. cases, targeted indeed severity extensive tagmus determine
of his or her illness as it impacts This the discussion therapies, drugs on a number including
therapeutic
being considered
from additional
electronystagmography,
or posturography
tives. This basic approach was given special consideration in the current clinical trial of Vertigo heel (drops) versus betahis-
attacks of ver-
with vertigos
of varying
tigo may avoid physical exertion and psychological stress and withdraw from social activities. Because such avoidance is
...................................................................................
often
associated
loss of subsetar-
COMMENTARY
self-esteem
quent behavior,
measures
get both the frequency and the severity of the attacks in order to improve the patient's quality of life and thus his or her state of health. research groups, subjectively The findings however, objectively ical pictures perceived
' .
A randomized double-blind study by Weiser et al. comparing the efficacy of Vertigoheel and betahistine was published in Arch Oto-
laryngol Head Neck 1998. While that first paper focussed on efficacy and tolerance of the two medications, this second article adds the parameter of quality of life and is therefore
to the first.
Taken together, these two papers provide an example of evidence-based medicine. This procedure should become the accepted standard because it demonstrates how quality control can be implemented in biological medicine. The results of this study, by confirming the equivalence of the antihomotoxic medication and the allopathic drug in improving quality of life, also document the cost effectiveness and lack of adverse effects of antihomotoxic therapy for mild forms of vertigo. Hartmut Heine, Ph.D. .
degree of severity
of their vertigo. In the process of subjective evaluation and care of individual vertigo patients, physicians repeatedly find
that even when they observe and document similar clinical conditions and functional limitations and in patients, subjective substantial of of
differences behavior
are evident
health Depending
on personality,
......................................................................
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QUALITY
OF LIFE
IN VERTIGO
PATIENTS:
A DOUBLE.BLlND
COMPARATIVE
STUDY
OF A HOMEOPATHIC
MEDICATION
Question I : In general, wouldyou sayyour healthis: Scale: excellent; very good;good;fair; poor
Question 2:
a. Cut down on the amount of time. you spent on work or other activities b. Accomplishedless than you would like c. Were limited in the kind of work or other activities d. Had difficulty performing the work or other activities (for example,it took extra effort) Scale: yes, no Question 5:
Scale:
not at all; a little bit; moderately;quite a bit; extremely Question 9:
Comparedto one year ago, how would you rate you[ health in general now? Scale: much better now than one year ago; somewhat better now than one year ago; about the same as one year ago; somewhat worse than one year ago; much worse than one year ago. Question 3:
These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4 weekL a. Did you Jeel foil of life? b. Have yoU been very nervous? c. Have you felt so down in the dumps that nothing could cheer you up? d. Have you felt calm and peaceful? e. Did you have a lot of energy? f. Have you felt downhearted and depressed? g. Did you feel worn out: h. Have you been happy? I. Did you feel tired? Scale: all of the time; most of the time; some of the time; a little of the time; none of the time
The following questions are about activities you might do during a typical day. Doesyour health now limit you in these activities? If so, how much? a, Vigorousactivities such as running,lifting heavy objects, participating in strenuous sports b. Moderateactivities, such as moving a table, pushing a vacuum cleaner,bowling, or playing golf c. Lifting or carrying groceries d. Climbing several flights of stairs e. Climbing one flight of stairs f. Bending,kneeling, or stooping g. Walking more than a mile h. Walking several hundred yards i. Walking one hundred yards
During the past 4 weeks,have you had any of the following problems with your work or other regular daily activities as a result of any emotionalproblems (such as feeling depressedor anxious)? a. Cut down on the amount of time you spent on work. or other activities b. Accomplishedless than yoo would like c. Did work or activities less carefully than usual Scale: yes, no Question 6:
Question
10:
During the past 4 weeks,to what extent has your physical health or emotional problems interfered with your normal social activities with. family, friends, neighbors,or circle of acquaintances? Scale: Not at all; slightly; moderately; quite a bit; extremely
During the past 4 weeks,how much of the time has your physical health or emotional problems interfered with your social activities (like visiting friends, relatives, etc.)? Scale: all of the time; most of the time; some of the time; a little of the time; none of the time Question II: How TRUEor FALSE is each of the following statements for you?
Questfon 7:
How much bodily pain have you had during the past 4 weeks? Scale: none; very mild; mild; moderate;severe;very severe
a. I
Doring the past 4 weeks,have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
Question 8: Duringthe past4 weeks, how.mochdid pain interferewith your normalwork (includingboth work outsidethe homeand housework)?
people b. I am as healthy as anybody I know c. I expect my health to get worse d. My health is excellent Scale: definitely true; mostly true; don't know; mostly false; definitely false
Tab. I: The SF-36 Health Survey for evaluating quality of life (German version).
Vertigoheel, manufactured by Biologische Heilmittel Heel GmbH of Baden-Baden, is a homeopathic medication containing the
(antivertigo neuroleptics,
drugs,
calcium
antagonists, (7-11).
is to convey the results of the assessments of Vertigoheel test. of qualand this aspect of
and placebos)
psychometric
ity of life and to investigate The results of the present published betahistine and intensity on assessing study were first performance in 1998 in a paper that focussed the effects of Vertigo heel and on the frequency, attacks duration, and only Methods of vertigo betahistine
ingredients Ambra 6X, Cocculus 4X, Conium 3X, and Petroleum 8X. Several studies have confirmed combination in treating drug the efficacy of this vertigos betahistine, served of varystudy, an H3
in a direct comparison
ing etiology (4-6, 12). In the present the anti vertigo receptor antagonist,
briefly discussed
Design of the Study For the purpose of daily comparison of the efficacy of Vertigo heel and beta his tine against vertigo over a treatment period of six weeks, the study was conceived as a multicentric, randomized, double-blind
3
as the refer-
ence substance. This drug has been widely tested in clinical studies; available data on it are abundant parisons and include reference direct com-
tric testing (12). For reasons mentioned above, however, a more detailed investigation particular of patients' subjective state of
health and the issue of quality of life is of interest. The purpose of the pre-
to other
substances
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QUALITY
OF LIFE
IN VERTIGO
PATIENTS:
A DOUBLE-BLIND
COMPARATIVE
STUDY
OF A HOMEOPATHIC
MEDICATION
of vertigo
with vertigo
How would you rate the severity of the fonowing symptoms in any vertigo attacks you. had since your last visit? a. rotating sensation b. swaying sensation c. sensation of being elevated d. everything goes black e. everything gets blurry f. general unsteadiness g. distUrbed coordination Scale:
Since your last visit, how often have you experb enced the following symptoms in connection with attacks of vertigo? a. physical weaknessand exhaustion b. difficulty in seeing c. difficulty in hearing d. tinnitus e. headache f. g. h. i. j. palpitations trembling limbs gastrointestinal disturbances nausea a feeling of heavinessand pressurein your head gans general mental exhaustion light-headedness difficulty in concentrating restless sleep or insomnia nervousness
g. I had trouble. reading h. It was hard for me to climb stairs i. j. It was hard for me to go down.. stairs It was hard for me to move around in the dark
duringspe-
k. It was hard for me to leave the house/ apartment I. It was hard forme to look down m. It was hard for me to do housework Scale: not true at all; a little bit true; moderately true; mostly true; very true
Questiop: Since yourlast visit, howbad haveyour attacks of vertigobeenwhenyou a. turnedyour head? b. bentover? c. stoodup? d. lay down? Scale: seno sensation of vertigo;very mild;moderate; vere;very severe
test
comparing
parallel
groups. to (for
the study.
The duration
of treatment
for
technique
with corre-
German version has also performed well in terms of its scale structure and reliability in several series of tests on healthy and ill individuals. consists The SF-36 questionnaire and 36 subquesphysical funcroleof 11 questions
the double-blind
details, see (12. Each patient kept a daily record of frequency, sity of vertigo primary life, each point rating attacks system. patient variables duration, using and intenthese of and assessed a four
tions in these 8 categories: targeted in assessing efficacy of tioning, role-physical, health, duration, and intensity vitality, social emotional,
or fiveSF-36
. .
frequency,
and mental health (Table 1). scores for individual positive ques-
the vertigo attacks (patient diaries) vertigo-specific symptoms (vertigoWhere needed, uniformly specific questionnaire) quality of life (normed naire) general efficacy SF-36 questionby patients tions were transposed reflected so that high scores assessments
Health Survey and a vertigo-specific questionnaire (see Tables 1 and 2) on the first and last days of treatment Patient (visits 1 and 6).
Demographics of
ratings
of quality of life. Scores in each category were then totaled and converted into a score on a scale of a to 100 (converted score = 100 x [actual total score - lowest
and physicians. Quality-of-Life The SF-36 Health for instrument This Questionnaire Survey is a general health-related (13). was the originally normed
varying etiology (including Meniere's disease and vasomotor disturbances) were included autonomic in the study. Excluded, with vertigo dysregulation, for examcaused by or con-
Thus a score of a correof life and a quality of life. groups, for the
assessing test
tumors,
quality of life; it is not illness-specific psychometric for use but developed countries,
treatment calculated
in English-speaking
drugs
during
meanwhile
total score in each category at visit 1 and visit 6 and for the difference between visit
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QUALITY
OF LIFE
IN VERTIGO
PATIENTS:
A DOUBLE-BLIND
COMPARATIVE
STUDY
OF A HOMEOPATHIC
MEDICATION
Vertigoheel
Category
VI 58.5
V6
Diff.
Diff. +25.8
Statistics P<O.OOI
87.1 +28.6
Tab.3:Vertigo-specific questionnaire. VI = scoreat beginning of treatment; V6 '" scoreafter six weeksof treatment; Difl. = difference; Statistics: Wilcoxon-Pratt test (2-tailed)
53.6
82.9 +29.3
P<O.OOI
58.4
87.1
+ 28.7 P<O.OOI
65.2
84.2 + 19.0
P<O.OOI
72.8
89.6
+16.8
P<O.OOI
4. limitationson daily activities 47.9 59.7 +1 L8 P<O.OOI 49.7 62.2 + 12.5 P<O.OOI
6 and visit 1. In this scoring system, positive differences correspond to increases in quality of life. Mann-Whitney statistics and the left boundaries of the 90% confidence interval served as standards of releover
emotional
phenomena
(Table
interval for
served
as
differences
score), total scores Vertigo Attacks In total, 119 patients group and from 15 licensed tions, cacy.) patients' evaluation duration, 14 of The (59 in the Vertigoheel group) particiwere of effiwere and 60 in the betahistine family practices 119 patients analysis groups
were calculated for each category and converted to a scale of 0 to 100 (converted score for The or
possi-
ble total score] x 100) for easier comparison. In each treatment group, average scores were calculated for each visit and for the difference between final and initial
pated in the study. (Due to protocol violathese excluded equivalent from statistical two medical revealed treatment histories. significant in terms
to ver-
status (visit 6 and visit 1). In this scoring system, positive improvements Whitney statistics differences correspond to in health. Here, too, Mannand the left boundaries
tigo, the second with activities and the fourth with other
of demography
reductions
and intensity
SF.36Score 100
Physical Health
80
the two groups (for details, see (12. Quality of Life data confirm
60
that
of treatment,
all patients
often considerable
declines in
40
their
quality
20
especially evident in the "vitality" and "role-emotional" areas (in the mental health summary measure) health and in the mearelethat by the
5
"role-physical" 0 BI A B6
BI B B6 Bt C B6 BI D B6
Fig.I: Theinfluence of Vertigoheel and betahistine on quality of life (summary measure: physical health)in patients with vertigo. VI = initial score(beginning of treatment); V6 = final score(after six weeksof treatment); A = physical functioning; B = role-physical; ( = bodily pain;D = generalhealth.*Wilcoxon-Pratt test (2-tailed; P<O.OS)
was
documented
in quality
of life in both
Statistically,
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QUALITY
OF LIFE
IN VERTIGO
PATIENTS:
A DOUBLE.BLlND
COMPARATIVE
STUDY
OF A HOMEOPATHIC
MEDICATION
improvement
improvement in both
treatment
to positive example,
quality
subjective 40
impairments symptoms, or
sleep under
decreased ment
protocols, in
the
decreases
two
treatment
Evaluation of Therapy Assessments of the efficacy of the therapies by both physicians roborated patients "very tests. A majority rated good" or and patients corthe results of the psychometric of the physicians freedom (= obvious improvement of the the
Fig. 2: The influence of Vertigoheel and betahistine on quality of life (summary measure:mental health) in patients with vertigo. VI = initial score (beginning of treatment); V6 = final score (after six weeks of treatment); A = vitality; B = role-emotional; C = social functioning; D = general mental health. 'Wilcoxon-Pratt test (2-tailed; P<O.OS)
and
as imwas from
and
corresponded quality
to improvements (severity
in
psychometric
procedures
to
According 94%
ther-
symptomatic and
83% of
to it) in the vertigo-specific significant The present study approaches the assesshealth. more they for scores. In some instances, amounted scores. scientific and guidequalment of quality The participating contented felt more capable ving, or moving without example, of life from the perspecand physical became patients
scoring system revealed higher the average to that A great effort applying deal has
improvements
The purpose
the efficacy of Vertigo heel (drops) of varying treatment mary intensity recorded Survey naire. served cal criteria etiology period. during
gone standard
(frequency,
duration,
lines for documenting ity of life in individuals nesses. The example administered of the
side assistance.
of vertigo attacks) the study also the effect of therapy and a vertigo-specific anti vertigo drug on quality questionbeta his tine subtypiby the SF-36 Health
of the SF-36 survey both the immensity work to procedures assessing interhealthadefor
cantly fewer limitations on both domestic and recreational activities than at the beginning increased lems, their ized. of treatment, significantly. and their sense of various Because tasks well they felt prob-
in the present
as a recognized symptoms
reference and
by psychological
social behavior
also normal-
quality
In a study of postcoronary rehabilitation demonstrated activation prognosis sions of quality phase, of social
patients Denollet
analysis of multinational clinical studies and research on international issues of health and health economics. In England,
as exprestwo to five
in both groups
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QUALITY
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A DOUBLE-BLIND
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OF A HOMEOPATHIC
MEDICATION
belonging
to Denollet's
Type D ("dis-
experimentellen Untersuchungen ("Biological treatment of vertigo with Vertigoheel: results of clinical experimental studies"). Bioi Med 1983; 12 (6): 531-2 (5) ClaussenCF,Bergmann J, Bertora G, ClaussenE. Klinisch-experimentelle Priifung und aquilibriometrische Messungenzum Nachweisder therapeutischenWirksamkeit eines homoopathischen Arzneimittels bestehend aus Ambra, Cocculus,Conium und Petroleum bei der DiagnoseVertigo und Nausea("Clinical experimental testing and equilibriometry prove the therapeutic efficacy of a homeopathic medication consisting of Ambra, Cocculus,Conium und Petroleum in cases of vertigo with nausea"). Arzneim-Forschl Drug Res 1984; 34: 1791-8 (6) Zenner S, Borho B, Metelmann H. Schwindel und seine BeeinfluBbarkeit durch ein homoopathischesKombinationspraparat ("The effects of a homeopathic combination medication on vertigo"). Erfahrungsheilkunde 1991;40 (6);423-9 (7) Elbaz P.Flunarizine and betahistine. Two different therapeutic approaches in vertigo compared in a double-blind study. Acta Octolaryngol Suppl 1988; 460; 143-8 (8) FraysseB, Bebear JP,Dubreuil C, et al. Betahistine dihydrochloride versus flunarizine. A double-blind study on recurrent vertigo with or without cochlear syndrome typical of Meniere'sdisease.Abstract Acta Otolaryngol 1991; 490 (Suppl.): 1-10 (9) KluyskensP,lambert P,D'Hooge D. Trimetazidine Versus Betahistine in Vestibular Vertigo. Double-blind Study. Drugs of Today 1990; 26 (Suppl 13): 13-22 (10) Canty P,Valentine J, Pap worth SJ.Betahistine in peri-
pheral vertigo. A double-blind, placebo-controlled, cross-over study of Serc@versus placebo.J laryngol Otol 1981; 95: 687-92 (II) Oosterveld WJ. Betahistine dihydrochloride in the treatment of vertigo of peripheral vestibular origin. A
double-blind placebo controlled study.
ized by severe depression and social alienof the patient group as a whole. In summary, study the results of the present that treating vertigo and
J laryngol
Otol
1984; 98: 37-41 (12) Weiser M, StrosserW, Klein P. Homeopathic vs Conventional Treatment of Vertigo - A Randomized Doubleblind Controlled Clinical Study. Arch Otolaryngol Head Neck Surg 1998; 124: 879-85 (13) Ware JE, Kosinski M, Keller SD.SF-36 Physical and Mental Health Summary Scales: A User's Manual.The Health Institute, New England Medical Center, Boston, MassachusettsDecember, 1994 (14) Bullinger M, Kirchberger I, Ware J. Der deutsche SF-36 Health Survey ("The German SF-36 Health Survey"). Z Gesundheitswiss1995; 3: 21-36 (15) Denollet J, Sys SU,Stroobant N, et al. Personality as independent predictor of long-term mortality in patients with coronary heart disease.lancet 1996; 347: 417-21
demonstrate
patients with Vertigo heel produces obvious improvement in both physical mental health (as expressions of quality of life) and that the effects of Vertigo heel are comparable to those of betahistine. apy is confirmed.
References (I) Kroenke K,Arrington ME,MangelsdorffAD.The prevalence of symptoms in medical outpatients and the adequacy of therapy. Arch Intern Med 1990; 150: 1685-9 (2) Stoll W. Sinnvolle Diagnostik und Therapie des Symptoms Schwindel("Meaningful diagnosis and therapy of symptomatic vertigo"). Dtsch Arztebl 1996; 93: A-460-4 (3) Hlatky MA. Patient preferences and clinical guidelines. JAMA 1995; 273; 1219-20 (4) ClaussenCF.Der Schwindel und seine biologische Behandlung mit Vertigoheel Ergebnissevon klinisch
Fur-
Authors' address: c/o Dr. Michael Weiser Gleisslestr. 77815 Biihl Germany 34
70002736/
KK
7
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