BIOLOGICAL THERAPYJOURNAL OF NATURAL MEDICINE

Reprinted fromVolume Vlll No. 3p. 49 andVolume Vlll No. 4p. 79.

Therapeutic Use of Lymphomyosot -Results of a Multicentre Use ObservationStudy on 3,512 Patientsby St. Zenner, H. Metelmann

FEATURE ARTICLETherapeutic Use of Lymphomyosot -Results of a Multicentre Use ObservationStudy on 3,512 Patients

reprinted from Biological Therapy, Vol. VIII, No. 3, June z990, p. 49 andBiological Therapy, Vol. VIII, No. 4, October 2990, p. 79

St. Zenner, H. Metelmann

The efficacy, tolerance, and mode o f use of the homeopathic preparation Lym-phomyosot was investigated f o r both the drops and ampoule drug forms in the contexto f a multicentre use observation study. 3,512 case histories were available for this studyfrom a total o f 264 doctors. The evaluation of therapeutic success, duration o f treat-ment and co-medication was carried out separately for the central indications lym-phoedema, inflammatory processes, and hyperplasia o f lymphatic organs. Toleranceof the preparation was very good.

1.1 Introduction

Drugs for exerting a therapeutic influence on the lymphaticsystem are available on the market in relatively small numbers.This is already apparent from the fact that e.g. the “rote Listen[the German list of controlled drugs] (1) has no category forclassifying these preparations and hence the few commercial-ly available “lymphatic” have to be arranged more or less ap-propriately under the main headings “Umstimmungsmittel”(“Alterants”) or “Antiphlogistika” (“&ti-inflammatories).

Yet there is quite clearly a need for such preparations: afterall, lymphoedemas of the upper limbs, to name but one ex-ample, are still counted among the most common complica-tions after surgical treatment of mastocarcinoma (2).

The therapy of lymphoedema normally implemented isbased; apart from a few drug endeavors, mainly on mechanicalprocedures (3). Massage in the centripetal direction of thelymph current is used as a therapeutic method. Pneumaticcompression with more or less complicated aids has been at-tempted up to the most recent times as a way of influencinglymphoedema. In most cases, however, the latter measureshamper an active life and are rarely successful (3).

Chronic diseases of the lymphatic organs also frequentlyrepresent a problem in the doctor’s practice. The first disorderto be mentioned in this context is chronic tonsillitis. One ofthe most feared complications of chronic tonsillitis is what isreferred to as toxicosis due to foci. According to Boenninghaus(4), 70% of all head foci are suspected of being in the tonsils.

Since the conservative therapeutic procedures usuallyemployed, such as painting, gargling, or oral antibiotics, haveno effect on the focus in the tonsils, it is usually only ton-sillectomy which is considered. (4).

However, the therapeutic options listed in many medicaltextbooks for treating diseases of the lymphatic system usuallydisregard the fact that there are also drugs withphytotherapeutic and homeopathic constituents for this in-dication area. If these are used at the appropriate time andfor a sufficiently long period; considerable therapeutic suc-cess can often be achieved. The preparation Lymphomyosotis just such a drug.

1.2 Drugs

Lymphomyosot is a homeopathic combination preparationwhich has already been commercially available for more than30 years and which contains various individual constituentswith a vegetable or mineral base. On the basis of thehomeopathic drug picture of the individual constituents, thepreparation has the following indications: lymphatism(overdevelopment of lymphatic organs); lymphoedema (post-operative and post-traumatic); lowered resistance, scrofula andother glandular swellings, tonsillar hypertrophy, and chronictonsillitis. Also for cleaning out the mesenchyma.

Several therapeutic successes have already been publishedfor Lymphomyosot in specific individual indications. In 1982,Kirchhoff (5) published his therapeutic successes with Lym-phomyosot in 80 female patients with post-operative arm

lymphoedema after mammectomy and axillary scrape. Anobservational study with L~phomyosot on sO children withrecurrent tonsillitis was published by Rinneberg in 1988 (6).The list of publications is further supplemented by several ex-periment reports. The aim of this study is to report treatmentresults relating to the entire indication spectrum of the prepara-tion in an extensive patient population. On the basis of theseresults, points of emphasis can be found within the therapeuticoptions which can form the basis for determining the test in-dications in subsequent clinical trials.

1.3 Method

The study reported below relates to a multicentre use obser-vation study. Data collection was effected with the aid of auniform report form which was made available to the par-ticipating doctors. All relevant patient and therapy data wereto be stated on this form using specific questions, e.g. age andsex, diagnosis, form of administration and dosage of Lym-phomyosot, duration of treatment, and success of therapy. Inaddition, the occurrence of any adverse drug effects was alsoasked for.

Specific inclusion and exclusion criteria were not given,since the study was intended to provide an accurate pictureof the patients treated in the doctor’s practice, the therapeuticmeasures effected, and the success of treatment. Selection ofthe presentation of Lymphomyosot and the dosage and dura-tion of treatment were left to the judgment of the individualdoctor.

In principle, the administration of additional drugs andother supplementary measures were permitted. But it wasnecessary to note them on the record form.

The record forms extended back over a period of 1 1/2years; all forms received at the company Biologische HeilmittelHeel GmbH between 1.1.1988 and 30.6.1989 were includedin the evaluation.

1.4 Trial doctors

A total of 264 doctors with various specializations par-ticipated in the study in all parts of the Federal Republic ofGermany and West Berlin. Table 1 shows a breakdown of thedoctors by specialization.

Table 1: Classification of doctors by specializationGeneral practitioner 80Doctor of general medicine 45Specialist in internal medicine 16Surgical specialist 2ENT specialist 22Pediatrician 41Naturopath 4Orthopedic specialist 1Gynecologist 1Dentist 1Doctor without specialization 51

A total of 3,572 cases of treatment had been documented

by the 264 participating doctors using the record forms.However, 60 of these (1.7%) had to be excluded from theevaluation due to omissions in the information provided. Astatement of diagnosis and an evaluation of therapeutic suc-cess in particular were regarded as indispensable for a con-clusive case history. Consequently, 3,512 record forms remain-ed for the final statistical evaluation.

1.5 Patients

All data and figures given in the descriptive evaluationbelow relate to the 3,512 patients whose treatment data hadbeen documented sufficiently precisely for statistical evalua-tion. In addition, sub-groups of this patient sample, whichshow particular common features, will be investigated furtherin the course of this consideration. The age and sex distribu-tion of the patients is shown in Figure i.

Figure 1: Age and sex distribution of the patients(n = 3,512)

Number of patients

500

250

IZZl malen _ female

o-1o 21-30 41-50 61-70 81-90 not stated11-20 31-40 51-60 71-80 91-99

Age group

Due to the high proportion of children, the mean age ofthe total patient population is calculated at 30.5 years. 2,094(59.6% ) patients were female, 1,418 (40.4%) male. The meanage of the female patients was noticeably higher, at 34.7 yea~,than that of the males (24.4 years). Another unusual featureis the double peak in the age distribution. Both phenomenaare explained by the fact that here, in essence, the age struc-tures of two patient groups of differing basic disease aresuperimposed. Whereas the one group relates to patients withinflammations primarily in the ENT area with an age peakaround 4 years of age, the second group consists overwhelm-ingly of female patients with Iymphoedemas and an age peakaround 55 years. This will be covered in more detail in thecourse of this consideration.

1.6 Disease duration and diagnoses

The diseases or complaints for which treatment with LP-phomyosot was instituted existed in the patients for widelydiffering periods of time. The shortest disease period up tothe commencement of treatment was 1 day, the longest 60years. Figure 2 shows a summary of disease duration.

Figure 2: Duration of disease/disordersprior to commencement of Lymphomyosotin patients treated (n = 3,512) ~ up to

Number of patients 1 week200

000

800

600

400

200

0

r

~ 1 week to1087 1 month

Iz!l924 ~ I month tc

1

1 year~ 1 year to

5 years_ 5 years to

10 years

255 more thanm 10 yearn

87 ~1 _ not stated

A rough ovemiew of the diagnoses will be given at this pointand the detailed evaluation provided later. The first aspectto be investigated is whether the use of Lymphomyosot isrestricted to the indications stated on the pack insert orwhether other areas of use over and above these are normalin doctors’ practices,

Table 2: Classification of patients by diagnosisDiagnosis Number of casesLymphatism 144

(overdevelopment of lymphatic organs)Lymphoedema 684Lowered resistance 319

(general susceptibility to infection)Scrofula 1Lymphadenitis 391Other glandular swellings 79Tonsillar hypertrophy 177Tonsillitis 594Other diagnosis 1,123

Consequently, the diagnoses will first be broken down bya principle of clarification which leans heavily on the word-ing of the pack insert (Table 2). In the subsequent detailedevaluation, a slightly different principle of classification willbe chosen for the purposes of systematic consideration.

As shown by Table 2, those prescribing the preparation didnot limit themselves exclusively to the areas of use stated onthe pack insert. 68 YO of the patients included in the study weretreated in accordance with the indications recommended bythe manufacturer. The remaining 329i0 received Lpphomyo-sot for therapy of various other disease states, which will bedealt with subsequently in the context of the detailed evalua-tion. Overall, this use observation study shows that the areaof application of Lymphomyosot is considerably larger thanexpected.

However, before looking in detail at therapy results for thevarious indications, consideration will firstly be given to thequestion of whether perhaps other variables apart from thediagnosis, e.g. the choice of presentation, the method of ad-ministration or the nature of accompanying therapy, play adecisive part in determining the success of treatment.

1.7. Presentations and methods of administrationLymphomyosot is available in two different presentations,

namely drops and ampoules. The choice of presentation wasleft to the doctor giving treatment. Both drops and ampocould be given, and also both presentations in conjunctionor one after the other. The evaluation showed that the ma-jority of the study doctors preferred to prescribe drops only.The latter were used in 2,722 patients (77.590). 491 patients(13.9% ) received only Lymphomyosot ampoules. The doctorsdecided in favor of combined use of drops and injection solu-tion in 294 cases (8.4 YO ). On 5 forms, the choice of presenta-tion was not stated. Figure 3 shows the percentage distribu-tion of the individual presentations in graph form,

Figure 3: Percentage proportions of patients treated withvarious presentations of Lymphomyosot

Patients (%) ( n = 3,512)

40 –

1 3 . 9[ {JlglllB

8.40.20

Drops Ampoules Drops +Ampoules Not stated

According to the recommendations of the manufacturer, theinjection solution of Lymphomyosot can be administered S.C,i.m., i.e., or iv. The evaluation of this use observation studyshowed that in fact use is made of all these administrationoptions in practice, albeit with differing frequency. An analysiswill be given below of those cases where only one methodof administration was used during the entire treatment. Whilstintramuscular injection led the field statistically with 438 cases,and exceeded all other methods of administration together infrequency, intravenous and subcutaneous administrationdisplayed approximately equal frequency (124 and 104 casesrespectively). Intracutaneous injection came last with 5 cases.

Additionally in 66 cases use was made of another ad-ministration option of the ampoule solution, namely oral ad-ministration in the form of a drink ampoule. Although thisis not a drink ampoule in the pharmaceutical sense, oral ad-ministration of the ampoule contents is possible in principle.The contents of one ampoule are usually diluted in a glassof water and swallowed, not sipped.

Whilst in the majorit y of patients the injection solution wasalways administered in the same way throughout the wholetreatment period, the doctors decided in favor of combineduse of more than one method of administration in 40 patients.A detailed analysis of all combinations would exceed the scopeof this evaluation, however. In a further 8 cases, no informa-tion was given on the method of administration. The relativefrequencies of the individual methods of administration areshown in Figure 4. It should be pointed out here that the

analysis of administration methods also included those pa-tients who simultaneously received drops.

Figure 4: Relative frequency of the various methods ofadministration of Lymphomyosot ampoules(n = 785)

Vm l.c.Sot.

L8. Dosage

The dosage of Lymphomyosot drops is stated as follows inthe user information: “Unless prescribed otherwise, take 15-20drops 3 times per day”. It was apparent that in the overwhelm-ing majority of cases (82.l?10 ), the study doctors observed thedosage stated on the pack insert and only chose a differentdosage in 15.2% of patients during the entire duration oftherapy. In a negligibly small proportion of cases (0.6 YO ), thestated guideline dose was given during one part of treatmentand a different dose in another part. Information about thedosage of drops was absent from 2.1% of evaluated forms.Figure 5 shows an overview of the frequency of the variousd~sages of Lymphomyosot drops. -

●

Figure 5: Percentage proportions of patients receivingvarious dosages of Lymphomyosot drops(n = 3,016)

~00 Patients (%) TBz. 1

75 – ~ 15-20 drops3 times per day

50 – ~ other dosage

_ more than25 one dosage_ not stated

o’n=2477 n=457 n=l? n=fjs

The dosage instructions for L~phomyosot ampoules in the.-user information state: “1 ampoule s.c, i.m, i.c, or i v .

daily in acute conditions, wtherwise 1-3 times per week. Therecord forms contained the following options to be ticked: 1= 1 ampoule per day; 2 = 1 ampoule per week; 3 = 2 am-poules per week; 4 = other dosage. The statistical evalua-tion showed that in almost half of all cases (48.8!Z0 ), the mid-dle dosage was preferred by the study doctors. Injections weregiven daily in 25.390 of patients, whilst 18.290 only receivedan injection once a week. Only in 4.190 of cases was a dif-ferent dosage of Lymphomyosot ampoules given. 3.6% of therelevant patient forms gave no information about the dosageof injection solution. The frequency of the various dosagesof Lymphomyosot ampoules is shown in Figure 6.

Figure 6: Percentage proportions of patients receivingvarious dosages of Lymphomyosot ampoules

(n = 785)

.00patients (%)

80 – ~ 1 ampouleper day

60 – B 2 ampoules48.8 per week

W 1 ampoule40 – per week_ other

20 – dosage_ not

~ statedn=199 n=383 n= 143 n=32 n=28

In summary it can be said that a clear tendency to use a“middle” dosage is identifiable in most doctors both for thedrops and for the ampoules of Lymphomyosot. In contrast,extreme dosages recede into the background in statistical terms.1.9 Classification of therapy results by presentation

It has already been noted earlier in this study that in orderto objectively evaluate the conclusiveness of the therapy resultsto be presented subsequently, some interfering variables shouldfirstly be analyzed which could have diminished the con-clusiveness of the therapy results. A possible interferingvariable in this context is the fact that use of two differentpresentations of the test preparation was observed in thisstudy, and that one of these presentations was administeredin five different ways. Whether and to what extent the therapysuccesses described are attributable to particular forms of ad-ministration will be analyzed below.

Firstly, however, a few comments should be made concer-ning the collection of the therapy results.

In order not to make collection of the therapy results un-necessarily difficult and in order to give the most equal possi-ble consideration to the numerous different disease picturestreated in this study with Lymphomyosot, a simple five-gradescale was used to assess treatment success. The grades, wereas follows: 1 = very good; 2 = good; 3 = satisfactory; 4= unsuccessful (i.e. no change); 5 = worse. We were awareof the problems of such a crude classification, but neverthelesschose this after thorough consideration.

In addition to the possibility of quantifiable statements, thisform of assessment scale offers the primary advantage thattherapy results achieved in relatively different types of diseasescan be compared directly with each other. This is particular-ly important because therapy results can be depicted in oneand the same graph not only with reference to areas of use,but also with reference to other features such as individualpresentations and methods of administration.

For the purposes of greater clarity, we have divided thetherapy results into 4 groups in the following diagrams: verygood/good; satisfactory; unsuccessful (i.e. no change); worse.Since the “worse” category makes up only a negligible pro-portion, most of the graphs show only 3 expressions of theaspect “therapy result”. Moreover, in order to ensure thegreatest possible compambility, absolute figures were not usedin the following graphs but only peramtage values. In this way,the therapy results are as comparable as possible, even if theywere taken from patient groups of differing size.

The first two illustrations in this respect are intended to in-dicate to what extent the different presentations and methodsof administration of Lymphomyosot can be regarded astherapeutically equivalent. The therapy results for the ad-ministration of drops, ampoules, and a combination of bothpresentations are compared with each other in Figure 7.

Figure 7: Therapy results with Lymphomyosot classifiedby presentation (n = 3,507)

Patients (%)h 100 – P

80 –o very good/60 – good~ satis-40 – factory

20 – ~ unsuc-cessful

0 = worseDrops Ampolues Drops + Ampoules

n=2722 n=491 n=294

It is apparent that with both presentations and also witha combination thereof, good and very good therapeutic suc-cess was achieved in the great majority of cases.

The second graph (Figure 8) is intended to clarif y the ques-tion of to what extent the method of Lymphomyosot ad-ministration influences the results of therapy. In order to ob-tain the most conclusive results possible, only those patientsin whom only one specific method of administration was usedduring the entire treatment period were taken into accountfor the individual administration methods; consequently, in-tracutaneous adminstration had to be excluded from theevaluation since only one single patient would have beenavailable with an assessment of “satisfactory’: Drops and “drinkampoules” were counted together in oral administration.

Figure 8: Therapy results with Lymphomyosot classifiedby method of administration (excl. i.c admini-stration) (n = 3,498)

Patients (%)100 –

very good/80 – good

60 – ~ satis-factory

40 –~ unsuc-

20 – Cedul

0 m worseoral i.m. iv. S.c. combination

n=2788 n=226 n=85 n=86 n=31 3It an be stated that the differences relating to the therapeutic

success rates are negligibly small and could also be determin-ed or partly determined by statistical fluctuations, especiallyas patient groups of very different sizes were compared in somecases.

1.10 Accompanying therapy

As already stated elsewhere in this study, additional drugsand non-drug measures were in principle permitted withrestriction in the Lymphomyosot use observation study if thedoctor giving treatment regarded them as necessary in the in-dividual case. However, in order to ensure that their possibleinfluence on the therapy results could be estimated more ef-fectively in retrospect, additional therapy of whatever kindhad to be recorded in full on the record form.

Before the various accompanying therapies specific to therelevant disease pictures are dealt with more fully in the con-text of the subsequent detailed evaluation, all major additionaltherapies will firstly be listed in full and their influence onthe therapy results represented in global terms.

Tables 3 and 4 list the major additional drug or non-drugmeasures employed in the patients under observation, brokendown by nature and number of cases. Since accompanyingtherapy differs markedly among GPs from practice to prac-tice and is very heterogenous, we have restricted ourselves forreasons of space to those therapies employed in more than1% of the teal patient population. Due to the occurrence ofmultiple listing, the total number of cases in Tables 3 and 4is greater than the number of patients in the relevant groups.The classification of the drugs administered additionally wascarried out, insofar as allopathics o r c o m m o nphytotherapeutics were involved, in accordance with the maingroup list of the “rote Listen. Homeopathic agents were sub-divided into single homeopathic agents and combinationpreparations and represented separately. Other drugs not listedin the “rote Listen or which could not be sensibly classifiedaccording to its classification scheme, are included in thecategory “Other drugs.”

LYMPHOMYOS~

Table 3: Accompanying drug therapy used in more than 1%of patients

Nature of drug administered Number of casesAnalgesics/Anti-rheumatics 44Antibiotics 83Antidiabetics 5Antihypertensives 8Anti-inflammatories 14Antitussives/Expectorants 131Beta-receptor blockers/ 5

Calcium antagonistsBroncholytics/Anti-asthmatics 27Diuretics 17Circulation-stimulating agents 9Influenza remedies 42Cardiac agents 8Coronary stimulants 4Oropharyngeal agents 28Rhinological agents 27Sexual hormones and their inhibitors 7Alterants/Immunostimulants 107Preparations for the veins/Varicose vein remedies 45Cytostatic gents/Metastasis inhibitors 29Single homeopathic agents 17Combination homeopathics 560Other drugs 400

Table4: Accompanying non-drug measures used in morethan 190 of patients

Nature of therapy Number of casesAcupuncture 27Balneotherapy 11Movement therapy 7Radiotherapy 40Dietary measures 20Autologous blood treatment 52Haematogenic oxidation therapy 7Hydrotherapy 10Inhalation 91Compression dressings 7Lymphatic drainage 255Massage 6Neural therapy 7Surgical measures 4Physical therapy 9Symbiosis guidance 6Compresses/dressings 39Other measures 53

Figure 9 shows that despite the many additional therapies,the patients receiving only Lymphomyosot are clearly in themajority statistically and make up more than half (exactly55.l% ) of the total patient population. This fact is particularlyimportant with regard to the following detailed evaluation ofthe therapy results in the individual indication areas. It can

therefore be assumed that the treatment successes presentedlater originate largely from patients treated exclusively withLymphomyosot.

Figure 9: Number of patients receiving various forms ofaccompanying therapy in addition to administra-tion of Lymphomyosot (n = 3,512)

Number of patients- “ -

2000 ~_, 1

1500 N

.no accompanying therapy accompanying non-drug therapy

accompanying drug therapy accompanying drug and nondrug therapy

Since nevertheless just over 45% of patients received addi-tional therapeutic treatment, a brief clarification will now begiven as to whether the treatment success in patients with ad-ditional therapy differs fundamentally from the success ratesof patients with Lymphomyosot therapy only. Figure 10therefore shows the therapy results in 4 groups: group 1 =Lymphomyosot therapy only; group 2 = further additionaldrugs; group 3 = additional non-drug measures; group 4 =additional &ugs an’d non-drug measures combined.

Figure 10: Therapy results with Lymphomyosot classifiedby accompanying therapy

Patients (%)1 Uu

80

I 7T

r i=I very good60 /good

B satis-40 factory

20 ~ unsuc-cessful

Cl - worse—no accompanying therapy accompanying non-drug therapy

accompanying drug therapy accompanying drug and non-drug therapyn=1937 n=998 n=219 n=358

As Figure 10 shows, the various configurations of accom-panying therapy differ remarkably little in their therapeuticsuccess rates. Accompanying non-drug therapy alone fallsslightly out of the frame due to somewhat poorer therapeuticresults. Detailed evaluation showed that this group containeda large proportion of patients with pronounced lymphoedema,in whom Lymphomyosot and simultaneous lymphaticdrainage were used due to the severity of the symptoms, andwhere simply due to the severity of the basic disease lesspositive results were to be expected.

It must also be considered that the patients with additionalnon-drug measures represent, at 219 cases, the statisticallysmallest group and that with a group of this order of sizestatistical fluctuations weigh more heavily than with largerpatient samples.

At any rate, it can be demonstrated on the basis of Figure10 that the therapy results of the patients with Lpphomyosottherapy only do not differ markedly from those with com-bined therapy. However, this should not be taken to indicatethat accompanying therapy is fundamentally superfluous oreven unfavorable. The question of whether treatment addi-tional to the administration of Lymphomyosot is necessaryand worthwhile can only be decided by the doctor giving treat-ment in the individual case, taking account of all the diseasesymptoms and constitutional factors applying to his patient.Since it tan be assumed that the group with additional therapycontained a higher proportion of patients with severe basicdiseases than the group without additional therapy, it cannotnecessarily be expected that the contribution made by the ad-ditional therapeutic measures to achieving treatment successin this negative selection from the total patient population im-mediately made itself felt in higher success rates.

Nevertheless, the comparison of therapy results for thevarious patient groups allows the conclusion to be drawn thatthe various forms of accompanying therapy employed do notin any way falsify the recorded treatment results as a whole.1.11. Duration of treatment

The most important preconditions to be met for optimumdrug effect include not only correct dosage but also a suffi-ciently long duration of treatment. The period over which thepreparation Lymphomyosot is normally used in the doctor’spractice is therefore of great interest. The data forms contained5 levels for recording the individual duration of treatment:

1. less than 1 week2.1 week to 1 month3.1 month to 3 months4.3 months to 6 months5. more than 6 months

Figure 11: Duration of treatment with Lymphomyosot(n = 3,512)

Number of patients

15001- i 382 I It Ez7zl 1236 0 up to

1 week

1EZI 1 week

to 1 months 1 month to

1

3 months~ 3 months to

422 6 monthsI#3iJ more than

I 2?14 6 months[ 27 _ not stated

Figure 11 shows how the study period statements on dura-tion of treatment are distributed over the individual levels.A mean value for the duration of therapy cannot sensibly bedculated on the basis of this data (especially due to the open-ended category “more than 6 months”). However, an approx-imate value for the median can be given. This is of the orderof 5 weeks. Thus approximately 50910 of patients were treatedwith Lymphomyosot for less than 5 weeks and the other 50 Yofor more than 5 weeks.

Another interesting aspect could be how the therapy resultsare influenced by the duration of treatment. Account mustbe taken here, however, of the fact that in this study, condi-tion development was not documented and hence no interimresults are available for assessing treatment success as a func-tion of treatment duration. Therefore, only therapy resultsfrom completed cases of treatment can be compared with eachother.

Since the duration of treatment was entirely a matter forthe judgment of the individual doctor, it must be assumed thatin general the more severe and more stubborn the underlyingdisease, the longer the patients were treated with Lym-phomyosot. Evidence that this is the case can be seen fromFigure 12 where the duration of treatment is plotted againstthe duration of the disorder. It can be clearly seen that withincreasing duration of illness, longer and longer treatmenttimes were given on the record forms.

Figure 12: Duration of treatment with Lymphomyosotas a function of duration of disease ordisorder prior to commencement of therapy(n = 3,481) Duration of

Duration of illness treatmentless than 1 week

o up to1 week to I month 1 week

1 month to I year EZZI 1 week to1 month

1 year to 5 years ~ I month to3 months

5 years to 10 years = 3 months to6 monthsmore than 10 years _ more than6 monthso .20 40 60 80

Patients (%) 100 R not stated

If the therapy results from the various patient groups withdiffering duration of illness or disorder are compared (Figure13), it is evident that the therapeutic success rates are lowerfor patients with longer lasting disease than for those withshorter duration of disease. This finding is not surprising,however, when it is considered that chronic conditions are bynature very much more difficult to treat than acute diseaseconditions. So it is all the more remarkable that, nevertheless,very good or good therapeutic success was achieved in over6770 of patients in the group with more than 5 years’ dura-tion of illness and in over 56910 of cases in the group with morethan 10 years’ duration of illness.

Figure 13: Therapy results with Lymphomyosot as afunction of disease or disorder duration priorto commencement of treatment (n = 3,481)

Patients (%)00

80

60

40

20

0 I iiziza

very good/goodsatis-factoryunsuc-cessfulworse

b c d e fDuration of disease or disorder

a =Iessthanl week d = I Yearto5 Yearsb=lweektol month e= - -5 years to 10 yearsc = Imonthtol year f = more than 10 years

Against the background of Figures 12 and 13 which showthat longer disease periods are accompanied by longer treat-ment periods and at the same time by rather poorer successrates, it could be expected that the therapeutic success ratesdecrease continuously in parallel with increasing duration oftreatment. This is not the case, however, as shown by Figure14. Rather, the patient group with a treatment duration ofmore than 6 months is distinguished by decidedly good suc-cess rates and indeed by the smallest proportion overall of verygood or good successes achieved in five groups. This is all themore remarkable since the patients with long duration of treat-ment must be regarded as a distinctly negative selection. Con-sequently, this surprising result can in all probability be in-terpreted to the effect that it was only in the patient groupwith the longest treatment duration that the effect potentialof the preparation Lymphomyosot was fully exploited andhence the poorer initial state was, as it were, overcompensated.Evidently there is, therefore, still a “therapeutic effect reserve”in the preparation even after a six-month treatment period,which certainly remained unused in some of the patients in

Figure 14: Therapy results with Lymphomyosot as afunction of duration of treatment (n # 3,485)

Patients (%)I t100

(30o very good)

60 goodEZj satis-

40 factory

~ unsuc-:0 Cessful

Ij - worsea t) c d e

Duration of treatmenta = less than 1 week d=lyearto5 yearsb=lweektol month e = 5 years to 10 yearsc = 1 month to 1 year f = more than 10 years

whom satisfactory therapeutic success was not achieved in thecontext of a shorter treatment period.

In this connection, a particularly interesting question is howthe therapy results for differing durations of treatment behavewith respect to a patient group whose disease or disorder dura-tion is not as widely scattered. To this end the patient groupwhose duration of disorder — represented on a logarithmicscale — would show the lowest breadth of scatter wasinvestigated.

Figure 15: Therapy results as a function of duration oftreatment in patients suffering from diseasefor between 5 and 10 years (n = 252)

Patients (%)

Duration of treatment

Figure 15 therefore shows the therapy results for the patientssuffering from disease for between 5 and 10 years. Due to the— — —considerably smaller number of patients (252 cases) comparedto the total patient population, a classification into 3 sub-groups with different durations of treatment was selected. Itis apparent that in this special patient selection, the therapyresults were in fact rated by the study doctors as increasinglybetter with increasing duration of treatment.

In principle, therefore, it can be stated that precisely inchronic disease conditions and disorders, Lymphomyosottherapy should not be ended too early in order to achieveoptimum treatment results.

1.12 Repeat treatment

It was also permitted in this use observation study todocument cases in which repeat treatment withLpphomyosot had already been carried out. It is thereforeof fundamental interest whether the therapy results in repeattreatments are better than in initial treatments, i.e. whetherthere is still a therapeutic effect reserve in the preparation aftercompletion of the first treatment too. Figure 16 shows thatthis is in fact the case. It is particularly noticeable that thepercentage of patients treated unsuccessfully in repeattreatments makes up less than a third of that recorded for firsttreatments. It can therefore be stated that it is worthwhile inmost cases to continue an initially apparently unsuccessfultreatment over a longer period, or if appropriate, at a laterdate.

Figure 16: Comparison of therapy results in initialtreatment and in repeat treatment (n =3,493)

Patients (%)00

75

I

u very good/good

50 ~ satis-factory

25 ~ unsuc-a?ssful

0- worse

Initial treatment Repeat treatmentn=2976 n=51 7

Figure 17: Ageandsex distribution of all patients withNumber of patients oedemas (n = 751)

?00

r

F

0-10 21-3i3 41-50 61-70 gl-y~l

11-20 31-40 51-60 71-80 not statedAge groups

2. Therapeutic use of Lymphomyosot in lymphoedema and ticulary interesting question in this context is whether equal-ly good therapy results were obtained with all forms ofoedema or whether Lpphomyosot shows superior effect par-ticularly in lymphoedemas.

other oedemasHaving discussed in detail the methodology of the study

and the different variables which may be important for theassessment of the therapy results, the individual indicationgroups will now be looked at in detail, taking particular ac-count of the therapy results achieved.2.1. Patients

Since lymphoedemas form the statistically largest singlediagnosis group with 684 cases, and in practice represent avery important indication area for the preparation Lym-phomyosot, these cases will be investigated first.

Lpphoedema is a protein-rich, pasty oedema due to a con-genital defect (e.g. in lymph vessel aplasia) or an acquired oc-clusion of lymph tracts with chronic lymphostasis (7). Lym-phomyosot exerts a channeling effect on the mesenchyma inthese diseases (8).

However, it was not exclusively lymphoedemas which weretreated in this L~phomyosot study. In a further 67 cases, thepreparation was used to treat oedemas of other kinds, primari-ly those due to cardiac or venous congestion. This means thata total of 751 patients were treated with Lymphomyosot dueto oedemas.

As mentioned earlier in this report, the oedema patientsare characterized by an age and sex distribution which dif-fers considerably from that of the total patient population.Whilst the total patient population includes a high propor-tion of children under the age of 10 years (3290), the patientswith oedemas display a practically symmetrical age distribu-tion with a peak in the 6th de=de and a proportion of only1.5 9i0 of children under the age of 10. A further conspicuousfeature is that female patients are statistically more in the ma-jority with 80.7% than among the patients as a whole. Theage and sex distribution of the oedema patients is shown inFigure 17. A mean age of just over 52 years was calculatedfor this patient group.

Figure 18 shows the statistical distribution of patients be-tween lymphoedemas and oedemas of other kinds. A par-

Figure 18: Number of patients with Iymphoedemas andoedemas of other kinds (n = 751)

Number of patients

750 – 684

500 –

250 —(57

0’Lymphoedema Other oedema

2.2. ResultsAs Figure 19 shows, markedly better results were achieved

Figure 19: Therapy results with Lymphomyosot inlymphoedema and oedema of other kinds (n= 7 5 1 )

Patients (%)r 1‘“”F ~ T-l I

Io very good/

60 good~ satis-

40 factory~ unsuc-

20 Cessful

0 m worse

Lymphoedema Other oedeman=&14 ~=~z

with the Iymphoedemas themselves despite a high proportion(61.2%) of very good or good therapeutic successes in oedemasof other kinds. These results will therefore be looked at indetail below.

In the following tables and graphs, the statements made bythe study doctors about the nature of the lymphoedemastreated are classified according to various criteria. It must bepointed out firstly that the evaluated details concerningetiology and localization were given spontaneously by doc-tors and were not requested by us using standard questions.This explains the relatively high proportion of imprecisestatements concerning the cause and localization of the lym-phoedemas treated.

The most interesting feature for the use of the Lym-phomyosot in practice is certainly the classification by etiology.On the basis of the statements of the study doctors, the pa-tients can be subdivided into a total of 5 groups:

14

2,

3,

4,

5.

Post-traumatic lymphoedema:All patients with the literal statement “post-traumatic lym-phoedema” and also entries of Iymphoedema following ac-cident, contusion, sprain, fracture, compression, etc. wereplaced in this group.

Inflammatory Iymphoedema:This group included patients with lymphoedema follow-ing lymphangitis, erysipelas, phlegmons, shingles, etc.

Post-operative lymphoedema:This group was mostly made up of patients with surgicallymph node removal due to neoplastic phenomena.

Lymphoedema following therapeutic X-ray treatment:This related to secondary lymphoedemas following radia-tion therapy of malignant lymph node diseases or lymphnode metastasis.

Lymphoedema of unknown cause:This last group included all lymphoedema patients wherea triggering cause was not known to the doctor giving treat-ment or was not notified to us.

Table 5: Classification of treatment cases by lymphoedemacausesNature of cause Number of Mean age in Mean dura- Therapeutic

cases year3 tion of success ratedisorder in

monthspost-traumatic 53 44 17 94.3%inflammatory 35 52 30.5 94.3%post-operative 247 55 31 93.9%fo l lowing thera- 9 52 15.5 loo9iopeutic X-raytreatmentunknown cause 340 51 21.5 96.2%

Table s shows a detailed breakdown of the above 5 lym-phoedema groups by number of cases, mean age, mean dura-tion of disorder; and therapeutic success rate. Here, as in thesubsequent tables, a simplified representation was chosen forthe therapy result for reasons of space, whereby all patients

who were treated with at least satisfactory success were add-ed together and related to the total number of cases in the rele-vant group in order to be expressed as a percentage. Whereappropriate, the therapy results were also represented in detailin the form of graphs. Here, however, we have restrictedourselves to those indication groups where a sufficiently largenumber of cases were available for evaluation. FOr this reason,a detailed breakdown of the data from patients with lym-phoedema following radiation therapy was dispensed withinthe following diagrams, since in this case the values cannotbe regarded as representative for this indication area due tothe small number of cases (9 patients).

Since the duration of treatment also constitutes a criterionwhich should always be taken into account in a critical evalua-tion of therapy results, the treatment periods of the 4 mostimportant lymphoedema groups are compared in Figure 20.It is evident here that in general, treatment was longest in post-operative Iymphoedema and shortest on the other hand inpost-traumatic edema.

Figure 20: Duration of treatment with Lymphomyosot in

post-traumatic

inflammatory

post-operative

lymphoedemas of various origin (n = 675)n up tob 1 week~ 1 week to

1 month~ 1 month to

3 months~ 3 months to

6 months_ more than

6 monthsunknown cause _ not stated

11, ,,, ,ii, ,,, ,,, ,i, ,,Jo 25 50 75 100

Patients (%)

Figure 21: Therapy results with Lymphomyosot inlymphoedemas of various origin (n = 675)

Patients (%)100

75 0 very good)good

50IZZ3 satis-

25 factory

m unsuc-0 Cessful

post-traumatic post-operativeinflammatory unknown cause

n=53 n=35 n=247 n=340

I

If the therapy results (Figure 21) are related to these treat-ment periods, it must be concluded that, precisely in the caseof post-traumatic lymphoedema, even better therapy resultswould presumably have been achieved if a correspondinglylonger duration of therapy had been observed. Another sur-prising aspect is the fact that evidently the patient group whichresponded best to L~phomyosot was that in which a precisecause of the Iymphoedema could not be stated. It can be seenfrom this and from the large number of patients in this groupthat Lymphomyosot seems to represent the therapeutic ofchoice precisely in diagnostically obscure cases of lym-phoedema and can also be used here with good success.

Apart from a classification according to etiology, abreakdown of the lymphoedemas treated by localization canalso be made. As Table 6 shows, the localization’s “upper ex-tremity” and “lower extremity” are the most importantstatistically. The other lymphoedemas involve almost ex-clusively, where precise statements on localization were made,individual cases such as blepharoedema, facial oedema, oroedema in the area of the nape of the neck. In Table 6 the4 patient groups formed on the basis of the stated lym-phoedema localization are broken down by number of cases,mean age, mean duration of disorder, and therapeutic suc-cess rate.

Table 6: Breakdown of cases treated by localizationof lymphoedema

Localization Number of Mean age in Mean dura- TherapeuticCases years tion of success rate

disorder inmonths

Upper extremity 203 56.5 32 96.1%Lower extremity 299 51.5 , 22 95.3%Other 18 48.5 14 10070localizationLocalization not 164 47.5 22 93.3%stated

Figure 22: Therapy results with Lymphomyosot inlymphoedemas of various localization (n =684).

Patients (%)00 –

80 –o very good/

Ao – goodEZl satis-

40 – factory~ unsuc-

20 – Cessful

0’Upper extremity Lower extremity Other localization/localization

not statedn=203 n=299 n= 1$2

The therapy results achieved with these groups are shownin Figure 22, where due to the small number of cases in the“other localization” group, these are collated with the group“localization not stated:

In order to be able to precisely assess the role ofaccompanying medication and the other accompanyingtherapies particularly in the treatment of lymphoedemas, thepatients were subdivided into various groups according to theadditional therapy carried out and these presented in a two-dimensional grid together with the relevant number of casesand the simplified therapeutic success rate (Table 7). Sincelymphatic drainage naturally plays a special role asaccompanying therapy for the indication area Iymphoedema,this group was extracted from the other non-drug therapyprocedures and presented separately.

Table 7: Number of patients and therapeutic success ratesin Iymphoedema as a function of accompanyingtherapy

Drug measures

NO== I ‘0 I ‘esmeasures

NoneNumber of patients 344 89Patients successfully treated 97.1% 92.1%

Lymphatic drainageNumber of patients 96 128Patients successfully treated 95.8% 91.4%

Other measuresNumber of patients 16 11Patients successfully treated 93.7% 100%

TotalNumber of patients 456 228Patients successfully treated 96.7% 92.1%

Total

43396.1%

22493.3%

2796.3%

68495.2%

It is apparent that irrespective of the relevant configurationof accompanying therapy, therapeutic successes were recordedin all groups, and in over 9070 of cases in each individualgroup. It can be concluded from this that the accompanyingtherapy does not play a decisive role in treatment success evenin the special indication area of lymphoedema. Lympho-myosot an therefore be described as a proven therapeutic fortreatment of lymphoedema of various origin and localization,which is outstandingly suitable for use with and withoutaccompanying therapy.

3. Possible uses of Lymphomyosot in inflammatory conditions.The second largest field of application for Lymphomyosot,

which is not second in importance to the complex lym-phoedema, is inflammatory conditions. In the data sheet thepreparation is recommended for use in lowered resistance(general susceptibility to infection) and in chronic tonsillitis.

During the course of the present use observation study itwas evident, however, that physicians sometimes use thepreparation Lymphomyosot in practice for indications overand above those cited by the manufacturer.3.1. Patients

A total of 2,135 cases classified under the generic term “in-flammatory conditions” were documented by the investigatorstaking part in the use observation study. Figure 23 shows theage and sex distribution of this group of patients.

Figure 23: Age and sex distribution of all patients with in-flammatory conditions (n=2135)

Number of patients 1

400

300

200

100

0 IEZZ male_ female.

0-1o 21 -~1) 41-50 61-70 81-50 Not stated11-20 31-40 51-60 71-80 90-’39

Age group

It was evident that the age distribution of this patient groupreached a peak in the first ten years of life and that the numberof patients decreased almost continuously with increasing age.The average age of all patients with inflammatory conditionswas 24.1 years. The number of children aged up to 10 was

almost 4090, the number up to 15 was over 479i0. To obtaina more accurate classification of the patients’ age structure inchildhood they were grouped in two year spans and separatedinto male and female, as shown in the bar chart (Figure 24).

Figure 24: Age and sex distribution of all children up to 15years old treated for inflammatory conditions(n=1006)

Number of patients150

100

50

ZZl male

o _ femaleo-1 2-3 4-5 G-7 8-9 10-11 12-13 14-15

Age group

It was clear that the peak was between the age of 4 and5. It was also evident that in childhood there were more malepatients (53.6% of those aged up to 15 were boys, 46.4% girls)whereas in the whole patient group with inflammatory con-ditions the female patients were in the majority with 54%.

The patients treated with Lymphomyosot suffered from verydifferent types of inflammatory or infectious conditions andthe diagnoses tonsillitis, rhinitis, sinusitis, bronchitis, lym-phadenitis and non-specific infections were those most quoted.In 1,556 roses there was only one diagnosis on the record sheetwhereas in the other 579 patients there were mixed infections.Table 8 gives an overview of the diagnoses named by the in-vestigators insofar as there was only one diagnosis. For reasonsof space we had to forgo listing the combinations. However,these patients were of course also included in the furtheranalysis.

I

Diagnoses Number of =sesTonsillitis 381Pharyngitis 32Rhinitis 82Sinusitis 69Otitis 27Parotitis 25Sialadenitis 1Stomatitis 7Gingivitis 3Laryngitis 10Pseudocroup 2Whooping cough 3Bronchitis 75Pneumonia 3Pleurisy 1Toxoplasmosis 1Infectious mononucleosis 2Rubella 1Lymphadenitis 298Lymphangitis 12Mastitis 4Dermatitis 22Furunculosis 6Hidradenitis 1Pyoderma 2Herpes simplex 5Herpes zoster 1Gastritis/gastroenteritis 1Pancreatitis 1Cholangitis 8Crohn’s disease 2Colitis 8Appendicitis 4Inflammation of the mesenteric glands 4Glomerulonephritis 6Urinary tract infections 13Prostatitis 1Deferentitis 1Adnexitis 3Phlebitis 6Osteomyelitis 1Non-specific infections 421(incl. general susceptibility toinfection)Table 8: Overview of the diagnoses reported by the in-

vestigators (single diagnosis) with the number ofrelevant cases.

888 of the 2,135 patients (41.6Y0 ) had previously alreadyreceived different types of medical treatment. Table 9 gives—the type of drugs administered together with the correspon-ding number of cases. They were mainly antibiotics, an-titussives/expectorants and drugs to stimulate the im-munological system. As drugs are given in the list which werealso mentioned in the case of mixed diagnoses, the total

number of cases in Table 9 is greater than the number of rele-vant patients. In the case of patients previously treated withother drugs it can be assumed that a large number were pro-blem cases which did not respond adequately to the therapypreviously carried out.

Type of drug administered Number of casesAntibiotics 502Antirheumatic agents/anti-inflammatory agents 19Antitussives/expectorants 125Broncholytics/anti-asthmatic agents 11Corticoids 4Remedies for skin diseases 3Influenza remedies 49Oral- and pharyngeal therapeuticagents 51Orological preparations 2Rhinological preparations 18Sulphonamides 6Drugs to stimulate the immunologicalsystem 95Urological preparations ~Venous and varicose vein remedies 5Vitamins 1Single homeopathic remedy 3Combination homeopathic remedies 72Other drugs 124Table. 9: Drugs used by the patients with inflammatory

conditions prior to treatment with Lympho-myosot.

3.2. Results

The following tables and charts classify the treatment casesallocated to inflammatory conditions according to variouscriteria, e.g. form of the disease (acute, chronic, recurrent),site, and type of concomitant therapy. Particular attentionshould be paid to the results of therapy in each case. As inthe section “lymphoedema’: for reasons of space, the therapyresults were presented in a simplified form in the tables sothat all the patients who responded very well, well, or satisfac-torily to treatment, and related to the total number of casesin the relevant group, were summarized and expressed as apercentage.

Regarding the indication “inflammatory processes;’ Lym-phomyosot is recommended mainly for chronic inflammationsby the manufacturer, in the first instance for chronic tonsillitis.However, the present study has shown that the preparationis also used in acute forms and that it has a surprisingly goodeffect. 30.6 % of the inflammations treated (654 cases) weretermed acute by the investigators or were put in this categoryby ourselves because of the short duration of symptoms.23.2 YO of inflammatory processes (495 cases) were of thechronic type. The largest group, with 44.670, was made up ofpatients with recurrent inflammations (953 cases). This patient

group also included the cases which the doctors designatedaschronic-recurrent and those described as’’generally suscep-tible to infection”. In 33 cases the preparation was used asfollow-up treatment only after the acute disease symptomshad regressed.

Table 10 gives a detailed classification of the different typesof inflammatory processes according to the number of cases,average age, average duration of symptoms, and percentageresponse to therapy.

type number average average therapeuticof cases age in duration response

years of symptoms rateacute 654 24.3 7.s Days 96.9910chronic 495 25.8 32 Months 92.9910recurrent 953 22.8 31 Months 93.8%follow-uptreatment 33 27.5 8.5 Months 100%

Table 10: Classification of treatment cases according to thetype of inflammatory processes

The large difference in the duration of symptoms isremarkable, from %5 days for acute and 32 or 31 months forchronic or recurrent infections. The highest response rates wereachieved for follow-up treatment and for acute inflammations.The results in chronic and recurrent processes were alsoevaluated as very successful, particularly in view of the longduration of symptoms which would indicate cases which wereextremely resistant to therapy.

Figure 25 gives a more informative presentation of theresults of treatment for the different types of inflammatorydiseases. Here it is evident that even in chronic processes aresponse to treatment was achieved in almost 70 YO of all cases,and in recurrent forms in almost 75 !ZO of cases; this was assess-ed by the relevant doctor as very good or good.

Further to Figure 25, Figure 26 shows in detail the relevanttreatment times necessary in the individual groups. It is evi-dent that there was a good correlation between the durationof treatment and the duration of symptoms which would in-dicate that in patients with a short case history, a short dura-tion of treatment was usually adequate whereas for persis-tent conditions treatment was correspondingly longer.

In addition to classification of the type of the disease, sub-division according to the site of the inflammatory processesis also of particular interest for practical use as it illustrates,for the different prescriber groups, the possible uses of Lym-phomyosot relevant to their specific specialist areas. Whenallocating the patients to the different groups we also clearlyallocated the cases where several inflammatory diagnoses weregiven on the record sheet.

To avoid overlapping between the individual groups, thediagnosis which was the most likely indication for administra-tion of Lymphomyosot was the one that determined theallocation.

Figure 25: Results of therapy with Lymphomyosot ininflammatory conditions (n=2135)

Patients (70 )

very good]good

satis-factoryunsuc-cessful

acute chronic recurrent follow-uptreatment

n=654 n=495 n=953 n=33

Figure 26: Duration of treatment with Lymphomyosot ininflammatory conditions (n=2135)

~ 1 month tochronic 3 months~ 3 months to

recurrent 6 months_ more than

follow-up 6 monthstreatment _ not stated

1 , I , t , I * 1 1 I , 1 1 t , I Io 20 40 60 80 100

Patients (%)

Table 11 shows the patients, placed according to the site ofinflammation, reported by the investigators in 9 groups,together with the relevant number of cases, average age,average duration of symptoms and therapeutic response rate.

It was evident that, without exception, the response rates(defined as at least a satisfactory response to treatment) wereclearly above 90 Yo in all groups. This, therefore, clearly illu-strates the broad spectrum of activity of the preparationLymphomyosot.

As other therapeutic measures, in addition to administra-tion of Lymphomyosot, were taken in just under half of allpatients we were also interested in the question of howspecifically in this group of indications response to therapywas affected by the type of concomitant medication or non-medicinal concomitant therapy. For this purpose we separatedthe patients into different groups according to the additionaltherapy carried out and illustrated this as a two-dimensionaltable showing the relevant number of patients and the overallresponse rate (Table 12). The purely homeopathic and an-tibiotic concomitant medication (the latter because of its par-

I

Site Number of Average Average Therapeuticcases age in duration response

years of symptoms ratein months

Tonsillitis 594 22.3 27 93.6V0OtherENT-area 473 22.4 18.5 93.99’0Bronchialsystem 105 32.1 35.5 93.3%Gastro-intestinal 24 41.1 42.5 10070Urogenitalsystem 28 42.4 31 loo9ioAppendagesof the skin 38 38.5 61.5 94.7%Lymph nodes/lymph tracts 391 21.6 11.5 94.89!0Other sites 61 26.0 11 96.7%Non-specificinfections 421 25.6 18.5 96.2%

Table 11: Classification of treatment cases according tosite of the inflammatory process

titular relevance in inflammatory processes) were shownseparately. It was clear that there was a high percentageresponse to therapy in all the groups. However, the patientsgiven concurrent antibiotic therapy did slightly worse thanthe treatment cases in the other groups. At first sight this couldgive the impression that a combination of Lymphomyosot plusantibiotic would not be beneficial. However, it should alwaysbe taken into account when comparing the different patientgroups, that this was a non-randomized group of patients andthat in each individual case the choice of therapy was left tothe doctor treating the patient. It should, therefore, beassumed that the patients receiving concurrent antibioticmedication were, on the basis of the severity of their disease,a particularly negative selection so that a high percentageresponse to therapy, equivalent to those in the other groups,was not expected from the outset.

M. Fitzen (9) in a paper published in 1986 also discussedthe question of efficacy of Lymphomyosot, with and withoutconcurrent antibiotic therapy. In this study, which did howeveronly include 10 patients, no marked difference was found inthe response to therapy between patients who received onlyLymphomyosot drops and those who were also given anti-biotics or chemotherapy. Lymphomyosot can, therefore, alsobe recommended for administration together with antibioticsfor therapy of inflammatory processes.

4. Therapeutic use of Lymphomyosot in hyperplasia of lym-phatic organs.

For many decades Lymphomyosot has been used successful-ly to treat hyperplasia of Iymphoepithelial organs, in par-ticular the pharyngeal and palatine tonsils. Hyperplasia ofthese organs is not in itself a disease but merely the mor-phological sequela of intense immunobiological activity (10).However, the increased size of the organs frequently causesa mechanical obstruction in the respiratory tract or esophagus

Non-medicinal

Medicinal NoMeasures

NoneNumber of patients 1151Those successfully treated 94.070

Only homeopathicremediesNumber of patients 254Those successfully treated 98.0%

AntibioticsNumber of patients 65

Those successfully treated 89.2%

Other drugsNumber of patients 414Those successfully treated 95.1910

TotalNumber of patients 1884Those successfully treated 94.6~o

Yes

8092.5%

6398.4%

1172.7%

9796.9%

25194.8%

Total

123193.970

31798.l%

7686.8V0

51195.59’0

213594.7T0

Table 12: Number of patients and therapeutic responserates for inflammatory processes related toconcomitant therapy

with very unfavorable sequelae for the whole body; these alsoinclude ~econdary inflam-mations of adjacent organs (10). Forthis reason we decided to show hyperplasias of lymphaticorgans separately from the inflammatory processes.

4.1. Patients

There were a total of 320 documented treatment cases for thisgroup of indications. In 115 patients the diagnosis of the in-vestigators was “tonsillar hypertrophy” or “tonsillarhyperplasia”. These terms are largely synonymous. Since,however, the expression “tonsillar hyperplasia” correspondsbetter to the pathological-anatomical basis and is more cor-rect, we decided to use this term in the rest of the report. In64 patients the diagnosis was “adenoid vegetations” which issynonymous with hyperplasia of the pharyngeal tonsil. 144cases diagnosed as “lymphatism” were also allocated to thisgroup. According to Roche (7) Iymphatism is understood tobe the tendency to hyperplasia of lymphatic organs.

Overlapping between these groups caused by mixeddiagnoses occurred in only 3 cases. It should be taken intoaccount that the expression “tonsillar hyperplasia” is the com-mon generic term for hyperplasia of palatine and pharyngealtonsils and, therefore, also includes the diagnosis “adenoidvegetations’: It is, therefore, quite correct to summarize bothdiagnoses under the generic term “tonsillar hyperplasia” or“tonsillar hypertrophy” as is the case in Table 2. However, forthe detailed analysis (Table 13, Figures 27 and 28) we decidedto show both diagnoses separately, as reported on the forms.

The average age of the whole patient group with hyper-plasias of lymphatic organs was just under 13 years old. 155

patients were male, 165 female. The age and sex distributionwas largely the same as that for patients with inflammatorydiseases, and did, therefore, not need to be shown separately.

4.2. Results

Table 13 gives an accurate classification of the 3 patient groupswith hyperplasia of lymphatic organs according to the numberof cases, average age, average duration of symptoms, andtherapeutic response rate. Figure 27 also compares the dura-tion of treatment for these groups. It was evident that dura-tion of therapy was about the same in all 3 patient groups.

I Diagnosis I number I average I average I therapeutic I

I in months iI Tonsillar I I I I II hyerplasia I 115 I 13.6 I 25 I 89.5% I

Adenoidvegetations I 64 I 7.8 I 18 I 87.5% ILymphatism 144 14.8 21 86,2%

Table 13: Classification of the patients with hyperplasia oflymphatic organs according to primary diagnos-is, tonsillar hypertrophy, adenoid vegetationsand Iymphatism

Figure 27: Duration of treatment with Lymphomyosot inpatients with hyperplasia of lymphatic organs(n=323)

n up tor .1 week

Tonsillar EZZl 1 week tohyperplasia 1 month

= 1 month toAdenoid 3 months

vegetations = 3 months to6 months

- more thanLymphatism 6 months

= not stated11, .1,1 , I , , I 1 I L I Jo 20 40 60 80 100

Patients (%)

Figure 28 also gives a detailed comparative overview of theresults of therapy. It can be seen that even for these chronicchanges in lymphatic orga”ns the rates for very good or goodresponses were over 5070 in each group.

In this connection it is remarkable that in over 78% of pa-tients no therapeutic measures in addition to the administra-tion of Lymphomyosot were carried out. Only 62 patientsreceived concomitant medicinal therapy; in 14 additional non-medicinal measures were carried out. Table 14 shows abreakdown of concomitant therapy with the number of casesand the therapeutic response rate.

Figure 28: Results of therapy with Lymphomyosot inhyperplasia of lymphatic organs (n =323)

Patients (%) 4—— t

Tonsillar Adenoid Lymphatismcessful

hyperplasia vegetations

n=l15 n=b4 n=144

5. Efficacy of Lymphomyosot in various other clinical pictures

Over 91% of the patients monitored were included in the threelarge diagnosis groups (oedema, inflammatory diseases andhyperplasia) already discussed. The remaining treatment caseswere distributed amongst a relatively large number of variousother clinical pictures of which the most common will bedetailed here and the response to therapy briefly illustrated.

Non-medicinal

Medicinal No Yes TotalMeasures

NoneNumber of patients 250 8 258

Those successfully treated 91.6% 75.0% 91.170

Only homeopathicremediesNumber of patients 30 1 31

Those successfully treated 10070 10070 10070

Other drugsNumber of patients 26 5 31

Those successfully treated 96.1% 85.7% 92.5%

TotalNumber of patients 306 141 320Those successfully treated 92.8~o 85.7V0 92.5%

Table 1A: Number of patients and therapeutic responserates in hypqlasia of lymphatic organsrelated to concomitant therapy.

In 79 patients, swelling of the lymph nodes, which couldnot definitely be attributed to Iymphadenitis, was the reasonfor therapy; in the majority of cases swollen lymph nodes ofundetermined origin were involved or swelling of the lymphnodes with no further details. The results of therapy in thisgroup of patients are listed in Table 15.

In 25 patients the diagnosis was “exudative diathesis”. Thisterm which is not in common use today was defined by Roche(7) as “particular disposition to inflammatory reactions of the

skin and mucosa and could, therefore, also be alloated to thecomplex of “inflammatory diseases’: The treatment results forthese patients are also given in Table 15.

Very good Satis- No Deter- Total/Good factory response iorated number

of pat.Diagnosis

Swollenlymph nodes 53 18 6 2 79

Exudativediatheses 11 10 4 – 25

Injuries andsequelae 32 7 2 – 41

Bronchialasthma 16 2 – – 18

Cervicalspine syndrome 12 3 – – 15

Hepatopathy 8 3 – – 11

Goiter 10 – 1 – 11

Migraine 6 3 1 – 10

Table 1s: Results of therapy in various other clinical picturesfor which Lymphomyosot was used

Furthermore, in the breakdown of therapy results we alsotook into account all the other clinical pictures for which atleast 10 treatment cases had been documented (see Table 15).

These examples have demonstrated that the principle ofdispersal and purification of the mesenchyme which forms thebasis of Lymphomyosot therapy, produced a good responsein very different diseases.6. Tolerability of the preparation

Lymphomyosot is very well tolerated. Adverse reactionswere reported in only one case after parenteral administra-tion of the ampoule solution (785 patients) and in 6 cases afteroral administration of the drops (3,016 patients). In the 7 casescited there was local redness at the site of the injection follow-ing subcutaneous administration; one 5 year old boy com-plained of a painful neck/sore throat and abdominal painsand a 2 year old vomited, a reaction which is very commonin this age group. One 14 year old boy reported unpleasantirritation which the doctor in charge did not consider serious.One 37 year old male suffered from diarrhea during the obser-vation period. A 67 year old male patient also complainedof nausea. One 5 year old girl reported restlessness at night.

Related to the number of individual ampoule doses ad-ministered of at least 8,500 and drops, at least 325,000, thevalue calculated for the side effect rate after parenteral ad-ministration was lower than 0.0118% and after oral ad-ministration, lower than 0.0018570. The causal relationshipbetween administration of the drug and the effects describedwas not proven in any case as not one single case wasdocumented where the same symptoms occurred afterwithdrawal when rechallenged. In addition none of the effectswas reported in more than one patient.

In 3,505 patients (over 99.8%) the preparation was toleratedwithout any problems over the duration of the treatmentperiod.7. Discussion

Observation studies on drugs already on the market are in-tended to examine the use of these preparations in practicein a very large number of patients. Accurate records are keptof efficacy in individual indications and of tolerability.

The present study demonstrated that the preparation Lym-phomyosot had some precisely defined duplications which cor-related well with the indications recommended by themanufacturer. In addition the homeopathic remedy produceda good response in a whole series of other clinical pictures.

There follows an overview of the main indications for thepreparation as evidenced during the course of the use obser-vation study:

1. Lpphoedema is the main indication for Lymphomyosot.The efficacy of the product in this indication, which has beenknown for a long time, was fully confirmed by the treatmentresults in 684 patients (Figure 29).

2. The second largest area of use for the preparation is ininflammatory diseases of the upper respiratory tract. Here itshould be taken into account that the doctor in practice whentreating influenza, colds etc often does not see tonsillitis orpharyngitis in isolation but that mixed forms made up ofseveral different types of inflammation are the rule. Also, thereFigure 29: Results of therapy with Lymphomyosot in

lymphoedemas (n=684)~UO Patients (%),

I very good/ satisfactory unsuccessful Igood .

I

is frequently overlapping between chronic tonsillitis and ton-sillar hyperplasia. The spectrum of activity of Lymphomyosottakes account of this circumstance; as the treatment resultsin a total of 1,244 showed (of these 594 with tonsillitis, 473with other inflammatory processes or infections of the ENTarea and 177 with tonsillar hyperplasia including adenoidvegetations), efficacy was good not only in tonsillar condi-tions but also in infections in other ENT areas (Figure 30).

Lymphomyosot Study

Figure 30: Results of therapy with Lymphomyosot in tonsillitis, other infections of the ENT area amtonsillar hyperplasia (n=1244)

Patients (%)00 ‘

m very good/good

80 – ~ satisfactory

tonsillitis Other ENT Tonsillarinfections hyperplasia

3. The broad s~ectrum of activity of Lymphomyosot in in-flammatory pr~cesses means that it is also possible to use thispreparation for lowered resistance (general susceptibility toinfection). The reliable effectiveness in this indication wasdocumented in 319 cases (Figure 31).

Figure 31: Results of therapy with Lymphomyosot jlowered resistance (general susceptibility {infection) (n= 319)

every good/ satisfactory unsuccessfulgood

4. In view of its affinity with the lymph system and its effi-cacy in inflammatory processes it is also beneficial to use thepreparation for inflammatory swelling of the lymph nodes(lymphadenitis). 391 treatment cases were evaluated. Here toothe results of therapy were convincing (Figure 32).

Figure 32: Results of therapy with Lymphomyosot in lym-phadenitis (n=391)

very good/ satisfactory unsuccessfulgood

However, to achieve optimal therapy results, therapy mustbe of adequate duration and adapted to the clinical conditionconcerned. In acute diseases the average duration of treatmentin this study was approximately 1-3 weeks; in chronic con-ditions and recurrent forms 1-3 months. However, sometimestreatment was carried out for over 6 months whereby amaz-ingly good results were achieved even for protracted diseaseprocesses. In view of the very good tolerability, Lym-phomyosot can be used for long periods usually without anyparticular problem.

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Mitglieder des Bundesverbandes der Pharmazeutischen In-dustrie e. V., Editio Cantor, Aulendorf/Wurtt.

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(3) Koslowski L., Irmer W., Bushe K.-A., Lehrbuch derChirurgie S. 713 f., F. K. Schattauer Verlag 1978

(4) Boenninghaus H.-G., Hals-Nasen-Ohren-Heilkunde, S.203 f., Springer-Verlag, 4. Auflage 1977

(5) Kirchhoff H.-W., Ein klinischer Beitrag zur Behandlungdes Lymphodems, Der Praktische Arzt, Heft 6 (1982)

(6) Rinneberg A.-L., Behandlung und Rezidivprophylaxeder Tonsillitis mit Lymphomyosot, BioL Med. 17, 4, 179-182(1988)

(7) Roche, Lexikon Medizin, Urban & Schwarzenberg, 2.Auflage 1987

(8) John J., Zur Klinik und Pharmakologie von Lympho-myosot, Biol. Med. 4, 4, 374-386 (1975)

(9) Fitzen M.; Frage aus der Praxis: Kann in der padiatri- Address of the authors:schen Praxis bei der Behandlung der Angina auf Antibiotika H. Metelmann, Apotheker,verzichtet werden? Biol. Med. 15, 4, 197-199 (1986) &

(10) Becker W., Naumann H.-H., Pfaltz C.-R., Hals-Na- St. Zenner, Arzt.sen-Ohren-Heilkunde, S. 334 f., Thieme-Verlag, 2. Auflage1983 Biologische Heilmittel Heel GmbH,

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