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la M edicina B iologica SELECTED PAPERS FROM ITALIAN MAGAZINE OF HOMEOPATHY, HOMOTOXICHOLOGY AND INTEGRATED MEDICINE TREATMENT OF WRINKLES AND SKIN SLACKENING USING THE INTRADERMAL INJECTION OF A COMPLEX HOMEOPATHIC REMEDY (MADE ® ) RESULTS OF A COHORT CLINICAL STUDY ON 681 PATIENTS

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Page 1: SELECTED PAPERS FROM la MedicinaBiologicamedicinabiologicayalternativa.com/made.pdfAesthetic Medicine, ˜gures are still im-pressive: CollagenImplants,Hyaluronic Acid ˜llers, Goretex

la Medicina B iologicaSELECTED PAPERS FROM

ITALIAN MAGAZINE OF HOMEOPATHY, HOMOTOXICHOLOGY AND INTEGRATED MEDICINE

TREATMENT OF WRINKLES AND SKIN SLACKENING USINGTHE INTRADERMAL INJECTIONOF A COMPLEX HOMEOPATHIC

REMEDY (MADE® )RESULTS OF A COHORT CLINICAL STUDY ON 681 PATIENTS

Page 2: SELECTED PAPERS FROM la MedicinaBiologicamedicinabiologicayalternativa.com/made.pdfAesthetic Medicine, ˜gures are still im-pressive: CollagenImplants,Hyaluronic Acid ˜llers, Goretex

L A M E D I C I N A B I O L O G I C A A P R I L E - G I U G N O 2 0 0 4

TREATMENT OF WRINKLESAND SKIN SLACKENING USINGTHE INTRADERMAL INJECTIONOF A COMPLEX HOMEOPATHICREMEDY (MADE ® )RESULTS OF A COHORT CLINICAL STUDY

ON 681 PATIENTS

W rinkles and skin slackening are the

most obvious sign of the passing of

time, i.e., ageing from a mere biological

viewpoint. However, they also re�ect

the psycho-neuro-endocrino-immuno-

logical (PNEI) vision of the human being:

in other words, the skin is the main tar-

get of one’s psychological experiences

during the somato-psychic process,

whereas it is the starting point of or-

ganic wounds that will eventually be-

come the “soul scar” during the psycho-

somatic process.

The beauty of the face has been always

connected with a smooth, glowing and

young skin. Therefore, in order to exor-

cise ageing, our society makes us turn

to Plastic Surgery or Aesthetic Medi-

cine, which are not often completely

successful or do not satisfy the pa-

tients’ requirements fully.

For more than �ve years, the homeo-

SUMMARY

M. De Bellis, N. Frasca

THER

APE

UTI

CS

1

pathic remedy MADE ® (Guna, Milan), has

been an e�ective alternative to con-

ventional pharmacological treatment

and can certainly be regar ded as a ref-

erence drug in Aesthetic Medici ne. The

cohort study hereunder, carried out be-

tween 1998 and 2003 on 681 patients,

has proved the e�cacy and good toler-

ability of MADE ® both in preventive and

therapeutic terms, in the homeo-

mesotherapic treatment of skin slack-

ening as well as all types of wrinkles,

especially linear periocular and peril-

abial wrinkles, showing the best re-

sults in patients aged between 30-40

years and 40-50 years.

SKIN AGEING, WRINKLES, MADE ® ,

HOMOTOXICOLOGY

KEY WORDS

Page 3: SELECTED PAPERS FROM la MedicinaBiologicamedicinabiologicayalternativa.com/made.pdfAesthetic Medicine, ˜gures are still im-pressive: CollagenImplants,Hyaluronic Acid ˜llers, Goretex

INTRODUCTION

The most signi�cant and obvious sign ofthe transition from youth to old age isthe appearance of facial wrinkles.

“Beauty” has always been associatedwith having young, smooth and glowingskin. However, apart from externalbeauty, the skin also re�ects a person’stroubles, anxiety and pain - it is a mir-ror of the soul and every wrinkle tellsthe story of that person’s experiences inlife.

The skin is the pattern on which thepsycho-neuro-endocrino-immunologi-cal (PNEI) vision of Medicine is basedand where the psychosomatic signs ofpsychological troubles become clearlyvisible over the years. The skin is alsothe starting point for the organic woundthat will eventually become the “soulscar” (non-acceptance of the self) du-ring the somato-psychic process.

On this basis, we can understand whynowadays, regardless of one’s level ofeducation, social class or religion, it hasbecome so important to “exorcise” theaging process, starting with trying to eli-minate the problem of wrinkles.

According to the American Society ofPlastic Surgeons(www.plasticsurgery.org/), blepharo-plasty and face lifts account for just athird of the total number of plastic sur-gery operations requested by Ameri-cans. Even in the non-surgical sector ofAesthetic Medicine, �gures are still im-pressive: Collagen Implants, HyaluronicAcid �llers, Goretex implants, BotulinicToxin, mechanical dermal abrasion andCO2 laser skin resurfacing are still themost common therapeutic strongholdfor specialists.

However, results do not always meet thepatients’ high expectations.For more than �ve years, the homeopa-thic remedy MADE® (GUNA, Milan),has been an e�ective alternative to con-ventional pharmacological treatment.In this article, the biological interpreta-

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tion of the etiopathogenesis of skinaging and wrinkles will be on the basisof the correct therapeutic rationale forthese problems: by studying the com-position of MADE®, we will be able toidentify this rationale in its homeophar-macological structure.

The results of an observation study, car-ried out between 1998 and 2003 on681 male and female patients, into thee�cacy of MADE® in the treatment ofwrinkles and slackening of the face andneck tissues, will be examined and de-scribed later on.

SKIN AGINGChronological aging of the skin is the re-sult of a mixture of biological, bioche-mical and molecular events establishedby the genetic code of each individual(chronoaging). This is why not all peo-ple grow old in the same way and theskin is not the same in all individuals.Other environmental chemical andphysical factors contribute to aging, andthese are of varying importance in de-termining its type and severity (photoa-ging).In order to fully understand the patho-genic mechanisms leading to aging ofthe skin, we need to analyse and con-sider the same mechanisms that lead togeneral organic aging and examine themetabolic and structural characteristicsof human skin. We also need to consider that chronoa-ging and photoaging could have a si-gni�cant impact on the alteration of so-me physiological cutaneous mecha-nisms, not only as independent eventsbut also as synergic factors.The results of skin aging are clearly vi-sible in loss of elasticity and turgidity,and the appearance of wrinkles. It canbe traced back to a slowdown in cellturnover (SYCOTIZATION Process ac-cording to classic Homeopathy).with a subsequent reduction in elastictissue and loss of the support structure(but not just the support structure asmaintained by Pischinger and Heine)represented by the subcutaneous, loose

�brillar connective tissue (dermis).

SKIN PHYSIOPATHOLOGY ANDTHE ROLE OF SUBCUTANEOUSCONNECTIVE TISSUE

The normal physiological process ofchronoaging a�ects all the structures ofthe tegumental system: at epidermis le-vel, one can see a reduction in mitoses,a tendency towards premature keratini-sation, the dispersion of Melanocytes,and a reduction in Langerhans cells. The basal membrane shows a progres-sive smoothing with the disappearanceof the epithelial crests and dermal pa-pillae.The dermis shows a loss of thicknessand thinning out of the vascular sup-port: the collagen �bres are fragmented;the elastic �bres are disorganised; theinterstitial substance tends to becomeuniform, and there are lower numbersof �broblasts, mastocytes and Langer-hans cells.

But what causes these phenomena?There are two main theories:1) according to the �rst theory ( “pro-

grammatic” ), the programming ofcell death lies within the genetic co-de;

2) according to the second theory ( “de-generative” ), aging is a process thatis dependent on exogenous factors(especially photoaging for the skin)and endogenous factors (hormonaland immunological factors, forexample) that synergically cause aseries of metabolic failures (Depo-sition Phase according to the Tableof Homotoxicosis) and alterations inmolecular syntheses. You need onlyto think about what happens in par-ticular areas of the face, such as theeyelids and some periocular areas –here a reduction in collagen type Isynthesis is clearly linked to age, butultraviolet radiation, and the subse-quent production of free radicals,causes a drastic reduction in elastinand collagen storage and this pro-bably a�ects post-transcription me-chanisms.

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WRINKLES

Wrinkles are the most visible evidenceof cutaneous atrophy and are caused bydamage to the collagen and elastic �-bres.We must remember that, as the skindoes not have its own muscular struc-tures, it is the contraction of the musclesbelow it that determines its shape. As ti-me goes by, due to changes in tone andelasticity, the skin can no longer relaxand the �rst marks remain etched on theskin and gradually get worse.Wrinkles can be divided into the follo-wing categories:• Linear wrinkles: these are linked to

facial expressions; at �rst they are re-versible and are more common inwomen. They mainly appear aroundthe eyes (crow’s feet), between theeyes (from frowning), around themouth (vertically on the upper lip oraround the mouth, due to smokingfor example), horizontally on the fo-rehead (related to emotions, in par-ticular to anxiety);

• Glyphic wrinkles: these are relatedto a greater accentuation of the or-dinary cutaneous structure. They ap-pear on cheeks in particular;

• Creases: these are caused by pro-longed facial expressions (for in-stance while sleeping);

• Wrinkles between the nose andmouth: these are deep incisures ap-pearing between the external edgeof the mouth and the nose wings,delimited by muscles (mouth orbi-cular and buccinator muscles).

HOMOTOXICOLOGICAL INTER-PRETATION OF THE ETIOPATHO-GENESIS OF WRINKLES AND SKINSLACKENING

According to homotoxicologicalphysiopathology, wrinkles can be cate-gorised under Deposition Phase – Im-pregnation of the Tegumental System(FIGURE 1) . From a homotoxicologicalpoint-of-view, it is apparent how wrin-kles and the slackening of face and necktissues are caused by changes in theMATRIX (in fact, both the Deposition

Phase and the Impregnation Phase arepart of the “Matrix Interstitial SubstancePhases”).The connective tissue has mistakenlybeen regarded as just a support tissue;the dermis, which has always been re-garded as just the tissue on which theskin lays.However, Homotoxicology regards thematrix as a truly specialised organicstructure, the “ Basic RegulationSystem”: all internal and external chan-ges to our environment a�ect cell me-chanisms via the interstitial substance. It is via the matrix that the cells are ableto communicate with the external en-vironment - the amount of informationstored in the matrix and passed on tocells as instructions on their physiolo-gical functioning is enormous. The ma-trix is the place where the neurovege-tative endings unravel and the psycho-

neuro-endocrino-immune informationis conveyed through the neural and en-docrine substances and cytokines. We know that correct cell functioning isbased upon the anatomical and func-tional integrity of the matrix, and ulti-mately on its “ cleanliness ” and its de-toxi�cation levels. An accumulation ofstress factors at this level can lead to apotential triggering of a pathologicalprocess. If these changes in the loose �-

brillar connective tissue are in the der-mis, then a subsequent pathological al-teration will obviously appear.In fact, it is essential to keep the dermiswell-drained and metabolically e�-cient in order to keep the skin lookingyoung.

The dermis is composed of:• F ibroblasts and �brocytes and their

extracellular metabolites• Collagen �bres and elastic �bres• Glycosaminoglycans (GAGs) and

proteoglycans (PGs)• Blood vessels and nerves• Immunocompetent cells

There are two di�erent areas in the der-mis:1. the papillary dermis , which is su-

per�cial and thin and located near

the dermatoepidermal junction, andis rich in matrix but poor in collagenand elastin;

2. the reticular dermis , a thicker arealocated between the papillary der-mis and the subcutaneous adiposetissue: it is rich in collagen and ela-stic �bres, contains lower quantitiesof matrix, and is well vascularised(blood and lymph capillaries a�e-rent from the underlying subcuta-

HOMOTOXICOLOGYSIX-PHASE TABLE

Simplified table

Impregnaz

i allergieemicrania

scl

depressione endogena,psicosi, neurosi da paura,sindrome psichica organica

schizofrenia,deficienza mentale

mania, catatonia

Di vis i one

biolog ica

Cronicizzazione Deficit Disaccoppiamento

sindrome metabolica diabete mellito blocco reattivo

Alterazione

disturbi psichicifunzionali

Reazione

sindrome depressivareattiva, sindromeipercinetica

Fissazione

psicosomatosi, nevrosi,fobie, depressionenevrotica

• M

FASIFF DELLA SOSTANZATT FONDAMENTALETT(MATRICE)AAFASIFF UMORALI

SISTEMIORGANICI

FASIFF CELLULARIfase diEscrezione

fase diInfiammazione(o( di Reazione))

fase diDeposito

fase diImpregnazione

fase diDegenerazione

fase diDedifferenziazione(o Neoplastica)

• CUTE E ANNESSI

• SISTEMANERVOSOVV

• SISTEMASENSORIALE

• APPARAPP TOAALOCOMOTOO ORETT

• SISTEMAC

• AU

• S

• SLI

• SIM

• AR

• AG

• SE

sudorazione

disturbi diconcentrazione

lacrimazione,otorrea

artralgie

di t bi di i

a

m

c

e

erodermia melanoma

tireotossicosi,intolleranza al glucosio

disturbi del climaterio

gastrite cronica,malassorbimento

gastrite atrofica, cirrosiepatica

bronchite cronica(ostruttiva)

bronchiectasia, enfisema

malattie autoimmuni, deficitimmunitario, infeff zioni croniche

alterazioni immunitarie,AIDS

insufficienza del sistemalinfatico

fibrosi linfoma, linfoma Hodgkin e

disturbi di aggregazione anemia, trombocitopenia leucemia

infezioni croniche delle vieurinarie

rene atrofico carcinoma

insufficienza cardiaca infarto del miocardio endotelioma

poliartrite cronica spondilosi sarcoma, condroma

iridociclite, tinnitus degenerazione maculare,anosmia

amaurosi, neoplasia

a morbo di Alzheimer gliosarcoma

non-Hodgkin

blocco delle reazioni

carcinoma bronchiale

carcinoma dello stomaco,carcinoma del colon

carcinoma tiroideo

PSICHE

ARIO

OORIO

LE

reticolocitosi

predisposizione adinfezioni

tosse,espettorazione

gastralgie

one” in regione

iv

l

deficit immunitario,infezioni acute

bronchite acuta

gastroenterite, gastrite

tiroidite

iporeattività

silicosi, ant

gastr

HomotoxicologicxHedemaedema linflinfaticoatico glllinflinfoadeniteoadenite

classificationof wrinkles

FIG. 1

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neous adipose tissue).The action of the homeopathic drugMADE ® is targeted on these two struc-tures.

The etiopathogenetic process that leadsto the destructuring of the dermis and,therefore, to wrinkles is characterizedby a series of connected events (TABLE 1) :- Phase 1 : a reduced supply of O2 andnutrients to the dermis cells caused bythe pollution of the matrix due to cata-bolites produced in cell turnovers (chro-noaging) and by undrained toxins (freeradical photoaging), causes a slowdownof intracellular metabolisms and sub-sequent enzymatic damage;- Phase 2 : the metabolic distress of the�broblast a�ects its activity leading toa drastic reduction in the incretion ofthe matrix components (in particularHyaluronic acid) and the collagen andelastic �bres;- Phase 3 : the connective tissue weaveloses compactness. The lack of glycosa-minoglycans has a dramatic e�ect onskin hydration (Hyaluronic acid is ahighly hydrophilic molecule) and its tur-gidity; the reduced vascularisation ofthe epidermis causes the skin to lose itsbrightness and normal lymphatic drai-nage is slowed down, resulting in a vi-cious cycle that is di�cult to break.

If any wrinkle treatment is to be reliablethen it must take all these pathogenicprocesses into consideration and notjust act on one aspect of them.A therapy that is simply a means ofcompensating for a de�ciency in Hya-luronic acid from chronoaging or inother components of the dermal matrix,would not take into account the fact that

wrinkles are primarily a METABOLICALTERATION (a result of su�ering agedcells).

Instead, a wrinkle treatment should bean integrated therapy where �broblastscan begin their synthesizing activity (af-ter speci�c organ preparation stimula-tion) as their proper metabolic functionhas returned as a result of the action ofthe coenzyme substrates of the Krebscycle and they, therefore, have su�cient“energy” levels to maintain theirneosynthesis activity.At the same time, the integrity of thefunctional structure of the dermisshould be maintained by means of con-tinuous detoxi�cation and drainage.The homeopathic drug MADE® acts onthis “cascade” via the synergic action ofits four nuclei of components (PICTURES 4-5)

1. INTERMEDIATE CATALYSTS(Vitamin C D6, Vitamin B1 D6, Vi-tamin B6 D6, Nicotinamid D6, Ac.Cis aconitum D6, Ac. FumaricumD6, Ac. Alpha-ketoglucaricum D6,Baryum oxalsuccinicum D6, Na-trium oxalaceticum D6, Natriumpyruvicum D8, Magnesium gluco-nicum D6, Manganum phosphori-cum D1);

2. “SUIS” ORGANOTHERAPIES(Collagen suis D8-D30-Funiculusumbilicalis suis D10-D30-Cutis suisD8-D30, Placenta suis D10, Mu-sculus suis D20, Hepar suis D10,Glandula suprarenalis suis D10);

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3. CLASSIC HOMEOPATHIC REMEDIES(Sulphur D12, Mercurius solubilisHahnemanni D20, Calcium �uora-tum D30, Galium aparine D6, Thu-ja D6);

4. HOMEOPATHIZED ENZYMES(Hyaluronidase D8-D30).

Through its own components, each ofthe drug’s four nuclei develops a struc-tural and functional tropism that is spe-ci�c to each of the steps in the processof the etiopathogenic cascade of wrin-kles (PICTURES 2-3-5) :

1 - THE NUCLEUS OF INTERMEDIATE CATALYSTS

Its elective target is the mitochondrionand, in particular, the Krebs cycle. It hasa release action on the mechanisms as-signed to energetic metabolism, via theenzymatic stimulation induced by ho-meopathic dilutions. The intermediate catalysts in MADE®are therefore vital, as without the relea-se of the oxidative phosphorylation pro-cesses and the cells’ renewed produc-tion of energy, the �broblasts could notreact to the proliferative trophic stimu-lation simultaneously induced by the“Suis” organotherapies.The core of the nucleus of catalysts is_-ketoglutaric acid, a Krebs cycle sub-strate that acts on the enzyme, _-keto-glutaric-dehydrogenase, which is oftenblocked in the initial phases (still rever-sible) of �broblast degeneration.Homeopathized vitamins are, of cour-se, included for their antioxidant activity(action against photoaging and protec-tion of the matrix glycosaminoglycans).Vitamin C was included as it is an im-portant cofactor in the transformation ofProline into Hydroxyproline.The two oligo elements ( Magnesiumgluconicum D6, Manganum phospho-ricum D10 ) are particularly importantfor their catalytic action on collagenmetabolism.

TAB. 1

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Elastin

Fibroblast

xon

Basement membra

Ground substances

Axon

Collagen

Mast ce

CapillarCapillaries

Biorhyths

HOMEOPATHICHYALURONIDASE INTERMEDIATE

CATALYSTS AND OLIGOELEMENTS

ORGANPREPARATIONS

“SUIS”

CLASSICHOMEOPATHY

REMEDIES

Immune cell

WRINKLESTh

nof

l i ti

Drainage of thconnective tissconnective tiss(antysycotic actio

Trophicstimulationof tissueso

Stimolazionetrofica

dei tessutid

+

+++

CATALYSTS

DRAINING DRUGSORGAN

PREPARATIONSSUIS

VASCULARDRUGS

HOMEOPATHICALLYPREPARED ENZYMESHyaluronidase D8/D30

CLASSICHOMEOPHATYREMEDIESSulphur D12; Mercuriussol. Hahn. D20; Calciumfluoratum D30; Galiumaparine D6; Thuja D6

Inhibition ofthe destructuring

action of autologouhyaluronidase

Drenaigeand constitutional

support

Tr ophic actionon skin

and connectivetissue

Antioxidant and catalyticaction on collagen

metabolism

INTERMEDIATE CATALYSTS AND OLIGOELEMENTSVit. C D6 / Vit. B1 D6 / Vit. B6 D6 / Nicotinamid D6 / Ac. Cis. aconit. D6 / Ac. fumaricum D6 / Ac. A-ketoglut. D6 / Barium oxalsucc. D6 / Natrium oxalac. D6 / Natrium pyruv. D8 / Magnesium gluconicum D6 / Manganum phosphoriucum D10

ORGANPREPARATIONSSUISKöllagen D8/D30; Funiculus umb. Suis D10/D30, Musculus Suis D20; Placenta Suis D10; Glandula suprar. Suis D10; Cutis Suis D8/D30

MADE ®

2 - THE NUCLEUS OF “SUIS” ORGANOTHERAPIES

In accordance with the observations ofDr. H. H. Reckeweg, “Organotherapy”with homeopathized organ preparationsis based on the use of pigs as donors.From a homeopathic point of view, wecan con�rm that a pig organ or homeo-pathized pig tissue is extremely similarto the human homologous organ and asa result of this “ similarity ” (greater thanthat of other animal species), the thera-peutic e�cacy of a homeopathizedpreparation is even greater.

This likeness is particularly apparent atimmunological level. The result is the marked organotropismof the “ Suis” protein for the human ho-mologous protein.

Due to pigs’ almost completely ine�ec-tive detoxi�cation systems, their tissuesand, therefore, their proteins are parti-cularly toxic (steatosis degeneration).One, therefore, creates a protein struc-ture that has the potential characteristicsof a nosode, plus the speci�c propertiesof organotropism.A “Suis” organotherapeutic homeopa-thic preparation is an organ-speci�c no-sode, that, via a subliminal immunolo-gical mechanism, triggers the immuneresponse of not only the entire RES

Ta rget sites

of MADE ®

components

FIG. 2

FIG. 3

FIG. 4

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TAB. 2

Some examples of tratment with MADE ® . Left side: before treatment; right side: after treatment.