Prof. Emilio Minelli

(1)

(2)

Prof. Emilio Minelli

Centro Collaborante OMS per la Medicina Tradizionale

Universit

à

degli Studi di Milano

Presentazione delle Ricerche in corso

sulle medicine tradizionali del

Centro di Documentazione

(3)

COS

’

E

’

?

Medicina Tradizionale /Medicina Complementare

MT/MC

secondo l’

OMS

:

¾

prezioso patrimonio di conoscenze, accumulate dalle

diverse comunità etniche nei secoli

¾

fonte inesauribile di esperienze teoriche e pratiche

¾

contributo alla promozione e alla tutela della salute

dell’umanità, a costi inferiori rispetto a quelli del sistema

medico occidentale

¾

più facilmente accettate da molte comunità etniche per il

riferimento a credenze e opinioni omogenee alle differenti

culture tradizionali

WHO

(4)

TERAPIE E TECNICHE TERAPEUTICHE USATE

COMUNEMENTE DALLA MC/MT COMUNEMENTE DALLA MC/MT

T

Esercizi

C

Terapie spirituali

C

T

I

C

T

Terapie manuali

T

C

Agopuntura/ Agopressione

C

T

C

Fitoterapici Chiropratica Omeopatia Omeoterapie Antroposofia Osteopatia Unani Ayurveda Medicina cinese

Incorpora il tocco terapeutico I

Incorpora talvolta questa terapia/tecnica terapeutica

T

Incorpora comunemente questa terapia/tecnica terapeutica

(5)

Epistemologia e MT/MC

Feyerabend

Feyerabend

[…]

se le organizzazioni

concettuali interne delle diverse teorie scientifiche, sono

incommensurabili,

ma se il linguaggio ha natura metaforica e,

contemporaneamente, descrive e istituisce il mondo,

esso ha anche un carattere

autotrasformativo ed è passibile di approssimazioni ai significati espressi da altre culture

Kuhn

[…] ci troviamo di

fronte a due mondi che per

l’incommensurabilità delle culture,

che si pone a partire da diversi principi logici, sono condannati

(6)

Le basi per la diffusione della MT/MC

2000 HEALTH FOR ALL

1979 Dichiarazione di

Alma

-

Ata

Cure Primarie disponibili per tutta la

popolazione

(7)

Popolazioni mondiali che

usano TM/CAM

Paesi che usano la medicina tradizionale all’interno delle cure primarie 60% 60% 70% 70% 70% 90% Ethiopia Benin India Rwanda Tanzania Uganda

Paesi in via di sviluppo che hanno usato la

medicina complementare e alternativa almeno una volta 42% 48% 49% 70% 80% Canada Australia France USA

Sources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001; World Health Organization, 1998; and government reports submitted to WHO.

(8)

Countries' progress in the field of

TM/CAM

WHO Global Survey and Database of National Policy and Regulation of TM/CAM and Herbal

Medicines including information from 142 of 192 countries, 2004

Summary report of the global survey on national policy on traditional medicine and

(9)

Number of Member States with Recently

Established Herbal Medicines Law or Regulation

0 2 4 6 8 10 12 14 16 14 4 5 2 8 7 13 16 9 5 Before 1986 1986 - 1987 1988 - 1989 1990 - 1991 1992 - 1993 1994 - 1995 1996 - 1997 1998 - 1999 2000 - 2001 2002 - 2003

Number of Countries before 1986: 14 Number of Countries Total: 83

65% of respondents have stablished herbal medicine law or regulation 42 (49%) declared regulations were in the process of being developed.

(10)

102

88

81

64

33

Lack of research data Lack of appropriate control

mechanisms

Lack of education and training

Lack of expertise

Other

Main Difficulties Regarding Regulatory

Issues on Traditional Medicines

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Member States' needs for WHO

Support

Member States' needs for WHO support

67 66 50 16 44 48 47 50 44 55 8 4 7 5 3 9 12 0 68 83 70 0 20 40 60 80 100 120 140

Information-sharing on regulatory issues

Herbal medicine safety monitoring workshops General guidelines on research and evaluation of

herbal medicines

Provision of databases

Herbal medicine regulation workshops

Global meetings

Other

Number of Member States

Much needed Needed Not needed 127 116 117 117 110 105

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Relazioni intercorrenti tra

sistema allopatico e

TM/CAM

•

Nei paesi in cui il sistema

sanitario è

basato sulla

medicina allopatica, o in

quelli in cui la Medicina

Tradizionale non è

stata

incorporata nel sistema

sanitario nazionale, la

Medicina Tradizionale è

spesso chiamata

•

“complementare”

•

“alternativa”

•

“non-convenzionale”

Tre sistemi di relazione:

•1.

integrato

•

2.

inclusivo

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WHO Traditional Medicine

Strategy 2002

-

2005

integrate TM/CAM with national health care systems

provide evaluation, guidance and support for effective regulation

ensure availability and affordability of TM/CAM, including essential herbal medicines

promote

therapeutically-sound use of TM/CAM by providers and consumers

1

2

3

4

Policy:

Safety, efficacy and quality:

Access:

Rational

(14)

Evidence base for traditional medicine

A

B

C

A. Clinical trial of randomizing

control (RCT)

B. Well conduct clinical study

C. Expert committee review or

clinical experience of respected

authors

“Using Clinical Guidelines to Improve Patient Care within the NHS 1996

8%

14%

(15)

L

’

Efficacia e il dibattito sulle Evidenze

DEFINIZIONE DEL LIVELLO DI EVIDENZA

[Tratto da USA Agency for Health Care Policy and Research, 1992]

Livelli di evidenza

• I a) Evidenza ottenuta da studi di meta-analisi effettuata su trials controllati randomizzati

• I b) Evidenza ottenuta da almeno un trial controllato randomizzato

• II a) Evidenza ottenuta da almeno uno studio ben definito controllato senza randomizzazione

• II b) Evidenza ottenuta da almeno un altro tipo di studio opportunamente definito, quasi-sperimentale

• III) Evidenza ottenuta da studi ben definiti descrittivi non sperimentali, come per esempio studi comparativi, studi di correlazione e studi basati su singoli casi

• IV) Evidenza ottenuta da rapporti o opinioni di comitati di esperti e/o

dall’esperienza clinica di autorità competenti

[“General guidelines for methodologies on research and evaluation

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(17)

Entusiasmo acritico

versus

scetticismo disinformato

9

Molti sostenitori della TM/CAM spesso ricercano

riconoscimenti continui—e talora indebiti—per l’efficacia della

TM/CAM nei diversi campi di azione.

9

Molti professionisti della medicina allopatica, spesso

appartenenti a paesi con una forte storia di TM, esprimono

grandi riserve e spesso aperto discredito nei confronti dei

supposti benefici della TM/CAM.

9

I legislatori lottano con i problemi della sicurezza e

dell’efficacia dei fitoterapici tradizionali, mentre i consumatori

non vorrebbero alcun limite di accesso alle terapie di

TM/CAM.

9

Insieme alla domanda crescente di TM/CAM, è aumentata

anche quella di evidenze su:

•

sicurezza

•

efficacia

(18)

La necessit

à

della ricerca scientifica

9

La grande diffusione della fitoterapia nei paesi industrializzati,

ove il modello medico-epistemologico prevalente è costituito dal

modello medico-scientifico, ha reso urgente il confronto

dell’immensa mole del patrimonio di conoscenze tradizionali

con le procedure di ricerca e validazione scientifiche, volte a

dimostrare la sicurezza e l’efficacia delle droghe singole o

associate in complessi in uso, talora, da millenni.

9

Per realizzare ciò, è importante un’attività congiunta di diverse

figure specialistiche che consentano di traslare l’uso, spesso

sicuro, delle ricette tradizionali all’interno delle società

industriali.

(19)

Revisione della letteratura sulla sicurezza e sull

’

efficacia

9

Una revisione della letteratura deve mostrare il livello attuale

di evidenza sulla sicurezza e sull’efficacia nell’uso di un

fitoterapico.

9

L’OMS ritiene che nuovi studi clinici dovrebbero essere

realizzati solo nei casi in cui l’uso tradizionale di una pianta

medicinale nell’uomo non abbia documentato con chiarezza la

sua sicurezza ed efficacia.

9

Se erbe medicinali, già conosciute, vengono riformulate in

nuove miscele, si deve tener conto dei requisiti di sicurezza ed

efficacia già definiti per ogni singola erba medicinale.

9

Comunque, non deve essere dimenticato che nuovi metodi di

preparazione possono alterare il profilo dei fitoterapici, usati

tradizionalmente, dal punto di vista chimico, tossicologico e

anche farmaceutico.

(20)

Sicurezza

Sicurezza

9

Vanno tenuti in considerazione gli effetti collaterali segnalati e

documentati (registrati secondo i ben definiti principi di farmaco

vigilanza) di erbe, miscele di erbe, specie correlate, costituenti

dell’erba, loro preparazioni e prodotti finiti.

9

L’assenza di qualsiasi documentato effetto collaterale non costituisce

un’assoluta garanzia di sicurezza per i prodotti fitoterapici. Comunque

può non essere necessaria una serie completa di test tossicologici.

9

Sappiamo, però, che esistono effetti collaterali che sono difficili o

impossibili da determinare dal punto di vista clinico. Per questo

devono, comunque, essere completati test che valutino:

immunotossicità (per es. Test per reazioni allergiche) genotossicità,

carcinogenicità e tossicità sul sistema riproduttivo.

9

Solo nel caso non esista documentazione di un prolungato uso storico di

fitoterapici o quando esistano dubbi sulla loro sicurezza, si deve

procedere a studi aggiuntivi sulla loro tossicità.

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Ricerca Clinica su Sicurezza ed Efficacia

Ricerca Farmacologica su Sicurezza ed

Efficacia

Ricerca sull

’

uso tradizionale

Cure Primarie

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FITOTERAPIA

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SARS

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SARS

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SARS

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• Zhao HY Clinical observation on acupuncture for treatment of central obesity Zhongguo Zhen Jiu. 2006 Sep;26(9):629-31.

• Cabioğlu MT, Ergene N.Changes in levels of serum insulin, C-Peptide and glucose after electroacupuncture and diet therapy in obese women. Am J Chin Med.

2006;34(3):367-76.

• Lee MS, Hwan Kim J, Lim HJ, Shin BC. Effects of abdominal electroacupuncture on parameters related to obesity in obese women: a pilot study. Complement Ther

Clin Pract. 2006 May;12(2):97-100. Epub 2006 Mar 23.

• Cabioğlu MT, Ergene N.Electroacupuncture therapy for weight loss reduces serum total cholesterol, triglycerides, and LDL cholesterol levels in obese women. Am J Chin Med. 2005;33(4):525-33.

• Qunli W, Zhicheng L. Acupuncture treatment of simple obesity. J Tradit Chin Med. 2005 Jun;25(2):90-4.

• Hsu CH, Hwang KC, Chao CL, Chang HH, Chou P. Electroacupuncture in obese women: a randomized, controlled pilot study. J Womens Health (Larchmt). 2005 Jun;14(5):434-40.

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Obesit

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metabolic genes. Toxicol Appl Pharmacol. 2006 Jan 1;210(1-2):78-85. Epub 2005 Aug 29.

• Bhatt AD, Dalal DG, Shah SJ, Joshi BA, Gajjar MN, Vaidya RA, Vaidya AB, Antarkar DS. Conceptual and methodologic

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randomized controlled pilot trial. Complement Ther Med. 2003

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• Eich H, Agelink MW, Lehmann E, Lemmer W, Klieser E. Acupuncture

in patients with minor depressive episodes and generalized anxiety. Results of an experimental study. Fortschr Neurol Psychiatr. 2000

Mar;68(3):137-44.

• Röschke J, Wolf C, Müller MJ, Wagner P, Mann K, Grözinger M, Bech

S.The benefit from whole body acupuncture in major depression. J

Affect Disord. 2000 Jan-Mar;57(1-3):73-81.

• Akhondzadeh, S.; Noorbala, A. A.; Tahmacebi-Pour, N.; Kashani, L.

Crocus sativus L. in the treatment of mild to moderate depression: a double-blind, randomized and placebo controlled trial. British Journal

of Clinical Pharmacology. 59(5):630, May 2005.

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Copyright 2003 by the American Psychological Association, Inc. 2003, Vol. 34, No. 1, 10–19

Depressione e Cure Primarie

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Alternative Medicine Review, Volume 11, Number 4 – 2006

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Cancro e Medicina

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I PRINCIPALI CAMPI DI USO DELLA MTC NEL SETTORE

DELLA TERAPIA COMPLEMENTARE IN ONCOLOGIA 1/3

• DOLORE

• Correlato alla malattia tumorale

• Correlato alla terapia antitumorale

• Correlato a tecniche diagnostico-terapeutiche invasive • Preanestesia e anestesia • Agopuntura • Elettroagopuntura • Laser-terapia • Auricolo-terapia • Moxibustione • Fitoterapia • EDEMA • Agopuntura

• Laser-terapia sui punti di agopuntura • DISPNEA • MOBILITA’ E RIABILITAZIONE • Agopuntura • Ginnastiche Mediche • LEUCOCITOPENIA • Agopuntura e Moxibustione • NAUSEA • Agopuntura • Digitopressione • TENS • SINTOMI VASOMOTORI • Agopuntura

• QUALITA’ DELLA VITA

• Agopuntura

• Fitoterapia

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• SISTEMA IMMUNITARIO • Agopuntura • Moxibustione • XEROSTOMIA • Agopuntura PREVENZIONE PREVENZIONE:

• TERAPIA PER L’INTERRUZIONE DEL FUMO O DELL’ALCOOL • Agopuntura • Laser-terapia • Aghi a dimora ALTRI ALTRI: • PERDITA DI PESO • Agopuntura • Fitoterapia • Moxibustione • ANORESSIA • Agopuntura • Fitoterapia • Moxibustione • Qi Gong • TOSSE • Agopuntura • Fitoterapia • ASTENIA • Agopuntura • Fitoterapia • Moxibustione

I PRINCIPALI CAMPI DI USO DELLA MTC NEL SETTORE

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• STIPSI • Agopuntura • Fitoterapia • Dietetica • INSONNIA • Agopuntura • Fitoterapia • INCONTINENZA • Agopuntura • CATETERISMI • Agopuntura • DISFAGIA • Agopuntura • LESIONI DA DECUBITO • Agopuntura • Fitoterapia • Infrarossi a sorgente multipla • PARESI • Agopuntura • ITTERO • Agopuntura • Fitoterapia • DIARREA • Agopuntura • Fitoterapia

I PRINCIPALI CAMPI DI USO DELLA MTC NEL SETTORE

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2 1 49 52 Dal 2000 al 2005, con abstract Cancer and CHM 14 8 64 86 Dal 2000 al 2005, con abstract Cancer and acupuncture fuori tema negativi positivi Numero Citazione

Evidenze cliniche in MTC in

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Cancer

Cancer and and acupunctureacupuncture

• Anxiety 3

• Breathlness/ dyspnea 2

• Chronic orofacial pain 1

• Clinical depression 3 • Decrease of PSA 1 • Distress 3 • Edema 2 • Fatigue 1 • Fibromyalgia 1 • Hot flashes 4

• Immune system stimulation 3

• Improve QOL 3

• Improve the function of liver 1

• Improvement of blood cells 1

• Loss of appetite 1

• Low urinary tract symptoms 1

• Menopausa related symptoms 1

• Nausea 15

• Osteoporosis 1

• Pain 9

• Palliative cancer care 1

• Recovery of intestinal function 1

• Sweating 1 • Throat diseases 1 • Vasomotor symptoms 3 • Vomiting 7 • Xerosostomia 6

Evidenze cliniche in MTC in

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Cancer

Cancer and CHMand CHM

• Anti-angiogenesis 1

• Anti-proliferative (blocking cancer transformation, growth inibitory effects on cancer, induce apoptosis) 27

• Arthritis 1

• Blood leucocyte reduction 1

• Body weight 1

• Colon cancer chemoprevention 1

• Hypnotic use 1

• Hypocromic anemia 1

• Immune enhancing effects 5

• Improving hepatic function after liver carcinomectosomy 3

• Increase of QOL 1

• Lessening menopausal symptoms 1

• Nausea- vomito 1

• Ostalgia relieving 1

• Preventing metastasis 1

• Preventing myalgia 1

• Recovery of hemopoietic function 1

• Stomatitis 1

• Survival rate 3

Evidenze cliniche in MTC in

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La ricerca

• Mitomycina C + Ginseng Î Effetto sinergico Matsuda H, Pharmacological study on

panax ginseng C. A. Meyer. XIV. Effect of 70% methanolic extract from red ginseng on the cytocidal effect of mitomycin c against rat ascites hepatoma AH 130. [Yakugaku Zasshi. 1992 Nov:112 (11):846-55.]

• Mitomycina C + Polyporus umbellatus Î Effetto sinergico [You Js, Comined

effects of chuling (Polyporous umbellatus) extract and mitomycin C on experimental liver cancer, Am J Chin Med. 1994;22(1):19-28.]

• Adriamycina + Baked Licorice Decoction Î Riduzione cardiotossicità [Ruizhi L., et

al. Utilizing Zhigancao Tang to relieve doxorubicin’s adverse effects, Chinese Journal of Chinese Materia Medica. 1995:20(1):56-57.]

• IL-2 + Astragalus membranaceus Î Potenziamento [Chu DT, The in vitro

potentiation of LAK cell cytotoxicity in cancer and AIDS patients induced by F3-a fractionatextract of astragalus membranaceus. Chung Hua Chung LIU Tsa Chih. 1994. May:16(3):167-71].

• Azathioprina + Ginseng Î Riduzione di efficacia [Shin HR, Kim JY, et al. The

cancer-preventive potential of Panax ginseng: a review of human and experimental evidence. Cancer Causes Control 200,11:565-76]

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La ricerca

Può inibire la fecondazione dell’ovocita Ginkgo D Trattamenti di fecondazione assistita Ipopotassiemia Liquirizia A Diuretici tiazidici Prodotti per il sistema cardiovascolare Controindicati in gravidanza Ginseng D Contraccettivi orali Prodotti per il sistema urogenitale e gli ormoni sessuali

Può interferire con i contraccettivi orali perché ha attività modulante ormonale

Liquirizia D

Terapia ormonale sostitutiva

Può aumentare il rischio di effetti collaterali con crisi ipertensive per la presenza di sinefrina Arancio amaro A Farmaci antidepressivi IMAO Prodotti per il sistema nervoso centrale

Può diminuire i livelli di fenitoina e la sua efficacia terapeutica Paeonia lactiflora

D Fenitoina

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• Paeonia lactiflora induce P450-2C9 (antiepilettici) • Ginseng inibisce P450-2D6 (antidepressivi triciclici)

• Liquirizia inibisce P450-3A4 (Lovastatina, Triazolam, Ketoconazolo)

La ricerca

(57)

Schisandra sinensis TrM Schisandra Plantago lanceolata, Plantago major PhR TrM Piantaggine Glycyrrhiza glabra PhR TrM Liquirizia Helicrysum angustifolium TrM Elicriso Centella asiatica TrM Centella Harpagophytum procumbens TrM Artiglio del diavolo 3 Allergie Allergie

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Urtica dioica TrM Ortica, Foglie Gentiana lTrMea TrM Genziana Trigonella foenum graecum TrM Fieno Greco Equisetum arvense TrM Equiseto Angelica sinensis PhR TrM Angelica cinese 3 Anemia Anemia

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• Wang Y, Zhu B. The effect of Angelica polysaccharide on

proliferation and differentiation of hematopoietic progenitor cells.

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Crataegus oxyacantha PhR TrM Biancospino 2 Angina Angina pectoris pectoris Astragalus membranaceus TrM ClR Astragalo 1

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Angina pectoris - Biancospino

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• Costa R et al. Étude comparée de l’activité cardiovasculaire des jeunes pousses, des feuilles et des fleurs de Crataegus oxyacantha L. III. Action protectrice sur le cœur isolés de rat vis-à-vis des agents arythmogènes et dans les arythmies par reperfusions. Plantes médicinales et Phytothérapie, 1986, 20:115–-128.

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• Miller AL. Botanical influences on cardiovascular disease. Altern Med Rev.

1998 Dec;3(6):422-31. Review.

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Chieh Ho Tsa Chih 1995;15:141-143.

• Lei ZY, Qin H, Liao JZ. Action of Astragalus membranaceus on left

ventricular function of angina pectoris. Chung Kuo Chung His I Chieh Ho

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Withania somnifera TrM Withania Valeriana officinalis TrM ClR Valeriana Salix alba TrM Salice Rhodiola rosea TrM Rodiola Primula veris TrM Primula, Fiori Passiflora incarnata TrM ClR Passiflora Melissa officinalis TrM ClR + PhR Melissa Melilotus officinalis TrM Meliloto Humulus lupulus TrM PhR Luppolo Hypericum perforatum ClR TrM Iperico Cimicifuga racemosa TrM Cimicifuga Centella asiatica PhR ClR Centella Crataegus oxyacantha TrM Biancospino Avena sativa TrM Avena 2 Ansia Ansia

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Ansia - Centella

• Bradwejn J, Zhou Y, Koszycki D, Shilk J: A double-blind, placebo-controlled study on the effects of Gotu Kola (Centella asiatica) on

acoustic startle response in healthy subjects. J Clin Psychopharmacol

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•

Kumar V, Jaiswal AK, Singh PN, Bhattacharya SK. Anxiolytic activity of

Indian Hypericum perforatum Linn: an experimental study. Indian J Exp Biol

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• Cerny A, Schmid K: Tolerability and efficacy of valerian/lemon balm in healthy volunteers (a double-blind, placebo-controlled, multicentre

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• Dressing H, Riemann D, Low H, et al: Insomnia: Are valerian/balm combinations of equal value to benzodiazepine? Therapiewoche

42:726-736,1992.

• Soulimani R, Fleurentin J, Mortier F, et al: Neurotropic action of the hydroalcoholic extract of Melissa officinalis in the mouse. Planta Med

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• Akhondzadeh S, Naghavi HR, Vazirian M, Shayeganpour A, Rachidi H, Khani M. Passionflower in the treatment of generalized anxiety: a pilot double-blind randomized controlled trial with oxazepam. J Clin Phar

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• Cropley M, Cave Z, Ellis J, Middleton RW. Effect of kava and valerian on human physiological and psychological responses to mental stress assessed under laboratory conditions. Phytother Res 2002;16:23-7. • Kohnen R, Oswald WD. The effects of valerian, propanolol, and their

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• Andreatini R, Sartori VA, Seabra ML, Leite JR. Effect of valepotriates (valerian extract) in generalized anxiety disorder: a randomized

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Zingiber officinalis TrM ClR Zenzero Withania somnifera TrM Withania Sambucus nigra TrM Sambuco Salix alba TrM ClR Salice Urtica dioica TrM ClR

Ortica, Parti aeree

Urtica dioica TrM Ortica, Foglie Echinacea angustifolia TrM Echinacea a. Boswellia serrata TrM ClR Boswellia Astragalus membranaceus TrM Astragalo 2 Harpagophytum procumbens TrM ClR

Artiglio del diavolo 1

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Artrite – Artiglio del diavolo

• Leblan D, Chantre P, Fournie B. Harpagpphytum procumbens in the treatment of knee and hip osteoarthritis. Four-month results of a

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• Ernst E, Chrubasik S. Phyto-anti-inflammatories: A systematic review of randomized, placebo-controlled, double-blind trials. Rheum Dis Clin

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• Atal, CK et al. Salai guggal ex-Boswellia serrata. A promising antihyperlipidemic and antiarthritic agent. lndian Journal of

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• Schmid B et al. Efficacy and tolerability of a standardized willow bark extract in patients with osteoarthritis: randomized placebo controlled, double-blind clinical trial. Phytother Res 2001;15:344-50.

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• Altman RD, Marcussen KC. Effects of ginger extract on knee pain in patients with osteoarthritis. Arthritis Rheum 2001;44:2531-38.

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Artrosi

Trigonella foenum graecum

TrM Fieno Greco

Eucalyptus globulus

TrM Eucalipto

Capsella Bursa pastoris

TrM Borsa pastore 2 Artrosi, Uso esterno Viscum album TrM Vischio Solidago virgaurea TrM Verga d'oro Equisetum arvense TrM Equiseto Curcuma longa PhR Curcuma Betula alba TrM Betulla Arctium lappa TrM Bardana Harpagophytum procumbens TrM ClR Artiglio del diavolo 2

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prospective, multicenter, double-blind trial versus diacerhein. Joint

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Plantago lanceolata, Plantago major TrM Piantaggine Glycyrrhiza glabra TrM Liquirizia Eucalyptus globulus TrM ClR Eucalipto Helicrysum angustifolium TrM Elicriso Althea officinalis TrM PhR Altea 1 Bronchite

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Chung His I Chieh Ho Tsa Chih 1995;15:141-143.

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