»N 1 4 6 5 - 3 7 5 3

Volume 8 • Issue 2 • lune 2 0 0 3

Focus on Alternative

and Complementary

Therapies

Ii

ffl^m Focus ort Alternative and Complementary Therapies

Editor-in-Chief Edzard Ernst , Laing Chair in Complementary Mediane Peninsula Medical Sclwol, Universities of Exeter & Plymouth

US Editor B r i a n B e r m a n , Complementary Medicine Program University of Maryland

Managing Editor Barbara W i d e r , Peninsula Medical Sclwol, Universities ofExeter & Plymouth

Associate Editors A d r i a n R W h i t e , Editorial Office M a x H P i t t l e r , Editorial Offlee A l y s o n L H u n t l e y , Editorial Office J o a n n a T h o m p s o n C o o n , Editorial Office Kat ja S c h m i d t , Editorial Office Peter G a n t e r , Editorial Office

International Editorial Board

J o h n A s t i n , San Francisco, USA D e n n i s A w a n g , White Rock BC, Canada Bruce Barrett , Madison, USA D a v i d Baxter, Newtonabbey UK A l a n Bensoussan, Penrith South DC, Australia M a r k B l u m e n t h a l , Austin, USA Heather B o o n , Toronto, Canada Barrie R Cassi le th , New York, USA T h o m a s YK C h a n , Hong Kong, China S i g r u n C h r u b a s i k , Frei bürg, Germany D e s m o n d C o r r i g a n , Dublin, Ireland T M i k e C u m m i n g s , London, UK Elisabeth de Lange-de Klerk, Amsterdam, The Netherlands D a v i d Eisenberg, Boston, USA Peter Fisher, London, UK V i n j a r F o n n e b o , Tromso, Norway A d r i a n e F u g h - B e r m a n , Washington, USA H a r l e y G o l d b e r g , Oakland, USA K a t h e r i n e G u n d l i n g , Sacramento, USA Elaine Harkness, Manchester, UK A n n a Har t , Preston, UK A n g e l o A Izzo, Naples, Italy W a y n e Jonas, Bethesda, USA Ted K a p t c h u k , Boston, USA K a r i n Kraf t , Rostock, Germany

D a v i d J K r o l l , Research Triangle Park, USA D a n a J Lawrence , Lombard, USA Klaus L i n d e , Munich, Germany Dieter M e l c h a r t , Munich, Germany L u c i n d a G M i l l e r , Amarillo, USA Dönal O ' M a t h ü n a , Columbus, USA K e n n e t h R Pelletier, Stanford, USA K a r l - L u d w i g Resch, Bad Elster, Germany M i c h a e l Rotb la t t , Los Angeles, USA Basil D Roufogal is , Sydney, Australia Stephen Sagar, Hamilton, Canada Debbie Shaw, London, UK Karen J S h e r m a n , Seattle, USA M i c h a e l S m i t h , Ottawa, Canada Cläre S tev inson , Bristol, UK P h i l i p p e Szapary, Philadelphia, USA Gerben ter Riet, Amsterdam, The Netherlands M a u r i t s v a n Tulder , Amsterdam, The Netherlands M a r j a Verhoef , Calgary, Canada Sunita V o h r a , Edmonton, Canada Hara ld W a l a c h , Freiburg, Germany Sara L Warber , Ann Arbor, USA A n d r e w W e i l , Tucson, USA H i t o s h i Yamashita , Fsukuba, Japan I r w i n Z i m e n t , Los Angeles, USA

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© 2003 Pharmaceutical Press

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Focus on Alternative and Complementary Therapies

Volume 8 • Issue 2 • June 2 0 0 3

Contents

E D I T O R I A L

• T h e c a t w a l k o f C A M - f a d a n d f a s h i o n i n c o m p l e m e n t a r y m e d i c i n e 167 Peter Canter

• E u r o p e a n h e r b a l m e d i a n e s r e g u l a t i o n s 169 Desmond Corrigan

I N T E R V I E W

• W a y n e ß Jonas 1 71

FOCUS

• C o m p l e m e n t a r y a n d a l t e r n a t i v e m e d i c i n e f o r a t o p i c d e r m a t i t i s 1 73 Katja Schmidt

• Placebo a n d p l a c e b o ef fects - a c o n c i s e r e v i e w 1 78 Harald Walach

DEBATE

• A r e h e r b - d r u g i n t e r a c t i o n s c l i n i c a l l y r e l e v a n t ? 1 88 Angela A Izzo Edzard Ernst

SUMMARIES AND COMMENTARIES

Herbal Medicine

• N o b e n e f i t o f Echinacea i n t h e t r e a t m e n t o f t h e c o m m o n c o l d ? 191 • H e r b a l c o m b i n a t i o n u s e f u l i n t h e t r e a t m e n t o f a c u t e U p p e r r e s p i r a t o r y t r a c t i n f e c t i o n s 193 • E f f e c t i v e h e r b a l P r o p h y l a x i s f o r m e n s t r u a l m i g r a i n e ? 194 • N o c o n v i n c i n g e v i d e n c e f o r use o f a n A y u r v e d i c h e r b a l f o r m u l a

i n t h e t r e a t m e n t o f a l c o h o l i c l i v e r disease 196 • K a v a a n d t h e p o t e n t i a l f o r d r u g i n t e r a c t i o n 197 • P o t e n t i a l f o r h e r b a l r e m e d y i n a l l e v i a t i n g p r e m e n s t r u a l S y n d r o m e S y m p t o m s 199

Vitamins, Minerais, Supplements and Dietary Approaches

• Soy m a y be o f b e n e f i t f o r m e n o p a u s a l w o m e n w i t h m o r e severe S y m p t o m s 201 • Z i n c n a s a l g e l m a y s h o r t e n d u r a t i o n a n d r e d u c e s e v e r i t y o f t h e c o m m o n c o l d 202

Homoeopathy

• A p o s i t i v e t r i a l o f h o m o e o p a t h y f o r l o w b a c k p a i n 205 • Effects o f o n e dose o f a 3 0 c H p o t e n c y o f T h y r o i d i n u m

o n w e i g h t r e d u c t i o n i n f a s t i n g p a t i e n t s 206 • H o m o e o p a t h i c A r n i c a f o r sequelae o f h a n d s u r g e r y 207

Acupundure

• A c u p r e s s u r e i m p r o v e s sleep q u a l i t y i n p a t i e n t s w i t h e n d - s t a g e r e n a l disease c o m p a r e d w i t h n o t r e a t m e n t c o n t r o l s ( b u t n o t c o m p a r e d w i t h s h a m acupressure ) 210

• A c u p u n c t u r e e f f e c t i v e a n d e f f i c a c i o u s f o r l o w b a c k p a i n 21 1

• E l e c t r o - a c u p u n c t u r e d u r i n g t h e m e n o p a u s e a l t e r e d m o o d b u t n o t v a s o m o t o r S y m p t o m s

Manipulative Therapies

• Does s p i n a l m a n i p u l a t i o n a f f o r d b e n e f i t i n t h e m a n a g e m e n t o f h e a d a c h e d isorders? 2 • P r o m i s i n g resul t s o f m a n i p u l a t i v e t h e r a p y a n d exercise i n t h e t r e a t m e n t o f

c e r v i c o g e n i c h e a d a c h e 2 1 6 • D o u b t s a b o u t t h e cos t -e f fec t iveness o f c h i r o p r a c t i c 21 8

Other Complementary Therapies

• I n v e s t i g a t o r s c l a i m t h a t s ta t i c m a g n e t s i m p r o v e S y m p t o m s o f p a i n a n d p h y s i c a l f u n c t i o n i n i n d i v i d u a l s w i t h c h r o n i c k n e e p a i n 220

• P r o m i s i n g resul t s o f a u t o l o g o u s b l o o d t h e r a p y f o r a t o p i c d e r m a t i t i s 221 • H u m a n p h a r m a c o l o g i c a l s t u d y o n a n a n t h r o p o s o p h i c c a r d i o t o n i c 222 • H y p n o t h e r a p y - a n e f f e c t i v e t r e a t m e n t f o r f u n c t i o n a l dyspeps ia? 224 • P s y c h o l o g i c a l c o p i n g s t y l e is n o t assoc ia ted w i t h s u r v i v a l i n Cancer 225 • Is p s y c h o l o g i c a l t h e r a p y e f f e c t i v e f o r c h r o n i c p a i n i n c h i l d r e n a n d adolescents? 226

S H O R T R E P O R T S 229

N E W S 274

B O O K R E V I E W S 276

N E W B O O K S 281

R E C E N T L I T E R A T U R E 282

2 0 6 Focus on Alternative and Complementary Therapies June 2003 8(2)

Effects of one dose of a 30 cH potency of Thyroidinum on weight reduction in fasting patients

Schmidt JM, Ostermayr B. D o e s a h o m e o p a t h i c u l t r a m o l e c u l a r d i l u t i o n o f T h y r o i d i n u m 3 0 c H af fec t t h e rate of b o d y w e i g h t r e d u c t i o n i n f a s t i n g p a t i e n t s ? A r a n d o m i s e d p l a c e b o - c o n t r o l l e d d o u b l e - b l i n d c l i n i c a l t r i a l . Homeopathy 2 0 0 2 ; 9 1 : 1 9 7 - 2 0 6 .

Aim T h e a i m o f t h e i n v e s t i g a t o r s was t o m e a s u r e t h e ef fects o f a h o m o e o p a t h i c u l t r a m o l e c u l a r d i l u t i o n u n d e r s t a n d -a r d i s e d c o n d i t i o n s i n a c l i n i c a l m o d e l .

Design R a n d o m i s e d , p l a c e b o - c o n t r o l l e d , d o u b l e - b l i n d , p a r a l l e l g r o u p , m o n o c e n t r e s t u d y .

Setting H o s p i t a l f o r n a t u r o p a t h y i n M u n i c h , G e r m a n y ; a h o s p i -t a l w i t h a t r a d i t i o n o f h o m o e o p a t h i c t r e a t m e n t s .

Part ic ipants Fas t ing p a t i e n t s t h a t e x p e r i e n c e d a S t a g n a t i o n o f r e d u c ­t i o n o f b o d y - w e i g h t af ter a w e i g h t r e d u c t i o n o f at least lOOg/day i n t h e p r e c e d i n g days . A t o t a l o f 2 0 8 p a t i e n t s p a r t i c i p a t e d , 102 r e c e i v e d T h y r o i d i n u m a n d 106 p l a c e b o .

Intervent ion O n e dose o f f i v e p e l l e t s o f e i t h e r T h y r o i d i n u m C 3 0 o r p l a c e b o .

Main outcome measures P r i m a r y o u t c o m e m e a s u r e was w e i g h t r e d u c t i o n o n t h e s e c o n d d a y a f t e r m e d i c a t i o n . S e c o n d a r y o u t c o m e

measures w e r e w e i g h t r e d u c t i o n o n t h e f i r s t a n d t h i r d d a y a f ter m e d i c a t i o n , c o m p l a i n t s a n d l a b o r a t o r y f i n d i n g s .

Main results P a t i e n t s t h a t r e c e i v e d T h y r o i d i n u m h a d less w e i g h t r e d u c t i o n o n t h e s e c o n d d a y a f ter m e d i c a t i o n t h a n p a t i e n t s t h a t r e c e i v e d p l a c e b o , t h e m e a n d i f f e r e n c e w a s 9 2 g [ 9 5 % c o n f i d e n c e i n t e r v a l ( C I ) 7 - 1 7 6 ] . A d j u s t m e n t f o r b a s e l i n e average w e i g h t r e d u c t i o n w e a k e n e d t h e a s s o c i a t i o n .

Authors ' conclusions ' P a t i e n t s r e c e i v i n g T h y r o i d i n u m 3 0 C h a d less w e i g h t r e d u c t i o n o n t h e s e c o n d d a y a f t e r t r e a t m e n t t h a n p a t i e n t s r e c e i v i n g p l a c e b o . H o w e v e r , t h e resul ts m u s t be i n t e r p r e t e d w i t h c a u t i o n because t h e r e w e r e n o s ig-n i f i c a n t d i f f e r e n c e s i n o t h e r o u t c o m e measures a n d a d j u s t m e n t f o r b a s e l i n e d i f f e r e n c e s r e n d e r e d t h e d i f f e r ­ence f o r t h e m a i n o u t c o m e m e a s u r e n o n - s i g n i f i c a n t . '

Address Josef M S c h m i d t , K r a n k e n h a u s für N a t u r h e i l w e i s e n , S a n a t o r i u m s p l a t z 2, D - 8 1 5 4 5 M u n i c h , G e r m a n y . E -mai l : j o s e f . m . s c h m i d t @ l r z . u n i - m u e n c h e n . d e

Summaries/Commenraries 2 0 /

Authors' reply Because of the lack of Space, w e c a n on ly reply to the ob ject ions .

In format ion on p r imary d iagnoses of the pa r t ic ipat ing patients can be found on p. 198 of our paper , where it reads: 'Fasting therapy is applied to a b r o a d spectrum of diagnoses inc luding hypertension, diabetes, Osteoarthritis, bronchial asthmo, migra ine, etc . ' Furthermore, detai led Information on diagnoses as wel l as on a g e , height, we ight , peculiar Symp­toms, etc. of each single patient is g iven in the füll p u b l i c a t i o n . 1

Yes, w e treated 31 men with p l a c e b o a n d 2 6 men wi th Thyro id inum. Randomisat ion was stratif ied for males a n d females, in blocks of six. A g a i n , an exact descr ipt ion had a l ready been given in our G e r m a n pub l icat ion , on p. 2 7 . To summarise: there were t w o sets of Containers, one for male a n d one for female patients. W e used M 0 0 1 - M 0 5 7 a n d F 0 0 1 -F154 . O n p. 2 0 0 of our paper , w e wro te : ' 21 1 patients we re e l ig ib le a n d a l located a randomisat ion number. Three patients (two Thyro id inum, one p lacebo) w i t h d r e w consent before open ing the Container. Thus, 2 0 8 patients actually received study m e d i c a t i o n . ' So, three Containers w e r e random-ised but not used. Two of them w e r e p rov ided for females, one for a man ( M 0 4 5 , conta in ing Thyroidinum). In a d d i t i o n , just once dur ing the trai l , one of the physicians on duty, by mistake, g a v e the study medicat ion out of a Container f rom the set p rov ided for female patients (Fl 16, conta in ing p lacebo) to a male patient. O f course, in the analysis this medicat ion was

counted for a male patient. Hence, to reconstruct the or ig ina l randomisat ion numbers of males it is necessary to a d d one Thyroid inum male ( M 0 4 5 ) a n d to subtract o n e p lacebo male (Fl 16), resulting in 2 7 T h y r o i d i n u m a n d 3 0 p l a c e b o males. A di f ference of three men is compat ib le wi th stratif ied randomisa­t ion in blocks of 6: M 0 5 5 - M 0 5 7 were p l a c e b o .

Instead of per fo rming an exp lo rato ry study befo re , w e des igned a n d c o n d u c t e d a two-step tr ial a c c o r d i n g to the sequent ial p l a n , w i th an inter im analys is after 5 0 patients. A s ign i f icant result (as wel l as a devastat ing one) w o u l d have led to terminat ion of the study in an ear ly s tage. Unl ike these extremes, the inter im analys is s h o w e d a very p romis ing , yet still not s ign i f icant result (p. 3 0 in G e r m a n pub l icat ion) . For that reason w e feit e n c o u r a g e d to cont inue the tr ial under the same condi t ions , up to 2 0 8 patients. C o m p a r e d w i th the inter im analys is , however , the d i f ference in w e i g h t reduct ion between groups on the second d a y after t reatment d w i n d l e d f rom 1 8 1 g to 9 2 g , whereas the basel ine di f ferences increased. These unexpected f indings w e a k e n e d the otherwise s ign i f icant result to a non-s igni f icant level ( P = 0 . 0 9 ) .

JM Schmidt, M u n i c h , G e r m a n y

Reference 1 Schmidt JM. Die Thyreoidinum-Studie am Krankenhaus für

Naturhei lweisen, 2 0 0 1 , ISBN 3 8 3 1 1 2 2 7 1 7 , p. 3 6 6 - 4 3 6 .