Homeopathic%20Products

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Homeopathic Products

• Principle of analogy or Law of Similars
• Small or infinitesimal doses (3X-30C)
• Avogadros number6x1023 23X
• Succussion and potentization (see
  http//www.boiron.com/en/htm/02_medi_homeo/prepa_m
  edi.htm)
• Ultra-high dilution effects
• Final product
• World Market
• USA

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Evidence??

• In vitro studies
• Animal studies
• Human studies
• Meta-analyses of human studies
• Implausibility, entrenched skeptics and
  overenthusiastic zealots

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In Vallance AK. J Alt Compl Med 1998449-76.
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In Vallance AK. J Alt Compl Med 1998449-76.
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In Vallance AK. J Alt Compl Med 1998449-76.
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Linde et al. Lancet 1997350834-843
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Reilly et al. Lancet 19943441601-06
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Jacobs et al. J Alt Compl Med 20006131-139
n126 in Nepal
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Jacobs et al. J Alt Compl Med 20006131-139
n126 in Nepal Jacobs et al. Pediatrics
199493719-725. N81 Nicaraqua
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Jacobs et al. Pediatr Infec Dis 200120177-183.
N75
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Jacobs et al. Pediatr Infec Dis 200120177-183.
N75
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Shang et al. Lancet 2005366726-732
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Shang et al. Lancet 2005366726-732
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Shang et al. Lancet 2005366726-732
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Shang et al. Lancet 2005366726-732
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Shang et al. Lancet 2005366726-732
Odds ratio for large, high quality trials (the
lower the value the higher the benefit) Homeopath
. N8 OR0.88 Conventional.
N6 OR0.58 Conclusions clinical effects of
homeopathy are placebo effects Critique how
about giving the OR for all included studies and
also the OR for thehigher quality studies (n21
for homeopathy and n9 for conventional). The
selection of clinical topics for study seem to
favor conventional drugs, e.g. respiratory
infections.
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http//www.homeopathicpharmacy.org/index.htm
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• Probiotics Terms
• Probiotic Probiotics are live microorganisms
  (bacteria or yeasts) which, when administered in
  adequate amounts, confer a health benefit on the
  host
• Prebiotic - nutritional supplement taken to
  increase the amounts of beneficial bacterial in
  the gut or vagina. Example FOS (fructose
  oligosaccharides)
• Biotherapeutic agent - microorganism used for
  specific therapeutic activity in humans
• Nutriceutical - food products with beneficial
  effects in preventing or treating diseases

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Predominant Flora Stomach
Stomach (0-103 cfu/ml) Gram aerobes,
Lactobacillus Streptococcus
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Predominant Flora Vagina
Vagina diverse aerobes anaerobes including
Lactobacillus jensenii, Lactobacillus
acidophilus, Lactobacillus casei.
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Predominant Flora Urinary Tract
Kidneys sterile
Bladder sterile
Urethra 101-102 E. coli
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Predominant Flora Intestines
Small intestine Proximal ileum (103-104 cfu/ml)
aerobic GramDistal ileum (1011-1012 cfu/ml)
Gram- anaerobes
Colon (1011-1012 cfu/ml) Bacteroides,
Eubacteria, Peptostreptococci, E. coli,
Bifidobacterium, Fusobacteria
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Functions of Normal Flora

• Digestion
• Production of vitamins
• Mucosal maturation
• Stimulate Immune System
• Attachment
• Intestinal transit
• Colonization resistance

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• Use of Probiotics for infections in Controlled
  Trials in Humans
• Prevention of Diarrhea
• Antibiotic associated diarrhea
• infantile diarrhea
• travelers diarrhea
• Treatment of Diarrhea
• Clostridium difficile disease
• HIV associated diarrhea
• acute diarrhea
• Prevention of vaginitis
• Miscellaneous situations

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Saccharomyces boulardii and Antibiotic Associated
Diarrhea in Hospitalized PatientsN180 site
University of Washington
Start Antibiotic
Stop Antibiotic
Stop Study
yeast or placebo continued for 14d
Start yeast or placebo
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Surawicz et al., Gastroenterol. 198996981
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Saccharomyces boulardii and Beta lactam
Antibiotic Associated Diarrhea in Hospitalized
PatientsN193 site University of Washington,
University of Kentucky
Start Antibiotic
Stop Antibiotic
Stop Study
yeast or placebo continued for 3d
Start yeast or placebo
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McFarland et al. Am J Gastroenterol
199590439-448
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Lactobacillus GG and AAD in childrenVanderhoof
et al. J. Pediatrics 135564-568,1999n202
outpaitnet children receiving oral antibioitcs
diarrhea26P, 8T
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DSouza et al., BMJ 20023241361
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Lactobacillus GG Prevention of Infantile
Nosocomial Diarrhea Methods

• DBPC in Poland
• 81 hospitalized children (1-36 months old)
• No diarrhea on admission
• Randomized during stay L. GG (12 x 109
  CFU/d) Placebo

Szajewska H. J Pediatr 2001138361-5.
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Lactobacillus GG Prevention of Infantile
Nosocomial Diarrhea Results
33.3
plt0.05
16.7
6.7
2.2
Placebo (n36)
L. GG (n45)
Szajewska H. J Pediatr 2001138361-5.
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Probiotic Prevention of Travelers Diarrhea NYC
travelers to developing countries n225 (Hilton
et al. J. Travel Med 1997441-43) 7.4/exposure
day for placebo 3.9/exposure day for
Lactobacillus GG (p0.05) Austrian travelers
to Turkey n-1016 (Kollaritsch et al. Fortschr
Med 1993111152-156) 39.1 placebo 28.7 S.
boulardii (p0.02)
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Lactobacilli and Pediatric Diarrhea Treatment (L.
rhamnosus and L. reuteri in hospital setting)
N69 Rosenfeldt et al., Pediatr Infec Dis
200221411
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Huang, et al., Digestive Diseases and Sciences,
Vol.47, No. 11 (Nov 2002)
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McFarland et al., JAMA 271, 1913-1918, (1994).
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S. boulardii High Dose Vancomycin for
Recurrent C. difficile Disease
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p0.05
16.7
S. boulardii (n18)
Placebo(n14)
Surawicz CM. Clin Infect Dis 2000311012-7.
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Other Uses for Probiotics

• Crohns Disease
• Ulcerative Colitis
• Pouchitis
• Allergy/Exema
• Irritable Bowel Syndrome Dental caries
• High Cholesterol Urinary Tract Infections
• Helicobacter pylori
• Lactose Intolerance
• Candida vaginal infections
• Bacterial Vaginosis
• Limited evidence

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Table 6.1. Controlled clinical trials
evaluating probiotics and Crohns
disease   Probiotic N Result Ref L.
rhamnosus GG 45 10.5 placebo 16.6 LGG,
ns Prantera 7 L. rhamnosus GG 11 2/4
relapse placebo 3/5 relapse LGG, ns Schultz
8 Saccharomyces boulardii 17 4.6 stools/day
placebo 3.3 stools/day in Sb Plein
9 Saccharomyces boulardii 32 6/16 relapse in
mesalamine 1/16 relapse in mesalamine/Sb
Guslandi 10 E. coli Nissle 1917 28 7/12 relapse
in prednisone 4/12 relapse in
prednisone/Ec Malchow 11   probiotic
significantly better than control, plt0.05
nsprobiotic not significantly different than
control
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Table 6.2. Clinical trials evaluating
probiotics and ulcerative colitis   Probiotic N
Result Ref E. coli (Nissle 1917) 116 73
relapse in mesalamine 67 relapse in Ec, ns
Rembacken 16 E. coli (Nissle 1917) 103 11
relapse in mesalamine 16 relapse in Ec,
ns Kruis 17 E. coli (Nissle 1917) 327 36
relapse in mesalamine 45 relapse in Ec,
ns Kruis 18 Saccharomyces boulardii 24 17/24 had
successful outcome Guslandi 10 VSL3
(mix) 20 15/20 had no relapse in 12
months Venturi 19   ns probiotic not
significantly different than standard treatment
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Lactobacillus GG to PreventInfantile Atopic
Disease

• DBPC in Finland
• Family history atopic disease (eczema, allergic
  rhinitis, asthma)
• Mothers randomized Lactobacillus GG (1 x 1010
  CFU/d) Placebo
• Mothers treated 2-4 weeks before deliveryInfants
  treated for 6 months
• Followed for 2 years

Kalliomaki M. Lancet 20013571076-9
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Lactobacillus GG and Infantile Atopic Disease
Results
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p0.008
23
L. GG (n64)
Placebo (n68)
Kalliomaki M. Lancet 20013571076-9
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Potential Advantages and Disadvantages of
Probiotics
Advantages
Disadvantages
Multiple Mechanisms of Action Resistance is
Infrequent Use May Reduce Exposure to
Antibiotics Delivery of Microbial Enzymes Well
Tolerated Benefit to Risk Ration is Favorable
Few Controlled Trials Persistence
Possible Translocation Possible Transfer of
Resistance Plasmids? Infection Possible Quality
Control Issues Regulatory Issues in USA
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Evidence supporting commercially available (USA)
probiotics
condition L. acidophilus L. reueri LGG Sb
AAD Uneven Good Good Good
Acute Adult ? ? Good Good
Acute pediatric ? ? Good Good
Traveler diarrhea ? ? Fair Fair
C. dif ? ? Limited Good
BV Good Good ? ?
L. acidophilusLactinex L. reueriProbiotica
LGGCulturelle SbFlorastor strains tested
not yet available in USA
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• Probiotics Summary
• Living microorganisms with multiple mechanisms of
  action
• Good safety profile
• Some applications to prevent and treat infectious
  diseases
• An alternative to antibiotics in some situations
• May have other applications, e.g. allergy,
  cancer, colitis, Crohns Disease, Ulcerative
  Colitis, IBS
• Product selection is very important