Download Features of Drugs used in IBD

Features of Drugs used in IBD
ALTERNATIVE MEDICATIONS
Alfred Gangl, MD
Professor of Gastroenterology and Hepatology
Medical University of Vienna, Austria
Falk Symposium 159, ISTANBUL, May 2007
ALTERNATIVE MEDICATIONS
Definition:
MEDICATIONS USED IN COMPLEMENTARY AND ALTERNATIVE
MEDICINE ( CAM )
Frequency of Use:
Mostly used:
30 - 50 % of Patients
With IBD in Europe and
North America
Homeopathy
Herbal Medicine
50 %
HOMEOPATHY (established 1810)
(Christian Friedrich Samuel Hahnemann, 1755 - 1843)
PubMed,Google,Medline Search, May 2007:
No clinical study reported to assess
Preparations and their efficacy in IBD
Critique:
Are clinical effects of homeopathy Placebo
effects ?
(A.Shang et al. Lancet 366,726-732;2005)
Degrees in homeopathy slated as unscientific
([email protected] 21 March 2007)
doi:10.1038/446352a
HERBAL DRUGS USED AND
TESTED IN IBD
Plantago ovata seeds
Boswellia serrata
(gum resin and extract H15)
Aloe vera gel
Wheat grass juice
Germinated barley
PLANTAGO OVATA SEEDS (dietary
fiber) COMPARED with MESALAMINE in
MAINTAINING REMISSION in UC.
(F Fernandez-Banares et al. Am J Gastroenterol 1999; 94:427-433.Spain)
AIM: assess efficacy and safety of PO over a period of 12 months
OBJECTIVE: Colonic fermentation of PO yields BUTYRATE
METHODS: 102 Patients with UC in remission randomized into 3 Groups
A PO-group: n=35 received PO seeds, 10 g twice daily
B MESALAMINE-group: n=37 , 500 mg 3 x daily (1.5 g total)
C PO plus MESAL.-group: n=30 , 20 g PO plus 1.5 g Mes./day
RESULTS: Failure Rate in Group A: 40%
Group B: 35%
Group C: 30%
CONCLUSION: Plantago ovata seeds might be as effective
as Mesalamine to maintain remission inUC
BOSWELLIC ACIDS IN IBD
> BOSWELLIC ACIDS INHIBIT THE LEUKOTRIENE BIOSYNTHESIS in neutrophilic granulocytes by INHIBITION
of 5-LIPOXIGENASE
(Ammon,Wien.Med.Wschr.2002:152;373 - 378)
> A SEMISYNTHETIC FORM OF acetyl-11-keto-betaBoswellic acid (sAKBA) CONFERS PROTECTION IN
EXPERIMENTAL MURINE COLITIS induced by Dextran
Sodium Sulfate
(Anthoni C et al.:AM J Physiol Gastrointest Liver Physiol,
2006; 290: G1131 - 7)
THERAPY OF ACTIVE CROHN´s
DISEASE WITH BOSWELLIA
SERRATA-EXTRACT H 15
(H.Gerhardt et al.: Z Gastroenterol 2001; 39: 11 - 17)
METHODS: Randomised,double-blind,verum-controlled
parallel group-Comparison for 8 weeks
PATIENTS: 102 pts.randomised, 19 drop out pts.
83 pts per protocol
H 15: n = 44; Boswellia extract,3x3 Tbl 0.4g (3.6g/d)
CONTROL: n = 39; Mesalazin 0.5g,3x3 Tbl (4.5g/d)
RESULTS:
CDAI reduced: by 90 in H15, by 53 in Mesalazin
CONCLUSION:
H15 not inferior to Mesalazin, in Benefit-Riskevaluation even superior over Mesalazin.
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
TRIAL OF Aloe vera gel FOR Active ulcerative colitis.
(L. Langmead et al.: Alimentary Pharmacology Therapeutics 19: 739-74;2004)
AIM: Evaluation of efficacy and safety of aloe vera gel
METHODS:
100 ml Aloe vera gel or Placebo orally twice daily
for 4 weeks
Outcome measures: Clinical,Endoscopic,Histologic Remission
Patients randomized
n = 49
Evaluable Patients
n = 44
Patients given Aloe vera
n = 30
Patients completing Study
n = 24
Patients given Placebo
n = 14
Patients completing Study
n = 11
RESULTS: Clinical Remission: 30 % in Aloe vera
7% in Placebo
Sigmoidoscopic Scores: Not different
Adverse Events: minor, similar in both groups
CONCLUSIONS: Further evaluation is needed
WHEAT GRASS JUICE IN THE TREATMENT OF
ACTIVE DISTAL ULCERATIVE COLITIS
A randomized double-blind placebo-controlled trial.
E Ben-Arye et al.:Scand J Gastroenterol 2002; 37: 444 -449
METHODS: 100 ml of wheat grass juice
or matching Placebo daily for 1 month
Randomized Patients
n = 24
Wheat Grass Juice
n = 12
Placebo Juice
n = 12
RESULTS: DAI improved in 10 Wheat grass Pts.
versus 5 Placebo
Rectal Bleeding improved in 9 Wheat grass Pts.
versus 7 Placebo
Several clinical symptoms tended to improve
CONCLUSION: Wheat grass juice is safe
and may prove to be beneficial.
GERMINATED BARLEY FOODSTUFF
Prolongs remission in Patients with ulcerative colitis.
(H Hanai et al.:Internat J Molec Med 13: 643 - 647; 2004)
BACKGROUND: Prebiotic, increases luminal Butyrate production by Bifidobact.and Eubact.limosum
AIM: Test efficacy of GBF as maintainance therapy in
59 UC Patients in remission
37 Pts. „conventional treatment“(5-ASA and/or steroids)
22 Pts. „conventional treatment“ plus 20g/d of GBF
for 12 months
RESULTS: CAI values and tapering
of steroid dose better in GBF (p<0.05)
CONCLUSION: GBF safe and
effective to prolong remission in UC.
HERBAL and various other
„NATURAL MEDICINES“ used
and tested in IBD
CHINESE MEDICINAL HERBS
Jian Pi Ling
(Sophora flavescens, radix, flos)
tablets
Yukui tang tablets
(herbal decoction enemas)
CURCUMIN
BOVINE COLOSTRUM ENEMAS
SEAL OIL
ACUPOINT CATGUT EMBEDDING
ACUPUNCTURE WITH MOXIBUSTION
CHINESE MEDICINAL HERBS
CLINICAL STUDY IN TREATING INTRACTABLE ULCERATIVE
COLITIS WITH TRADITIONAL CHINESE MEDICINE.
(Zhongguo Zhong Xi Yi Jie He Za Zhi. 1994 Jul; 14 (7): 400 -2 )
METHODS: 153 pts were randomized into 3 treatment groups
Group I: Jian Pi Ling tablet with retention enema of
Radix Sophorae flavescentis and Flos Sophora
decoction per night
Group II: SASP and retention enema of Dexamethasone
Group III:Placebo with retention enema as in Group I
After 90 days fiberendoscopy,check for pathologic and immunologic
parameters in every patient and group comparison
RESULTS: Curative rates in Group I,II,III were 53% 28% 19%
Total effective rates in I,II,III were 86% 60% 45%
Group I : B-lymphocytes decreased markedly
CONCLUSION: Group I had best therapeutic program .
CURCUMIN THERAPY:
Pilot study in 5 pts with UC and in 5 pts with CD
(P.R.HOLT et al.: Dig Dis Sciences 2005; 50: 2191 - 2193)
Curcumin, a spice component (turmeric) administered in
Open label study for 12 weeks: 9 of 10 Pts.improved
Need for double-blind placebo-controlled follow up
studies postulated.
BOVINE COLOSTRUM ENEMA:
Pilot study in 14 pts with distal UC ( 4 weeks)
(Z.KHAN et al.:Aliment Pharmacol Ther 2002; 16: 1917 - 1922)
N = 8 : Colostrum enema 100 ml,
2 x daily (10% solution)
N = 6 : Placebo (albumin solution)
Both groups: Mesalazine, 1.6 g/d
Reduced joint pain after short-term duodenal
administration of SEAL OIL in Patients with IBD.
(T. Bjorkkjaer et al.: Scand J Gastroenterol 2004 ; 39:1088 -94)
PATIENTS: 19 with extraintestinal manifestation
of joint pain (9 Crohn, 10 UC )
TREATMENT: 10 ml SEAL OIL or 10 ml SOY OIL
via Nasoduodenal feeding tube, 3 times daily for 10 days
RESULTS: SEAL OIL reduced
(P<0.05)
duration of morning stiffness
number of tender joints
intensity of pain
doctors scoring of rheumatic disease activity.
Beneficial effects of SEAL OIL at day 10 lasted up to
6 months whereas SOY OIL tended to aggravate condition
ACUPOINT CATGUT EMBEDDING THERAPY
FOR TREATMENT OF ULCERATIVE COLITIS
( LI HJ et al.:ZHONGGUO ZHEN JIU 2006; 26: 261 - 3 . Article in Chinese)
METHODS: 116 Pts. with UC, randomized into 2 groups
TREATMENT GROUP: n = 56 catgut embedding at
several traditional acupoints
CONTROL GROUP: n = 60 Salicylazosulfapyridine,
4 - 6 g / day
Clinical symptoms and endoscopy before and at weeks 4 and 6-8
after treatment compared between groups.
RESULTS: Therapeutic effects in the treatment group better
than in control group (No details given in abstract)
CONCLUSION: Acupoint Catgut Embedding Therapy has better
therapeutic effect on UC with less adverse reactions.
ACUPUNCTURE and MOXIBUSTION
TREATMENT of ULCERATIVE COLITIS:
Randomized controlled study by S Joos et al (Germany)
Scand J Gastroenterol 2006; 41: 1056 - 63
PATIENTS: n = 29 with mild to moderately active UC
n = 15 traditional acupuncture and moxa
n = 14 sham acupuncture (Control group)
METHODS:
All Pts. treated in 10 sessions over a period of 5 weeks
and followed up for 16 weeks
Main outcome: Changes in CAI, QOL,well being,markers
of inflammation
RESULTS: CAI decreased from 8.0 to 4.2 in TCM
from 6.5 to 4.8 in Controls
In both groups significant improvements in
general well being and QOL, however,
NO DIFFERENCES BETWEEN GROUPS
CONCLUSIONS: Traditional and sham acupuncture
seem to offer some therapeutic benefit.
SUMMARY
¾Alternative therapies are frequently used,
¾Homeopathy has not been tested in IBD.
¾Herbal drugs have been tested in IBD,
mostly in small groups of patients
¾Plantago ovata seeds may be considered
as effective in mild to moderate UC
> Boswellia serrata in CD.
> Jian Pi Ling tablets reported (in Chinese)
to be effective in „intractable“ UC should
not be used outside TCM.
CONCLUSION
¾Preliminary studies with Aloe vera,wheat
grass juice, germinated barley food stuff,
seal oil, acupuncture and acupuncture
with moxibustion etc in IBD look promising.
¾Further trials are welcome not only to
evaluate efficacy in IBD but even more
importantly safety and toxicity.
¾ Regulations on purity,admixture of
potentially harmful impurities and on
stability of herbal drugs are needed.
An Oral Supplement Enriched With Fish Oil,
Soluble Fiber, and Antioxidants for Corticosteroid Sparing in Ulcerative Colitis.
(A RANDOMIZED CONTROLLED TRIAL by D.L. Seidner et al.
Clin Gastroenterol Hepatol 2005;3:358 - 369)
Mild to moderate UC,
Pts.randomized
n = 121
DAI from 3 - 9 on a
Study completed by
12 point scale
n = 86
Usual Diet plus 18 oz
Nutritional Supplement
Including Vit.E,C,Selenium
Or
Carbohydrate based
Placebo for 6 months
UCNS
n =59
Study completed by
n = 36
RESULTS: Improvement in
clinical response plus
decreased requirement for
corticosteroids
Placebo
n = 62
Study completed by
n = 50