Transcript Document 7271673

Adverse Event Associated with Turmeric Preparation :
Consumer Reporting Experiences
by
Mrs. Wimon Suwankesawong
Thai Adverse Product Reaction Monitoring Center
Food and Drug Administration
Thailand
Introduction (1)

Turmeric, Curcuma longa Linn., is a
herbal plant extensively cultivated in
Thailand
Its rhizome is used in
traditional medicines for
many indications
Major chemical constituents
of rhizomes are volatile oil
(6%) and curcumenoids(5%)

Introduction (2)

In 1999,the single formulation of
turmeric was selected as herbal
medicine for the Thai National Essential
Drug list for anti-flatulence
-
250 mg powder of
dried turmeric rhizome
Introduction (3)

Turmeric is believed to be
effective and safe


adverse effect : nausea, vomiting
diarrhea constipation, pruritus,
headache, dizziness, palpitation
Curcumin, an active ingredient in
turmeric, has been reported to induce
gastric ulceration in rats
Objective

To investigate and categorize
adverse events associated with
turmeric preparations
Study design

Prospective time-series design
Method (1)


Setting
 Fifty government hospitals
Study population

Patients who prescribed turmeric
product during April 1, 2001-March
30,2003
Method (2)
Data collection


Hospital pharmacist interviewed the
patients to collect baseline data
Patients were asked to send back a
postcard with formalized questions after
1-2 weeks to report their experience using
turmeric products


Effective
Adverse event
Result (1)

Patients taking turmeric product = 978

Lost follow up
= 342 (34.96%)

Study population
= 636

Patient with adverse event
= 220 (34.59%)
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
Female
= 158 (71.8%)

Mean age
= 48

Underlying disease
= 126
Number of adverse events
= 479
Results (2)
AEs : System-organ classes
n=479 (%)
GI system disorders
 abdominal pain, n/v,
anorexia, diarrhea
186 (38.83)
Body as a whole-general
disorders
 fatigue, chest discomfort,
therapeutic response
decreased(ineffective)
148 (30.90)
Results (3)
AEs : System-organ classes n=479 (%)
Central & peripheral nervous
system disorder
 headache, dizziness
51 (10.82)
Respiratory system disorders
 dyspnoea,cough
48 (10.02)
Skin and appendages disorders 32 (0.84)
 rash, pruritus
Discussion

Lost of follow up



Direct consumer reporting system
Mild adverse event
GI system disorder

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Volatile oil : stomach distress
Follow up period : 2 week (too short)
Quality of products : ineffective
Compliance : low
Conclusion

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Single turmeric product : safe
 GI system disorder
Further study
 GI system disorder associated
with single turmeric preparation

Labeled on product insert