Evidence-Based Medicine: Irene Bayubay Cory Dayag Aimie Klain Quillope Reniere Lagazo

EVIDENCE-BASED MEDICINE
IRENE BAYUBAY
CORY DAYAG
RENIERE LAGAZO
AIMIE KLAIN QUILLOPE
General Data
Name: M.V
Age:35
Sex: Female
Address: Iguig Cagayan
Religion: Roman Catholic
DOB: 1/19/84
Date of Consult: 1/6/2020
Chief Complaint
Dizziness
HISTORY OF PRESENT ILLNESS
2 weeks PTC patient started to complain of
dizziness describe as rotatory usually occur
after heavy work , and relieve by taking
rest. No consult done , no medication
taken.
1 week PTC dizziness became more
frequent now associated with occasional
tinnitus. Still no consult done.
3 days PTC still with above sing and
symptom thus consult done.
REVIEW OF SYSTEMS
(+) Occasional headache
(+) Occasional nausea
(-) vomiting
(-)nape pain
(-)chest pain
(-)DOB
(-)abdominal pain
(-)Dysuria
(-)polyuria
(-) nocturia
(-) weight loss
PAST MEDICAL HISTORY
(-) HPN
(-) History of previous hospitalization
(-) History of previous surgery
PERSONAL SOCIAL
-housewife
-non smoker
-non alcoholic
PHYSICAL EXAMINATION
- Conscious and coherent
- No pallor, no jaundice, no cyanosis
- Anicteric sclera, pink palpebral conjunctiva, no CLAD
- Symmetrical chest expansion, no retractions, CBS
- Adynamic precordium, NRR, no murmur, PMI at 5th ICS LMCL
- Globular soft non tender abdomen
-grossly female
-no gross deformity, FEP
Clinical Dilemna
Is Ginkgo Biloba as effective
as Betahistine in the
treatment of vertigo, using
RCT?
P: patients with vertigo
I: Ginkgo Biloba vs Betahistine
C:
O: treatment of vertigo
M: RCT
Treatment of vertigo and gingko biloba betahistine
CRITICAL APPRAISAL
• Is it relevant?
• Is it valid?
• What are the results?
• Is it applicable to my
patient?
Is it relevant?
• The study is conducted to compare the efficacy and
safety of ginkgo biloba and betahistine in the treatment of
vertigo.
Is it valid?
1. Was the assignment of patients randomized?
Randomization stratified by centers was carried out by the
sponsor’s biometrics department using a validated
computer program that matched treatments to drug
numbers in a 1 : 1 ratio
Is it valid?
2. Were all the patients who entered the trial properly
accounted for and attributed at its conclusion?
Of 169 patients screened, 160 were eligible, received
treatment as randomly allocated, and were included in the
full analysis set (EGb 761, 80 patients; betahistine, 80
patients). Three patients in the EGb 761 group (unexpected
improvement/remission, 1 patient; violation of inclusion/
exclusion criteria, 2 patients) and two patients in the
betahistine group (withdrawal of informed consent without
giving the reason) terminated the study prematurely.
Is it valid?
3. Were patients, the clinicians and study personnel “blind” to
treatment?
Blinding was achieved by a double-dummy technique: that is, all
patients received the same number of film-coated tablets (EGb 761
or placebo) and capsules (betahistine or placebo) in a way that
each patient received only one active drug. Drug and placebo
tablets and drug and placebo capsules, respectively, were
indistinguishable in appearance and taste; all packages and labels
were identical except for the drug numbers. Each patient was
handed the drug package with the lowest drug number still
available at the recruiting site. This procedure guaranteed blinding
of patients, investigators, and site staff, concealment of allocation,
and balance of treatment group sizes.
Is it valid?
4. Were the groups similar at the start of the trial?
Is it valid?
5. Were the groups treated equally?
The treatment period was 12 weeks, during which patients
took either 240 mg per day (120 mg b.i.d.) Ginkgo biloba
extract EGb 761 or 32 mg per day (16 mg b.i.d.) betahistine
dihydrochloride.
Is it valid?
6. Overall, is the study valid?
Yes
What are the results?
1. How large was the treatment effect?
With a sample size of 80 patients per treatment arm the
study did not have statistical power to prove equivalence of
the two treatments. The findings should therefore be
interpreted as descriptive.
In this randomized, double-blind, multicenter clinical trial, we
found Ginkgo biloba extract EGb 761 and betahistine to be
equally effective in the treatment of vertigo.
However, with a sample size of 80 patients per treatment
arm the study did not have statistical power to prove
equivalence of the two treatments. The findings should
therefore be interpreted as descriptive.
Are the results applicable to my
patient?
• This study provides evidence that Ginkgo biloba extract
EGb 761 is at least as effective as the world’s most
frequently prescribed antivertiginous agent, betahistine, in
the treatment of unspecified vertiginous syndromes
Are the results applicable to my
patient?
• Are the likely treatment benefits worth the potential harm
and costs?
4G (ginkgobiloba)= 23pesos
Vert (betahistine)= 48 pesos

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