Critical Appraisal for Article Therapy

What question did the study ask?

Patients : vertigo pada meniere disease
Intervention : penggunaan dosis rendah pada terapi gentamici intratympani
Comparison : meniere disease dan tanpa meniere disease
Outcome(s) : efektifnya penggunaan dosis rendah pada terapi gentamicin
intratympani
1a. R- Was the assignment of patients to treatments randomised?
What is best? Tidak dijelaskan di dalam jurnal apakah
pasien dilakukan randomised apa tidak.
This paper: Yes No Unclear
1b. R- Were the groups similar at the start of the trial?
What is best? Pada setiap grup disamakan jadwal
terapinya.

Our study included 13 patients with

Definite MD and seven patients with
NMPV. In MD group, one treatment series
consisted of a maximum of 3 weekly
intratympanic gentamicin
injections of 0.3 mL (12 mg) of gentamicin.
In NMPV group, the schedule was similar
but dosage per injection
was 0.5 mL (20 mg). Another similar series
of injections were repeated for
recurrences

terdapat dalam SUBJECT AND

METHODS (halaman 112)
This paper: Yes No Unclear
2a. A Aside from the allocated treatment, were groups treated equally?
What is best? Setiap kelompok di perlakukan sama.

Pre and posttreatment pure tone average

(PTA) (0.5, 1, 2,
3 kHz) along with SDS were compared. A
change of more than
10 dB in PTA or >15% in SDS was
considered significant. If
patient developed any hearing loss, that was
informed to the
patient and further dosing was left to the
choice of the patient

terdapat dalam SUBJECT AND

METHODS (halaman 112)
This paper: Yes No Unclear
 2b. A Were all patients who entered the trial accounted for? and were they
analysed in the groups to which they were randomised?
What is best? Penelitian ini tidak mengatakan apakah di
acak atau tidak, tetapi pasien yang selama
analisis dan follow up pada pasien meniere
disease adalah 13 pasien (hanya 10 pasien
yang tidak mengalami vertigo dan 3 pasien
mengalami vertigo). Pada non meniere
disease adalah 7 pasien (3 pasien tidak
mengalami vertigo, 3 pasien mengalami 2
episode vertigo dan 1 pasien mengalami 3
episode vertigo.)

Maniere disease : The number of

injections given in primary schedule varied
from 1 to 3 with 10 out of 13 patients
(76.9%) needing all 3
doses. Most of the patients (76.9%) didnt
have any recurrences
during the 6 months of followup. Only
three patients
had experienced episodes of definitive
vertigo.
Non meniere disease : The number of
injections given in primary schedule
varied from 2 to 3 with 6 out of seven
patients (85.7%)
needing all 3 doses. Three (42.9%) patients
didnt have any
recurrences during the 6 months of
followup. Among the rest, three patients
(42.9%) had experienced 2 episodes of
vertigo and one patient (14.3%) had 3
episodes of vertigo

terdapat dalam RESULT (halaman 113)

This paper: Yes No Unclear
3. M - Were measures objective or were the patients and clinicians kept blind
to which treatment was being received?
What is best? Penelitian ini tidak mengatakan blind
tetapi pemilihan pasien melalui rekam
medis pasien sebelumnya, pemeriksaan dan
investigasi dari data pasien.

Data was collected from patients in a

specially designed case
record form by taking detailed history,
performing relevant
examination and investigations.
 terdapat dalam SUBJECT AND
METHODS (halaman 111)
This paper: Yes No Unclear

What were the results?

1. How large was the treatment effect?

Pada pasien meniere disease adalah 13 pasien (76.9%) hanya 10 pasien yang tidak
mengalami vertigo dan 3 pasien mengalami vertigo. Pada non meniere disease adalah 7
pasien (85.7%) 3 pasien tidak mengalami vertigo, 3 pasien mengalami 2 episode vertigo
dan 1 pasien mengalami 3 episode vertigo.

Maniere disease : The number of injections given in primary schedule varied

from 1 to 3 with 10 out of 13 patients (76.9%) needing all 3
doses. Most of the patients (76.9%) didnt have any recurrences
during the 6 months of followup. Only three patients
had experienced episodes of definitive vertigo.
Non meniere disease : The number of injections given in primary schedule
varied from 2 to 3 with 6 out of seven patients (85.7%)
needing all 3 doses. Three (42.9%) patients didnt have any
recurrences during the 6 months of followup. Among the rest, three patients (42.9%) had
experienced 2 episodes of
vertigo and one patient (14.3%) had 3 episodes of vertigo

terdapat dalam RESULT (halaman 113)

What is the measure?
Relative Risk (RR) = risk of the
outcome in the treatment group / risk
of the outcome in the control group.
Absolute Risk Reduction (ARR) =
risk of the outcome in the control
group - risk of the outcome in the
treatment group. This is also known as
the absolute risk difference.
Number Needed to Treat (NNT) =
inverse of the ARR and is calculated
as 1 / ARR.
Pada meniere disease yang mengalami vertigo
menujukkan P<0.001 setelah injeksi (96.6%) dan
non meniere disease yang mengalami vertigo
menunjukkan p<0.001 setelah injeksi (90.1%).
Hasil tersebut menujukkan terapi tersebut
menurukan resiko terjadinya kegagalan.
Pada meniere disease dari 13 pasien(92.3%)
hanya 1 pasien yang mengalami vertigo yang
parah (7.7%) (P=0.337) dan pada non meniere
disease dari 7 pasien tidak ada yang mengalami
kegagalan (90.1%) (P<0.001).
Pada meniere diasease 13 pasien hanya 10
pasien berpengaruh gentamicin dosis rendah
selama 2 tahun untuk menghindari 1 orang dari
kejadian vertigo dan non meniere disease 7
pasien hanya 3 berpengaruh gentamicin dosis
rendah selama 2 tahun untuk menghindari 1
kejadian vertigo.
 KESIMPULAN

Terapi gentamicin secara intratimpani efektif untuk mengontrol vertigo pada meniere disease
(MD) dan non meniere (NMPV) disease dengan dosis rendah (<30 mg/ml) untuk
menimalkan efek samping insufisiensi vestibular kronik atau hilangnya pendengaran. Pada 13
pasien yang mengalami meniere disease dan 7 pasien mengalami non meniere diasease
(NMPV). Pada grup yang mengalami meniere diasese diberikan injeksi gentamicin secara
intratimpani selama 3 minggu dengan dosis 0.3 ml (12 mg) dan begitu juga NMPV dengan
jadwal yang sama tetapi dosis yang diberikan 0.5 ml (20 mg). Hasil dari angka terjadinya
vertigo dari kedua grup setelah terapi p<0.001 atau terapi tersebut menurunkan terjadinya
vertigo. Hasil dari meniere disease tidak yang mengalami efek samping kehilangan
pendegaran selama terapi. Maka dari itu terapi injeksi gentamicin secara intratimpani dengan
dosis rendah merupakan prosedur yang sangat efektif untuk mengontrol terjadinya vertigo
dengan pasien meniere disease maupun pasien non meniere disease (NMPV).