Tugas Evidance Based Medicine

EVIDENCE BASED MEDICINE OF REPETITIVE TRANSCRANIAL

MAGNETIC STIMULATION

Oleh:

Hestika Deliana, S.Ked 04054821820050

Fidyah Pratiwiw,S.Ked

Vicra Aditya, S.Ked

Pembimbing : dr. Achmad Ridwan, MO, M.Sc

BAGIAN ILMU KEDOKTERAN MASYARAKAT- ILMU KEDOKTERAN

KELUARGA FAKULTAS KEDOKTERAN UNIVERSITAS SRIWIJAYA

2019
 SKENARIO
Roger, a 26 year old student, has been diagnosed with major depression. He has tried three different
antidepressant medications in the past with no improvement. Reluctant to try a further prescribed
medication he asks about non-pharmacologic alternatives. You have heard that repetitive
transcranial magnetic stimulation (rTMS) has been trialed for treatment resistant depression but
you are not sure if its effectiveness has been proven. You tell Roger that you will look into this for
him.

P Roger, a 26 year old student, with major depression, treatment-resistant depression

(treatment failure after two or more courses of antidepressants)

I Repetitive transcranial magnetic stimulation (rTMS)

C No rTMS

O Reduction in depressive symptoms, improved quality of life, remission of illness

 Clinical Question
Is repetitive transcranial stimulation effective in treating major depression?

 Search Term/Search/Keyword
repetitive transcranial stimulation AND depression
 Searching
https://www.ncbi.nlm.nih.gov/pubmed/30984044

 ABSTRACT
Background: Major depressive disorder (MDD) is common in youth and treatment
options are limited. We evaluated the effectiveness and safety of repetitive transcranial
 magnetic stimulation (rTMS) in adolescents and transitional aged youth with treatment
resistant MDD.
Methods: Thirty-two outpatients with moderate to severe, treatment-resistant MDD, aged
13–21 years underwent a three-week, open-label, single center trial of rTMS
(ClinicalTrials.gov identifier NCT01731678). rTMS was applied to the left dorsolateral
prefrontal cortex (DLPFC) using neuronavigation and administered for 15 consecutive
week days (120% rest motor threshold; 40 pulses over 4 s [10 Hz]; inter-train interval, 26
s; 75 trains; 3,000 pulses). The primary outcome measure was change in the Hamilton
Depression Rating Scale (Ham-D). Treatment response was defined as a >50% reduction
in Ham-D scores. Safety and tolerability were also examined.
Results: rTMS was effective in reducing MDD symptom severity (t = 8.94, df = 31, p <
0.00001). We observed 18 (56%) responders (≥ 50% reduction in Ham-D score) and 14
non-responders to rTMS. Fourteen subjects (44%) achieved remission (Ham-D score ≤ 7
post-rTMS). There were no serious adverse events (i.e., seizures). Mild to moderate, self-
limiting headaches (19%) and mild neck pain (16%) were reported. Participants ranked
rTMS as highly tolerable. The retention rate was 91% and compliance rate (completing all
study events) was 99%.
Conclusions: Our single center, open trial suggests that rTMS is a safe and effective
treatment for youth with treatment resistant MDD. Larger randomized controlled trials are
needed

 Critical Appraisal

VALIDITY:Are the results of the trial valid? (Internal Validity)

Yang dinilai FRISBEC

F: Patient Follow-Up Drop out pada penelitian ini adalah

Were all patients who entered the trial 7/39 x 100% = 17.9%
properly accounted for at its conclusion? Drop out pada penelitian ini
Losses to follow-up should be less than kurang dari 20%.
20% and reasons for drop-out given.
Was follow-up long enough? Enough

R: Randomization
Were the recruited patients representative of Yes
the target population?
Was the allocation (assignment) of patients Yes
to treatment randomized and concealed?

I: Intention to Treat Analysis

Were patients analyzed in the groups to Yes
which they were randomized?
Were all randomized patient data analyzed? Yes
If not, was a sensitivity or “worst case
scenario” analysis done?
S: Similar Baseline Characteristics of
Patients
Were groups similar at the start of the trial? Yes

B: Blinding
Were patients, health workers, and study Yes
personel “blind” to treatment?
If blinding was impossible, were blinded
raters and/or objective outcome measures
used?
E: Equal Treatment
Aside from the experimental intervention, Yes
were the groups treated equally?
Conflict of Interest
Are the sources of support and other No
potential conflicts of interest acknowledged
and addressed?
Summary of Article’s Validity
 Notable study strengths or weaknesses or This research is valid.
concerns?
How serious are the threats to validity and
in what direction could they bias the study
outcomes?
IMPORTANCY (What were the results?)

Yang dinilai/dihitung

CER 1

EER 0.78

RR 0.78

RRR (/RBI 0.22 (22%)

Dilihat dari RRR, dianggap
sangat bermakna (> 50%)

ARI/ABI 0.22

NNT 4.5
(diperlukan 5 orang yang
menggunakan rMTS untuk
mencegah 1 major depression
disorder)

Summary Penelitian ini tidak bermakna

secara klinis

APPLICABILIITY
Will the results help me in caring for my patient? (ExternalValidity/Applicability)

Is my patient so different to those in the No

study that the result cannot apply?
 Is the treatment feasible in my setting? Yes

Will the potential benefits of treatment Yes

outweigh the potential harms of treatment
for my patient?

Present Absent Total

Experiment 14 4 18

Control 14 0 14