Critical Appraisal On Therapy Articles

Nama Alberthus Donni Budi Prasetya

Nomor Mahasiswa 15151
Kelompok / Group 8/ B
Judul Jurnal Comparison of PPIs and H2-receptor antagonists
plus prokinetics for dysmotility-like dyspepsia

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

What question did the study ask?

Patients : Pasien dengan dysmotility-like dyspepsia fungsional

Intervention : Diberi H2-receptor antagonists dan prokinetics
Comparison : Diberi obat PPIs (Proton Pump Inhibitors)
Outcome : Penurunan score dysmotility-like dyspepsia symptom dan kepuasaan
pasien setelah 28 hari

1a. Was the assignment of patients to treatments randomised?

Ya. Dikatakan di dalam jurnal bahwa penelitian ini menggunakan sistem randomized
open label trial di 3 rumah sakit dan 9 klinik medis. Pembagian pasien pun menggunakan
central computergenerated randomization. Para pasien pun mendapat salah satu dari
treatment secara acak.

Page 1518 (Materials and Method) This study was a randomized open-label trial conducted
in three hospitals (Moriguchi Keijinkai Hospital, Osaka Saiseikai Nakatsu Hospital, and
Arisawa General Hospital) and nine general medical clinics (Murotani Clinic, Majima Clinic,
Morikawa Clinic, Hashimoto Clinic, Kiyota Clinic, Arisawa General Hospital, Amemoto Clinic,
Isowa Clinic, and Mii Clinic) in Japan from January 2009 until April 2010.

Page 1518 (Material and Method) Subjects were randomly allocated to receive one of the
following treatments for 4 wk: (1) rabeprazole 10 mg od (PPI); or (2) famotidine 10 mg bid
plus mosapride 5 mg tid (H2RA + Prok).

Page 1518 (Materials and Method) Group allocations were assigned in equal numbers
using a central computergenerated randomization list stratified for each participating
institution. Subject compliance was assessed by counting the returned medication. Subjects
were considered to have complied with treatment if they took at least 75% of the dispensed
medication. Subjects attended their clinic at randomization and after 4 wk of treatment.
1b. Were the groups similar at the start of the trial?
Ya. Dijelaskan di dalam jurnal bahwa subject yang diuji di kedua grup memiliki characteristic
yang hampir sama. Dijelaskan pula di dalam table yang juga menunjukan bahwa perbedaan
subject di kedua grup hampir sama.

Page 1519 (Results) Baseline demographic

characteristics and symptom scores of the
patients who completed the treatment period
are given in Table 1. There were no significant
differences between the characteristics of the
two treatment groups at baseline.

2a. Aside from the allocated treatment, were groups treated equally?
Ya, karena di dalam jurnal diketahui bahwa semua subject mendapat perlakuan yang sama
kecuali untuk treatment yang memang diuji. Keda grup mendapat perlakuan dan larangan
yang sama dari pihak peneliti.

Page 1518 (Materials and Methods) Nonsteroidal anti-inflammatory drugs, acetylsalicylic acid or
steroids were not permitted at any time during the study.

2b. Were all patients who entered the trial accounted for? - and were they analysed in
the groups to which they were randomised?

Ya. Semua subject, baik yang included maupun yang excluded dilaporkan di jurnal. Di mana
dari 146 pasien, 32 pasien yang excluded saat follow up. Menghasilkan 57 orang di masing
masing treatment yang dilakukan sampai selesai. Semua pasien diperlakukan dengan
treatment yang sesuai di grupnya masing masing,yang dipilih secara random. Dan dikatakan
adanya intention to treat pada penelitian ini.

Page 1519 (Material and Methods) Data are presented as mean SD. The intention-to-
treat analysis included all randomized subjects. A subject who withdrew at any time was
considered a dropout.

Page 1519 (Results) A total of 146 patients were randomized. Thirty-two patients were
excluded in the follow-up period (30 lost to follow-up, two for non-compliance), leaving 114
patients for inclusion in the analysis. Fifty-seven patients were randomized to receive PPI
treatment, and 57 to receive H2RA + Prok treatment (Figure 1).

3a. Were measures objective or were the patients and clinicians kept blind to which
treatment was being received?
Tidak Jelas. Karena di dalam jurnalnya sendiri tidak disebutkan secara langsung bahwa
penelitian ini di lakukan secara blind. Tidak dituliskan apakah menggunakan sistem double
blind atau tidak. Hanya disebutkan bahwa penelitian ini sistem randomized open label trial.
What were the results?

1. How large was the treatment effect?

Subject Satisfaction
Totals
Yes No
a b a+b
PPI
50 7 57
Treatment
c d c+d
H2 RA + Prok
34 23 57
Totals a+c b+d a+b+c+d
84 30 114

1. Control Event Rate (CER) = a/(a+b) = 50/57 = 87,7%

Kemungkinan terjadinya kepuasan pasien penderita dyspepsia fungsional dengan
pengobatan PPI adalah sebesar 87,7%.

2. Experimental Event Rate (EER) = c/(c+d) = 34/57= 59,6%

Kemungkinan terjadinya kepuasan pasien penderita dyspepsia fungsional dengan
pengobatan H2 RA + Prok adalah sebesar 59,6%.

3. Relative Risk (RR) = EER/CER = 59,6/87,7= 0,68

Kemungkinan terjadinya kepuasan pasien dyspepsia fungsional yang diberikan
treatment H2 RA + Prok adalah 0,68 kali dibanding dengan treatment PPI.

4. Absolute Risk Reduction (ARR) = ( |CER EER| ) = ( | 87,7% 59,6 %| ) = 28,1 %

Keuntungan absolut dengan treatment PPI adalah sebesar 28,1% dalam memberi
kepuasan kepada pasien dengan penyakit dyspepsia fungsional.

5. Relative Risk Reduction (RRR) = ( |CER EER| ) / CER =

( |87,7 % - 59,6 %| ) / 87,7 % = 0,32
Treatment menggunakan H2 RA + Prok membuat pasien dengan dyspepsia
fungsional puas 0,32 kali dibanding dengan treatment PPI.

6. Number Needed To Treat (NNT) = 1/ARR = 1/28,1% = 3,5 ~ 4

Butuh 4 orang untuk diberi pengobatan dengan H2 RA + Prok dalam 28 hari untuk
mencegah 1 pasien yang tidak puas.

2. How precise was the estimate of the treatment effect?

Confidence Interval (CI) menunjukan presisi dan ketepatan hasil penelitian

tersebut. Confidence Interval (CI) ARR dapat dihitung dengan rumus:

95%CI =

95%CI =
95%CI = 1,96 x 0,00424 + 0,00198

95%CI = 0,154

95% CI ARR = 28,1% 15,4% 95% CI ARR = 0,127- 0,435

Artinya karena nilai CI cukup sempit, bisa diartikan bahwa hasil penelitian
bisa merefleksikan secara precise dan tepat nilai sebenarnya di populasi.