Apakah cara melakukan randomisasi Ya, semua pasien yang masuk dalam
dirahasiakan? kelompok kontrol maupun kelompok
eksperimen dicatat karakteristiknya dari
awal penelitian. Hal ini dibuktikan pada
metode halaman 1 paragraf ke-2 yang
dipilih yaitu wanita hamil yang
mengalami gejala mual muntah dengan
usia kehamilan 6-16 minggu yang
datang untuk periksa dan sebelumnya
belum pernah mendapatkan
penanganan terhadap mual muntahnya.
Subjects were selected only if they
sought treatment for the symptoms of
morning sickness between 6 to 16
weeks of pregnancy without having
received any treatment earlier for the
same. USG confirmed singleton
intrauterine pregnancy in all cases.
Women are excluded from the study if
they were beyond 16 weeks of
gestation, had multiple gestation,
gestational trophoblastic disease,
hyperemesis gravidarum, ovarian cyst,
gastroesophageal reflux disease or other
forms of acid peptic disorders, chronic
or serious diseases of major organs o if
the containing food, spices, or
beverages, or taking medication other
than those permitted but eh study
protocol were also excluded.
Apakah follow-up kepada pasien cukup Ya, pasien di follow up dengan jelas.
panjang dan lengkap? Dijelaskan pada metode paragraph ke-3
dan pada hasil dan pembahasan.
Terbukti bahwa terdapat 75 wanita
hamil yang menjadi subjek penelitian
dan terdapat 15 wanita tidak terfollow
up (6 pada kelompok A dan 5 pada
kelompok AB, serta 2 pada masing-
masing kelompok yang tidak memenuhi
syarat). Yang dilakuakan analisis
sampai akhir hanya 63 subjek dibagi
menjadi 34 pada kelompok A dan 29
pada kelompok B. Kelompok A
diberikan 1 tablet yang berisi 150 mg
ekstrak jahe kering diberikan 3kali
sehari dan kelompok B 1 tablet doxinate
yang berisi 10 mg doxylamine dan 10
mg pyridoxine diberikan 3 kali sehari.
Out of the total 78 subjects, 15 subjects
[19.23%], six in Group A and five in
Group AB were lost to follow-up, and
an additional four (two in each group)
were non-eligible due to protocol-
violation. The difference in withdrawal
numbers between groups was not
statistically significant. The efficacy
analysis, in essence was carried out
with the 63 subjects who competed the
study as per protocol, since withdrawn
subjects did not present for even the
first follow-up visit.
Subjects were randomly allocated
(using computer generated random
number list) to one of the following two
treatment groups- Group a: the study
drug LHR-2445AE, one tablet each
tablet containing 150 mg of
standardized extract of dried ginger)
three times daily or Group B; the
comparator drug DOXINATE, one
tablet each tablet containing
doxylamine 10 mg, as succinate, and
pyridoxine 10 mg, as hydrochloride)
two or three times daily.
Apakah pasien dianalisis di dalam grup Ya, pasien dalam kelompok kontrol
di mana mereka dirandomisasi? maupun kelompok eksperimen
dianalisis dalam grup dimana mereka
dirandomisasi. Hal ini dibuktikan pada
metode pada paragraph ke-3 bagaimana
peneliti melakukan randomisasi pada
subjek penelitian.
Subjects were randomly allocated
(using computer generated random
number list) to one of the following two
treatment groups- Group a: the study
drug LHR-2445AE, one tablet 9each
tablet containing 150 mg of
standardized extract of dried ginger)
three times daily or Group B; the
comparator drug DOXINATE, one
tablet 9each tablet containing
doxylamine 10 mg, as succinate, and
pyridoxine 10 mg, as hydrochloride)
two or three times daily. The medication
was supplied by the sponsor in coded
packaging to protect its identity from
the subject. This was, however, known
to the investigators. For each individual
subject, the study consisted of 3 weeks
of active treatment, with follow-up visits
at the end of first and second weeks.
Routine laboratory tests (blood counts,
liver function tests, serum creatinine
and fasting glucose) were done at
baseline and repeated at the end of
study to assess safety. The subjects were
followed up as per routine hospital
protocol till delivery to note any
untoward long-term effects in the fetus
or mother.
Apakah pasien, klinisi, dan peneliti Ya, peneliti blind terhahap obat yang
blind terhadap terapi? akan diberikan. Hal ini dibuktikan pada
halaman 1 pada bagian metode pada
paragraf 3. Dan diperjelas di metode
pada paragraph pertama bahwa study
ini menggunakan desain penelitian
single blind, prospective, randomized,
controlled trial.
Metode : The resent study was
designed as single blind, prospective,
randomized, controlled trial and was
conducted in accordance with good
clinical practice guidelines.
Randomization and blinding :
Subjects were randomly allocated
(using computer generated random
number list) to one of the following two
treatment groups- Group a: the study
drug LHR-2445AE, one tablet 9eavh
tablet containing 150 mg of
standardized extract of dried ginger)
three times daily or Group B; the
comparator drug DOXINATE, one
tablet 9each tablet containing
doxylamine 10 mg, as succinate, and
pyridoxine 10 mg, as hydrochloride)
two or three times daily. The
medication was supplied by the sponsor
in coded packaging to protect its
identity from the subject. This was,
however known to the investigators. For
each individual subject, the study
consisted of 3 weeks of active treatment,
with follow-up visits at the end of first
and second weeks. Routine laboratory
tests (blood counts, liver function tests,
serum creatinine and fasting glucose)
were done at baseline and repeated at
the end of study to assess safety. The
subjects were followed up as per
routine hospital protocol till delivery to
note any untoward long-term effects in
the fetus or mother.
Apakah karakteristik grup pasien sama Ya, karakteristik pasien sama. Hal ini
pada awal penelitian, selain dari terapi tertulis dalam metode paragraph ke 2.
yang diberikan? Subjects were selected only if they
sought treatment for the symptoms of
morning sickness between 6 to 16
weeks of pregnancy without having
received any treatment earlier for the
same. USG confirmed singleton
intrauterine pregnancy in all cases.
Women ere excluded from the study if
they were beyond 16 weeks of
gestation, had multiple gestation,
gestational trophoblastic disease,
hyperemesis gravidarum, ovarian cyst,
gastroesophageal reflux disease or
other forms of acid peptic disorders,
chronic or serious diseases of major
organs o if the containing food, spices,
or beverages, or taking medication
other than those permitted but eh study
protocol were also excluded.
Seberapa penting hasil penelitian ini? Hasil dari penelitian adalah jahe efektif
mengurangi mual muntah pada ibu
hamil.
Obat oral 19 10 29
47 16 63
Relative Risk Absolute Risk Number Needed to
Reduction (RRR) Reduction (ARR) Treat (NNT)
CER EER CER-EER/CER CER-EER 1/ARR
19/29 28/34 0.65-0.82/0.65 0.65-0.82 1/0.17
0.65 0.82 0.65-1.26=0.61 0.17 5.8
95% CI
3. Apakah hasil penelitian yang valid dan penting tersebut applicable (dapat
diterapkan) dalam praktek sehari-hari?
Apakah value dan preferensi pasien kita Iya, pasien telah memenuhi value
dipenuhi dengan terapi yang akan kita dari penelitian dengan pemberian
berikan? terapi jahe dapat mengurangi
keluhan mual muntah pada ibu
hamil.