BIDANG KESEHATAN
TELAAH ARTIKEL :
A DOUBLED-BLIND, CROSSOVER-RCT IN T2DM FOR EVALUATING
HYPOGLYCEMIC EFFECT OF P. INDICUS, M. CHARANTIA, P. VULGARIS AND
A. PANICULATA IN CENTRAL JAVA
Disusun Oleh :
Hestika Wulandari (0613520029)
Peminatan Promosi Kesehatan
Kelas Reguler
B. PEMBAHASAN
Pada penelitian yang berjudul “A Doubled-Blind, Crossover-RCT In T2DM For
Evaluating Hypoglycemic Effect Of P. Indicus, M. Charantia, P. Vulgaris And A. Paniculata
In Central Java” yang ditulis oleh Mahalul Azam, Charles Ong Saerang , Sri Ratna Rahayu,
Fitri Indrawati, Irwan Budiono, Arulita Ika Fibriana, Muhammad Azinar, Nur Anna C.
Sa'dyah, Erwin Budi Cahyono, dan Ronny Lesmana yang terbit pada tahun 2016 ini,
meneliti ekstrak campuran Pterocarpus indicus, Momordica charantia, Phaseolus vulgaris
dan Andrographis paniculata dapat menurunkan glukosa plasma pada pasien Diabetes
Mellitus (DMT2) Tipe 2. Empat puluh Tiga (43) pasien DMT2, yang terdiri dari 10 laki-
laki dan 33 perempuan berpartisipasi dalam studi klinis terkontrol positif, double-blind, dan
crossover ini dengan pemberian ekstrak campuran (22 mg/kgBB) atau glibenklamid 5 mg
setiap hari saat sarapan. Perlakuan pemberian ekstrak atau glibenklamid diberikan selama
satu bulan, kemudian obat diganti setelah satu minggu periode washout dan terakhir
diberikan terapi kombinasi setelah periode wash out juga. Kemanjuran ekstrak campuran
diukur dengan menggunakan Glukosa Plasma Puasa (FPG) dan Glukosa Plasma
Pascaprandial (PPG) dua jam. Empat puluh satu subjek menyelesaikan studi. Data dianalisis
menggunakan SPSS 19 dengan students T-Test, dan p<0,05 dianggap signifikan. Dalam
penelitian ini menyimpulkan bahwa pemberian ekstrak dapat menurunkan FPG dan PPG
meskipun tidak sebaik pengobatan glibenklamid sedangkan pengobatan kombinasi adalah
yang terbaik untuk menurunkan FPG.
CONSORT 2010 checklist of information to include when reporting a randomised trial*
A.
Item Reported
Section/Topic No Checklist item on page No
Title and abstract
1a Identification as a randomised trial in the title 108
1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 108
Introduction
Background and 2a Scientific background and explanation of rationale 109
objectives
2b Specific objectives or hypotheses 109
Methods
Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 109
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 109
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were
110
actually administered
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they
110
were assessed
6b Any changes to trial outcomes after the trial commenced, with reasons 110
7b When applicable, explanation of any interim analyses and stopping guidelines 110
Randomisation:
Allocation 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers),
concealment describing any steps taken to conceal the sequence until interventions were assigned 111
mechanism
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to
110
interventions
Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those
110
assessing outcomes) and how
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 110
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 112
Results
Participant flow (a 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and
111
diagram is strongly were analysed for the primary outcome
recommended)
13b For each group, losses and exclusions after randomisation, together with reasons 110
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 111
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was
111
by original assigned groups
Outcomes and 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its
110
estimation precision (such as 95% confidence interval)
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 111
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing
112
pre-specified from exploratory
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) 112
Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 113
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 113
Other information
Registration 23 Registration number and name of trial registry 108
Protocol 24 Where the full trial protocol can be accessed, if available 114
Funding 25 Sources of funding and other support (such as supply of drugs), role of funders 114
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also
recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic
trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
C. TELAAH ARTIKEL
CONSORT 2010 dikembangkan melalui kolaborasi dan konsensus antara ahli
metodologi uji klinis, pengembang pedoman, spesialis terjemahan pengetahuan, dan
editor jurnal. Terdapat beberapa bagian yang belum terjelaskan secara rinci menganut
dari “CONSORT 2010 checklist of information to include when reporting a
randomised trial”, yaitu :
1. Secara keseluruhan artikel ini telah memenuhi penulisan CONSORT mulai dari
title and abstract, hingga introduction
2. Pada item 3b – Important changes to methods after trial commencement (such as
eligibility criteria), with reasons, dalam artikel ini penentuan kriteria kelayakan
peserta penelitian hanya menyebutkan tentang usia peserta yaitu 30-60 tahun
namun tidak dijelaskan alasannya.
3. Pada item 4a - Eligibility criteria for participants, dalam artikel ini sdah
mencantumkan kriteria inklusi peserta penelitian namun belum terdapat kriteria
eksklusi peserta penelitian.
4. Pada item 7a – How sample size was determined, dalam artikel ini tidak
menjelaskan bagaimana menentukan besar sampel, hanya menyebutkan ukuran
sampel minimal 20 pasien DMT2 di masing-masing kelompok.
5. Pada item 11b Kesamaan intervensi – If relevant, description of the similarity of
interventions, penelitian ini adalah Uji Klinis Acak pertama yang melaporkan
efektivitas pengobatan herbal ekstrak campuran Pterocarpus indicus, Momordica
charantia, Phaseolus vulgaris dan Andrographis paniculata pada efek
hipoglikemik. Artikel ini tidak deskripsikan kesamaan intervensi dengan
penelitian sebelumnya secara khusus.
6. Pada poin 14a Hasil perekrutan - Dates defining the periods of recruitment and
follow-up, dalam penelitian ini tidak terdapat tanggal yang menjelaskan periode
perekrutan dan follow up.
7. Hasil penelitian tidak dapat digeneralisasikan secara luas, namun interpretasi
peneltian cukup konsisten dengan hasil, artikel ini menyampaikan keseimbangan
manfaat dan kerugian dari hasil penelitian, dan mempertimbangkan bukti relevan
lainnya.
REFERENSI :
Azam M, Saerang C, Rahayu SR, Indrawati F, Budiono I, Fibriana AI, et al. A doubled-
blind, Crossover-RCT in T2DM for evaluating hypoglycemic effect of P. Indicus,
M. charantia, P. vulgaris and A. paniculata in Central Java. J Nat Remedies. 2016 ;
16 (3) : 108–114.
Zabor EC, Kaizer AM, Hobbs BP. Randomized Controlled Trials. Chest. 2020 Jul; 158
(1S) :S79–87.
RISET DAN PENGEMBANGAN TERKINI
BIDANG KESEHATAN
Disusun Oleh :
Hestika Wulandari (0613520029)
Peminatan Promosi Kesehatan
Kelas Reguler
B. PEMBAHASAN
Rekomendasi WHO untuk melakukan aktifitas fisik bagi kesehatan menurut Global
Recommendations on Physical Activity for Health (2010)6
1. Kelompok usia: 5–17 tahun
Untuk anak-anak dan remaja, aktivitas fisik meliputi bermain, games, olahraga, jalan-
jalan, rekreasi, pendidikan jasmani, atau latihan yang telah direncanakan, dalam konteks
kegiatan keluarga, sekolah, dan masyarakat.
2. Kelompok usia: 18–64 tahun
Pada orang dewasa berusia 18-64 tahun, aktivitas fisik meliputi aktivitas fisik pada waktu
senggang, transportasi (berjalan kaki atau bersepeda), pekerjaan, pekerjaan rumah
tangga, bermain, permainan, olahraga atau latihan yang direncanakan, dalam konteks
sehari-hari, keluarga, dan kegiatan masyarakat.
3. Kelompok usia: 65 tahun ke atas
Pada orang dewasa yang lebih tua dari kelompok usia 65 tahun ke atas, aktivitas fisik
termasuk aktivitas fisik waktu luang, transportasi (berjalan kaki atau bersepeda),
pekerjaan (jika individu masih terlibat dalam pekerjaan), pekerjaan rumah tangga,
bermain, olahraga, dalam konteks kegiatan sehari-hari, keluarga dan masyarakat.
Pedoman WHO tentang aktivitas fisik dan perilaku menetap dikembangkan dengan
menggunakan, dan memperbarui secara sistematis, bukti yang dikumpulkan untuk
pengembangan pedoman aktivitas fisik nasional baru-baru ini yang memenuhi tiga kriteria
berikut: (1) telaah bukti telah dilakukan sesuai dengan standar dan proses sistematik yang
ketat dan terdokumentasi dengan baik; (2) penilaian kepastian bukti menggunakan metode
Grading of Recommendations Assessment, Development and Evaluation (GRADE) atau
metodologi yang setara yang dideskripsikan dan didokumentasikan secara jelas dan (3)
tinjauan bukti ditujukan pada populasi yang diminati tanpa batasan pada tingkat pendapatan
negara atau negara.2 Rekomendasi yang ditetapkan yaitu membahas tiga kelompok usia: 5–
17 tahun ; berusia 18–64 tahun; dan 65 tahun ke atas. Klasifikasi Levels of Evidence for
Prognostic Studies berdasarkan pada klasifikasi yang dikembangkan oleh American Society
of Plastic Surgeons (ASPS) adalah pada level 3 yaitu rekomendasi yang berdasarkan pada
Case-control study or systematic review of these studies.7
C. KESIMPULAN
EBM merupakan praktik yang memadukan bukti terbaik yang ada, keterampilan
klinis, dan nilai-nilai pasien. EBM bertujuan membantu klinisi agar pelayanan medis
memberikan hasil klinis yang optimal kepada pasien. Penggunaan bukti ilmiah dari riset
terbaik memungkinkan pengambilan keputusan klinis yang lebih efektif, bisa diandalkan,
aman, dan cost-effective. Secara keseluruhan, rekomendasi WHO tersebut menegaskan
pentingnya aktivitas fisik aerobik dan penguatan otot secara teratur dan pengurangan
perilaku menetap. Manfaat diperoleh dari melakukan sejumlah aktivitas fisik dan ini berlaku
untuk orang-orang dari segala usia dan kemampuan. Manfaat meluas juga di luar sektor
kesehatan karena semakin banyak bukti di berbagai bidang menunjukkan dampak sosial,
ekonomi, dan lingkungan yang saling terkait dari populasi yang lebih aktif secara fisik.
Sekarang, saatnya bekerja untuk memastikan dan mendukung penerapan dan penerapan
pedoman global baru ini untuk masa depan yang lebih sehat dan aktif di seluruh dunia.
DAFTAR PUSTAKA
Disusun Oleh :
Hestika Wulandari (0613520029)
Peminatan Promosi Kesehatan
Kelas Reguler
ABSTRACT
Abstract 2 See the PRISMA 2020 for Abstracts checklist. 1
INTRODUCTION
Rationale 3 Describe the rationale for the review in the context of existing knowledge. 1
Objectives 4 Provide an explicit statement of the objective(s) or question(s) the review addresses. 2
METHODS
Eligibility criteria 5 Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses. 2
Information sources 6 Specify all databases, registers, websites, organization’s, reference lists and other sources searched or consulted to identify studies. 2
Specify the date when each source was last searched or consulted.
Search strategy 7 Present the full search strategies for all databases, registers and websites, including any filters and limits used. 2
Selection process 8 Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened 2
each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the
process.
Data collection 9 Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they 2
process worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation
tools used in the process.
Data items 10a List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in 2
each study were sought (e.g. for all measures, time points, analyses), and if not, the methods used to decide which results to collect.
10b List and define all other variables for which data were sought (e.g. participant and intervention characteristics, funding sources). 2
Describe any assumptions made about any missing or unclear information.
Study risk of bias 11 Specify the methods used to assess risk of bias in the included studies, including details of the tool(s) used, how many reviewers 2
assessment assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process.
Effect measures 12 Specify for each outcome the effect measure(s) (e.g. risk ratio, mean difference) used in the synthesis or presentation of results. 2
Synthesis methods 13a Describe the processes used to decide which studies were eligible for each synthesis (e.g. tabulating the study intervention 2
characteristics and comparing against the planned groups for each synthesis (item #5)).
13b Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or 2
data conversions.
13c Describe any methods used to tabulate or visually display results of individual studies and syntheses. 2
13d Describe any methods used to synthesize results and provide a rationale for the choice(s). If meta-analysis was performed, describe 2
the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used.
13e Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta- 2
regression).
13f Describe any sensitivity analyses conducted to assess robustness of the synthesized results. 2
Reporting bias 14 Describe any methods used to assess risk of bias due to missing results in a synthesis (arising from reporting biases). 2
assessment
Certainty 15 Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome. 2
assessment
Location
Item where item is
Section and Topic Checklist item
# reported
RESULTS Page
Study selection 16a Describe the results of the search and selection process, from the number of records identified in the search to the number of studies 3
included in the review, ideally using a flow diagram.
16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded. 3
Study characteristics 17 Cite each included study and present its characteristics. 3
Risk of bias in 18 Present assessments of risk of bias for each included study. 3
studies
Results of individual 19 For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimates and its 5
studies precision (e.g. confidence/credible interval), ideally using structured tables or plots.
Results of syntheses 20a For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies. 3
20b Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its 6
precision (e.g.
confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect.
20c Present results of all investigations of possible causes of heterogeneity among study results. 4
20d Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results. 4
Reporting biases 21 Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed. 4
Certainty of 22 Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed. 4
evidence
DISCUSSION Page
Discussion 23a Provide a general interpretation of the results in the context of other evidence. 5
23b Discuss any limitations of the evidence included in the review. 5
23c Discuss any limitations of the review processes used. 6
23d Discuss implications of the results for practice, policy, and future research. 6
From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.
BMJ 2021;372:n71. doi: 10.1136/bmj.n71