ANALISIS JURNAL“REDUCTION IN THE INCINDENCE OF

TYPE 2 DIABETES WITH LIFESTYLE INTERVENTION OR METFORMIN”

RINA P 08711101PUTRI R 10711035IMAM H 10711202INDRA S 10711227

RINGKASAN KASUS PPK

Seorang wanita umur 67 tahun dengan hipertensi dan obesitas datang ke dokter puskesmas untuk mengontrol tekanan darahnya karena merasa nyeri kepala dan pusing. Pasien tidak merasakan gejala klinis DM, hanya ditemukan poliuri dan lemah di kaki. Karena ada program dokter keluarga, maka wanita tersebut mengecek gula darah sewaktu dan hasilnya 232 mg/dL. Dokter memberikan obat berupa Adalat (nifedipi, obat antihipertensi), glibenklamid, metformin, dan glukodex.

Question Component Your QuestionP-Patien or Population Pasien nondiabetes dengan umur

>25 tahun, IMT 24 atau lebih (22 untuk asia), KGD 95-125 mg/dl dan 140-199 mg/dl setelah 2 jam menerima 75 g glukosa oral.

I-Intervention Metformin 850 mg 2x/hari

C-Comparison Perbaikan pola gaya hidup

O-Outcome Perbaikan gaya hidup dan metformin menurunkan kejadian diabetes pada orang dengan risiko tinggi

The well-built clinical question :

Terapi mana yang lebih baik antara perubahan gaya hidup dan metformin untuk menurunkan angka kejadian DM type 2 pada orang dengan risiko tinggi?

How participants were allocated to interventions (e.g., "random allocation", "randomized", or "randomly assigned").

Ada pada hal 393 ;“Methods We randomly assigned 3234

nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo, metformin (850)”

Scientific background and explanation of rationale.

Ada pada hal 393 ;“Diabetes mellitus, formerly called non-insulin-

dependent diabetes mellitus, is a serious, costly disease affecting approximately 8 percent of adults in the United States.”

Eligibility criteria for participants and the settings and locations where the data were collected.

Ada pada hal 394 ;“We conducted a clinical trial involving persons at 27

centers who were at high risk for diabetes. Eligibility criteria included an age of at least 25 years, a bodymass index (the weight in kilograms divided by the square of the height in meters) of 24 or higher (22 or higher in Asians), and a plasma glucose concentration of 95 to 125 mg per deciliter (5.3 to 6.9 mmol per liter) in the fasting state («125 mg per deciliter in the American Indian clinics)....”

Precise details of the interventions intended for each group and how and when they were actually administered.

Ada pada hal 394 ;“Participants were randomly assigned to one of

three interventions: standard lifestyle recommendations plus metformin (Glucophage) at a dose of 850 mg twice daily, standard lifestyle recommendations plus placebo twice daily, or an intensive program of lifestyle modification.”

Specific objectives and hypotheses.

Ada pada hal 393 ;“We hypothesized that modifying these factors

with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes.”

Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements.

Ada pada hal 394 ;“The primary outcome was diabetes, diagnosed on the basis of an

annual oral glucose-tolerance test or a semiannual fasting plasma glucose test, according to the 1997 criteria of the American Diabetes Association......”

“The secondary: In addition to the semiannual measurements, fasting plasma glucose was measured if symptoms suggestive of diabetes developed.”

How sample size was determined and, when applicable,

explanation of any interim analyses and stopping rules

.Ada pada hal 394 ;” Eligibility criteria included an age of at least 25 years,

a bodymass Index (the weight in kilograms divided by the square of the height in meters) of 24 or higher ...

Eligible persons were excluded if they were taking medicines known to alter glucose tolerance or if they had illnesses that could seriously reduce their life expectancy or their ability to participate in the trial....”

Method used to generate the random allocation sequence, including details

of any restriction

Tidak dijelaskan didalam jurnal.

Method used to implement the random allocation sequence, clarifying whether the sequence

was concealed until interventions were assigned

Tidak dijelaskan didalam jurnal.

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups

.Ada pada hal 393 ;“The Diabetes Prevention Program Research

Group conducted a large, randomized clinical trial involving adults in the United States who were at high risk for the development of type 2 diabetes.”

Statistical methods used to compare groups for primary outcome(s)

; Methods for additional analyses, such as subgroup analyses and adjusted analyses.

Ada pada hal 394 ;

Flow of participant through each stage (a diagram is strongly recommended). Specifically, for each group report the number of participant randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Discribe protocol deviations from study planned, together with reasons.

Ada pada hal 395 ;

Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.

If done, how the success of blinding was evaluated.

Ada pada hal 394 ;Assignments to metformin and placebo were double-

blinded.”“The blinded treatment phase was terminated one

year early, in May 2001, on the advice of the data monitoring board, on the basis of data obtained through March 31, 2001, the closing date for this report.”

Dates defining the periods of recruitment and follow up.

Ada pada hal 395 ;From 1996 to 1999, we randomly assigned 3234 study

participants to one of the three interventions (1082 to placebo, 1073 to metformin, and 1079 to the intensive lifestyle intervention).

The participants were followed for an average of 2.8 years”

Baseline demographic and clinical characteristics of ech group.

Ada pada hal 395 ;“Base-line characteristics, including all measured

risk factors for diabetes, were similar among the three study groups (Table 1).”

Number of participant (denominator) in eah group included in each analysis and whether the analysis was by “intention – to – treat.” State the result in absolut number as when feasible (eg, 10/20, not 50%)

Ada pada hal 395 ;“From 1996 to 1999, we randomly assigned 3234 study

participants to one of the three interventions (1082 to placebo, 1073 to metformin, and 1079 to the intensive lifestyle intervention).”

For each primary and secondary outcome, a summary of result for aech group, and the estimated effect and it’s precision (eg, 95% convident interval).

Ada pada hal 397 ;"The estimated cumulative incidence of diabetes at three

years was 28.9 percent, 21.7 percent, and 14.4 percent in the placebo, metformin, and lifestyle-intervention groups, respectively. On the basis of these rates, the estimated number of persons who would need to be treated for three years to prevent one case of diabetes during this period is 6.9 (95 percent confidence interval, 5.4 to 9.5) for the lifestyle intervention and 13.9 (95 percent confidence interval, 8.7 to 33.9) for metformin.”

Adress multiplicity by reporting any other analyses peformed, including sub group analyses and adjusted analyses, indicating those prespecipied and those exploratory.

Di dalam jurnal tidak dijelaskan

All important adverse events or side effects in each intervention group.

Ada pada hal 397 & 401 ;

Interpretations of the result, taking into account study hypotheses, sources of

potential bias or imprecision, and outcomes.

Ada pada hal 398 ;” Our results support the hypothesis that type 2

dibetes can be prevented or delayed in persons at high risk for the disease.”

Generalizability (external validity) of the trial findings.

Ada pada hal 399 ;“Previous studies have not demonstrated that

drugs used to treat diabetes are effective for its prevention, perhaps because of small samples and the lack of data on adherence to the prescribed regimens. In contrast, metformin was effective in our study, althoughless so than the lifestyle intervention.”

General interpretation of the result in the context of current evidence.

Ada pada hal 401 ;“In summary, our study showed that treatment with

metformin and modification of lifestyle were two highly effective means of delaying or preventing type 2 diabetes. The lifestyle interventions was particularly effective, with one case of diabetes prevented per seven persons treated for three years. Thus, it should also be possible to delay or prevent the development of complications, substantially reducing the individual and public health burden of diabetes.”

THERAPY WORKSHEETIs the research valid? Comments

1a. Was the assignment of patients randomised?

1a. Pasien diambil secara acak dari 27 pusat klinik dengan mengambil 3234 pasien nondiabetik namun risiko tinggi DM

1b. Was the randomisation list concealed? 1b. Pengacakan tidak dilakukan secara sembunyi

1c. Were subjects and clinicians blind ‘ to which treatment was being received?

1c. Antara subjek dan peneliti dibutakan

2a. Were all subjects who entered the trial accounted for at its conclution?

2a. Semua partisipan diperhitungkan dalam hasil yaitu berjumlah 3234 orang dengan rincian plasebo 1082, metformin 1073, dan gaya hidup 1079

2b. Were they analysed in the groups to which they were randomised?

2b. Diambil dari 27 pusat klinik secara acak sebanyak 3234 orang dengan kriteria yang memenuhi. Sesuai dengan tabel 1

Cont....

3a. Aside from the experimental treatment, were the groups treated aqually?

3a. Di dalam jurnal tidak disebutkan

3b. Were the groups similar at the start of the trial?

3b. Dari awal sampai akhir penelitian berjumlah 3234 orang dan sebanyak 99,6% masih hidup.