Format Laporan Journal Reading

Judul Tulisan

Sildenafil adjunctive therapy to risperidone in the treatment of the negative symptoms of schizophrenia: a double-blind randomized placebo-controlled trial Penulis : Akhondzadeh, S., Ghayyoumi R., Rezaei F., Salehi B., Modabbernia A.H., Maroufi A., Esfandiari G.R., Naderi M., Ghebleh F., Tabrizi M., Rezazadeh S.A. Nama jurnal, volume, nomor dan tahun terbit Psychopharmacology (2011) 213:809815 :

Topik Judul dan abstrak

No

Keterangan

1 1. Indicate the studys material (ex plant) and subject (human or animal) 2. Provide in the abstract an informative and balanced summary of what was done and what was found 1. Menjelaskan subyek penelitian 2. Memberikan ringkasan yang informatif dan seimbang atas apa yang dilakukan dan apa yang ditemukan (hasil) dalam abstrak

Ditemukan di halaman berapa, jelaskan hal 809 abstract 1. investigate the effect of sildenafil added to risperidone as augmentation therapy in patients with chronic schizophrenia and prominent negative symptoms 2. Although both protocols significantly decreased the score of the positive, negative, and general psychopathological symptoms over the trial period, the combination of risperidone and sildenafil showed a significant superiority over risperidone alone in decreasing negative symptoms and PANSS total scores over the 8-week trial (between-subjects factor; F=4.77, df=1; P=0.03; F=5.91, df=1, P=0.02 respectively) 1. Pasien yang digunakan adalah pasien skizofrenia kronik dan yang memiliki gejala negative yang menonjol 2. secara signifikan menurunkan skor gejala psikopatologis positif, negatif, dan umum selama masa percobaan,

kombinasi risperidone dan sildenafil menunjukkan keunggulan signifikan atas Risperidone sendiri dalam menurunkan gejala negatif dan nilai total PANSS selama sidang 8 minggu Introduksi Latarbelakang 2 Explain the scientific background and rationale for the investigation being reported Menjelaskan latar belakang yang ilmiah dan rasional mengapa penelitian perlu dilakukan hal 809 introduction paragraph 1 Schizophrenia is a debilitating illness, rating as one of the leading causes of lost years of quality of life since it affects general health, functioning, autonomy, subjective well being, and life satisfaction of those who suffer from it The illness imposes a disproportionate burden on patients, their families, the healthcare systems, and the society. penyakit ini membebani kehidupan pasien, keluarga pasien, kesehatan pasien serta kehidupan social pasien hal 810 introduction paragraph 2 Theories bridging the dopamine and the NMDA hypotheses of schizophrenia into one conceptual framework argue that dopamine activity is under the control of NMDA inhibitory receptors.. Teori menjembatani dopamin dan hipotesis NMDA skizofrenia menjadi satu kerangka kerja konseptual berpendapat bahwa aktivitas dopamin adalah di bawah kendali penghambatan NMDA reseptor. hal 810 methods paragraph 1 The trial was a prospective, 8 week, double-blind study of parallel groups of patients with chronic schizophrenia and was undertaken in three psychiatric hospitals in Iran, from December 2008 to May of 2010.. dalam 8 minggu , kelompok parallel double-blind pada pasien skizofrenia kronis pada 3 rumah sakit jiwa di iran

Tujuan

State specific objectives, including any prespecified hypotheses Menentukan tujuan spesifik, termasuk hipotesis yang diajukan.

Bahan dan Cara Bahan

Clearly defined how the material were collected and prepared Menjelaskan bagaimana data dikumpulkan dan disiapkan.

Participant Subyek penelitian

Eligibility criteria for participant / subject Kriteria subyek penelitian

Intervensi

Precise details of the intervention intended for each group and how and when they were actually administered Menjelaskan intervensi yang dilakukan pada tiap kelompok perlakuan dengan detail. Termasuk bagaimana dan kapan intervensi diberikan.

desember 2008 hingga may 2010. hal 810 dan 811 methods participants paragraph 1 Eligible participants in the study were 40 patients with chronic schizophrenia (four women and 36 men) with ages ranging from 18 to 45 years (Table 1). All participants were inpatients, in the active phase of illness, and met DSM-IV-TR (American Psychiatric Association 2000) criteria for schizophrenia. Minimum score of 60 on the Positive and Negative Syndrome Scale (PANSS) (Kay et al. 1987) (range, 84 127) and 20 on the negative subscale (range, 2035) was required for entry into the study 40 pasien dengan skizofrenia kronik ( 4 wanita dan 36 pria )dengan usia 18 45 tahun. Pasien dengan indikasi rawat inap dan termasuk dalam criteria DSM-IV-TR. mengecualikan pasien dengan signifikan tingkat depresi. Perempuan hamil dan menyusui dan mereka dalam usia reproduktif tanpa kontrasepsi yang memadai juga dikecualikan. hal 811 intervention paragraph 1 Twenty patients were randomly allocated to risperidone(6 mg/day) plus sildenafil (75 mg/day), and 20 patients were allocated to risperidone (6 mg/day) plus placebo for an 8week, double-blind, placebo-controlled study. Starting dosage of risperidone was 2 mg/day and was increased in 2 mg increments daily to 6 mg/day. Patients were started on sildenafil 25 mg/day, and the dosage was increased to 75 mg/day at the end of the first week 20 pasien secara acak di alokasikan risperidone ( 6mg/ hari )ditambah sildenafil ( 75mg/hari), dan 20 pasien di alokasikan risperidone ( 6mg/hari) ditambah placebo dalam 8

Outcome

Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors). Menjelaskan pengukuran outcome, baik utama maupun sekunder,

Besar sampel

Subject number used in the study Jumlah subyek penelitian.

Metode statistik

Statistical methods used to compare groups for primary outcome(s) and other outcome Metode statistik yang digunakan untuk membandingkan hasil kelompok satu dengan yang kelompok

minggu dengan double-blind , placebo-controlled study. hal 811 outcome paragraph 1 The principal measure of outcome was the PANSS that has been used in several studies in Iran (Akhondzadeh et al. 1999, 2006, 2007). PANSS total score was considered as primary efficacy and secondary efficacy parameters included the PANSS subscales. The PANSS includes 30 items on three subscales, seven items covering positive symptoms, seven items covering negative symptoms, and 16 covering general psychopathology.. Skor total PANSS dianggap sebagai efikasi primer dan parameter efikasi sekunder termasuk yang PANSS subscales. PANSS ini mencakup 30 item pada tiga subscales, tujuh item meliputi gejala positif, tujuh item meliputi gejala negatif, dan 16 meliputi umum psikopatologi.. hal 810 methods participants paragraph 1 table 1 Eligible participants in the study were 40 patients with chronic schizophrenia (four women and 36 men) with ages ranging from 18 to 45 years.. subyek penelitian 40 pasien 4 diantranya wanita dan 36 pria usia 18 45 tahun.. hal 811 statistical analysis paragraph 1 The two groups as a between subjects factor (group) and the five measurements during treatment as the within-subjects factor (time) were considered. This was done for positive, negative, and general psychopathology subscale, and PANSS total scores. Kedua kelompok sebagai antara subyek faktor (kelompok) dan lima pengukuran selama pengobatan sebagai faktor dalam subyek (waktu) yang dipertimbangkan. Hal ini dilakukan untuk positif, negatif, dan

umum psikopatologi subskala, dan skor total PANSS. Hasil Alur penelitian 1 0 Defining the periods of study and follow-up Menjelaskan waktu penelitian dan follow-up hal 812 results paragraph 1 tabel 1 Sixty-two patients were screened for the study, and 40 were randomized to groups for trial medication (20 patients in each group) .Twelve patients from Kuidistan University of Medical Sciences, 12 patients from Arak University of Medical Sciences, and 16 patients from Roozbeh psychiatric hospital were recruited to this study.. Pasien disposisi dan karakteristik 62 pasien disaring untuk penelitian, dan 40 secara acak kelompok untuk pengobatan percobaan (20 pasien dalam kelompok masing-masing). Dua belas pasien dari Kuidistan Universitas Ilmu Kedokteran, 12 pasien Anak dari University of Medical Sciences, dan 16 pasien Roozbeh dari rumah sakit jiwa direkrut untuk ini penelitian For each primary and secondary hal 811 outcome paragraph outcome, a summary of results for 1 each group . The mean decrease in the PANSS Untuk tiap outcome utama dan score from baseline was used as the sekunder, ringkasan atas hasil main outcome measure of patient bagi tiap kelompok. response to treatment. Treatment response was defined as at least 50% improvement in the PANSS total score Respon pengobatan didefinisikan sebagai setidaknya 50% peningkatan dalam skor total PANSS Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes. Interpretasi hasil, memperhitungkan hipotesis penelitian, sumber bias atau ketidaktepatan dan bahaya yang berhubungan dengan keragaman hal 814 disscussion paragraph 1 The results of this study document that both groups of schizophrenic patients demonstrate significant improvement on the PANSS total score and on all subscales during the 8 weeks of treatment with risperidone.. kedua kelompok pasien skizofrenia menunjukkan peningkatan yang

Outcome dan estimasi

1 1

Diskusi Interpretasi

1 2

analisis dan outcome.

Generalizability

1 3

Generalizability (external validity) of the trial findings. Apakah hasil penelitian dapat digeneralisasikan di masyarakat.

Overall evidence

1 4

General interpretation of the results in the context of current evidence. Interpretasi umum terhadap hasil dalam konteks bukti terkini.

signifikan pada skor total PANSS dan pada semua sub-skala selama 8 minggu pengobatan dengan risperidone. hal 815 disscussion paragraph 3 The limitation of the present study, including the short duration of study, was that only patients with chronic schizophrenia and a fixed dose of sildenafil were taken into consideration, and this indicates the need for further research hasil penelitian dapat digunakan kepada pasien skizofrenia kronis.. hal 815 disscussion paragraph 3 the present study provides evidence for sildenafil as a potential adjunctive treatment strategy for treatment of negative symptoms of schizophrenia. penelitian ini memberikan bukti untuk sildenafil sebagai strategi pengobatan yang potensial untuk adjunctive pengobatan gejala negatif skizofrenia.