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Konda Kinanti Muroso
Efficacy of Modified Cellulose in comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial
"Sternotomi median saat ini merupakan akses utama untuk operasi jantung. Infeksi situs bedah (SSI) sternum adalah komplikasi yang menyusahkan dalam pembedahan jantung setelah median sternotomi. Insidensi SSI superfisial dan dalam pascaoperasi jantung bervariasi dari 1,3 hingga 12,8%. Bone wax adalah zat yang tidak dapat diserap dan diyakini bahwa bone wax dapat menyebabkan peradangan dan secara mekanis menghambat aktivitas osteoblastik, yang pada akhirnya dapat menyebabkan peningkatan risiko dehisensi sternum pascaoperasi. Selulosa Termodifikasi adalah alat pelindung sternum yang menutupi sternum setelah median sternotomi, dan memiliki perlindungan mekanis khusus yang mencegah lesi dan rasa sakit pascaoperasi. Tujuan penelitian ini untuk mengevaluasi efektifitas Selulosa Termodifikasi dibandingkan dengan bone wax pada pasien pasca operasi jantung dalam mengurangi infeksi luka operasi pascaoperasi, efek hemostasis dari Selulosa Termodifikasi dibandingkan dengan bone wax, dan tingkat kepuasan para spesialis bedah
Metodologi: Studi ini merupakan uji klinis terandomisasi, tunggal, dan dilakukan di sentral tunggal. Studi dilakukan pada pasien dewasa yang dilakukan operasi bedah jantung, dan dibagi menjadi kelompok yang menggunakan Selulosa Termodifikasi dan kelompok yang menggunakan bone wax. Keluaran pascaoperasi yang dinilai adalah infeksi luka operasi, pendarahan intraoperatif dari sternum, dan tingkat kepuasaan spesialis bedah.
Hasil: Pasien pada kelompok Selulosa Termodifikasi memiliki infeksi luka operasi superifsial yang lebih rendah daripada kelompok bone wax, 2,9% vs 8,2%, p = 0,018. Kejadian infeksi luka operasi dalam juga lebih rendah pada kelompok Selulosa Termodifikasi dibandingkan kelompok bone wax, 1% vs 2,9%, p= 0,284 namun secara statistik tidak bermakna. Perdarahan sternum intraoperatif menunjukkan bahwa Selulosa Termodifikasi menyerap lebih banyak darah dibandingkan kelompok bone wax (84,97 ± 115,99 vs 81,18 ± 14,62, p = 0,012).
Kesimpulan: Selulosa Termodifikasi memiliki kejadian infeksi pascaoperasi dan jumlah pendarahan dari sternum yang lebih rendah secara bermakna. dibandingkan dengan bone wax.
Introduction: Median sternotomy is currently the main access for cardiac surgery. However, surgical site infection (SSI) of the sternum is a distressing complication in cardiac surgery after a median sternotomy. The incidence of postoperative superficial and deep SSI in cardiac surgery varies from 1.3 to 12.8%. In addition, bone wax is a nonabsorbable substance; it is believed that it may cause inflammation and mechanically inhibit osteoblastic activity, which may eventually lead to an increased risk of postoperative sternal dehiscence. Modified Cellulose is a sternal protection device that covers the sternum after median sternotomy, it has specific mechanical protection that prevents lesions on the sternum.
The aim of this study was to evaluate the effectiveness of Modified Cellulose compared with bone wax in post-cardiac surgery patients in reducing surgical site infection, the hemostasis effect between Modified Cellulose compared with bone wax, and surgeons’ satisfaction.
Methods: This study was conducted on adult patients who underwent cardiac surgery, and were divided into groups using Modified Cellulose and groups using Bone wax. Postoperative outcomes assessed were surgical wound infection, the quantity of blood lost from the sternal edges in the treatment and control group , and the degree of surgeon satisfaction. This study is a randomized, single, clinical trial conducted in a single centre Results: Patients in Modified Cellulose group developed less superficial surgical site infection compared to bone wax group (2.9% vs 8.2%, p = 0.018). Deep surgical site infection is also lower in the Modified Cellulose group compared to the bone wax group (1% vs. 2.9%, p = 0.284) but not statistically significant. Intraoperative sternal bleeding showed that Modified Cellulose absorbed more than the sterile drapes in the bone wax group (84.97 ± 115.99 vs 81.18 ± 14.62, p = 0.012).
Conclusion: Modified Cellulose had a significantly lower incidence of postoperative infection and bleeding from the sternum compared to bone wax."
Jakarta: Fakultas Kedokteran Universitas Indonesia, 2022
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UI - Tugas Akhir  Universitas Indonesia Library
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R. Mirsyam Ratri Wiratmoko
Efikasi penggunaan Varenicline pada program berhenti merokok studi randomized single blind clinical trial placebo controlled = Efficacy of varenicline, an A4B2 nicotinic acetylcholine receptor partial agonist, vs placebo for smoking cessation a randomized controlled trial
"Merokok dapat meningkatkan angka morbiditas dan mortalitas.World Health Organization (WHO) memprediksi pada tahun 2020 penyakit yang disebabkan oleh rokok akan menyebabkan kematian sebanyak 8.4 juta orang di dunia dan setengahnya berasal dari Asia. Varenicline, sebagai agonis parsial reseptor α4β2 nikotin asetilkolin, memiliki potensi yang cukup baik pada program berhenti merokok dengan cara melepaskan withdrawal effect dari nikotin dan menurunkan kebutuhan akan nikotin.
METODE. Uji acak tersamar ganda antara bulan Juli 2012 sampai dengan Desember 2012 dengan 12 minggu waktu terapi dan 12 minggu waktu pengamatan status merokok. 80 laki-laki perokok yang bersedia mengikuti penelitian dibagi kedalam kelompok varenciline dan kelompok plasebo.Varenicline dititrasi hingga 2x1 mg (n=40) dan plasebo (n=40) ditambah konseling mingguan.
HASIL. Pada pengamatan 4 minggu (minggu 1-4) setelah 12 minggu terapi menunjukkan 55% peserta kelompok varenicline berhenti merokok dibandingkan kelompok plasebo sebesar 27,5%. (Prevalence Ratio [PR] 2,0). Pada pengamatan minggu ke 5-8, 52.5% peserta pada kelompok varenicline masih berhenti merokok dibandingkan dengan 20% pada kelompok plasebo (PR, 2,6). Pada pengamatan minggu 9-12, 47,5% peserta pada kelompok varenicline masih berhenti merokok dibandingkan 17,5% pada kelompok plasebo (PR, 2,7). Rerata hari pertama bebas rokok pada kelompok varenicline adalah 40,63 hari, sedangkan pada kelompok plasebo 56,43 hari. Efek samping yang paling banyak pada penggunaan varenicline adalah mual yang terdapat pada 9 peseerta (22,5%). Rerata kadar CO awal adalah 18,46 ppm, rerata Fagerstrom test untuk ketergantungan nikotin adalah 6,4 dan rerata indeks Binkman adalah 317,9.
KESIMPULAN. Varenicline memiliki efikasi yang baik, aman dan dapat ditoleransi baik sebagai farmakoterapi program berhenti merokok.
Smoking has increased risk of morbidity and mortality. World Health Organization predicts that by 2020, disease caused by smoking will result in the deaths of around 8.4 million people in the world and half of these deaths from Asia. Varenicline, a partial agonist at the α4β2 nicotinic acetylcholine receptor, has the potential to aid smoking cessation by relieving nicotine withdrawal symptoms and reducing the rewarding properties of nicotine.
METHOD. A randomized, single-blind, placebo controlled trial conducted between July 2012 and December 2012 with a 12 week treatment period and 12 week follow-up of smoking status. 80 male adult smokers who volunteered for the study divide into varenicline and placebo group. Varenicline titrated to 1 mg twice daily (n=40) or placebo (n=40) for 12 weeks, plus weekly smoking cessation counseling.
RESULT. During 4 weeks (weeks 1-4) after 12 weeks of treatment, 55% of participants in the varenicline group were continuously abstinent from smoking compared with 27.5% in the placebo group (Prevalence Ratio [PR] 2,0). For weeks 5 through 8, 52.5% of participants in the varenicline group were continuously abstinent compared with 20% in the placebo group (PR, 2,6). For weeks 9-12, 47.5% of participants in the varenicline group were continuously abstinent compared with 17.5% in the placebo group (PR, 2,7). Mean of first day free of smoking used Varenicline for smoking cessation was 40,63 days and mean of first day free of smoking used placebo was 56.43 days. The most adverse event with varenicline was nausea, which occurred in 9 Participants (22,5%). Mean of CO level was 18,46 ppm, mean of Fagerstrom score for nicotine dependence was 6,4, and mean of Brinkman index was 317,9.
CONCLUSION. Varenicline is an efficacious, safe, and well-tolerated smoking cessation pharmacotherapy."
Jakarta: Fakultas Kedokteran Universitas Indonesia, 2013
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UI - Tesis Membership  Universitas Indonesia Library
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Marvin Pili
Perbandingan luaran klinis, length of stay, nyeri pascaoperasi antara Enhanced Recovery After Surgery dan protokol konvensional pada Unilateral Total Knee Replacement: Sebuah uji klinis acak tersamar tunggal = Comparison of clinical outcomes, length of stay, postoperative pain between Enhanced Recovery After Surgery and conventional protocol in Unilateral Total Knee Replacement: A Single-blind randomized clinical trial
"Pendahuluan: Enhanced Recovery After Surgery (ERAS) bertujuan untuk menstandardisasi manajemen perioperatif dan meningkatkan luaran klinis. Implementasi ERAS pada total knee replacement (TKR) mengurangi mortalitas, transfusi, komplikasi, dan length of stay (LOS) tanpa mempengaruhi readmisi. Studi ini bertujuan mengevaluasi ERAS pada pasien TKR unilateral di Indonesia.
Metode: Penelitian ini menggunakan desain klinis acak tersamar tunggal di RSUPN Dr. Cipto Mangunkusumo dan RS Fatmawati, Jakarta, dengan 55 pasien TKR unilateral berusia 60-70 tahun dengan OA grade III-IV sebagai subjek. Metode analisis data melibatkan SPSS dengan uji normalitas, Chi-square, T tidak berpasangan, dan Mann Whitney untuk menilai efektivitas ERAS dibandingkan dengan protokol konvensional.
Hasil: Hasil menunjukkan bahwa protokol ERAS meningkatkan skor Knee Special Score (KSS) (p=0,001, mean difference=4,09) dan Oxford Knee Score (OKS) (p<0,001, mean difference=4,98), serta mengurangi durasi rawat inap (p<0,001, mean difference=-2,15 hari) dan nyeri pascaoperasi (p<0,001, mean difference=-2,01) dibandingkan protokol konvensional. Faktor pre-operatif dan post-operatif seperti usia, komorbiditas, dan mobilisasi dini memberikan pengaruh terhadap durasi lama rawat inap. ERAS efektif menurunkan nyeri pascaoperasi dan meningkatkan skor KSS serta OKS. Integrasi edukasi praoperatif, manajemen nyeri, mobilisasi dini, dan perawatan perioperatif komprehensif meningkatkan hasil fungsional.
Kesimpulan: Program ERAS secara signifikan memperbaiki skor KSS, OKS, mengurangi durasi rawat inap, dan menurunkan nyeri pascaoperasi pada pasien TKR unilateral dibandingkan protokol konvensional.
Introduction: Enhanced Recovery After Surgery (ERAS) aims to standardize perioperative management and improve clinical outcomes. ERAS implementation in total knee replacement (TKR) reduces mortality, transfusions, complications, and length of stay (LOS) without affecting readmissions. This study aims to evaluate ERAS in unilateral TKR patients in Indonesia.
Methods: This study utilized a single-blind randomized clinical trial design at RSUPN Dr. Cipto Mangunkusumo and RS Fatmawati, Jakarta, involving 55 unilateral TKR patients aged 60-70 years with grade III-IV OA. Data analysis methods included SPSS, normality tests, Chi-square, independent T-tests, and Mann Whitney tests to evaluate the effectiveness of ERAS compared to conventional protocols.
Result: The results show that the ERAS protocol improves Knee Society Score (KSS) (p=0.001, mean difference=4.09) and Oxford Knee Score (OKS) (p<0.001, mean difference=4.98) scores, reduces length of stay (p<0.001, mean difference=-2.15 days), and decreases postoperative pain (p<0.001, mean difference=-2.01) compared to conventional protocols.
Discussion: Pre-operative and post-operative factors such as age, comorbidities, and early mobilization influence the length of stay. ERAS effectively reduces postoperative pain and improves KSS and OKS scores. Integrating preoperative education, pain management, early mobilization, and comprehensive perioperative care enhances functional outcomes.
Conclusion: The ERAS program significantly improves KSS, OKS scores, reduces length of stay, and decreases postoperative pain in unilateral TKR patients compared to conventional protocols."
Jakarta: Fakultas Kedokteran Universitas Indonesia, 2024
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UI - Disertasi Membership  Universitas Indonesia Library
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Gede Yuda Atmaja
Perbandingan persepsi nyeri terapi analgetik ketorolac dan meloxicam pada pasien pasca ureterorenoskopi di RS Meuraxa, Banda Aceh: single blinded randomized controlled trial = Comparison of pain perception between ketorolac and meloxicam as analgetic in post ureterorenoscopy patients in Meuraxa Hospital, Banda Aceh: single blinded randomized controlled trial
"Tujuan: Penelitian ini bertujuan untuk mebandingkan efek analgetik, efek samping, lama rawatan dan perbandingan biaya antara ketorolac intravena dengan Meloxicam oral pada pasien pasca ureterorenoskopi.
Metode: Pasien yang menjalani tindakan ureterorenoskopi di Rumah Sakit Meuraxa, Banda Aceh dari bulan Juli sampai September 2017. Pasien yang memenuhi kriteria inklusi dibagi menjadi dua kelompok, yaitu kelompok terapi analgetik dengan ketorolac 30 mg dan kelompok Meloxicam 7,5 mg. Efek analgetik kedua kelompok diamati selama dalam rawatan di rumah sakit yang dinilai dengan Visual Analog Scale VAS . Hubungan antar variabel dinilai dengan menggunakan Chi Square dan Mann-Whitney U.
Hasil: 46 pasien yang terlibat dalam penelitian ini dengan rata-rata usia 40.57 13.53 tahun, dimana 23 pasien mendapat terapi ketorolac dan 23 pasien mendapat terapi meloxicam. Lama rata-rata rawatan pada kedua kelompok pasien adalah 3.13 0.46 hari. Pada penelitian ini tidak ditemukan adanya perbedaan yang signifikan pada nilai VAS pada kedua kelompok analgetik baik pada rawatan hari pertama p 0.134 , kedua p 0.623 maupun ketiga p 0.529 . Komplikasi yang paling sering dikeluhkan pasien adalah mual, yang terjadi 7 30.4 pasien kelompok ketorolac dan 2 8.7 pasien kelompok meloxicam, namun tidak ada perbedaan yang signifikan pada kedua kelompok ini p 0.063 . Terdapat perbedaan yang cukup jauh pada biaya yang diperlukan untuk terapi analgetik selama dalam perawatan, dimana kelompok ketorolac rata-rata menghabiskan Rp. 162.384,00 sedangkan kelompok meloxicam sebesar Rp. 5.604,00.
Kesimpulan: Tidak ada perbedaan yang signifikan pada kedua kelompok analgetik baik dari nilai VAS, efek samping maupun lama rawatan di rumah sakit. Namun kelompok analgetik meloxicam memerlukan biaya yang lebih rendah bila dibandingkan dengan kelompok analgetik ketorolac.
Aim: Purpose of this study to compare analgesic effects, side effects, length of hospitalization and cost between intravenous ketorolac and oral Meloxicam in post ureterorenoscopy patients.
Methods: Patients undergoing ureterorenoscopy at Meuraxa Hospital, Banda Aceh from July to September 2017. Patients who met the inclusion criteria were divided into two groups, analgetic therapy with ketorolac 30 mg group and the Meloxicam 7.5 mg group. The analgesic effects of both groups were observed during the hospitalization and assessed with Visual Analog Scale VAS . Association between variables were assessed using Chi Square and Mann Whitney U.
Results: Forty six patients were involved in this study with an average age of 40.57 13.53 years, 23 patients received ketorolac therapy and 23 patients received meloxicam therapy. The mean length of hospitalization in both groups was 3.13 0.46 days. There was no significant difference in VAS values in both analgesic groups on the first day p 0.134 , second day p 0.623 or third day p 0.529 . The most common side effect was nausea, which occurred in 7 30.4 patients of ketorolac group and 2 8.7 patients in the meloxicam group, but there was no significant difference in both groups p 0.063 . There is a considerable difference in the costs required for analgesic therapy during hospitalization, in which the average ketorolac group spends Rp 162.384,00 while the meloxicam group spends Rp 5.604,00.
Conclusion: There were no significant differences in both analgesic groups either from VAS values, side effects or length of hospitalization. However, the meloxicam analgesic group requires a lower cost when compared with the ketorolac group"
Jakarta: Fakultas Kedokteran Universitas Indonesia, 2018
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UI - Tesis Membership  Universitas Indonesia Library
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Lidwina Anissa
Efektivitas dan efek samping blacksoap sebagai tambahan terapi baku skabies: sebuah uji klinis acak tersamar tunggal = Efficacy and side effects of blacksoap as an adjuvant therapy of scabies: a single-blind randomized
"Latar belakang: Skabies adalah penyakit kulit akibat infestasi ektoparasit berupa tungau Sarcoptes scabiei var hominis. Transmisi terjadi melalui kontak kulit secara langsung dan kontak dengan fomite. Risiko penularan skabies tinggi di komunitas yang tinggal bersama, contohnya asrama, pondok pesantren, panti jompo, dll. Prinsip tata laksana skabies meliputi penggunaan skabisid untuk pasien dan narakontak secara serempak. Sediaan permetrin merupakan pilihan utama, dengan tingkat kesembuhan 61,1% pada hari ketujuh. Blacksoap® adalah produk sabun yang diakui sebagai pendamping terapi skabies. Sampai saat ini belum ada penelitian mengenai efektivitas dan efek samping penggunaan Blacksoap®.
Tujuan: Membandingkan proporsi kesembuhan skabies dan efek samping pada kelompok yang mendapatkan kombinasi krim permetrin dan Blacksoap® dan kelompok yang mendapatkan kombinasi krim permetrin dan sabun bayi; membandingkan skor VAS gatal dan TEWL sebelum dan sesudah pemberian terapi pada kedua kelompok.
Metode: Sebuah uji klinis acak tersamar tunggal dilakukan di Pondok Pesantren Al Islami, Cibinong, Bogor pada September hingga Oktober 2018. Terdapat 78 orang santri yang memenuhi kriteria penelitian, tetapi hanya 69 subjek penelitian (SP) menyelesaikan penelitian. Alokasi kelompok dilakukan secara cluster randomization berdasar tempat tinggal. Kelompok intervensi mendapatkan krim permetrin 5% dan Blacksoap®, sedangkan kelompok kontrol mendapatkan krim permetrin 5% dan sabun bayi. Dilakukan pemeriksaan kerokan kulit, skor VAS gatal dan TEWL. Subjek penelitian kemudian di follow-up pada minggu ke-1 dan minggu ke-4 untuk menilai kesembuhan, skor VAS gatal, TEWL, dan efek samping pengobatan. 
Hasil: a minggu pertama lebih rendah dibanding kelompok kontrol (75% vs. 81,1%), proporsi kesembuhan kelompok intervensi pada minggu ke-4 lebih tinggi dibanding kelompok kontrol (96,9% vs. 91,9%). Tidak terdapat perbedaan bermakna skor VAS gatal pada kelompok intervensi dan kontrol pada minggu ke-1 (p=0,793) dan minggu ke-4 (p=0,123). Tidak terdapat perbedaan bermakna median dan perubahan skor TEWL pada kelompok kontrol dan intervensi pada minggu ke-1 dan minggu ke-4.  Tidak terdapat perbedaan efek samping bermakna pada kedua kelompok.
Kesimpulan: Efektivitas pengobatan skabies sebanding antara penambahan atau tanpa Blacksoap®. Perbaikan skor VAS dan TEWL, serta efek samping penambahan Blacksoap® sebanding dengan tanpa Blacksoap®.
Background: Scabies is a skin disease due to ectoparasitic infestation in the form of Sarcoptes scabiei var hominis. Transmission occurs through direct skin contact and contact with fomite. The transmission risk is high among communities living together, such as dormitories, boarding schools, nursing homes, etc. The principles of scabies management include the use of scabicide for patients and close contact simultaneously. Permethrin cream is the first line therapy, with a cure rate of 61.1% on the seventh day. Blacksoap® is a soap product which is recognized as an adjuvant to scabies therapy. Until now there has been no research on the effectiveness and side effects of using Blacksoap®.
Objectives: To compare the cure rate of scabies treatment with standard therapy with and without Blacksoap®, to compare itch intensity using visual analogue scale (VAS) score and transepidermal water loss (TEWL) score before and after receiving therapy between two groups, and to evaluate the side effects of the therapy.
Methods: A single-blind randomized controlled trial was conducted in Cibinong, Bogor, from September to October 2018. A total of 78 students were eligible for the study's criteria. In the end, there were only 69 samples finished the study. Cluster randomization was done to allocate the samples. Intervention group obtained standard therapy and Blacksoap®, meanwhile control group obtained standard therapy and baby soap. Skin scrapings, pruritus VAS score and TEWL score were assessed. Follow up was done on 1st and 4th week to assess the cure rate, pruritus VAS score, TEWL score and the side effect of therapy.
Results: The cure rate of intervention group was lower compared to that of control group on the first week (75% vs. 81,1%). The cure rate of intervention group is higher compared to that of control group on the fourth week (96,9% vs. 91,9%).  There is no significant difference of pruritus VAS score and TEWL score between two groups on the first and fourth week. There is no significant difference of side effects between two group on the first and forth week.
Conclusion: The effectiveness of scabies treatment was similar between standard therapy with or without Blacksoap®. Decrease of VAS, TEWL score and side effects were similar between two groups on the first and fourth week."
Depok: Fakultas Kedokteran Universitas Indonesia, 2019
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UI - Tesis Membership  Universitas Indonesia Library
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Safety and efficacy of NC120 for improving lipid profile: a double blind randomized controlled trial
"Background: the use of statin to lower blood cholesterol is often associated with bothersome adverse effects such as myopathy and liver dysfunction. NC120 is herbal lipid lowering drug containing red yeast rice (RYR) extract, guggulipid, and chromium picolinate, and expected to have better safety profile. The aim of this study was to evaluate the efficacy and safety profiles of NC120 in lowering blood lipid.
Methods: this was a double blind randomized clinical trial comparing NC120 with placebo in subjects with hypercholesterolemia. Two capsules of NC120 or placebo were administered twice a day for 28 days. Blood total-cholesterol, LDL-cholesterol, and triglyceride were measured on day-0, day-7, and day-28. Unpaired t-test was used to compare study parameter between groups, and one-way ANOVA was used to compare within group.
Results: 25 subjects received NC120 and 24 subjects received placebo. Significant decrease of total cholesterol and LDL-cholesterol were observed since day-7 in NC120 group, while the changes in placebo group were not significant at all time of observation. No significant decrease of triglyceride was observed in NC120 group and in placebo group. Side effects were minor and comparable between the two groups.
Conclusion: NC120 is effective in reducing total cholesterol and LDL-cholesterol, but not triglyceride. This drug shows a good safety profile, and thus can be considered for patients who can not tolerate statin drugs."
Jakarta: Faculty of Medicine University of Indonesia, 2019
610 UI-IJIM 51:1 (2019)
Artikel Jurnal  Universitas Indonesia Library
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Christa Desire Gracia
Perbandingan kualitas hidup pasien akne vulgaris derajat sedang berdasarkan Acne-QoL-INA menggunakan terapi standar dengan dan tanpa ekstraksi lesi akne: Uji klinis acak terkontrol tersamar tunggal = A comparison of the quality of life of patients with moderate acne vulgaris based on Acne-QoL-INA using standard therapy with and without acne lesion extraction: Single-blind randomized controlled clinical trial
"Latar belakang: Akne vulgaris (AV) adalah penyakit unit pilosebasea kronis tersering yang dapat menimbulkan dampak psikologis berat dan mengganggu kualitas hidup penderitanya. Penggunaan terapi ajuvan yaitu ekstraksi lesi akne yang dikombinasikan dengan terapi standar dapat memperbaiki kondisi klinis dan kualitas hidup penderita akne. Pengukuran kualitas hidup penting dilakukan untuk menilai keberhasilan terapi. Saat ini telah tersedia kuesioner kualitas hidup spesifik akne berbahasa Indonesia (Acne-QoL- INA) yang tervalidasi, namun belum pernah ada data mengenai perbandingan kualitas hidup antara terapi kombinasi dan terapi standar.
Metode: Studi uji klinis acak terkontrol tersamar tunggal ini dilakukan pada subjek akne vulgaris dewasa derajat sedang berdasarkan kriteria Lehmann yang dibagi ke dalam kelompok terapi kombinasi standar dan ekstraksi lesi akne (terapi kombinasi) serta terapi standar tanpa ekstraksi lesi akne (terapi standar). Skor kualitas hidup berdasarkan kuesioner Acne-QoL-INA dinilai pada baseline, minggu ke-4, dan minggu ke-8 setelah terapi. Selain itu, penilaian jumlah lesi dan derajat keparahan akne diukur pada setiap kunjungan oleh seorang evaluator secara tersamar melalui foto klinis.
Hasil: Sebanyak 40 subjek dengan median usia 24 tahun (18–48), 17,5% laki-laki dan 82,5% perempuan berpartisipasi dalam penelitian ini. Skor Acne-QoL-INA baseline untuk kelompok kombinasi dan kelompok terapi standar masing-masing adalah 41 (37,5– 57) dan 45,5 (37–63), meningkat menjadi 79 (67,5–94,5) dan 72,5 (59,25–98,5) pada minggu ke-8 namun tidak berbeda bermakna secara statistik antar kedua kelompok (p=0,602). Jumlah lesi baseline pada kedua kelompok masing-masing 35 dan 32, menurun menjadi 18 dan 13 pada minggu ke-8 (p<0,0001) dan perbaikan derajat keparahan menjadi akne ringan pada 100% subjek di minggu ke-8.
Kesimpulan: Tidak ada perbedaan dalam skor Acne-QoL-INA dan perbaikan klinis antara kelompok terapi kombinasi dan terapi standar pada pasien AV sedang. Namun, terapi kombinasi cenderung meningkatkan kualitas hidup dan pengurangan lesi lebih baik daripada terapi standar.
Background: Acne Vulagis (AV) is the most commom chronic disease of the pilosebaceous unit that can have a significant psychological impact and reduce the quality of life. The use of adjuvant therapy such as acne lesion extraction, in combination with standard therapy could better improve clinical outcomes and quality of life. Assessing quality of life is crucial to evaluate the success of therapy. Currently, there has been a validated acne-specific quality of life questionnaire in Indonesian (Acne-QoL-INA), but there is no existing data on the comparison of quality of life between combination therapy and standard therapy.
Method: This single-blinded randomized controlled study was conducted on adult subjects with moderate acne vulgaris based on Lehmann criteria, who were divided into combinations of standard therapy with acne lesion extraction (combination therapy) group, and standard therapy without acne lesion extraction (standard therapy) group. Quality of life score based on the Acne-QoL-INA questionnaire was assessed at the baseline, 4th, and 8th week after therapy. Additionally, the assessment of lesion number and acne grading is also measured at each visit by a blinded evaluator through clinical photos.
Results: A total of 40 subjects with a median age of 24 years old (18–48), comprising 17.5% males and 82.5% females, participated in this study. The baseline Acne-QoL-INA scores for the combination therapy and the standard therapy group were 41 (37.5–57) and 45.5 (37–63), respectively. These scores increased to 79 (67.5–94.5) and 72.5 (59.25– 98.5) at week 8 but did not show statistically significant differences between the two groups (p=0.602). The baseline lesion count in both groups was 35 and 32, respectively, and decreased to 18 and 13 at week 8 (p<0.0001), with an improvement in the severity to mild acne in 100% of subjects by week 8.
Conclusion: There was no difference in Acne-QoL-INA scores and clinical improvement between the combination therapy and standard therapy groups in moderate AV patients. However, combination therapy tended to improve the quality of life and lesion reduction better than standard therapy."
Jakarta: Fakultas Kedokteran Universitas Indonesia, 2024
SP-pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Lubis, Andri M.T.
Comparison of Glucosamine-Chondroitin sulfate with and without methylsulfonylmethane in grade I-II knee osteoarthritis: a double blind randomized controlled trial
"Background: Glucosamine, chondroitinsulfate are frequently used to prevent further joint degeneration in osteoarthritis (OA). Methylsulfonylmethane (MSM) is a supplement containing organic sulphur and also reported to slow anatomical joint progressivity in the knee OA. The MSM is often combined with glucosamine and chondroitin sulfate. However, there are controversies whether glucosamine chondroitin sulfate or their combination with methylsulfonylmethane could effectively reduce pain in OA. This study is aimed to compare clinical outcome of glucosamine chondroitin sulfate (GC), glucosamine chondroitin sulfate methylsulfonylmethane (GCM), and placeboin patients with knee osteoarthritis (OA) Kellgren Lawrence grade I II. Methods: a double blind, randomized controlled clinical trial was conducted on 147 patients with knee OA Kellgren Lawrence grade I II. Patients were allocated by permuted block randomization into three groups: GC (n=49), GCM (n=50), or placebo (n=48) groups. GC group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of saccharumlactis; GCM group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of MSM; while placebo group received three matching capsules of saccharumlactis. The drugs were administered once daily for 3 consecutive months VAS and WOMAC scores were measured before treatment, then at 4th, 8th and 12th week after treatment. Results: on statistical analysis it was found that at the 12th week, there are significant difference between three treatment groups on the WOMAC score (p=0.03) and on the VAS score (p=0.004). When analyzed between weeks, GCM treatment group was found statistically significant on WOMAC score (p=0.01) and VAS score (p<0.001). Comparing the score difference between weeks, WOMAC score analysis showed significant difference between GC, GCM, and placebo in week 4 (p=0.049) and week 12 (p=0.01). In addition, VAS score also showed significant difference between groups in week 8 (p=0.006) and week 12 (p<0.001). Conclusion: combination of glucosamine chondroitinsulfate methylsulfonylmethane showed clinical benefit for patients with knee OAK ellgren Lawrence grade I II compared with GC and placebo. GC did not make clinical improvement in overall groups of patients with knee OA Kellgren Lawrence grade I II."
Jakarta: University of Indonesia. Faculty of Medicine, 2017
616 UI-IJIM 49:2 (2017)
Artikel Jurnal  Universitas Indonesia Library
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Masruroh
Efek aktivitas berjalan kaki terstruktur dalam memelihara fungsi kognitif pada usia lanjut : Uji klinis acak tersamar tunggal = Effect of structured walking activity in maintaining cognitive function in elderly : Single-Blind randomized controlled trial
"[Latar Belakang : Jumlah usia lanjut (Usila) makin meningkat dan tumbuh cepat, yang membawa konsekuensi meningkatnya gangguan terkait usia, termasuk penurunan fungsi kognitif. Penelitian ini bertujuan untuk mengetahui efek pemberian aktivitas berjalan kaki terstruktur, yaitu minimal 6000 langkah/hari, terintegrasi dalam aktivitas sehari-hari dengan kecepatan yang nyaman selama 12 minggu, dalam memelihara fungsi kognitif pada usia lanjut dengan fungsi kognitif normal di komunitas.
Metode : Desain penelitian ini adalah studi ekperimental, berupa uji klinis acak tersamar tunggal. Subyek terdiri dari 20 orang Usila pada kelompok perlakuan yang diberikan aktivitas berjalan kaki terstruktur, dan 19 orang Usila pada kelompok kontrol yang beraktivitas sebagaimana biasanya, selama 12 minggu. Subyek dinilai fungsi kognitifnya menggunakan MoCA Ina pada awal dan akhir perlakuan. Aktivitas berjalan kaki diukur menggunakan pedometer.
Hasil : Aktivitas berjalan kaki terstruktur yang mampu dilakukan oleh kelompok perlakuan adalah 7531 langkah/hari, dan kelompok kontrol adalah 3527 langkah/hari (p=0,000). Pada akhir penelitian, skor total MoCA pada kelompok perlakuan (median=29) adalah lebih tinggi (p=0,022) dibandingkan kelompok kontrol (median=27), dan begitu pula untuk selisih skor MoCA antara awal dan akhir penelitian (rerata selisih pada kelompok perlakuan adalah 3,35; kelompok kontrol adalah 1,47; p=0,003). Efek perlakuan pada domain fungsi kognitif menunjukkan skor Visuospasial/Fungsi Eksekusi secara siknifikan (p=0,08) lebih tinggi pada kelompok perlakuan dibandingkan kelompok kontrol. Selisih skor domain MoCA pada awal dan akhir penelitian ditemukan lebih besar pada kelompok perlakuan pada domain Visuospasial/Fungsi Eksekusi, Bahasa, dan Abstraksi.
Kesimpulan : Aktivitas berjalan kaki terstruktur 7500 langkah/hari memiliki efek positif dalam memelihara fungsi kognitif usia lanjut secara umum, dengan domain yang paling dipengaruhi adalah Visuospasial/Fungsi Eksekusi. Aktivitas ini juga memberikan peningkatan yang lebih besar pada fungsi kognitif secara umum dan pada domain Visuospasial/Fungsi Eksekusi, Bahasa, dan Abstraksi.;Background : Fast growing of elderly population increases disorders related to aging, including decreasing of cognitive function. The objective of this study is to evaluate the effect of structured walking activity, that characterized by minimally 6000 steps/day, integrated to daily activities, with comfortable pace, for 12 week, in maintaining cognitive function in elderly with normal cognitive function in community.
Method : This study design was experimental, single-blind randomized controlled trial. The subjects were 39 elderly, consist of 20 subjects in intervention group and 19 subject in control group. Intervention group were given structured walking activity, and control group did their usual activity, for 12 weeks. Cognitive function were assessed using MoCA Ina in the beginning and end of the study. Walking activity was measured using pedometer.
Results : Amount of walking activity that was able to do was 7531 steps/day in intervention group, and 3527 steps/day in control group (p=0,000). In the end of study, total MoCA score in intervention group (median=29) is significantly better (p=0,022) than control group (median=27), and so did the improvement of MoCA score in the end of study (mean of increasing score in intervention group was 3,35, and in control group was 1,47, p=0,003). Effect on domain of cognitive function showed Visuospatial/Executive function score in intervention group was signifantly better than control group. Improvement in Visuospatial/Excecutive function, Language, and Abstraction domains‟ score was also found larger in intervention group.
Conclusion : Structured walking activity, about 7500 steps/day had a positive effect in maintaining general cognitive function in elderly, and Visuospatial/Executive function was the most influenced domain. The effect of this activity also showed larger improvements in general cognitive function and Visuospatial/Excecutive function, Language, and Abstraction domains., Background : Fast growing of elderly population increases disorders related to aging, including decreasing of cognitive function. The objective of this study is to evaluate the effect of structured walking activity, that characterized by minimally 6000 steps/day, integrated to daily activities, with comfortable pace, for 12 week, in maintaining cognitive function in elderly with normal cognitive function in community.
Method : This study design was experimental, single-blind randomized controlled trial. The subjects were 39 elderly, consist of 20 subjects in intervention group and 19 subject in control group. Intervention group were given structured walking activity, and control group did their usual activity, for 12 weeks. Cognitive function were assessed using MoCA Ina in the beginning and end of the study. Walking activity was measured using pedometer.
Results : Amount of walking activity that was able to do was 7531 steps/day in intervention group, and 3527 steps/day in control group (p=0,000). In the end of study, total MoCA score in intervention group (median=29) is significantly better (p=0,022) than control group (median=27), and so did the improvement of MoCA score in the end of study (mean of increasing score in intervention group was 3,35, and in control group was 1,47, p=0,003). Effect on domain of cognitive function showed Visuospatial/Executive function score in intervention group was signifantly better than control group. Improvement in Visuospatial/Excecutive function, Language, and Abstraction domains‟ score was also found larger in intervention group.
Conclusion : Structured walking activity, about 7500 steps/day had a positive effect in maintaining general cognitive function in elderly, and Visuospatial/Executive function was the most influenced domain. The effect of this activity also showed larger improvements in general cognitive function and Visuospatial/Excecutive function, Language, and Abstraction domains.]"
Fakultas Kedokteran Universitas Indonesia, 2014
SP-PDF
UI - Tugas Akhir  Universitas Indonesia Library
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Intan Airlina Febiliawanti
Perbandingan Bersihan Kolon Antara Polyethylene Glycol dan Sodium Phosphate Pada Persiapan Kolonoskopi : Uji Klinis Acak Tersamar Tunggal = Bowel Preparation for Colonoscopy with Polyethylene Glycol versus Sodium Phosphate Based Lavage : A Single Blind Randomized Clinical Trial
"Latar belakang. Bersihan kolon yang adekuat berkaitan dengan persiapan kolonoskopi yang baik namun hingga saat ini belum ada penelitian mengenai dua preparat bersihan kolon yang paling umum digunakan di Indonesia yaitu polyethylene glycol (PEG) dan sodium phosphate (SP).
Tujuan. Mengetahui perbandingan bersihan kolon antara PEG dan SP pada pasien yang akan dilakukan kolonoskopi di Indonesia. Metode. Uji klinis acak tersamar tunggal, satu sentral penelitian di pusat endoskopi saluran cerna (PESC) RS. Cipto Mangunkusumo (RSCM) pada pasien usia lebih dari 18 tahun yang menjalani kolonoskopi periode Maret ? September 2014. Randomisasi manual, teknik sampling konsekutif dilakukan untuk mengalokasikan preparat PEG dan SP, kemudian penilaian bersihan kolon secara tersamar tunggal dilakukan oleh dua orang dengan Boston Bowel Preparation Scale (BBPS). Nilai adekuat bila skor ≥ 5. Analisis dilakukan dengan intention to treat.
Hasil. Dari 135 subyek yang dirandomisasi, dieksklusi 14 subyek sehingga yang dianalisis 121 subyek (PEG n=62; SP n=59). Semua subyek menjalani penelitian hingga selesai. Bersihan adekuat pada PEG 88,7% dengan rerata skor BPPS 5,89, sedangkan pada SP 89,8% dengan rerata skor BPPS 6,34 (nilai p=0,84). Didapatkan nilai Control Event Rate (CER) 11,3%, Experiment Event Rate (EER) 10,17%, Absolute Risk Reduction (ARR) 1,13%, Relative Risk Reduction (RRR) 9,92%, dan Number Needed to Treat (NNT) untuk SP sebesar 90 subyek. Efek samping pada PEG adalah mual (19,4%), rasa tidak enak (3,2%), muntah (1,6%) sedangkan pada SP hanya rasa tidak enak (5,1%). Kedua kelompok tidak mengalami alergi.
Kesimpulan. Tidak ada perbedaan bermakna secara statistik dan klinis antara PEG dan SP dalam bersihan kolon yang adekuat menggunakan skor BPPS.
Background. Adequate clearance of the colon is associated with a good preparation for colonoscopy. Up until now research on colon adequate clearance by using two of the most commonly used preparations in Indonesia, namely polyethylene glycol and sodium phosphate has not been done.
Aims. To compare the effectivity of PEG and SP in colon clearance for patients undergoing colonoscopy in Indonesia.
Design and Methods. A single blind randomized clinical trial in one centre at gastrointestinal endoscopy centre RSCM, was conducted on patients aged over 18 years old that had colonoscopy in the period from March to September 2014. Consecutive manual randomization was performed to allocate the PEG and SP lavage and assessment of adequate colon clearance will be evaluated by two investigators using the Boston Bowel Preparation Scale (BBPS). Adequate score if > 5. Analysis was done by intention to treat.
Results. From the 135 randomized subjects, 14 was excluded, and 121 subjects obtained (PEG n=62; SP n=59). All subjects completed the research. Adequate clearance in PEG was 88.7% with BPPS mean score 5.89. While, SP had adequate clearance of 89.8% with BPPS mean score 6.34 (p value=0.84). Analysis resulted in CER 11.3%, EER 10.17%, ARR 1.13%, RRR 9.92%, and NNT for SP was 90 subjects. Side effects in PEG participants were nausea (19.4%), unpleasant taste (3.2%), vomit (1.6%) while in SP participants only experienced unpleasant taste (5.1%). Both groups did not experience allergic reaction.
Conclusion. There was no significant difference in terms of adequate colon clearance preparation between PEG and SP using BPPS score."
Jakarta: Fakultas Kedokteran Universitas Indonesia, 2014
SP-Pdf
UI - Tugas Akhir  Universitas Indonesia Library
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