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"Background: Nigella sativa (NS) seed extract shows diuretic activity, inhibits sympathetic nervous system overactivity and increases the production of Nitric Oxide in in vivo studies, thus it has a potential use as an adjuvant antihypertensive for elderly population. This study aimed to determine the effect of Nigella sativa seed extract to systolic blood pressure (SBP) and diastolic blood pressure (DBP) of elderly patients with hypertension. Methods: a double-blind, randomized controlled trial was conducted on elderly subjects with hypertension in three outpatient clinics in Cipto Mangunkusumo National Hospital Jakarta Indonesia from June to September 2011. Subjects were divided into intervention group given 300 mg Nigella sativa seed extract twice daily for 28 days and into another group which was given placebo. Blood pressure were measured on day 1 and 28. Intention o treat analysis using unpaired t-test to compare blood pressure after intervention between the two groups was performed. Results: of a total of 85 patients, 76 subjects fulfilled the study criteria and were randomized into 2 groups, with 38 subjects in each group. Both groups were comparable in all important prognostic factors. The mean systolic blood pressure of the NS group was decreased from 160.4 (SD 15.7) mmHg to 145.8 (SD 19.8) mmHg, and from 160.9 (16.3) mmHg to 147.53 (SD 22.0) mmHg in the placebo group (p=0.36). The mean diastolic blood pressure in the NS group was decreased from 78.3 (SD 11.9) to 74.4 (SD 8.2) mmHg, and from 79.0 (SD 12.4) to 78.2 (SD 8.9) in the placebo group (p=0.35). Reported adverse events include dyspepsia in 6 subjects (15.7%), nausea in 3 subjects (7.8%), and constipation in 2 subjects (5.2%). No electrolyte abnormalities, liver and renal toxicities, or orthostatic hypotension were observed. Conclusion: although a trend towards a slight decrease in blood pressure was observed, Nigella sativa has not been proven to be effective in reducing blood pressure in elderly patients with hypertension.

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Latar belakang: ekstrak biji Nigella sativa (NS) pada penelitian in vivo menunjukkan potensi sebagai anti hipertensi karena memiliki efek diuretik, meningkatkan produksi Oksida Nitrit dan menghambat overaktivitas sistem saraf simpatis, sehingga potensial digunakan sebagai obat anti hipertensi pada pasien usia lanjut. Penelitian ini bertujuan untuk mengetahui pengaruh pemberian ekstrak biji NS pada perubahan tekanan darah sistolik (TDS) dan tekanan darah diastolik (TDD) pasien usia lanjut dengan hipertensi.

Metode: dilakukan uji klinis acak tersamar ganda mulai Juni hingga September 2011 terhadap 76 pasien usia lanjut dengan hipertensi di tiga poliklinik di RS Cipto Mangunkusumo Jakarta Indonesia. Dengan alokasi tersamar, subyek dibagi menjadi kelompok yang mendapat kapsul berisi ekstrak biji NS 300 mg sebanyak 2 kali sehari selama 28 hari dan kelompok yang mendapat plasebo. Tekanan darah (TD) diukur pada hari ke-1 dan ke-28. Dilakukan analisis dengan uji-t tidak berpasangan untuk melihat perbedaan tekanan darah pada kedua kelompok setelah intervensi dengan prinsip analisis intention to treat. Hasil: dari 85 subjek yang memenuhi kriteria awal, didapatkan 76 subjek yang sesuai kriteria penelitian dan dirandomisasi menjadi dua kelompok, masing-masing terdiri dari 38 subjek. Pada akhir pengamatan, TDS kelompok NS turun dari 160,4 (SD 15,7) menjadi 145,8 (SD 19,8) mmHg and pada plasebo turun dari 160,9 (SD 16,3) menjadi 147,53 (SD 22,0) mmHg (p=0,36). TDD pada kelompok NS turun dari 78,3 (SD 11,9) menjadi 74,4 (SD 8,2) dan pada kelompok plasebo turun dari 79,0 (SD 12,4) menjadi 78,2 (SD 8,9) mmHg. Efek simpang yang dilaporkan adalah dispepsia pada 6 subjek (15,7%), mual pada 3 subjek (7,8%) dan konstipasi pada 2 subjek (5,2%). Tidak didapatkan gangguan elektrolit, gangguan fungsi ginjal, hati, maupun hipotensi ortostatik. Kesimpulan: meskipun menunjukkan kecenderungan penurunan tekanan darah, Nigella sativa belum terbukti dapat menurunkan tekanan darah pasien usia lanjut dengan hipertensi"

"This article describes and analyzes the activities and impact of the Seikatsu Club movement in Japan, a social and political movement of Japanese women. Based on our analysis, we attempt to demonstrate the following conclusions: 1. The Seikatsu movement has been remarkable as a vehicle for recruiting and mobilizing women locally both in community activities and electoral politics. 2. For many women, participating in the public, political sphere is transformational and for a smaller minority, values and goals have been redefined and they have gained a new sense of empowerment. For the latter group of 'New Women', greater gender consciousness appears to be developing. 3. While the movement's goals and those of many individuals within it are challenging to prevailing Japanese politics and economics, there are contradictions. Organizationally, hierarchy and paternalistic male leadership have been dominant, despite the formally democratic structure. And aspects of the movement's ideology (e.g. linkage to domestic producers, non-professional housewives seeking electoral office) are profoundly conservative. 4. The movement has demonstrated considerable success at the ballot box in local areas in recent years, although its geographic scope and numerical depth remains limited. Still, it is among the few non-party groups of independents to attain increased representation at the local level. However, commitment to electoral rotation and income sharing may limit the growth of female professional politicians arising from the Seikatsu movement. 5. Seikatsu-elected proxies have achieved incremental policy impact on a number of issues at the local level and movement groups have become active as service providers and policy implementers as well through new administrative partnerships with sympathetic mayors and bureaucrats."

"ABSTRAKPendahuluan: Hipoksia adalah kondisi dimana jaringan tubuh mengalami kekurangan oksigen. Hal ini dapat memicu pembentukan radikal bebas dan menyebabkan kerusakan jaringan. Antioksidan, contohnya enzim katalase diketahui memiliki kemampuan untuk menanggulangi radikal bebas. Enzim katalase berperan untuk mengubah hidrogen peroksida menjadi air dan oksigen. Penelitian ini bertujuan untuk mempelajari aktivitas spesifik enzim katalase pada jaringan otak tikus yang mengalami hipoksia sistemik berkelanjutan. Metodologi: Penelitian ini menggunakan 15 ekor tikus yang dibagi menjadi 5 kelompok, yaitu kontrol dan 4 kelompok perlakuan yang dipaparkan pada kondisi hipoksia sistemik selama 1, 3, 5, dan 7 hari. Aktivitas spesifik katalase pada jaringan otak tikus kemudian diukur menggunakan spektorofotometer. Data dianalisis secara statistik dengan uji one way ANOVA. Hasil: Hasil menunjukkan bahwa aktivitas spesifik katalase menurun pada 3 hari pertama secara bertahap dan meningkat secara bertahap pula pada hari selanjutnya, ke 5 dan 7. Akan tetapi tidak ditemukan perbedaan yang bermakna (p > 0.05, p= 0.293) diantara semua kelompok. Kesimpulan: aktivitas spesifik katalase jaringan otak pada penelitian ini tidak menunjukkan perubahan secara signifikan pada keadaan hipoksia sistemik berkelanjutkan.

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ABSTRACTIntroduction: Hypoxia is a condition of deprivation oxygen supply to the tissue. This condition leads to the formation of free radical and further lead to the tissue damage. Antioxidant, such as catalase enzyme, was known for its ability counter the free radical. Catalase enzyme works by converting hydrogen peroxide into water and oxygen. The aim of this study is to observe the specific activity of catalase enzyme in brain tissue of rats exposed to continuous systemic hypoxia. Methods: This study used 15 rats that was divided into 5 groups: the control, and 4 experimental groups that were exposed with hypoxia for 1, 3, 5, and 7 days. The specific activity of catalase in brain tissue was then measured with spectrophotometer. The data were statistically analyzed by one way ANOVA test. Result: A steady decreased of specific activity of catalase in the first 3 days of exposure and then increase in the 5th and 7th days.. There were no significance differences between all groups (p>0.05, p=0.293 ). Conclusion: It is concluded that the specific activity of catalase in brain tissue of rats showed no significant changes during continuous systemic hypoxia."

"immune regulatory potency as it works on the macrophage and T cell to control inflammation and T cell dysregulation in elderly. None has been known about its effect on elderly with various states of frailty syndrome, which have different level of chronic low grade inflammation. This study aimed to determine the effect of alphacalcidol on inflammatory cytokines (IL-6, IL-10, g-IFN ) and T cell subsets (CD4/CD8 ratio and CD8+ CD28-) of elderly with various stages of frailty syndrome. Methods: from January to July 2017, a double blind randomized controlled trial (RCT) with allocation concealment, involving 110 elderly subjects from Geriatric Outpatient Clinic Cipto Mangunkusumo Hospital Jakarta, was conducted to measure the effect of 0.5 mcg alphacalcidol administration for 90 days to inflammatory cytokines (IL-6, IL-10, g-IFN) from PBMC culture supernatant, as well as CD4/CD8 and CD8+CD28- percentage using flow cytometry. Statistical analysis using SPSS version 20 was performed with t-test to measure mean difference. Results: of 110 subjects involved in the RCT consisting of 27 fit, 27 pre-frail and 56 frail elderly, 25(OH)D serum level was found to be as low as 25.59 (12.2) ng/ml in alphacalcidol group and 28.27 (10.4) ng/ml in placebo group. Alphacalcidol did not decrease IL-6 (p=0.4) and g- IFN (p=0.001), but it increased IL-10 (p=0,005) and decreased IL6/IL10 ratio (p=0.008). Alphacalcidol increased CD4/CD8 ratio from 2.68 (SD 2.45) to 3.2 (SD 2.9); p=0.001 and decreased CD8+ CD28- percentage from 5.1 (SD 3.96) to 2.5 (1.5); p<0.001. Sub group analysis showed similar patterns in all frailty states. Conclusion: Alphacalcidol improves immune senescence by acting as anti-inflammatory agent through increased IL-10 and decreased IL6/IL-10 ratio and also improves cellular immunity through increased CD4/CD8 ratio and decreased CD8+ CD28- subset in elderly. This effect is not influenced by frailty state.

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Latar belakang: Alfakalsidol, suatu analog vitamin D, menunjukkan potensi regulasi imun saat bekerja pada makrofag dan sel T untuk mengontrol peradangan dan disregulasi sel T pada lansia. Saat ini belum diketahui efeknya pada orang tua dengan berbagai keadaan sindrom frailty yang memiliki peradangan kronis tingkat rendah yang berbeda. Penelitian ini bertujuan untuk mengetahui pengaruh alfakalsidol pada sitokin inflamasi (IL-6, IL-10, g-IFN) dan subset sel T (CD4/CD8 rasio dan CD8 + CD28-) lansia dengan berbagai status sindrom frailty. Metode: selama Januari hingga Juli 2017, uji coba terkontrol acak buta ganda (RCT) dengan penyembunyian alokasi, melibatkan 110 subjek lansia dari Poliklinik Geriatri RS Cipto Mangunkusumo Jakarta, dilakukan untuk mengukur efek pemberian alfakalsidol 0,5 mcg selama 90 hari terhadap inflamasi. Pengukuran sitokin (IL-6, IL-10, g-IFN) dari supernatan kultur PBMC, serta persentase CD4/CD8 dan CD8+ CD28- menggunakan flow cytometry dilakukan. Analisis statistik menggunakan SPSS versi 20 dilakukan dengan t-test untuk mengukur perbedaan rata-rata. Hasil: dari 110 subjek yang terlibat dalam RCT yang terdiri dari 27 orang sehat, 27 pra-lemah dan 56 orang lanjut usia lemah, 25 (OH) D serum adalah 25,59 (12,2) ng/ml dalam kelompok alfakalsidol dan 28,27 (10.4) ng / ml dalam kelompok plasebo. Alfakalsidol tidak menurunkan IL-6 (p=0,4) dan g-IFN (p=0,001), tetapi meningkatkan IL-10 (p=0,005) dan menurunkan rasio IL6/IL10 (p=0,008). Alfakalsidol meningkatkan rasio CD4/CD8 dari 2,68 (SD 2,45) menjadi 3,2 (SD 2,9); p=0,001 dan penurunan CD8+ CD28- persentase dari 5,1 (SD 3,96) menjadi 2,5 (1,5); p<0,001. Analisis sub kelompok menunjukkan pola yang sama di semua status frailty. Kesimpulan: alfakalsidol meningkatkan penuaan kekebalan dengan bertindak sebagai agen anti-inflamasi melalui peningkatan IL-10 dan penurunan rasio IL6/IL-10 dan juga meningkatkan imunitas seluler melalui peningkatan rasio CD4/CD8 dan penurunan CD8+ CD28-subset pada lansia. Efek ini tidak dipengaruhi oleh status frailty"

"scleroderma is an autoimmune disease characterized by organ fibrosis, resistant to standard treatment. It is suspected the addition of Physalis angulata Linn. (Ciplukan) extract as adjuvant therapy can improve the scleroderma skin fibrosis. The aim at this study is to evaluate the effect of ciplukan extract as adjuvant on scleroderma skin fibrosis in standard therapy, based on modified Rodnan skin scale (MRSS), inflammatory biomarkers, immunology and serum fibrosis. Methods: double-blind, randomized clinical trial was performed in scleroderma patients with stable disease at Cipto Mangunkusumo hospital and Hasan Sadikin hospital during November 2015−March 2017 who met the selection criteria and continued to receive standard therapy. The subjects were randomly allocated into two groups: the study group received the ciplukan extract 3 x 250 mg / day for 12 weeks and the placebo group. Examination of MRSS, ESR, P1NP, BAFF and sCD40L was performed every 4 weeks until the end of the study. Results: fifty-nine subjects completed the study. They consisted of 29 subjects of the treatment group and 30 of the placebo group, with an average age of 41 (SD 9) years, the proportion of women: male = 9 : 1. There was a significant improvement of skin fibrosis in the study group with a highly significant decrease in MRSS (35.9% VS 6.3%, p <0.001) and a relative decrease in P1NP levels (17.8% VS 0.7%, p = 0.002). No decrease in ESR, BAFF and sCD40L levels in both groups. There was a weak but significant positive correlation between MRSS with P1NP levels (r = 0.236, p = 0.036). Conclusion: Ciplukan extract with dose 3 x 250 mg for 12 weeks as adjuvant on scleroderma standard therapy alleviates skin fibrosis significantly based on MRSS and P1NP levels.

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Latar belakang: skleroderma merupakan penyakit autoimun yang resisten terhadap pengobatan standar, penambahan ekstrak herba ciplukan (Physalis angulata Linn) diduga dapat memperbaiki fibrosis kulit skleroderma. Penelitian ini bertujuan mengkaji peran ekstrak herba Ciplukan sebagai terapi ajuvan untuk fibrosis kulit skleroderma yang mendapat terapi standar, berdasarkan MRSS, biomarker inflamasi, imunologi dan fibrosis serum.

Metode: uji klinis acak tersamar ganda pada pasien skleroderma stabil yang berobat jalan di RSCM dan RSHS sejak November 2015−Maret 2017 yang memenuhi kriteria inklusi dan menerima terapi standar. Subjek secara random terbagi dua: kelompok uji yang mendapat ekstrak herba C iplukan 3x 250 mg/hari selama 12 minggu dan kelompok plasebo. Pemeriksaan MRSS, LED, P1NP, BAFF dan sCD40L dilakukan setiap 4 minggu hingga akhir penelitian.

Hasil: lima puluh sembilan subjek menyelesaikan penelitian, 29 subjek kelompok uji dan 30 subjek kelompok plasebo, rerata usia 41 (SB 9) tahun, proporsi wanita : pria = 9 : 1. Ditemukan perbaikan fibrosis kulit bermakna pada kelompok uji dengan penurunan relatif MRSS sebesar 35,9% dibandingkan plasebo 6,3% dengan p < 0,001 dan penurunan relatif bermakna kadar P1NP sebesar 17,8% dibandingkan plasebo 0,7% dengan p = 0,002. Tidak ditemukan penurunan kadar LED, BAFF dan sCD40L pada kedua kelompok. Terdapat korelasi positif bermakna antara MRSS dengan kadar P1NP (r = 0,236, p = 0,036).

Kesimpulan: pemberian ekstrak etanol herba ciplukan dosis 3 x 250 mg selama 12 minggu sebagai terapi ajuvan pada skleroderma dalam terapi standar, secara klinis dan statistik menunjukkan perbaikan kelainan fibrosis kulit berdasarkan MRSS dan biomarker fibrosis P1NP serum secara bermakna dibandingkan kontrol."

"Trauma pada nervus ischiadicus merupakan cedera saraf tepi yang mengakibatkan perubahan secara morfologi dan seluler pada neuron dan akson. Pemulihan paska cedera nervus ischiadicus seringkali belum optimal secara fungsional. Saat ini, PRP dikembangkan menjadi salah satu pilihan terapi alternatif selain tindakan pembedahan. Hal ini disebabkan PRP mengandung sitokin dan neurotropin yang berperan dalam regenerasi saraf. Penelitian ini bertujuan untuk melihat peranan PRP pada regenerasi saraf motorik tikus model sciatica dengan crush injury. Penelitian eksperimental ini menggunakan blok biologis tersimpan medulla spinalis dan nervus ischiadicus dari tikus wistar jantan yang diberi perlakuan kontrol, sciatica dan sciatica dengan PRP yang diterminasi hari ke-7 dan 42 di Departemen Anatomi, Fakultas Kedokteran, Universitas Indonesia. PRP sebanyak 0,2 ml diberikan pada area bekas jepitan memakai absorbable gelatin sponge. Penilaian regenerasi saraf dilakukan dengan melihat densitas neuron di medulla spinalis menggunakan pewarnaan khusus toluidine blue dan imunohistokimia protein S100B di sitoplasma sel schwann nervus ischiadicus. Didapatkan hasil signifikan pemeriksaan densitas neuron pada hari ke-7 dan 42 antara kelompok sciatica dan kelompok sciatica + PRP serta hasil signifikan pada pemeriksaan ekspresi protein S100B pada hari ke-7 pada kelompok kontrol maupun kelompok sciatica dengan kelompok sciatica + PRP. Penelitian ini menunjukkan bahwa pemberian PRP dapat meningkatkan proliferasi sel schwann dan berperan dalam neuron survival.

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Trauma to the ischiadicus nerve is a peripheral nerve injury that results in morphological and cellular changes in neurons and axons. Post-injury recovery of the ischiadicus nerve is often not functionally optimal. Currently, PRP has been developed as an alternative therapy option to surgery. This is because PRP contains cytokines and neurotrophins that play a role in nerve regeneration. This study aims to look at the role of PRP in motor nerve regeneration of sciatica model rats with crush injury. This experimental study used stored biological blocks of the spinal cord and nervus ischiadicus from male Wistar rats treated with control, sciatica and sciatica with PRP terminated on days 7 and 42 at the Department of Anatomy, Faculty of Medicine, University of Indonesia. PRP as much as 0.2 ml was given to the crush injury area using absorbable gelatin sponge. Assessment of nerve regeneration was performed by looking at the density of neurons in the spinal cord using toluidine blue special staining and immunohistochemistry of S100B protein in the cytoplasm of schwann cells of the ischiadicus nerve. There were significant results in the examination of neuron density on days 7 and 42 between the sciatica group and the sciatica + PRP group and significant results in the examination of S100B protein expression on day 7 in the control group and the sciatica group with the sciatica + PRP group. This study shows that PRP administration can increase schwann cell proliferation and play a role in neuron survival."

"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.

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Latar belakang: glukosamin-kondroitin sulfate sering digunakan untuk mencegah degenerasi lutut lebih lanjut pada osteoartritis (OA). Metilsulfonilmetan (MSM) adalah suplemen yang mengandung belerang organik dan juga dilaporkan memperlambat progresifitas kerusakan anatomis pada OA lutut. MSM sering dikombinasikan dengan glukosamin dan kondroitin sulfat. Namun, masih terdapat kontroversi apakah glucosamin-kondroitin sulfat atau kombinasinya dengan methylsulfonylmethane secara efektif dapat mengurangi rasa sakit pada OA. Penelitian ini bertujuan membandingkan perbaikan klinis glukosamin-kondroitin sulfat (GK), glukosamin-kondroitin sulfat-metilsulfonilmetan (MSM) (GKM) dan plasebo pada pasien osteoartritis derajat Kellgren-Lawrence I dan II.

Metode: suatu uji klinis acak tersamar ganda dilakukan pada 147 pasien dengan OA lutut derajat Kellgren-Lawrence I atau II. Subyek dibagi menjadi 3 kelompok, dengan metode randomisasi blok permutasi, yaitu kelompok GK (n=49), GKM (n=50) dan plasebo (n=48). Kelompok GK mendapat 1500 mg glukosamin + 1200 mg kondroitin sulfat + 500 mg sakarumlaktis; kelompok GKM mendapat 1500 mg glukosamin + 1200 mg kondroitin sulfat + 500 mg MSM; kelompok plasebo menerima 3 kapsul yang serupa berisi sakarum laktis. Obat-obatan ini diberikan sekali sehari selama 3 bulan berturut-turut. Skor VAS dan WOMAC dinilai sebelum pemberian terapi, kemudian pada minggu ke 4, 8 dan 12.

Hasil: pada analisa statistik ditemukan perbedaan signifikan pada minggu ke 12, dimana kelompok GK pada skor WOMAC berbeda signifikan dibandingkan dengan GKM dan plasebo (p=0,005), sedangkan GKM pada skor VAS berbeda signifikan dibandingkan dengan GK dan plasebo (p=0,001). Pada analisis lebih lanjut ditemukan bahwa terdapat perbedaan signifikan pada kelompok GKM dan GM pada skor VAS. Efektivitas pemberian per 4 minggunya ditemukan berbeda bermakna pada kelompok GKM dan plasebo (p<0,005).

Kesimpulan: kombinasi glukosamin-kondroitin sulfat-metilsulonilmetan menunjukkan manfaat klinis yang lebih baik untuk pasien OA sendi lutut Kellgren-Lawrence derajat I dan II dibandingkan dengan GK dan plasebo. Sedangkan suplemen GK secara umum tidak menunjukkan manfaat klinis yang lebih baik pada pasien OA sendi lutut derajat Kellgren Lawrence I-II."

"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.

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Latar belakang: penggunaan obat golongan statin untuk menurunkan kolesterol darah sering disertai efek samping yang mengganggu seperti mialgia dan gangguan fungsi hati. NC120 adalah obat herbal yang mengandung ekstrak ragi beras merah, guggulipid, dan chromium picolinat yang diharapkan tidak menimbulkan efek samping seperti statin. Penelitian ini merupakan uji klinik dengan disain acak tersamar ganda, menurunkan lipid darah.

Metode: penelitian ini merupakan uji klinik dengan disain acak tersamar ganda, membandingkan NC120 dengan plasebo pada subjek dengan hiperkolesterolemia. NC120 atau plasebo diberikan dengan dosis 2 kapsul dua kali sehari selama 28 hari. Kadar kolesterol total, kolesterol LDL dan trigliserida diukur pada hari-0, hari-7, dan hari-28. Uji t-test tidak berpasangan digunakan untuk membandingkan parameter penelitian antar kelompok, sedangkan uji ANOVA satu arah digunakan untuk analisis dalam satu kelompok.

Hasil: 25 subjek mendapat NC120 dan 24 subjek mendapat plasebo. Penurunan bermakna pada kadar kolesterol total dan kolesterol-LDL terlihat pada kelompok yang mendapat NC120, sedangkan pada kelompok plasebo tidak terlihat perbedaan bermakna. Tidak terlihat penurunan yang bermana pada kadar trigliserida pada kelompok NC120, maupun kelompok plasebo. Efek samping umumnya ringan dan seimbang pada kedua kelompok.

Kesimpulan: NC120 efektif menurunkan kadar kolesterol total dan kolesterol-LDL, tapi tidak efektif menurunkan trigliserida. NC120 menunjukkan profil keamanan yang cukup baik, dan obat ini dapat dipertimbangkan tidak bisa merekomendasikan sesuatu berdasar satu RCT apalagi jumlah sampel masih terbatas terutama untuk pasien hiperkolesterolemia yang tidak toleran terhadap statin."

"Background: sarcopenia contributes to the development of frailty syndrome. Frailty syndrome is potentially improved by modifying insulin resistance, inflammation, and myostatin level. This study is aimed to investigate the effect of metformin on handgrip strength, gait speed, myostatin serum level, and health related quality of life (HR-QoL) among non diabetic pre frail elderly patients.Methods: a double blind randomized controlled trial study was conducted on non-diabetic elderly outpatients aged >60 years with pre frail status based on phenotype and/ or index criteria (Cardiovascular Health Study and/ or Frailty Index 40 items) consecutively recruited from March 2015 to June 2016 at Cipto Mangunkusumo Hospital. One hundred twenty subjects who met the research criteria were randomized and equally assigned into 3 x 500 mg metformin or placebo group. The study outcomes were measured at baseline and after 16 weeks of intervention.Results: out of 120 subjects, 43 subjects in metformin group and 48 subjects in placebo group who completed the intervention. There was a significant improvement on the mean gait speed of metformin group by 0.39 (0.77) second or 0.13 (0.24) meter/second that remained significant after adjusting for important prognostic factors (p = 0.024). There was no significant difference on handgrip strength, myostatin serum level, and HR QoL between both groups.Conclusion: 3 x 500 mg metformin for 16 weeks was statistically significant and clinically important in improving usual gait speed as one of the HR QoL dimensions, but did not significantly improve the EQ 5D index score, handgrip strength, nor myostatin serum level.

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Latar belakang: sarkopenia berkontribusi terhadap terjadinya sindrom frailty. Sindrom frailty berpotensi membaik dengan memodifikasi faktor inflamasi, resistensi insulin, dan miostatin. Penelitian ini bertujuan mempelajari pengaruh metformin terhadap kekuatan genggam tangan, kecepatan berjalan, konsentrasi miostatin serum, dan kualitas hidup terkait kesehatan pada pasien lanjut usia (lansia) non-diabetes dengan pre-frail.

Metode: studi ini merupakan uji klinis acak tersamar ganda yang dilakukan pada pasien rawat jalan berusia ≥ 60 tahun dengan status pre-frail berdasarkan kriteria fenotip dan/atau indeks (Cardiovascular Health Study dan/atau Frailty Index 40 items) di Rumah Sakit Cipto Mangunkusumo yang direkrut dari bulan Maret 2015 sampai Juni 2016. Subjek yang memenuhi kriteria penelitian dirandomisasi menjadi grup metformin (3 x 500 mg) atau grup plasebo (amilum 3 x 500 mg). Luaran penelitian diukur pada awal studi dan 16 minggu setelah intervensi. Hasil: dari 120 subjek, 43 subjek dari grup metformin dan 48 subjek dari grup plasebo yang menyelesaikan penelitian. Terdapat peningkatan kecepatan berjalan pada kelompok metformin sebesar 0,39 (0,77) detik atau 0,13 (0,24) meter/detik yang tetap bermakna setelah disesuaikan dengan faktor prognostik penting (p=0,024). Tidak didapatkan perbedaan bermakna kekuatan genggam tangan, konsentrasi miostatin serum, dan kualitas hidup terkait kesehatan antara kedua kelompok perlakuan.

Kesimpulan: pemberian metformin 3 x 500 mg selama 16 minggu secara bermakna meningkatkan kecepatan berjalan sebagai salah satu dimensi kualitas hidup terkait kesehatan, namun tidak meningkatkan secara bermakna skor indeks EQ-5D, kekuatan genggam tangan, dan konsentrasi miostatin serum."

"Latar belakang : Nigella sativa dilaporkan memiliki efek antijamur terhadap Candida albicans. Candida albicans adalah jamur yang menyebabkan kandidiasis oral. Tujuan : Menganalisis efektivitas antijamur ekstrak biji Nigella sativa terhadap viabilitas Candida albicans. Metode : Candida albicans ditambahkan pada 96-microwell plate yang telah dilapisi saliva buatan, kemudian dipaparkan ekstrak biji Nigella sativa dengan konsentrasi 6.25%-50% dan amphotericin B 1µl (250mg/ml) sebagai kontrol positif. Viabilitas Candida albicans dihitung dengan uji MTT. Hasil : Nilai optical density Candida albicans lebih rendah setelah pemberian ekstrak biji Nigella sativa dibandingkan dengan kelompok tanpa perlakuan. Kesimpulan : Viabilitas Candida albicans setelah dipaparkan ekstrak biji Nigella sativa turun dibandingkan dengan kelompok tanpa perlakuan dan viabilitas Candida albicans menurun seiring dengan peningkatan konsentrasi ekstrak biji Nigella sativa.

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Back ground : Nigella sativa has antifungal effect against Candida albicans. Candida albicans is a fungi that causes oral candidiasis.

Objective : To analyze the antifungal effectiveness of the extract of Nigella sativa seed on the viability of Candida albicans.

Methods : Candida albicans was added on 96-well plate that had lined been by artificial saliva and exposed by the extract of Nigella sativa seed 6.25%-50% and amphotericin B 1µl (250mg/µl) was used as positive control. The viability of Candida albicans was determined by MTT assay.

Result : The optical density value of Candida albicans after exposed by the extract of Nigella sativa seed was lower than the negative control.

Conclusion : The viability of Candida albicans after exposed by the extract of Nigella sativa seed was decreased than the negative control and viability of Candida albicans was decreased as increasing concentrations of the extract of Nigella sativa seed."