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Pengaruh ekstrak biji nigella sativa terhadap profil lipid pasien usia lanjut dengan lispidemia: studi klinis acak tersamar ganda = Effect of Nigella Sativa Seed Extracts on Lipid Profile in Elderly Patients With Dyslipidemia: a Randomized Double-blind Clinical Trial

Latar Belakang. Nigella sativa atau jinten hitam merupakan obat herbal yang telah lama digunakan untuk mengobati dislipidemia. Namun, belum banyak studi yang mempelajari efikasi obat tersebut dan sebagian besar subjek telah yang diteliti adalah populasi usia muda. Tujuan. Menentukan pengaruh ekstrak biji N. sativa terhadap kadar kolesterol total, LDL, HDL, dan trigliserida pada pasien usia lanjut dengan dislipidemia. Metode. Studi ini merupakan uji klinis acak tersamar ganda yang dilakukan selama periode September-Desember 2011 di RS. Cipto Mangunkusumo, Jakarta. Subjek penelitian adalah pasien usia 60 tahun atau lebih dengan dislipidemia yang berobat ke Poliklinik Penyakit Dalam, Geriatri, dan Metabolik Endokrin. Subjek dirandomisasi ke dalam dua kelompok, yaitu kelompok intervensi yang menerima ekstrak biji N. sativa 2x300 mg per hari dan kelompok kontrol. Subjek yang telah mendapat statin sebelum penelitian melanjutkan konsumsi statin, sedangkan subjek yang belum mendapat statin diberikan simvastatin 1x10 mg per hari. Seluruh subjek diamati selama 56 hari. Pada akhir penelitian, dilakukan pemeriksaan kolesterol total, LDL, HDL, dan trigliserida. Hasil. Sebanyak 96 subjek direkrut, 52 pada kelompok intervensi dan 44 pada kelompok kontrol. Pada akhir studi, 41 subjek pada kelompok intervensi dan 37 subjek pada kelompok kontrol menyelesaikan penelitian dan ikut dalam analisis. Rerata kadar kolesterol total kelompok intervensi dan kelompok kontrol adalah 195,0 (SB 55,8) mg/dL dan 201,0 (SB 37,7) mg/dL (p=0,587). Rerata kadar LDL kelompok intervensi dan kontrol adalah 123,0 (SB 30,0) mg/dL dan 130,0 (SB 30,5) mg/dL (p=309). Rerata kadar HDL kelompok intervensi dan kontrol adalah 48,9 (SB 12,5) mg/dL dan 53,2 (SB 17,1) mg/dL (p=205). Rerata kadar trigliserida kelompok intervensi dan kontrol adalah 146,3 (SB 77,7) dan 115,3 (SB 43,5) mg/dL (p=0,031). Efek simpang yang dilaporkan pada kelompok intervensi adalah urtikaria (2%), mual (2%), lemas (2%), diuresis (2%), dan diare (2%). Simpulan. N. sativa belum terbukti dalam memperbaiki profil lipid pada pasien usia lanjut dengan dislipidemia.
Kata kunci. Nigella sativa, usia lanjut, dislipidemia


Background. Nigella sativa or black seed is an herb used for years to treat dyslipidemia. However, researches studying the efficacy are lacking, and most subjects participating in previous studies were young adults. Objectives. To determine the effect of N. sativa seed extracts on total cholesterol, LDL, HDL, and triglyceride in elderly patients with dyslipidemia. Methods. This was a randomized, double-blind clinical trial conducted between September 2011 and December 2011, at Cipto Mangunkusumo Hospital, Jakarta. Subjects were 60 year-old or older patients who visited Internal Medicine, Geriatrics, and Endocrinology outpatient clinics. Subjects were randomly assigned to intervention group (who received N. sativa seed extract, 300 mg bid) and control group. Subject who had been consuming statins prior to enrollment were asked to continue medication. Subject who had never received statins were given simvastatin, 10 mg once a day. All subject were followed for 56 days. In the end of this study, total cholesterol, LDL, HDL, and triglyceride were measured. Results. A total of 96 subjects were recruited, 52 subjects in the intervention group, and 44 subjects in the control group. In the end of study, 41 subjects in the intervention group and 37 subjects in the control group finished the study and were analyzed. The means of total cholesterol of intervention and control group were 195,0 (SD 55,8) mg/dL and 201,0 (SD 37,7) mg/dL (p=0,587). The means of LDL of intervention and control group were 123,0 (SD 30,0) mg/dL and 130,0 (SD 30,5) mg/dL (p=309). The means of HDL of intervention and control group were 48,9 (SD 12,5) mg/dL and 53,2 (SD 17,1) mg/dL (p=205). The means of triglyceride of intervention and control group were 146,3 (SD 77,7) and 115,3 (SD 43,5) mg/dL (p=0,031). Adverse events in the intervention group were urticaria (2%), nausea (2%), lethargy (2%), diuresis (2%), and diarrhea (2%). Conclusion. N. sativa had not been proven to improve lipid profile in the elderly with dyslipidemia.
Keywords. Nigella sativa, elderly, dyslipidemia