EFEKTIVITAS JAMU TETES SOMAN 1® TERHADAP HbA1C DAN EVALUASI ADVERSE EVENTS PADA PASIEN DIABETES MELLITUS TIPE 2 DI RUMAH SAKIT

https://doi.org/10.22146/jmpf.265

Nur Atikah(1*), Zullies Ikawati(2), M. Eko Cahyanto(3)

(1) 
(2) 
(3) 
(*) Corresponding Author

Abstract


Penelitian ini dilakukan untuk mengetahui efektivitas jamu tetes Soman 1® terhadap HbA1C dan mengetahui adverse events pada pasien diabetes mellitus tipe 2 di rumah Sakit UGM.

Rancangan penelitian adalah experimental double blind, dengan teknik consecutive sampling pada pasien rawat jalan, dengan diagnosa diabetes mellitus tipe 2 di Rumah Sakit UGM. Sejumlah 30 pasien masuk dalam kriteria inklusi, kemudian dilakukan random allocation untuk menentukan pasien menerima perlakuan uji jamu tetes Soman 1® kombinasi metformin atau plasebo kombinasi metformin selama 12 minggu. Pasien yang di drop out berjumlah 3 orang. Uji independent t-test digunakan untuk membandingkan rata-rata penurunan HbA1C pada kedua kelompok, dengan nilai signifikansi p < 0,05. Sedangkan evaluasi adverse events yang dialami pasien selama penelitian dideskripsikan persentase kejadiannya.

Hasil penelitian menunjukkan terdapat tendensi penurunan rata-rata HbA1C yang lebih tinggi pada kelompok uji (0,79%) dibandingkan dengan plasebo (0,38%), walaupun, secara statistik tidak ada perbedaan yang signifikan, dengan nilai p = 0,345 (p>0,05). Begitu pula secara klinis, penurunan rata-rata HbA1C pada kelompok uji cenderung lebih tinggi daripada kelompok plasebo, dengan nilai selisih perbedaan rerata penurunan HbA1C diantara kedua kelompok adalah 0,41%, walaupun secara klinis tidak berbeda signifikan (< 0,6%). Jumlah kejadian adverse events yang terjadi pada kelompok uji adalah 27 adverse events, antara lain mual (33,33%), diare (20%), nyeri perut (20%), nyeri badan, lemas dan pusing masing-masing 13,33%, alergi/gatal-gatal, nafsu makan meningkat, tenggorokan sakit, konstipasi, mulut terasa pahit, sakit pinggang, susah tidur, kaki kaku/pegal dan mengantuk masing-masing 6,67%, sedangkan pada kelompok plasebo, adverse events yang terjadi yaitu diare (13,33%) dan mual (6,67%).

Kata Kunci: diabetes mellitus tipe 2, jamu tetes Soman 1®, HbA1c, adverse events


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References

Akilen, R., Tsiami, A., Devendra, D., dan Robinson, N., 2010. Glycated haemoglobin and blood pressure-lowering effect of cinnamon in multi-ethnic Type 2 diabetic patients in the UK: a randomized, placebo-controlled, double-blind clinical trial. DIABETICMedicine, 27: 1159–1167.

Allen, R.W., Schwartzman, E., Baker, W.L., Coleman, C.I., dan Phung, O.J., 2013. Cinnamon Use in Type 2 Diabetes: An Updated Systematic Review and Meta-Analysis. Annals of Family Medicine, 11: 452–459.

Ashraf, R., Khan, R., dan Ashraf, I., 2011. Garlic (Allium sativum) supplementation with standard antidiabetic agent provides better diabetic control in type 2 diabetes patients. Pakistan journal of pharmaceutical sciences, 24: 565–70.

Bamosa, A.O., Kaatabi, H., Lebdaa, F.M., Elq, A.M., dan Al-Sultanb, A., 2010. Effect of Nigella sativa seeds on the glycemic control of patients with type 2 diabetes mellitus. Indian J Physiol Pharmacol, 54: 344–354.

Bayan, L., Koulivand, P.H., dan Gorji, A., 2014. Garlic: a review of potential therapeutic effects. Avicenna Journal of Phytomedicine, 4: 1–14.

Benedetti, F., 2005. Neurobiological Mechanisms of the Placebo Effect. Journal of Neuroscience, 25: 10390–10402.

Cicero, A.F.., Derosa, G., dan Gaddi, A., 2004. What do herbalists suggest to diabetic patients in order to improve glycemic control? Evaluation of scientific evidence and potential risks. Acta Diabetol, 41: 91–98.

Dans, A.M.L., Villarruz, M.V.C., Jimeno, C.A., Javelosa, M.A.U., Chua, J., Bautista, R., dkk., 2007. The effect of Momordica charantia capsule preparation on glycemic control in Type 2 Diabetes Mellitus needs further studies. Journal of Clinical Epidemiology, 60: 554–559.

Fouqueray, P., Pirags, V., Inzucchi, S.E., Bailey, C.J., Schernthaner, G., Diamant, M., dkk., 2013. The Efficacy and Safety of Imeglimin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy. Diabetes Care, 36: 565–568.

Lacy, C.F., Armstrong, L., Goldman, M.P., dan Lance, L.L., 2014. Metformin, dalam: Drug Information Handbook. Lexi-comp, USA, hal. 954–956.

Lee, Y.-M., Gweon, O.-C., Seo, Y.-J., Im, J., Kang, M.-J., Kim, M.-J., dkk., 2009. Antioxidant effect of garlic and aged black garlic in animal model of type 2 diabetes mellitus. Nutrition Research and Practice, 3: 156.

Liu, J.P., Zhang, M., Wang, W., dan Grimsgaard, S., 2002. Chinese herbal medicines for type 2 diabetes mellitus, dalam: Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd, hal. 1–130.

Medagama, A.B., 2015. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials. Nutrition Journal, 14: 1–12.

Mohtashami, R., Amini, M., Fallah Huseini, H., Ghamarchehre, M., Sadeqhi, Z., Hajiagaee, R., dkk., 2011. Blood glucose lowering effects of Nigella sativa L. seeds oil in healthy volunteers: a randomized, double-blind, placebo-controlled clinical trial., 3: 90–94.

Ramli, N.S., Ismail, P., dan Rahmat, A., 2014. Influence of Conventional and Ultrasonic-Assisted Extraction on Phenolic Contents, Betacyanin Contents, and Antioxidant Capacity of Red Dragon Fruit (Hylocereus polyrhizus). The Scientific World Journal, 2014: 1–7.

Raut, N.A. dan Gaikwad, N.J., 2006. Antidiabetic activity of hydro-ethanolic extract of Cyperus rotundus in alloxan induced diabetes in rats. Fitoterapia, 77: 585–588.

Simrén, M., Månsson, A., Langkilde, A.M., Svedlund, J., Abrahamsson, H., Bengtsson, U., dkk., 2001. Food-Related Gastrointestinal Symptoms in the Irritable Bowel Syndrome. Digestion, 63: 108–115.

Smith-Palmer, J., Brändle, M., Trevisan, R., Orsini Federici, M., Liabat, S., dan Valentine, W., 2014. Assessment of the association between glycemic variability and diabetes-related complications in type 1 and type 2 diabetes. Diabetes Research and Clinical Practice, 105: 273–284.

Soman, 2015. 'Kandungan Soman 1', . URL: http://www.somanindonesia.co.id/home/produk/kandungan-soman-1?showall=&limitstart= (diakses tanggal 27/8/2015).

Takao, T., Matsuyama, Y., Yanagisawa, H., Kikuchi, M., dan Kawazu, S., 2014. Association between HbA1c variability and mortality in patients with type 2 diabetes. Journal of Diabetes and its Complications, 28: 494–499.

WHO, 2014. 'Diabetes', WHO. URL: http://www.who.int/mediacentre/factsheets/fs312/en/ (diakses tanggal 27/8/2015).



DOI: https://doi.org/10.22146/jmpf.265

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