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Effect of Nigella Sativa oil versus metformin on glycemic control and biochemical parameters of newly diagnosed type 2 diabetes mellitus patients

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Abstract

Purpose

Nature is a phenomenal treasure of remedies. Numerous previous studies reported that Nigella sativa NS improved glycemic control, reduced insulin resistance, and improved lipid profile. NS was never investigated before as a monotherapy for newly diagnosed type 2 diabetes mellitus T2DM patients. Our aim was to investigate the potential metabolic benefits of NS monotherapy in newly diagnosed T2DM patients.

Method

Prospective, open-label randomized clinical trial at outpatient endocrinology clinic at Ain-Shams University hospital. Eligible patients were randomly assigned to either metformin tablets or NS oil capsules. Both groups received treatment for 3 months. Glycemic index (FBG, 2 h pp, A1C, insulin sensitivity %S, secretory function %B, insulin resistance IR), lipid profile (TC, LDL, HDL, TG), liver and kidney functions (AST, ALT, Sr cr), total antioxidant capacity TAC, weight, waist circumference WC and body mass index BMI were assessed at baseline and at the end of treatment period.

Results

A concentration of 1350 mg/day NS in newly diagnosed T2DM patients was inferior to metformin in terms of lowering FBG, 2 h pp, and A1C or increasing %B. However, NS was comparable to metformin in lowering weight, WC, and BMI significantly. NS was comparable to metformin in regards of their effects on fasting insulin, %S, IR, ALT, TC, LDL, HDL, TG, and TAC. Metformin showed significant increase in AST and creatinine which was reserved in NS group.

Conclusion

NS administration in newly diagnosed T2DM was tolerable with no side effects as compared to metformin; however, it was inferior to metformin in terms of diabetes management.

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Authors and Affiliations

  1. Department of pharmacy practice, Faculty of Pharmacy and drug technology, Heliopolis University for Sustainable Development, Cairo Governorate, Egypt

    Hebatallah Ahmed Mohamed Moustafa

  2. Department of Clinical Pharmacy, Faculty of pharmacy, Ain Shams University, Cairo Governorate, Egypt

    Lamia Mohamed El Wakeel & Nagwa Ali Sabri

  3. Department of Internal Medicine and Endocrinology, Faculty of Pharmacy, Ain Shams University, Cairo Governorate, Egypt

    Mohamed Reda Halawa

  4. Department of pharmacology & toxicology, faculty of pharmacy and drug technology, Heliopolis University for Sustainable Development, Cairo Governorate, Egypt

    Alshaymaa Zaki El-Bahy

  5. Department of Pharmacognosy, Faculty of Pharmacy, Ain Shams University, Cairo Governorate, Egypt

    Abdel Nasser Singab

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  1. Hebatallah Ahmed Mohamed Moustafa
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  2. Lamia Mohamed El Wakeel
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  3. Mohamed Reda Halawa
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Correspondence to Lamia Mohamed El Wakeel.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

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Moustafa, H.A.M., El Wakeel, L.M., Halawa, M.R. et al. Effect of Nigella Sativa oil versus metformin on glycemic control and biochemical parameters of newly diagnosed type 2 diabetes mellitus patients. Endocrine 65, 286–294 (2019). https://doi.org/10.1007/s12020-019-01963-4

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