Anti-hyperglycemic, Anti-hyperlipidemic, Anti-inflammatory, and Antioxidant Efficacy of <i>Ferula assa-foetida</i> in Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, and Placebo-Controlled Trial

Abstract

Background: Despite the accessibility of synthetic antidiabetic drugs for the management of type 2 diabetes mellitus (T2DM), their side effects and cost have drawn significant attention to novel natural alternatives for treatment. Objectives: The present study evaluated the effectiveness of Ferula assa-foetida as a potential therapeutic agent against T2DM. Methods: A double-blind, randomized controlled clinical trial was conducted at Ayatollah Taleghani Medical and Educational Center, Abadan University of Medical Sciences, Abadan, Iran. A simple randomization method using a table of random numbers to create a random sequence was applied, and allocation concealment was performed sequentially using numbered, sealed, and opaque envelopes to hide random allocation. Patients received capsules (250 mg × 2/day) of either starch (placebo, n = 10) or F. assa-foetida (assa-foetida, n = 10) for 90 days. Biochemical parameters, physical activity (PA), and diet were evaluated at baseline and the end of the study. Results: Oral administration of F. assa-foetida for 90 days showed an increase in the median and IQR of ESR [10.5 (11.3) mm/h at baseline and 12 (8) mm/h on day 90, within group mean difference: -4.8 mm/h, 95% CI: -8.7, -0.84; P = 0.017] and a reduction in HDL-C [40 ± 10.03 mg/dL at baseline and 32.3 ± 6.9 mg/dL on day 90, within group mean difference: 7.7 mg/dL, 95% CI: 0.2, 14.2; P = 0.046] was found in the assa-foetida group. Patients in the assa-foetida-treated group showed a higher value of serum glutamic pyruvic transaminase (SGPT) compared with the placebo on day 90 [25 (12) vs. 16.5 (7.5), respectively, between group mean difference: -7.71 IU/L, 95% CI: -13.92, -1.49; P = 0.036]. The assa-foetida-treated group consumed fewer snacks and desserts [48 (6) vs. 57 (14), between group mean difference: 9.1, 95% CI: 1.7, 16.6; P = 0.021] on day 90 compared to the placebo, more from whole grains [23 (3) vs. 11 (5), within group mean difference: 12.9, 95% CI: 7.1, 18.6; P = 0.018], refined grains [20.5 (6) vs. 16 (9.25), within group mean difference: -7, 95% CI: -13.3, -0.7; P = 0.034], and potatoes [6 (4) vs. 2 (3.75), within group mean difference: -4, 95% CI: -7.2, -0.8; P = 0.028], and less from nuts and seeds [19 (2.5) vs. 22.5 (6.5), within group mean difference: 2.2, 95% CI: 0.2, 4.2; P = 0.041] on day 90 compared to baseline. At the same time, the patients in the placebo group consumed more refined grains [22 (5.5) vs. 15 (4.25), within group mean difference: -6.3, 95% CI: -10.6, -2.1; P = 0.012] and legumes [20 (5.25) vs. 14.5 (2.5), within group mean difference: -4.7, 95% CI: -8.8, -0.49; P = 0.035]. Conclusions: Taking the assa-foetida supplement alone without following positive changes in dietary intake is insufficient to demonstrate the anti-hyperglycemic, anti-inflammatory, and antioxidant efficacy of F. assa-foetida in patients with T2DM.