Efficacy of Pistacia lentiscus Plant (Rumi Mastagi) in Comparison to Levosulpiride in Patients with Diabetic Gastroparesis: A Double-Blind Non-Inferior Randomised Control Trial Study

Abstract

Introduction: Gastrointestinal neuropathies are frequently found in diabetic patients. The pathogenesis of diabetic gastroparesis (DG) is multifactorial. The usual treatment for DG includes dietary modifications, prokinetic and antiemetic agents. There is increasing demand for more effective medicines to treat DG. The current study was conducted on the Pistacia lentiscus stem extract to add to the armamentarium of DG treatment and to find the efficacy of P. lentiscus plant extract (mastic gum) in comparison to levosulpiride in DG for improvement in gastroparesis symptoms and gastric emptying scintigraphy (GES) in a single centric double-blind non-inferiority randomised control trial.

Methods: Thirty-eight individuals were recruited and equally randomised into two study groups based on Gastroparesis Cardinal Symptom Index (GCSI) score and TC₉₉ Radionuclide GES, mastic gum group and levosulpiride group. Both pre and post-intervention (8 weeks) GCSI scores were calculated, GES was performed to quantify the improvement in gastric emptying. Power analysis was performed using G*POWER software version 3.1.9.7 and data analysis using SPSS 23.0, variables measured in mean ± standard deviation (SD). Various statistical tests were used such as independent t-test, Chi-square test or Fisher's exact test, Wilcox Mann-Whitney test, analysis of variance (ANOVA) test, and posthoc pairwise tests.

Results: The mastic gum is found effective in the improvement of 4 h gastric emptying percentage from the mean (SD) 76.60 (± 9.96) to mean (SD) 97.20 (2.17)% (P < 0.001). Mastic gum has the property of HbA1c reduction, which is more significant than that of levosulpiride (P = 0.044). Mastic gum also had significant Low density lipoprotein (LDL) (mg/dL) levels reduction, (P < 0.001), compared to levosupiride. An absolute increase was observed in haemoglobin (HB) level in mastic gum at a 2-month mean (SD) of 1.03 (0.77) (g/dL) (P-value <0.001).

Conclusions: To our knowledge, this is the first study to compare the effect of levosulpiride with mastic gum concerning improvement in diabetic gastroparesis (DG) using GES. In the study, mastic gum was found to have great properties to improve DG with many important pleiotropic effects.

Keywords: Chios mastic gum (CMG); HOMA IR; diabetic gastroparesis (DG); gastric emptying (GE); gastrointestinal cardinal symptom index score (GCSI); inflammatory bowel disease (IBD); radionuclide gastric emptying scintigraphy (GES); the half-maximum inhibitory concentration IC (50) non-alcoholic fatty liver disease (NAFLD).

Figure 1

Box-and-Whisker plot below depicts the distribution of 4-h emptying (%) over different time points. In each box, the middle horizontal line represents the median 4 h emptying (%), upper and lower bounds of the box represent the 75^th and the 25^th centiles of 4-h emptying (%) respectively, and the upper and lower extents of the whiskers represent the Tukey limits for 4-h emptying (%) at each of the time points

Figure 2

The line graph depicting the change in T^1/2 (mins) over time in the two groups. Group A was having more reduction in T^1/2 (min), in comparison to Group B

Figure 3

Graphs depict the change in LDL (mg/dL) over time in the two groups at various time points, suggesting a more and persistent fall in LDL levels in Group A in comparison to Group B. Within the group A, changes were statistically significant reduction (P-value, Friedman’s test <0.001)

Figure 4

The role of oleic acid in insulin biosynthesis and secretion and improved glucose tolerance (taken from J. M. Castellano et al. Diabetes, vol. 62, no. 6, Jun. 2013)