Real-world safety and effectiveness of Pistacia lentiscus (mastic gum) in patients with diabetic gastroparesis: 24-week interim analysis postintervention.

INTRODUCTION: Gastrointestinal neuropathies are frequently found in diabetic patients. AIM: The aim of this study was to find out the safety, adverse reactions, and long-term effectiveness of Pistacia lentiscus plant extract (mastic gum) in diabetic gastroparesis (DG) with respect to sustainable improvement in gastroparesis symptoms (Gastrointestinal Cardinal Symptom Index [GCSI] score) by observational follow-up study of a single-centric double-blind noninferiority randomized control trial. MATERIALS AND METHODS: Thirty-eight individuals were recruited and equally randomized in two study groups based on GCSI score and TC99 radionuclide gastric emptying scintigraphy (GES), i.e. the mastic gum group and the levosulpiride group. After 24 weeks, the GCSI score was recalculated in both the groups, and patients were evaluated for the safety, adverse reactions, and long-term effectiveness of mastic gum and the standard drug levosulpiride. RESULTS: In the extended study, mean GCSI score changes at 24 weeks were statistically significant (P < 0.001) (t-test) between the two groups. In the mastic gum arm, the change in mean GCSI score at 24 weeks was statistically nonsignificant mean ± (standard deviation [SD]) 16.7± (3.81) compared to the GCSI score at 2-month postintervention mean (SD) 16.35± (2.27) (intragroup P = 0.89) (repeated measures ANOVA). It strongly indicates that mastic gum provided a sustainable improvement in DG symptoms in comparison to levosulpiride, with excellent subjective well-being postintervention, without any obvious significant adverse effects. CONCLUSION: Six-month (24-week) interim analysis of patients suggests that mastic gum gives a sustainable improvement in DG symptoms without any obvious adverse effects as compared to levosulpiride.

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.

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.