Efficacy of Pro-Kinetic Agents in Type 2 Diabetes Mellitus Patients With Gastroparesis Using Lactulose Hydrogen Breath Testing: A Randomized Trial

Abstract

The aim of the study was to determine the efficacy of prokinetic agents in diabetic gastroparesis patients. MethodThis was a randomized open-label trial conducted on 50 patients with type 2 diabetes experiencing diabetic gastroparesis, which was diagnosed with the lactulose hydrogen breath test. After randomization, all 50 patients were divided into four arms (cinitapride, metoclopramide, levosulpiride, and domperidone) of different prokinetics and followed up for four weeks; after which, repeat gastroparesis cardinal symptom index score and orocecal transit time were recorded in order to assess the response to the treatment. ResultThere was no statistically significant difference among the four groups in terms of all the baseline characteristics except for gender (p=0.032). The follow-up gastroparesis cardinal symptom index was collected for 50 patients but repeat orocecal transit time could be performed only in 37 patients. In all four groups, there was a statistically significant (p<0.05) improvement in terms of orocecal transit time and gastroparesis cardinal symptom index scores. But there was no statistically significant difference in relative efficacy amongst these study groups. ConclusionOur study showed statistically significant improvement with four prokinetics drugs in terms of gastroparesis cardinal symptom index score and orocecal transit time, but there was no statistically significant benefit of one prokinetic drug over the other. Our study showed promising results with regard to prokinetic use in diabetic gastroparesis.

Normal and disordered gastric emptying in diabetes: recent insights into (patho)physiology, management and impact on glycaemic control

“…Based on anecdotal reports, subcutaneous metoclopramide may be effective in treating vomiting episodes. Other D2 receptor antagonists, including domperidone, may improve symptoms to a comparable extent to metoclopramide [ 70 ]. Tardive dyskinesia (more common with metoclopramide than domperidone) and QTc (corrected QT interval) prolongation with the potential for arrhythmia are important concerns, although the risk of tardive dyskinesia may be as low as 0.1% per 1000 patient-years with metoclopramide [ 71 ].…”

Neuropatía gastrointestinal diabética. Una revisión de la literatura

“…El padecer de neuropatía autonómica gastrointestinal secundaria a la diabetes mellitus, como es la gastroparesia, también conlleva sus propias complicaciones, siendo una de ellas la disbiosis intestinal, pues se ha comprobado que aquellos que sufren esta complicación de la diabetes poseen una microbiota intestinal caracterizada por Fusobacteria, Lachnoclostridium, Fusobacterium_mortiferum, entre otros, a diferencia de los Bacteroidetes, Firmicutes y Proteobacteria que poseen las personas sanas (19). En casos severos la gastroparesia diabética puede llevar al paciente a sufrir malnutrición, deshidratación e incluso desequilibrios hidroelectrolíticos (20).…”

“…Entre estos fármacos se encuentran la metoclopramida, domperidona, cisapride (12), así como itopride y trimebutina, pero su uso se recomienda únicamente a corto plazo (3). De ellos se ha afirmado que no existe diferencia significativa entre los efectos positivos causados por el uso de metoclopramida, cinitaprida, levosulpirida y domperidona, al ser estos valorados por la escala de puntajes de síntomas cardinales de gastroparesia y el tiempo de tránsito orocecal (20), sin embargo, hay que considerar sus mecanismos de acción y efectos adversos antes de su prescripción.…”