A preliminary report on the use of Midodrine in treating refractory gastroesophageal disease: Randomized Double-Blind Controlled Trial.


Journal

Acta bio-medica : Atenei Parmensis
ISSN: 2531-6745
Titre abrégé: Acta Biomed
Pays: Italy
ID NLM: 101295064

Informations de publication

Date de publication:
19 03 2020
Historique:
received: 15 05 2019
accepted: 05 02 2020
entrez: 20 3 2020
pubmed: 20 3 2020
medline: 13 1 2021
Statut: epublish

Résumé

Gastroesophageal reflux disease (GERD) is a common disease with various clinical presentations. Acid suppression with proton pump inhibitors and lifestyle modification may not lead to satisfactory response in a substantial portion of patients. We investigated the possible effect of midodrine in patients with refractory GERD. Patients suffering from GERD and were refractory to one-month course of pantoprazole 40mg twice daily entered the study. This was a pilot, randomized, double-blind, and placebo-controlled study. After randomization, one group received Midodrine 5mg before meals for one month, and the other group received placebo for the same period. Meanwhile, pantoprazole was continued 40mg twice daily in both arms. The severity of symptoms was evaluated by the visual scoring system. Quality of life (QoL) in both groups was measured using a standardized version of Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD). A total of twenty patients were enrolled in this study. There was a significant interaction between the groups and time on all measured scores based on QOLRAD questionnaire. All the markers in the Midodrine group had significant improvement over time, but the placebo group did not show any significant improvement. Both visual severity score and total QoL score in Midodrine arm showed a U shape change during  6 weeks. Midodrine before a meal could be useful in alleviating symptoms and improving QoL in the patients with refractory gastroesophageal disease.

Sections du résumé

BACKGROUND
Gastroesophageal reflux disease (GERD) is a common disease with various clinical presentations. Acid suppression with proton pump inhibitors and lifestyle modification may not lead to satisfactory response in a substantial portion of patients. We investigated the possible effect of midodrine in patients with refractory GERD.
METHODS
Patients suffering from GERD and were refractory to one-month course of pantoprazole 40mg twice daily entered the study. This was a pilot, randomized, double-blind, and placebo-controlled study. After randomization, one group received Midodrine 5mg before meals for one month, and the other group received placebo for the same period. Meanwhile, pantoprazole was continued 40mg twice daily in both arms. The severity of symptoms was evaluated by the visual scoring system. Quality of life (QoL) in both groups was measured using a standardized version of Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD).
RESULTS
A total of twenty patients were enrolled in this study. There was a significant interaction between the groups and time on all measured scores based on QOLRAD questionnaire. All the markers in the Midodrine group had significant improvement over time, but the placebo group did not show any significant improvement. Both visual severity score and total QoL score in Midodrine arm showed a U shape change during  6 weeks.
CONCLUSIONS
Midodrine before a meal could be useful in alleviating symptoms and improving QoL in the patients with refractory gastroesophageal disease.

Identifiants

pubmed: 32191657
doi: 10.23750/abm.v91i1.8486
pmc: PMC7569571
doi:

Substances chimiques

Adrenergic alpha-1 Receptor Agonists 0
Proton Pump Inhibitors 0
Midodrine 6YE7PBM15H
Pantoprazole D8TST4O562

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

70-78

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Auteurs

Kamran Bagheri Lankarani (K)

. lankaran@sums.ac.ir.

Gholam Reza Sivandzadeh (GR)

. ghsivand@sums.ac.ir.

Marziyeh Zare (M)

Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences. marziyeh.zare70@gmail.com.

Mohammadali Nejati (M)

. nejati@sums.ac.ir.

Ramin Niknam (R)

. peymanip@sums.ac.ir.

Ali Reza Taghavi (AR)

. ataghavi@sums.ac.ir.

Fardad Ejtehadi (F)

. edjtehadif@sums.ac.ir.

Mahvash Alizade Naini (MA)

. Alizadem@sums.ac.ir.

Maryam Moini (M)

. Dornam@hotmail.com.

Mohammad Hossein Anbardar (MH)

. anbardarm@sums.ac.ir.

Payam Peymani (P)

Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.. peymanip@sums.ac.ir.

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