Buspirone for early satiety and symptoms of gastroparesis: A multi-centre, randomised, placebo-controlled, double-masked trial (BESST)

for the NIDDK Gastroparesis Clinical Research Consortium

doi:10.1111/apt.17479

Buspirone for early satiety and symptoms of gastroparesis: A multi-centre, randomised, placebo-controlled, double-masked trial (BESST)

for the NIDDK Gastroparesis Clinical Research Consortium

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Patients with gastroparesis and related disorders have symptoms including early satiety, postprandial fullness and bloating. Buspirone, a 5-HT₁ receptor agonist, may improve fundic accommodation. Aim: To determine if buspirone treatment improves early satiety and postprandial fullness in patients with symptoms of gastroparesis. Methods: This 4-week multi-centre clinical trial randomised patients with symptoms of gastroparesis and moderate-to-severe symptoms of fullness (Gastroparesis Cardinal Symptom Index [GCSI] early satiety/postprandial fullness subscore [ES/PPF]) to buspirone (10 mg orally) or placebo three times per day. The primary outcome was a change in the ES/PPF from baseline to 4 weeks. The primary analysis was per protocol intention-to-treat ANCOVA of between-group baseline vs. 4-week differences (DoD) in ES/PPF adjusted for baseline ES/PPF. Results are reported using both nominal and Bonferroni (BF) p values. Results and conclusions: Ninety-six patients (47 buspirone, 49 placeboes; 92% female, 50% delayed gastric emptying, 39% diabetic) were enrolled. There was no between-groups difference in the 4-week ES/PPF primary outcome: −1.16 ± 1.25 (SD) on buspirone vs −1.03 ± 1.29 (SD) on placebo (mean DoD: −0.11 [95% CI: −0.68, 0.45]; p = 0.69). Buspirone performed better than placebo in patients with severe-to-very severe bloating at baseline compared to patients with none to moderate: (ES/PPF DoD = −0.65 vs. 1.58, p_TX*GROUP = 0.003; p_BF = 0.07). Among individual GCSI symptoms, only bloating appeared to improve with buspirone vs. placebo. Conclusions: Patients with moderate-to-severe early satiety/postprandial fullness and other symptoms of gastroparesis did not benefit from buspirone treatment to improve the ES/PPF primary outcome compared with placebo. There was a suggestion of the benefit of buspirone in patients with more severe bloating. Trial Registration: ClinicalTrials.gov NCT0358714285.

Original language	English (US)
Pages (from-to)	1272-1289
Number of pages	18
Journal	Alimentary Pharmacology and Therapeutics
Volume	57
Issue number	11
DOIs	https://doi.org/10.1111/apt.17479
State	Published - Jun 2023

ASJC Scopus subject areas

Gastroenterology
Pharmacology (medical)
Hepatology

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10.1111/apt.17479

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@article{04ce0d39018c44afbbd341e2abd40ece,

title = "Buspirone for early satiety and symptoms of gastroparesis: A multi-centre, randomised, placebo-controlled, double-masked trial (BESST)",

abstract = "Background: Patients with gastroparesis and related disorders have symptoms including early satiety, postprandial fullness and bloating. Buspirone, a 5-HT1 receptor agonist, may improve fundic accommodation. Aim: To determine if buspirone treatment improves early satiety and postprandial fullness in patients with symptoms of gastroparesis. Methods: This 4-week multi-centre clinical trial randomised patients with symptoms of gastroparesis and moderate-to-severe symptoms of fullness (Gastroparesis Cardinal Symptom Index [GCSI] early satiety/postprandial fullness subscore [ES/PPF]) to buspirone (10 mg orally) or placebo three times per day. The primary outcome was a change in the ES/PPF from baseline to 4 weeks. The primary analysis was per protocol intention-to-treat ANCOVA of between-group baseline vs. 4-week differences (DoD) in ES/PPF adjusted for baseline ES/PPF. Results are reported using both nominal and Bonferroni (BF) p values. Results and conclusions: Ninety-six patients (47 buspirone, 49 placeboes; 92% female, 50% delayed gastric emptying, 39% diabetic) were enrolled. There was no between-groups difference in the 4-week ES/PPF primary outcome: −1.16 ± 1.25 (SD) on buspirone vs −1.03 ± 1.29 (SD) on placebo (mean DoD: −0.11 [95% CI: −0.68, 0.45]; p = 0.69). Buspirone performed better than placebo in patients with severe-to-very severe bloating at baseline compared to patients with none to moderate: (ES/PPF DoD = −0.65 vs. 1.58, pTX*GROUP = 0.003; pBF = 0.07). Among individual GCSI symptoms, only bloating appeared to improve with buspirone vs. placebo. Conclusions: Patients with moderate-to-severe early satiety/postprandial fullness and other symptoms of gastroparesis did not benefit from buspirone treatment to improve the ES/PPF primary outcome compared with placebo. There was a suggestion of the benefit of buspirone in patients with more severe bloating. Trial Registration: ClinicalTrials.gov NCT0358714285.",

author = "{for the NIDDK Gastroparesis Clinical Research Consortium} and Parkman, {Henry P.} and Yates, {Katherine P.} and Irene Sarosiek and Bulat, {Robert S.} and Abell, {Thomas L.} and Koch, {Kenneth L.} and Braden Kuo and Madhusudan Grover and Gianrico Farrugia and Paul Silver and Amirah Abdullah and Maurer, {Alan H.} and Zubair Malik and Miriel, {Laura A.} and James Tonascia and Frank Hamilton and Pasricha, {Pankaj J.} and McCallum, {Richard W.}",

note = "Publisher Copyright: {\textcopyright} 2023 John Wiley & Sons Ltd.",

year = "2023",

month = jun,

doi = "10.1111/apt.17479",

language = "English (US)",

volume = "57",

pages = "1272--1289",

journal = "Alimentary Pharmacology and Therapeutics",

issn = "0269-2813",

publisher = "Wiley-Blackwell",

number = "11",

}

TY - JOUR

T1 - Buspirone for early satiety and symptoms of gastroparesis

T2 - A multi-centre, randomised, placebo-controlled, double-masked trial (BESST)

AU - for the NIDDK Gastroparesis Clinical Research Consortium

AU - Parkman, Henry P.

AU - Yates, Katherine P.

AU - Sarosiek, Irene

AU - Bulat, Robert S.

AU - Abell, Thomas L.

AU - Koch, Kenneth L.

AU - Kuo, Braden

AU - Grover, Madhusudan

AU - Farrugia, Gianrico

AU - Silver, Paul

AU - Abdullah, Amirah

AU - Maurer, Alan H.

AU - Malik, Zubair

AU - Miriel, Laura A.

AU - Tonascia, James

AU - Hamilton, Frank

AU - Pasricha, Pankaj J.

AU - McCallum, Richard W.

PY - 2023/6

Y1 - 2023/6

N2 - Background: Patients with gastroparesis and related disorders have symptoms including early satiety, postprandial fullness and bloating. Buspirone, a 5-HT1 receptor agonist, may improve fundic accommodation. Aim: To determine if buspirone treatment improves early satiety and postprandial fullness in patients with symptoms of gastroparesis. Methods: This 4-week multi-centre clinical trial randomised patients with symptoms of gastroparesis and moderate-to-severe symptoms of fullness (Gastroparesis Cardinal Symptom Index [GCSI] early satiety/postprandial fullness subscore [ES/PPF]) to buspirone (10 mg orally) or placebo three times per day. The primary outcome was a change in the ES/PPF from baseline to 4 weeks. The primary analysis was per protocol intention-to-treat ANCOVA of between-group baseline vs. 4-week differences (DoD) in ES/PPF adjusted for baseline ES/PPF. Results are reported using both nominal and Bonferroni (BF) p values. Results and conclusions: Ninety-six patients (47 buspirone, 49 placeboes; 92% female, 50% delayed gastric emptying, 39% diabetic) were enrolled. There was no between-groups difference in the 4-week ES/PPF primary outcome: −1.16 ± 1.25 (SD) on buspirone vs −1.03 ± 1.29 (SD) on placebo (mean DoD: −0.11 [95% CI: −0.68, 0.45]; p = 0.69). Buspirone performed better than placebo in patients with severe-to-very severe bloating at baseline compared to patients with none to moderate: (ES/PPF DoD = −0.65 vs. 1.58, pTX*GROUP = 0.003; pBF = 0.07). Among individual GCSI symptoms, only bloating appeared to improve with buspirone vs. placebo. Conclusions: Patients with moderate-to-severe early satiety/postprandial fullness and other symptoms of gastroparesis did not benefit from buspirone treatment to improve the ES/PPF primary outcome compared with placebo. There was a suggestion of the benefit of buspirone in patients with more severe bloating. Trial Registration: ClinicalTrials.gov NCT0358714285.

AB - Background: Patients with gastroparesis and related disorders have symptoms including early satiety, postprandial fullness and bloating. Buspirone, a 5-HT1 receptor agonist, may improve fundic accommodation. Aim: To determine if buspirone treatment improves early satiety and postprandial fullness in patients with symptoms of gastroparesis. Methods: This 4-week multi-centre clinical trial randomised patients with symptoms of gastroparesis and moderate-to-severe symptoms of fullness (Gastroparesis Cardinal Symptom Index [GCSI] early satiety/postprandial fullness subscore [ES/PPF]) to buspirone (10 mg orally) or placebo three times per day. The primary outcome was a change in the ES/PPF from baseline to 4 weeks. The primary analysis was per protocol intention-to-treat ANCOVA of between-group baseline vs. 4-week differences (DoD) in ES/PPF adjusted for baseline ES/PPF. Results are reported using both nominal and Bonferroni (BF) p values. Results and conclusions: Ninety-six patients (47 buspirone, 49 placeboes; 92% female, 50% delayed gastric emptying, 39% diabetic) were enrolled. There was no between-groups difference in the 4-week ES/PPF primary outcome: −1.16 ± 1.25 (SD) on buspirone vs −1.03 ± 1.29 (SD) on placebo (mean DoD: −0.11 [95% CI: −0.68, 0.45]; p = 0.69). Buspirone performed better than placebo in patients with severe-to-very severe bloating at baseline compared to patients with none to moderate: (ES/PPF DoD = −0.65 vs. 1.58, pTX*GROUP = 0.003; pBF = 0.07). Among individual GCSI symptoms, only bloating appeared to improve with buspirone vs. placebo. Conclusions: Patients with moderate-to-severe early satiety/postprandial fullness and other symptoms of gastroparesis did not benefit from buspirone treatment to improve the ES/PPF primary outcome compared with placebo. There was a suggestion of the benefit of buspirone in patients with more severe bloating. Trial Registration: ClinicalTrials.gov NCT0358714285.

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UR - http://www.scopus.com/inward/citedby.url?scp=85152893782&partnerID=8YFLogxK

U2 - 10.1111/apt.17479

DO - 10.1111/apt.17479

M3 - Article

C2 - 37052334

AN - SCOPUS:85152893782

SN - 0269-2813

VL - 57

SP - 1272

EP - 1289

JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

IS - 11

ER -

Buspirone for early satiety and symptoms of gastroparesis: A multi-centre, randomised, placebo-controlled, double-masked trial (BESST)

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