Response and Adverse Event Rates With Placebo in Gastroparesis: A Systematic Review and Meta-analysis

Wise, Journey L.; Ingrosso, Maria Rosa; Ianiro, Gianluca; Black, Christopher J; Ford, Alexander C.; Lacy, Brian E.

doi:10.1016/j.cgh.2022.09.033

Cited by 7 publications

(5 citation statements)

References 55 publications

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“…Over 50% of the patients in the metoclopramide group showed improvement in all symptoms except anorexia 228 . However, it is important to note that a recent meta‐analysis suggested that the placebo effect plays a significant role in gastroparesis studies, and a treatment duration of 3 weeks may be too short to assess the efficacy of medication in gastroparesis studies 229 …”

Section: Dopamine‐2 Receptor Antagonistsmentioning

confidence: 99%

“…228 However, it is important to note that a recent meta-analysis suggested that the placebo effect plays a significant role in gastroparesis studies, and a treatment duration of 3 weeks may be too short to assess the efficacy of medication in gastroparesis studies. 229 In another study, 285 patients with type 1 or type 2 diabetes and a previous diagnosis of gastroparesis were randomly assigned to receive metoclopramide nasal spray (10 mg q.i.d. or 14 mg q.i.d.…”

Section: Gastroparesismentioning

confidence: 99%

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Prokinetics‐safety and efficacy: The European Society of Neurogastroenterology and Motility/The American Neurogastroenterology and Motility Society expert review

Bor,

Kalkan,

Savarino

et al. 2024

Neurogastroenterology Motil

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BackgroundProkinetics are a class of pharmacological drugs designed to improve gastrointestinal (GI) motility, either regionally or across the whole gut. Each drug has its merits and drawbacks, and based on current evidence as high‐quality studies are limited, we have no clear recommendation on one class or other. However, there remains a large unmet need for both regionally selective and/or globally acting prokinetic drugs that work primarily intraluminally and are safe and without systemic side effects.PurposeHere, we describe the strengths and weaknesses of six classes of prokinetic drugs, including their pharmacokinetic properties, efficacy, safety and tolerability and potential indications.

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Section: Dopamine‐2 Receptor Antagonistsmentioning

confidence: 99%

Section: Gastroparesismentioning

confidence: 99%

Prokinetics‐safety and efficacy: The European Society of Neurogastroenterology and Motility/The American Neurogastroenterology and Motility Society expert review

Bor,

Kalkan,

Savarino

et al. 2024

Neurogastroenterology Motil

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“…First, did study subjects truly have GP? Many studies performed in the 1980s and 1990s used imprecise inclusion criteria that resulted in enrollment of subjects with functional dyspepsia (FD) rather than GP [9 ▪ ]. Furthermore, gastric emptying scans were frequently performed incorrectly [10 ▪ ].…”

Section: Treatment Design: Why Do Many Gastroparesis Studies Fail?mentioning

confidence: 99%

“…Fifth, were study durations appropriate? While many clinical trials were performed for four weeks or less, evidence supports a minimum study duration of eight weeks [9 ▪ ]. Sixth, did the mechanism of action make sense?…”

Section: Treatment Design: Why Do Many Gastroparesis Studies Fail?mentioning

confidence: 99%

“…Aggregating results from 23 RCTs involving 1011 patients with GP, a recent systematic review and meta-analysis revealed a pooled placebo response rate of 29.3% [95% confidence interval (CI), 23.7–35.2%] (Fig. 1) [9 ▪ ]. Several factors were associated with placebo response rates in GP trials, including GP etiology, use of validated questionnaires for symptom evaluation, duration of treatment, drug:placebo randomization ratio, dosing schedule, and use of confirmed GP diagnosis for trial inclusion (see Table 2).…”

Section: The Power Of Placebomentioning

confidence: 99%

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Gastroparesis: time for a paradigm change

Lacy,

Wise,

Cangemi

2023

Current Opinion in Gastroenterology

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Purpose of review Gastroparesis (GP) is a syndrome defined by symptoms and delayed gastric emptying in the absence of mechanical obstruction. Typical symptoms include nausea, vomiting, abdominal pain, and early satiety. Only one medication is currently FDA-approved for the treatment of GP. This review highlights recent research findings pertaining to GP and provides evidence to support a change in the current GP diagnostic and treatment paradigm. Recent findings An analysis of GP trials over the past four decades demonstrates the power of placebo and the need to perform longer studies with clearly defined patient populations. Two studies highlight the need to evaluate patients with suspected GP carefully and to perform gastric emptying studies properly. The misdiagnosis of GP symptoms is reviewed, preceded by a discussion of whether GP should be considered a disorder of gut-brain interaction. Finally, new data on therapies that target the pylorus are highlighted. Summary Gastroparesis is frequently over-diagnosed and incorrectly diagnosed. Performing a proper gastric emptying study which adheres to standard protocol, and accurately interpreting the results in the context of the individual patient, are critical to making an accurate diagnosis of GP. The treatment paradigm needs to shift from simply aiming to accelerate gastric emptying to treating global symptoms of a chronic syndrome that may represent gut-brain dysfunction in many patients.

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WITHDRAWN: Evidence Synthesis to Advance Clinical Practice and Scientific Research: A CGH Pillar

Singh

2023

Clinical Gastroenterology and Hepatology

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Response and Adverse Event Rates With Placebo in Gastroparesis: A Systematic Review and Meta-analysis

Cited by 7 publications

References 55 publications

Prokinetics‐safety and efficacy: The European Society of Neurogastroenterology and Motility/The American Neurogastroenterology and Motility Society expert review

Prokinetics‐safety and efficacy: The European Society of Neurogastroenterology and Motility/The American Neurogastroenterology and Motility Society expert review

Gastroparesis: time for a paradigm change

WITHDRAWN: Evidence Synthesis to Advance Clinical Practice and Scientific Research: A CGH Pillar

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