Randomised clinical trial: the effects of amitriptyline on drinking capacity and symptoms in patients with functional dyspepsia, a double-blind placebo-controlled study

Braak, Breg; Klooker, Tamira K.; Wouters, Mira M.; Lei, Alejhandra; Wijngaard, René M. van den; Boeckxstaens, Guy E.

doi:10.1111/j.1365-2036.2011.04775.x

Cited by 56 publications

(65 citation statements)

References 52 publications

(69 reference statements)

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“…A systematic review ( 72 ) identifi ed 13 RCTs evaluating psychotropic drugs in FD. Th ere were three trials (126)(127)(128) involving 339 FD patients comparing TCAs with placebo. Th ere was a statistically signifi cant eff ect in reducing dyspepsia symptoms (RR=0.74; 95% CI=0.61-0.91) with an NNT of six (95% CI=6-18).…”

Section: Conditional Recommendation Moderate Quality Evidencementioning

confidence: 99%

ACG and CAG Clinical Guideline: Management of Dyspepsia

Martin

Lacy

Andrews

et al. 2017

American Journal of Gastroenterology

492

520

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Section: Conditional Recommendation Moderate Quality Evidencementioning

confidence: 99%

ACG and CAG Clinical Guideline: Management of Dyspepsia

Martin

Lacy

Andrews

et al. 2017

American Journal of Gastroenterology

492

520

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“…22 A recent trial of amitriptyline for FD used maximal satiety as an outcome parameter when drinking 100 mL of a nutrient drink at every minute. 16 However, amitriptyline did not affect the subjects' drinking capacity or the postprandial symptoms evoked by the drink test, although the total clinical symptom score and nausea were reduced after treatment. The NDT has several advantages in clinical trials of FD treatments, including its noninvasiveness, easy performance, and low cost.…”

Section: Discussionmentioning

confidence: 99%

“…6,7,14,15 A NDT was used in a clinical trial of amitriptyline, although amitriptyline did not affect the drinking capacity of the subjects or the postprandial symptoms evoked by the drink test in FD patients. 16 It is not determined whether the results of drink tests can reflect response of prokinectic drug. Itopride is currently available in Korea and Japan, indicated for the treatment of FD.…”

Section: Introductionmentioning

confidence: 99%

Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia

Lim¹,

Choi²,

Baeg³

et al. 2014

J Neurogastroenterol Motil

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Background/AimsThe drink test has been regarded as a surrogate marker of gastric accommodation. The aims of this study were to develop a novel nutrient drink test (NDT) protocol and investigate its potential for application to a clinical trial of functional dyspepsia (FD). MethodsA novel NDT was designed, involving drinking 125 mL of nutrient 4 times at 5-minute intervals or until maximal tolerability. Healthy volunteers and patients with FD rated their symptoms every 5 minutes for 20 minutes in a developmental study. Patients with FD were enrolled in an open trial of itopride for 4 weeks. NDT was performed before and after treatment. Improvement of integrative symptoms score during NDT after treatment for more than 50% compared with baseline was defined as responder. ResultsTotal aggregate symptom scores, sum of symptom scores measured during NDT, were higher in FD patients (n = 40, 368.1 ± 245.3) than in controls (n = 19, 215.9 ± 171.2) (P = 0.018) in a developmental study. In an open trial of itopride, symptom scores measured during NDT decreased significantly at all time points after treatment in responders (n = 49), whereas did not in non-responders (n = 25). Total aggregate symptom score for NDT correlated significantly with integrative dyspeptic symptom score, sum of 8 symptom scores of NDI questionnaire, at baseline (r = 0.374, P = 0.001) and after treatment (r = 0.480, P ＜ 0.001). ConclusionsOur novel NDT can quantify dyspeptic symptoms and reflected therapeutic effects of itopride treatment in a clinical trial of FD patients. This NDT can be used as an effective parameter in clinical trials or drug development programs for assessing effects of novel therapies on postprandial symptoms.

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“…The findings of this study argue against the use of this class of agents in FD, but this should not be extrapolated to all psychotropics [37]. In fact, a smaller study in 38 patients showed benefit with amitriptyline over placebo in improving total symptom score and nausea [38]. More recently, a study in FD patients with weight loss and no anxiety or depression, showed that mirtazapine 15 mg in the evening for 8 weeks was superior to placebo in improving overall symptom score, early satiation, nutrient tolerance and weight recovery.…”

Section: Pharmacotherapymentioning

confidence: 99%

Therapeutic Options for Functional Dyspepsia

Vanheel¹,

Tack²

2014

Dig Dis

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Functional dyspepsia (FD) is defined by the presence of chronic gastroduodenal symptoms in the absence of organic or systemic disease that explains them, and a negative upper endoscopy. According to the Rome III consensus, FD can be subdivided into PDS (postprandial distress syndrome) and EPS (epigastric pain syndrome). In patients with mild symptoms, reassurance and lifestyle adjustments are often sufficient. Pharmacotherapy, for those with more severe or persisting symptoms, includes the use of proton pump inhibitors (PPIs), prokinetics and psychotropic agents. In those diagnosed with Helicobacter pylori infection, eradication is recommended, although the symptom impact is often limited. PPIs are the initial therapy of choice for EPS, while prokinetics can be used in PDS. Tricyclic antidepressants can be used for refractory symptoms, especially in EPS. Emerging therapies include the novel gastroprokinetic agent acotiamide for PDS, fundus-relaxing 5-HT_1A agonists in patients with PDS/early satiation and mirtazapine for FD with weight loss.

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Randomised clinical trial: the effects of amitriptyline on drinking capacity and symptoms in patients with functional dyspepsia, a double-blind placebo-controlled study

Abstract: SUMMARY BackgroundFunctional dyspepsia is one of the most prevalent (15-40%) functional gastrointestinal disorders. Antidepressants such as amitriptyline are often used in these patients, but clinical studies are currently lacking.

Cited by 56 publications

References 52 publications

ACG and CAG Clinical Guideline: Management of Dyspepsia

ACG and CAG Clinical Guideline: Management of Dyspepsia

Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia

Therapeutic Options for Functional Dyspepsia

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