The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD): Assessing the Content Validity in Patients with Idiopathic or Diabetic Gastroparesis

Objectives The aim of this preliminary study was to compare the effectiveness of domperidone and acupuncture for the management of diabetic gastroparesis. Methods This was a preliminary, prospective non-randomised, unblinded case-crossover study conducted in patients with longstanding, uncontrolled diabetes mellitus and gastroparesis. All patients received domperidone (20 mg four times a day) for 12 weeks, followed by a 2–3 week washout period, and then biweekly acupuncture treatments for 8 weeks. Gastric emptying rate, glucose and glycated haemoglobin (HbA1C) levels were measured at start and end of each treatment period. At each of these timepoints patients completed the Gastroparesis Cardinal Symptom Index (GCSI), the Satisfaction with Life Scale (SWLS), and the Short-Form 36 Health Survey Update (SF-36). Results The trial was curtailed after only eight participants could be recruited in 3 years. The mean age of patients was 57.1±9.9 years, the male:female ratio was 1:7 and mean body mass index (kg/m2) was 25.2±1.2. There was no change in any of the outcome parameters after treatment with domperidone. Acupuncture was associated with a decrease in scores for almost all cardinal symptoms of the GCSI, as well as in increased total score on the SWLS (p=0.002) and the social functioning domain of the SF-36 (p=0.054). Acupuncture did not lead to an improvement in gastric emptying, or glucose control from baseline. Conclusions Acupuncture treatment may lead to symptomatic improvement in patients with diabetic gastroparesis. Within the limitations of this preliminary, non-randomised and unblinded study, it appears that this effect may be due to non-specific mechanisms.

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Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD)

Neurogastroenterology & Motility ◽

10.1111/j.1365-2982.2012.01879.x ◽

2012 ◽

Vol 24 (5) ◽

pp. 456-463 ◽

Cited By ~ 66

Author(s):

D. A. Revicki ◽

M. Camilleri ◽

B. Kuo ◽

L. A. Szarka ◽

J. McCormack ◽

...

Keyword(s):

Clinical Trials ◽

Daily Diary ◽

Symptom Index ◽

Cardinal Symptom

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M1216 Gastroparesis Cardinal Symptom Index (GCSI): Use of a Daily Diary Versus Two Week Recall

Gastroenterology ◽

10.1016/s0016-5085(09)61719-4 ◽

2009 ◽

Vol 136 (5) ◽

pp. A-374-A-375

Author(s):

Henry P. Parkman ◽

Michael Camilleri ◽

Braden Kuo ◽

Nancy J. Norton ◽

Susmita Paladugu ◽

...

Keyword(s):

Daily Diary ◽

Symptom Index ◽

Cardinal Symptom

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W1391 Reliability and Validity of the Gastroparesis Cardinal Symptom Index-Daily Diary

Gastroenterology ◽

10.1016/s0016-5085(10)63282-9 ◽

2010 ◽

Vol 138 (5) ◽

pp. S-714

Author(s):

Henry P. Parkman ◽

Braden Kuo ◽

Lawrence A. Szarka ◽

Julie McCormack ◽

Michael Camilleri ◽

...

Keyword(s):

Reliability And Validity ◽

Daily Diary ◽

Symptom Index ◽

Cardinal Symptom

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The Short-Term Effects of Acupuncture on Patients with Diabetic Gastroparesis: A Randomised Crossover Study

Acupuncture in Medicine ◽

10.1136/acupmed-2014-010670 ◽

2015 ◽

Vol 33 (3) ◽

pp. 204-209 ◽

Cited By ~ 9

Author(s):

Guomin Li ◽

Chengfei Huang ◽

Xuezhu Zhang ◽

Hui Xie ◽

Haiyan Cheng ◽

...

Keyword(s):

Fasting Blood Glucose ◽

Gastrointestinal Symptoms ◽

Sham Acupuncture ◽

Diabetic Gastroparesis ◽

Gastric Retention ◽

Short Term ◽

Symptom Index ◽

Cardinal Symptom ◽

Hba1c Levels ◽

Short Term Effects

Background Acupuncture may improve gastrointestinal symptoms in patients with various disorders, but its efficacy in diabetic gastroparesis is unclear. Objective To evaluate the short-term effects of acupuncture on gastric emptying and gastroparesis symptoms in patients with diabetic gastroparesis. Methods In a single-blind controlled crossover trial, 25 patients with diabetic gastroparesis were randomly assigned to undergo 1 week of real acupuncture (RA) treatment followed by 1 week of sham acupuncture (SA) treatment, or vice versa, with a washout of 1 month in between. Before and after each intervention, gastric retention, the Gastroparesis Cardinal Symptom Index (GCSI), fasting blood glucose (FBG) and HbA1c levels were measured. Results 21 patients completed the study. Compared with SA treatment, RA treatment was associated with significantly greater reductions in gastric retention at 2 h (−11.1±7.0%; 95% CI −13.6% to −6.2%; p<0.01) and at 4 h (−5.0±2.8%; 95% CI −6.0% to −0.2%; p=0.04) and in GCSI score (−8.0±3.4; 95% CI −8.4 to −2.8; p<0.01). There were no significant differences in FBG and HbA1c levels between RA and SA treatments. Conclusions In patients with diabetic gastroparesis, 1 week of short-term manual acupuncture reduces gastric retention and improves gastroparesis symptoms.

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Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

Journal of Pharmaceutics and Therapeutics ◽

10.18314/jpt.v4i1.1050 ◽

2018 ◽

Vol 4 (1) ◽

Author(s):

Jason Heckert ◽

Ron Schey ◽

Henry Paul Parkman

Keyword(s):

Abdominal Pain ◽

Daily Diary ◽

Open Label ◽

Symptom Index ◽

Early Satiety ◽

Postprandial Fullness ◽

Fda Guidance ◽

Idiopathic Gastroparesis ◽

A Prospective Study ◽

Cardinal Symptom

Granisetron transdermal system (GTS; Sancuso®), a patch delivering a 5-HT3 receptor antagonist, has been shown to improve nausea and vomiting in gastroparesis. Recent FDA guidance on gastroparesis suggests daily scoring of symptoms to show efficacy. Aim: Determine the efficacy and onset of therapeutic response of GTS in improving specific symptoms and overall symptoms of gastroparesis in patients with gastroparesis using a daily symptom diary for gastroparesis. Methods: Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting were enrolled. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) captured severity of symptoms at baseline for one week and during two weeks of treatment with GTS. Key Results: 14 patients (age 41.5±17 years; 13 females) with refractory gastroparesis (5 idiopathic, 9 diabetic) participated in this open label study. Nausea, early satiety, postprandial fullness, abdominal pain, GCSI-DD composite score, and overall symptom severity significantly improved (p<0.05) during treatment when compared to the baseline week. Nausea significantly decreased on day 5 (p<0.01) of treatment. Episodes of vomiting did not significantly change. Side effects included pruritus (2 patients) and redness (1) at the patch site, headache (1), constipation (1), and poor patch adherence (5). Conclusions & Inferences: GTS significantly reduced nausea severity in patients with gastroparesis. There were also significant improvements in early satiety, postprandial fullness, and abdominal pain. Nausea improvement occurred on the fifth day of treatment. Thus, GTS has therapeutic effect on nausea, as well as other gastroparesis symptoms, in patients with gastroparesis as captured using a daily diary for gastroparesis.

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