Acupuncture Treatment for Gastroparesis: a Pilot Study

Nausea Clinical Trial

Official title:

Acupuncture Treatment for Gastroparesis: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643577
• Other study ID #: NA_00044436
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 26, 2012
• Last updated: August 31, 2016
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: August 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Gastroparesis is a disorder characterized by delayed gastric emptying leading to symptoms of nausea, vomiting, bloating, and abdominal pain. A common cause is diabetes but even more often it occurs in otherwise healthy individuals. The symptoms of gastroparesis can significantly alter a patient's quality of life. Current therapies are limited. In this study, the investigators seek to determine if twice weekly acupuncture treatments can improve symptoms of gastroparesis.

Description:

Gastroparesis is a disorder characterized by delayed gastric emptying leading to symptoms of nausea, vomiting, bloating, and abdominal pain. A common cause is diabetes but often it occurs in otherwise healthy individuals in whom the disorder is said to be idiopathic. The symptoms of gastroparesis can significantly alter a patient's quality of life and may result in absenteeism or frequent ER visits and hospitalizations for dehydration caused by intractable nausea and vomiting.

Current treatment for gastroparesis includes dietary and lifestyle modifications, tight glycemic control in diabetics, and supportive care for symptoms, like anti-emetics for nausea. Prokinetic therapies to enhance gastric emptying such as metoclopramide, domperidone, and erythromycin have varying degrees of effect. Unfortunately they are often limited by side effects. Metoclopramide, the only pharmacologic agent that is FDA approved for the treatment of gastroparesis, in particular crosses the blood brain barrier and may cause CNS side effects, reported to be 10-25% of the time. The most rare but most worrisome adverse reaction is tardive dyskinesia associated with prolonged use of metoclopramide, prompting the FDA to label it with a blackbox warning. Use of erythromycin is limited to acute flares, as prolonged use causes tachyphylaxis. Finally, domperidone may have equal efficacy as metoclopramide and is available in 58 countries. However, it is not FDA approved in the US but can be obtained with an Investigational New Drug Application. Given these constraints, novel therapies to improve symptoms are needed.

Preliminary studies from Asia and the US have shown a potential role for acupuncture in improving gastroparetic symptoms and gastric motility in diabetic and non-diabetic patients. It is our plan to expand on the available research by using validated instruments to measure changes in severity of symptoms and quality of life, incorporating randomization and blinding, and correcting for possible placebo effect.

Our hypothesis is that twice weekly acupuncture treatments can improve symptoms of gastroparesis with an effect that lasts beyond the last treatment date without inducing side-effects. We also hypothesize that gastric emptying may improve compared to baseline values. This is a pilot study of 20 gastroparetic patients who will be randomized to standard medical therapy + acupuncture designed to treat gastroparesis vs. standard medical therapy + acupuncture designed to treat unrelated musculoskeletal and arthralgia complaints.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants will be at least 18 years old and able to provide informed consent.

• Participants will have symptoms of idiopathic gastroparesis for at least 6 months duration prior to enrollment with documented abnormal solid phase gastric emptying scintigraphy

Exclusion Criteria:

• Gastroparesis due to: diabetes, medication (e.g. post-chemotherapy), iatrogenic post-surgical gastroparesis, and severe neurologic conditions such as Parkinson's disease known to be associated with gastroparesis.

• An active eating disorder,

• Participants currently lactating, or preparing to conceive will also be excluded.

• A history of inflammatory bowel disease

• Known bowel obstruction, or strictures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Gastroparesis
• Nausea
• Vomiting

Intervention

Procedure:
• Acupuncture for gastroparesis
A series of acupuncture points selected for the treatment of gastroparesis will be used at each of the 10 acupuncture sessions
• Acupuncture for musculoskeletal pain
Acupuncture points selected for the treatment of musculoskeletal pain will be used during each of the 10 acupuncture sessions

Locations

Country	Name	City	State
United States	Johns Hopkins Integrative Medicine & Digestive Center	Lutherville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic improvement using GCSI	To determine whether acupuncture treatment designed to treat gastroparesis significantly improves symptoms of gastroparesis measured by the Gastroparesis cardinal symptoms index (GCSI)	10 weeks	No
Secondary	Gastric emptying time	To determine whether acupuncture treatment designed to treat gastroparesis significantly improves gastric emptying measured by the Smart Pill	5 weeks	No
Secondary	Small bowel and colonic transit time	To determine whether acupuncture treatment designed to treat gastroparesis significantly alters small bowel and colonic motility using Smart Pill	5 weeks	No