Acupuncture Treatment for Gastroparesis: a Pilot Study
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|ClinicalTrials.gov Identifier: NCT01643577|
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis Nausea Vomiting Abdominal Pain||Procedure: Acupuncture for gastroparesis Procedure: Acupuncture for musculoskeletal pain||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture Treatment for Gastroparesis: a Pilot Study|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Active Comparator: Acupuncture protocol for gastroparesis
Patients randomized to this arm will receive an acupuncture protocol that with points designed to treat gastroparesis
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
Placebo Comparator: Acupuncture for musculoskeletal pain
Patients randomized to this arm will receive acupuncture therapy consisting of points designed to treat musculoskeletal pain.
Procedure: Acupuncture for musculoskeletal pain
Acupuncture points selected for the treatment of musculoskeletal pain will be used during each of the 10 acupuncture sessions
- Symptomatic improvement using GCSI [ Time Frame: 10 weeks ]To determine whether acupuncture treatment designed to treat gastroparesis significantly improves symptoms of gastroparesis measured by the Gastroparesis cardinal symptoms index (GCSI)
- Gastric emptying time [ Time Frame: 5 weeks ]To determine whether acupuncture treatment designed to treat gastroparesis significantly improves gastric emptying measured by the Smart Pill
- Small bowel and colonic transit time [ Time Frame: 5 weeks ]To determine whether acupuncture treatment designed to treat gastroparesis significantly alters small bowel and colonic motility using Smart Pill
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643577
|United States, Maryland|
|Johns Hopkins Integrative Medicine & Digestive Center|
|Lutherville, Maryland, United States, 21093|