Acupuncture Treatment for Gastroparesis: a Pilot Study
Acupuncture Treatment for Gastroparesis: a Pilot Study
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.
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.
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