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 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