A Study to Evaluate the Role of Alternative Medicine in Difficult to Treat GERD Patients

Summary

Patients with refractory GERD on BID PPI's assigned to the acupuncture group will have significant improvement in their symptoms after receiving acupuncture for 6 weeks as compared to sham acupuncture given for the same duration.

Primary Aim 1:To determine the efficacy of acupuncture in the treatment of refractory GERD.

Participants with refractory GERD on BID PPIs randomized to yoga will have a significant relief in the symptoms of reflux.

Primary Aim 2:To determine the efficacy of yoga in the treatment of refractory GERD.

Conditions

• Gastroesophageal Reflux Disease

Interventions

PROCEDURE

Acupuncture

Each patient will undergo a 30 minute session, twice a week, for a total of 12 sessions. The technique will involve electro-stimulation at predefined points followed by needle manipulation. The acupoints that will be used are: * ST-36: 3 finger breadths inferior to lower edge of patella between tibialis anterior muscle and the tibia, 1 finger breadth lateral to the anterior crest of the tibia. * PC-6: 2 finger breadths proximal to and in the middle of the most distal transverse crease of the wrist, between the tendons of palmaris longus and flexor carpi radialis. * CV-12: 4 finger breadths superior to the umbilicus.

PROCEDURE

Sham Acupuncture

The acupoints for SAC are: * LI-4 : adjacent to and at the middle of the radial side of the 2nd metacarpal bone, at the same level as the end of the crease when the thumb and index fingers approximate. * GB-32: on the lateral aspect of the thigh 5 finger breadths proximal to the popliteal crease, 2 finger breadths inferior to GB31. * UB -15: 1.5 finger breadths lateral to the midline of the spine on a level between the 5 th and the 6 th thoracic vertebrae.

OTHER

Yoga

The participants in this arm will undergo a 60 min session of yoga exercises. These exercises are specifically designed for reflux symptoms by a yoga instructor. This includes a set of specific physical postures (asana) and breathing techniques within the four-element setup. The set of asana are divided into (a) standing, (b) sitting, and (c) lying down positions. The session will begin with asana in standing position, followed by a position called Shavasan (relaxation), then asana in sitting down position followed by Shavasan, finally asana in lying down position followed by Shavasan. At the end of all asana, Pranayam (special breathing exercises) will be practiced.

Sponsors & Collaborators

• Kansas City Veteran Affairs Medical Center

  collaborator FED

• Midwest Biomedical Research Foundation

  lead OTHER

Principal Investigators

• Prateek Sharma, MD · Kansas City VA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-05-31

Completion

2015-01-31

Countries

• United States

Study Locations