Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00591877 |
| Other study ID # |
PS0045 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
December 27, 2007 |
| Last updated |
October 25, 2012 |
| Start date |
December 2012 |
| Est. completion date |
January 2015 |
Study information
| Verified date |
October 2012 |
| Source |
Midwest Biomedical Research Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
BACKGROUND
Prevalence and burden of disease:
Gastroesophageal reflux disease (GERD) defined as presence of symptoms of heartburn and/or
acid regurgitation is a common chronic disorder. It is a significant health problem
especially in the Western population associated with a huge economic burden and impaired
quality of life (1, 2). The prevalence of GERD in the adult population of the United States
is 40% (symptoms at least once a month). Approximately 20% report GERD related symptoms
weekly while 14% report them on a daily basis.
The leading gastrointestinal symptoms evaluated in a primary care office setting are those
related to a diagnosis of GERD. The mainstay of treatment for GERD symptoms at present time
are proton pump inhibitors (PPI) in combination with life style changes. In fact, PPI have
become one of the most commonly written prescriptions, trends suggesting that per year
scripts have doubled since 1999. It is estimated that Americans spend in excess of 10
billion US dollars/year on PPIs and two of the top five selling drugs in the United States
are PPIs (5). For patients who prefer to refrain from long-term medication use, may benefit
from acid-reflux surgeries such as Nissen fundoplication. However, acid-reflux reducing
procedures are associated with operative morbidity and mortality including several
complications including gas bloat syndrome. A large number of patients who undergo surgery
for reflux symptoms may eventually relapse and require PPIs. Thus, treatment of reflux,
either pharmacological or surgical, is costly (6-9) and presents a significant economic
burden on the health-care delivery system.
Social Impact of the disease:
GERD symptoms are associated with bodily pain, impaired social, emotional and physical
functioning which has a profound impact on daily living. Much research has been done to
evaluate the true burden of GERD on our society. For instance, 40% of patients with
nighttime symptoms of GERD reported that such symptoms affected their ability to function
the next day. Furthermore, 27% of these patients reported that their own night-time symptoms
affected their spouses ability to sleep (10). Clearly, this data indicates a huge number of
Americans who report the effects of heartburn on personal and spousal quality of life. GERD
symptoms need to be addressed effectively as successful treatment for GERD results in
improvements in health related quality of life (11, 12). In the treatment of GERD, the goal
should be complete symptom resolution as this has been shown to be associated with a
clinically significant improvement in health related quality of life (HRQL) (13).
Refractory GERD:
Despite life style changes and compliant therapy with PPI, a large number of patients may
have persistent symptoms and classified to have refractory GERD, a distinctive group that is
difficult to manage (14). The putative reasons remain poorly defined but likely include
contributions from factors such as non-acid reflux, visceral hypersensitivity, and abnormal
esophageal motor events (14). A study by Tack et al investigated mechanisms for poor
response to PPI therapy and showed persistence of acid reflux in 11%, bile reflux alone in
38% and a combination of acid and bile reflux in 26%. However, persistence of acid or bile
reflux does not prove a causal relationship with symptoms (15). Also, in this group of
individuals with acid or bile reflux on BID PPI's, a possible treatment option is Nissen's
fundoplication, the utility of which is yet to be proven in this cohort. There is no
consensus definition of refractory GERD and generally, it is defined as non-response of
symptoms to optimum PPI trial. The goal of providing symptomatic relief to these refractory
patients is extremely challenging in view of limited options. It is to these patients that
the investigators would like to evaluate in a feasibility study the use of complementary
medicine modalities including acupuncture and yoga that may be relatively safe,
cost-effective therapies to help with the distressing symptoms of GERD.
Complementary and alternative medicine:
Complementary and alternative medicine (CAM) is a group of diverse medical and health care
systems, therapies and products that are not presently considered to be part of conventional
medicine. These methods have been used for centuries in the eastern culture for a myriad
group of diseases. CAM became popular in the US in the 1990's where majority of people used
it as a complement to conventional medicine and not as an alternative (16-18). Recently,
there has been much interest in applying these modalities not as secondary therapies to
conventional treatment but as the primary method. Amongst them acupuncture and yoga have
gained a great deal of popularity.
Acupuncture (AC):
Acupuncture is part of the traditional Chinese medicine a complete system of healing that
dates back to 200 BC. The general theory of acupuncture is based on the premise that there
are patterns of energy flow (Qi) through the body that are essential for health and
disruptions of this flow are believed to be responsible for disease. Studies have shown that
AC modulates the endorphin system via the central pain processing pathways (19, 20).
Acupuncture has been widely used for various gastrointestinal disorders. It is conceivable
that acupuncture may be effective in patients with GERD because it has been shown to alter
acid secretion, GI motility and visceral pain (21, 22).
The pathogenesis of GERD is multifactorial. The predominant mechanism postulated to cause
GERD is transient relaxation of the lower esophageal sphincter (TLESR). Pathological reflux
may also occur due to low LES pressures (23). Studies have shown that acupoint stimulation
can decrease the rate of TLESR's and hence prevents reflux (24). The investigators propose
to use 3 acupoints ST-36, PC-6, CV-12 for treatment of symptoms of GERD. These points are
described in the subsequent sections. Acupuncture will be performed by Dr. Santosh Sharma
who has the expertise in this treatment modality and is currently offering his therapy for
several years at the Veterans Affairs Medical Center, Kansas City.
Yoga:
Yoga refers to a combination of breathing exercises and postures designed to involve
specific muscle groups with systemic effects on the various organ systems. Yoga originated
in India at least 3000 years ago. The practice of yoga came to US in 1890 and gained
popularity in 1960s because of a rising interest in and cultural acceptance of alternative
modalities and mind body therapies. Yoga is offered in local YWCA, health clubs and yoga
centers and in hospitals as part of disease prevention and management programs (25).The most
popular form is Hatha yoga. As discussed below, the usefulness of yoga has been studied in
certain chronic illnesses such as back pain with promising results. The investigators
propose to use yoga exercises specifically designed for reflux symptoms. Dr. Vijay Kumar
will be offering yoga classes to patients with refractory GERD. Dr. Vijay Kumar is a
Professor of Computer Science at University of Missouri - Kansas City and has been offering
classes for several years at various levels.
Evidence for use of acupuncture and yoga:
Several randomized controlled trials have been conducted demonstrating the beneficial
effects of acupuncture. A randomized controlled study in 29 patients with mild to moderate
ulcerative colitis with a 4 month follow up after completion of acupuncture sessions showed
a statistically significant improvement in colitis activity index (CAI) as compared to the
control group. The study concluded that acupuncture provided an additional therapeutic
benefit to patients with mild to moderate ulcerative colitis (26).
Another randomized 3-arm study was conducted to assess the efficacy and safety of
traditional Chinese acupuncture compared with sham acupuncture (needling at defined
non-acupuncture points) and conservative therapy in patients with chronic pain due to
osteoarthritis of the knee. Addition of acupuncture led to significant improvement in the
symptoms (27). Recently, Dickman et al evaluated the efficacy of adding acupuncture (twice a
week over 4 weeks) as compared to doubling the PPI dose in 30 refractory GERD patients(28).
The acupuncture group demonstrated a significant decrease in mean daytime heartburn scores
compared to high-dose PPI group. Mean nighttime heartburn and regurgitation scores improved
only in the acupuncture group. Thus this study showed that adding acupuncture as compared to
doubling the PPI dose was more effective in controlling symptoms of GERD in patients on
standard dose of PPI.
Similar benefits have been demonstrated with the use of yoga. A randomized controlled trial
compared yoga, exercise and self care book for chronic low back pain showed that yoga was
more effective than a self-care book for improving function and reducing chronic low back
pain and the benefits persisted for at least several months (29). Yoga was also found to be
useful in improving symptoms related to irritable bowel in a randomized trial conducted in
Canada (30).
CLINICAL RELEVANCE OF THIS STUDY GERD is a well known, widely prevalent, clinical entity.
The symptoms of GERD if not relieved can affect the daily functioning/productivity of
individuals. This can be especially frustrating for some patients, who may spend hundreds of
dollars every year on prescription medications, and are still not able to obtain relief of
their symptoms. In the United States alone, it is estimated that PPI costs alone make up
over $10billion/year (5). However, despite these staggering costs, it is clear that even PPI
therapy is not the definitive answer for all patients. Indeed, it has been reported that 37%
of patients receiving PPIs also note concomitant antacid use. This finding underscores the
fact that even with PPI therapy, a large percentage of patients do not achieve full symptom
relief. When left untreated--or when treated inadequately--severe GERD can progress to
esophagitis, esophageal ulcers, esophageal strictures, laryngeal disease, chronic cough,
Barrett's esophagus, and esophageal adenocarcinoma. Clearly, such patients with refractory
symptoms are the ones in the direst need for additional modalities of therapy. Yoga and
acupuncture may be a promising option for these patients, as they represent cost-effective,
yet underused, options which may be usefully employed to control the symptoms of GERD.
Data Collection:
Patient demographics, order of randomization, responses to questionnaires, and antacid use
will be collected by the study coordinator and recorded in a database.
RISK AND BENEFIT TO THE STUDY PARTICIPANT:
This pilot prospective study has the potential to identify new treatments for GERD symptoms.
The participants in this study may experience relief from their GERD symptoms persistent on
high dose acid suppressive therapy. This may improve their quality of life and level of
functioning. The risks to the study group are minimal. There is minor risk of bruising,
needle breakage and infection with the acupuncture needles and musculoskeletal symptoms in
patients undergoing yoga. If the study shows significant improvement in reflux symptoms with
acupuncture or yoga, then these methods may have a wider application to the entire spectrum
of GERD symptoms with the prospect of avoiding pharmacologic and surgical therapies.
STATISTICAL METHODS AND DATA ANALYSIS:
Data Analysis:
Data will be analyzed with the help of a statistical software program. Categorical and
continuous variables will be compared using the Student's t-test and chi-square test. A p
value of < 0.05 will be considered significant.
