Introduction:
Gallstone disease is a significant health problem affecting 10%-15% of the adult population.
Gallstone diseases include cholelithiasis, choledocholithiasis or intrahepatic gallstones. In
Hong Kong, gallstones are found in 2-3% of the population and 20% of the gallstones are
symptomatic. To date, cholecystectomy is the gold standard treatment for acute cholecystitis.
Laparoscopic cholecystectomy is the preferred modality for elective cholecystectomy and is
advised mainly for symptomatic gallstones such as acute cholecystitis or biliary
pancreatitis. It is recommended that the cholecystectomy should be performed within weeks
after resolution of any episode of complications. However, in Hong Kong, the average waiting
time for cholecystectomy ranged from 9 months to years. The prolonged waiting time increases
the risk of severe complications such as high conversion rate of acute inflammation,
pancreatitis, cholecystitis; obstructive jaundice or gallbladder cancer.
Acupuncture has been extensively applied in clinical practice to treat symptomatic gallstone
diseases in the ancient Traditional Chinese Medicine (TCM) diagnoses of hypochondrite pain ,
jaundice or pyretic thoracic retention. The mechanism of acupuncture had been studied with
(1) increasing of the excretory function of gall bladder; (2) increasing the relaxation of
the sphincter of Oddi and (3) increasing the secretion of bile. All the above actions aim at
promoting the spontaneous clearance of gallstones from the biliary system to the gut. In
fact, gallstone clinic are commonly available in acupuncture department of Chinese Medicine
Hospitals in China for daily practice. Owing to the poor clinical trial methodology, the
evidence of effectiveness of acupuncture were not well established yet.
As a highly recognized traditional therapy, acupuncture has been increasingly used for the
treatment of pain. Early studies in both animals and human subjects found that
electroacupuncture (EA) stimulation on certain acupoints could induce the release of
endogenous opioid peptides and modulate the activities of related receptors in the brain.
These opioid peptides mainly include endomorphin, β-endorphin, enkephalins, and dynorphin.
Furthermore, EA stimulation also could modulate central neurotransmitters, including
serotonin and dopamine, which play important roles in pain signal processing. In addition, it
was found that EA can help antagonize smooth muscle relaxation. Based on these findings, EA
may be useful in fostering the expelling effect of the smooth muscle of the gallbladder.
There had been case reports and case series supporting the use of EA in the treatment of
symptomatic gallstones. However, only one controlled trial has reported EA in treating
gallstone diseases on 120 patients with total excretion of gallstones with confirmed with
ultrasonography (Treatment group 30% vs control group 16.7%, p<0.05) with stone size smaller
than 1cm. However, this study did not report any adverse event during the course of
treatment. Apart from absence of adverse events reporting, the reference study did use the
percentage of patients with total excretion of gallstone confirmed by ultrasound scanning as
the primary outcome. Bearing in mind safety as the first priority, the study did not adopt
any blinding in the clinical trial and could overestimate the effectiveness of acupuncture in
treating gallstone diseases. With our proposed rigorous conduction of clinical trial in terms
of objective assessment of primary outcome and the blinding of assessor, the investigators
hope to confirm the effectiveness of acupuncture in gallstone diseases despite of the results
published in China. In fact, many patients in Hong Kong are waiting for cholecystectomy with
average time of 9 months to years owing to the less urgency of the operation. The
investigators hope this study could confirm the effectiveness of acupuncture on gallstone
diseases so as to develop more evidence. To substantiate the effectiveness and safety of EA
as an alternative intervention for symptomatic gallstones in clinical practice, this study
aims at pioneering a well-designed, long-term, large-scale controlled trial for further
evaluation of the effectiveness of EA in treating gallstone diseases.
Aims: to evaluate the effectiveness and safety of EA as an alternative treatment in
symptomatic gallstone diseases. Based on the pragmatic nature of the trial, this study will
also explore the health economic evaluation of additional acupuncture services against usual
care.
Methods: A two arm pragmatic randomized controlled trial design will be conducted at the
Prince of Wales Hospitals. 132 patients diagnosed of symptomatic gallstone diseases are on
waiting list for cholecystectomy or being recommended to have cholecystectomy by surgeons
will be allocated in either EA group (n = 66); or control group (n=66). Treatment group will
be offered 20 sessions of EA in 10 weeks, while the control group will remain in the usual
care for solely assessment. Primary outcome is the proportion of patients with total
clearance of gallstones after treatment with confirmation by ultrasonography. The secondary
outcome is the monitoring the incidence of common bile duct stone by liver function test
(LFT) and MRCP.
Implication of this study The most expected and clinically significant findings should be the
exploratory effectiveness of EA that promotes the excretion of the gallstones. In addition,
if EA is found to be effective, results from this study can form a solid basis for funding
routine establishment of an EA service care model for among symptomatic gallstone diseases
patients. Based on the pragmatic nature of the trial, this study will also explore the health
economic evaluation of additional acupuncture services against usual care which could
facilitate to give an overview for setting up to the integrative medical service.
Aims and Hypotheses to be Tested:
This study aims to evaluate the effectiveness and safety of EA in the treatment of
symptomatic gallstone diseases compare with usual care
Hypotheses:
EA could produce greater effects than usual care in treating symptomatic gallstone diseases
and increase the rate of excretion.
Objectives
To determine whether EA treatment is more effective than usual care in the management of
symptomatic gallstone diseases; and
To determine whether EA, compared with usual care, can increase clearance rate as
confirmed by ultrasonography,
To determine the safety of EA in the management of gallstone diseases
To explore the health economic assessment of both EA and usual care