Acupuncture As An Effective Treatment For Moderate Obstructive Apnea

A Proposed Pilot Study: Acupuncture as an Effective Treatment for Moderate Obstructive
Sleep Apnea
Principal Investigator: Connie L. Christie, L.Ac. Dipl. OM
pg. 1
Connie L. Christie, 2013
Abstract:
This proposal is a non-randomized pragmatic single-arm pilot study designed to evaluate the
feasibility of conducting a clinical trial to determine whether acupuncture provides relief from
the symptoms of moderate obstructive sleep apnea (OSA). Ten subjects who have failed OSA
treatment using CPAP, based upon an initial sleep assessment, will be diagnosed and treated with
a known acupuncture protocol for the diagnosis of Lung, Kidney and/or Spleen vacuity with
excess of phlegm and/or blood stasis. They will be given 16 treatments bi-weekly over an 8
week period. The primary outcome objective is to assess the feasibility and utility of using
acupuncture to treat OSA in cases unresponsive to or noncompliant with CPAP. The secondary
outcome objective is to determine the conditions for a future controlled trial. The primary
outcome will be measured by statistically comparing the physical responses of acupuncture
treatment on moderate OSA as measured by polysomnography (PSG), Epworth Sleepiness Scale
(ESS) and quality of life changes as measured on the Your Health and Well-Being, SF-36v2
questionnaire.
This pilot study will specifically contribute to the body of research on the use of acupuncture for
moderate obstructive sleep apnea and also add to the growing evidence base for the effectiveness
of complementary medicine in treating modern health concerns.
pg. 2
Purpose Statement of the Research and Why It Is Needed
Obstructive Sleep Apnea (OSA) presents a significant health risk to the general population due
to daytime sleepiness resulting in increased motor vehicle and occupational accidents, loss of job
productivity, cognitive dysfunction, depression, life threatening cardiac arrhythmias, severe
hypoxemia during sleep, and increased risk factors related to cerebrovascular and cardiovascular
disease, hypertension, and diabetes (Chesnutt M, 2011) (Pagel JF, 2008). Current treatment
approaches include behavior modification, oral devices, continuous positive airway pressure
(CPAP) and surgery. While the best treatment option is CPAP, it is not well tolerated by a
significant percentage of those for whom it is prescribed, leading to a clear indication of the need
for alternative effective treatment options.
There has been very little direct research on the effect of acupuncture on obstructive sleep apnea
although preliminary research studies between 2002 and 2008 at So Paulo University Hospital
in Brazil show some promising results. Additional research is needed to further validate and
expand this work.
pg. 3
Significance
This pilot study will specifically contribute to the body of research on the use of acupuncture for
moderate obstructive sleep apnea and also add to the growing evidence base for the effectiveness
of complementary medicine in treating modern health concerns.
Goals and Objectives
The overall goal of this pilot study is to evaluate the feasibility of conducting a clinical trial to
determine whether acupuncture provides relief from the symptoms of moderate OSA.
The primary objective is to assess the feasibility and utility of using acupuncture to treat OSA in
cases unresponsive to or noncompliant with CPAP. The secondary outcome objective is to
determine the conditions for a future controlled trial.
Specific Aims
1. Determine the feasibility of recruiting and retaining subjects for a randomized
controlled trial of acupuncture treatment of moderate OSA unresponsive to or non-
compliant with CPAP.
2. Determine the sample size for a randomized control trial (RCT).
3. Assess the safety of acupuncture as an intervention for moderate OSA.
4. Observe the physical responses of acupuncture treatment on moderate OSA as
measured by polysomnography (PSG), Epworth Sleepiness Scale (ESS) and quality
of life changes as measured on the Your Health and Well-Being, SF-36v2
questionnaire.
pg. 4
Background
Need for Treatment
Obstructive sleep apnea has become an increasingly important health concern with consequences
for an individuals health and well-being, as well as an economical and societal burden due to
occupational and motor vehicle accidents. (Pagel JF, 2008) (Patil SP, 2007).
In 1993, the prevalence of OSA was estimated to be 2% for women and 4% for men (Young T,
1993). Data from a more recent longitudinal study, the Wisconsin Cohort Study, indicated
higher numbers for adults between the ages of 30-60, that is, 4-9% for women and 9-24% for
men. Although harder to estimate, with the rise in obesity, children are increasingly being tested
for sleep apnea at sleep centers. One 2007 study estimated there was a 7% prevalence in
adolescents. (Johnson EO, 2006).
OSA is a sleep disorder characterized by recurrent episodes of upper airway obstruction
(collapsing of the airway) resulting in apneas (a cessation of airflow for 10 seconds or greater),
and hypopneas (reduction of airflow associated with oxyhemogoblin desaturation). OSA occurs
secondary to functional and mechanical obstruction of the airway during sleep. The most
prevalent symptom is excessive daytime sleepiness, followed by impaired cognitive function and
mood disorder. Predisposing factors for OSA are obesity, male sex, increasing age, genetic
predisposition, craniofacial variations, nasal obstruction, large neck circumference, use of
alcohol and sedatives, and smoking. (Doghramji P., 2008). The prevalence of OSA is higher in
people with the following comorbid conditions: hypertension, coronary artery disease (previous
cerebrovascular accident and ischemic heart disease), and diabetes mellitus. (Patil SP, 2007).
pg. 5
Pathophysiology
The pathogenesis of OSA involves neurophysiologic pathways, throat pathophysiology and
inflammation, and dysfunctional muscular tension and tonus. Current understanding of the
pathophysiologic mechanisms of OSA suggests a balance of anatomic imposed mechanical loads
and compensatory neuromuscular responses (Patil SP, 2007).
Alterations in upper airway structures such as tonsillar hypertrophy, retrognathia, variations in
craniofacial structures, jaw position and acromegaly are known to be associated with OSA (Patil
SP, 2007). In addition, obesity, which is considered a major risk for sleep apnea, could narrow
and compress the upper airway and contribute to collapsibility (Patil SP, 2007).
Normally the pharyngeal dilator muscles maintain pharyngeal patency via reflex pathways from
the central nervous system. If anatomically mechanical loads are altered or if the dynamic
neuromuscular responses to the upper airway change, then increased pharyngeal collapsibility is
possible. During the respiratory cycle, various muscles (tonic muscular activity during
expiration and phasic muscular activity during inspiration) stabilize the upper airway while
pharyngeal motor output is modulated by several mechanisms: 1) the wake vs sleep state
dependent mechanism, 2) response of local mechanoreceptors to negative pressure, and 3)
ventilator control mechanisms. Neuromuscular responses affecting the reduction of upper
airway muscle activity which occurs with sleep onset are controlled by serotonergic, cholinergic,
noradrenergic and histaminergic pathways. OSA patients have been observed to have elevated
muscle activity during wakefulness that can be reduced with the application of positive airway
pressure (Patil SP, 2007). Individuals not having OSA start with lower muscle activity and have
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no response to the application of positive airway pressure. This suggests that the compensatory
muscle activity of OSA patients during wakefulness is then loss during sleep, which leads to
upper airway obstruction. In other words, the balance of the anatomically imposed mechanical
load during wakefulness is lost during sleep when neuromuscular responses take over.
Pathology in the neuromuscular responses has also been observed (Patil SP, 2007).
Inflammatory and denervation changes in the upper airway muscular layer of the pharynx occur
in patients suffering from OSA (Boyd JH, 2007). One study examining the tissue cells of a
control group (n=7) versus the tissue cells of OSA patients (n=11) revealed a three-fold increase
of inflammatory cells for OSA patients. Tissue examination also showed OSA patients had
significantly increased upper airway mucosa, as well as showing a 5.7 fold increase in
intramuscular nerve fibers in OSA patients as compared to the control group. This data suggests
OSA patients may be unable to generate adequate muscular dilating forces while asleep (Boyd
JH, 2007).
Diagnosis
OSA is diagnosed with a comprehensive sleep study utilizing polysomnography (PSG), the gold
standard. More recently, home portable monitors for diagnosis are gaining in popularity due to
lower cost and ease of use, although error rates are significantly higher with the portable monitor
(Ballard RD, 2008). The PSG measures 16 different parameters during sleep. The most
important measurements are: airflow, respiratory effort, blood oxygen saturation, snoring,
apneas, and hypoapneas. The frequency of obstructive events as measured by the PSG is
reported as the Apnea-Hypopnea Index Scale (AHI). These are measured as respiratory arousal
events per hour.
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An AHI of > 5 and < 15 is diagnosed as mild OSA, an AHI > 15 and < 30 is a diagnosis of
moderate OSA and severe OSA is an AHI > 30.
There are two validated subjective self-reporting tools utilized in sleep apnea. The Epworth
Sleepiness Scale (ESS) rates subjective experiences of daytime sleepiness and alertness. The
Multiple Sleep Latency Test (MSLT) measures, in minutes, the time it takes for a person to fall
asleep during the day.
The importance of diagnosing and treating OSA can be identified by the risks associated with not
treating it. The risks of untreated OSA include increased motor vehicle and occupational
accidents due to daytime sleepiness, loss of job productivity, social and cognitive dysfunction,
reduced vitality, depression, cardiovascular disease, impotence, severe hypoxemia during sleep,
hypertension, and diabetes (Chesnutt M, 2011) (Pagel JF, 2008).
Standard Treatment
Treatment includes behavior modification, oral devices, nasal continuous positive airway
pressure (CPAP) and surgery. The optimal treatment is nasal CPAP. CPAP works by providing a
continuous positive airway pressure applied via a nasal mask. This low pressure, ranging
between 4.5 and 10 cm of oxygen, acts as a splint to keep the nasopharyngeal airway open.
CPAP is known to abolish apneas, hypoapneas and snoring as well as improve sleep quality and
quantity (Sullivan CE, 1981). Treating OSA may address the chronic associated comorbidities of
obesity, hypertension, cardiovascular disease, and cerebrovascular events. One nasal expiratory
positive airway pressure (EPAP) device, Provent therapy, is a FDA approved alternative therapy
to CPAP for OSA. It consists of disposable, nightly-use nasal devices that create a high
expiratory resistance resulting in positive pressure throughout exhalation that keeps the upper
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airway open. It has been shown to significantly reduce AHI with nightly adherence (Berry RB,
2011). Both CPAP and EPAP have adverse effects including dry mouth and throat, breathing
discomfort, insomnia, oxygen desaturation, nasal congestion or discomfort and oropharyngeal
pain (Berry RB, 2011). The first research to show that training of the upper airway muscles can
significantly improve sleep related outcomes including reduction of the AHI was published in
2005 (Puhan MA, 2005). Research has shown that regularly playing the Australian wind
instrument, the didgeridoo, is an effective treatment for OSA and is well accepted by subjects.
The study showed that after 4 months of playing the didgeridoo for 20 minutes daily 5 days a
week there was a significant reduction is daytime sleepiness and AHI in subjects with moderate
OSA. The investigators hypothesize that playing the didgeridoo trains the upper airway muscles
thereby increasing airway dilation and wall stiffening.
Treatment Challenges
Although it is the gold standard, CPAP is not without its drawbacks. CPAP is considered highly
effective in only 62% of patients. It is not tolerated by 20to 30 % of patients and its major
limitation is poor patient compliance. (Padma A, 2007) (Wright J, 2000). Adequate compliance
is defined as CPAP use for at least 4 hours per night, 5 nights a week (Santamaria J, 2007).
Using these criteria, compliance rates are between 46-67% (Santamaria J, 2007) (Kribbs NB,
1993). Further, only 50%-75% of patients who were prescribed CPAP continue to use it after
one year (Stepnowsky C Jr, 2003).
Poor compliance can be due to any of the following: lack of portability, cost, pump noise, mask
leaks and discomfort, dry throat and mouth, claustrophobic feelings, local tissue injury to face
and nasal bridge, unintentional mask removal, nasal irritation or congestion, epistaxis, rhinitis,
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pressure intolerance and aerophagia (swallowing air causing stomach bloating) (Padma A, 2007)
(Hoffstein V, 1992) (Kakkar RK, 2007).
Acupuncture: Research and Review
Introduction
Clinical research has been conducted on acupuncture since the 1950s (White A, 2004). Studies
have been published in the United States since the early 1970s. Older research published in
China reported positive results using acupuncture that upon review lacked the rigor and scientific
standards to be considered valid and adequate. Good research on acupuncture can be
challenging when adhering to the scientific standards for randomized controlled trials, due to
biomedical standards not accounting for the unique holistic paradigm of acupuncture. Unlike a
drug, acupuncture treatment generally involves an individualized treatment plan based on a
specific diagnosis for the individual rather than a one-size-fits-all protocol. Further, a
satisfactory acupuncture placebo has yet to be developed.
The ongoing research challenge addresses the value of acupuncture research using the current
biomedical standards of blinded, randomized controlled trials. The question is how to best
design an acupuncture study that is similar to the delivery of acupuncture in current clinical
practice that utilizes traditional diagnostic methods and applies individualized treatment.
(Hammerschlag R, 1998).
Acupuncture research tends to achieve positive results when designed as a pragmatic study that
examines the effectiveness of acupuncture treatment compared to another form of treatment or
no treatment (Kaptchuk TJ, 2010), rather than a comparison to a placebo. In the pragmatic study,
isolating a specific mechanism of action is not important. This type of research is also called
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whole system research and provides valuable information on clinical outcomes (Hawe P,
2004).
Importance of Research on Acupuncture and Obstructive Sleep Apnea
The question to ask regarding acupuncture and obstructive sleep apnea is whether obstructive
sleep apnea could be resolved with acupuncture treatment. There currently is no evidence of that
and no research to date has attempted to answer that question.
But, preliminary research has shown that acupuncture was better than placebo and that a single
session can reduce the negative effects of moderate OSA (Freire AO, 2007) (Friere AO, 2010).
What is needed is a double-blind, randomized controlled trial to determine the efficacy of
acupuncture in the treatment of OSA, ideally with long-term follow-up to demonstrate if there
are lasting results.
But first, smaller studies are needed to validate diagnostic methods, identify optimal acupuncture
treatment protocols, and document long term follow-up.
This proposed pilot study is designed to address the question of whether acupuncture could be an
effective treatment for patients who fail CPAP, for any reason. This could lead to additional
research to determine how acupuncture compares with CPAP as an effective treatment for OSA.
Acupuncture Research Related to OSA
Acupuncture is known to help with somnolence, cognitive impairment, throat diseases, snoring,
muscular tension and tonus, and structural issues as well as to affect neurophysiological
pathways - all issues associated with OSA. Excessive daytime sleepiness (somnolence) and
cognitive impairment such as poor memory and mood disorder are among the most common
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symptoms of OSA. Respiratory issues of the throat, snoring, structural muscular tension and
tonus issues as well as dysfunction of neurophysiological pathways are all possible contributors
to OSA (Patil SP, 2007) (Boyd JH, 2007) (Woodson T, 1991) (Maciocia G, 2008).
Although there has been limited research on acupuncture and OSA, there are a number of studies
with positive results for the symptoms of OSA and associated conditions.
Most of the research studies conducted on acupuncture and somnolence have been indirect, as
the focus has been on treating insomnia. It can be inferred that treating insomnia improves
daytime sleepiness. Various research shows positive evidence that acupuncture improves
insomnia (Lin Y, 1995) (Li LF, 2010) (Cao HJ, 2009) (Kalavapalli R, 2007).
Many studies have been conducted using acupuncture to improve cognitive function, including
poor memory and mood disorders. One Cochrane review found over 105 studies for treating the
symptoms of vascular dementia which include memory loss and personality disorders, with
reported benefits of 70 to 91% for the treatment group. (Peng W, 2007 ). Another study of
acupuncture for vascular dementia found significant therapeutic effects on memory when using 5
acupoints, namely, Tanzhong (CV-17), Zhongwan (CV-12), Qihai (CV-6), Zusanli (ST-36) and
Xuehai (SP-10) (Yu J, 2006). Three of these points, Tanzhong (CV-17), Zusanli (ST-36) and
Xuehai (SP-10) will be used in this pilot study. This study involved 60 hospital in-patients
diagnosed with vascular dementia who were randomly assigned to either the treatment group or
the control group. Both groups were administered a mini-mental status examination (MMSE),
the Hasegewas dementia scale revised (HDS-R) and activities for daily living (ADL). Both
groups were given medication and acupuncture treatment. However, the treatment group was
administered additional acupuncture sessions daily on the aforementioned five acupoints for a
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period of 6 weeks. At the end of the 6-week period, both groups were again administered the
MMSE, HDS-R and ADL. While both groups improved, the treatment group scores (80%
effective rate) were significantly higher than those in the control group (46.7% effective rate),
with a significant difference of p< 0.05.
Studies on the effectiveness of acupuncture for mood disorders, especially depression, have
found acupuncture to be as effective as medication and/or psychotherapy. (Allen J, 1998) (Luo
H, 1998).
These studies provide evidence that acupuncture has had positive results on the two main
symptoms of OSA, those being daytime sleepiness and mood disorder. The following are
acupuncture studies that explore some of the pathophysiologic mechanisms of OSA that involve
neurophysiologic pathways, throat pathophysiology, and dysfunctional muscular tension and
tonus.
Research on acupuncture analgesia reveals that acupuncture stimulates nerves that send impulses
to the spinal cord and the central nervous system (CNS) which then release neurotransmitter
chemicals that block pain signals (Pomeranz B, 1988). It may be possible that acupuncture has
CNS effects that would influence the neurophysiologic pathways involved in OSA. Acupuncture
analgesia research has also shown that one of the hormones released is adrenocorticotrophic
hormone (ACTH). This hormone stimulates the adrenal cortex, releasing cortisol which is
known to block inflammation in the body. Inflammation in the pharynx could play a role in
pharyngeal occlusion in OSA (Boyd JH, 2007).
Research on acupuncture for treatment of the throat has primarily been limited to sore throat, that
is inflammation of the throat, and there is extensive literature on the application of acupuncture
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for throat diseases. In Chinese medicine, the throat is described as the open-the-wind-way
and includes specific points that treat it (Ji ZH, 2012). One study using acupuncture for
dysphonia associated with benign pathological tissue changes in the pharynx revealed significant
improvement in voice quality of the treatment group (Yiu E, 2006).
In this study, 24 participants between 19 and 51 years old, were divided into two groups, a
treatment group and a placebo group. Both groups were given acupuncture, but only the
treatment group was given acupuncture sessions using points specifically related to throat
problems and vocal functions. All participants got 10 sessions within a 20-day period, with a
pre- and post-acoustic analysis of their voice range profile, and a perceptual analysis of voice
quality and quality of life measurement. A comparison between the two groups showed a
significant improvement for the treatment group in measures of voice activity and participation
profile (VAPP), self-perceived severity, and emotion scores. The VAPP had a mean change of
33.34, while the emotion scores had a mean change of 18.75, both with a p 0.01. Voice
quality of breathiness and roughness ratings showed a mean improvement of 1 and 0.25 units
respectively, with p values of 0.02 and 0.04.
Another more recent Iranian study on postoperative sore throat found promising results using
one acupoint, Neiguan (PC-6) (Esmaeili S, 2013). A non-randomized clinical study with 228
subjects undergoing elective surgeries were separated into a treatment group and a control group.
The control group was administered acupuncture as described, in addition to the routine medical
care both groups received. Postoperatively, the incidence of sore throat was measured and
compared, with 14% of the treatment group experiencing a sore throat compared to 29.8% of the
control group with a p> 0.05.
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Snoring, like somnolence, has been written about extensively in TCM (Maciocia G, 2008). There
is a pattern of insomnia that particularly addresses snoring, that of phlegm-heat. Snoring is
considered an excess pattern always involving phlegm (Maciocia G, 2008). One study of 120
subjects, addressing insomnia as a pattern of phlegm and heat, showed a 97% improvement rate.
(Cui R, 2003). The acupoints selected were Baihui (GV-20), Shenting (GV-24), Sishencong
(EXHN-1), Shenmen (HT-7), Neiguan (PC-6), Zhongwan(CV-12), Fenglong (ST-40) and
Gongsun (SP-4). This study was of 120 subjects who were randomly divided into a treatment
group and a control group. Each group consisted of a series of outpatients between the ages of
28 and 67 suffering from insomnia, which was diagnosed as interior-stirring by phlegm-heat. A
sleep efficiency grading system was adopted and all of the cases in the study were determined to
have a sleep efficiency of less than 60%. The treatment group was administered acupuncture
with the points described above, plus estazolam 1-2 mg. daily over a period of 10 days, while the
control group received estazolam 1-2 mg. with no acupuncture. Both groups were given 3
courses of treatment, after which the effects were evaluated. The measurement for the treatment
group was superior at a 96.7% effective rate compared to 86.7% for the control group. Statistical
significance was not provided. Three of those acupoints will be used in this proposed study:
Baihui (GV-20), Neiguan (PC-6), and Fenglong (ST-40).
Acupuncture research studies involving post-stroke treatment and muscle atrophy show that
acupuncture affects muscular tension and tonus and well as the nerve pathways of motor
function. One randomized controlled study of stroke patients receiving acupuncture showed a
beneficial therapeutic effect on motor function (Sallstrom S K. A., 1996). A group of 45
consenting stroke rehabilitation patients with an average age of 57, were randomly assigned to
either a control group (21) or an acupuncture group (24). The median time from stroke to
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inclusion in the study was 40 days, with inclusion criteria consisting of hemiparesis following a
first stroke. Both groups received a full complement of multi-disciplinary individually adapted
rehabilitation, but the control group received no acupuncture treatments while the acupuncture
group received classical acupuncture according to their traditional Chinese medicine diagnosis
for 30 minutes 3-4 times weekly for 6 weeks. All participants were administered a
neuropsychological screen battery, as well as motor function, ADL and quality of life
questionnaires upon entry into the group, and again 6 weeks later. While both groups improved,
the results for the acupuncture group were significantly higher, particularly in the quality of life
measurements of: 1) emotional reactions--the acupuncture and control groups had respectively,
a mean change of 9.3 (p=0.02) and -3.8; 2) sleep--the acupuncture and control groups had
respectively, a mean change of 15.2 (p=0.004) and -11.6; 3) pain--the acupuncture and control
groups had respectively, a mean change of 12.6 (p=0.004) and 3.4; and 4) physical movement--
the acupuncture and control groups had respectively, a mean change of 40.5 (p=0.0001) and
20.7.
Another Chinese study with stroke patients found that acupuncture needling significantly
improved the muscle strength, muscle tonus, and muscle spasticity in stroke patients (Luo BD,
2010). This was a 30-day study of 106 patients diagnosed with spastic paralysis who were
divided into two groups an observation group who were administered a balanced muscular
tension needling method at the side of extensor and flexor of limbs, and a control group, who
were administered acupuncture at Jianyu (LI-15), Quchi (LI-11), Waiguan (TH-5), etc . Results
from this study showed a total effective rate of 96.3% for the observation group compared to
84.6% in the control group with a p <0.01. This is significant for OSA as one of the proposed
pg. 16
mechanisms of OSA focuses on the collapse of the pharyngeal muscles. In Chinese medicine
atrophy is described as a withering of the muscles, sinews and channels.
One etiology of atrophy can be an injury to the muscles. This corresponds to a proposed etiology
of OSA, relating damage to the pharyngeal tissue from the vibratory trauma of severe snoring
(Woodson T, 1991). Using this perspective, the principle of treatment of atrophy and OSA would
be similar as acupuncture is used to support the withering muscles. In the Woodson study,
tissue samples from 12 patients were analyzed and compared, with examinations compared
between snorers, non-snorers and those with severe obstructive sleep apnea. The assessment of
the physicians participating in this study was that pharyngeal tissues in individuals who suffer
from severe snoring or OSA appear to be subject to damage from the vibrations associated with
snoring. The study also showed a substantial difference between the tissues of non-snorers and
severe snorers.
Maciocia presents numerous modern Chinese literature articles citing the treatment of throat
atrophy with acupuncture (Maciocia G, 2008).
Acupuncture and Obstructive Sleep Apnea
There is very little direct research on acupuncture and sleep apnea as it is a condition that was
not described until 1965, and was unknown to those who developed Chinese medicine and
acupuncture. The few research articles on acupuncture and OSA available in English are
discussed below.
One study from China demonstrated that auricular acupressure is effective as an early
prevention and treatment for sleep apnea syndrome (SAS). (Wang X, 2003). Through
monitoring with PSG in a study group of 45 (30 of whom received auricular acupressure and 15
pg. 17
of whom were in a control group), changes in clinical symptoms, AHI, apnea index, hypopnea,
and mean oxygen saturation (mSa02) were measured. Compared to the control group, the AAP
(auricular acupressure) group showed significant reduction in all PSG measurements with p =
0.01.
In 2004, a Chinese study published on OSA otherwise referred to as Obstructive Sleep Apnea-
Hypopnea syndrome (OSAHS) in this study, was abstracted and translated by Bob Flaws (Flaws
B., 2005). This comparison study conducted from November 1999 to 2003 consisted of 183
subjects and was an attempt to identify the Chinese medical disease mechanisms for OSA and
arrive at discrete patterns of treatment. 122 Subjects with OSAHS were compared with 61
subjects that did not have OSAHS for the signs and symptoms of phlegm, Qi vacuity and blood
stasis. The exact details regarding eligibility criteria were not discussed. The outcome
measures were signs and symptoms of phlegm, Qi vacuity and blood stasis. Each corresponding
sign or symptom was subjectively assigned a number between 1 and 3 to rate severity.
Responses were then group totaled and the numerical results were compared between the
OSAHA group and the non-OSAHA group. Statistical significance was not provided.
According to the study investigators, the results suggested a strong role of phlegm dampness, Qi
vacuity and blood stasis in OSAHS.
Two preliminary research studies from Brazil have shown positive results using acupuncture to
treat moderate OSA with acupuncture. The first study, a single-blinded randomized, placebo
controlled pilot trial, showed acupuncture to be more effective than placebo treatment (sham
acupuncture) in reducing respiratory events assessed by PSG in patients presenting with
moderate OSA. (Freire AO, 2007). This study was conducted between January 2002 and
August 2004 at the So Paulo university hospital. 36 subjects were enrolled in the study.
pg. 18
Eligibility was a diagnosis of moderate OSA, that is an AHI of > 15 and < 30 events per hour,
confirmed by a full PSG study and no prior experience with acupuncture. There were three
arms, each with 12 subjects: 1) acupuncture group, 2) placebo group, and 3) control group. The
subjects were randomized via a blinded, independent researcher selecting a treatment order on a
closed piece of paper out of a box. The acupuncture group received treatment of the following
acupoints: Neiguan (PC-6), Lieque (LU-7), Hegu(LI-4), Yingxiang (LI-20), Baihui (GV-
20),Lianquan ( CV-23), Zusanli (ST-36), Fenglong (ST-40), Sanyinjiao (SP-6) and Zhaohai (KI-
6). The placebo group received sham acupuncture, that is, needling at non-acupoints with no
further details specified. The control group received diet and sleep hygiene counseling. In
addition to the PSG study data, there were 2 other measured outcomes: the validated functional
scales of EES and the SF-36 lifestyle questionnaire. 26 subjects completed the study.
Results from the PSG data showed a significant improvement in the acupuncture group as
follows: AHI decreased by 50.5% (P=0.0005), apnea index (AI) decreased by 79% (P=0.0008),
the number of respiratory events decreased by 43% (P=0.0008), sleep onset had a 67% shorter
latency and sleep efficiency increased by 8%. The sham group showed a significant
improvement in only one parameter, sleep efficiency, (14%) while the control group had a
significant improvement of 12% in sleep efficiency. The control group experienced significantly
greater respiratory events (53%). In addition, the acupuncture group had both a significant
improvement in their ESS scores (P=0.028) and the following SF-36 scores: role physical
(P=0.016), bodily pain (P=0.017), vitality (P=0.024), and mental health (P=0.005). The sham
group had a significant increase in the mental health dimension of the SF-36 (P=0.033) while the
control group had a significant negative change in their mental health dimension (P=0.029).
pg. 19
The second study, a follow up to the 2007 study, demonstrated that both a single manual
acupuncture (MA) treatment and a 10 HZ electro-acupuncture (EA) treatment produced
significantly reduced AHI and other nocturnal respiratory events evaluated on PSG in moderate
OSA patients (Friere AO, 2010).
This study was conducted between January 2007 and August 2008, at the So Paulo university
hospital. 40 subjects were enrolled in the study. Eligibility was a diagnosis of moderate OSA,
AHI > 15 and < 30 events per hour, confirmed by a full PSG study, no prior experience with
acupuncture and between 30 to70 years of age. There were four arms, each with 10 subjects: 1)
manual acupuncture (MA) group, 2) 2 Hz electroacupuncture (EA), 3) 10 Hz electroacupuncture
(EA) and 4) control group. The subjects were randomized (not described) via a blinded,
independent researcher. The MA group received treatment of the following acupoints: Kongzui
(LU-6), Lieque (LU-7), Hegu(LI-4), Yingxiang (LI-20), Baihui (GV-20),Lianquan ( CV-23),
Zusanli (ST-36), Fenglong (ST-40), Zhaohai (KI-6), and the extra point Shanglianguan (EX
HN22). The EA groups received the identical acupoints with electrodes placed on Lianquan
(CV-23), Shanglianguan (EX HN22), Hegu (LI-4) and Zusanli (ST-36) with frequencies of either
2 or 10 Hz. The control group had no treatment which was not elaborated on in the study. The
only outcome measured was PSG data. Each subject obtained a baseline PSG prior to treatment
and then again immediately after. Changes in PSG showed a significant improvement in the MA
and 10 Hz EA groups, respectively, of AHI (MA: pre 21.9, post 11.2 and EA: 20.6, 9.9),
(P=0.005, P=0.005), AI (MA: 5.15, 0.7 and EA: 8.2, 0.3), (P=0.038, P=0.009), and respiratory
events (MA: 120.5, 61.0 and EA: 117.0, 56.0), (P=0.039, P=0.014). No significant changes were
noted in the 2 Hz electro-acupuncture or control group. The study focused on the lack of motor
competence in OSA that the investigators suspected was either the result of an inflammatory
pg. 20
condition or central mechanism that reduced the airway dilator muscles. They postulated that
positive results involved the serotonergic pathways and the anti-inflammatory effects of
acupuncture. In addition, they speculated that the 10 Hz EA produced stronger muscle toning
than the 2 Hz EA. These two studies present the first English language research suggesting that
acupuncture may have a future role in management of moderate OSA.
Challenges
Research on acupuncture and obstructive sleep apnea is really in a beginning stage. While the
preliminary research from Brazil is exciting and inspires further inquiry, both studies have some
issues. The 2007 study may be difficult to replicate. Also, in that study, patient safety was
questioned as OSA-diagnosed patients were denied treatmentthat is, they were given placebos,
and in the case of the control group, no treatment. The control group had a greater number of
respiratory events and their AHI index deteriorated. The investigators dismissed any ethical
concerns due to the general lack of funds in the Brazilian health care system to care for its
population but it would be difficult to replicate this study in another country such as the United
States.
Another concern this author has about the Brazilian studies, is the lack of rationale for treatment
and choice of treatment points. There was no traditional diagnosis using a Chinese medicine
disease mechanism or syndrome pattern, nor were the acupoints chosen from any explained
rationale. The study states that acupoints were selected individually due to specific
characteristics of each point. Although the study showed significant positive results, it is
unknown whether the results were optimal since Chinese Medicine principles were not applied.
pg. 21
Treatment Protocol Rationale
The limited literature and research on OSA and acupuncture add additional challenges to
designing a study that adequately presents diagnostic patterns of OSA and then follows an
optimal acupuncture treatment protocol.
This study proposes to treat OSA as disharmonious patterns of Qi vacuity with phlegm stasis.
The vacuity can be Lung, Kidney or Spleen, or any combination of these three. The treatment
protocol for these patterns was derived from Bob Flaws online course, Sleep Apnea Treated
with Chinese Medicine (Flaws B, 2003). The protocol consists of a core group of acupoints that
focus on vacuity and phlegm stasis and limited additional points to be utilized, depending on
other presenting symptoms of Liver Qi stagnation, blood stasis, and Stomach organ involvement.
The proposed acupoints are listed in Table 1. Six of the core acupoints: Neiguan (PC-6),
Lieque (LU-7), Baihui (GV-20), Lianquan (CV-23), Sanyinjiao (SP-6), Fenglong (ST-40) were
utilized in both the 2007 and 2010 Brazilian studies. And the core acupoint, Shanglianquan (EX
HN22) was utilized in the 2010 Brazilian study.
This author has found the diagnosis of Qi vacuity and phlegm, often with Liver Qi stagnation
and/or blood stasis, to be congruent with clinical observation and peer consultations.
The root disease mechanism of OSA can be shown to originate in vacuity. The upper airway
collapses due to this vacuity. This could be Lung, Kidney or Spleen vacuity or any combination
of these three and a branch excess of phlegm and/or blood stasis.
According to Chinese medicine theory, respiration is governed by the Lungs and Kidneys. The
Lungs also govern the Qi of the entire body. The Lungs downbear the Qi while the Kidney Qi
grasps the downbeared Lung Qi. Cessation of breathing is caused by vacuity in the Lungs as
pg. 22
they are responsible for inhalation and exhalation. Lung Qi is supported by the Spleen which
upbears the Qi to the Lungs. During obstructive sleep apnea either there is not enough Lung Qi
to move the breath or there is an obstruction in the free flow of Lung Qi. Lung Qi can be
vacuous if there is not enough Spleen Qi or Kidney Qi. Spleen Qi provides the post-heaven Qi
and the Kidneys support the pre-heaven Qi.
Liver Qi stagnation can further obstruct the free flow of Lung Qi by either invading the Stomach
or causing counterflow or by transforming into heat which ascends and disrupts the Lung Qi.
Phlegm is commonly present in obstructive sleep apnea (Flaws B., 2005). When the Spleen is
vacuous, it fails to move and transform dampness thus engendering phlegm. The lungs then
store the phlegm. Phlegm turbidity is also engendered when Qi and blood become obstructed
and stagnate. Qi is needed to circulate the blood in the body. If the blood cannot move normally
and uninhibited through the body, as when Qi is vacuous or stagnates, there will be blood
obstruction and stagnation known as blood stasis.
Research Design and Methods
Research Goals and Aims
The research goal is to assess the effectiveness of an 8-week acupuncture protocol on symptoms
of moderate obstructive sleep apnea (OSA).
Specific Aim 1: Assess self-reported daytime sleepiness pre and post acupuncture treatment
using the Epworth Sleepiness Scale (ESS).
pg. 23
Specific Aim 2: Assess self-reported health and well-being pre and post acupuncture treatment
using the SF-36V2 .
Specific Aim 3: Assess polysomnography (PSG) changes from pre to post acupuncture
treatment.
Specific Aim 4: Gather information about the feasibility of a large scale randomized clinical trial
using acupuncture to treat moderate OSA.
Overview
This proposed pilot study is a non-randomized, pragmatic single arm study. The goal is to use
the results from this pilot study to plan a randomized controlled trial to assess the feasibility,
utility and safety of using an acupuncture protocol as a therapeutic intervention for treating OSA.
This study proposal utilizes a TCM diagnosis with an individualized treatment plan and
evaluation of the effectiveness of an acupuncture protocol as provided in a normal clinical
practice. In order to support methodological rigor and reproducibility, the treatment protocol is
restricted to a fixed set of acupuncture points with a limited selection of additional points as
needed and no other treatments of any kind.
The treatment protocol assumes a traditional Chinese medicine (TCM) diagnosis that includes
Lung, Spleen and/or Kidney organ deficiencies and an excess of phlegm. This is based on the
Chinese medicine etiology of OSA occurring through the above organ deficiencies, with phlegm
being the result of the deficiencies. If a patient has a different TCM diagnosis, he or she will not
be included in the study.
The study is non-randomized and single arm because it is preliminary research to determine if
further study and resources are warranted.
pg. 24
Sixteen subjects will be recruited with moderate OSA who have failed a prescribed treatment of
CPAP. Prior to receiving the study treatment, all subjects will be required to provide PSG data to
be used as a baseline for comparison with a follow up PSG at the end of the 8 week treatment
period.
Subjects will be diagnosed and treated with an acupuncture protocol by one of three licensed
acupuncturists. The subjects will receive acupuncture bi-weekly for 8 weeks. At the completion
of 8 weeks of acupuncture treatment, the subjects will undergo a post-treatment PSG study
evaluation of the participants response to treatment. This will also include pre and post
treatment assessments of the ESS and the SF-36v2 questionnaires. Pre to post treatment
changes in PSG, ESS and SF-36v2 will be statistically analyzed.
Participants
a. Recruitment, Consent and Initial Screening
Prior to any contact with potential subjects, Institutional Review Board (IRB) approval will be
obtained. Participants will be recruited through outpatient pulmonary centers and private
physician offices in the Los Angeles area via flyers (Appendix 1). Subjects are eligible to
participate if they have a diagnosis of moderate OSA confirmed through a PSG study and have
failed CPAP. Failure of CPAP is determined by either the patient having notified their
physicians that they are unable to comply with CPAP (for any reason) or if their physician has
found through analyzing their respiratory data that they are non-compliant. Individuals who
respond to the flyers will be initially screened by phone. If they meet the initial screening
criteria as defined below under, Inclusion and Exclusion Criteria, an initial interview will be
arranged. Screened potential subjects will be asked to come into the Los Angeles clinic for an
initial interview to further evaluate for inclusion and exclusion criteria. At that time, the subjects
pg. 25
will be provided with information on the study purpose and process. This will include the
requirements and the risks of participation such as the possible risks of acupuncture: pain,
bleeding, infection, fainting, hematomas and pneumothorax as detailed in the consent form
(Appendix 2). Potential subjects will be given the opportunity to ask questions before signing
the consent form which includes their agreement to comply with the treatment plan and
scheduled appointments. Once the consent form is signed, each participant will be assigned a
numeric code that will be used on all data collection materials for the duration of the study.
Next, each participant will be assigned to one of the three listed research practitioners in the city
of their choice, and an initial diagnosis and treatment visit will be scheduled.
Subjects will not be paid for their participation but will receive a total of 16 free acupuncture
treatment sessions over an eight week period. Treatment will be provided at three private clinics
in Whittier, San Pedro, and Los Angeles, CA by three licensed acupuncturists, also known as the
research practitioners. Each acupuncturist has at least 5 years of experience. Participants will be
instructed to continue to be compliant with their personal physicians instructions and all
prescribed medications, but asked to agree not to introduce any new form of treatment, herb or
nutritional supplement during their eight week acupuncture treatment. If at any time during the
treatment a participant needs additional medical treatment for their OSA, they will be referred to
their primary care provider and removed from the study.
b. Randomization
No randomization is required as it is a single arm. All patients in the study will be given the core
acupuncture treatment and additional points per presenting TCM pattern as determined by the
treating research practitioner.
pg. 26
c. Inclusion and Exclusion Criteria
Inclusion criteria are subjects, male and female, between the ages of 18 and 70 who have a
diagnosis of moderate OSA, which is a score of 15 to 30 Apnea Hypopnea Index (AHI) events
per sleep hour as diagnosed through a PSG study. In addition, each subject must have been
prescribed CPAP as treatment and due to non-compliance, no longer utilizing it. By limiting
eligibility to this population, the study does not attempt to persuade or deny any subject
prescribed standard OSA treatment.
Exclusion criteria are:
pregnant or nursing women

alcohol use greater than daily use of 1 drink for women or 2 drinks for men. One drink is
defined as either: 12 fluid ounces of beer, 5 fluid ounces of wine or 1.5 fluid ounces of
distilled alcohol.
morbid obesity, defined as BMI 40
significant lung disease
neurological disease
mental impairments
facial structural abnormalities
central sleep apnea
severe sleep apnea
mild sleep apnea
use of psychotropic medications
use of sleeping medications
use of recreational drugs or marijuana
oropharyngeal surgeries
current use of oral devices for OSA
Confidentiality
Subject confidentiality will be maintained per patient HIPAA standards.
pg. 27
Treatment Protocol
a. Treatment Protocol Rationale
The limited literature and research on OSA and acupuncture are challenges to designing a study
that adequately presents diagnostic patterns of OSA and then follows an optimal corresponding
TCM acupuncture treatment protocol.
This study proposes to treat OSA as disharmonious patterns of Qi vacuity with phlegm stasis.
The vacuity can be Lung, Kidney or Spleen, or any combination of these three. The treatment
protocol for these patterns was derived from a Chinese comparison study (Flaws B., 2003). The
protocol consists of a core group of acupoints that focus on vacuity and phlegm stasis with
additional points utilized depending on other presenting symptoms, primarily Liver Qi
stagnation, blood stasis and Stomach organ involvement. This author has found the diagnosis of
Qi vacuity and phlegm, often with Liver Qi stagnation and/or blood stasis, to be congruent with
clinical observation and collegial consultations. The proposed points are listed in Table 1.
pg. 28
Table 1. Acupuncture Treatment Points
Core Acupuncture Points

Point Function Needle Depth
Danzhong (CV-17) open the chest Qi 0.5 to 1 cun
Neiguan (PC-6) quiet the spirit, promote sleep 1 to 1.5 cun
Baihui (GV-20) quiet the spirit, promote sleep, lift the Qi 0.5 to 1 cun
Sanyinjiao (SP-6) tonify Spleen 1 to 1.5 cun
Fenglong (ST-40) resolve phlegm 1 to 1.5 cun
Taixi ( KI-3) tonify Kidneys 0.5 to 1 cun
Lieque (LU-7) Tonify Lungs, clear throat obstructions 0.5 1 cun
Lianquan (CV-23) local, disinhibit the throat Qi 0.5 to 1.2 cun
Shanglianquan (EX local, disinhibit the throat Qi 0.5 to 1.2 cun

HN22)
Additional points utilized depending on presenting symptoms
Taichong (LV-3) soothe the Liver Qi 0.5 to 1.5 cun
Xingjian (LV-2) clear Liver heat 0.5 cun
Neiting (ST-44) clear Stomach heat 0.5 to 1 cun
Jiexi (ST-41) move stagnated Stomach Qi 0.5 cun
Zusanli (ST-36) tonify the Stomach, clear counterflow Qi 1 to 1.5 cun
Xuehai (SP-10) Move blood stasis 1 to 1.5 cun
pg. 29
b. Initial Consultation Examination
At the initial visit each subject will be asked to fill out the study intake forms (Appendix 3) and
to complete the Epworth Sleepiness Scale (Appendix 4) and the SF-36v2 questionnaires
(Appendix 5). Each participant will then be evaluated by the treating research practitioner and
given a TCM diagnosis. In order to continue with treatment, a single or multiple organ pattern of
Lung, Spleen and Kidney deficiency with an excess of phlegm must be present. If this pattern is
not present, then the subject will be disqualified from the study. Following this initial
consultation, eight weeks of twice-a-week treatments will be scheduled.
c. Study Procedure
Subjects will be treated twice a week for 8 weeks for a total of 16 treatments. Needles to be used
are 0.18 mm x 30mm, spring type, disposable, sterilized Acuzone brand, made in Korea. All
subjects will receive the core acupoints (see Table 1) bi-laterally and up to three additional
acupoints from Table 1 as prescribed by the research practitioner. The research practitioner will
record the actual acupoints needled and type of manual stimulation for each treatment. Needles
will be retained for 30 minutes. Each needle will be inserted to the minimal depth specified in
Table 1 and de Qi obtained. Tonification and sedation of an acupoint will occur with angular
manual needling respectively, in the direction of the channel and in the opposite direction of the
channel. Minimal sites needled will be 14 if only using the core treatment, with a maximum of
20 needled sites if using any additional points. No other treatments such as moxibustion,
cupping, electrical stimulation or manual therapy will be given during any treatment. All
acupoint locations will be measured with an elastic cun band for precision using the location as
described in Peter Deadmans text, A Manual of Acupuncture.
pg. 30
Evaluation of each participant at baseline will include initial PSG data, and the two subjective
functional questionnaires: Epworth Sleepiness Scale and Your Health and Well-Being SF-36v2
. Two weeks after the final treatment, subjects will return to the clinic to fill out post-treatment
ESS, Your Health and Well-Being SF-36v2 , and the VAS on satisfaction. Participants will be
scheduled with Los Angeles Sleep Study Institute, Los Angeles, CA for a post-treatment sleep
study.
Outcome Measurements (Pre and Post Treatment)
Sociodemographic & Clinical Data
All sociodemographic and clinical data will be collected and included in the final report.
Primary Outcome
AHI from polysomnography sleep study data. This data includes measurements of airflow,
respiratory effort, blood oxygen saturation, snoring, apneas and hypopneas.
Secondary Outcomes
1. Epworth Sleepiness Scale developed by Johns and validated in 1991 (Johns MW, 1991).
It is a self-administered questionnaire that is widely used for patients with OSA. It
provides a simple standardized method of measuring an individuals level of daytime
sleepiness. The 8-item questionnaire assesses situations of daytime sleepiness using a
scale of 1 to 5. The summation of the scores, ranging from 0 24, result in a single
measurement of daytime sleep propensity. A score of 10 or more is considered sleepy
and a potential referral to a sleep specialist. A score of 18 or more is very sleepy.
pg. 31
2. Your Health and Well-Being SF-36v2 . This is a validated generic health survey of
36-items that yields an 8-scale profile of functional health and well-being (Ware, 1993).
This 12-item questionnaire assesses state of health and well-being using a rating of a 5
level response scale. The results are grouped as physical functioning, role-physical,
bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
The scale has demonstrated good psychometric properties for physical and mental health
summaries. Licensed use has been requested from Quality Metric Incorporated.
3. Satisfaction. Subject satisfaction with the results of the study will be recorded using the
Visual Analog Scale (VAS). The VAS data is recorded on a scale of 0mm not satisfied
to 100mm -- completely satisfied.
4. Adverse events. Any adverse events will be recorded and included in the published
results. Adverse events can include but are not limited to the following: pain following
treatment, minor bruising, infection, needle sickness; and in the rare case, a broken
needle.
Statistical Power
Utilizing the AHI change for pre- to post- acupuncture treatment of moderate OSA from the
2010 Brazilian study (Friere AO, 2010), a power calculation (STATA10) determined that a
minimum of 10 subjects will be needed to achieve a statistical power of 90%.
Data Management and Statistical Analysis
All patient data sheets will be kept confidential and in a locked office. A unique patient study ID
but no patient names will be placed on the data forms. Study identifiers kept in a study logbook
will be assigned to each patient to protect their confidentiality. When undergoing statistical
analysis, the forms will be transferred to the primary investigators locked office. Patient
pg. 32
identifiers will be stored separately from the data files on the primary investigators password
protected computer. No one but the study team will have access to this identifier list.
Data of continuous variables will be compared with a t-test, while categorical variable
proportions will be compared with a chi-square test. A p value of <0.05 defines statistical
significance.
Challenges and Limitations
Challenges and limitations exist related to recruitment and funding. It could be difficult to
identify individuals that have failed CPAP, as there currently are no standards requiring
collection and assimilation of this data. Furthermore, obtaining treatment compliance from
subjects that have already exhibited non-compliance may be challenging.
Funding will be necessary to complete this study due to the inherent expense of a PGS sleep
study.
Dissemination Plan
The results of the study will be published in an appropriate peer-reviewed journal.
pg. 33
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Appendix 1
pg. 39
Appendix 2
PILOT STUDY: ACUPUNCTURE TREATMENT FOR OSA CONSENT FORM
TITLE
Proposed Pilot Study: Acupuncture as a Treatment for Moderate Obstructive Sleep Apnea
PRINCIPAL INVESITIGATOR
Connie L. Christie, L. Ac., Dipl. OM, MATCM
(509) 590-5780
RESEARCH PRACTITIONERS
Connie L. Christie, L. Ac., Dipl. OM, MATCM (509) 590-5780
Birgitta Sween, L. Ac. Dipl. OM, MATCM (310) 221-0008
Carol Lee, L. Ac., MSOM (310) 430-6087
PURPOSE
You are being asked to participate in a research study because you have been diagnosed with moderate
obstructive sleep apnea (OSA) and have been unsuccessful in using CPAP (continuous positive airway
pressure ) treatment. CPAP is the standard treatment for moderate OSA and is known to be successful
in treating this disorder.
The purpose of this research study is to evaluate whether acupuncture may be an effective treatment
for moderate obstructive sleep apnea. There has been very little research done using acupuncture to
treat OSA, therefore we dont know if OSA will respond to acupuncture treatments. However, research
has shown acupuncture to be useful in treating many of the symptoms associated with moderate OSA
including snoring, daytime sleepiness, anxiety and depression.
PROCEDURES
You have been screened for inclusion in this study. If you decide to participate you will be scheduled for
an initial study intake visit. Please read this consent form carefully and be prepared to ask any questions
you have before you sign it.
This study involves a course of twice a week acupuncture treatments for eight weeks. You may receive
your acupuncture treatments in one of the following cities: Whittier, San Pedro or Los Angeles. Once
you have been assigned a treatment location and corresponding research practitioner, you cannot
change locations. It is important that you visit your research practitioner twice a week once treatment
has started. If you fail to attend two appointments without letting your research practitioner know, you
will be disqualified from the study. You will be asked to fill out two questionnaires, one before you start
treatment and one after you finish the 8 weeks of acupuncture..
Plan to allow one hour for each treatment. Needles will be inserted into your body and may be
stimulated until you feel a sensation. The sensation may feel like warmth, aching, heaviness or even an
electric sensation. The actual duration the needles will remain in will be 30 minutes.
pg. 40
RISKS AND DISCOMFORTS
The three licensed acupuncturists involved in this study each have a masters degree in acupuncture and
Oriental medicine and a minimum of 5 years experience. They are trained and qualified to perform
acupuncture safely.
The risks from acupuncture are minimal. Some people may experience sharpness when the needles are
first inserted. As with any procedure that involves breaking the skin, there is a slight risk of bleeding,
minor bruising or infection and very rarely a pneumothorax (punctured lung). Sterile disposable needles
are used for all treatments.
Following the acupuncture treatment, some people may initially feel light-headed, drowsy or dizzy upon
arising from the treatment table. If this happens to you, let your research practitioner know. These
sensations usually go away quickly. If at any time during the treatment you are uncomfortable, the
treatment can be stopped.
BENEFITS
You will not receive any money for being in the study. You may or may not receive benefit from this
study. However, by being in the study, you may contribute to research that may benefit others with your
condition in the future.
CONFIDENTIALITY
Your name, phone number, and study records will be kept confidential by the principal investigator,
Connie Christie. Research records may be reviewed and/or copied by study personnel such as the
principal investigator and research practitioners.
Information concerning all subjects will be kept strictly confidential. Neither your name nor your identity
will be used for any publication or publicity purposes. All precautions to maintain confidentiality of your
study records will be taken.
COSTS
There will be no cost to you to participate in this study. You will not have to pay for the acupuncture
treatments. You will be responsible for the cost of transportation to and from the appointments.
CONTACT INFORMATION FOR QUESTIONS AND CONCERNS

If you have concerns or questions about this study, such as scientific issues, how to do any part of it, or
to report injury problem or side effect, please contact Connie Christie at 509-590-590-5780 or email
connie@acupuncture-rolfing.com.
If you have questions or concerns about your role and rights as a research participant, would like to
obtain information or offer input, or would like to register a complaint about this study, you may
contact, anonymously if you wish, the Office for Human Research Protections at 866-447-4777.
PARTICIPATION
Participation in this research is completely voluntary. You have the right to say no. You may change
your mind at any time and withdraw. You may choose not to answer specific questions or to stop
participating at any time.
pg. 41
You may be removed from the study if you are not able to complete the visits or if your doctor feels it is
in your best interest.
Your signature below means that you voluntary agree to participate in this research study.
SIGNATURES:
_______________________________________________________________
Signature of Subject Date and Time
_______________________________________________________________
Printed Name of Subject
_______________________________________________________________
Witness Date and Time
______________________________________________________________
Signature of Principal Investigator Date and Time
pg. 42
Appendix 3
pg. 43
Medical History Questionnaire INTAKE FORM: OSA PILOT STUDY
Page 2 of 4
Please complete the following as accurately as possible:
Indicate if you have had any of the following:

Anemia or other Blood Disorder HIV/ AIDS
Antibiotic Use (Heavy) Hoarseness
Bleeding Disorder Indigestion
Birth Trauma Irritable Bowel Syndrome
Cancer Jaundice
Cardiac Pacemaker Kidney Disease
Change in Bowel or Bladder Function Lupus Erythmatosis
Change in a Wart or Mole Lymph nodes removed
Colitis Lyme Disease
Congenital Abnormalities Measles
Crohn's Disease Meninigitis
Diabetes Multiple Sclerosis
Emphysema Mental Disease
Epilepsy or Convulsions Non-healing Sores
Epstein Barr Virus (EBV) Pancreatitis
Fibromyalgia Peptic Ulcer
Glaucoma Pneumonia
Gall Stones Polio
Genital Disorder Respiratory Problems
Genital Herpes Rheumatic Fever
Gynecological Disorder Sexually Transmitted Disease
Heart Disease Skin Disease
Hepatitis A/B/C Stroke
Hernia Surgical Implants
High Blood Pressure Thyroid Disorder
High Cholesterol Tuberculosis
Herpes Unusual Bleeding or Discharge
History of Smokeless Tobacco Urinary Problems or Infections
History of Drinking Alcohol Other________________
History of Recreational Drugs Other________________
History of Smoking
Cardiovascular
Do you have or have you had?
Mitral valve Palpitations Poor circulation
Spider veins Irregular heart beat
Cold hands/feet Varicose veins
Skin and Hair

Do you have or have you had?
Dry skin Eczema Acne
Hives Skin rashes
Itching Hair loss
pg. 44
pg. 45
Medical History Questionnaire INTAKE FORM: OSA PILOT STUDY
Page 4 of 4
Please complete the following as accurately as possible:
Diet:
Food Cravings?_______________________________________
Food Intolerance?_____________________________________
How many glasses/cups do you drink each day of the following?
Water____ Soda_____ Coffee____ Tea_____ Alcohol_____
How many servings do you consume per day?

Meat________Sugar/sweets__________ Dairy_______
Do you prefer __________ hot or _______ cold drinks?

Taste Preferences (Indicate 1 - 5, 1=most liked, 5=least liked)
Salty ___ Sour____ Bitter____ Sweet____ Spicy____
Female Menstrual History:

Are you still menstruating?_________ Age of your first period:_________
Length of monthly cycle (days):_________
Length of period (days): Date of your last period:________
Do you have any of the following?
Irreg Menses Heavy flow Painful periods
PMS Light flow Uterine fibroids
No flow Blood clots Cystic breasts
Are you perimenopausal?____________ Symptoms________________
Are you menopausal?_______________ Symptoms__________________
Do you have or had you had?

Menstrul Cramps Breast Pain
Menstrual Blood Clots Breast Cysts
Excessive Bleeding Emotional Changes with Period
PMS Hot Flashes
Breast Swelling Vaginal yeast(Candida)
Infertility
Male Urology History:

Premature Ejaculation Prostate Problems
Impotence
Family History:
Father Living - Age_______ Deceased -at Age_______ Cause________
Mother Living - Age_______ Deceased -at Age_______ Cause________
Siblings Gender____________ Health Status____________________________
Children Gender____________ Health Status____________________________
Do any of your blood relatives have or have they had?
Alcoholism Heart Disease Mental Illness
Cancer High Blood Pressure Obesity
Diabetes Kidney Disease Stroke
pg. 46
Appendix 4
pg. 47
APPENDIX 5
SF- . All
Rights Reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Standard, US
Version 2.0)
Your Health and Well-Being
This survey asks for your views about your health. This information will help keep track of how you feel
and how well you are able to do your usual activities. Thank you for completing this survey!
For each of the following questions, please mark an X in the one box that best describes your answer.
1. In general, would you say your health is:
Excellent Very good Good Fair Poor
1 2 3 4 5
2. Compared to one year ago, how would you rate your health in general now?
Much better now than one year ago
Somewhat better now than one year ago
About the same as one year ago
Somewhat worse now than one year ago
Much worse now than one year ago
1 2 3 4 5
3. The following questions are about activities you might do during a typical
day. Does your health now limit you in these activities? If so, how much?
Yes, limited a lot
Yes, limited a little
No, not limited at all
a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
1................... 2.................. 3
b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
1................... 2.................. 3
c. Lifting or carrying groceries
1................... 2.................. 3
d. Climbing several flights of stairs
1................... 2.................. 3
e. Climbing one flight of stairs
1................... 2.................. 3
f. Bending, kneeling, or stooping
1................... 2.................. 3
g. Walking more than a mile
1................... 2.................. 3
h. Walking several hundred yards
1................... 2.................. 3
I. Walking one hundred yards
1................... 2.................. 3
pg. 48
j. Bathing or dressing yourself
1................... 2.................. 3
4. During the past 4 weeks, how much of the time have you had any of the following problems with
your work or other regular daily activities as a result of your physical health?
All of the time
Most of the time
Some of the time
A little of the time
None of the time
a. Cut down on the amount of time you spent on work or other activities.
1......... 2........ 3......... 4......... 5
b. Accomplished less than you would like
1......... 2........ 3......... 4......... 5
c. Were limited in the kind of work or other activities
1......... 2........ 3......... 4......... 5
d. Had difficulty performing the work or other activities (for example, it took extra effort)
1......... 2........ 3......... 4......... 5
5. During the past 4 weeks, how much of the time have you had any of the following problems with
your work or other regular daily activities as a result of any emotional problems (such as feeling
depressed or anxious)?
All of the time
Most of the time
Some of the time
None of the time
a. Cut down on the amount of time you spent on work or other activities
1......... 2........ 3.......... 4......... 5
b. Accomplished less than you would like
1......... 2........ 3.......... 4......... 5
c. Did work or other activities less carefully than usual
1......... 2........ 3.......... 4......... 5
6. During the past 4 weeks, to what extent has your physical health or
emotional problems interfered with your normal social activities with
family, friends, neighbors, or groups?
Not at all Slightly Moderately Quite a bit Extremely
1 2 3 4 5
7. How much bodily pain have you had during the past 4 weeks?
None Very mild Mild Moderate Severe Very Severe
1 2 3 4 5 6
8. During the past 4 weeks, how much did pain interfere with your normal
work (including both work outside the home and housework)?
Not at all A little bit Moderately Quite a bit Extremely
pg. 49
1 2 3 4 5
9. These questions are about how you feel and how things have been with you during the past 4 weeks.
For each question, please give the one answer that comes closest to the way you have been feeling.
How much of the time during the past 4 weeks.
All of the time
Most of the time
Some of the time
None of the time
a. Did you feel full of life?

1.......... 2.......... 3.......... 4.......... 5
b. Have you been very nervous?
1.......... 2.......... 3.......... 4.......... 5
c. Have you felt so down in the dumps that nothing could cheer you up?
1.......... 2.......... 3.......... 4.......... 5
d. Have you felt calm and peaceful?
1.......... 2.......... 3.......... 4.......... 5
e. Did you have a lot of energy?
1.......... 2.......... 3.......... 4.......... 5
f. Have you felt downhearted and depressed?
1.......... 2.......... 3.......... 4.......... 5
g. Did you feel worn out?
1.......... 2.......... 3.......... 4.......... 5
h. Have you been happy?
1.......... 2.......... 3.......... 4.......... 5
i. Did you feel tired?
1.......... 2.......... 3.......... 4.......... 5
10. During the past 4 weeks, how much of the time has your physical health or emotional problems
interfered with your social activities (like visiting friends, relatives, etc.)?
All of the time
Most of the time
Some of the time
None of the time
1 2 3 4 5
11. How TRUE or FALSE is each of the following statements for you?
Definitely true
Mostly true
Don't know
Mostly false
Definitely false
a. I seem to get sick a little easier than other people

1............ 2........... 3........... 4........... 5
pg. 50
b. I am as healthy as anybody I know
1............ 2........... 3........... 4........... 5
c. I expect my health to get worse
1............ 2........... 3........... 4........... 5
d. My health is excellent
1............ 2........... 3........... 4........... 5
THANK YOU FOR COMPLETING THESE QUESTIONS!
pg. 51

Acupuncture As An Effective Treatment For Moderate Obstructive Apnea

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Acupuncture As An Effective Treatment For Moderate Obstructive Apnea

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A Proposed Pilot Study: Acupuncture as an Effective Treatment for Moderate Obstructive

Principal Investigator: Connie L. Christie, L.Ac. Dipl. OM

outcome will be measured by statistically comparing the physical responses of acupuncture

treatment on moderate OSA as measured by polysomnography (PSG), Epworth Sleepiness Scale

of complementary medicine in treating modern health concerns.

productivity, cognitive dysfunction, depression, life threatening cardiac arrhythmias, severe

for alternative effective treatment options.

expand this work.

of complementary medicine in treating modern health concerns.

Goals and Objectives

cases unresponsive to or noncompliant with CPAP. The secondary outcome objective is to

determine the conditions for a future controlled trial.

1. Determine the feasibility of recruiting and retaining subjects for a randomized

controlled trial of acupuncture treatment of moderate OSA unresponsive to or non-

compliant with CPAP.

2. Determine the sample size for a randomized control trial (RCT).

3. Assess the safety of acupuncture as an intervention for moderate OSA.

4. Observe the physical responses of acupuncture treatment on moderate OSA as

measured by polysomnography (PSG), Epworth Sleepiness Scale (ESS) and quality

of life changes as measured on the Your Health and Well-Being, SF-36v2

Need for Treatment

adolescents. (Johnson EO, 2006).

OSA is a sleep disorder characterized by recurrent episodes of upper airway obstruction

predisposition, craniofacial variations, nasal obstruction, large neck circumference, use of

The pathogenesis of OSA involves neurophysiologic pathways, throat pathophysiology and

pathophysiologic mechanisms of OSA suggests a balance of anatomic imposed mechanical loads

and compensatory neuromuscular responses (Patil SP, 2007).

Alterations in upper airway structures such as tonsillar hypertrophy, retrognathia, variations in

dependent mechanism, 2) response of local mechanoreceptors to negative pressure, and 3)

ventilator control mechanisms. Neuromuscular responses affecting the reduction of upper

events per hour.

moderate OSA and severe OSA is an AHI > 30.

asleep during the day.

hypertension, and diabetes (Chesnutt M, 2011) (Pagel JF, 2008).

discomfort, insomnia, oxygen desaturation, nasal congestion or discomfort and oropharyngeal

thereby increasing airway dilation and wall stiffening.

one year (Stepnowsky C Jr, 2003).

(Hoffstein V, 1992) (Kakkar RK, 2007).

Acupuncture: Research and Review

standards to be considered valid and adequate. Good research on acupuncture can be

drug, acupuncture treatment generally involves an individualized treatment plan based on a

satisfactory acupuncture placebo has yet to be developed.

examines the effectiveness of acupuncture treatment compared to another form of treatment or

Importance of Research on Acupuncture and Obstructive Sleep Apnea

and no research to date has attempted to answer that question.

What is needed is a double-blind, randomized controlled trial to determine the efficacy of

are lasting results.

treatment protocols, and document long term follow-up.

Acupuncture Research Related to OSA

with a significant difference of p< 0.05.

found acupuncture to be as effective as medication and/or psychotherapy. (Allen J, 1998) (Luo

neurophysiologic pathways, throat pathophysiology, and dysfunctional muscular tension and

pharyngeal occlusion in OSA (Boyd JH, 2007).

improvement in voice quality of the treatment group (Yiu E, 2006).

respectively, with p values of 0.02 and 0.04.

control group with a p> 0.05.

is a pattern of insomnia that particularly addresses snoring, that of phlegm-heat. Snoring is

(EXHN-1), Shenmen (HT-7), Neiguan (PC-6), Zhongwan(CV-12), Fenglong (ST-40) and

28 and 67 suffering from insomnia, which was diagnosed as interior-stirring by phlegm-heat. A

Baihui (GV-20), Neiguan (PC-6), and Fenglong (ST-40).

beneficial therapeutic effect on motor function (Sallstrom S K. A., 1996). A group of 45

atrophy is described as a withering of the muscles, sinews and channels.

atrophy with acupuncture (Maciocia G, 2008).