Clinical Practice
Compared to studies in pain management, fewer studies are available
investigating the efficacy of acupuncture in the treatment of headache
disorders. Interpreting the efficacy of acupuncture in headache management is
likewise difficult, due to difficulties in study design. Despite the absence of
evidence-based medicine supported proof of efficacy of acupuncture in headache
management, accumulated literature seems to suggest acupuncture as a potentially
useful option for the treatment of migraine and tension-type headache. Even less
scientific evidence evaluating acupuncture's role in the management of other
types of headache exists. A systematic review by the Cochrane Collaborative
assessed the efficacy of acupuncture in treatment of migraine, tension-type, and
other types of headaches.[81] Twenty-six trials including 1151 patients were
reviewed. Majority of the trials were found to have some methodological and/or
reporting shortcomings and too small sample size. The Cochrane review
concluded that straightforward recommendations for widely use of acupuncture in
the clinical practice could not be made at present, but some forms of
acupuncture seemed to be beneficial and those patients who wanted to try
acupuncture should not be discouraged.
Treatment Principle
Utilizing the principles of the Chinese medicine mentioned above, acupuncture
aims to restore the balance of Yin and Yang, clean the blockade of meridians,
and resume the Qi flow. Ultimately, the goal of acupuncture is to reduce the
headache frequency and severity. In migraine patients with temporal throbbing
quality, excessive Yang exists with a deficiency of Yin. In order to rebalance
the Yin and Yang, the practitioner should supplement the Yin by tonifying the
Yin acupoints in the foot (Sanyinjiao SP 6 and Taichong LR 3), and eliminate the
excessive Yang by draining Yang points in the head (Taiyang, Extraordinary
Meridian Head-and-Neck Point 5, EX-HN 5) and hand (Hegu LI4). Stimulation of the
Yin points will soothe the patient, reduce the anxiety and improve sleep.
Suppression of the Yang points will relieve the acute headache. Needling of the
Ashi points in the head may also suppress the pain.
Migraine
Among the clinical trials in the Cochran review,[81] 16 trials were conducted on
migraine patients. Eleven migraine trials compared the effectiveness of "true"
acupuncture and "sham" acupuncture. The number of days with headache, frequency
of attacks, and attack intensity were compared. Most trials reported differences
in favor of acupuncture for at least one outcome. In five trials, the
acupuncture group did significantly better than the sham group. Three showed
trends in favor of acupuncture. Two trials found no significant difference
between true and sham acupuncture. The remaining one trial was inconclusive due
to the high dropout rate during the study. Overall, the majority of the migraine
trials showed at least a trend in favor of true acupuncture. One of the
sham-controlled studies was done by Vincent.[29] They studied patients with
chronic migraine though exact diagnostic criteria were not specified. Thirty
patients were randomly divided into true acupuncture and sham
acupuncture group. Needles were inserted into the classical acupoints with
defined depth (1 to 2 cm) in the treatment group but only 2 mm depth at the
nonacupoints in the sham group. Because the acupuncture practitioner was
experienced and difficult to blind, the author described the design as a
single-blinded, randomized controlled trial. A four-week baseline period was
followed by 6 weekly treatments and an initial 6-week follow-up period. Further
follow-ups were carried out at 4 months and 1 year posttreatment. Headache
diaries and analgesic intake records were kept throughout the baseline,
treatment and the initial 6-week follow-up period. In addition, headache diaries
and analgesic intake records were kept for 2 weeks at 4-month, and 2 weeks at
1-year follow-up. Both groups achieved reduction in weekly pain score and
numbers of analgesic intakes after the treatment, compared to the baseline.
However, the true acupuncture group achieved a significantly greater reduction
in pain
score than the sham group (48% vs. 14%). The treatment group tended to use less
analgesic medications (38% vs. 28%) but the result did not reach the statistical
difference due to the small sample size. The improvement in pain from the
treatment group remained substantially better than the control group at 4-month
and 1-year follow-ups, although the difference failed to reach significance,
again due to inadequate sample. Another randomized placebo-controlled study on
30 migraine patients was done by Ceccherelli and Ambrosio.[82] Both acupuncture
and acupuncture placebo groups received weekly treatment session for 10 weeks.
At the end of the treatment, the acupuncture group achieved 84% of pain
reduction compared to the baseline (P< 0.001), and the placebo group 50%
(nonsignificant). The pain reduction in these groups was not compared for
statistical difference. Patients with greater than 50% pain reduction at the end
of treatment in both groups were followed; the therapeutic result
seemed to last longer in the acupuncture group (average 13 months) than the
placebo group (average 3 months). Again, no statistical comparison was done.

A randomized study was recently done to compare acupuncture with flunarizine in
the prophylactic treatment of migraine.[69] One hundred and sixty women who met
IHS migraine diagnostic criteria were randomly divided into acupuncture and drug
therapy group, without using sham acupuncture control. The acupuncture group
received weekly treatment session for the first 2 months and then once a month
for the next 4 months. The drug group received daily flunarizine for the first 2
months and then once a month for the next 4 months. Both group achieved
significant reduction of migraine frequency and symptomatic analgesic intake
after the treatment. However, the number of migraine attacks per month was
significantly lower in the acupuncture group than in flunarizine group at 2- and
4-month follow-up (2.95 vs. 4.10; 2.30 vs. 2.93). The number of analgesics used
was also significantly lower in acupuncture group at 2-month follow-up (5.13 vs.
6.7). The total number of patients reporting side
effects was significantly lower in acupuncture group than in flunarizine group
(10/77 vs. 29/73). Additional study comparing acupuncture with ergot plus
caffeine also showed significantly better outcomes in acupuncture group
regarding reduction in headache severity and frequency.[83]
Tension-Type Headache
The role of acupuncture in tension-type headache is unclear. In the same
systemic review by Cochrane Collaborative,[81] results of four sham-controlled
trials were evaluated. Acupuncture was found to significantly improve the
headache indices compared to sham acupuncture in one trial. One study reported
no significant differences between acupuncture and placebo, but the reviewers
felt there was a trend favoring acupuncture in reducing the headache frequency
and medication use. The result of the remaining studies was uninterpretable due
to either lack of actual data, or the large baseline difference between the
treatment and control groups and too small a sample size. A randomized
placebo-controlled crossover design study evaluated 18 patients with chronic
tension-type headache (CTTH) recruited by neurologists.[70] The diagnostic
criteria used were not described. After a 3-week baseline period, patients were
randomized into two groups. Patients received either 3 weekly session of true
acupuncture or sham acupuncture followed by 3 weeks of observation before being
crossed over for the next 3 weekly session of treatment using the other type of
acupuncture. Both the real and sham acupuncture achieved significant reduction
of period index score which measured the pain relief. However, the true
treatment group did significantly better than the sham-needling group. White and
colleagues completed a multicenter randomized controlled trial on 50 patients
who met the diagnostic criteria of IHS for episodic tension-type headache
(ETTH).[84] Patients received either acupuncture treatment or sham procedure
weekly for 6 weeks, followed by once a month follow-up for the next 2 months.
Patients in the acupuncture group reported a significantly lower headache pain
score during the treatment period, compared to the sham group. The follow-up at
2 months tended to favor the true acupuncture but slightly missed statistical
significance. A randomized, placebo needle controlled study
of 69 patients with either ETTH or CTTH was done by Karst et al.[85] Patients
were diagnosed using IHS criteria and the practitioner was not blinded. Patients
received treatment 2 times per week for 5 weeks. With respect to headache pain
score and frequency, both the real and placebo acupuncture groups achieved
significant decreases immediately, 6 weeks and 5 months after the treatment.
There was no appreciable difference between these two groups. However, there was
a significant improvement in the quality of life parameters (clinical global
impressions, Nottingham Health Profile) after the true treatment, compared with
sham placebo. In another controlled trial, 30 patients with tension-type
headache diagnosed according to IHS criteria and demographically matched entered
the study.[28] After a 4-week baseline period, they received either the true or
sham acupuncture once a week for 8 weeks, and followed up at 1, 6, and 12 months
thereafter. The sham needles were inserted 2 to 4 mm
into the nonacupoints in the same body regions. Compared to baseline, at 1
month after the end of treatment and for the 12-month follow-up, the frequency
of headache, analgesic consumption and the headache index in both groups
significantly decreased over time; Although no difference was detected, the real
acupuncture group exhibited a trend favoring a better outcome than the placebo
needing, with 44.3% versus 21.4% decrease in headache frequency, 58.3% versus
27.8% in headache index, 57.7% versus 21.7% in analgesic intake. When the sample
size is increased, the likelihood of detecting the significant difference
between these two groups should increase.
Cluster Headache
No randomized controlled trial of acupuncture in the treatment of cluster
headache can be found in Pubmed search. A few case reports documenting the
benefit of acupuncture in the treatment of cluster exist. Gwan reported a single
case treated by acupuncture.[86] The patients had at least 8-year history of
chronic cluster headache and failed the conventional medical treatments. After
receiving a total of 13 weekly session of acupuncture treatment, the patients
remained headache free in the next 3-month follow-up. The long-term benefit was
unknown. Dana recently reported another case with multiple daily cluster
headaches despite the continuous use of prednisone, verapamil, and oxygen for 2
years.[71] After five biweekly acupuncture treatments, the patient successfully
weaned off all the medications and remained headache free for 8 months. Over the
next 2 years, the headache occasionally recurred, which was well controlled by
the combination of rofecoxib and acupuncture. In a small
controlled trial, the effect of acupuncture on the CSF met-enkephalin levels
and beta-endorphin levels was studies.[75] Seven patients with ongoing cluster
headache cycle received at least 5 weekly acupuncture treatments for headache.
CSF samples were collected 1 week prior to the treatment as the baseline, and
within 60 minutes after the 3rd acupuncture. Compared to samples from the
age-matched healthy volunteers, there were significantly lower CSF
met-enkephalin levels in the cluster patients. The levels were significantly
raised after the acupuncture treatment. The CSF beta-endorphin levels of
headache sufferers were no different from the controls and were unchanged after
acupuncture treatment. Only 2 out of 7 patients reported decrease of either
headache frequency or severity that started the third treatment session.
Considering the episodic nature of cluster headaches, these case reports bear
little significance.
Other Types of Headache
Two studies have been reported on the effect of acupuncture on supra-orbital
headache.[87,88] Due to methodological problems-lack of control groups,
inconsistent diagnostic criteria, and retrospective design-the overwhelmingly
positive benefits of these studies are suspect.
Adverse Effects of Acupuncture
One of the advantages of using acupuncture is the relatively low incidence of
side effect, compared to the other treatments for the same condition.[3]
However, as an invasive procedure, adverse events do occur and should be
recognized by the practitioner. When needles are incorrectly placed, the
potential for adverse events increases. Patients should be informed of the
potential risk of this technique before treatment. In White's survey of 78
acupuncturists involving 31 822 consultations, a total of 2178 adverse events
were reported for an incidence of 684 per 10 000.[89] The most common side
effects included bleeding, needling pain, aggravation of symptoms, and
aggravation followed by resolution of symptoms. The side effects of acupuncture
can also be divided into severe and minor categories. The less common but severe
side effects include infection, and tissue and organ trauma. When the
acupuncture needle is used repeatedly or inappropriately, acupuncture can carry
the risk of
infection. Practitioners should use sterile disposable, single-use needles. In
Norheim's survey involving over 1200 physician and nonphysician
acupuncturists,[90] the reported infections, in the order of incidence were
local skin infection, perichondritis on the auricle, arthritis, and
osteomyelitis. Transmission of AIDS and hepatitis have also been reported.[91]
Pneumothorax is the most frequent serious complication in the category of organ
trauma.[91] Thirty-five cases of pneumothorax were reported in Norheim's
survey.[90] Among those more common but minor side effects, fainting during the
treatment is the most commonly encountered condition, followed by increased pain
and nausea and vomiting.[90]
Contraindications
In general, acupuncture is a safe procedure. There are a few contraindications
to the use of acupuncture.[91,92] It is recommended that acupuncture applied
with electrical stimulator (EA) should be avoided in patient with cardiac
pacemakers. Obviously, acupuncture should also be avoided to those with skin and
soft tissue infections, bleeding disorders, or patients on anticoagulants. It is
not recommended in infants or children, though there is no specific age cutoff.
Pregnancy
Acupuncture has been used to treat nausea and vomiting associated with early
pregnancy,[93-95] and is considered safe,[95] though there are few data
regarding the safety of using acupuncture for headache in pregnant women.
Acupuncture practitioners should know that certain acupoints, such as LI4 and
SP6, are contraindicated for pregnant women[13]; LI4 and SP6 are otherwise
commonly used acupoints for headache management.[69,83,96] These two points may
be used to assist induction of labor at term and preparation of first trimester
abortion due to their purported effect on the cervix.[97,98]
Potential Interaction with Medications
Sixteen drugs have been reported to be able to mediate the analgesic effect of
acupuncture, especially, electroacupuncture analgesia (EAA).[99-108] Most of
these experiments were done using the animal models. Among them, meperidine,
metoclopramide, and doxepin potentiate EAA[99,107]; promethazine, propranolol,
and dexamethasone attenuate the EAA.[102,106,108] The listed drugs are
frequently used in the headache management.[109]
Research
In response to the dramatic growth in alternative/complimentary medicine in the
United States, the NIH has set up the Office of Alternative Medicine to oversee
the development of this field. Each year, over 10 million dollars in grants are
awarded in sponsorship of alternative medicine research, including
acupuncture.[2] To meet current research standards, NIHCDP recommended clear
guidelines be established regarding enrollment procedures, eligibility criteria,
diagnostic methods, and study design.[3]
Design Difficulties
Both published studies and clinical experience suggest that patients may respond
to acupuncture, but some of the clinical research has demonstrated the
opposite.[3] The paradoxical outcome may reflect the state of the research. At
least two difficulties exist in the design of acupuncture research. The first
difficulty is how to select a control or comparable standard. There is urgent
need to set up a universal control method in the clinical study of acupuncture.
Currently, three approaches are used in the acupuncture headache research. In
the first trial design, patients in the acupuncture treatment group are either
compared to no control or those in an untreated group (waiting-list).[87,88]
This design may demonstrate that acupuncture treatment is better than not doing
anything, but cannot discriminate this effect from placebo or other nonspecific
treatment effect. From research standpoint, this type of design is of little
value. The second design compares acupuncture to the
nonneedling treatment modalities such as transcutaneous nerve stimulation,
drug, and physiotherapy.[69,110,111] The research result can show whether the
efficacy of acupuncture is comparable to the other proven treatment options, but
does not address the question whether needle insertion and manipulation (ie,
sham needle control) can invoke comparable antinociception. The FDA may be more
interested in comparing the effect of acupuncture treatment to other treatment
options.[3,10] Sham-needling is the third control design and is considered a
gold standard to scientists who investigate the theoretical mechanism of
acupuncture. Sham acupuncture is the technique that does not stimulate known
acupoints.[3] The sham needles can be placed in nonacupoints. A modified type of
sham acupuncture, "mini" sham needling seems to be a more acceptable and
credible control condition; With this technique, the sham needle is inserted 1
to 2 mm into the skin and away from the acupoint.[29,112] This
procedure minimizes the needling effect but maintains the psychological
impact,[112] and it is felt that the differences between the groups may be
attributed to specific treatment characteristics rather than nonspecific
psychological (placebo) factors.[29] The adequacy of the control condition can
be further confirmed by observing no difference between true and sham
acupuncture groups, in how each group perceives the credibility of their
treatments.[29,85]

In addition to the selection of controls, how to maintain double blinding is the
second research difficulty. Because the performance of acupuncture requires
skill and training, it is difficult to "blind" the practitioner.[29,85] The
practitioner will know whether he is doing true acupuncture versus placebo
acupuncture in the study subjects. Thus, single-blinding of study subjects
without blinding the practitioner may be more practical.[112] Some authors still
consider their studies as "double-blinded" when both the patients and evaluating
physicians are blinded, but not the actual acupuncture performer.[25,28] Another
point is that patients who have received acupuncture treatment in the past may
know whether they are receiving true or sham treatment in the study. Recruiting
acupuncture-naïve subjects precludes this design flaw.

Conclusion
Despite preliminary research evidence suggesting acupuncture may suppress
nociceptive TNC and spinal DH neurons via modulation of the release of
neuropeptides and neurotransmitters, the exact mechanisms by which acupuncture
relieves the headache are not fully understood. Empiric evidence and results of
clinical investigations suggest that acupuncture may be a promising treatment
option in the treatment of headache, especially migraine. Acupuncture is a safe
and minimally invasive procedure, and may specifically benefit those patients
who can not tolerate headache medications. Further well-designed acupuncture
studies should illuminate acupuncture's analgesic mechanisms and value in
managing various headaches.

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Address all correspondence to Dr. Chong-hao Zhao, California Headache and Pain
Center, 201 South Buena Vista Street, Suite 238, Burbank Medical Plaza, Burbank,
CA 91505.








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