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## Complete Summary

#### GUIDELINE TITLE

Special treatment situations: alternative headache treatments. Standards
of care for headache diagnosis and treatment.

#### BIBLIOGRAPHIC SOURCE(S)

Mauskop A, Graff-Radford S. Special treatment situations: alternative
headache treatments. In: Standards of care for headache diagnosis and
treatment. Chicago (IL): National Headache Foundation; 2004. p. 115-22.
\[21 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Primary headaches including:

-   Migraine (with or without aura)

-   Tension-type headache (TTH)

-   Cluster headache

-   Chronic daily headache (CDH)

-   Chronic tension-type headache (CTTH)

-   New daily persistent headache

-   Hemicrania continua

#### GUIDELINE CATEGORY

Management\
Prevention\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Neurology

#### INTENDED USERS

Health Care Providers\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To improve the medical treatment of headache

-   To provide recommendations on the newer, or alternative, approaches
    to managing headache

#### TARGET POPULATION

Patients diagnosed with primary headache

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Alternative Headache Treatments**

1.  Patient education

    -   Provision of printed materials

    -   Discussion of trigger factors

    -   Setting realistic treatment expectations

2.  Herbal remedies and supplements

    -   Feverfew

    -   Butterbur root extract (Petadolex®)

    -   Riboflavin

    -   Coenzyme Q~10~

    -   Magnesium

3.  Botulinum toxin type A (Botox®)

4.  Transcutaneous electrical nerve stimulation (TENS) (considered, but
    not recommended)

5.  Vagus nerve stimulation (VNS) (considered, but not recommended)

6.  Cold or pressure application

    -   Application of fluoromethane vapocoolant spray

7.  Acupuncture

8.  Use of intraoral dental appliances

9.  Manipulative treatment (i.e., chiropractic and osteopathic care)
    (considered, but not recommended)

10. Physical therapy

11. Cognitive behavioral therapy

12. Psychiatric therapy (considered, but not recommended, except in
    patients with coexisting psychiatric disorder)

13. Biofeedback

14. Relaxation training

15. Hypnosis

16. Neural blockade

17. Exercise

18. Homeopathy (considered, but not recommended)

#### MAJOR OUTCOMES CONSIDERED

Not stated

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review\
Review of Published Meta-Analyses

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The guidelines presented in this monograph represent the consensus of an
advisory panel of practitioners chosen by the National Headache
Foundation (NHF) for their expertise. In addition to incorporating the
US Headache Consortium\'s recommendations, their conclusions reflect
clinical experience and the most recent medical literature.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Not stated

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not applicable

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Alternative Headache Treatments**

Once patients have received an accurate diagnosis and been reassured
that their attacks are not caused by a secondary or more serious
pathology, clinicians and patients should work together to identify the
most appropriate treatment plans. Although pharmacologic management
presents many effective options, the therapy of most patients can be
optimized with the addition of various nonpharmacologic approaches. This
chapter looks at some of the newer, or alternative, approaches to
managing headache. These approaches are summarized in the table below.

+---------------------------------------------+------------------------+
| **Alternative Headache Treatments**         |                        |
+=============================================+========================+
| **TREATMENT**                               | **EFFECTIVE/SAFE**     |
+---------------------------------------------+------------------------+
| Feverfew                                    | Yes/Yes                |
|                                             |                        |
| Butterbur root extract (Petadolex®)         | Yes/Yes                |
|                                             |                        |
| Riboflavin                                  | Yes/Yes                |
|                                             |                        |
| Magnesium                                   | Yes/Yes                |
|                                             |                        |
| Botox®                                      | Possible/Yes           |
|                                             |                        |
| Transcutaneous electrical nerve stimulation | No/Yes                 |
| (TENS)                                      |                        |
|                                             | Possible/Yes           |
| Cold application                            |                        |
|                                             | Possible/Guarded       |
| Intraoral appliances                        |                        |
|                                             | Yes/Yes                |
| Acupuncture                                 |                        |
|                                             | No/Questionable        |
| Manipulative treatment                      |                        |
|                                             | Possible/Not known     |
| Physical therapy                            |                        |
|                                             | Yes/Yes                |
| Cognitive behavioral treatment              |                        |
|                                             | Yes/Yes                |
| Biofeedback                                 |                        |
|                                             | Yes/Yes                |
| Relaxation therapy                          |                        |
|                                             | Possible/Some risks    |
| Nerve blocks                                |                        |
|                                             | No/Yes                 |
| Homeopathy                                  |                        |
+---------------------------------------------+------------------------+

**Patient Education**

Patient education (see National Headache Foundation guideline on
\"Patient Education\") is an essential component of any treatment plan.
Migraine patients should be given a basic explanation of the physiologic
etiology of headache. Printed materials are an effective way to educate
patients about the role of genetic predisposition, as well as the
relationship between headache and the central nervous system, the
peripheral nervous system, and vascular and humeral mechanisms.
Patients\' knowing that their attacks are a real and treatable condition
may enhance compliance with therapy and ultimately improve the chance
for a successful treatment outcome.

Trigger factors (see table below) should be discussed; these may be
different for each patient. Clinicians should work with patients to set
realistic treatment expectations, with an emphasis on management, not
cure, and should encourage patients to remain active partners in their
treatment throughout its course.

+-----------------------------------------------------------------------+
| **Some Potential Triggers of Migraine Headache**                      |
+=======================================================================+
| -   Emotional stress                                                  |
|                                                                       |
| -   Changes in behavior: missing meals, changes in sleep duration     |
|                                                                       |
| -   Environmental factors: light, noise, odors, allergens, barometric |
|     changes                                                           |
|                                                                       |
| -   Foods and beverages: chocolate, cheese, cured meats, caffeine     |
|     beverages, alcohol                                                |
|                                                                       |
| -   Chemicals: aspartame, monosodium glutamate, benzene,              |
|     insecticides, nitrates                                            |
|                                                                       |
| -   Drugs                                                             |
+-----------------------------------------------------------------------+

**Herbal Remedies and Supplements**

Herbal remedies remain very popular, in part because they are perceived
to be natural and therefore safer than prescription drugs. This
perception is often not accurate, as the Food and Drug Administration
(FDA) does not regulate herbal and nutritional remedies. One herb that
appears to be safe and possibly effective in the prevention of migraine
headaches is feverfew. This herb has been subjected to double-blind
trials and has an extensive safety record. A second herbal remedy,
butterbur root extract (the only purified form of this extract is sold
as Petadolex) has 2 published trials of safety and efficacy. Herbal
remedies have the potential to interact with prescription drugs and
should always be used under a physician\'s supervision. Specifically,
feverfew can cause increased bleeding time and enhance the effect of
aspirin and warfarin. Because of lack of regulation, patients should use
only products manufactured by large and reputable companies.

Riboflavin (vitamin B~2~) has been studied at doses of 400 mg per day
(divided), and although it can take several months to provide optimal
efficacy, it may benefit some patients with migraine. There are no known
significant adverse effects. Coenzyme Q~10~, another supplement, has
been subjected to one open-label trial that suggested efficacy; the
results were later confirmed in a double-blind trial using a 300 mg
dose. Magnesium has been studied extensively, both for acute treatment
intravenously (IV) and for preventive treatment. The IV acute studies
suggest it may be effective for treating acute attacks of migraine. In
oral doses of 400 to 600 mg per day, the results of 3 of the 4
double-blind studies were strongly positive. The negative study had a
very high incidence of diarrhea, which suggests that the magnesium salt
used in this study was poorly absorbed. Magnesium oxide and chelated
magnesium tend to be better tolerated.

**Botulinum Toxin Type A**

Botulinum toxin type A (Botox® \[Btt A\]) was approved by the FDA in
1989 for the treatment of blepharospasm and strabismus. Widespread use
of Btt A for the treatment of forehead wrinkles (approved by the FDA in
2002) led to the discovery of its efficacy in relieving headaches. Many
anecdotal reports and several controlled trials confirm the efficacy of
Btt A in preventing migraine headaches. The effect of a single Btt A
treatment lasts an average of 3 months. The procedure takes 5 to 10
minutes and causes minimal discomfort. Approximately 10 to 20 sites are
injected at each session. The dosage and the location of the sites to be
injected remain subject to continuing study. In general, the number and
the location of the injection sites depend on pain distribution and the
presence of trigger points. Side effects from Btt A injections are very
rare and mild.

**Transcutaneous Electrical Nerve Stimulation (TENS)**

The use of TENS has been reserved primarily for the treatment of body or
extremity pains because of fear of potential epileptogenic effects of
electric current running through the head. With proper placement of
electrodes and the use of low-intensity currents, it appears to be safe
to apply this technique to the head. However, there is little objective
evidence about the efficacy of TENS. Considering the inconvenience and
the limited efficacy, this treatment is not recommended.

**Vagus Nerve Stimulation (VNS)**

VNS is an approved procedure for the treatment of drug-refractory
epilepsy. Several case reports and indirect evidence from epilepsy
trials suggest that VNS may also be effective in the treatment of
refractory migraines. That anticonvulsants are effective in the
prevention of migraines suggests that VNS may also work in migraines.
However, in the absence of a controlled trial, it is premature to
recommend this treatment for migraine headaches.

**Cold or Pressure Application**

Cold or pressure application to the head has been shown to be an
effective headache strategy. Application of vapocoolant spray
(fluoromethane) has been demonstrated to decrease myofascial pain in
tension-type headache. The use of cold gel packs is beneficial as a
self-help technique.

**Acupuncture**

Although there is no consensus in the clinical literature to support the
efficacy of acupuncture, studies have shown that some patients
experience significant pain relief. A meta-analysis of 14 controlled
trials of acupuncture indicates a strong trend in favor of acupuncture.

**Intraoral Dental Appliances**

Intraoral dental appliances have also been used to treat headache, but
more definitive studies are needed. The patient should be made aware of
the risks associated with intraoral splint therapy other than
conventional full arch coverage stabilization devices.

**Chiropractic, Osteopathic Medicine, and Physical Therapy**

The value and cost-effectiveness of chiropractic, osteopathic medicine,
and physical therapy in migraine have not been proven in clinical
trials. Conflicting results and poor clinical trial design limit the
ability to judge the effectiveness of manipulative treatments. Physical
therapy, although limited in its study, has proven more effective than
manipulative treatment in selected cases.

**Cognitive Behavioral Therapy (CBT)**

CBT is designed to help patients identify and change maladaptive
behaviors that may be aggravating the headaches. CBT is usually combined
with other behavioral therapies but has been shown to be effective on
its own. The goals are to identify the maladaptive thoughts, develop an
action plan to deal with the headache, and encourage long-term
implementation of the techniques. CBT is discussed in detail in a
separate guideline titled \"Behavioral Interventions for Management of
Primary Head Pain\".

**Psychiatric Therapy**

Psychiatric therapy is not indicated, except in patients with coexisting
psychiatric disorder.

**Biofeedback**

Biofeedback refers to the use of monitoring instruments to detect,
amplify, and display internal physiologic processes, so the patient may
learn to alter the process at will. Patients should be selected based on
their motivation, as well as equipment availability. A meta-analysis has
indicated that the benefit of biofeedback is similar to that of
prophylactic therapy. Biofeedback may also serve as an excellent adjunct
to pharmacologic therapy. Biofeedback is discussed in detail in a
separate guideline titled \"Behavioral Interventions for Management of
Primary Head Pain.\"

**Relaxation Training**

Relaxation training is a biobehavioral approach that involves
progressive muscle relaxation, breathing exercises, or imagery. A
meta-analysis has suggested that relaxation is as effective as
biofeedback. The treatment may be enhanced by combining relaxation and
biofeedback and adding pharmacologic intervention where appropriate.
Patients should be selected if they are motivated and likely to use the
techniques. Relaxation training is discussed in detail in a separate
guideline titled \"Behavioral Interventions for Management of Primary
Head Pain.\"

**Hypnosis**

Hypnosis may be an excellent tool in a small subgroups of patients who
are willing to undergo the procedure and suitable for it.

**Neural Blockade**

Neural blockade\--occipital, supraorbital, sphenopalatine ganglion,
stellate ganglion, cervical facet, epidural, etc.\--may serve a
diagnostic or therapeutic role in headache patients. The specific role
of neural blockade in migraine and tension-type headache may be more
limited to occipital or supraorbital block in the acute stage when the
pain is localized. The effect of this procedure may be only to change
what is being perceived by the brain, however, and does not imply that
the pain is generated from the structure injected. Trigger point
injections to the muscles of mastication or the cervical muscles may
also aid the therapeutic outcome.

**Exercise**

The benefits of exercise are generally accepted. Sleep may be improved
with regular exercise, and that in turn helps headache. It is also
suggested that routine exercise may enhance central pain inhibition.
Although there are no specific studies showing a direct relationship
between exercise and headache, developing an appropriate exercise
regimen with the patient is encouraged.

**Homeopathy**

Homeopathy has not proven effective in controlled clinical trials. Even
if safe, it may not provide any specific benefit beyond a placebo
effect.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically
stated.

In addition to incorporating the US Headache Consortium\'s
recommendations, the conclusions reflect clinical experience and the
most recent medical literature.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate use of alternative headache treatments

#### POTENTIAL HARMS

Herbal remedies have the potential to interact with prescription drugs
and should always be used under a physician\'s supervision.
Specifically, feverfew can cause increased bleeding time and enhance the
effect of aspirin and warfarin.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

Drug therapy is constantly evolving as new research, clinical trials,
case reports, and opinions are published. Many of the drugs recommended
in these guidelines are not approved by the US Food and Drug
Administration (FDA) for treatment of headache, nor are they necessarily
the same as those therapies recommended by the manufacturer for labeled
indications. Their use in headache, however, may be supported by the
scientific literature and by the authors\' clinical experiences. While
efforts have been made to ensure accuracy, the authors and publisher do
not assume responsibility for the consistent updating of available
information for these guidelines, nor for any errors or omissions, nor
for any consequences thereof. The onus is on the practitioner to
evaluate recommendations in light of the clinical condition of the
patient and recent medical literature. The authors advise the
practitioner to consult other sources, especially the manufacturers\'
warnings and precautions, before prescribing any drug with which they
are unfamiliar. Practitioners are also advised that while these
guidelines will address the needs of many patients, there will be
circumstances calling for exceptions to these recommendations.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Foreign Language Translations\
Patient Resources\
Slide Presentation

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Mauskop A, Graff-Radford S. Special treatment situations: alternative
headache treatments. In: Standards of care for headache diagnosis and
treatment. Chicago (IL): National Headache Foundation; 2004. p. 115-22.
\[21 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2004

#### GUIDELINE DEVELOPER(S)

National Headache Foundation - Private Nonprofit Organization

#### SOURCE(S) OF FUNDING

National Headache Foundation

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Alexander Mauskop, MD, FAAN, and Steven Graff-Radford, DDS

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: None available

Print copies: Available from the National Headache Foundation, 820 N.
Orleans, Suite 218, Chicago, IL 60610; Phone: (888) NHF-5552; Web
address: [www.headaches.org](http://www.headaches.org/)

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   The complete headache chart. Chicago (IL): National Headache
    Foundation (NHF); 2 p. Electronic copies available in Portable
    Document Format (PDF) from the [National Headache Foundation Web
    site](http://www.headaches.org/consumer/presskit/hachart.pdf)

-   National Headache Foundation fact sheet. Chicago (IL): National
    Headache Foundation (NHF); 2004 Oct. 2 p. Electronic copies
    available in Portable Document Format (PDF) from the [National
    Headache Foundation Web
    site](http://www.headaches.org/consumer/presskit/factsheet.pdf).

Print copies: Available from the National Headache Foundation, 820 N.
Orleans, Suite 218, Chicago, IL 60610; Phone: (888) NHF-5552; Web
address: [www.headaches.org](http://www.headaches.org/)

#### PATIENT RESOURCES

The National Headache Foundation (NHF) has created a variety of
educational resources for patients, including informative brochures, a
patient diary for migraines, Power Point presentations, and patient
guides; many of these resources are available in both Spanish and
English. Some of these items are available as print copies for purchase
through the [NHF online
store](http://www.headaches.org/consumer/storeindex.jsp). Electronic
versions of other resources are available through the consumer education
section of the [NHF Web
site](http://www.headaches.org/consumer/educationindex.html).

Print copies: Available from the National Headache Foundation, 820 N.
Orleans, Suite 218, Chicago, IL 60610; Phone: (888) NHF-5552; Web
address: [www.headaches.org](http://www.headaches.org/).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on April 13, 2005. The
information was verified by the guideline developer on April 26, 2005.

#### COPYRIGHT STATEMENT

These guidelines are for reference purposes only and are not to be mass
produced. This information is copyrighted by the National Headache
Foundation, 2005.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008