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Botulinum Toxin

Single-Site Botulinum Toxin Type A Injection for Elimination of Migraine Trigger Points (January 2004) Pharmaco-Economic Effect of Botulinum Type A (BTX-A) on the Difficult to Manage Headache Patient (March 2003)
Botulinum Toxin Type B for Refractory Cluster Headache (May 2002)
Botulinum Toxin: Efficacy in Migraine, Tension, and Cluster Headache: A Review (February 2002)
Botulinum Toxin for Cluster Headache; 10 Patients (August 2001)
Botulinum Toxin A for Refractory Chronic Daily Headache (Posted August 2001)
Treatment of Chronic Cervical-Associated Headache with Botulinum Toxin A: A Pilot Study  (Posted June 2001)
Prophylactic Treatment of Chronic Tension-Type Headache - Using Botulinum Toxin Type A  (Posted May 2001)
Treatment of Tension-Type Headache with Botulinum Toxin (Posted Feb 2001)
A follow-up study of 60 patients after an assumed first period of Cluster Headache  (Posted Nov 2000)
Differential Effects of Botulinum Toxin A (Botox) - Injections in the Treatment of Refractory Headaches: A Preliminary Report.(Posted June 2000)
How We Do Botox  (Posted March 1998)

Treatment of Chronic Cervical-Associated Headache
With Botulinum Toxin A:  A Pilot Study

Freund BJ, Schwartz M Headache, 2000

To see whether therapy with botulinum toxin A may prove to be an effective treatment for headache of musculosketal origin.

Headache is a common finding associated with neck injury.  Cervicogenic headache, which is believed to be attributable to injury of the ligaments, muscles, or joints of the cervical spine, is centered in the occipital region with pain referred to the frontotemporal region.  Botulinum toxin A produces prolonged muscle relaxation, which is dose dependent and can be easily targeted to affected muscles.

Fourteen subjects who received botulinum toxin A and 12 who received saline completed the study.  At both 2 and 4 weeks post injection, the treatment group showed a significant improvement in pain and range of motion from preinjection levels.  The placebo group demonstrated no statistically significant changes at any post-treatment time.

Treatment of Tension-Type Headache with Botulinum Toxin:
1-year follow-up

MA Relja, Cephalalgia, May 2000

Introduction and Objective:
It has been shown in double-blind, placebo-controlled studies, that Botulinum-A is significantly better than placebo for symptomatic relief of pain in patients with tension-type headache. Here we present long-term follow-up of patients treated with botulinum for tension-type headache. The objective is to evaluate the long-term benefit of botulinum toxin type A (BTX-A) for the symptomatic relief of pain associated with chronic tension-type headache (TTH).

Twenty-five patients with TTH, who had been resistant to standard therapy, were enrolled into a 15 month, open-label, prospective study. The patients received BTX-A as Botox, by intramuscular injection into the most tender pericranial muscles every 3 months. Tenderness of the pericranial muscles was evaluated by manual palpation performed bilaterally in the frontalis, temporalis, trapezius, and sternocleidomastoideus muscles. Clinical assessment was performed at 4 week intervals using the total tenderness score and a home diary kept by each patient.

In total, 24 patients completed the study. There was a constant improvement in the number of headache-free days over the 15 month period. Total tenderness score showed a sustained trend of decreasing during the study. In addition, headache severity was significantly lower at months 9, 12 and 15 compared with months 3 and 6, suggesting an improvement in quality of life. Safety records showed no serious adverse event.

This is the first prospective long-term study where BTX-A inuections were found to be an effective and safe prophylactic treatment for TTH in patients for whom standard therapy has failed.

Differential Effects of Botulinum Toxin A (BOTOX) injections in the Treatment of Refractory Headaches: A Preliminary Report

Background and Objective:
BOTOX injections have been used successfully for the treatment of blepharospasm, cervical dystonia, and other conditions associated with persistent muscle spasm or hyperfunctional muscles. There are recent reports of the efficacy of pericranial BOTOX injections in reducing the frequency and intensity of migraine attacks, along with anecdotal reports of the beneficial effects of BOTOX injections in the treatment of cervicogenic headaches and myofascial head and neck pain. Our ongoing study is aimed at assessing the efficacy of BOTOX in treating a variety of headache syndromes, which have proven refractory to multiple standard treatments.

We identify refractory headache patients through the Headache and Pain Management centers at Beth Israel Deaconess Medical Center and Harvard Medical School. Patients with suboptimal response to at least five prophylactic and symptomatic medications, along with poor response to non-drug treatments, are selected for study. BOTOX is injected into the frontalis, glabellar, temporalis, corrugator, occipital, and cervical paraspinal muscles, depending upon the physical examination and characteristic of the headache syndrome. Satisfactory response is indicated by at least a 50% reduction over a two month period in three categories: frequency of headaches, intensity of headache pain, and use of medications.

19 subjects (average age 40.6 +/- 17 years) have been treated to date with an average dose of 37 units (range 25-100 units). 13 patients (68%) have met the criteria for satisfactory response. Transient injection-site discomfort was the most frequently reported adverse effect; no other significant adverse effects were noted.

BOTOX is a safe and effective modality in the prophylactic treatment of patients with refractory headache syndromes.

How We Do Botox (March 1998)

The patient consents to the procedure and signs the appropriate consent form.

The patient will receive materials on Botox (package insert, articles, etc.)

The patient agrees to track their headaches on a calendar after the injections, so that we can follow the progress of the injections.

The patient will be prepped and draped in the usual fashion. Sterile precautions will be utilized.The Botox will be diluted with 4 ml. of 0.9% sodium chloride without preservative. The dilution is done according to the package insert for Botox. The insulin syringes with 27 gauge 5/8" needles will be filled to .08 ml. each with the Botox solution. This equals 2 units of Botox.

Twelve syringes with 2 units each of Botox will be drawn up. The patient will be placed in a supine position and the injections will be placed in various locations under the scalp, primarily in the front. Twelve injections will be given with 2 units (.08 ml. each), which totals 24 units for the patient.

The patient will be observed for any ill effects; however, most patients tolerate the procedure well. The observation will continue for 30 minutes after the completion of the injections.