William J. Binder

Botulinum toxin type A (BOTOX) for treatment of migraine headaches: An open-label study

ABSTRACT OBJECTIVE: The object of this clinical experience was to evaluate the correlation between pericranial botulinum toxin type A (BOTOX, Allergan Corp, Irvine, CA) administration and alleviation of migraine headache symptoms. STUDY DESIGN AND SETTING: A nonrandomized, open-label study was performed at 4 different test sites. The subjects consisted of 106 patients, predominantly female, who either (1) initially sought BOTOX treatment for hyperfunctional facial lines or other dystonias with concomitant headache disorders, or (2) were candidates for BOTOX treatment specifically for headaches. Headaches were classified as true migraine, possible migraine, or nonmi-graine, based on baseline headache characteristics and International Headache Society criteria. BOTOX was injected into the glabellar, temporal, frontal, and/or suboccipital regions of the head and neck. Main outcome measures were determined by severity and duration of response. The degrees of response were classified as: (1) complete (symptom elimination), (2) partial (≥50% reduction in headache frequency or severity), and (3) no response [neither (1) nor (2)]. Duration of response was measured in months for the prophylactic group. RESULTS: Among 77 true migraine subjects treated prophylactically, 51% (95% confidence interval, 39% to 62%) reported complete response with a mean (SD) response duration of 4.1 (2.6) months; 38% reported partial response with a mean (SD) response duration of 2.7 (1.2) months. Overall improvement was independent of baseline headache characteristics. Seventy percent (95% confidence interval, 35% to 93%) of 10 true migraine patients treated acutely reported complete response with improvement 1 to 2 hours after treatment. No adverse effects were reported. CONCLUSIONS: BOTOX was found to be a safe and effective therapy for both acute and prophylactic treatment of migraine headaches. Further research is needed to explore and develop the complete potential for the neuroinhibitory effects of botulinum toxin.

Botulinum toxin A for hyperkinetic facial lines : results of a double-blind, placebo-controlled study

Previous work on patients with muscular dystonia has shown that small intramuscular doses of botulinum toxin A eliminated hyperkinetic facial lines for approximately 6 months. The purpose of this study was to determine the efficacy of botulinum toxin A injections in eliminating facial wrinkles in aesthetic surgery patients who do not have muscular dystonia. Eleven healthy subjects were studied in a double-blind fashion. On both sides of the face, 0.2 cc of either normal saline or botulinum toxin A was injected into the forehead or into the periorbital wrinkles (crows feet). Documentation of results was made by photographs taken of the patients during repose and during facial animation before and after injection. Assessment of facial wrinkles was done from a grading system in which the patient and the facial plastic surgeon were asked to judge the severity of the wrinkles on a scale from 0 to 3, with 0 reflecting no facial wrinkles and 3 reflecting severe facial wrinkling. Nine of 11 subjects injected with botulinum toxin A noted a significant improvement in the severity of their facial wrinkles in comparison with the side of the face injected with saline, with a rating improvement of 2 points. Two of 11 subjects noted a moderate improvement, with a rating improvement of 1 point. No patient injected with saline reported an improvement in the severity of the facial wrinkles on the control side. There were no serious complications. Botulinum toxin A is an efficacious method of nonsurgically eliminating facial wrinkles and may play a role in the cosmetic enhancement of the aging face.

Method of Injection of OnabotulinumtoxinA for Chronic Migraine: A Safe, Well‐Tolerated, and Effective Treatment Paradigm Based on the PREEMPT Clinical Program

Chronic migraine (CM) is a prevalent and disabling neurological disorder. Few prophylactic treatments for CM have been investigated. OnabotulinumtoxinA, which inhibits the release of nociceptive mediators, such as glutamate, substance P, and calcitonin gene‐related peptide, has been evaluated in randomized, placebo‐controlled studies for the preventive treatment of a variety of headache disorders, including CM. These studies have yielded insight into appropriate patient selection, injection sites, dosages, and technique. Initial approaches used a set of fixed sites for the pericranial injections. However, the treatment approach evolved to include other sites that corresponded to the location of pain and tenderness in the individual patient in addition to the fixed sites. The Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) injection paradigm uses both fixed and follow‐the‐pain sites, with additional specific follow‐the‐pain sites considered depending on individual symptoms. The PREEMPT paradigm for injecting onabotulinumtoxinA has been shown to be safe, well‐tolerated, and effective in well‐designed, controlled clinical trials and is the evidence‐based approach recommended to optimize clinical outcomes for patients with CM.

Treatment of Hyperfunctional Lines of the Face with Botulinum Toxin A

&NA; Since Botulinum toxin A became a mainstay therapy for blepharospasm, its use in treating other dystonic conditions, spastic‐ity disorders, as well as hyperfunctional lines of the face has increased exponentially in recent years. The following article summarizes our experience in establishing a safe and reliable method of administration of botulinum toxin A for treating hyperfunctional lines of the face.

Procedures for Administering Botulinum Toxin Type A for Migraine and Tension-type Headache

Headache can be debilitating, causing lost productivity at work or school, impaired quality of life, and disruptions in family and social life.1,2 The limited clinical efficacy of current preventive therapies for headache, coupled with the substantial side effects of these treatments, indicate that headache prevention is an area of unmet medical need. Botulinum toxin type A (BoNT-A) is used to treat a variety of overactive muscle and pain disorders.3-5 Intramuscular injections of BoNT-A may provide an effective, long-lasting, and well-tolerated new approach to headache prevention and management for selected patients. Investigators have used injection techniques with differing anatomical injection sites, doses, and concentrations of BoNT-A. The method of administering BoNT-A for headache therapy will determine, in part, the overall clinical outcome. Optimizing the protocol for clinical use of BoNT-A is, therefore, likely to improve the outcomes of therapy. This article provides a review of current practical procedures for adminis-

Reconstruction of Posttraumatic and Congenital Facial Deformities with Three-dimensional Computer-assisted Custom-designed Implants

The principles, method, and benefits of combining three-dimensional computed tomography (CT) and computer-aided design/computer-aided manufacture (CAD/ CAM) technology for development of custom-designed prostheses are applied in the repair of posttraumatic and congenital facial contour deficiencies. Each prosthesis is generated to fit the bone defect exactly, with external contours adjusted to compensate for overlying soft-tissue disparities. Three representative case reports from a series of 17 demonstrate the applications and advantages of using this technique. Some patients had residual defects after primary repair of posttraumatic deformities. Others had defects after orthognathic relapses for congenital deformities. Without a relatively minor surgery and a high degree of predictability, many of these patients would not have pursued further treatment. All but one of the surgeries were performed on an outpatient basis, providing an accurate, simple, and cost-effective method of contour restoration with limited morbidity and reduced operative time.

Mentoplasty — A clinical analysis of alloplastic implants

Different types of alloplastic implants are currently being utilized in performing mentoplasty. A review of the literature points out the number of prostheses that have been used. Each type of material has inherent physical properties which determine its characteristics for use as a chin implant. The type of implant and method selected in chin augmentation depends upon accurate preoperative evaluation and full understanding of the properties of alloplastic substances.

Facial rejuvenation and volumization using implants.

Whereas traditional concepts of facial aging focus on the descent of soft tissue secondary to gravitational effects, it is now well established that volumetric changes involving different levels of soft tissue loss reveal craniofacial skeletal deficiencies that, together, contribute to the changes evident in the aging face. Thus, effective facial rejuvenation requires a comprehensive paradigm that identifies and addresses all anatomic elements involved in the aging process. Contemporary practices in facial rejuvenation have expanded far beyond the rhytidectomy procedure to involve deeper and more fundamental levels of dissection for the purpose of elevating and replacing volume. Alloplastic implants offer a long-term, multidimensional solution to facial rejuvenation by concomitantly augmenting skeletal deficiency, restoring lost soft tissue volume, and smoothing irregularities in the facial contour. Facial augmentation using implants represents a straightforward, simple procedure with minimal risks and long-lasting benefits. By applying accurate and judicious techniques for preoperative analysis, selecting the appropriate implant, and with correct surgical placement of the implants, the facial plastic surgeon can achieve successful facial volumization and restore the youthful appearance of the aging patient.

Insights into the Functional Anatomy Behind the PREEMPT Injection Paradigm: Guidance on Achieving Optimal Outcomes

To provide clinically relevant insights on the identification of the muscles and techniques involved in the safe and effective use of onabotulinumtoxinA for chronic migraine prophylaxis.

Long-term effects of onabotulinumtoxinA on facial lines: a 19-year experience of identical twins.

Hyperfunctional lines in the skin are produced by repeated contraction of the underlying muscles. By inhibiting the release of acetylcholine from the presynaptic terminal of the neuromuscular junction, BoNTA inhibits the contraction of muscles, and as such, may serve to prevent or limit the formation of new wrinkles. To date, however, there have been no prospective studies conducted on wrinkle prevention with repeated use of BoNTA. Binder published a unique case report of twins, one regularly treated with onabotulinumtoxinA, whereas the other twin had only had 2 treatments over the course of 13 years. In Binder’s report, photographic documentation showed that the treated twin did not exhibit forehead or glabellar lines at rest, whereas mild resting lines were evident in the sporadically treated twin. This article is a 6-year follow-up of the same twins, as in Dr. Binder’s case study. This case report describes the effects of long-term repeated treatment with onabotulinumtoxinA over a 19-year period. The authors provide a photographic evaluation to assess whether repeated treatments of onabotulinumtoxinA may prevent the formation of hyperfunctional wrinkles or delay the onset of atrophic rhytides that may become permanent.