Doses Of BTX Research Articles

Dose-Effect Relationship of Botulinum Toxin Type A in the Management of Strabismus: A Review.

Botulinum toxin type A (BTXA) is a well-accepted non-surgical therapy for strabismus. However, its dose and technique vary widely. We reviewed published evidence on the dose effect of BTXA in treating various types of strabismus.Articles on BTXA therapy outcomes were reviewed to study doses and brands of BTXA used and their efficacy for specific types of strabismus. Researchers indicated that greater dosages may be used safely without increasing the risk of complications.The review suggested a positive dose-response relationship of BTX to success but with a higher risk of complications. No single dose of BTX could be recommended for strabismus management.

Effect of multiple injections of botulinum toxin into painful masticatory muscles on bone density in the temporomandibular complex

BackgroundAdverse effects of masticatory muscle injections of Botulinum Toxin (Btx) have been noted in animal and, less dramatically, human studies.ObjectiveAmong women treated in multiple community‐based private practices, to compare TMJ bone density and mandibular condylar volume between patients with myofascial TMJD receiving multiple masticatory muscle Btx treatments and similarly diagnosed women not receiving such treatment.MethodsCohorts consisted of women whose treatment charts indicated a diagnosis of myofascial TMJD: 35 received at least 2 Btx treatment cycles; 44 received none. Bone density at pre‐specified regions of interest (ROI) was defined by grey scale values from Cone Beam CT, adjusting for a fixed density phantom included in each scan. Mean bone density and mandibular condyle volume were compared between groups. Dose‐response effects were tested within the Btx‐exposed group.ResultsThe mean density of primary and secondary ROIs was similar between exposure groups, as was condylar volume. Among Btx‐exposed women, increasing dose of Btx to the temporalis muscle was inversely proportional to the density of the trabecular area of the mandible body. Many Btx‐exposed women received smaller doses of Btx to the masseter muscles than in most TMJD Btx clinical trials.ConclusionMasticatory muscle injections of Btx failed to produce clinically significant TMJ bone‐related changes. Should Btx receive regulatory approval for treatment of myofascial TMJD, a phase IV study is recommended to evaluate potential adverse effects of Btx on bone and muscle when administered at higher doses and/or for more treatment cycles.

Botulinum toxin can help with foot symptoms in patients with pachyonychia congenita

Pachyonychia congenita (PC) is a rare genetic skin disease which is estimated to affect between 5,000 and 10,000 people worldwide. PC can cause severe pain, especially affecting weight-bearing areas, which accompanies thickening of the skin on the feet (keratoderma). Although there are options for treating the various symptoms of PC, most of them are not especially effective at improving the keratoderma and the pain. The successful use of botulinum toxin (Btx) injections for treating keratoderma in PC patients has been documented in three reports over the past decade. The injection technique, doses of Btx, and methods of anesthesia varied between the reports and the patients. In recent years, the authors, who are based in Israel, have adopted the same approach and refined the injection technique and anesthesia procedure, and have adjusted the Btx doses to improve the treatment. The purpose of this study was to describe the authors four-year experience during which they administered a total of 30 Btx injections to five PC patients following the protocol they have designed. The conclusions of the study were that Btx treatment of PC-associated keratoderma following an optimized protocol leads to a major change in patients’ quality of life. The best improvement scores concerned patients’ morning feet burning and ability of long-distance walking (> 500 m). The scores were significantly better if the intervals between Btx injections were less than 100 days. This is a summary of the study: A treatment protocol for botulinum toxin injections in the treatment of pachyonychia congenita-associated keratoderma

A treatment protocol for botulinum toxin injections in the treatment of pachyonychia congenita‐associated keratoderma

Severely debilitating plantar keratoderma pain is the most distressing clinical feature of pachyonychia congenita (PC). Several earlier publications have reported therapeutic success with plantar injections of botulinum toxin (Btx). To describe our 4-year experience during which we administered a total of 30 plantar Btx injections to five patients with PC following an optimized protocol. Five patients with PC (age 21-54 years) who were treated at our medical centre from April 2015 to June 2018 were included in the study. After an ultrasound-guided nerve block performed by an anaesthesiologist, the patients received plantar intradermal injections of Btx A. To ascertain the effect of the treatment, we used a dedicated quality-of-life questionnaire for patients with PC (PCQoL) and asked the patients to evaluate the intensity of eight parameters pertaining to their symptoms at baseline and before every treatment session. At study closure, patients were asked to evaluate the maximal improvement in the same eight parameters throughout the study period. All patients demonstrated a decrease in PCQoL scores during the follow-up period. All patients showed a significant improvement in PCQoL after the first treatment session and at the last evaluation (P = 0·043). The scores with the best improvement concerned morning feet burning and long-distance walking (> 500 m). The scores were significantly lower if the intervals between Btx injections were <100 days. Btx treatment of PC-associated keratoderma following an optimized protocol leads to a major change in patients' quality of life. What's already known about this topic? Plantar pain is considered by patients to be the most severe and debilitating manifestation of pachyonychia congenita (PC). Over the past few years, a number of reports have shown that plantar injections of botulinum toxin (Btx) reduce or even eliminate pain, blistering and callosities in patients with PC. However, the injection technique, doses of Btx and methods of anaesthesia varied between reports and patients. What does this study add? Here we report our 4-year experience in providing 30 treatments to five patients following an optimized protocol. Btx was found to provide a quantifiable improvement in all patients treated. What is the translational message? Btx treatment of PC-associated keratoderma using a structured approach, which includes the use of a sufficient dose of Btx (200-400 U of onabotulinumtoxinA or 500-1000 U of abobotulinumtoxinA), and regular intervals between treatment sessions (of < 100 days), leads to a major change in patients' quality of life.

Unclear results for the use of botulinum toxin therapy for TMD pain.

A comprehensive search was carried out on major databases such as PubMed, EMBASE and Cochrane CENTRAL. Reference lists of the included studies were explored along with journals likely to contain studies relevant to the topic. The search was restricted to the English language. The inclusion criteria included randomised and quasi-randomised controlled trials including parallel or cross-over studies comparing botulinum toxin therapy (BTX) versus any alternative intervention or placebo. Quality assessment and data extraction were done following the Cochrane risk of bias tool and recommendations. All of the steps in the review, including the search and selection process, were done independently by two reviewers. Disagreements were discussed with one another until consensus was reached. Five relevant studies were included in the review, which consisted of 117 participants. Two trials revealed a significant inter-group difference in myofascial pain reduction. Another trial that compared BTX with fascial manipulation showed no significant difference in pain relief for temporomandibular disorders (TMDs), while the remaining two trials showed no significant difference between the BTX and placebo groups. Meta-analysis was not performed due to the considerable variation in study methods and evaluation of the results. All five studies were targeted primarily on the masseter and temporalis muscles and most of them administered injections at bilateral muscle sites. The methods used to find the muscles to target were all based on physical examination, with three studies using electromyography (EMG) as guidance. The dose of BTX ranged from 70U to 300U, the majority used being 100-150U. All studies gave a single session of BTX and re-evaluated participants at least one month following the injection. No consensus could be reached on the therapeutic benefit of BTX on TMDs.

Early effect of Botox-A injection into the masseter muscle of rats: functional and histological evaluation.

BackgroundThe purpose of this study was to evaluate the change of food intake after different dosages of botulinum toxin A (BTX) injection in the animal model. Additionally, the dimensional and histological change at 14 days after BTX injection was also evaluated.MethodsThe comparative study was performed using the BTX injection model in rats (n = 5 for each group). Group 1 was the saline-injected group. Group 2 was the 5-unit BTX-injection group to each masseter muscle. Group 3 was the 10-unit BTX-injection group to each masseter muscle. Food intake rates and body weight were checked daily before and after BTX injection until 10 days. All animals were sacrificed at 14 days after BTX injection, and the specimens underwent hematoxylin and eosin stain and immunohistochemical staining for myosin type II (MYH2).ResultsThe recovery of food intake in groups 2 and 3 decreased significantly compared with group 1 from day 2 to day 7 and day 9 after injection (p < 0.05). The BTX-treated masseter muscles were significantly smaller than those in group 1 (p = 0.015). The immunohistochemical findings demonstrated that the expression of MYH2 was significantly higher in group 3 compared to groups 1 and 2 (p < 0.001).ConclusionsBTX injection to the masseter muscle in rats demonstrated short food-intake-rate reduction with recovery until 10 days after injection. The thickness of the masseter muscle and MYH2 expression were significantly changed according to the injected dose of BTX.

Botulinum toxin A: First-line therapy for idiopathic detrusor overactivity

Botulinum toxin A: First-line therapy for idiopathic detrusor overactivity

Botulinum Toxin a in the Treatment of Sialorrhea

To review the efficacy and safety of botulinum toxin A (BTX) in the treatment of sialorrhea. A PubMed search and reference list review was performed to find clinical trials on BTX in the treatment of sialorrhea. The search was limited to English-language trials involving human subjects. Articles from 1965 to October 2006 were searched, using key words botulinum, botulinum toxin, Botox, sialorrhea, saliva, salivary gland, and drooling. Reports of 15 studies were found on BTX in the treatment of sialorrhea in human subjects. Four controlled trials are presented in detail, and 11 uncontrolled studies are summarized. One controlled trial found that BTX caused significant reductions in patients' severity and frequency of drooling compared with placebo. Another found significant saliva reductions in the treatment group receiving the highest dose of BTX but found no subjective improvement compared with the placebo group. A third study comparing BTX with placebo found significant improvements in subjective and objective measures of drooling in the treatment group. A fourth controlled trial found significant reductions from baseline levels of drooling after patients received BTX injections. Similar efficacy was found between the BTX and scopolamine treatment groups. Evidence indicates that BTX is a safe and effective treatment for sialorrhea. More research is needed to determine the ideal dose, injection location, and technique of BTX injections.

Ａ型ボツリヌス毒素を用いた顔面神経麻痺後遺症の治療効果

Once synkinesis and facial contracture after facial nerve palsy have developed, spontaneous recovery is unpredictable and many patients suffer from unpleasant symptoms for a long time. This paper examined the results of treating facial synkinesis and contracture using botulinum toxin type A (BTX). Eleven patients with synkinesis or facial contracture were treated with BTX, and the effects of this treatment were compared with patients with blephalospasm (BS) and hemifacial spasm (HFS) by assessing the degree satisfaction, therapeutic interval, and dose of BTX. Therapeutic effects were also evaluated by recording the width of the affected eyelid and investigation of the facial score using the Sunnybrook grading system before and after treatment.Compared to the BS and HFS patients, the patients' satisfaction levels were higher, therapeutic intervals were longer, and the doses of BTX were lower. In all patients, the width of the affected eyelid increased significantly and the Sunnybrook facial score improved after treatment. The degree of satisfaction tended to be higher in patients treated at an earlier date than in those treated at over 60 months. No severe side effects were observed. These findings suggest that BTX injection is useful and safe for the treatment of facial synkinesis and contracture.

Treatment of gustatory sweating with low-dose botulinum toxin A: a case report

Frey's syndrome, gustatory sweating in the preauricular area, is an unpleasant phenomenon occurring during meals after surgery on the parotid gland. Recently, botulinum toxin A (BTX) has been shown to reduce the symptoms, but the variation in the reported doses is large. Objective. To quantify the effect of treatment with low-dose BTX in a case of Frey's syndrome over a period of 6 months. Material and methods. A 56-year-old woman was treated with 10 U Botox given as 20 single, intracutaneous injections of 0.5 U, one for each cm2, 3 years after resection of the parotid gland. Before treatment and repeatedly during the 6-month period, the sweating was rated subjectively on a 100-mm visual analog scale (VAS) and by a severity index, and objectively by assessment of the extent of the involved skin area using Minor's iodine-starch test, staining the area of sweating dark. Results. The treatment decreased the involved area from 20 to 5 cm2 and the VAS ratings from 98 to 8 mm. The index showed that treatment affected the sweating intensity, not the frequency. After the 6-month period the patient was still satisfied, but the involved skin area had increased; however, not entirely to pretreatment values. Conclusions. The effect of BTX injections for gustatory sweating obtained in this case was comparable to results reported using higher doses. Low doses of BTX can therefore be used in the treatment of Frey's syndrome, but studies to clarify the dose–response relationship, in terms of both time-course and obtained effect, are needed.

Botulinum toxin A injection for chronic tennis elbow — A potential new mode of treatment

AbstractChronic tennis elbow is not a serious disease but patients may suffer greatly. First studies with injection of Botulinum toxin A (Btx A) have shown promising results.In 18 patients a single dose of Btx A was injected into the origin of the forearm extensors. The site of injection was determined by local tenderness and pain provocation on finger and wrist extension. A significant clinical improvement was seen at two weeks following injection. The effect was noted up to the last follow-up at 14 weeks. Pain, as self-assessed on a visual analogue scale, was also significantly reduced. A significant decrease of muscle strength was only seen for the third finger two weeks after injection. It slowly returned to normal thereafter.A single injection of Btx A seems to be a promising therapy in chronic tennis elbow. It can be carried out in an outpatient setting, and allows the patients to continue working.

A randomised, double-blind, dose-ranging study to evaluate efficacy and safety of three doses of botulinum toxin type A (Botox) for the treatment of spastic foot

Botulinum toxin A (BTX) injections have been used successfully in the treatment of post-stroke foot spasticity, but the optimal dose-response relationship for selected muscles has yet to be established. The aim of this study was to outline beneficial and unwanted effects of three different doses of BTX in the treatment of spastic foot. In this randomised, double-blind, dose-ranging study, 45 spastic feet were randomly allocated to one of three groups, each of which was treated with a different dosage of BTX. The doses were decided on the basis of suggestions in the literature. Outcome measures (Modified Ashworth Scale, Medical Research Council Scale, gait assessment, presence of Achilles tendon clonus, Visual Analogue Scales for Gait Function and Pain, Adverse Effects scale) were applied at baseline, 4 weeks and 4 months after treatment. All the groups showed significant scales scores improvements after treatment with BTX. Group II (mean BTX total dose: 322 U) and Group III (mean BTX total dose: 540 U) showed a greater and more prolonged response than Group I (mean BTX total dose: 167 U). Group III showed the highest rate of adverse effects 4 weeks post-treatment. BTX injections constitute a useful and safe method of improving post-stroke foot spasticity, associated pain, gait speed and function. In particular, the medium BTX dosages (320 UI spread over 2-5 muscles) were found to be both safe and effective in producing long-lasting improvement of spastic foot dysfunction.

Botulinum toxin A in patients with oromandibular dystonia: long-term follow-up.

To study the safety and efficacy of botulinum toxin A (BTX) in patients with oromandibular dystonia (OMD) and to compare the treatment results of the various subtypes of OMD. OMD is one of the most challenging forms of dystonia to treat. Pharmacologic therapies are generally not effective, and there are no surgical alternatives. Of 202 patients diagnosed clinically to have OMD in a movement disorders clinic over a period of 10 years, 162 patients satisfied the study inclusion criteria. The masseters and submentalis complex were the only two muscle groups injected with BTX in this group of patients. The mean age was 57.9+/-15.3 years and the mean follow-up period was 4.4+/-3.8 years. More than half the patients had jaw-closing (JC) dystonia. A total of 2,529 BTX treatments were administered into the masseter muscles, submentalis complex, or both during a total of 1,213 treatment visits. The mean doses of BTX (per side) were 54.2+/-15.2 U for the masseters and 28.6+/-16.7 U for the submentalis complex. The mean total duration of response was 16.4+/-7.1 weeks. The mean global effect of BTX was 3.1+/-1.0 (range, 0 to 4, where 4 equals the complete abolition of the dystonia), with the JC dystonia patients responding best. Fifty-one patients (31.5%) reported adverse effects with BTX in at least one visit. Complications such as dysphagia and dysarthria were reported in 135 (11.1%) of all treatment visits. BTX is a safe and effective long-term treatment for OMD. JC dystonia responds better than jaw-opening or mixed dystonias, and the treatment of the latter types of OMD are more likely associated with dysphagia and dysarthria. Jaw-opening dystonia can be treated successfully by injecting the submentalis complex.

Botulinum toxin type A injection for the treatment of frown lines.

Patients who have exaggerated frown lines frequently ask for treatment because others mistake them to be constantly angry or annoyed. Current treatment options (surgery or implants) do not address the underlying cause of these lines, namely the excessive nerve stimulation. The mechanism of action of BTX makes it an ideal agent to target the major cause of these lines. BTX inhibits calcium metabolism in the presynaptic neuron, thereby inhibiting neuromuscular transmission and producing muscle paralysis. The current medical literature indicates that BTX can be used safely and effectively for the cosmetic treatment of frown lines. The procedure can be performed in an ambulatory setting and the use of an EMG instrument may provide better direction for the placement of the drug. However, the benefits are transient and repeated injections are necessary. The adverse effects associated with BTX injections were mild and transient. Currently, there are no safety data on the long-term effects of continuous BTX injections for the treatment of frown lines. However, studies on the long-term use of BTX at doses to treat blepharospasm and Meige's disease have shown no serious adverse effects or production of antibodies to BTX. Muscle biopsies taken from patients who have received numerous doses of BTX for more than 7 years have not shown any signs of atrophy or permanent muscle degeneration. The medical literature supports BTX therapy as an option for the treatment of cosmetic facial frown lines. However, there is not enough information on what patient characteristics are ideal in a candidate to achieve optimal response with BTX. Also, no data are available on the safety and efficacy of continuous injections in the long-term use of BTX for facial frown lines. Therefore, the use of BTX to treat frown lines should be examined carefully against other therapeutic options.

Development of resistance to botulinum toxin type A in patients with torticollis.

Between 1984 and 1992, 559 patients with torticollis were treated with botulinum toxin type A (btx) injections. Twenty-four of these 559 patients (4.3%) had serological evidence of antibodies to btx by mouse neutralization assay. Some of the 559 patients had only one or two injection series, whereas others were lost to follow-up, so that the actual prevalence of serologically detectable antibodies may be higher than 4%. In addition, some patients who improved after btx injections lost benefit and stopped developing muscle atrophy from adequate doses of btx, without serological evidence of antibodies. To evaluate the risk factors for btx resistance (loss of benefit and muscle atrophy after injections with or without serological evidence of antibodies), we reviewed the records of a cohort of torticollis patients injected over 2-45 months (mean, 23 months) beginning in 1988. Eight of 76 patients (10.5%) developed btx resistance. Compared to nonresistant patients from the same cohort, these eight patients received more frequent injections, had more "booster injections" 2-3 weeks after an initial injection, and received higher doses of btx per treatment. In order to minimize the risk of developing btx resistance, therefore, we recommend that physicians wait as long as possible (at least 1 month) between btx injections, avoid booster injections, and use the smallest possible doses.

Time course of distant effects of local injections of botulinum toxin.

Botulinum toxin A (btx) is used to treat focal dystonias. From accidental intoxications it is known that btx can cause generalized pathologic single-fiber electromyography (SFEMG) findings. We monitored the onset and course of these disturbances in eight patients who received a small dose of btx (2-22 ng) for therapy of focal dystonias in the head/neck region for the first time via repeated SFEMG investigations at days 0, 3, 6, 9, 12, 28, and 56. Recordings were performed in the extensor digitorum brevis muscle, and in two patients additionally in the tibialis anterior muscle. In six of these patients we found an increase of jitter and blocking. The onset of these changes was in the range of 3-13 days after injection. Fiber density showed a tendency to increase. There was no correlation between SFEMG findings and the dose of injected btx. Possible mechanisms for these observations may be either a very efficient local uptake and retrograde axonal transport via the spinal motor neurons or a systemic distribution via the blood circulation.