Botulinum Neurotoxin Type A Treatment Research Articles

Multimodal Physiotherapy as an Add-On Treatment to Botulinum Neurotoxin A-Therapy in Patients with Cervical Dystonia

<b>Background:</b> The treatment of choice for cervical dystonia comprises a local injection of botulinum neurotoxin type A (BoNT-A). Whether additional physiotherapy can achieve better results is not clearly documented in the literature. The present study aims to show possible effects of physiotherapy as an add-on treatment to therapy with botulinum neurotoxin type A in terms of pain, severity of dystonia, statics and function of the cervical spine as well as the quality of life in order to optimize the treatment of cervical dystonia. <b>Design/Methods:</b> This is a prospective, single-center, interventional study of a target patient population comprising 20 participants. The study is divided into 2 phases, with each phase lasting for 3 months. During the first phase, the usual BoNT-A will be applied. In addition, the baseline values will be collected and these assessments will be repeated at an interval of 6 weeks. In the second phase, participants will undergo a physiotherapy program consisting of two 45 min sessions per week in addition to the BoNT-A treatment. The assessments will be undertaken at the same intervals as in the first phase. <b>Analysis:</b> In order to determine the effect of the add-on physiotherapy program, the following parameters will be measured for each assessment: quality of life using the SF- 36 score and the range of motion determined by the ZEBRIS measurement system which will comprise the primary endpoints. Furthermore, for each assessment the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and electrical activity from the trapezius and the sternocleidomastoid muscles measured by a surface electromyography will be recorded. Descriptive statistical analysis will be performed for all of the collected data. Possible changes in the measured values will be compared to the baseline values over the 2 periods by means of the Wilcoxon-test at a significance level of p<0.05. For the statistical analysis the software SPSS 22.0 will be used. <b>Trial registration:</b> Deutsches Register Klinischer Studien: DRKS00006562

Transurethral intraprostatic injection of botulinum neurotoxin type A for the treatment of chronic prostatitis/chronic pelvic pain syndrome: results of a prospective pilot double-blind and randomized placebo-controlled study.

To evaluate the effect of botulinum neurotoxin type-A (BoNT-A) on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refractory to medical therapy. Between November 2011 and January 2013, 60 men aged ≥18 years with CP/CPPS, and with National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) scores ≥10 and pain subscale scores ≥8, who were refractory to 4-6 weeks' medical therapy, underwent transurethral intraprostatic injection of BoNT-A or normal saline in a prospective pilot double-blind randomized study. The patients' NIH-CPSI total and subscale scores, American Urological Association (AUA)-symptom score (SS), visual analogue scale (VAS) and quality of life (QoL) scores and frequencies of diurnal and nocturnal urination were evaluated and compared at baseline and at 1, 3 and 6 months after injection and also were compared between the two groups. A total of 60 consecutive patients were randomized to a BoNT-A (treatment) or normal saline (placebo) group. In the treatment group at the 1-, 3- and 6-month evaluation the NIH-CPSI total and subscale scores, and the AUA-SS, VAS and QoL scores, along with frequencies of diurnal and nocturnal urinations, had significantly improved compared with baseline values (P < 0.05). By contrast, in the placebo group, none of these values showed improvement and the values were significantly different from those in the treatment group. Although the differences between the two groups in AUA-SS and frequencies of nocturnal urination were not significant at 1-month follow-up, repeated-measure analysis showed significant improvement in each of these values over the entire follow-up period in the treatment group. The most prominent improvement was related to the pain subscale score, which decreased by 64.76, 75.63 and 79.97% at 1, 3 and 6 months after treatment compared with baseline, followed by the VAS score, which decreased by 62.3, 72.4 and 82.1% at each follow-up, respectively. Only two patients developed mild transient gross haematuria, which was managed conservatively. Transurethral intraprostatic BoNT-A injection maybe an effective therapeutic option in patients with CP/CPPS as it reduces pain and improves QoL.

Cost analysis of the use of botulinum toxin type A in Spain

To estimate treatment costs of blepharospasm, cervical dystonia(CD), upper limb spasticity (ULS) and spasticity in children with cerebral palsy (SCCP) with botulinum neurotoxin type A (BoNT-A) in Spain. Annual BoNT-A treatment costs were calculated (2013 ex-factory price () applying RDL 8/2010 and RDL 9/2011 deductions), based on initial dose (id), average dose (ad) and maximum dose (md) according to Summary of Product Characteristics of Botox® (100U/50U), Dysport®(500U) and Xeomin® (100U) and considering the use of complete vials.In addition, annual treatment costs were calculated considering the useof vials in more than one patient and also patient population annual treatment costs based on diseases' prevalence. Annual BoNT-A treatment costs per patient were estimated at between 265 and 2,120 with savings from 10% to 55% accordingto the selected BoNT-A. CD and ULS treatment provided the greatest cost per patient. Botox® provided greater savings in ULS (id/ad), CD(id), and in blepharospasm and SCCP (id/ad/md). Dysport® treatment was less costly in CD (md) and ULS (md), while Xeomin® was in CD(ad). Based on the estimated treated population in Spain, the annual treatment costs ranged from 368,392 to 13,958,836 depending on indication, dose and BoNT-A considered. The appropriate BoNT-A choice would lead to considerable savings for the National Health System. Botox® would generate lower costs per patient than other BoNT-A products in 9 out of 12 scenarios considered.

Time Course Analysis of the Effects of Botulinum Neurotoxin Type A on Pain and Vasomotor Responses Evoked by Glutamate Injection into Human Temporalis Muscles

The effect of botulinum neurotoxin type A (BoNTA) on glutamate-evoked temporalis muscle pain and vasomotor responses was investigated in healthy men and women over a 60 day time course. Subjects participated in a pre-BoNTA session where their responses to injection of glutamate (1 M, 0.2 mL) and saline (0.2 mL) into the temporalis muscles were assessed. On Day 1, BoNTA (5 U) was injected into one temporalis muscle and saline into the contralateral temporalis muscle, in a randomized order. Subjects then received intramuscular injections of glutamate (1 M, 0.2 mL) into the left and right temporalis muscles at 3 h and subsequently 7, 30 and 60 days post-injection of BoNTA. Pain intensity, pain area, and neurogenic inflammation (skin temperature and skin blood perfusion) were recorded. Prior to BoNTA treatment, glutamate evoked significantly greater pain and vasomotor reactions (P < 0.001) than saline. BoNTA significantly reduced glutamate-evoked pain intensity (P < 0.05), pain area (P < 0.01), skin blood perfusion (P < 0.05), and skin temperature (P < 0.001). The inhibitory effect of BoNTA was present at 3 h after injection, peaked after 7 days and returned to baseline by 60 days. Findings from the present study demonstrated a rapid action of BoNTA on glutamate-evoked pain and neurogenic inflammation, which is in line with animal studies.

The effects of botulinum toxin injection frequency on calf muscle growth in young children with spastic cerebral palsy: A 12-month prospective study

This study was a 12-month prospective investigation of changes in the medial gastrocnemius (MG) muscle morphology in children aged 2-5years with spastic cerebral palsy (CP) who had received no previous intramuscular injections of botulinum neurotoxin type-A (BoNT-A) and were randomised to receive either single or multiple (three) BoNT-A injections to the gastrocsoleus. MG morphological changes were compared to age-matched typically developing (TD) peers. Thirteen children with spastic CP with a mean age of 45 (15) months and 18 TD children with a mean age of 48 (14) months participated in the study. The principal outcome measures were MG muscle volume, fascicle length, pennation angle and physiological cross-sectional area (PCSA), which were obtained using 2D and 3D ultrasound. The single and multiple injection frequency groups significantly increased MG muscle volume at 12months relative to the baseline by 13 and 15%, respectively. There were no significant differences in the MG muscle volume 28.5 (12.3) versus 30.3 (3.8)ml, fascicle length 48.0 (10.4) versus 44.8 (1.2)mm or PCSA 7.0 (1.2) versus 6.6 (1.7)cm(2) between the single and multiple injection groups, respectively, at 12months follow-up. The change in MG muscle volume in the single and multiple injection groups was significantly lower than the TD peers by 66 and 60%, respectively. In young children with spastic CP, naive to BoNT-A treatment, MG muscle growth over 12months does not appear to be influenced by intramuscular BoNT-A injection frequency. However, MG muscle growth in the spastic CP groups was significantly lower than the age-matched TD peers. It is unclear whether this is an effect of intramuscular BoNT-A injections or reduced growth rates in children with spastic CP in general. Controlled investigations and longitudinal studies with multiple measurement time points are required in order to determine the influence of BoNT-A treatment on muscle physiological and mechanical growth factors in young children with spastic CP.

Use of botulinum neurotoxin A in uncontrolled salivation in children with cerebral palsy: a pilot study

This study investigated the safety and efficacy of botulinum neurotoxin type-A (BNT-A) injections into the salivary glands for treatment of sialorrhea in children with cerebral palsy (CP) and assessed the clinical factors that affect treatment outcome. The parotid and submandibular glands of nine CP patients were injected with BNT-A 1.4U/kg in each parotid gland, and 0.6U/kg in each submandibular gland. All children had neurological disorders. Gross motor function classification system levels ranged from I to V. All children had moderate to severe intellectual disability. A telephone interview with one parent determined response to treatment. Drooling intensity and frequency were measured with the drooling severity and frequency scale. After BNT-A treatment, the patients were followed up for 6 months using self-assessed rating scales for drooling intensity, discomfort and treatment effect (drooling impact scale). All parents reported an improvement in sialorrhea in the first week. Drooling was very intensive at baseline, and moderate 2 weeks after treatment. Maximum response occurred at 2–8 weeks. The use of BNT-A in uncontrolled salivation in children with CP can be considered acceptable and effective. Malocclusion and anterior salivation are closely related clinical characteristics and should be taken into account when planning treatment.

Reduction of TRPV1 expression in the trigeminal system by botulinum neurotoxin type-A

Botulinum neurotoxin type-A (BoNT-A) is clinically used for patients with pain disorders and dystonia. The precise mechanism whereby BoNT-A controls pain remains elusive. Here, we studied how BoNT-A affects the expression of the transient receptor potential vanilloid subfamily member 1 (TRPV1), a cation channel critically implicated in nociception, in the trigeminal system. Histological studies revealed that subcutaneous BoNT-A injection (0.25, 0.5, or 5ng/kg) into the face targeted the ophthalmic division of trigeminal ganglion (TG) neurons and decreased TRPV1-immunoreactive neurons in the TG and TRPV1-immunoreactive fibers in rat trigeminal terminals. Of note, TG neurons that received projections from the dura mater, a principal site of headache generation, had reduced TRPV1 expression. BoNT-A-induced cleavage of SNAP25 (synaptosomal-associated protein of 25-kDa) in the TG became obvious 2days after BoNT-A administration and persisted for at least 14days. Quantitative real-time RT-PCR (reverse transcription-polymerase chain reaction) data indicated that the TRPV1-decreasing effects of BoNT-A were not mediated by transcriptional downregulation. By employing a surface protein biotin-labeling assay, we demonstrated that BoNT-A inhibited TRPV1 trafficking to the plasma membrane in primary TG neurons. Moreover, Y200F-mutated TRPV1, which is incapable of trafficking to the plasma membrane, was expressed in PC12 cells by transfection, and pharmacological studies revealed that TRPV1 in the cytoplasm was more predisposed to proteasome-mediated proteolysis than plasma membrane-located TRPV1. We conclude that the mechanism by which BoNT-A reduces TRPV1 expression involves the inhibition of TRPV1 plasma membrane trafficking and proteasome-mediated degradation in the cytoplasm. This paradigm seems to explain how BoNT-A alleviates TRPV1-mediated pain. Our data reveal a likely molecular mechanism whereby BoNT-A treatment reduces TRPV1 expression in the trigeminal system and provide important clues to novel therapeutic measures for ameliorating craniofacial pain.

Efficacy and Safety of Long-term Botulinum Toxin Treatment in Craniocervical Dystonia: A Systematic Review

Botulinum neurotoxins have been shown to be a safe and effective therapeutic option for most forms of focal dystonia, and are now considered to provide the best symptomatic treatment in these disorders. However, only a few papers addressed the long-term efficacy and safety of repeated treatments with this drug. This article reviews the data from clinical trials that have assessed the long-term results of botulinum neurotoxin type A (BoNT-A) and type B in the treatment of the different forms of focal craniocervical dystonia, cervical dystonia (CD), blepharospasm, oromandibular, and laryngeal dystonia. Studies on the long-term effects of BoNT-A therapy have demonstrated that the majority of patients comply with this repeated treatment because they experience a positive and stable effect over time. It is still unclear whether in patients with focal dystonia the mean dose of BoNT-A changes over time. In spite of the wide spectrum of side effects reported to be associated with BoNT-A treatment, there is no evidence of specific side effects due exclusively to the long-term use of such drugs. The only exception to these positive long-term findings is the occurrence of a subgroup of patients with CD who fail to maintain a sustained response after the first or second effective treatment, partly owing to the development of neutralizing antibodies against the toxin. Longitudinal studies aimed at defining the risk factors for this abnormal pattern of response to botulinum toxin treatment are currently being conducted.

Urinary incontinence in children: botulinum toxin is a safe and effective treatment option

This study's aim was to assess the use of intravesical injection of botulinum neurotoxin type A (BoNT-A) as a treatment of overactive bladder (OAB) in children. A 6-year retrospective study of children who received BoNT-A for OAB was performed. Treatment outcome was classified as complete success (CS), partial success (PS) or treatment failure (TF). Of the 57 patients who received BoNT-A treatment for OAB, 35 were males. CS occurred in 74.2% of males and 54.5% of females. PS was achieved in 20% of males and 18.2% of females. TF occurred in 2.9% of males and 22.7% of females. Anticholinergics had previously been used and had been effective in 58.6% and 83.3% of males and females. Significant side effects to medications were experienced in 12 (41.4%) males and 4 (22.2%) females. Of these, BoNT-A achieved CS in seven (53.3%) males and two (50%) females and PS in three (25%) males and one (25%) female. BoNT-A was successful in seven (58.3%) males and two (66.7%) females where anticholinergics were ineffective. BoNT-A has a role in a carefully selected subgroup of children with overactive bladder symptoms including those with medication side effects and treatment compliance issues. It may have a role in patients who do not respond to conventional therapy.

Botulinum Neuro-Toxin Type-A In The Treatment Of Chronic Tension Type Headache Associated With Pericranial Tenderness

Both peripheral and central nociceptive mechanisms are responsible in chronic TTH. Analgegics are used in the acute treatment of chronic TTH and antidepressants are used in prophylactic treatment. However, further studies are needed to bring out new treatment options. The aim of our study is to investigate the effectiveness of Botulinum Neuro-toxin Type-A (BoNTA) in the treatment of chronic TTH associated with pericranial tenderness (PT). 14 patients with chronic TTH with PT were included in the study. 50 units Botox(®) injection was applied to the pericranial muscles (5 units for each muscles bilaterally: frontal, temporal, semispinalis capitis, spenius capitis and trapezius muscles) for each patient. Severity of headache was evaluated by VAS (Visual Analogue Scale) and number of days with headache per month were recorded before treatment and 2nd and 4th months after treatment. Number of days with headache per month were 19.57 ± 3.25 before treatment, 15.28 ± 4.37 at the 2nd month after treatment and 15.78 ± 3.90 at the 4th month after treatment. Severity of headache was 65.71 ± 9.16 before the treatment, 50.71 ± 13.56 at the 2nd month after treatment and 54.28 ± 10.35 at the 4th month after treatment (p<0.05). Frequency and severity of headache before treatment were significantly decreased at the 2nd month after treatment and this significance continued at the 4th month after treatment (p<0.05). BoNTA treatment may be usefull in the treatment of patients with chronic TTH associated with PT.

Evolution of dose and response to botulinum toxin A in cervical dystonia: a multicenter study

Botulinum neurotoxin (BoNT) is an effective treatment for cervical dystonia (CD). Long-term changes of several variables, including the dose of BoNT, in these patients is largely unknown. We reviewed the clinical charts of 275 patients with CD treated with BoNT type A (BoNT-A) for at least 5 years since 1989 at ten tertiary centers. The mean dose of BoNT-A per session during the first 5 years of treatment was calculated and the appearance of resistance was noted. The dose of BoNT-A for the whole group showed a significant trend to increase over time (year 1: 180 ± 65 U; year 5: 203 ± 63 U; ANOVA: p < 0.0001). However, when we studied the evolution of the dose of BoNT-A for those patients (n = 49) first injected after 2000 (introduction of current BOTOX preparation in our country), there was no significant increase in dose (year 1: 181.8 ± 75 U; year 5: 181.7 ± 75 U; ANOVA p: ns). A total of 19 patients became secondary nonresponders; all but one of these patients began BoNT-A treatment before 2000. In summary, there is a statistically significant increase of mean dose of BoNT-A per session over time, and this could be explained by the appearance of secondary nonresponders. On the other hand, those patients initially treated after 2000 did not show any statistically significant increase in dose for 5 years. This could be explained by better experience and techniques, fewer immunogenic problems with the current BoNT-A, and also less variability of the dose per vial.

In the Human Urothelium and Suburothelium, Intradetrusor Botulinum Neurotoxin Type A Does Not Induce Apoptosis: Preliminary Results

BackgroundIntradetrusor injections of botulinum neurotoxin type A (BoNTA) are emerging as the preferred second-line treatment for neurogenic and idiopathic overactive bladder (OAB). In animal experiments, intradetrusor BoNTA injections have been shown to cause apoptosis in the bladder urothelium and suburothelium but not the detrusor. ObjectiveTo investigate BoNTA-induced apoptosis in patients with refractory neurogenic OAB. Design, setting, and participantsTwelve refractory OAB patients with neurogenic detrusor overactivity resulting from multiple sclerosis (MS) and seven controls were included prospectively. MeasurementsThe number of apoptotic cells before and 4 wk after first intradetrusor BoNTA (300 U of BOTOX [Allergan, Irvine, CA, USA]) injections were estimated using terminal deoxynucleotidyl transferase-mediated dUTP nick-end labelling (TUNEL) staining. Results and limitationsComparison of TUNEL-positive cells (yes vs no) in the bladder urothelium and suburothelium revealed no significant differences in OAB patients before (4 of 12, 33%) versus after (3 of 12, 25%) BoNTA treatment (p=0.99). In addition, no significant differences (p=0.99) were found in OAB patients versus controls. Because our findings are based on first intradetrusor BoNTA injections only, it is unclear whether the results could be extrapolated to repeat injections. ConclusionsIn contrast to preliminary animal experiments, first intradetrusor BoNTA injections for treating refractory neurogenic OAB—a highly effective treatment—did not induce apoptosis in the bladder urothelium and suburothelium.

Complete Continence after Botulinum Neurotoxin Type A Injections for Refractory Idiopathic Detrusor Overactivity Incontinence: Patient-Reported Outcome at 4 Weeks

BackgroundObjective improvement following intradetrusor injections of botulinum neurotoxin type A (BoNTA) is well documented. Although patient-related outcome measures are highly recommended for monitoring overactive bladder symptoms, no study before has dealt with the question of patient-reported complete continence after BoNTA treatment using validated questionnaires. ObjectiveTo investigate the change in patient-reported continence rate after intradetrusor injections of BoNTA for treatment of refractory idiopathic detrusor overactivity (IDO) incontinence. Design, setting, and participantsSeventy-four patients (51 women, 23 men) with refractory IDO incontinence treated for the first time with intradetrusor injections of 200 U BoNTA were evaluated in this nonrandomised, open-label, cohort study. MeasurementsChanges in patient-reported urinary frequency, urgency incontinence, and stress incontinence were assessed using the condition-specific validated short form of the Urogenital Distress Inventory (UDI 6) before and 4 wk after BoNTA treatment. Results and limitationsThe patient-reported outcome of complete continence (defined as a score of 0 in both the urgency and stress incontinence subscales of the UDI 6) was 51% (38 of 74) 4 wk after intradetrusor injections of BoNTA. In patients who were not completely continent, median urgency incontinence scores reduced significantly from 100 to 0 (p<0.001), stress incontinence scores from 33 to 0 (p<0.001), and median urinary frequency scores from 100 to 33 (p<0.001), respectively. The inclusion of patients with mixed incontinence may have resulted in underestimation of the complete continence rate. ConclusionsAn excellent response with >50% of patients reporting complete continence 4 wk after BoNTA treatment reveals the efficacy of this emerging treatment for patients with refractory IDO incontinence. Furthermore, in those in whom complete continence was not achieved, there was a notable and significant reduction in reported urgency incontinence, stress incontinence, and urinary frequency.

Suburothelial Myofibroblasts in the Human Overactive Bladder and the Effect of Botulinum Neurotoxin Type A Treatment

BackgroundAn increasing body of evidence suggests a possible role of suburothelial myofibroblasts (MFs) in bladder mechanosensation and in the pathophysiology of detrusor overactivity (DO). ObjectiveTo determine whether markers of MFs, including gap junction protein connexin43 (Cx43) and c-kit have altered immunohistochemical expression in the suburothelium of patients with neurogenic DO (NDO) or idiopathic DO (IDO) and whether this is affected by successful treatment of DO with botulinum neurotoxin type A (BoNTA). Design, setting, and participantsPatients with NDO (n=10) or IDO (n=11) were treated in a single-centre, open-label study of intradetrusor BoNTA injections. Control tissue was obtained from 10 patients undergoing pelvic-floor repair procedures who had no overactive bladder (OAB) symptoms. This study is registered with ClinicalTrials.gov, number NCT00662064. InterventionsBladder biopsies performed with flexible cystoscopes were obtained from control subjects and from NDO and IDO patients before BoNTA treatment and at 4 wk and 16 wk after treatment. They were studied with quantitative immunofluorescence using antibodies to connexin 43 (Cx43), vimentin, and c-kit. MeasurementsDifferences in Cx43, vimentin, and c-kit immunoreactivity between control subjects and NDO or IDO patients (primary outcomes). Changes in NDO or IDO, Cx43 immunoreactivity, and c-kit immunoreactivity after BoNTA treatment (secondary outcomes). Results and limitationsCx43 immunoreactivity was increased in both IDO and NDO patients compared to controls, but remained unchanged after BoNTA treatment. C-kit immunoreactivity was similar in NDO/IDO patients and controls and remained unchanged after BoNTA treatment. ConclusionsIncreased gap junction formation in the suburothelium has been demonstrated in biopsies from humans with DO. It is hypothesised that this change could have a significant role in the pathogenesis of the detrusor abnormality. Successful treatment of NDO or IDO does not appear to be associated with changes in the expression of Cx43 or c-kit on suburothelial MFs.

The Analgesic Effect of Botulinum-toxin A on Postwhiplash Neck Pain

The effectiveness of botulinum neurotoxin type A (BTXA) injections in relieving the neck pain and reduced motion that evolve after whiplash injury (WI) has been controversial. To test the long-term efficacy of a tender point injection of BTXA in relieving neck pain in patients with WI. Twenty patients with cervical myofascial pain, 2 to 48 weeks after WI, were randomly assigned to receive either 200 U of BTXA or placebo at 4 tender points and were seen during the follow-ups 3, 6, 9, 12, and 24 weeks after the injections. Outcome measures included the intensity of pain as evaluated by a 10-cm Visual Analog Scale (VAS) and a 5-point Verbal Rating Scale (VRS), quality of life as evaluated by the SF-36 questionnaire, treatment efficacy as per the global assessment of the physician and patient, intensity of pain in response to mechanical pressure, range of cervical motion, and use of other therapies and their adverse effects. A time-dependent improvement in all the parameters was found in both groups, which was consistently larger in the BTXA-treated group, but mostly not at a significant level. Significant differences between the groups were found only in the percentages of patients who achieved 50% or more of reduction in intensity (VAS and average VRS) at 24 weeks (50% vs. 0%, P>0.05 and 70% vs. 11%, P>0.05, respectively). Systemic adverse effects tended to be more common in the BTXA-treated group (40% vs. 0%, P=0.07). Study results suggest that BTXA treatment has some efficacy when administered within 1 year of the WI. However, a large, well-designed clinical trial is needed to draw final conclusions.

Botulinum Toxin Type A Treatment of Multiple Upper Facial Sites

Aesthetic treatment planning must address subjects' goals and include subject-reported outcomes. The objective was to compare the effect of botulinum neurotoxin type A (BoNTA) with placebo on subject-reported outcomes and to assess the utility of 64 U of BoNTA to treat the entire upper face. Forty female subjects were randomized to receive 64 U of BoNTA or identical placebo injections (double-masked) divided among 16 sites of the upper face and were followed for 12 weeks. Subjects unimproved at Week 4 were eligible for open-label BoNTA treatment and were followed through Week 16. Main outcome measures were scores on seven items of the Facial Line Outcomes Questionnaire (FLO-7) and results on the Self-Perception of Age (SPA) for assessing age of appearance relative to actual age. BoNTA treatment resulted in significant improvements on the FLO-7 scores that were maintained throughout the study. BoNTA treatment also reduced age of appearance in a majority of subjects. Placebo had no effects on any measure. No serious adverse events occurred. Sixty-four-unit BoNTA treatment of upper facial rhytids safely and significantly improves subject-reported outcomes, as measured by the FLO-7 and SPA, and results in a younger, more satisfying, relaxed appearance.

Botulinum-A toxin: an exciting new treatment option for prostatic disease

Recently, botulinum neurotoxin type A (BoNT-A) application in the lower urinary tract has been extended to prostate disorders and we would like to review the literature on the mechanisms of action and clinical efficacy of BoNT-A treatment in the prostate. The information was gathered from MEDLINE, abstracts from recent urological meetings and from personal experience. BoNT has demonstrated promising preliminary results for male prostatic disease and translational research suggests a novel mechanism of action of BoNT in the prostate. It is important to remember that the application of BoNT in the prostate is not approved by the regulatory agencies and caution should be applied until larger randomised clinical studies are completed.