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The aim of the present study was to investigate the effect of botulinum toxin type A (BTX-A) injection in the lateral pterygoid (LP) muscle on temporomandibular joint (TMJ) clicking. The study enrolled seven patients with a total of 11 joints; all patients were stage I or II of Wilke's staging for internal derangement. BTX-A was injected in the ipsilateral LP muscle with electromyogram (EMG) guidance and the subjects were assessed for 4 months. Maximum inter-incisal opening, range of lateral movement, and the presence of a click were recorded throughout the follow-up period, and magnetic resonance imaging (MRI) was ordered at the end of the 4 months. The results showed that the decrease in inter-incisal opening and side to side movement immediately postoperative was statistically significant, while the difference by the end of the follow-up period was insignificant. MRI showed a marked improvement in disc position postoperatively. It may be concluded that BTX injection in the LP muscle leads to the disappearance of joint clicking clinically and a significant improvement in disc position as shown on MRI.
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There was no significant difference between verum and placebo in a mixed linear model analysis (p = 0.084) with regard to the primary end-point, reduction of days with moderate to severe headache. Six patients withdrew from the study before the second injections, but an intention-to-treat (ITT) analysis gave a similar result (p = 0.27). There were no significant differences favouring verum in any of the secondary efficacy measures. Side-effects of onabotulinum toxin A were minor and short-lasting.
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Piriformis Muscle Syndrome (PMS) is caused by sciatic nerve compression in the infrapiriformis canal. However, the pathology is poorly understood and difficult to diagnose. This study aimed to devise a clinical assessment score for PMS diagnosis and to develop a treatment strategy.
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Language can impact emotion, even when it makes no reference to emotion states. For example, reading sentences with positive meanings ("The water park is refreshing on the hot summer day") induces patterns of facial feedback congruent with the sentence emotionality (smiling), whereas sentences with negative meanings induce a frown. Moreover, blocking facial afference with botox selectively slows comprehension of emotional sentences. Therefore, theories of cognition should account for emotion-language interactions above the level of explicit emotion words, and the role of peripheral feedback in comprehension. For this special issue exploring frontiers in the role of the body and environment in cognition, we propose a theory in which facial feedback provides a context-sensitive constraint on the simulation of actions described in language. Paralleling the role of emotions in real-world behavior, our account proposes that (1) facial expressions accompany sudden shifts in wellbeing as described in language; (2) facial expressions modulate emotional action systems during reading; and (3) emotional action systems prepare the reader for an effective simulation of the ensuing language content. To inform the theory and guide future research, we outline a framework based on internal models for motor control. To support the theory, we assemble evidence from diverse areas of research. Taking a functional view of emotion, we tie the theory to behavioral and neural evidence for a role of facial feedback in cognition. Our theoretical framework provides a detailed account that can guide future research on the role of emotional feedback in language processing, and on interactions of language and emotion. It also highlights the bodily periphery as relevant to theories of embodied cognition.
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We evaluated the efficacy of Botulinum toxin type A (BTXA) as an alternative to surgical intervention to facilitate phonation in 34 laryngectomized patients (31 males and 3 women) who were unable to produce tracheoesophageal voice because of spasm of the middle and inferior pharyngeal constrictor muscles (PCM). EMG was recorded to confirm activity in these muscles during attempted vocalization. Parapharyngeal nerve block (Carbocaine 2%, 5 cc) was used to demonstrate short-term fluent voice after relaxation of the pharyngeal constrictor muscle. At a later occasion, 100 U of Botox (Allergan) in ten patients and 50 U in two patients were injected unilaterally at one location in the PCM percutaneously under EMG guidance. All patients then underwent a voice therapy program. In 11 out of 12 patients an improvement of phonation was evident after 24-48 h and it was long lasting. This result was also seen in a patient previously myotomized without improvement. Only one patient needed to be reinjected every 3 months. At a follow-up after 3 months the EMG recorded in four patients showed a low-amplitude or complete absence of activity in the treated muscle. No side effects developed. BTX therapy, especially when associated with the speech therapy, is efficacious in restoring voice to laryngectomees who are unable to voice because of spasm of the PCMs. Our results confirm previous reports. This method is our approach of choice in managing PCM spasm because it is non-invasive, not painful, has few or no side effects, and is frequently long-lasting.
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Within the first week, 78 percent of patients were free of pain. In 82 percent of patients, complete healing of the fissure occurred within the first three months. Eight patients experienced relapses within the first six months of therapy, three of whom needed surgical intervention. The healing rate after six months was 79 percent. No healing occurred in 21 patients, and they had to undergo surgery. Transitory fecal incontinence resulted in seven cases.
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12 28-day-old Wistar rats were divided into two groups as Botox group (n= 6) and control group (n = 6) which received anesthesia only. In Botox group, Botox was injected into the right masseter muscle, while only sterile saline into the left muscle. When the rats were 75-day-old, CT scan and 3D reconstruction were performed for cephalometry. The masseter muscles at both sides were weighed. Histologic study of masseter muscle and mandible was also performed.
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OT enhanced individualized functional outcomes following BTX-A injections in the upper limbs of children with CP.
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Esophageal achalasia is a primary motility disorder characterized by impaired lower esophageal sphincter relaxation and absence of esophageal peristalsis leading to impaired bolus transit, manifested with symptoms such as dysphagia, regurgitation, retrosternal pain, and weight loss. The standard diagnostic tool is esophageal manometry which demonstrates incomplete relaxation of the lower esophageal sphincter and impaired esophageal peristalsis. Recently, a new advanced technique, high-resolution manometry (HRM) with the addition of pressure topography plotting, using multiple sensors to capture the manometric data as a spatial continuum, allows a detailed pressure recording of the esophageal motility. This technique, currently the gold standard for the diagnosis of achalasia, has led to a subclassification of three manometric types that seem to have different responsiveness to treatment. Because its pathogenesis is as yet unknown, achalasia treatment options are not curative. Type II achalasia patients respond better to treatment compared to those with types I and III. Low-risk patients with type I or II achalasia have good outcome with both graded pneumatic dilatations and laparoscopic Heller myotomy, while type III achalasia patients respond better to laparoscopic Heller myotomy. Although, type III achalasia patients responds less in comparison to types I and II to laparoscopic Heller myotomy. Peroral endoscopic myotomy is a promising new technique but long-term follow-up studies for its safety and efficacy must be performed. This article reviews the current therapeutic options, highlighting the impact of HRM to predict the outcome and the new insights for the treatment of achalasia.
This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U (CFL only; n = 227) or 44 U (24 U for CFL + 20 U for GL; n = 260) to retreatment with the same dose. Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U (n = 101) or placebo (n = 96). Primary efficacy end point (Day 30) was the proportion of subjects who achieved a CFL severity rating of none or mild (maximum smile) on the investigator-assessed Facial Wrinkle Scale (FWS). Additional efficacy end points and adverse events were evaluated.
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Botulinum toxin type A (BoNT-A) has been recently suggested as prophylaxis therapy for the treatment of primary headache chronic forms. Several studies on its efficacy are available, but results are often contradictory and not univocal. The effects of BoNTA on chronic forms of both tension- type headache and migraine have been investigated. In this study we introduce our five-year long experience with BoNT-A (Botox, Allergan, Irvine, CA). The employed dosage was 100 U and the Fixed Sites-Fixed Doses (FSFD) protocol was used. The period of study was April 2001 to July 2006. A sum of 1347 patients suffering from chronic daily headache (CDH) were treated. We registered in these patients the number of headache days per month and observed their reduction in relation to the number of injections. The best results were found after 12 months of treatment, with patients being free of attacks 23 days per month. The BoNT-A treatment was safe and well tolerated, as only 1.6% of patients reported adverse events, and they were all mild and transient. In conclusion, BoNT-A therapy appears to be an efficacious new therapeutic choice in the prophylaxis of CDH, especially for patients not responding to previous prophylactic treatments.
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All 115 patients completed the study. Mean pretreatment brow height was 18.59 mm at the right lateral canthus and 18.55 mm at the left lateral canthus. After treatment, the mean brow height was 21.91 mm on the right site and 21.89 mm on the left site. The decrease in discrepancy between the right and left brow heights resulting from symmetrical Botox treatment was statistically significant (P < .01). In 83 of 115 patients (72.1%), treatment was successful, with success defined as posttreatment asymmetry of either 0 or 1 mm.
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The mean reduction of hyperhidrotic area was 29.9 cm(2) (range, 27-43 cm(2)), corresponding to a reduction of 78.5%. Apart from painful injections, no side effects were observed.
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The number of treatments per patient ranged from 1 to 7. Statistically significant improvements in mean total and domain V-RQOL scores were calculated for every injection (P<.01) (no postinjection questionnaires were available for the seventh injections). The magnitude of the effect remained constant for later injections. Eighty-two percent of the population recorded at least 1 category of improvement in overall self-assessed voice rating with each injection.
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A double-blind study was performed on 212 consecutive patients (58 men, 154 women) with essential blepharospasm, who received one injection of Botox and one injection of Dysport in two separate treatment sessions (at the first session the patients randomly received one of the drugs, at the second the other drug was given. The patients' mean age was 66.4 years +/- 8.14 (range 39-86 years). The average dose of Botox per treatment was 45.4 IU +/- 13.3 (range 25-85 IU) and of Dysport 182.1 IU +/- 55.1 (range 100-340 IU). We used an empirical ratio Botox:Dysport of 1:4 (IU) in order to ensure equal doses. All patients had received botulinum toxin injections prior to the present study (mean 15.3 injections +/- 9.4; range 1-43 injections). The effect of Botox lasted 7.98 weeks +/- 3.8 (range 0-16 weeks), while the effect of Dysport lasted 8.03 weeks +/- 4.6 (range 0-22 weeks). Side effects (ptosis, tearing, blurred vision, double vision, hematoma, foreign body sensation) were observed with Botox in 36 of 212 (17.0%) of the treatment sessions and with Dysport in 51 of 212 sessions (24.1%). Ptosis was observed with Botox in 3 cases (1.4%) and with Dysport in 14 cases (6.6%). There was no statistically significant difference in the duration of the treatment effect between the two preparations (P = 0.42). The total number of side effects was lower with Botox than with Dysport; the significance of the difference was moderate (P < 0.05). However, the rate of occurrence of ptosis was significantly lower with Botox (P < 0.01). The bioequivalence, which varies between 1:3 and 1:6 (Botox:Dysport) in the literature, was found to be 1:4 in this study.
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Variability in self-ratings of the V-RQOL suggest that perceived disability related to AdSD should be actively monitored. Further, auditory-perceptual judgments may provide an accurate index of the potential impact of the disorder on the speaker. Similarly, LO was supported as a simple clinical measure that serves as a reliable index of voice change over time.
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Botulinum toxin (Botox) injection into the lower esophageal sphincter (LES) has been used for the treatment of achlasia cardia since the 1990s. Currently it is indicated for patients who are not candidates for definitive therapy like Heller's myotomy or pneumatic dilation and in those who have recurrence of symptoms after definitive treatments. We present a case of severe anaphylaxix due to Botox. The purpose of this case is to highlight one of the under-reported adverse effects of Botox. Anaphylactic reactions to Botox are very rare with only one other case being reported and have not been emphasized enough to be widely known in clinical practice.
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Children with neurogenic hyper-reflexive bladder in whom classical therapy with anticholinergic drugs and intermittent catheterization fails are threatened by high intravesical pressure, vesicoureteral reflux, and impairment of kidney function. Surgery, such as bladder augmentation, is often necessary in such cases. To obviate surgery in these high-risk children, we investigated the use of detrusor injection of botulinum-A toxin (Botox).
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Thirteen patients met the study criteria. Eleven were female patients and had a diagnosis of multiple sclerosis. Sixty-five injection sessions involved >360 units of onabotulinumtoxinA administered within a 90-day interval. Median interval between injections was 54 days (interquartile range [IQR], 30-71 days) and median dose administered was 800 units (IQR, 600-1000 units). Seventy injection sessions involved <360 units of onabotulinumtoxinA administered >90 days after prior injection. Median interval between these injections was 113 days (IQR, 97-158 days) and median dose administered was 200 units (IQR, 100-300 units). The maximum cumulative dosage injected was 1900 units (1500 units for lower extremities and 400 units for bladder). This patient did not experience any AE. There was a total of 6 AEs (general and/or extremity weakness or leg pain) that occurred in 4 patients, of a total of 183 injection sessions. These AEs all eventually resolved. There were no life-threatening AEs in either group.
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Bladder injection of BoNTA (predominantly 200 U onabotulinumtoxinA; Allergan Ltd., Marlow, Buckinghamshire, UK) in an outpatient setting.
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Botulinum toxin type A (BoNT/A) is the principal therapy for patients with cervical dystonia. Repeated treatments over many years are required in most cases. This retrospective review evaluates the dose of BoNT/A used to treat cervical dystonia and the interval between treatments during a 2-year observation period. Outcomes data were abstracted from the medical records of 172 patients at 3 different sites who had received BoNT/A between January and December 1998. A total of 1059 treatments were assessed. Mean per-treatment doses throughout the 2-year study ranged from 241.80 to 254.07 units. The mean interval between treatments was 108.48 days during the first year of observation and 114.14 days during the second year. These findings indicate that doses of and intervals between BoNT/A treatments for cervical dystonia were consistent throughout 2 years of observation.
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Non-kinematic measures appear to be superior in making such predictions. Specifically, measures of cramp severity, frequency, and latency during performance of a specific set of writing and drawing tasks were predictive factors. Since kinematic was not used to determine the injection pattern and the injections were visually guided, it may still be possible to use individual patient kinematics for better outcomes.
The main objective of this pilot study was to investigate the safety of administering onabotulinumtoxinA towards the sphenopalatine ganglion in 10 patients with intractable chronic migraine with an open, uncontrolled design. We also collected efficacy data to provide an indication as to whether future placebo-controlled studies should be performed.
Loading influences tendon healing, and so does inflammation. We hypothesized that the two are connected. 48 rats underwent Achilles tendon transection. Half of the rats received Botox injections into calf muscles to reduce mechanical loading. Cells from the regenerating tissue were analyzed by flow cytometry. In the loaded group, the regenerating tissue contained 83% leukocytes (CD45(+)) day 1, and 23% day 10. The M1/M2 macrophage ratio (CCR7/CD206) peaked at day 3, while T helper (CD3(+)CD4(+)) and Treg cells (CD25(+) Foxp3(+)) increased over time. With Botox, markers associated with down-regulation of inflammation were more common day 5 (CD163, CD206, CD25, Foxp3), and M1 or M2 macrophages and Treg cells were virtually absent day 10, while still present with full loading. The primary variable, CCR7/CD206 ratio day 5, was higher with full loading (p = 0.001) and the Treg cell fraction was lower (p < 0.001). Free cage activity loading is known to increase size and strength of the tendon in this model compared to Botox. Loading now appeared to delay the switch to an M2 type of inflammation with more Treg cells. It seems a prolonged M1 phase due to loading might make the tendon regenerate bigger.
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Both brands are effective and safe in treating HFS; efficacy is long-lasting. The differences in outcome and side effects confirm that, albeit the active drug is the same, Botox and Dysport should be considered as two different drugs.
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To assess the impact on QOL of BTX-A treatment in patients with bilateral primary axillary hyperhidrosis.
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Onabotulinum toxin A (BT-A) is now one of the authorized prophylaxis treatments for chronic migraine (CM) thanks to previous clinical trials, which usually required a pharmacologic washout as a precondition for demonstrating its efficacy. Aim of our study was to assess the efficacy in daily clinical practice of BT-A injections in refractory CM patients, regardless of medication overuse without any standardized withdrawal protocol and without stopping the ongoing prophylaxis treatment as well. We treated 44 refractory CM patients (37 females and 7 males) trimonthly without any modification in symptomatic, or prophylactic drug therapy. Main efficacy variables included number of headache, or migraine days and episodes, total cumulative headache hours, MIDAS and HIT-6 scores; all items were assessed at baseline and at the 12-, 24-, and 36-week follow-up. All variables showed a statistically significant improvement at week 36. In general, more than 50 % of patients had a good clinical outcome (including all improved patients, either partial or full responder) and that the percentage of drug abuser patients significantly decreased from 75 to 50 %, thanks to a spontaneous reduction of the symptomatic drug intake. Adverse events were uncommon and did not require treatment discontinuation. Onabotulinum toxin A treatment in refractory CM patients with unsatisfactory prophylactic drug treatments and pharmacological abuse is effective in improving clinical outcome and quality of life. This result may be achieved through a flexible pharmacologic approach tailored to each patient's needs; moreover, the patient himself can be often expected to reduce drug consumption spontaneously.
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Subjects (N = 322) were randomized to the use of BoNTA (75 U or 50 U/axilla) or placebo in this 52-week, multicenter, double-blind study.
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.