Botox Group Research Articles

Chronic effects of a flexible and minimalist footwear on clinical, functional and gait biomechanical aspects in the knee osteoarthritis: a single-blind randomized clinical trial

Chronic effects of a flexible and minimalist footwear on clinical, functional and gait biomechanical aspects in the knee osteoarthritis: a single-blind randomized clinical trial

Topical Diltiazem Cream Versus Botulinum Toxin A for the Treatment of Chronic Anal Fissure

A double-blind randomized clinical trial to compare topical diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure. Chronic anal fissures remain a challenging condition. Topical diltiazem and BTA are promising agents in the treatment of anal fissure. As to date diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study. One hundred thirty-four patients were randomized to receive either diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months. After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the diltiazem group, and this difference was statistically significant (P = 0.012). BTA yields higher healing rates in the short term, though after 3 months diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012.

An early botulinum toxin A treatment in subacute stroke patients may prevent a disabling finger flexor stiffness six months later: a randomized controlled trial

Objective: The study asked whether an early botulinum toxin A (BTX-A) injection in subacute stroke patients may prevent a disabling finger flexor stiffness six months later. Design: Single-blind, randomized pilot study. Setting: Inpatient rehabilitation centre. Subjects: Eighteen stroke patients, interval 4–6 weeks, non-functional arm, Fugl-Meyer arm score (0–66) <20, beginning elevated finger flexor tone, randomly allocated to group A or B. Interventions: In group A patients 150 units BTX-A (Xeomin) injected into the deep and superficial finger (100 units) and wrist flexors (50 units), no injection in group B patients. Comprehensive rehabilitation in both groups. Main measures: Primary variable was the Modified Ashworth Scale score (0–5) of the finger flexors; secondary variables were whole arm muscle tone with REPAS (a summary rating scale for resistance to passive movement), its motor control with the Fugl-Meyer arm score, and a disability scale, blindly assessed at T0 (start), T1 (four weeks) and T6 (six months). Results: Homogeneous groups at T0. Significantly less finger flexor stiffness in the BTX-A group at T1 and T6, the mean (SD) Modified Ashworth Scale scores in group A (B) were: 1.7 ± 0.5 (1.6 ± 0.5) at T0; 0.4 ± 0.5 (1.9 ± 0.7) at T1; and 1.4 ± 0.7 (2.4 ± 0.9) at T6. Among the secondary measures, the disability score, namely the items pain and passive nail trimming, was lower in group A at T1 and T6. Conclusions: The results indicate an effect of early BTX-A injection on finger flexor stiffness six months later, presumably attributable to a reduced contracture development. Effect size calculation suggests inclusion of at least 17 patients per group excluding drop-outs in a warranted placebo-controlled trial.

Effects of treadmill running on rat gastrocnemius function following botulinum toxin A injection

Exercise can improve and maintain neural or muscular function, but the effects of exercise in physiological adaptation to paralysis caused by botulinum toxin A has not been well studied. Twenty-four rats were randomly assigned into control and treadmill groups. The rats assigned to the treadmill group were trained on a treadmill three times per week with the running speed set at 15 m/min. The duration of training was 20 min/session. Muscle strength, nerve conduction study and sciatic functional index (SFI) were used for functional analysis. Treadmill training improved the SFI at 2, 3, and 4 weeks (p = 0.01, 0.004, and 0.01, respectively). The maximal contraction force of the gastrocnemius muscle in the treadmill group was greater than in the control group (p < 0.05). The percentage of activated fibers was higher in the treadmill botox group than the percentage for the control botox group, which was demonstrated by differences in amplitude and area of compound muscle action potential (CMAP) under the curve between the groups (p < 0.05). After BoNT-A injection, treadmill improved the physiological properties of muscle contraction strength, CMAP amplitude, and the recovery of SFI.

Botulinum Toxin Injection in Epicardial Autonomic Ganglia Temporarily Suppresses Vagally Mediated Atrial Fibrillation

Autonomic denervation may suppress atrial fibrillation (AF) vulnerability. This study was designed to assess the short- to mid-term effects of botulinum toxin, a cholinergic neurotransmission blocker, on AF inducibility. A total of 23 mongrel dogs were studied. The sinus node and atrioventricular node epicardial fat pads were exposed through a right lateral thoracotomy. Botulinum toxin (Botox, 50 U per fat pad) or 0.9% normal saline (control) was injected into the center of each of the 2 fat pads. The electrophysiological effects were evaluated at 1, 2, and 3 weeks (7 to 8 animals at each time point) with and without cervical vagal stimulation. The vagal stimulation effects on the sinus and atrioventricular nodes were inhibited, and dispersion of atrial effective refractory period was lower at 1 week in the Botox group. Significant suppression of AF inducibility was observed at 1 week but disappeared at 2 and 3 weeks. These changes were not observed in the control group. Temporary suppression of vagally mediated AF, for at least 1 week, was achieved with botulinum toxin injection in this canine model. This effect might be associated with reduced dispersion of effective refractory period. A temporary autonomic block using botulinum toxin might be a novel therapeutic option for several clinical conditions such as post-cardiac surgery AF.

Effect of the botulinum toxin type A on myocutaneous flap expansion in minipigs model

To investigate the histologic effect of botulinum toxin type A (Botox A) injection on myocutaneous flap expansion in minipigs model. Seven minipigs were included in this study. Two symmetric tattoo area, 10 cm x 6 cm in size, were selected on the bilateral flank of the pigs. The Botox A was injected into one tattoo area randomly, 4 U every point, 2 cm apart, with a total dose of 96 U. The same dose of sterile normal saline (0.9%) was injected in the same fashion on the opposite side as control. 3 days after injection , two 200 ml expanders were inserted beneath the cutaneous muscle at the tattoo area. After complete expansion of 200 ml, the specimens were drawn from both groups symmetrically and were stained by means of HE and Masson. The histologic changes of myocutaneous flap were compared. Thickness of each layer in myocutaneous flap was measured in histological section. The thickness of cutaneous muscle, capsule, dermis were (275.74 +/- 28.93) microm, (468.03 +/- 34.28) microm, (1990.79 +/- 102.10) microm in Botox group, and (409.13 +/- 44.63) microm, (626.55 +/- 44.05) microm, (2508.44 +/- 70.71) microm in saline group, respectively, show a significant difference between the two groups (P < 0.01). The Masson stained slice showed that collagen average gray of capsule in Botox group was 185.38 +/- 9.56, which was significantly higher than that in the saline group (120.77 +/- 10.31, P < 0.01). Light microscope (HE stained sections ) showed that muscle in Botox group was significantly atrophy and cross-section of muscle fiber decreased. The muscle fiber in saline group was generally normal. It was observed through transmission electron microscope that the light and dark band of muscle cell became fuzzy and the Z line bending in Botox group. The light and dark band in saline group arranged neatly, the Z line was clear. Application of Botox A in myocutaneous flap expansion can make the muscle atrophy and reduce the content of collagen in capsule layer, making the myocutaneous flap thinner which is suitable for reconstruction in face and neck.

A pilot study of botulinum toxin for interstitial cystitis/painful bladder syndrome

Preliminary studies using botulinum toxin (BTX) have demonstrated some benefits in treating interstitial cystitis (IC)/painful bladder syndrome (PBS) pain. The purpose of this study was to investigate the efficacy of a periurethral injection of BTX to block urethral visceral and somatic afferent fibers, for the treatment of IC/PBS. Twenty adult women with IC/PBS were identified from the Female Urology Clinic at our hospital. Symptom evaluation was performed using a female modification of the Chronic Prostatitis Symptom Index (CPSI), AUA Symptom Index, Graded Chronic Pain Scale, Perceived Stress Scale, and symptom improvement Visual Analog Scale (VAS). All patients were randomized to receive either botulinum toxin A (BTX-A) or placebo (normal saline). Patients randomized to BTX-A received 50 U diluted in 2 cm(3) normal saline injected periurethrally. The physician and patient were blinded to the treatment. BTX was administered to nine women. There were no complications or side effects reported. There was no improvement between placebo and BTX-A groups in the CPSI score at 3-month follow-up (P=0.97). Additionally, there were no improvements in the other symptom indices. At follow-up, the mean VAS for the BTX group was -0.3, indicating the subjects' symptoms were the same as at the start of the study. Periurethral injection of botulinum toxin in women did not effectively treat the pain of IC/PBS. While the results from this study are negative, there is still a valid rationale for further investigations of novel injection protocols given the dearth of current effective treatments.

Subcutaneous Injection of Botulinum Toxin A Is Beneficial in Postherpetic Neuralgia

To assess the benefits of subcutaneous injection of botulinum toxin A (BTX-A) for the treatment of postherpetic neuralgia (PHN). We investigated the therapeutic benefits of BTX-A in subjects with PHN in a randomized, double-blind, placebo-controlled study. Sixty subjects with PHN were randomly and evenly distributed into BTX-A, lidocaine, and placebo groups. After randomization, one of the following solutions was injected subcutaneously in the affected dermatome: 5u/mL BTX-A, 0.5% lidocaine, or 0.9% saline (placebo). Visual analog scale (VAS) pain and sleeping time (hours) were evaluated at the time of pretreatment, day 1, day 7, and 3 months posttreatment. Opioid usage was calculated at day 7 and 3 months posttreatment. Compared with pretreatment, VAS pain scores decreased at day 7 and 3 months posttreatment in all three groups (P<0.01). However, the VAS pain scores of the BTX-A group decreased more significantly compared with lidocaine and placebo groups at day 7 and 3 months posttreatment (P<0.01). Sleep time (hours) had improved at day 7 and at 3 months compared with pretreatment in all three groups, but the BTX-A group improved more significantly compared with lidocaine and placebo groups (P<0.01). The percent of subjects using opioids posttreatment in the BTX-A group was the lowest (21.1%) compared with the lidocaine (52.6%) and placebo (66.7%) groups (P<0.01). Subcutaneous administration of BTX-A significantly decreased pain in PHN and reduced opioid use compared with lidocaine and placebo at day 7 and 3 months post-treatment. It also increased subjects' sleep times.

Neuronox versus BOTOX for spastic equinus gait in children with cerebral palsy: a randomized, double-blinded, controlled multicentre clinical trial

The aim of this study was to evaluate the efficacy and safety of a newly manufactured botulinum toxin, Neuronox, compared with BOTOX for the treatment of the spastic equinus gait in children with cerebral palsy. A total of 127 children with cerebral palsy, aged 2 to 10 years, who presented at three university hospitals with spastic equinus gait were assessed for eligibility to participate in this double-blinded, randomized, controlled trial. Of the 119 eligible participants (mean age 4.33 y; SD 2.07; 76 males and 43 females; 79 with diplegia and 40 with hemiplegia), 57 were classified as Gross Motor Function Classification System level I, 29 as level II, and 33 as level III. Participants were randomly assigned to receive an injection of Neuronox (n=60) or BOTOX (n=59) to the calf muscles at a dose of 4U/kg for those with hemiplegia and 6U/kg for those with diplegia. Assessments were performed at baseline (V1) and at 4 (V2), 12 (V3), and 24 (V4) weeks after the intervention. The primary outcome measure was response rate at V3, with a positive response being defined as at least a 2-point increase in the Physicians' Rating Scale (PRS) score. The non-inferiority margin was set as -20% for the difference in the response rate. The secondary outcome measures included PRS score, passive range of motion (PROM) of the ankle and knee, and Gross Motor Function Measure 88 (GMFM-88). Any adverse events were investigated for safety implications. The response rate of the Neuronox group at V3 was not inferior to that of the BOTOX group (90% lower limit=-11.58%). There were significant improvements in PRS, PROM of ankle dorsiflexion, and GMFM scores at V2, V3, and V4 in both groups. The changes in PRS score were not statistically different between the two groups in serial evaluation (p=0.96). PROM of the ankle dorsiflexion increased without any significant difference between the two groups, either overall (p=0.56) or at each visit (V2, p=0.32; V3, p=0.66; V4, p=0.90). The increase in GMFM score in serial measurements were not significantly different between the two groups (p=0.16), whereas it was larger in the BOTOX group than in the Neuronox group at V2 and V4 (p=0.03 and 0.05 respectively). The frequency of adverse events was not significantly different between the two groups (p=0.97), and drug-related complications of Neuronox treatment were not addressed. The outcomes of Neuronox, based on PRS, proved to be as effective and safe as those of BOTOX for the treatment of spasticity in individuals with cerebral palsy.

Comparison Between Botulinum Toxin and Corticosteroid Injection in the Treatment of Acute and Subacute Tennis Elbow

To compare botulinum toxin type A injection with corticosteroid injection in the treatment of tennis elbow. In this prospective, randomized, double-blind, drug-controlled trial,19 affected elbows of 16 patients were randomly assigned to receive injection with botulinum toxin type A (Botox group) or triamcinolone acetonide (steroid group). We used the Visual Analog Scale, pain-free grip strength, and World Health Organization Quality of Life Brief Questionnaire to assess the perception of pain, grip strength, and quality of life, respectively. Measures were performed before and at 4, 8, and 12 wks after the treatment. Four weeks after the treatment, the Botox group had smaller decrease in pain (P = 0.02) but greater decrease in grip strength (P = 0.01). The difference in grip strength remained significant at 8 wks (P = 0.03). No significant differences in quality of life were observed throughout the study period. Corticosteroid is superior to botulinum toxin type A in relieving pain in tennis elbow at 4 wks after injection. Because botulinum toxin injection did not relieve pain significantly but is associated with weakness, the muscle weakness caused by botulinum toxin is unlikely to be the sole mechanism of the pain relief observed in previous studies.

Comparison between Neurectomy and Botulinum Toxin A Injection for Denervated Skeletal Muscle

Neurectomy and botulinum toxin A (BoNT-A) injection cause denervated muscle atrophy, but questions remain about their clinical utility. We investigated time-series alterations of rat muscle weight, functional deficits, signaling pathways, and microscopic structures, to gain an understanding of the clinical implications. Between 2008 and 2009, the maximal calf circumference of patients for calf reduction either by neurectomy or BoNT-A injections were recorded for study. A rat skeletal muscle model was established through repeated or dose-adjusted BoNT-A injections and neurectomy. The survival, apoptosis pathways, functional deficits, and microscopic structures were investigated using Western blot, sciatic functional index (SFI), and transmission electron microscopy (TEM), respectively. The rat muscle weight ratio of the BoNT-A group had recovered to 89.3 +/- 3.8% by week 58, but it never recovered in the neurectomy group. Muscle weight reduction by BoNT-A not only depended on the dose, but additive effects were also obtained through repeated injections. Rat SFI demonstrated rapid recovery in both groups. Molecular expressions showed a coherent and biphasic pattern. p-Akt and apoptosis-inducing factor (AIF) were upregulated significantly, with a peak at 8 weeks in the neurectomy group (p < 0.01), but cleaved caspase-9 and caspase-3 showed no significant changes in either group. TEM findings showed irreversible and reversible inner-structure disruption and sarcomere discontinuity in the neurectomy and BoNT-A groups, respectively. We demonstrated that denervation induced lasting muscle weight and structural changes of different degrees. Muscle weight reduction by BoNT-A was related to frequency and dose. AIF-mediated caspase-independent apoptosis was significantly different for neurectomy and BoNT-A injection.

Botulinumtoxin A treatment in toddlers with cerebral palsy

In this study the aim was to evaluate the effect of botulinum toxin A (BoNT-A) treatment on muscle tone, contracture development and gait pattern in young children with cerebral palsy (CP). Fifteen children with spastic CP (mean age = 16 months) were included in a randomized control study. All received a daily stretching programme and children in the BoNT-A group additionally received two injections, 6 months apart in the gastrocnemius muscle. Outcomes were assessed at baseline, and after 1 and 3.5 years. A 3D gait-analysis was performed at 5 years of age. Plantarflexor muscle tone in the BoNT-A group was significantly reduced after 3.5 years, while the muscle tone at the ankle and knee in the control group remained unchanged. The change-score in knee-flexion muscle tone between the groups was significantly different after 3.5 years. The knee joint ROM was significantly increased at 1 year in the BoNT-A group but reduced at the knee and ankle joints in the control group after 3.5 years. No group differences were found for gait analysis, GMFM-66 or PEDI. Early treatment of BoNT-A in children with spastic CP may decrease muscle tone and decelerate contracture development after 3.5 years. The effect on gait development remains inconclusive.

Apoptotic Action of Botulinum Toxin on Detrusor Muscle in Rats

Aims: To examine botulinum toxin A (BTX-A)-induced apoptosis in the detrusor muscle in male rats. Methods: The bladder wall and prostate in adult male Sprague-Dawley rats were injected with BTX-A (10 U at each site). Tissues were harvested after 2 weeks, then the effects of BTX-A on proliferative and apoptotic indices were determined using proliferative cell nuclear antigen and TUNEL staining, respectively. In addition, real-time polymerase chain reaction was used to measure mRNA expressions of the apoptosis-related gene, bcl-2, and BAX in detrusor muscle. Results: Although bladder weight was significantly increased in the BTX-A group compared to controls, no significant changes in prostate weight were identified. While significant increases in proliferative cells were apparent in the vesical mucosa after staining, no significant changes were noted in apoptotic or proliferative cells in detrusor muscle or prostate. In addition, no significant changes between the BTX-A group and controls were seen for mRNA expressions of bcl-2/β-actin or BAX/β-actin in detrusor muscle. Conclusions: The lack of significant changes in cellular dynamics of the detrusor muscle in the current study suggests that BTX-A injection into detrusor muscle for overactive bladder may not induce bladder atrophy.

The effects of BOTOX injections on emotional experience.

Although it was proposed over a century ago that feedback from facial expressions influence emotional experience, tests of this hypothesis have been equivocal. Here we directly tested this facial feedback hypothesis (FFH) by comparing the impact on self-reported emotional experience of BOTOX injections (which paralyze muscles of facial expression) and a control Restylane injection (which is a cosmetic filler that does not affect facial muscles). When examined alone, BOTOX participants showed no pre- to posttreatment changes in emotional responses to our most positive and negative video clips. Between-groups comparisons, however, showed that relative to controls, BOTOX participants exhibited an overall significant decrease in the strength of emotional experience. This result was attributable to (a) a pre- versus postdecrease in responses to mildly positive clips in the BOTOX group and (b) an unexpected increase in responses to negative clips in the Restylane control group. These data suggest that feedback from facial expressions is not necessary for emotional experience, but may influence emotional experience in some circumstances. These findings point to specific directions for future work clarifying the expression-experience relationship.

Minimally invasive application of botulinum toxin A in patients with idiopathic rhinitis

BackgroundNasal hypersecretion due to idiopathic rhinitis can often not be treated sufficiently by conventional medication. Botulinum toxin A (BTA) has been injected into the nasal mucosa in patients with nasal hypersecretion with a reduction of rhinorrhea lasting for about 4 to 8 weeks. Since the nasal mucosa is well supplied with glands and vessels, the aim of this study was to find out if the distribution of BTA in the nasal mucosa and a reduction of nasal hypersecretion can also be reached by a minimally invasive application by sponges without an injection.MethodsPatients were randomly divided into two groups. The effect of BTA (group A, C, D) or saline as placebo (group B) was investigated in 20 patients with idiopathic rhinitis by applying it with a sponge soaked with BTA (40 units each nostril) or saline. Subgroups C and D contained these patients of group A and B who did not improve in symptoms one week after the original treatment (either BTA or saline) who then received the alternative medication. Changes of symptoms (rhinorrhea, nasal obstruction) were scored by the patients in a four point scale and counted (consumption of tissues, sneezing) in a diary. The patients were followed up weeks 1, 2, 4, 8 and 12.ResultsThere was a clear reduction of the amount of secretion in group A compared to group B, C and D. This did not correlate with the tissue consumption, which was comparably reduced in group A and B, but reduced less in group C and D. Sneezing was clearly reduced in group A but comparably unchanged in group B and C and increased in group D. Nasal congestion remained unchanged.ConclusionIn some patients with therapy-resistant idiopathic rhinitis BTA applied with a sponge is a long-lasting and minimal invasive therapy to reduce nasal hypersecretion.

Botulinum Neurotoxin-A for Treatment of Refractory Neck Pain: A Randomized, Double-Blind Study

To investigate the efficacy and tolerability of Botulinum neurotoxin-A (BoNT-A) in the patients with refractory neck pain. An analgesic effect is suggested for BoNT-A by a number of animal studies. Two blinded studies suggested efficacy of BoNT-A in a chronic neck pain. Forty-seven subjects were enrolled in a prospective, double-blind, placebo-controlled study. A total of 150 to 300 units of BoNT-A were injected into the neck and shoulder muscles based on pain localization. Subjects completed the visual analog scale (VAS), Pain Frequency Questionnaire and the Modified Oswestry Pain Questionnaire (MOPQ) at baseline, 3 and 8 weeks after the treatment. The primary outcomes consisted of: 1) > or =50% improvement on the VAS; and 2) > or =30% reduction in pain day frequency. The secondary outcome was an improvement of ADL in MOPQ. Excellent responders (ERs) were those who met all three outcomes. At 2 months, a significant reduction in the mean VAS (pain intensity) was noted in the BoNT-A group compared with the placebo (P = 0.0018, CI 95% from 2.51 to 7.89). At 2 months, there were six ERs in the BoNT-A group and one ER in the placebo group (P = 0.0152). Administration of BoNT-A into the neck and shoulder muscles for treatment of chronic refractory neck pain met one of the two primary outcomes: reduction in pain intensity. More ERs were noted in the Botox group.

Botulinum Toxin Type A—A Novel Treatment for Provoked Vestibulodynia? Results from a Randomized, Placebo Controlled, Double Blinded Study

Vestibulodynia is an increasingly recognized problem among women and is often difficult to treat. This randomized, double blinded, placebo-controlled study aimed to evaluate the efficacy of Botox in the treatment of vestibulodynia. Sixty-four women were randomized to receive Botox (N = 32) or saline placebo (N = 32). Botulinum toxin A (20 I.E.) diluted in 0.5 mL saline or 0.5 mL saline was injected in the musculus bulbospongiosus at baseline. Pain was measured monthly on a visual analog scale (VAS) Likert scale. Sexual function was measured using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale at baseline and at 3 and 6 months follow up. Quality of life was measured using the 36-item short-form (SF-36). Sixty women (94%) completed the 6 months follow up. Both Botox and placebo produced significantly pain reduction (P < 0.001). There was no significant difference in the median VAS score between the groups at 6 months follow up (P = 0.984). An improvement on the FSFI full score from baseline until 6 months was not significantly different between the groups (P = 0.635). In the placebo group a statistical significant larger reduction in sexual distress was observed from baseline until 6 months follow up compared to the Botox group (P = 0.044). No statistical significant differences were observed between the B- and P-groups in regard to the SF-36 scores. Injection of 20 I.E. Botox in the vestibule of women diagnosed with vestibulodynia does not reduce pain, improve sexual functioning, or impact the quality of life compared to placebo and evaluated at 3 and 6 moths follow up. Both the Botox group and the placebo groups experienced a reduction in pain on the VAS Likert scale at 6 months follow up. Women with vestibulodynia have difficulty with sexual function and present with sexual distress, which has to be addressed in conjunction with pain to eliminate the disorder.

Comparing two types of botulinum‐A toxin detrusor injections in patients with severe neurogenic detrusor overactivity: a case‐control study

To compare the efficacy of two types of botulinum toxin type A (BTX-A; Dysport, Ipsen Ltd, Slough, UK) or Botox (Allergan Inc., Irvine, CA, USA) and examine the possible dose-effect relation for Dysport in those patients, as multifocal detrusor injections with BTX-A are effective for severe neurogenic detrusor overactivity in adults. This was an open-label, observational case-control study comparing Dysport and Botox, and the dose-effect relation for Dysport. The patients included were treated with either Dysport (cases; 500, 750, or 1000 IU), or with Botox (controls: 300 IU, and exceptionally 200 or 400 IU). The continence volume (primary), mean and maximum catheterized volume, and antimuscarinic use were assessed, and cystometric variables measured were overactivity volume (primary), detrusor compliance, and cystometric capacity. All variables were assessed at baseline, 3 and 9 months after treatment, and results analysed using analysis of variance (paired) t-tests, chi-square tests and regression analysis. There were 28 cases and 28 matched controls; their demographic characteristics, bladder management, and baseline values were comparable between the groups. At 3 months there was a significant improvement in cystometric variables and continence volume in both groups, but in mean catheterized volume and reduced use of antimuscarinics in cases only. At 9 months there was no significant improvement over baseline except for the continence volume in the cases. There were no significant differences in results between the groups except for the continence volume at 3 months (459 mL after Dysport and 396 mL after Botox; P=0.015). There was no dose-related response for Dysport at 3.8 months of follow-up. The interval between injections (9.5, 14.5 and 16.1 months for Dysport 500, 750, and 1000 IU; 10.1 months for Botox) was not significant. There were nine non-responders in the Dysport group and seven in the Botox group; the patient characteristics and baseline data were comparable to those of the responders. There was transient hypoasthenia in one of the responders (750 IU Dysport). A single treatment session with either Dysport or Botox in a setting combined with antimuscarinics might improve the patient's condition for up to a year. There was no clear dose-related effect for Dysport in adults.

Improvement in quality of life after botulinum toxin‐A injections for idiopathic detrusor overactivity: results from a randomized double‐blind placebo‐controlled trial

OBJECTIVE To determine whether botulinum toxin-A (BTX-A) treatment has an effect on the quality of life (QoL) of patients with overactive bladder (OAB) refractory to anticholinergics. PATIENTS AND METHODS This was a single centre, randomized, double-blind, placebo-controlled trial. Participants were men and women with idiopathic detrusor overactivity (IDO). Participants were randomised to receive either 200 U of BTX-A (Botox(R), Allergan Inc., Irvine, CA, USA; n = 16) or placebo (n = 18) via a trigone-sparing flexible cystoscopic technique. QoL was assessed using the King's Health Questionnaire (KHQ) at baseline and at 4 and 12 weeks, after injection. At 12 weeks patients were 'unblinded' and a further open-label follow-up in the BTX-A group occurred at 24 weeks. The changes in the subdomains of the KHQ were assessed over the study period. RESULTS Overall QoL was significantly improved in the BTX-A treated patients compared with placebo in the blinded part of the study. When analysing the KHQ subdomains, 'Incontinence Impact', 'Emotions', 'Physical Limitations', 'Social Limitations' and 'Severity Measures' were significantly improved in those that received BTX-A compared with placebo. The 'Symptom Severity' domain was also significantly improved at 4 weeks but not at 12 weeks. At 12 weeks 'Role Limitations' also became statistically significant in favour of BTX-A. The open-label extension study suggested these benefits last for at least 24 weeks. CONCLUSIONS BTX-A bladder injections at 200 U appear to improve QoL in patients with OAB symptoms and IDO refractory to anticholinergics for at least 24 weeks. As well as the improvement seen in clinical parameters with this form of therapy, perhaps of more importance to the patient, is the improvement in QoL.

Botulinum Toxin A in the Treatment of Chronic Tension‐Type Headache With Cervical Myofascial Trigger Points: A Randomized, Double‐Blind, Placebo‐Controlled Pilot Study

To evaluate the efficacy of botulinum toxin A (BT-A) as a prophylactic treatment for chronic tension-type headache (CTTH) with myofascial trigger points (MTPs) producing referred head pain. Although BT-A has received mixed support for the treatment of TTH, deliberate injection directly into the cervical MTPs very often found in this population has not been formally evaluated. Patients with CTTH and specific MTPs producing referred head pain were assigned randomly to receive intramuscular injections of BT-A or isotonic saline (placebo) in a double-blind design. Daily headache diaries, pill counts, trigger point pressure algometry, range of motion assessment, and responses to standardized pain and psychological questionnaires were used as outcome measures; patients returned for follow-up assessment at 2 weeks, 1 month, 2 months, and 3 months post injection. After 3 months, all patients were offered participation in an open-label extension of the study. Effect sizes were calculated to index treatment effects among the intent-to-treat population; individual time series models were computed for average pain intensity. The 23 participants reported experiencing headache on a near-daily basis (average of 27 days/month). Compared with placebo, patients in the BT-A group reported greater reductions in headache frequency during the first part of the study (P = .013), but these effects dissipated by week 12. Reductions in headache intensity over time did not differ significantly between groups (P = .80; maximum d = 0.13), although a larger proportion of BT-A patients showed evidence of statistically significant improvements in headache intensity in the time series analyses (62.5% for BT-A vs 30% for placebo). There were no differences between the groups on any of the secondary outcome measures. The evidence for BT-A in headache is mixed, and even more so in CTTH. However, the putative technique of injecting BT-A directly into the ubiquitous MTPs in CTTH is partially supported in this pilot study. Definitive trials with larger samples are needed to test this hypothesis further.