Botulinum toxin type A for the treatment of trigeminal neuralgia: results from a randomized, double-blind, placebo-controlled trial Botulinum toxin-type A: could it be an effective treatment option in intractable trigeminal neuralgia? Botulinum Toxin A in Postherpetic Neuralgia: A Parallel, Randomized, Double-Blind, Single-Dose, Placebo-controlled Trial Botulinum toxin type-A (BOTOX) in the treatment of occipital neuralgia: a pilot study. Subcutaneous injection of botulinum toxin a is beneficial in postherpetic neuralgia. Two doses of botulinum toxin type A for the treatment of trigeminal neuralgia: observation of therapeutic effect from a randomized, double-blind, placebo-controlled trial Acute Treatment of Trigeminal Neuralgia With Onabotulinum Toxin A The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Clinico-immunologic aspects of botulinum toxin type B treatment of cervical dystonia Efficacy of botulinum toxin type A for treatment of persistent myofascial TMD pain: A randomized, controlled, double-blind multicenter study Distant effects of locally injected botulinum toxin: a double-blind study of single fiber EMG changes. Kinematic Aiming Task: Measuring Functional Changes in Hand and Arm Movements After Botulinum Toxin-A Injections in Children with Spastic Hemiplegia
Aim : To investigate the efficacy , safety and tolerability of intradermal and /or submucosal administration of botulinum toxin type A ( BTX-A ) for patients with trigeminal neuralgia ( TN ) . Methods : In this r and omized , double-blind , placebo-controlled study , 42 TN patients were r and omly allocated into two groups , namely , intradermal and /or submucosal injection of BTX-A ( 75 U/1.5 mL ; n = 22 ) or saline ( 1.5 mL ; n = 20 ) in the skin and /or mucosa where pain was experienced . The primary endpoints were pain severity ( assessed by the visual analogue scale ) and pain attack frequency per day . The secondary endpoint was the patient ’s overall response to treatment , assessed using the Patient Global Impression of Change scale . Patients with ≥ 50 % reduction in mean pain score at week 12 were defined as responders . Results : A total of 40 patients completed the study .  BTX-A significantly reduced pain intensity at week 2 and pain attack frequency at week 1 . The efficacy was maintained throughout the course of the study . More BTX-A treated patients reported that pain had improved by the end of the study . Significantly more responders were present in the BTX-A group ( 68.18 % ) than in the placebo group ( 15.00 % ) . BTX-A was well tolerated , with few treatment-related adverse events . Conclusions : BTX-A may be an efficient , safe and novel strategy for TN treatment Background Botulinum toxin type A ( BTX-A ) has been reported to have analgesic effects independent of its action on muscle tone , mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia (TN).The aim of our work was evaluating the efficacy , safety , and tolerability of BTX-A for the treatment of intractable idiopathic TN . Methods This was a r and omized , single-blinded , placebo-control study carried out on 20 Egyptian patients with intractable TN . Patients received a one-time subcutaneous administration of BTX-A using “ follow the pain ” method . The primary efficacy measure was reduction in pain severity on the 10-cm VAS score as well as in paroxysms frequency from the baseline to week 12 ( endpoint last observation carried forward [ LOCF ] ) . Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint . Results Pain reduction at the 12-week endpoint was significant in BTX-A group ( p<0.0001 ) ; VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of 6.5 compared with a decrease of 0.3 for placebo , also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale . Conclusion These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases Objectives : Cumulative evidence support a beneficial effect of botulinum toxin A ( BTX-A ) in postherpetic neuralgia ( PHN ) . We aim ed to assess efficacy , safety , and tolerability of BTX-A in the management of PHN , performing a r and omized , double-blind , single-dose , placebo-controlled trial . Methods : Thirty adults with PHN were r and omized either to BTX-A or placebo .  Severity of pain was evaluated by patients using a visual analogue scale ( VAS ) and quality of sleep was assessed using a 5-item question naire . Primary outcome was reduction in VAS score , with a greater than 50 % reduction being considered clinical ly significant . Secondary outcomes were reduction in sleep score and maintenance of VAS score after treatment , with over 50 % maintenance considered clinical ly meaningful . Results : Thirteen patients from the experimental arm achieved an at least 50 % reduction in VAS score , compared with none of the placebo patients ( NNT=1.2 , 95 % CI , 2 - 1 ; ARR=0.87 , 95 % CI , 055 - 096 ; P<0.001 ) . BTX-A patients showed significant reduction in VAS pain scores between baseline and week 2 , which persisted for a median period of 16 weeks . BTX-A patients showed significant reduction in sleep scores between baseline and week 2 , which remained unchanged until 16th week ( P<0.001 ) . Treatment was well tolerated . Discussion : Data confirm that BTX-A is effective and well tolerated in the treatment of PHN OBJECTIVE To determine the efficacy of occipital nerve blocks using reconstituted botulinum toxin type-A ( BTX-A ) in providing significant and prolonged pain relief in chronic occipital neuralgia . BACKGROUND Occipital neuralgia is a unilateral or bilateral radiating pain with paresthesias commonly manifesting as paroxysmal episodes and involving the occipital and parietal regions . Common causes of occipital neuralgia include irritation or injury to the divisions of the occipital nerve , myofascial spasm , and focal entrapment of the occipital nerve . Treatment options include medication therapy , occipital nerve blocks , and surgical techniques . BTX-A , which has shown promise in relief of other headache types , may prove a viable therapeutic option for occipital neuralgia pain . METHODS Botulinum toxin type-A ( reconstituted in 3 cc of saline ) was injected into regions traversed by the greater and lesser occipital nerve in 6 subjects diagnosed with occipital neuralgia . Subjects were instructed to report their daily pain level ( on a visual analog pain scale ) , their ability to perform daily activities ( on several quality of life instruments ) and their daily pain medication usage ( based on a self-reported log ) , 2 weeks prior to the injection therapy and 12 weeks following injection therapy . Data were analyzed for significant variation from baseline values . RESULTS The dull/aching and pin/needles types of pain reported by the subjects did not show a statistically significant improvement during the trial period . The sharp/shooting type of pain , however , showed improvement during most of the trial period except weeks 3 - 4 and 5 - 6 . The quality of life measures exhibited some improvement . The headache-specific quality of life measure showed significant improvement by 6 weeks which continued through week 12 . The general health- and depression-related measures showed no statistical improvement . No significant reduction in pain medication usage was demonstrated . CONCLUSIONS Our results indicate that BTX-A improved the sharp/shooting type of pain most commonly known to be associated with occipital neuralgia . Additionally , the quality of life measures assessing burden and long-term impact of the headaches , further corroborated improvement seen in daily head pain OBJECTIVE To assess the benefits of subcutaneous injection of botulinum toxin A ( BTX-A ) for the treatment of postherpetic neuralgia ( PHN ) . DESIGN We investigated the therapeutic benefits of BTX-A in subjects with PHN in a r and omized , double-blind , placebo-controlled study . Sixty subjects with PHN were r and omly and evenly distributed into BTX-A , lidocaine , and placebo groups . MEASURES After r and omization , 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 . RESULTS 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 ) . CONCLUSIONS 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 Background In the majority of cases , trigeminal neuralgia ( TN ) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve . Although prophylactic pharmacological treatment is first choise , considering of insufficient effect or unacceptable side effects , neurosurgical treatment or lesion treatment should be considered . In addition to all these procedures mentioned above , one approach has been based on local intradermal and /or submucosal injections of Botulinum Toxin Type A ( BTX-A ) . Methods We conducted a r and omized , double-blind , placebo-controlled since November 2012 , and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A. Eighty four patients were r and omized into following groups : placebo ( n = 28 ) ; BTX-A 25U  ( n = 27 ) ; BTX-A 75U ( n = 29 ) . Follow-up visits were conducted every week after the injection , and the overall duration of the study for each patient were 8 weeks to observe the pain severity , efficacy and adverse reactions at endpoint . Results The visual analogue scale ( VAS ) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1 , and sustained until week 8 throughout the study . There was no significant difference in VAS between 25U and 75U groups throughout the study . The response rates of 25U group ( 70.4 % ) and 75U group ( 86.2 % ) were significantly higher than placebo group ( 32.1 % ) at week 8 , and there was no significant difference between 25U and 75U groups . Evaluation of the Patient Global Impression of Change ( PGIC ) demonstrated that 66.7 % ( 25U group ) and 75.9 % ( 75U group ) of the patients reported that their pain symptoms were ‘ much improved ’ or ‘ very much improved ’ versus 32.1 % of the placebo group , and there was also no significant difference between 25U and 75U groups . All adverse reactions were grade d as mild or moderate . Conclusions BTX-A injection in TN is safe and efficient . It is a useful treatment for refractory TN . Lower dose ( 25U ) and high dose ( 75U ) were similar in efficacy in short-term Abstract A double-blind , r and omized , placebo-controlled study of patients with essential trigeminal neuralgia and treatment with a single injection of onabotulinum toxin A ( BTX )  was carried out . The efficacy , safety , and tolerability of either 1 mL 0.9 % saline plus 50 U of BTX or only 1 mL of 0.9 % saline injected subcutaneously in the affected area were evaluated . Cases with involvement of the third branch of the trigeminal nerve also received intramuscularly either 10 U of BTX or matching placebo in the masseter muscle , ipsilateral to the pain location . Pain was assessed with the visual analog scale ( VAS ) . Twenty subjects were administered BTX , and 16 subjects received placebo .  Two months after the intervention , a trend to statistical significance was observed for the VAS mean values in subjects treated with BTX and those who received placebo ( VAS 4.9 vs 6.63 , t test , P = 0.07 ) . Three months after the injection , significant differences were observed in the average VAS score for subjects treated with BTX and those treated with placebo ( VAS 4.75 vs 6.94 , respectively ; t test , P = 0.01 ) . Onabotulinum toxin A was well tolerated and seems to be a safe and useful therapy for patients with essential trigeminal neuralgia Cervical dystonia ( CD ) is characterized by abnormal , involuntary contractions of the cervical and /or shoulder muscles . Direct injection of Botulinum toxin type A ( BTX-A ) into the affected muscles has been used successfully to treat this condition . However , clinical resistance to BTX-A therapy develops in a limited number of patients . Moreover , an unknown proportion of treated patients have a suboptimal response to their present therapy . BTX-B is antigenically distinct from BTX-A and possesses a different mechanism of action . Three r and omized , double-blind , placebo-controlled clinical trials evaluated the safety and efficacy of BTX-B ( Elan 's BTX-B evaluated as NeuroBloc ) as a treatment for patients with CD . Patients received a single dose of BTX-B ranging from 2,500 to 10,000 U. The primary efficacy evaluation for each of these studies used the Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) total score . Additional efficacy measures included the TWSTRS severity , disability , and pain subscale scores , as well as the Patient Analog Pain Assessment and Patient 's and Physician 's Global Assessment s of Change . In all three studies , groups receiving BTX-B displayed statistically significant improvements in TWSTRS total score and other efficacy end points compared with those who received placebo treatment . The clinical benefits after BTX-B treatment lasted 12 to 16 weeks and were observed in both BTX-A-responsive and BTX-A-resistant patients . In general , treatment with BTX-B was well tolerated and most of the reported adverse events were of short duration , mild to moderate in severity , and anticipated . The results from the three controlled clinical trials demonstrate the safety and efficacy of BTX-B in the treatment of patients with CD , including those who are resistant to BTX-A treatment In this multicenter study of 100 patients with cervical dystonia , we examined the immunogenicity of botulinum toxin type B ( BTX-B ) and correlated the clinical response with the presence of blocking antibodies ( Abs ) using a novel mouse protection assay . One-third of the patients who were negative for BTX-B Abs at baseline became positive for BTX-B Abs at last visit . Thus , the high antigenicity of BTX-B limits its long-term efficacy & NA ; Evidence of an effect by botulinum toxins is still lacking for most pain conditions . In the present r and omized , placebo‐controlled , crossover multicenter study , the efficacy of botulinum toxin type A ( BTX‐A ) was investigated in patients with persistent myofascial temporom and ibular disorders ( TMD ) . Twenty‐one patients with myofascial TMD without adequate pain relief after conventional treatment participated . A total of 50 U of BTX‐A or isotonic saline ( control ) was r and omly injected into 3 st and ardized sites of the painful masseter muscles . Follow‐up was performed after 1 and 3 months , followed by a 1‐month washout period , after which crossover occurred . Pain intensity at rest was the primary outcome measure , while physical and emotional function , global improvement , side effects , and clinical measures were additional outcome measures . There was no main difference between drugs ( ANOVA ; P = .163 ) , but there was a significant time effect ( P < .001 ) , so BTX‐A reduced mean ( SD ) percent change of pain intensity by 30 ( 33 % ) after 1 month and by 23 ( 30 % ) after 3 months compared to 11 ( 40 % ) and 4 ( 33 % ) for saline . The number of patients who received a 30 % pain reduction was not significantly larger for BTX‐A than after saline at any follow‐up visit . The number needed to treat was 11 after 1 month and 7 after 3 months . There were no significant changes after treatment in any other outcome measures , with the exception of pain on palpation , which decreased 3 months after saline injection ( P < .05 ) . These results do not indicate a clinical relevant effect of BTX‐A in patients with persistent myofascial TMD pain . Botulinum toxin type A is not an effective adjunct to conventional treatment in persistent myofascial temporom and ibular disorders We used single fiber electromyography ( SFEMG ) to study 42 patients who had enrolled in a double-blind , placebo-controlled trial undertaken to assess the efficacy of botulinum toxin ( BTX ) injection of neck muscles to treat torticollis . SFEMG in a limb muscle was performed before treatment , 2 , and 12 weeks after injection of placebo or BTX . Before treatment , the mean jitter was 26.8 microsec in patients who were to receive BTX , and 25.7 microsec in the placebo group . Two weeks after injection , mean jitter in the group receiving BTX was 43.6 microsec . In the placebo group , it was 26.5 microsec ( P = less than .05 ) . Twelve weeks after injection , mean jitter in the BTX group was 35.5 ; for the placebo group it was 24.5 . Fiber density did not change in any patient during the study . There were no remote clinical effects of BTX . Injection of BTX into muscles affected with focal dystonia is a promising and safe treatment , but there are sub clinical effects on uninjected muscles Rameckers EAA , Speth LAWM , Duysens J , Vles JSH , Smits-Engelsman BCM : Kinematic aim ing task : measuring functional changes in h and and arm movements after botulinum toxin-a injections in children with spastic hemiplegia . Am J Phys Med Rehabil 2007;86:538–547 . Objective : To describe different aspects of a kinematic aim ing task ( KAT ) as a quantitative way to assess changes in arm movements within 2 wks after botulinum toxin-A ( BTX-A ) injections in children with spastic hemiplegia . Design : Intervention study r and omized clinical trial ; follow-up within 4 wks after baseline measurement . Results : The KAT gave a high intraclass correlation on movement time , spread of end points ( END ) , and index of performance effective ( IP-E ) . After BTX-A , a significant increase of END and IP-E was shown if precision dem and in the KAT was high , whereas the inverse occurred when speed was more important . These functional changes coincided with a significant decrease of the maximum voluntary contraction of the flexor muscles of the forearm . Muscle tone measured with the Ashworth scale did show a nonsignificant decrease of muscle tone , as did the stretch restricted angle and the active and passive ranges of motion of the elbow and wrist . Conclusions : Muscle force decreased immediately after BTX-A , showing the direct effect of BTX-A. The KAT is an adequate , reproducible way to quantify functional changes after BTX-A in the upper limb . BTX-A has an inverse effect in the precision task when accuracy is important , and it has a positive effect when speed prevails
Conclusion Based on the current evidence , BTX-A may be an effective and safe option for the treatment of neuralgia .
Aim This meta- analysis was performed to evaluate the efficacy and safety of botulinum toxin-A ( BTX-A ) for the treatment of neuralgia .