OBJECTIVE: To assess the therapeutic efficacy and safety of botulinum toxin type A (BTX-A) for treating idiopathic trigeminal neuralgia (ITN) in patients ≥80 years old. METHODS: Selected patients (n = 43) with ITN, recruited from the neurology clinic and inpatient department of the Second Affiliated Hospital of Soochow University between August 2008 and February 2014, were grouped by age, one subset (n = 14) ≥80 years old and another (n = 29) <60 years old. Each group scored similarly in degrees of pain registered by the visual analogue scale (VAS). Dosing, efficacy, and safety of BTX-A injections were compared by group. RESULTS: Mean dosages of BTX-A were 91.3±25.6 U and 71.8±33.1 U in older and younger patients, respectively (t = 1.930, p = 0.061). The median of the VAS score in older patients at baseline (8.5) declined significantly at 1 month after treatment (4.5) (p = 0.007), as did that of younger patients (8.0 and 5.0, resp.) (p = 0.001).The median of the D values of the VAS scores did not differ significantly by group (older, 2.5; younger, 0; Z = −1.073, p = 0.283). Two patients in each group developed minor transient side effects (p = 0.825). Adverse reactions in both groups were mild, resolving spontaneously within 3 weeks. CONCLUSIONS: BTX-A is effective and safe in treating patients of advanced age (≥80 years old) with ITN, at dosages comparable to those used in much younger counterparts (<60 years old).
INTRODUCTION: The antinociceptive effect of botulinum toxin-A (BTX-A) in trigeminal neuralgia (TN) has been described. We evaluated effects of BTX-A in relieving pain in patients with refractory TN at National Hospital of Sri Lanka.
MATERIALS AND METHODS: Pain in patients with TN was assessed using a visual analog from 0 to 10. Three months after commencement of drug therapy with ≥2 drugs including one first-line drug (carbamazepine/oxcarbazepine), pain scores were re-assessed. Twenty-two patients who did not report improvement of ≥50% at 90 days' posttreatment were recruited. They were given adjunct BTX-A directly to the trigger point (if identified) or intradermal. Pain scores were assessed at 10, 20, 30, 60, and 90 days' posttreatment.
RESULTS: There was a statistically significant improvement in mean pain scores at 10, 20, 30, 60, and 90 days' posttreatment (5.59 [standard deviation (SD) = 2.7], 5.68 [SD = 2.6], 5.27 [SD = 3.2], 4.77 [SD = 3.7], and 5.32 [SD = 4.0]) compared to pre-BTX-A treatment (7.14, SD = 2.2). Percentage reduction in mean pain score ranged from 20.4% to 33.1%. Maximum response was at day 60 post-BTX-A (50% had ≥50% reduction in pain). No significant difference was found in response with higher doses and injection strategy.
CONCLUSION: Consistent statistically significant reductions in pain scores at the aforesaid intervals compared to pretreatment means that there is a place for BTX in refractory TN.
PURPOSE: Masticatory muscle pain disorders respond well to conservative therapy; however, in some patients the pain becomes refractory. Botulinum toxin type A (BoT-A) therapy has been shown to be an effective modality in the management of refractory headache disorders. Conversely, there are conflicting reports in the literature regarding the efficacy, safety, and predictors of therapeutic response to BoT-A therapy for management of refractory masticatory muscle pain.
MATERIALS AND METHODS: We performed a retrospective chart review of patients who underwent at least 2 injection cycles of 100 U of BoT-A for refractory masticatory myalgia in the Department of Oral and Maxillofacial Surgery, Massachusetts General Hospital, between May 2012 and June 2016. Information regarding demographic, diagnostic, and therapeutic characteristics was extracted and analyzed. The χ2 test was used for analysis between independent and dependent variables. Forward step-wise-type logistic regression analysis was conducted to determine the predictors of outcome.
RESULTS: Among 116 participants, 30.6% reported significant relief in pain for a mean period of 10.1 weeks. A total of 16.4% of participants reported at least 1 adverse effect. The effectiveness of the BoT-A therapy was found to be statistically associated with the presence of muscle hypertrophy (P = .004), range of motion (P = .02), concurrent use of opioid analgesics (P = .003), and local anesthetic trigger-point injections (P = .003). Logistic regression analyses suggested that the presence of muscle hypertrophy and occurrence of adverse effects were predictors of positive outcome. On the contrary, concurrent use of opioid analgesics was found to be a predictor for no or minimal relief.
CONCLUSIONS: BoT-A therapy provides significant relief for approximately one third of patients with refractory masticatory muscle pain. Therapy is associated with a mild risk of adverse effects. The presence of muscle hypertrophy, occurrence of an adverse effect, and concurrent use of opioid analgesics were found to be predictors of outcome response.
BACKGROUND: Several RCT studies including ours, seem to prove the role of Botulinum toxin type A (BTX-A) in the treatment of trigeminal neuralgia (TN), but no standardized dosing regimen has been established. In our study, we compare two different methods of administration: single-dose or repeated-dose strategy which was most frequently applied over the years in our centre. METHODS: An open-label trail was conducted. One hundred patients with classic TN symptoms were recruited, and randomly and equally apportioned to single- or repeated-dose group. Patients in the single-dose group received a local BTX-A injection of 70 to 100 U. The repeated-dose group received an initial BTX-A injection of 50 to 70 U and then another of equal volume 2 weeks later. All patients were followed for 6 months. RESULTS: In the single- and repeated-dose groups, 44 and 37, respectively, completed the entire study. The groups were statistically similar in TN frequency, time between treatment and effect, time to peak effect, VAS scores, and rates of adverse reactions (latency and duration). However, the single-dose group experienced significantly longer duration of effect ( P = 0.032). CONCLUSIONS: The single- and repeated-dosing BTX-A regimens were largely comparable in efficacy and safety. This study suggests that repeated dosing has no advantage over single dosing of BTX-A for TN. Dosing should be adjusted for the individual patient.
BACKGROUND: Botulinum toxin type-A (BTX-A) has been successfully utilized to treat trigeminal neuralgia. In this study, through the use of a new technique, the efficacy of the injection of BTX-A to the maxillary and mandibular nerves was evaluated.
METHODS: A total of 27 patients were injected with 100 Units of BTX-A to the maxillary and mandibular nerves. Visual analogue scale score and pain frequency were assessed before treatment and at the first week, second month, and sixth month after treatment. Patients with ≥50% reduction in mean pain score at the second and sixth month were defined as responders.
RESULTS: A total of 27 patients were included in the study. BTX-A significantly reduced pain intensity and pain attack frequency at the first week, second month, and sixth month after treatment. At the second month, 74.1% of patients, at the sixth month, 88.9% of patients responded to treatment. Forty-four percent of patients did not experience any pain at the sixth month. The mean recurrence period was 87.7 ± 20.4. BTX-A was well tolerated and showed few treatment-related adverse events.
CONCLUSION: Injection to the maxillary and mandibular roots seems to be a highly effective method. In the event of recurrence, after each injection, the pain severity and attack frequency decreased.
Myofascial pain of the muscles of mastication is a common temporomandibular disorder. Patients unresponsive to conservative treatment modalities pose a therapeutic challenge to the treating clinician. The efficacy of intramuscular botulinum toxin injections for recalcitrant cases is still not well established due to mixed results from clinical trials. The Diagnostic Criteria of Temporomandibular Disorders (DC/TMD) classified chronic muscle pain broadly into a localized pattern (when pain is localized to the site of palpation or the muscle palpated) and a referring pattern (when the pain spreads beyond the boundary of the muscle being palpated). The medical records of 25 consecutive patients treated with botulinum were analysed retrospectively. Significant pain reduction was achieved in 69.2% of the patients with localized myofascial pain and 16.7% of the patients with referring myofascial pain (P=0.015). Seventy-seven per cent of the patients with localized myofascial pain reported using less analgesic throughout the follow-up period, whereas only 25% of the patients with referring myofascial pain (P=0.017). The effects of botulinum toxin in responsive patients subsided after a mean of 3.21 months. Patients with localized myofascial pain benefited from botulinum toxin injections, but patients with referring myofascial pain responded poorly to this treatment.
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 randomized, 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 randomized 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 graded 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. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
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 randomized, 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.
A randomized controlled trial was performed to compare the short-term effectiveness of botulinum toxin injections and physiatric treatment provided by means of Fascial Manipulation techniques in the management of myofascial pain of jaw muscles. Thirty patients with a Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) diagnosis of myofascial pain were randomized to receive either single-session botulinum toxin injections (Group A) or multiple-session Fascial Manipulation (Group B). Maximum pain levels (VAS ratings) and jaw range of motion in millimeters (maximum mouth opening, protrusion, right and left laterotrusion) were assessed at baseline, at the end of treatment, and at a three-month follow-up. Both treatment protocols provided significant improvement over time for pain symptoms. The two treatments seem to be almost equally effective, Fascial Manipulation being slightly superior to reduce subjective pain perception, and botulinum toxin injections being slightly superior to increase jaw range of motion. Differences between the two treatment protocols as to changes in the outcome parameters at the three-months follow-up were not relevant clinically. Findings from the present investigation are in line with literature data supporting the effectiveness of a wide spectrum of conservative treatment approaches to myofascial pain of the jaw muscles. Future studies on larger samples over a longer follow-up span are needed on the way to identify tailored treatment strategies.
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 randomized, double-blind, placebo-controlled study, 42 TN patients were randomly allocated into two groups, namely, intradermal and/or submucosal injection of BTX-A (75 U/1.5 mL; <i>n</i> = 22) or saline (1.5 mL; <i>n</i> = 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. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
To assess the therapeutic efficacy and safety of botulinum toxin type A (BTX-A) for treating idiopathic trigeminal neuralgia (ITN) in patients ≥80 years old.
METHODS:
Selected patients (n = 43) with ITN, recruited from the neurology clinic and inpatient department of the Second Affiliated Hospital of Soochow University between August 2008 and February 2014, were grouped by age, one subset (n = 14) ≥80 years old and another (n = 29) <60 years old. Each group scored similarly in degrees of pain registered by the visual analogue scale (VAS). Dosing, efficacy, and safety of BTX-A injections were compared by group.
RESULTS:
Mean dosages of BTX-A were 91.3±25.6 U and 71.8±33.1 U in older and younger patients, respectively (t = 1.930, p = 0.061). The median of the VAS score in older patients at baseline (8.5) declined significantly at 1 month after treatment (4.5) (p = 0.007), as did that of younger patients (8.0 and 5.0, resp.) (p = 0.001).The median of the D values of the VAS scores did not differ significantly by group (older, 2.5; younger, 0; Z = −1.073, p = 0.283). Two patients in each group developed minor transient side effects (p = 0.825). Adverse reactions in both groups were mild, resolving spontaneously within 3 weeks.
CONCLUSIONS:
BTX-A is effective and safe in treating patients of advanced age (≥80 years old) with ITN, at dosages comparable to those used in much younger counterparts (<60 years old).
