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Background: Spasticity and dystonia are movement impairments that can occur in childhood-onset neurological disorders. Severely affected individuals can be treated with intrathecal baclofen (ITB). Concomitant use of ITB and opioids has been associated with central nervous system (CNS) depression. This study aims to describe the clinical management of this interaction, based on a case series and review of literature., Methods: Four individuals with childhood-onset CNS disorders (age 8-24) and CNS-depressant overdose symptoms after the concomitant use of ITB and opioids are described. The Drug Interaction Probability Scale (DIPS) was calculated to assess the cause-relationship (doubtful <2, possible 2-4, probable 5-8, and highly probable >8) of the potential drug-drug interaction. A literature review of similar previously reported cases and the possible pharmacological mechanisms of opioid-baclofen interaction is provided., Results: After ITB and opioid co-administration, three out of four patients had decreased consciousness, and three developed respiratory depression. DIPS scores indicated a possible cause-relationship in one patient (DIPS: 4) and a probable cause-relationship in the others (DIPS: 6, 6, and 8). Discontinuation or adjusting ITB or opioid dosages resulted in clinical recovery. All patients recovered completely. In the literature, two articles describing nine unique cases were found., Conclusion: Although the opioid-ITB interaction is incompletely understood, concomitant use may enhance the risk of symptoms of CNS-depressant overdose, which are potentially life-threatening. If concomitant use is desirable, we strongly recommend to closely monitor these patients to detect interaction symptoms early. Awareness and monitoring of the potential opioid-ITB interaction is essential to reduce the risk of severe complications., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Objective: The aim of this study was 1) to describe the rate of intrathecal baclofen (ITB)-associated complications at a large tertiary center, and 2) to evaluate the impact of patient-related factors on the likelihood of developing such complications., Methods: A retrospective single-center study was carried out. A total of 301 eligible patients were included in the analysis. Univariate regression models were used to evaluate the impact of age, sex, diagnosis, ambulation status, modified Ashworth scale score, body mass index, diabetes status, and pain level on the likelihood of developing a device-related infection, pump malfunction, catheter malfunction, and other clinically significant complications., Results: Overall, 27% of patients experienced an ITB-related complication. The most common complications included infection (6%, 18/301), pump malfunction (7.3%, 22/301), and catheter malfunction (14%, 42/301). The univariate analyses revealed that the patient's ambulatory status had a significant impact on the likelihood of developing a catheter-related malfunction. Furthermore, a trend toward significance was identified between patients' preoperative body mass index and device-related infection. Finally, the risk of suffering any ITB-related complications was statistically correlated with the number of years that had passed since the initial pump implantation., Conclusions: The authors' analysis reveals a previously underrecognized association between ambulatory status at the time of ITB pump implantation and the incidence of catheter-related complications, and confirms the impact of time since surgery on the risk of developing any ITB-related complication. The patient's age, sex, diagnosis, diabetes status, or pain level at baseline were not associated with the risk of complications. Collectively, these insights contribute novel information to the existing literature, providing practical value for physicians in guiding patient selection for ITB therapy.

Objective: This review highlights adverse effects of baclofen and tizanidine in older community-dwelling adults., Data Sources: A literature search was conducted, including search terms of "adverse effect," "baclofen," "elderly," "falls," "fractures," and "tizanidine." Studies were included if they described community-dwelling adults aged 50 years and older who received oral baclofen or tizanidine. The Federal Drug Administration Adverse Event Reporting System (FAERS) data were compiled for adverse effect incidence., Study Selection and Data Extraction: The literature search was completed in July 2019 and updated in June 2023. Reviews performed by 2 independent reviewers yielded 15 records. FAERS identified 486 (baclofen) and 305 (tizanidine) adverse effects of interest., Data Synthesis: Two retrospective cohort studies evaluating baclofen use in older adults showed increased hospitalizations for encephalopathy in chronic kidney disease (7.2% vs 0.1%) and end-stage renal disease (daily dose 20 mg or more; relative risk [RR] 19.8, 95% CI = [14.0-28.0]). Other articles were case reports; 10 articles reported dyskinesias, encephalopathy or disorientation, and drowsiness associated with baclofen, and 5 articles reported bradycardia and/or hypotension with tizanidine. The FAERS Public Dashboard revealed 12.1% and 28.7% overall incidence of adverse effects of interest, with a 27.8% and 29.2% incidence of falls for baclofen and tizanidine, respectively. Baclofen and tizanidine are associated with concerning adverse effects in older adults. Alternative agents should be considered, but, if necessary, providers should start at lower doses and increase slowly., Conclusions: This review highlights the importance of using baclofen and tizanidine with caution in older adults., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Aims: Post-lumbar puncture headache occurs in 5% to 12% of children. The purpose of this study was to determine the frequency and predictors of post-lumbar puncture headache in children with hypertonia undergoing lumbar puncture for intrathecal baclofen trial. Methods: This was a retrospective single-center review of all 43 children (<18 years) with hypertonia and/or dyskinesia undergoing intrathecal baclofen trial from 2013-2022. Predictors of post-lumbar puncture headache were evaluated via 2-way paired t test and Fisher exact test. Results: Seven subjects (16.3%) developed post-lumbar puncture headache. Of patients who developed post-lumbar puncture headache, 3 required emergency care or hospitalization. One was misdiagnosed with constipation. The 16 patients without opening pressure measured were excluded from subsequent analyses. Of the 27 patients with documented opening pressure, the mean opening pressure was 24.0 cm H 2 O (SD 6.5) and 5 (18.5%) had elevated opening pressure (>28 cm H 2 O). Mean opening pressure was higher for those with post-lumbar puncture headache (28.6 vs 22.4 cm H 2 O, P  = .014). Sixty percent of patients with elevated opening pressure developed post-lumbar puncture headache. Baclofen pumps were placed in 4 (80%) patients with elevated opening pressure and 6 (85.7%) with post-lumbar puncture headaches without complications. Interpretation: The risk of post-lumbar puncture headache after intrathecal baclofen trial was higher than reported in the literature, likely because of greater rates of elevated opening pressure. Physicians may use opening pressure to predict risk for post-lumbar puncture headache and should educate families about symptoms. Elevated opening pressure or post-lumbar puncture headache may not preclude baclofen pump placement., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: To assess the complication risks associated with intrathecal baclofen (ITB) pumps in cerebral palsy (CP) patients undergoing posterior spinal fusion (PSF) and to determine if timing of pump implantation before or during PSF impacts the risk of complications., Methods: A prospectively collected multicenter database was retrospectively reviewed to identify CP patients undergoing PSF from 2008 to 2023. Patients were divided into 2 cohorts: those with an ITB pump (ITB cohort) and those without (non-ITB cohort). The ITB cohort was further categorized by placement of the pump prior to or during PSF. Cohorts were then compared in terms of postoperative complications, perioperative complications, and need for revision surgery., Results: Four hundred six patients (ITB n = 79 [53 prior to, 26 during PSF], non-ITB n = 326) were included in this analysis. At an average follow-up of 4.0 years (range 2-10 years), there were no significant differences between the ITB and non-ITB cohorts in the rate of perioperative complications (5.0% vs 6.5%, p = 0.80), revision surgeries (2.5% vs 4.6%, p = 0.54), or any complication type, regardless of whether pumps were placed prior to or during PSF, aside from longer surgical times in the latter group., Conclusion: Complication rates are similar for ITBs placed prior to and during PSF. Patients with spastic CP may safely be treated with ITB pumps without increased risks of complication or further reoperation/revision following PSF., Level of Evidence: Level III., (© 2023. The Author(s), under exclusive licence to Scoliosis Research Society.)

Objective: To analyze the effectiveness and tolerability of various regimens for the use of tolperisone hydrochloride (TH) in the treatment of patients with acute nonspecific lower back pain (ALBP)., Material and Methods: 90 patients with ALBP (54.3 [48.7; 61.3] years) were divided into 2 groups: group 1 ( n =45) received basic therapy - NSAIDs, B vitamins and TH sustained release (450 mg/day per os ), group 2 ( n =45) used basic treatment and TH 2 ml intramuscularly 2 times a day for 5 days with a transition to a TH sustained release 450 mg/day per os . The total duration of the study was 30 days. We analyzed the visual analogue pain scale (VAS-B), the results of the modified modified Schober test (MMST), the medication adherence scale (Drug Attitude Inventory - DAI-10), the Epworth daytime sleepiness scale (ESS), functional activity associated with low back pain (Roland-Maurice questionnaire, RM), duration of TH intake (days), frequency and characteristics of adverse events (AE). At the screening visit, all patients were additionally divided depending on the intensity of pain according to VAS-B («mild», «moderate», «severe»)., Results: There were no significant differences on the VAS-B scale between groups 1 and 2 in patients with mild pain; there was significantly more complete pain control in group 2 with moderate pain after 14 and 30 days, ( p =0.0013, 14 days; p =0.0021, 30 days); among patients with severe pain, the best result after 30 days was observed in group 2 ( p =0.0016). In all patients the range of motion in the lumbosacral spine (MSST) significantly increased and functional activity (RM) improved compared to the initial state: more significant in group 2 with moderate pain after 14 and 30 days and with severe pain after 30 days. There was a high adherence to therapy (DAI-10), more pronounced in the first 14 days in patients of group 1. Excessive daytime sleepiness (ESS) was not observed. For moderate pain, patients in group 2 used TH for a significantly shorter period of time (16.4±1.6 days) compared to patients in group 1 (19.6±2.2 days, p =0.0022). AE were mild and did not serve as a reason to refuse therapy., Conclusion: A protocol for prescribing TH was proposed, based on stratification of patients according to VAS-B.The use of TH for ALBP is effective and safe. The proposed protocol for stratifying patients according to VAS-B level allows identifying the patients with step-by-step scheme of prescribing the drug for a period of 14 to 30 days.

Background: The growth of oral muscle relaxant prescriptions among older adults in the United States is concerning due to the drugs' adverse sedative effects. Baclofen is a gamma-aminobutyric acid agonist muscle relaxant that is associated with encephalopathy. We characterized the risk of fall and fracture associated with oral baclofen against other muscle relaxants (tizanidine or cyclobenzaprine) in older adults., Methods: We designed a new-user, active-comparator study using tertiary health system data from Geisinger Health, Pennsylvania (January 2005 through December 2018). Older adults (aged ≥65 years) newly treated with baclofen, tizanidine, or cyclobenzaprine were included. Propensity score-based inverse probability of treatment weighting (IPTW) was used to balance the treatment groups on 58 baseline characteristics. Fine-Gray competing risk regression was used to estimate the risk of fall and fracture., Results: The study cohort comprised of 2205 new baclofen users, 1103 new tizanidine users, and 9708 new cyclobenzaprine users. During a median follow-up of 100 days, baclofen was associated with a higher risk of fall compared to tizanidine (IPTW incidence rate, 108.4 vs. 61.9 per 1000 person-years; subdistribution hazard ratio [SHR], 1.68 [95% CI, 1.20-2.36]). The risk of fall associated with baclofen was comparable to cyclobenzaprine (SHR, 1.17 [95% CI, 0.93-1.47]) with a median follow-up of 106 days. The risk of fracture was similar among patients treated with baclofen versus tizanidine (SHR, 0.85 [95% CI, 0.63-1.14]) or cyclobenzaprine (SHR, 0.85 [95% CI, 0.67-1.07])., Conclusions: The risk of fall associated with baclofen was greater than tizanidine, but not compared to cyclobenzaprine in older adults. The risk of fracture was comparable among the older users of baclofen, tizanidine, and cyclobenzaprine. Our findings may inform risk-benefit considerations in the increasingly common clinical encounters where oral muscle relaxants are prescribed., (© 2023 The American Geriatrics Society.)

Intrathecal baclofen (ITB) therapy effectively treats spasticity caused by brain or spinal cord lesions. However, only a few studies compare the course of treatment for different diseases. We investigated the change in daily dose of baclofen per year and its associated adverse events in patients presenting with the three most common etiologies at our institute: hereditary spastic paraplegia, cerebral palsy, and spinal cord injury. The ITB pumps were implanted from July 2007 to August 2019, with a mean follow-up period of 70 months. In patients with hereditary spastic paraplegia, baclofen dosage was reduced after eight years following ITB introduction, and the treatment was terminated in one patient owing to disease progression. In patients with cerebral palsy, the dosage increased gradually, and became constant in the 11th year. Patients with spinal cord injury gradually increased their baclofen dosage throughout the entire observation period. Severity and adverse event rates were higher in patients with cerebral palsy than in others. The degree and progression of spasticity varied depending on the causative disease. Understanding the characteristics and natural history of each disease is important when continuing ITB treatment.

Competing Interests: Competing interests: None declared.

Background: The activities related to intrathecal baclofen (ITB) therapy could not be interrupted at the outbreak of COVID-19 pandemic due to possible life-threatening related complications such as withdrawal and over dosage syndromes. In this study we reported the different adopted strategies to manage patients with an ITB implanted infusion pump during the pandemic period and studied the impact of these strategies on experiences reported from patients and their caregivers, assessed through a specific survey., Methods: Thirty-five patients (mean age: 43.71±12.33 years) were included. Their clinical and medical data were recorded and observed from March 2020 to March 2021 and different strategies implemented in order to limit patients and providers risk of exposure to COVID-19. The impact of these strategies was assessed trough a survey that was performed after the first two months of pandemic (coinciding with the period of general lockdown) and after one year from the pandemic onset., Results: We observed a statistically significant improvement of the following items: difficulties in reaching medical clinic (P=0.0072), continuation of physical therapy (P=0.0021) and feelings of anxiety in medical conditions (P=0.0006). Considering the difficulties in communications with the medical staff we obtained optimal scores both at the beginning of pandemic and after one year from the pandemic onset without significant difference., Conclusions: Our survey showed that the adopted strategies provided a feeling of confidence and safety among ITB patients and their caregivers during the COVID-19 pandemic. We think that a clear communication is always of paramount importance to manage these patients.

Since the first implantation in July 2001, the intrathecal baclofen (ITB) therapy for patients with generalized spasticity has been used in Slovenia for 20 years. The aim of this retrospective study was to evaluate the rates of different complications, especially if catheter-related complications were less frequent after the introduction of the coated catheter type in February 2013, and the potential correlation between higher baclofen doses and the incidence of complications. We retrospectively collected data from all patients in the registry during the period from 3 July 2001 to 31 December 2021. Among 138 patients (48 females), 120 patients had the first ITB system implanted at the University Medical Centre Ljubljana. Forty-three complications were reported in 38 patients (27%), with a total complication rate of 0.203/1000 days or 0.074/pump year. The most frequent was catheter-related (0.083/1000 days or 0.030/pump year), followed by skin-related (0.063/1000 days or 0.023/pump year) and pump-related complication (0.026/1000 days or 0.009/pump year). The incidence of catheter-related complications decreased significantly since the use of Ascenda type catheter: 14/7 complications per 88/147 implantations ( P  = 0.008). Patients with complications had a statistically significantly higher dose of baclofen: median 400 µg/24h vs. median 300 µg/24h ( P  = 0.016). Our retrospective analysis confirmed a significant decrease of catheter-related complications after the implementation of Ascenda type catheter in February 2013. Patients with a higher ITB dose had a statistically significantly higher incidence of complications. The total complication rate was a bit higher as previously reported in other studies, which is consistent with a long follow-up time., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Baclofen and tizanidine are both muscle relaxants that carry the risk for neuropsychiatric events in older adults but there is a lack of data directly comparing their safety. This study aimed to investigate the relative risk between these two medications in causing injury and delirium in older adults., Methods: This was a retrospective cohort study that was completed in an integrated healthcare system in the United States and included patients aged 65 years or older who started baclofen or tizanidine for the treatment of musculoskeletal pain from January 2016 through December 2018. Outcomes included new incidence of injury (concussion, contusion, dislocation, fall, fracture, or other injuries) and delirium. The cohort was followed from the initiation of therapy until the first occurrence of any of the following events: end of the index drug exposure, end of health plan membership, death, or the study end date of December 31st, 2019. Descriptive statistics were used to compare baseline patient characteristics between baclofen and tizanidine treatment groups. Cox proportional hazards model was used to calculate adjusted hazard ratios (HRs) with 95% confidence intervals., Results: The final study cohort included 12,101 and 6,027 older adults in the baclofen and tizanidine group respectively (mean age 72.2 ± 6.2 years old, 59% female). Older adults newly started on baclofen had a greater risk of injury (HR = 1.54, 95% CI = 1.21-1.96, P = < 0.001) and delirium (HR = 3.33, 95% CI = 2.11-5.26, p = <0.001) compared to those started on tizanidine., Conclusion: The results of this study suggest that baclofen is associated with higher incidences of injury and delirium compared to tizanidine when used for the treatment of musculoskeletal pain. Future studies should investigate if these risks are dose-related and include a comparison group not exposed to either drug., (© 2023 The American Geriatrics Society.)

Objective: To quantify the risk of encephalopathy associated with oral baclofen compared with other muscle relaxants-tizanidine or cyclobenzaprine., Patients and Methods: We conducted a new-user, active-comparator study of 2 pairwise cohorts using tertiary health system data from Geisinger Health in Pennsylvania (January 1, 2005, through December 31, 2018). Adults (aged ≥18 years) newly treated with baclofen or tizanidine were included in cohort 1. Adults newly treated with baclofen or cyclobenzaprine were included in cohort 2. Propensity score-based inverse probability of treatment weighting (IPTW) was used to balance the respective cohorts on 45 patient characteristics. Fine-Gray competing risk regression was used to estimate the risk of encephalopathy., Results: Cohort 1 included 16,192 new baclofen users and 9782 new tizanidine users. The 30-day risk of encephalopathy was higher in patients treated with baclofen vs tizanidine (IPTW incidence rate, 64.7 vs 28.3 per 1000 person-years) with an IPTW subdistribution hazard ratio (SHR) of 2.29 (95% CI, 1.43 to 3.67). This risk persisted through 1 year (SHR, 1.32 [95% CI, 1.07 to 1.64]). Similarly in cohort 2, baclofen vs cyclobenzaprine was associated with a greater risk of encephalopathy at 30 days (SHR, 2.35 [95% CI, 1.59 to 3.48]) that persisted through the first year of treatment (SHR, 1.94 [95% CI, 1.56 to 2.40])., Conclusion: The risk of encephalopathy was greater with baclofen vs tizanidine or cyclobenzaprine use. The elevated risk was apparent as early as 30 days and persisted through the first year of treatment. Our findings from routine care settings may inform shared treatment decisions between patients and prescribers., (Copyright © 2022 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Objective: To examine the efficacy, dosing, and safety profiles of intrathecal and oral baclofen in treating spasticity after spinal cord injury (SCI)., Data Sources: PubMed and Cochrane Databases were searched from 1970-2018 with keywords baclofen, spinal cord injury, and efficacy., Study Selection: The database search yielded 588 sources and 10 additional relevant publications. After removal of duplicates, 398 publications were screened., Data Extraction: Data were extracted using the following population, intervention, comparator, outcomes, and study designs criteria: studies including adult patients with SCI with spasticity; the intervention could be oral or intrathecal administration of baclofen; selection was inclusive for control groups, surgical management, rehabilitation, and alternative pharmaceutical agents; outcomes were efficacy, dosing, and adverse events. Randomized controlled trials, observational studies, and case reports were included. Meta-analyses and systematic reviews were excluded., Data Synthesis: A total of 98 studies were included with 1943 patients. Only 4 randomized, double-blinded, and placebo-controlled trials were reported. Thirty-nine studies examined changes in the Modified Ashworth Scale (MAS; 34 studies) and Penn Spasm scores (Penn Spasm Frequency; 19 studies), with average reductions of 1.7±1.3 and 1.6±1.4 in individuals with SCI, respectively. Of these data, a total of 6 of the 34 studies (MAS) and 2 of the 19 studies (Penn Spasm Frequency) analyzed oral baclofen. Forty-three studies addressed adverse events with muscle weakness and fatigue frequently reported., Conclusions: Baclofen is the most commonly-prescribed antispasmodic after SCI. Surprisingly, there remains a significant lack of large, placebo-controlled, double-blinded clinical trials, with most efficacy data arising from small studies examining treatment across different etiologies. In the studies reviewed, baclofen effectively improved spasticity outcome measures, with increased efficacy through intrathecal administration. Few studies assessed how reduced neural excitability affected residual motor function and activities of daily living. A host of adverse events were reported that may negatively affect quality of life. Comparative randomized controlled trials of baclofen and alternative treatments are warranted because these have demonstrated promise in relieving spasticity with reduced adverse events and without negatively affecting residual motor function., (Copyright © 2022 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: Complications of intrathecal baclofen treatment (ITB) with an implanted pump can be severe and require surgery. Surgical implantation techniques and catheter materials for continuous ITB treatment have improved over the past years with the aim to reduce complications., Objective: To assess: 1) the type and rate of complications of ITB that require surgical intervention, 2) which risk factors influence the occurrence of complications, and, specifically, 3) whether complication rate is influenced by type of catheter used., Methods: A retrospective cohort study was conducted including all children (<18 years old) in one university medical center with pump implantation between 2001 and 2017. All complications requiring surgery were recorded. Risk factors for surgical intervention were determined using multiple logistic regression analysis. Catheter related complications between two types of catheters (silicone vs coated) were compared., Results: In total, 88 complications of ITB treatment requiring surgery were found in 47 (36.2%) out of 130 children. These included catheter-related complications (55.7% of all complications), infections (21.6%), cerebrospinal fluid leakage (14.8%), and pump-related complications (7.9%). The silicone catheter type, used until 2012, was found to be a significant risk factor for complications (Odds Ratio 3.75; 95% CI: 1.30-10.83). Since the introduction of the coated catheter type, in 2012, the rate of catheter-related complications decreased, from 0.15 to 0.10 complications per pump year., Conclusion: The rate of surgical complications of intrathecal baclofen in children is high, and most frequently catheter-related. The number of complications decreased since the introduction of a new, coated, catheter in 2012. This study helps to inform children and their caregivers about the risk of possible complications of ITB, and to identify directions for future improvement of ITB care., (© 2022 Published by Elsevier Ltd on behalf of European Paediatric Neurology Society.)

This is a case of a 19-year-old male with a history of remote severe traumatic brain injury (TBI) with an intrathecal baclofen (ITB) pump for dystonia management. Given concern for lack of efficacy despite increasing doses of ITB, his catheter was evaluated and found to be epidural rather than intrathecal. The baclofen dose was down-titrated and he underwent catheter revision. Post-op, his baclofen dose was up-titrated and complicated by significant behavioral changes including aggressive physical and verbal behaviors resulting in hospitalization. Work-up was negative for infection, new neurologic pathology, and epileptic activity. Psychiatric medications were adjusted but the behaviors persisted. Due to concern that the increased baclofen dose was causing his mood instability, his pump was down-titrated. As the dosage decreased, the frequency of outbursts also decreased. Throughout these dose adjustments, his dystonia remained stable and overall functional status improved. This is one of the first cases demonstrating that ITB may exacerbate mood instability in patients with TBI.

Falls are common in elderly patients, and prevention of fall is important for safety and for reduction of health care costs. Sleep medications are among many potential causes of fall. In this study, we examined relationship of sleep medication with fall from January 2017 to December 2017. 726 falls occurred in 442 patients, and the average age at the time of fall was 60.7 ± 23.8 years. Fall was most common in patients with neurological disease, followed by gastroenterological, ophthalmological, respiratory, and orthopedic conditions. Sleep medication was used in 223 falls (31%). Fall occurred at all times of day, but with a different distribution in patients with and without use of sleep medication. Thus, the rate of falls from 22:00 to 6:00 was significantly higher in patients using sleep medication (62% vs. 18%, p<0.01). There was also a significantly higher rate of multiple falls in patient using sleep medication (p<0.01). Zolpidem (25%, n=63), a non-benzodiazepine, was the most frequently used sleep medication, followed by brotizolam (16%, n=41) and etizolam (13%, n=32), which are both benzodiazepines. Multiple falls from 22:00 to 6:00 occurred significantly more frequently in patients using ≥2 types of sleep medications compared to one (53% vs. 17%, p<0.01). Taking multiple sleeping pills makes it easier to fall, and even drugs with a short half-life, which are considered to be safe, can cause falls at night in elderly patients. The results of this study show that careful selection of sleep medications is required to prevent fall in elderly patients., Competing Interests: Financial support was from institutional sources only. None of the authors have a conflict of interest to declare.

Objectives: Intrathecal baclofen (ITB) is a cost-effective therapy for patients with severe spasticity. The most common complications are catheter-related complications (CRCs) including kinking/occlusion, blockage, migration, fracture, disconnection, and CSF leak. Our objective was to determine the CRC rate in a large cohort of adults with newly implanted ITB pump systems with polymer reinforced silicone catheters., Materials and Methods: This is a retrospective study of a prospectively maintained database consisting of patients who had undergone implantation of ITB pump systems with Ascenda (Medtronic, Minneapolis) catheters from 2013 to 2020. Over this seven-year period, 141 patients underwent ITB pump system implantations; 126 of which had a minimum of one-year follow-up., Results: The 126 patients with a minimum of one year follow-up (average 43 month; range 12-89), had an average age of 51 years (63% male). Severe spasticity was due to spinal cord injury (38%), traumatic brain injury (15%), cerebral palsy (13%), multiple sclerosis (11%), stroke (10%), and other (13%). Nine (7.1%) CRCs occurred in 7 (5.6%) patients (median 6 mo. post-implant): 5 intrathecal catheter occlusions (range 3-52 months post-implant), two fractures in one patient (6 months), one disconnection at the catheter pump interface (2 months), and one due to kinking at 84 months No migrations occurred., Conclusions: Reported CRCs have been high for ITB pump systems. Ours is the first large cohort, long-term study of CRCs related to reinforced catheters; additionally, our low CRC rate compares favorably to previously published data. Thus, implantation of reinforced catheters may be associated with a low CRC rate., (© 2021 International Neuromodulation Society.)

There are many medications available to treat spasticity, but the tolerability of medications is the main issue for choosing the best treatment. The objectives of this study were to compare the efficacy and adverse effects of tolperisone compared to baclofen among patients with spasticity associated with spinal cord injury. Patients received baclofen plus physical therapy (BAF+PT, n=135) or tolperisone plus physical therapy (TOL+PT, n=116), or physical therapy alone (PT, n=180). The modified Ashworth scale score, the modified Medical Research Council score, the Barthel Index score, and the Disability Assessment scale score were improved (P<0.05 for all) in all the patients at the end of 6 weeks compared to before interventions. After 6 weeks, the overall coefficient of efficacy of the intervention(s) in the BAF+PT, TOL+PT, and PT groups were 1.15, 0.45, and 0.05, respectively. The patients of the BAF+PT group reported asthenia, drowsiness, and sleepiness and those of the TOL+PT group reported dyspepsia and epigastric pain as adverse effects. When comparing drug interventions to physical therapy alone, both baclofen plus physical therapy and tolperisone plus physical therapy played a significant role in the improvement of daily activities of patients. Nonetheless, baclofen plus physical therapy was tentatively effective. Tolperisone plus physical therapy was slightly effective. In addition, baclofen caused adverse effects related to the sedative manifestation (Level of Evidence: III; Technical Efficacy Stage: 4).

Objective: We studied physicians' opinions and experiences concerning clinical concerns, perceived severity, occurrence, and management of baclofen withdrawal due to abrupt discontinuation., Methods: A nationwide 26-question electronic survey was distributed via e-mail to physicians (N = 952) representing varying specialties who manage spasticity with baclofen. A total of 110 physicians provided responses to the survey (response rate = 11.6%). Results were evaluated using descriptive statistics., Results: Withdrawal from both oral and intrathecal (IT) baclofen was recognized as a significant concern and was observed by most respondents. However, approximately 75% and 35% of respondents or their clinic sites lack established management protocols for managing anticipated interruption of oral or IT baclofen, respectively., Conclusions: These findings highlight the need for further research on and the development of guidelines for the prevention and treatment of baclofen withdrawal. The results of this survey, along with a systematic literature review and multidisciplinary stakeholder input, may be helpful in establishing guidelines for the treatment and prevention of baclofen withdrawal., (Copyright © 2021 Elsevier Inc. All rights reserved.)

BACKGROUNDWolfram syndrome is a rare ER disorder characterized by insulin-dependent diabetes mellitus, optic nerve atrophy, and progressive neurodegeneration. Although there is no treatment for Wolfram syndrome, preclinical studies in cell and rodent models suggest that therapeutic strategies targeting ER calcium homeostasis, including dantrolene sodium, may be beneficial.METHODSBased on results from preclinical studies on dantrolene sodium and ongoing longitudinal studies, we assembled what we believe is the first-ever clinical trial in pediatric and adult Wolfram syndrome patients with an open-label phase Ib/IIa trial design. The primary objective was to assess the safety and tolerability of dantrolene sodium in adult and pediatric Wolfram syndrome patients. Secondary objectives were to evaluate the efficacy of dantrolene sodium on residual pancreatic β cell functions, visual acuity, quality-of-life measures related to vision, and neurological functions.RESULTSDantrolene sodium was well tolerated by Wolfram syndrome patients. Overall, β cell functions were not significantly improved, but there was a significant correlation between baseline β cell functions and change in β cell responsiveness (R2, P = 0.004) after 6-month dantrolene therapy. Visual acuity and neurological functions were not improved by 6-month dantrolene sodium. Markers of inflammatory cytokines and oxidative stress, such as IFN-γ, IL-1β, TNF-α, and isoprostane, were elevated in subjects.CONCLUSIONThis study justifies further investigation into using dantrolene sodium and other small molecules targeting the ER for treatment of Wolfram syndrome.TRIAL REGISTRATIONClinicalTrials.gov identifier NCT02829268FUNDINGNIH/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (DK112921, DK113487, DK020579), NIH/National Center for Advancing Translational Sciences (NCATS) (TR002065, TR000448), NIH training grant (F30DK111070), Silberman Fund, Ellie White Foundation, Snow Foundation, Unravel Wolfram Syndrome Fund, Stowe Fund, Eye Hope Foundation, Feiock Fund, Washington University Institute of Clinical and Translational Sciences grant UL1TR002345 from NIH/NCATS, Bursky Center for Human Immunology & Immunotherapy Programs.

Objective: To evaluate the effectiveness and safety of intrathecal baclofen treatment of spasticity, administered via a cervical catheter tip., Design: A review of PubMed and the Cochrane Library up to September 2020. No restriction in study design. Two reviewers independently evaluated eligibility, extracted data and evaluated risk of bias. Studies were included in which patients were treated with intrathecal baclofen for spasticity, with the catheter tip at or above the first thoracic level, independent of diagnosis and age., Results: Thirteen studies were eligible, with a moderate to critical risk of bias. Improvement in spasticity was seen only in the upper extremity in 6% of subjects, only in the lower extremity in 2%, in both upper and lower extremities in 50% and without specification of location in 41%. Upper extremity function improved in 88% of cases. Neither drug-related (1%) nor technical (21%) complications occurred more often than in lower placement of the tip. Effects on respiratory function and sleep apnoea were not investigated., Conclusion: Cervically administered intrathecal baclofen seems to improve upper extremity spasticity and function, without causing more complications than thoracolumbar intrathecal baclofen. However, the mainly drug-related complications have not been thoroughly investigated and the available literature is of poor methodological quality. Further research is needed to confirm the efficacy and safety of this procedure.

Background: Baclofen is commonly used in both pediatric and adult patients to treat spasticity secondary to spinal cord and cerebral pathology. A broad range of symptoms and severity of baclofen toxicity have been described. However, to our knowledge, there are no reports to date of baclofen toxicity mimicking brain death in pediatric patients., Objective: We reviewed the presentation, clinical course, diagnostic studies including imaging and electroencephalography, and outcome of a patient with transient coma and loss of brainstem reflexes mimicking brain death secondary to baclofen toxicity., Methods: During a baclofen pump refill, a 12-year-old boy with cerebral palsy had inadvertent injection of 12,000 μg of baclofen into the pocket around his pump. Within an hour, he presented with acute altered mental status that rapidly progressed to a comatose state with absent brainstem reflexes., Results: After appropriate management, the patient returned to his neurological baseline by hospital day 3., Discussion: We reviewed the literature for varying presentations of baclofen toxicity and associated electroencephalography findings, mechanism of overdose, and different management options. In this case, the mechanism of baclofen toxicity was suspected to be secondary to extravasation from the pump pocket and subsequent systemic absorption., Conclusions: Patients with baclofen toxicity may have a dramatic presentation and an initial examination mimicking brain death. Given its rarity, this clinical entity may not be readily recognized, and there is potential for misinterpretation of diagnosis and prognosis. It is important for physicians to be familiar with this clinical scenario to avoid false declaration of brain death., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Aim: This study aims to examine the adverse event (AE) rate for intrathecal baclofen (ITB) therapy in an Australian paediatric population and to clarify type and frequency of AEs., Methods: AE data were extracted from the Australian Paediatric ITB Research Group national database, to include the first 5 years of data collection. Raw data were collated and analysed descriptively., Results: Data were collected for 40 patients. Forty-seven AEs in 23 patients were reported. Ten (25%) patients required surgical intervention related to their AE. Five patients (12.5%) required pump removal. The most frequent ITB-related AEs were catheter dysfunction (24%), drug overdose, withdrawal or sensitivity (19%), seromas and haematomas (15%) and infections (13%)., Conclusions: The AE rate for ITB therapy is high and needs to be considered when counselling patients regarding ITB as a therapeutic option., (© 2020 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Background: Patients with cerebral palsy and other static encephalopathies (CP) are known to be at increased risk of sleep-related breathing disorders (SRBD). Few studies have reviewed whether intrathecal baclofen (ITB) can contribute to SRBD., Objective: To assess the prevalence of SRBD in patients with CP receiving ITB by using nocturnal polysomnography (NPSG)., Methods: We performed a retrospective chart review of patients receiving ITB who had NPSG at Children's Hospital Colorado (CHCO) and Seattle Children's Hospital (SCH) from 1995 to 2019. The Gross Motor Function Classification System (GMFCS) measured the severity of motor disability. Screening sleep questionnaires collected subjective data and NPSG provided objective data of SRBD., Results: All patients except one were GMFCS 4 or 5 with median age at ITB pump placement of 9.7 years. The screening questionnaire for SRBD detected one or more nighttime symptoms in > 82% of all patient groups. Pre-ITB criteria for a SRBD was met in 83% of patients at CHCO and 91% at SCH. Post-ITB prevalence remained similarly high., Conclusions: NPSG identified a high prevalence of SRBD in these cohorts from CHCO and SCH. Our study showed neither improvement nor worsening of SRBD in patients receiving ITB.

Background: Eperisone is a commonly prescribed oral muscle relaxant, but few studies have been conducted of eperisone-induced hypersensitivity reactions., Objective: The purpose of this study was to investigate the clinical manifestations of eperisone-induced immediate-type hypersensitivity, and to evaluate the role of an intradermal test (IDT) in eperisone-induced anaphylaxis., Methods: This study was based on a retrospective review of medical records from 23 patients diagnosed as eperisone-induced immediate-type hypersensitivity with certain or probable causality. Intradermal tests were performed with a sterile 10 mg/mL eperisone solution., Results: Immediate-type hypersensitivity reactions to eperisone occurred within 15 minutes in 8.7%, within 30 minutes in 52.2%, and within 60 minutes in 82.6% of the patients, cumulatively. All patients showed cutaneous symptoms. Gastrointestinal symptoms were the second-most frequent (65.2%), respiratory symptoms (56.5%) followed, and cardiovascular symptoms were the least (39.1%). Nine (39.1%) patients were categorized as severe anaphylaxis. The mean onset time of severe anaphylaxis was 28.89 minutes, which was significantly shorter than non-severe anaphylaxis (p = 0.011). Five patients among the severe anaphylaxis group were evaluated with IDT, and all showed positive results. In contrast, all of the four patients who have done IDT among the moderate anaphylaxis group showed negative results. There was a significant relationship between severe anaphylaxis and positive IDT results (p = 0.008)., Conclusions: Eperisone-induced immediate-type hypersensitivity is not uncommon in Korea, and the IDT could be a useful and safe diagnostic tool, especially in severe anaphylaxis.

Competing Interests: Competing interests: None declared.

Objectives: Intrathecal baclofen (ITB) pumps are an effective treatment for spasticity; however infection rates have been reported in 3-26% of patients in the literature. The multidisciplinary ITB service has been established at The National Hospital for Neurology and Neurosurgery, UCLH, Queen Square, London for over 20 years. Our study was designed to clarify the rate of infection in our ITB patient cohort and secondly, to formulate and implement best practice guidelines and to determine prospectively, whether they effectively reduced infection rates., Methods: Clinical record review of all patients receiving ITB pre-intervention; January 2013-May 2015, and following practice changes; June 2016-June 2018., Results: Four of 118 patients receiving ITB during the first time period (3.4%, annual incidence rate of infection 1.4%) developed an ITB-related infection (three following ITB pump replacement surgery, one after initial implant). Infections were associated with 4.2% of ITB-related surgical procedures. Three of four pumps required explantation. Following change in practice (pre-operative chlorhexidine skin wash and intraoperative vancomycin wash of the fibrous pocket of the replacement site), only one of 160 ITB patients developed infection (pump not explanted) in the second time period (0.6%, annual incidence rate 0.3%). The infection rate related to ITB surgical procedures was 1.1%. In cases of ITB pump replacement, the infection rate was reduced to 3.3% from 17.6%., Conclusions: This study suggests that a straightforward change in clinical practice may lower infection rates in patients undergoing ITB therapy., (© 2019 International Neuromodulation Society.)

We report a case of a 53-year-old woman who presented initially with sepsis and later in her stay developed a severe and rapidly progressing hyperthermia after a decrease in oral baclofen dosage. Her fever peaked at 42.5 ○ C (108.5 ○ F), creating a broad differential diagnosis and complicating her initial sepsis diagnosis. When the oral baclofen dose was increased, the fevers resolved which confirmed the clinical diagnosis of baclofen withdrawal. Dose reductions of oral baclofen should be made gradually and with caution, and patients should be monitored for fevers as a possible symptom of baclofen withdrawal., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

What Is Known and Objective: Tolperisone is a centrally acting muscle relaxant under development in the United States as a treatment for acute and painful symptoms of muscle spasms. The objective of this three-way, randomized, blinded, three-period crossover study was to assess the safety and cognitive effects of tolperisone compared to placebo and the widely used muscle relaxant cyclobenzaprine in healthy volunteers., Methods: Subjects were randomized to 1 of 3 treatment arms to receive tolperisone (150 mg), cyclobenzaprine (10 mg) or placebo 3 times per day (TID) in 3 separate study periods. Subjects completed a driving test on the Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim), a validated driving simulator, on day 1 at time to maximum plasma concentration, on day 2 before the morning dose of study drug and on day 3 at steady state following the morning dose. Subjects were assessed on various driving parameters and on a computer-administered digit-symbol substitution test (CogScreen symbol digit coding test). The driving scenario is a monotonous 100 km highway route on which subjects are instructed to maintain speed and lane position., Results and Discussion: The performance of subjects who had received tolperisone was not significantly different from those who had received placebo in terms of the primary end point: standard deviation of lateral position, a measure of weaving. Subjects who had received tolperisone also performed comparably to those who had received placebo on a range of secondary measures assessing driving ability, cognition and psychomotor performance. In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability. Despite their markedly poorer driving performance after receiving cyclobenzaprine, few subjects reported feeling unsafe to drive on day 1 (10.3%) and day 2 (3.4%). The incidence of adverse events was similar for tolperisone (36.4%) and placebo (29.0%) and was greater for cyclobenzaprine (45.4%)., What Is New and Conclusion: Subjects who received tolperisone (150 mg TID) experienced no impact on various measures of driving, self-reported sleepiness and cognition measures compared to placebo, in contrast to those who received the widely used muscle relaxant cyclobenzaprine (10 mg TID)., (© 2020 The Authors. Journal of Clinical Pharmacy and Therapeutics published by John Wiley & Sons Ltd.)

Background: Intrathecal baclofen (ITB) is an effective treatment for spasticity, and therapeutic levels may be optimized using surgically implanted pumps. Though these devices are effective, complications can pose significant challenges to patients, decreasing the therapeutic effect and potentially requiring reoperation. As such, it is critical that complications associated with ITB be effectively characterized., Methods: We queried the Manufacturer and User Facility Device Experience (MAUDE) database for cases reported during the past 3 years documenting adverse events specifically related to ITB pumps. We identified 1935 adverse events that were individually analyzed and categorized by type of complication., Results: Out of the 1935 unique adverse events identified from the MAUDE database, 25.7% were device-related complications (n = 497). Of those, 50.3% were catheter-specific (n = 250), 21.3% (n = 106) were pump-specific, and 28.3% (n = 141) were included, more generally, in catheter or device erosion., Conclusions: The MAUDE database may be a useful resource for evaluating ITB pump complications across a larger data set. By characterizing the complications and providing values for their total occurrences, patients and physicians may have more realistic expectations for the outcomes and morbidity of this device., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Study Design: Experimental study with mice., Objectives: Spasticity is a common complication after spinal cord injury (SCI) and has detrimental aspects, such as persistent pain and involuntary muscle spasms. This study aimed to assess the influence of antispastic therapy on locomotor function after SCI., Setting: University-based laboratory in Fukuoka, Japan., Methods: A mouse model of spasticity was developed by producing incomplete SCI at the 9th thoracic level. At 8 weeks after SCI, an antispastic drug, baclofen, was intraperitoneally administered to six injured and two sham-operated mice. The severity of spasticity was evaluated by the modified Ashworth scoring (MAS) system, and locomotor function was evaluated by the Basso-Beattie-Bresnahan (BBB) scale/Basso mouse score (BMS)., Results: The administration of baclofen significantly improved spasticity in the SCI mice and the mean MAS decreased to from 6.2 to 2.8. However, at the same time, it significantly exacerbated the locomotor dysfunction of the SCI mice and the mean BMS decreased from 4.7 to 2.3. The time-course of the changes in locomotor function coincided with the time-course of the spasticity score. We also confirmed that the administration of baclofen was not associated with any changes in either locomotor function or spasticity of the sham-operated control mice., Conclusions: Our results suggest that spasticity has a certain beneficial effect on ambulation ability. It is important to note that antispastic treatments may be associated with a risk of impairing the preserved function of chronic SCI patients.

A 76-year-old man developed recurrent encephalopathy, visual disturbance, myoclonus, generalised seizures and atonic drop attacks on a background of a gastrectomy for adenocarcinoma and stable chronic lymphocytic leukaemia. He presented to three different hospitals and was admitted twice, with normal investigations. His symptoms transiently improved during each admission (and with starting levetiracetam) but recurred each time on hospital discharge. Subsequent careful inspection of his medication box identified that his community pharmacy had in error been dispensing baclofen 80 mg per day instead of his prescribed Buscopan 80 mg per day. This case highlights the importance of physically inspecting a patient's medications and emphasises the spectrum of baclofen-related toxicity; it also highlights potential deficiencies in the pharmacy dispensary process and the need for multiple checks by patients and professionals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: High-risk combinations of controlled medications, such as those involving opioid analgesics, are under increased scrutiny because of their contribution to the opioid epidemic in the United States. Responsible prescribing guidelines indicate that the triple drug combination--opioids, benzodiazepines and skeletal muscle relaxants, especially carisoprodol--should not be concurrently prescribed., Methods: This pharmacoepidemiologic study was designed to primarily examine the characteristics of patients receiving this triple combination compared to the group receiving only opioids and benzodiazepines., Results: Results show that, while the number of exposed patients has declined since 2012, approximately 17,000 Floridians were prescribed this combination in 2017 alone. Demographically, recipients of these prescriptions were younger, more likely to be female, and geographically-localized. Furthermore, these patients were more frequently associated with a prescriber in the top 1% of opioid and/or benzodiazepine prescribing, have more multiple provider episodes ("doctor shopping"), and receive higher mean daily opioid dosages., Conclusions: These findings raise important questions as to how frequently prescribers are checking prescription drug monitoring programs, following US Centers for Disease Control and Prevention opioid prescribing guidelines, and/or handling the clinical challenges associated with pharmaceutical management of patients with complex, painful health conditions., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Intrathecal baclofen infusion trial is a sophisticated tool for selecting patients for permanent intra thecal baclofen infusion therapy We report our clinical experience of fifteen patients with refractory spasticity who underwent a continuous ITB trial using a temporary intraspinal indwelling catheter prior to permanent pump implantation. Patients underwent placement of a temporary intrathecal catheter that was connected to an external pump. Multisource feedback was obtained from the various healthcare professionals involved (Staff Nurse, Specialist nurse, physiotherapist, Doctor, family members, patient) regarding progress of test over 48-72 h. Average Modified Ashworth score after the trial was less than 2. Some degree of dose related minor adverse events (AEs) occurred in 8 patients, with the most common being nausea, constipation, urinary retention and hypotension. 10 patients received pump implant. 5 patients did not receive a pump because of AEs or because the goals were not met. 1 patient had pump removed after 4 years because of infection., (Crown Copyright © 2019. Published by Elsevier Ltd. All rights reserved.)

Introduction: Although fibromyalgia symptoms negatively affect patients' sexual life, sexual desire in women diagnosed with fibromyalgia has been understudied., Aim: To describe and compare sexual desire in women diagnosed with fibromyalgia and healthy control women, and to investigate the influence of fibromyalgia and its pharmacologic treatment on sexual desire among women diagnosed with fibromyalgia., Methods: 164 women diagnosed with fibromyalgia participated in the study. Participants' sexual desire, fibromyalgia symptoms, symptom interference in daily life activities, and perceived quality of life were measured. Further sociodemographic and health-related data were also recorded. 87 healthy women were selected as a control group, and their sexual desire was compared with those of women diagnosed with fibromyalgia., Main Outcome Measures: Main outcome measures included the Sexual Desire Inventory and the Fibromyalgia Impact Questionnaire., Results: When compared with healthy control subjects, women diagnosed with fibromyalgia exhibited a significantly lower mean score on total desire (47.92 ± 17.48 vs 26.33 ± 21.95; P < .001), solitary desire (10.52 ± 5.96 vs 5.74 ± 7.01; P < .001), and dyadic desire (37.40 ± 13.98 vs 20.59 ± 16.94; P < .001). Women diagnosed with fibromyalgia who were taking antidepressants scored significantly lower on dyadic desire (P < .001), solitary desire (P < .001), and total desire (P < .001) than those who were not. Furthermore, a negative correlation between desire (dyadic and solitary) and Revised Fibromyalgia Impact Questionnaire (total and all subscales) was found. Linear regression showed that taking antidepressants, age, and the total Fibromyalgia Impact Questionnaire score explained 16% of the variance of total desire., Clinical Implications: Knowing how fibromyalgia symptoms and their pharmacologic treatment affect women's sexual desire may have implications for designing care strategies according to individual needs., Strengths & Limitations: To the best of our knowledge, this is the first study that focuses on studying the impact of fibromyalgia on dyadic and solitary sexual desire. Limitations are related to having used an online questionnaire for data collection, having recruited the participants through a convenience sampling technique and not being able to isolate whether certain results are related to fibromyalgia symptoms or are side effects of the pharmacologic treatment used for symptom control., Conclusion: Fibromyalgia impact seems to negatively influence dyadic and solitary sexual desire in women. In addition, other factors such as age or taking antidepressant drugs may result in lower sexual desire in these patients. López-Rodríguez MM, Pérez Fernández A, Hernández-Padilla JM, et al. Dyadic and Solitary Sexual Desire in Patients With Fibromyalgia: A Controlled Study. J Sex Med 2019;16:1518-1528., (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Bullous pemphigoid (BP) is an autoimmune disorder which is usually chronic, with blistering that predominantly affects the skin and occasionally the mucosa, and which includes several different types. One of them is a very rare dyshidrosiform type which is localized on the hands and feet with small or large blisters on the palmoplantar surfaces. BP resulting from a drug reaction is a relatively rare occurrence, and so far more than 50 different medications have been identified as triggers. The aim of this article was to present the case of a paraplegic patient who developed this rare dyshidrosiform type of BP while he was being neurologically treated with baclofen. In spite of therapy with systemic and topical corticosteroids and other measures, successful treatment was achieved only after eliminating baclofen from the patient's regimen. His general state of health was seriously endangered due to nasal and skin methicillin-resistant Staphylococcus aureus (MRSA), urinary infection, and oral mycosis (soor), and he was at high risk of sepsis and a fatal outcome. Through our efforts, however, we managed to achieve an excellent outcome. According to our knowledge, this was the first case of baclofen-induced dyshidrosiform BP.

Introduction: Cyclobenzaprine is a skeletal muscle relaxant primarily used in the treatment of pain. Its use during lactation is a matter of concern as its level of exposure to infants through human milk is still unknown., Main Issue: The aim of this study was to determine cyclobenzaprine concentrations in the milk samples collected from two lactating mothers., Management: The present study describes the analysis of cyclobenzaprine in human milk using liquid chromatography mass spectrometry, which determined the drug concentration-time profiles in human milk., Conclusion: This study shows low levels of concentrations of cyclobenzaprine in human milk with calculated relative infant dose of 0.5%. However, due to the sedative properties of cyclobenzaprine, regular clinical assessment of the infant is recommended to evaluate for long-term effects.

Objective: To report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation., Design: Retrospective open label study. Mean duration of follow-up 64 months., Setting: Primary-care and referral center, ambulatory and hospitalized care., Participants: Patients (N=116) undergoing continuous ITB trials between 2006 and 2017., Interventions: Continuous application of baclofen via a temporary intrathecal catheter connected to an external pump., Main Outcome Measures: Assessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events., Results: A total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P=.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up., Conclusions: Continuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events., (Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)