Efficacy Of Baclofen Research Articles

Comparative Efficacy of Baclofen and Diazepam in Treating Spasticity Following Acquired Spinal Cord Injuries: A Randomized Controlled Trial

Abstract Introduction: Spasticity is a pervasive and debilitating condition. Anti-spastic medications like Baclofen and Diazepam are most commonly used for spasticity management. Objectives: The study aimed to evaluate and compare the efficacy of Baclofen with that of Diazepam in the management of spasticity following acquired spinal cord injuries. Methods: In this randomised open-label study involving 60 patients, 30 patients received 5 mg of oral Baclofen thrice daily and 30 patients received 5 mg of oral Diazepam thrice daily for the management of spasticity. The extent of spasticity was measured by Modified Ashworth Scale (MAS). The efficacy of these drugs was measured with the mean improvement in the above parameters on days 7, 14, 28, 56 and 90 from the start of pharmacotherapy. Results: Baseline muscle spasticity scores were comparable. At the endpoint, mean improvement in tone of right and left hip flexors (1.43 vs. 0.87), hip adductors (1.30 vs. 0.87), knee flexors (0.80 vs. 0.37), ankle plantar flexors (0.80 vs. 0.37) and ankle dorsiflexors (1.23 vs. 0.93) were significantly higher in Baclofen group (p<0.05), while the tone of right and left hip abductors, hip and knee extensors showed no significant difference among the groups. Conclusion: Baclofen was found to be superior to Diazepam in terms of efficacy, especially for flexor spasticity of lower limbs in acquired spinal cord injuries.

Efficacy of Baclofen as Add-on Therapy for Refractory Gastroesophageal Reflux Disease: A Meta-analysis.

As a GABAB receptor agonist, baclofen has demonstrated efficacy in alleviating symptoms of refractory gastroesophageal reflux disease (r-GERD). This meta-analysis aims to evaluate the safety and effectiveness of baclofen as an add-on therapy for this condition. We conducted a comprehensive search of the PubMed, Embase, and Web of Science databases for studies published up until October 2023. Subsequently, we performed a meta-analysis encompassing all eligible trials. From 719 records, 10 studies were included, most of these studies were moderate risk. The findings demonstrated that the addition of baclofen as a supplementary treatment effectively improves symptoms (GERD Q score) in r-GERD (standardized mean difference=-0.78, 95% CI: -1.06 to -0.51, I2=0%). The addition of this treatment also resulted in a decrease in the frequency of nonacidic reflux episodes (standardized mean difference=-0.93, 95% CI: -1.49 to -0.37, I2=63%) and an improvement in DeMeester scores (standardized mean difference=-0.82, 95% CI: -1.61 to -0.04, I2=81%) among patients with r-GERD when compared with the use of proton pump inhibitor (PPI) drugs alone. However, no significant disparity was observed in terms of reducing acid reflux episodes (standardized mean difference=-0.12, 95% CI: -0.49 to 0.19, I2=0%) and proximal reflux (standardized mean difference=-0.47, 95% CI: -1.08 to 0.14, I2=60%). Baclofen as an add-on treatment can effectively improve the symptoms of patients with r-GERD and reduce the incidence of nonacidic reflux and improve DeMeester score. However, long-term use of baclofen leads to an increased incidence of side effects and is not effective in reducing the occurrence of acid reflux.

A Retrospective Review of Baclofen Treatment for Children with Rumination Syndrome at a Single Center.

Baclofen can decrease rumination frequency in adults with rumination syndrome. Outcomes of baclofen treatment in children with rumination syndrome have not been described. The aim of this study was to examine the safety and efficacy of baclofen in children with rumination syndrome in combination with behavioral therapy at a single center. We performed a retrospective review of children aged 0-18years with rumination syndrome based on Rome criteria and prescribed baclofen by a pediatric gastroenterologist at the Nationwide Children's Hospital, Columbus, Ohio, USA, between 2012 and 2019. Children without follow-up data or who were prescribed baclofen for other symptoms were excluded. We identified 44 children with rumination syndrome who were prescribed baclofen by a pediatric gastroenterologist. Seventeen either did not have follow-up data or never started the medication. We included 27 patients in the study: 22 (81.5%) female, median age 14.5years (range 10-18years) and 100% Caucasian. Twenty patients (74%) received baclofen 5mg and seven patients (26%) received baclofen 10mg three times daily. Most patients received behavioral therapy and baclofen simultaneously. Thirteen patients (48%) reported improvement in symptoms, primarily a decrease in rumination frequency, at their first follow-up visit. Regurgitation frequency per week decreased after starting baclofen (p<0.05). One patient experienced dizziness. No other side effects were reported. Nearly half of our patients with rumination syndrome improved after baclofen. It was well tolerated with minimal side effects. This suggests that baclofen in addition to behavioral therapy can improve symptoms of rumination syndrome. Prospective, controlled studies in a larger cohort of children with rumination syndrome are needed to confirm these findings.

Activation of GABAB receptors in central amygdala attenuates activity of PKCδ + neurons and suppresses punishment-resistant alcohol self-administration in rats

Alcohol use despite negative consequences is a core phenomenon of alcohol addiction. We recently used alcohol self-administration that is resistant to footshock punishment as a model of this behavior, and found that activity of PKCδ + GABAergic neurons in the central amygdala (CeA) is a determinant of individual susceptibility for punishment resistance. In the present study, we examined whether activation of GABAB receptors in CeA can attenuate the activity of PKCδ + neurons in this region, and whether this will result in suppression of punishment- resistant alcohol self-administration in the minority of rats that show this behavior. Systemic administration of the clinically approved GABAB agonist baclofen (1 and 3 mg/kg) dose- dependently reduced punishment-resistant alcohol self-administration. Bilateral microinjections of baclofen into CeA (64 ng in 0.3 µl/side) reduced the activity of PKCδ + neurons, as measured by Fos expression. This manipulation also selectively suppressed punished alcohol self-administration in punishment-resistant rats. Expression analysis indicated that virtually all CeA PKCδ + neurons express the GABAB receptor. Using in vitro electrophysiology, we found that baclofen induced hyperpolarization of CeA neurons, reducing their firing rate in response to depolarizing current injections. Together, our findings provide a potential mechanism that contributes to the clinical efficacy of baclofen in alcohol addiction. Therapeutic use of baclofen itself is limited by problems of tolerance and need for dose escalation. Our findings support a mechanistic rationale for developing novel, improved alcohol addiction medications that target GABAB receptors, and that lack these limitations, such as e.g., GABAB positive allosteric modulators (PAM:s).

Effects of baclofen on insular gain anticipation in alcohol-dependent patients — a randomized, placebo-controlled, pharmaco-fMRI pilot trial

RationaleOne hallmark of addiction is an altered neuronal reward processing. In healthy individuals (HC), reduced activity in fronto-striatal regions including the insula has been observed when a reward anticipation task was performed repeatedly. This effect could indicate a desensitization of the neural reward system due to repetition. Here, we investigated this hypothesis in a cohort of patients with alcohol use disorder (AUD), who have been treated with baclofen or a placebo. The efficacy of baclofen in AUD patients has been shown to have positive clinical effects, possibly via indirectly affecting structures within the neuronal reward system.ObjectivesTwenty-eight recently detoxified patients (13 receiving baclofen (BAC), 15 receiving placebo (PLA)) were investigated within a longitudinal, double-blind, and randomized pharmaco-fMRI design with an individually adjusted daily dosage of 30–270 mg.MethodsBrain responses were captured by functional magnetic resonance imaging (fMRI) during reward anticipation while participating in a slot machine paradigm before (t1) and after 2 weeks of individual high-dose medication (t2).ResultsAbstinence rates were significantly higher in the BAC compared to the PLA group during the 12-week high-dose medication phase. At t1, all patients showed significant bilateral striatal activation. At t2, the BAC group showed a significant decrease in insular activation compared to the PLA group.ConclusionsBy affecting insular information processing, baclofen might enable a more flexible neuronal adaptation during recurrent reward anticipation, which could resemble a desensitization as previously observed in HC. This result strengthens the modulation of the reward system as a potential mechanism of action of baclofen.Trial registrationIdentifier of the main trial (the BACLAD study) at clinical.gov: NCT0126665.

Baclofen in alcohol use disorder: An analysis of the data provided by the French "Temporary Recommendation for Use" 2014-2017 cohort.

Alcohol use disorder (AUD) is a devastating illness for which effective treatments are lacking. Studies over the last two decades have shown that baclofen, a GABA-B agonist, could be a promising treatment for AUD. However, the efficacy of baclofen is still controversial, and studies have shown that it may be associated with an excess of hospitalizations and deaths. In March 2014, the French Health Safety Agency granted a “Temporary Recommendation for Use” (TRU) regulating the prescription of baclofen in subjects with AUD. The TRU allowed physicians to prescribe high-dose baclofen (up to 300 mg/d). The doses were adjusted, and tailored to the needs of each patient. Between March 2014 and March 2017, TRU clinical data were collected for a total of 6,939 subjects. The recorded data included information on alcohol consumption, the intensity of alcohol cravings, and adverse events. The present article proposes an analysis of the data provided by the TRU. Subjects for which data were missing regarding baclofen daily dosage, alcohol consumption or craving scores were discarded from the analyses. A cohort of two groups of subjects was analyzed. The first group included all TRU subjects suitable for analyses (5,550 subjects), and the second group included subjects followed for at least 365 days (169 subjects). Comparisons were made between baseline and endpoint of the follow-up period. The results show that a majority of subjects in the whole cohort had received doses of over 80 mg/d. The mean dose of baclofen at the endpoint was >110 mg/d in the second group of subjects. Doses of >80 mg/d were not associated with an increase in adverse events after adjustment for the follow-up duration. In terms of efficacy, comparisons between baseline and endpoint show that baclofen treatment significantly decreased alcohol consumption and alcohol cravings, and significantly increased the number of subjects with null or low-risk alcohol consumption according to WHO criteria.

Clinical trial: a controlled trial of baclofen add-on therapy in PPI-refractory gastro-oesophageal reflux symptoms.

Proton pump inhibitors (PPI) have no effect on non-acid reflux events which can continue to provoke gastro-oesophageal reflux disease (GERD) symptoms. Baclofen, a γ-aminobutyric acid agonist, can decrease non-acid reflux but its symptomatic benefit in refractory GERD symptoms is understudied. To assess the efficacy of baclofen 10mg t.i.d. vs placebo as add-on therapy in PPI-refractory GERD symptoms, in a randomised, double-blind, placebo-controlled study. Patients with persisting typical GERD symptoms on b.i.d. PPI therapy were randomised to 4 weeks of baclofen 10mg or placebo t.i.d. Before and after treatment, patients underwent 24 h impedance-pH monitoring on-PPI. Throughout the study, patients filled out ReQuest diaries. Data were analysed using mixed models. About 60 patients were included (age 47.5 years [range 19-73], 41f/19 m), 31 patients were randomised to baclofen. One patient withdrew consent and five in the baclofen group stopped treatment due to side effects. There was a trend towards a better response for general wellbeing in the baclofen-treated group compared to placebo (p= 0.06). When subdividing patients according to symptom association probability (SAP), only the SAP+ (n= 25) group improved significantly with baclofen (pcorr = 0.02), and worsened with placebo (pcorr = 0.008). The total number of reflux events decreased over time (p= 0.01), mainly due to the baclofen condition (pcorr = 0.1). The number of reflux events with a high proximal extent dropped significantly after baclofen (pcorr = 0.009), but not placebo. Baclofen decreases several reflux parameters in PPI refractory GERD symptoms, but pH-impedance monitoring is necessary before treatment as only SAP+ patients experience clinical benefit after 4 weeks.

Relative Efficacy of Baclofen and Topiramate as Monotherapy Versus Combination Therapy in Alcohol Dependence

Relative Efficacy of Baclofen and Topiramate as Monotherapy Versus Combination Therapy in Alcohol Dependence

Pressure and length of the lower esophageal sphincter as predictive indicators of therapeutic efficacy of baclofen for refractory gastroesophageal reflux-induced chronic cough

BackgroundTherapeutic efficacy of baclofen is suboptimal in the treatment of refractory gastroesophageal reflux-induced chronic cough (GERC). The purpose of the study is to identify its therapeutic predictors in a prospective clinical study. Methods138 patients with suspected refractory GERC were treated with baclofen. Before the therapy, all the patients underwent esophageal manometry and multichannel intraluminal impedance-pH monitoring to establish the diagnosis. After the efficacy of baclofen was evaluated, a stepwise logistic regression analysis was performed to identify the therapeutic predictors of baclofen and to establish a regression prediction model. ResultsThe overall response rate of baclofen treatment was 52.2% (72/138). The lower esophageal sphincter pressure (LESP) (odds ratio (OR) = 0.592, P = 0.000) and lower esophageal sphincter length (LESL) (OR = 0.144, P = 0.008) were independent predictors of baclofen efficacy. The optimal cut-off point to predict baclofen efficacy for LESP was 11.00 mmHg, with a sensitivity of 83.7% and specificity of 79.1% while that for LESL was 2.35 cm, with a sensitivity of 81.6% and specificity of 72.1%. The highest predictive specificity (90.7%) was achieved when both LESP and LESL were jointly used. ConclusionsLESP and LESL may be used to screen the patients with refractory GERC suitable for baclofen therapy and help improve the therapeutic precision. Clinical trial registrationChiCTR- ONC-13003123.

Baclofen approval in france: A balance between two conceptions of medicine

In October 2018, France became the first country to officially approve baclofen for alcohol use disorder (AUD), even if the French Drug Agency (ANSM) officially stated that the efficacy of baclofen in AUD could be not established at this stage, in the light of the available evidence. The decision of the ANSM comprised obvious political aspects, as baclofen approval followed a decade-long practice of off-label prescription, where doses used could reach 300 mg per day or more. This situation led to a prolonged and ferocious debate between those who questioned such a widespread and unevidenced practice, and those who defended the place of an “common sense” empirical medicine. The French story of baclofen echoes other similar controversial off-label prescribing practices in the country, from the pioneer use buprenorphine for opioid use disorder in the 1990s, to the more recent off-label use of hydroxychloroquine during the COVID-19 outbreak. In each case, similar “pros” and “cons” arguments were opposed, highlighting the difficult interpenetration between evidence-based medicine on the one hand, and on-the-ground practice on the other hand.DisclosureBenjamin Rolland declare having received fees for lectures and expertise from Ethypharm. He was the principal investigator of a phase-1 study funded by Ethypharm

Reduced motor cortex GABABR function following chronic alcohol exposure.

The GABAB receptor (GABABR) agonist baclofen has been used to treat alcohol and several other substance use disorders (AUD/SUD), yet its underlying neural mechanism remains unclear. The present study aimed to investigate cortical GABABR dynamics following chronic alcohol exposure. Ex vivo brain slice recordings from mice chronically exposed to alcohol revealed a reduction in GABABR-mediated currents, as well as a decrease of GABAB1/2R and G-protein-coupled inwardly rectifying potassium channel 2 (GIRK2) activities in the motor cortex. Moreover, our data indicated that these alterations could be attributed to dephosphorylation at the site of serine 783 (ser-783) in GABAB2 subunit, which regulates the surface expression of GABABR. Furthermore, a human study using paired-pulse-transcranial magnetic stimulation (TMS) analysis further demonstrated a reduced cortical inhibition mediated by GABABR in patients with AUD. Our findings provide the first evidence that chronic alcohol exposure is associated with significantly impaired cortical GABABR function. The ability to promote GABABR signaling may account for the therapeutic efficacy of baclofen in AUD.

The Histologic Effect of Baclofen in Rat’s brain: An Experimental Study

Background: Baclofen is the only clinically available metabotropic GABAB receptor agonist. Several reports has been discussed the efficacy of baclofen but the available data on its effect of the behavior and brains' histology are still limited.Objectives: This work aims to assess the effects of long term exposure to baclofen (8weeks) on behavior and brains' histology in ratsMethods: Analysis of data of Twenty five healthy male Albino rats were performed. Rats weighing about 200–210 g with mean age of 65 days were randomly selected and categorized into three groups: Group 1(LD50 group): included five rats that gavaged with single dose of baclofen to test the LD50 of drug (145mg per Kg) .Group 2. (control group):included eight rats were gavaged with distilled water for 2 months. Group 3.(baclofen group): included 12 rats gavaged with 15mg/kg of baclofen (1/10th LD50) for 2 month. Behavioral Tests were conducted on all animals in group 2 and 3 including: Open-field test ,Open -field habituation task ,and object recognition(Novel) to examine the influence of drug on the cognition of rats. All animals were euthanized with ether after 24hours of last day of treatment. Brains were excised and collected from rats of group 2 and 3.Fixation of tissues was done using buffered solution of ten percent of formalin for twenty four hours with paraffin wax embedding. Sectioning and staining by hematoxylin and eosin protocol (H&E) and prepared to be examine histologically. To differentiate between the data of group 2 and 3 ,statistical analysis was performed by 1- way analysis of variance (ANOVA) .Least significant difference test with Duncan test was used . Value of P of equal or less than 0.05 means the difference is significant .Results: This study revealed that the rats of baclofen group traveled a greater total distance(in both sessions) when compared with those of control indicating their hyperactivity. The zone specific analysis showed that the rats that were administered with baclofen consumed markedly greater time nearby the walls in the peripheral part in the arena throughout the first and 2nd 15- min session in comparison with those of control group indicating the generalized hyperactivity and exploration. Rats of control group preferred the novel object in comparison with those of baclofen group. However there is no marked difference in the index of discrimination among rats of group 2 and 3. Histological sections of rats’ brains in group that were administered with 15mg/kg of baclofen for 2 month( baclofen group) revealed a diminished thickness in the pyramidal cells’ layer, irregular faintly stained cells with shrinkage in the some pyramidal nerve cells, dark staining cytoplasm and losing the characteristics of their nuclei.Conclusions:Chronic administration with baclofen (15mg/kg/day/2months) induces changes in the brain histology in rats, however, baclofen has no adverse effect on the behavior. To the best of our information, our work is the 1st that focus on the influence of baclofen on both the behavior and brains' histology. Our data suggesting that baclofen may have clinical utility.

Gabapentin versus baclofen for treatment of refractory gastroesophageal reflux-induced chronic cough

Refractory gastroesophageal reflux-induced chronic cough (GERC) is a special type of gastroesophageal reflux disease (GERD) with predominant cough resistant to pragmatic standard anti-reflux therapy including antisecretory agents alone or in combination with promotility agents but with a favorable response to intensified anti-reflux treatment. The condition is not rare and is difficult to treat. Neuromodulators such as baclofen and gabapentin are considered potential therapeutic options for refractory GERC. Limited data indicate that gabapentin and baclofen could attenuate the cough symptom in patients with refractory GERC by blockade of gastroesophageal reflux or by direct antitussive effects. However, no study has compared the efficacy of these two drugs in treatment of refractory GERC. In an open-labeled randomized clinical study, we demonstrated that, as add-on therapy, gabapentin and baclofen had a similar prevalence of therapeutic success for suspected refractory GERC but gabapentin may be more preferable because of its fewer central side effects. The efficacy of baclofen and gabapentin was suboptimal, so further studies are needed to select the patients with refractory GERC suitable for precise treatment using these two neuromodulators.

Effect of baclofen on physiotherapy in the management of spastic cerebral palsy

A description of Cerebral Palsy (CP) is, a group of stable disorders of the development of movement and posture, causing activity limitations that are attributed to no progressive disturbances that happened in the developing fetal or infant brain.To evaluate the role of oral Baclofen on Physiotherapy in reducing spasticity of cerebral palsy.This study was performed in the Department of Anatomy and Department of Pediatrics, University Hospital, Banaras Hindu University, Varanasi and Kiran Society, Varanasi. Patients aged between 2 years to 14 years of both sexes satisfying the inclusion and exclusion criteria were randomly enrolled into two groups; Group A included 60 patients who received only physiotherapy and Group B included 60 patients who received baclofen along with physiotherapy. Spasticity parameters were evaluated using modified Ashworth scale, physical rating scale like knee recurvatum, angle for crouch gait and foot contact. All patients were followed up at 4 weeks interval and were evaluated after of 24 weeks. Ethical clearance was obtained from the concerned authority. Data management and statistical analysis were performed using MS excel.Physiotherapy was highly effective in reducing tone in spastic cerebral palsy. Similar was the observation when baclofen was added to physiotherapy regimen. However, when compared, the efficacy of baclofen along with physiotherapy was far superior as compared to physiotherapy alone. However, none of the treatment modalities has significant effect on knee recurvatum.Addition of baclofen to physiotherapy regimen is superior to physiotherapy alone for reducing muscle tone and improving the joint angle stiffness as well as gait.

Individualized, High-Dose Baclofen for Reduction in Alcohol Intake in Persons With High Levels of Consumption.

Alcohol use disorders (AUD) are common and impairing. Many pharmacologic interventions have been approved for AUD; baclofen is one among these. More than a dozen randomized controlled trials (RCTs) have examined the safety and efficacy of baclofen in AUD; these RCTs have been pooled in 4 recent meta-analyses, each with different study selection criteria, different objectives, different methods, and different results. The general impression from these meta-analyses is that the benefits with baclofen are unimpressive in patients with AUD. With the background that individualized, rather than fixed, high dosing with baclofen could be critical for success, a large (n = 320), industry-independent, 62-center French RCT (the Bacloville trial) examined whether individually uptitrated, high-dose baclofen could reduce alcohol consumption in heavy drinkers across a year of treatment. The study design, the high dropout rate, and the statistical methods of this trial threw up several complexities; in consequence, the main primary and secondary outcomes could not be satisfactorily interpreted. However, there were many other secondary outcomes that seemed to favor baclofen over placebo, though certain concerns remained. This RCT is explained and its findings are carefully dissected and interpreted. It is concluded that individualized treatment with high-dose baclofen (30-300 mg/d) may be a useful second-line approach in heavy drinkers who wish to reduce levels of alcohol intake; baclofen may be particularly useful in patients with liver disease, for whom certain other pharmacologic interventions are relatively contraindicated. However, the risk of serious adverse events with high-dose baclofen, and its pharmacodynamic interaction with alcohol, must both be kept in mind. Practical issues are discussed.

The Efficacy of Baclofen to Treat Gastroesophageal Reflux disease in Children Aged 6 Months to 12 Years: A Clinical Trial Study

Background Gastroesophageal Reflux is a physiological phenomenon, which occurs in infants, children, and normal adults. Various studies have shown that Baclofen is a potent inhibitor of lower esophageal sphincter and has beneficial effects in adult reflux disease. We aimed to evaluate the Baclofen effect in pediatric Gastroesophageal disease. Materials and Methods: Children 6 months to 12 years old, with Gastroesophageal reflux disease were enrolled in this Clinical trial study. Patients referred to Taleghani Children’s Center in Gorgan, Golestan province, Iran from May to August 2019. Patients were randomly divided into two intervention group and control group. The controls received only proton pump inhibitor 1 mg per kg treatment, and intervention group received proton pump inhibitor (PPI) plus baclofen 0.25 mg per kg two times per day. Patient data including age, gender, family history, growth status, reflux symptoms, previous drug treatment history, and symptoms in two groups, were compared. Results: Fifty-four patients in the baclofen treatment group and 58 patients in the non-baclofen treatment group were included. The mean age of the patients was 6.61+ 3.55 years. The most common symptoms of all patients were abdominal pain (73.2%), nausea (73.2%), regurgitation (64.3%), and dental erosion (55.4%). The rate of recovery was significantly related to gender, with 69.9% of patients having moderate to full recovery (p = 0.017). Weight gain in baclofen treated group was significantly higher. Conclusion: The results suggest that baclofen along with routine Gastroesophageal reflux treatments in children can help reduce or improve symptoms of the disease. Due to limited studies, further studies are needed to confirm the positive effect of this drug with higher sample size.

Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial.

Increasing evidence suggests that the function of the GABAergic system is abnormally low in autism spectrum disorder (ASD). Baclofen, which functions as a selective agonist for GABAB receptors, does appear promising for the treatment of ASD. We conducted a 10-week randomized-controlled study aimed at evaluating the potential of baclofen as an adjuvant therapy to enhance the effect of risperidone in children with ASD. Sixty-four children (3-12years) with moderate-to-severe irritability symptoms of ASD were included. We used the Aberrant Behavior Checklist-Community Edition (ABC-C) for the outcome measures on each of the follow-up visits (weeks 0, 5, and 10). Analysis of the combined data revealed significant improvement for all the ABC subscales (irritability: F = 51.644, df = 1.66, p < 0.001, lethargy: F = 39.734, df = 1.38, p < 0.001, stereotypic behavior: F = 25.495, df = 1.56, p < 0.001, hyperactivity: F = 54.135, df = 1.35, p < 0.001, and inappropriate speech: F = 19.277, df = 1.47, p = 0.004). Combined treatment with baclofen and risperidone exerted a greater effect on improvement of hyperactivity symptoms at both midpoint [Cohen's d, 95% confidence interval (CI) = - 3.14, - 5.56 to - 0.72] and endpoint (d, 95% CI = - 4.45, - 8.74 to - 0.16) when compared with treatment with placebo plus risperidone. The two treatments achieved comparable results for other outcome measures. Our data support safety and efficacy of baclofen as an adjuvant to risperidone for improvement of hyperactivity symptoms in children with ASD.

Authors' reply to commentary on "Gulati P, Chavan BS, Sidana A. Comparative efficacy of baclofen and lorazepam in the treatment of alcohol withdrawal syndrome".

Authors' reply to commentary on "Gulati P, Chavan BS, Sidana A. Comparative efficacy of baclofen and lorazepam in the treatment of alcohol withdrawal syndrome".

Comparative efficacy of baclofen and lorazepam in the treatment of alcohol withdrawal syndrome.

Background:Benzodiazepines (BDZs) have been the treatment of choice for alcohol withdrawal syndrome (AWS); however, they are associated with several side effects and also have abuse potential. In some studies, the use of baclofen has been effective in reducing symptoms of alcohol withdrawal symptoms.Aim:The objective of this study was to compare the efficacy of baclofen and benzodiazepine (lorazepam) in reducing symptoms of AWS.Materials and Methods:It was a single-center, randomized, open-label study. Patients with alcohol dependence syndrome were enrolled in the study and randomized into two groups using computer-generated random table number. Baclofen (experimental group, 10 mg three times a day) and BZDs (control group, lorazepam, 8–12 mg/day in divided doses) were orally administered for reducing symptoms of alcohol withdrawal. Both groups received Vitamin B1 (100 mg/day through intramuscular route) and psychotherapeutic interventions. The severity of alcohol dependence was assessed by using the Severity of Alcohol Dependence Questionnaire, and alcohol withdrawal was assessed with the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar).Results:Sixty-six patients were randomized (baclofen n = 34, benzodiazepine (BZD) group n = 32). Two patients (one patient in each group) had complicated withdrawal symptoms and were dropped from the final analysis. There was a significant reduction in alcohol withdrawal symptoms in both groups. There were no significant differences in CIWA-Ar scores between the two groups. Both the drugs were well-tolerated.Conclusion:Baclofen and lorazepam are comparable in efficacy and tolerability in reducing symptoms of AWS.

Commentary on "Gulati P, Chavan BS, Sidana A. Comparative efficacy of baclofen and lorazepam in the treatment of alcohol withdrawal syndrome. Indian J Psychiatry. 2019;61:60-4".

Commentary on "Gulati P, Chavan BS, Sidana A. Comparative efficacy of baclofen and lorazepam in the treatment of alcohol withdrawal syndrome. Indian J Psychiatry. 2019;61:60-4".