Vinay Goyal1, Nonica Laisram2, Ranjan Kumar Wadhwa3, Shashank Yashwant Kothari4. 1. Formerly, Senior Resident, Department of Physical Medicine and Rehabilitation, VMMC and Safdarjang Hospital , New Delhi, India . 2. Professor and Head of Department, Department of Physical Medicine and Rehabilitation, VMMC and Safdarjang Hospital , New Delhi, India . 3. SAG Officer, Department of Physical Medicine and Rehabilitation, VMMC & Safdarjang Hospital , New Delhi, India . 4. Retd. Professor, Department of Physical Medicine and Rehabilitation, VMMC & Safdarjang Hospital , New Delh, India .
Abstract
INTRODUCTION:Spastic cerebral palsy (CP) is the most common form of CP. Diazepam and Baclofen are the most commonly used oral drugs to manage spasticity. Study was designed to evaluate and compare their effects and safety in CP children. AIM: Study was aimed to assess and compare outcome of oral Diazepam and Baclofen in spastic cerebral palsy children in terms of extent of reduction of spasticity and side effects profile. MATERIALS AND METHODS: Randomized prospective follow-up study was done for one year after giving Diazepam and Baclofen in weekly incremental doses upto recommended maximum dose to 60 children for three months. Two primary outcome measures were spasticity reduction and adverse effect profile. Spasticity reduction was measured by Modified Ashworth's Scale (MAS) and Range of Motion improvement (ROM). RESULTS: After random allocation, there was no baseline difference between groups. Mean MAS score improved from 1.96±0.4 at baseline to 1.63±0.40 and 1.41± 0.36 at 1 month and 3 months for Diazepam and from 1.84±0.64 to 1.57±0.59 and 1.31± 0.48 respectively for Baclofen. Within the group reduction was significant with p-value = 0.0001. Intergroup comparison showed no statistically significant difference with p-value of 0.48 and 0.22 at 1 and 3 months. Baseline ROM showed significant improvement at 1 and 3 months with p value of 0.004 and 0.001 for Diazepam and 0.01 and 0.000 for Baclofen respectively with no statistically significant difference among two groups. Drowsiness was most common observed side effect in both the groups. CONCLUSION: Patients showed significant improvement in spasticity as measured by Mean MAS score and range of motion in Diazepam as well as Baclofen group. Both drugs were found safe for use in children. Study couldn't establish any difference between the two drugs. However studies with bigger sample size and longer follow- up assessing functional improvement in patients will be required in near future.
RCT Entities:
INTRODUCTION:Spastic cerebral palsy (CP) is the most common form of CP. Diazepam and Baclofen are the most commonly used oral drugs to manage spasticity. Study was designed to evaluate and compare their effects and safety in CP children. AIM: Study was aimed to assess and compare outcome of oral Diazepam and Baclofen in spastic cerebral palsychildren in terms of extent of reduction of spasticity and side effects profile. MATERIALS AND METHODS: Randomized prospective follow-up study was done for one year after giving Diazepam and Baclofen in weekly incremental doses upto recommended maximum dose to 60 children for three months. Two primary outcome measures were spasticity reduction and adverse effect profile. Spasticity reduction was measured by Modified Ashworth's Scale (MAS) and Range of Motion improvement (ROM). RESULTS: After random allocation, there was no baseline difference between groups. Mean MAS score improved from 1.96±0.4 at baseline to 1.63±0.40 and 1.41± 0.36 at 1 month and 3 months for Diazepam and from 1.84±0.64 to 1.57±0.59 and 1.31± 0.48 respectively for Baclofen. Within the group reduction was significant with p-value = 0.0001. Intergroup comparison showed no statistically significant difference with p-value of 0.48 and 0.22 at 1 and 3 months. Baseline ROM showed significant improvement at 1 and 3 months with p value of 0.004 and 0.001 for Diazepam and 0.01 and 0.000 for Baclofen respectively with no statistically significant difference among two groups. Drowsiness was most common observed side effect in both the groups. CONCLUSION:Patients showed significant improvement in spasticity as measured by Mean MAS score and range of motion in Diazepam as well as Baclofen group. Both drugs were found safe for use in children. Study couldn't establish any difference between the two drugs. However studies with bigger sample size and longer follow- up assessing functional improvement in patients will be required in near future.
Authors: M R Delgado; D Hirtz; M Aisen; S Ashwal; D L Fehlings; J McLaughlin; L A Morrison; M W Shrader; A Tilton; J Vargus-Adams Journal: Neurology Date: 2010-01-26 Impact factor: 9.910
Authors: Jacki Peck; Ivan Urits; Joshua Crane; Alexandra McNally; Nazir Noor; Megha Patel; Amnon A Berger; Elyse M Cornett; Hisham Kassem; Alan D Kaye; Omar Viswanath Journal: Psychopharmacol Bull Date: 2020-10-15