Gabapentin's Effects On Spasticity In MS
A Placebo-Controlled, Randomized Trial
Cutter NC, Scott DD, Johnson JC, Whiteneck G
Arch Phys Med Rehabil 2000 Feb;81(2):164-9
Univ of Colorado Health Sciences Center, Denver, USA
PMID# 10668769; UI# 20132203
To investigate the effect of Gabapentin on subject self-report and physician-administered Spasticity scales in individuals with Multiple Sclerosis.
Design & Setting
Prospective, double-masked, placebo-controlled, crossover design. The Multiple Sclerosis Center at the Denver Veterans Affairs Medical Center.
Subjects were titrated to either 900mg Gabapentin orally three times a day or placebo over a 6-day period.
Subjects underwent a 14-day washout and then were crossed over. No other changes were made to their medication regimen.
Main Outcome Measures
The outcome measures were divided into two categories: subject self-report scales physician-administered scales.
Subject self-report scales included the Spasm Frequency Scale, Spasm Severity Scale, Interference With Function Scale, Painful Spasm Scale, and Global Assessment Scale.
Physician-administered scales included the Modified Ashworth Scale, Clonus Scale, Deep Tendon Reflexes, Plantar Stimulation Response, and the Kurtzke Expanded Disability Status (EDSS) Scale.
Digit Span and Digit Symbol subtests of the WAIS-R Intelligence Scale were administered to assess for possible impaired concentration.
The Fatigue Impact Scale was administered to assess for changes in Fatigue. The adjective generation technique was administered to assess for alterations in mood.
A statistically significant reduction in the impairment of Spasticity was found in the Gabapentin-treated subjects compared with placebo.
As measured by the self-report scales of the Spasm Severity Scale, Interference With Function Scale, Painful Spasm Scale, and Global Assessment Scale and by the Physician-Administered Scales of the Modified Ashworth and plantar stimulation response.
No significant difference was noted in the Digit Span, Digit Symbol, adjective generation technique, and EDSS.
Gabapentin reduces the impairment of Spasticity, compared with placebo, without the side effects of worsening concentration and Fatigue.
Gabapentin For Relief Of Upper Motor Neuron Symptoms In Multiple Sclerosis
Mueller ME, Gruenthal M, Olson WL, Olson WH
Arch Phys Med Rehabil 1997 May;78(5):521-4
Univ of Louisville School of Medicine, Dept of Internal Medicine, KY, USA
PMID# 9161373; UI# 97305098
To examine the efficacy of Gabapentin in the treatment of Spasticity and painful muscle Spasms in patients with Multiple Sclerosis.
Design & Setting
Double-blind, placebo-controlled crossover study. Free-standing, 93-bed, university-affiliated rehabilitation hospital.
There were 15 patients between the ages of 18 and 50 who had laboratory-supported definite Multiple Sclerosis with Spasticity and leg cramps severe enough to interfere with daily activities, including Sleep.
The patients received the placebo or 400mg Gabapentin orally three times a day for 48 hours with an 11-day washout period. If the patients were on currently accepted modes of therapy, including oral Baclofen, their current medication was not changed.
Main Outcome Measures
The outcome measures were Visual Faces Scale rating, Kurtzke Disability Scale, Quantitative Surface Electromyography, Ashworth Scale, presence or absence of Clonus in response to Rapid Ankle Dorsiflexion and Wrist Extension, presence or absence of reflex withdrawal in response to Nailbed Pressure to the first finger, and assessment of Babinski Response.
Statistically significant improvements for the Gabapentin treated patients were found in the Ashworth Scale, Visual Faces Scale, and Kurtzke Disability Scale.
At a dose of 400mg orally three times a day, Gabapentin may be of value in the treatment of the Spasticity and painful muscle cramping experienced by patients with Multiple Sclerosis.
Neural Therapy In The Treatment Of MS
Gibson RG, Gibson SL
J Altern Complement Med 1999 Dec;5(6):543-52
Glasgow Homoeopathic Hospital, Scotland
PMID# 10630348; UI# 20094044
To assess the therapeutic potential of Neural Therapy, a modified form of Acupuncture, in Multiple Sclerosis.
Design & Setting
A pilot study followed by a double-blind, placebo-controlled randomized study. The Glasgow Homoeopathic Hospital, Glasgow, Scotland.
An unselected group of 61 new patients referred to the Glasgow Homoeopathic Hospital, suffering from any type of Multiple Sclerosis, who fulfilled the criteria of Schumacher and had a Disability Status Score (DSS) or Expanded Disability Status Scale (EDSS) grade of 1-7.
Neural therapy, which is the injection of small amounts of local anesthetic without Adrenaline, into specific trigger points in the ankles and around the greatest circumference of the skull.
Main Outcome Measures
Improvements in the Kurtzke scales and the DSS or EDSS assessments.
Sixty-five percent (65%) of the patients in the pilot study (n = 40) and seventy-six percent (76%) of the patients in the double-blind trial (n = 21) benefitted from this treatment as assessed by Kurtzke scale improvements.
On long-term follow-up of 2.0 to 3.5 years, more than 50% of the patients continued to show improved Kurtzke scale ratings. Improvements could be rapid.
No toxic side effects were noted when injections were administered at a frequency of once or twice weekly or less.
Neural therapy is an effective, nontoxic and inexpensive treatment for Multiple Sclerosis that can confer both immediate and long-term benefits.
Tizanidine Treatment Of Spasticity Caused By Multiple Sclerosis
US Tizanidine Study Group
Smith C, Birnbaum G, Carter JL, Greenstein J, Lublin FD
Neurology 1994 Nov;44(11 Suppl 9):S34-42; discussion S42-3
St. Agnes Hospital, White Plains, New York
PMID# 7970009; UI# 95060044
This multicenter, stratified, randomized, placebo-controlled, double-blind trial evaluated Tizanidine for use in the United States for Spasticity secondary to MS.
The 15-week trial was divided into baseline (weeks 0 and 1), titration (2 mg to a maximum of 36 mg/d; weeks 2 to 4), and plateau (weeks 5 to 13) phases, followed by dose tapering (week 14) and a final visit (week 15).
Primary efficacy parameters were scores on Muscle Tone (Ashworth Scale) and type and frequency of Muscle Spasms (patient diaries).
All efficacy parameters were evaluated by the physician/assessor, and the physician/prescriber was responsible for all dosage adjustments.
The patient, physician/assessor, and physician/prescriber made global evaluations of AntiSpastic efficacy.
Tizanidine produced a significantly greater reduction than placebo in Spasms and Clonus (patient diaries) but no significant differences in Ashworth scores.
Patients and physician/prescribers, but not physician/assessors, gave significantly better scores in the overall assessment of efficacy and tolerability.
No significant differences in other secondary efficacy parameters were noted. Adverse events were reported for 66 (61%) of the 109 placebo-treated patients and 101 (91%) of the 111 Tizanidine-treated patients; 6 (6%) and 14 (13%) discontinued treatment, respectively.
Patient and physician perception of improvement demonstrated more consistent differences between groups than did the Ashworth Scale, perhaps because of inexperience with this measure or failure to consider time between drug administration and assessment.
Treatment Of Spasticity With Repetitive Magnetic Stimulation; A Double-Blind Placebo-Controlled Study
Nielsen JF, Sinkjaer T, Jakobsen J
Mult Scler 1996 Dec;2(5):227-32
Aarhus Univ Hospital, Dept of Neurology, Denmark
PMID# 9050361; UI# 97193949
The effect of repetitive Magnetic Stimulation on Spasticity was evaluated in 38 patients with Multiple Sclerosis in a double-blind placebo-controlled study.
One group was treated with repetitive Magnetic Stimulation (n = 21) and the other group with sham stimulation (n = 17). Both groups were treated twice daily for 7 consecutive days.
Primary end-points of the study were changes in the patients self-score, in clinical Spasticity score, and in the stretch reflex threshold.
The self-score of ease of daily day activities improved by 22% (P = 0.007) after treatment and by 29% (P = 0.004) after sham stimulation.
The clinical Spasticity score improved -3.3 +/- 4.7 arbitrary unit (AU) in treated patients and 0.7 +/- 2.5 AU in sham stimulation (P = 0.003).
The stretch reflex threshold increased 4.3 +/- 7.5 deg/s in treated patients and -3.8 +/- 9.7 deg/s in sham stimulation (P = 0.001).
The data presented in this study supports the idea that repetitive Magnetic Stimulation has an AntiSpastic effect in Multiple Sclerosis. Future studies should clarify the optimal treatment regimen.
Tizanidine In The Treatment Of Spasticity Caused By Multiple Sclerosis
United Kingdom Tizanidine Trial Group
Neurology 1994 Nov;44(11 Suppl 9):S70-8
PMID# 7970014; UI# 95060049
Tizanidine was evaluated in a prospective, double-blind, randomized, placebo-controlled trial in 187 patients with MS.
Taken orally for 9 weeks and preceded by a titration phase for a period of 3 weeks starting at 2 mg daily, Tizanidine produced a significant reduction in spastic muscle tone compared with placebo treatment.
Within the effective dose range of 24 to 36 mg given daily in three doses, Tizanidine achieved a 20% mean reduction in muscle tone.
Approximately 75% of patients, with all degrees of Spasticity, reported subjective improvement without an increase in muscle weakness, but there was no improvement in activities of daily living depending on movement.
Tizanidine achieved its maximum effect on Spasticity within 1 week of the start of treatment; the benefit was maintained for at least 1 week after discontinuation of therapy.
A variety of adverse events was recorded by patients taking Tizanidine, but these were minor and reversible, and rarely limited treatment. Tizanidine is a well-tolerated and effective drug for symptomatic treatment of Spasticity.