Feb 1, 2003
D M Pizzi
Real Living with Multiple Sclerosis
FROM COOLING VESTS to bee-sting therapy, individuals continually look to alternative treatments to ease their MS symptoms. Yet no data from welldesigned, controlled, large-scale trials exist to gauge the efficacy and safety of most of these therapies.
This is true of marijuana and other hemp derivatives. There are small studies and anecdotal reports aiming these substances improve some MS symptoms, such as spasticity and tremor. A new study, reported at the recent Sixth Congress of the European Federation of Neurological Societies, discounted the use of cannabis to treat MS tremor. Although based on a small sample, the report concluded that as shown by objective outcome measures cannabis use doesn't improve tremor in individuals with MS.
The double-blind, randomized, controlled, crossover trial consisted of 14 individuals with upper-limb-action tremors (6 men and 8 women, aged 35 to 46 years). All study subjects were recruited from the general neurology outpatient clinics at Derriford Hospital, Plymouth, and the Royal Cornwall Hospital, Truro, both in England. The lead investigator was Patrick Fox, MD, research registrar in neurology at the University of Plymouth.
The mean score on the 0-10 Expanded Disability Status Scale (EDSS) for these individuals was 6.25 (range 3.5 to 7.5). With a score of 6.0 or higher, people need an assistive device for walking. No subject had used cannabis within the past 30 days. Patients who answered yes to a history of psychotic illness or ischemic heart disease were excluded from the trial.
Study participants received either placebo or Cannador (Weleda International), a cannabis extract supplied in capsules containing 2.5 mg of tetrahydrocannabinol (THC). The dose was increased every 3 days until patients reached a maximum dose of 10 mg twice daily or experienced intolerable adverse effects. Follow-up was performed by phone every 3 days, and patients were subjected to 3, biweekly clinical assessments.
Following an initial treatment regimen of either placebo or cannabis, each patient was switched to the other treatment group for the remainder of the study.
The primary outcome measure was a functionally significant reduction in upper limb tremor (defined as a 50% reduction of EDSS score). Secondary outcome measures included testing a patient's performance on spiral drawings, evaluating a timed, 9-hole pegboard test, counting the number of taps a patient could make on calculator keys within 10 seconds, and evaluating the numbers from an arm-ataxia rating scale.
A different doctor monitored the patients' progress, and 2 additional assessors evaluated patient outcomes, ensuring the blinded nature of the study. Thirteen of 14 patients completed the trial, with 1 discontinuing for personal reasons.
The results showed little difference in primary or secondary outcome measures in the cannabis-treated patients, other than a decrease of 3 taps on the calculator test. However, 5 patients taking cannabis reported subjective improvement, compared to only 1 taking placebo. No subjects improved on all treatment measures. Adverse effects were more common with Cannador; they included drowsiness, light-headedness, memory disturbance, dysphoria, euphoria, increased appetite, and dry mouth. Individuals receiving placebo experienced light-headedness, memory disturbance, and poor concentration.
Many patients thought their symptoms had improved, although, in terms of objective measures, this wasn't the case. "It has to either be a mood effect, and they don't mind [about their tremor symptoms] as much, or it could be the tremor is occurring less frequently, but just as severe when it occurs," said Dr. Fox. "Overall, these data do not support a role for cannabis in the functional improvement of MS tremor, although given the subjective improvement noted, it remains possible to argue for a role in the palliation of symptoms."
A previous study, published in Nature (March 3, 2002), showed that the use of cannabinoids (marijuana derivatives) reduced the incidence of spasticity and tremor in mice suffering from a disease similar to MS. Other studies, however, such as one reported in Neurology (May 14, 2002), report that cannabinoid therapy isn't significantly effective in controlling severe MS spasticity in humans. A largescale study involving more than 600 individuals with MS is underway in England to determine if marijuana derivatives can help alleviate spastic symptoms.
The NMSS Medical Advisory Board advises against cannabis as a treatment
for MS. In the United States, it is still illegal in most states for physicians
to prescribe marijuana for any condition.
© 2003, Real Living with Multiple Sclerosis