THE USE OF CANNABIS IN TREATING MUSCLE SPASTICITY Evidenced Based Critical Appraisal Topic The Use of Cannabis in Treating Muscle Spasticity Carmen Mittleider BSN, RN, FNP-s University of Mary Nurs 568 THE USE OF CANNABIS IN TREATING MUSCLE SPASTICITY Evidenced Based Critical Appraisal Topic The Use of Cannabis in Treating Muscle Spasticity Carmen Mittleider, BSN, RN, FNP-s Date: March 3, 2014 Clinical Scenario A thirty eight year old male presents to the clinic with complaints of worsening muscle spasticity due to his Multiple Sclerosis. He has had neurology consults and has had trials of baclofen, tizanidine, anticonvulsants, and benzodiazepines. He has not noticed much improvement with these medications. His mother died of complications from multiple sclerosis at the young age of forty-two. He is looking at other medication modalities for spasticity treatment. Clinical Question In patients diagnosed with multiple sclerosis and disabling spasticity, does the use of cannabis improve muscle spasticity? Articles Corey-Bloom, J., Wolfson, T., Gamst, A., Jin, S., Marcotte, T., Bentley, H., & Gouaux, B. (2012). Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebocontrolled trial. Canadian Medical Association Journal, 184, 1143-1150. doi: 10.1503/cmaj.110837 Notcutt, W., Langford, R., Davies, P., Ratcliffe, S., and Potts, R. (2012). A placebocontrolled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex (nabiximols). Multiple Sclerosis Journal, 18, 219-228. doi: 10.1177/1352458511419700 Summary and Appraisal of Key Elements Study 1 Core-Bloom, Wolfson, Gamst, Jin, Marcotte, Bentley, & Gouaux (2012), conducted a randomized, double-blind, placebo-controlled crossover design. This study was a Level 2 level of evidence. This study looked at adult patients with multiple sclerosis and spasticity. Participants were recruited from a regional multiple sclerosis clinic or by referral from specialists. Eligibility criteria were spasticity and moderate increase in tone, according to the Ashworth scale, with score of greater or equal to 3 at the elbow, hip, or knee. Participants were randomly assigned to either the intervention (smoked cannabis once daily for three days), or control (identical placebo cigarettes, once daily for three days). Phase 1 was followed by an 11 day washout period, after which the participants crossed over to the opposite treatment group for Phase 2. Thirty-seven participants were randomized at the beginning of the study, with 30 THE USE OF CANNABIS IN TREATING MUSCLE SPASTICITY completing the trial. Strengths included two different screenings looking at medication histories, substance abuse, psychiatric disorders, determining spasticity according to the Ashworth scale, toxicology screening, and cognitive testing. The primary outcome was change in spasticity as measured by the score on the Ashworth scale. The secondary outcome was assessing patients daily for pain, physical performance, and cognitive function. Limitations involved that some participants had previously used cannabis and may be biased to the positive effects of it. Of the 30 participants that completed the protocol, smoking cannabis reduced patient scores on the Ashworth scale by an average of 2.74 points (95% bootstrap Cl 2.20 to 3.14) more than the placebo (p<0.001). The order of the treatment, cannabis in Phase 1 or 2, did not significantly affect the outcome. Study 2 Notcutt, Langford, Davies, Ratcliffe, & Potts (2012) used a Level 2 level of evidence study to assess spasticity in multiple sclerosis after withdrawal of Sativex, an extract of cannabis delivered as an oromucosal spray. An enriched enrollment randomized withdrawal study design was used. Eligible subjects with ongoing benefit from Sativex for at least twelve weeks entered this five week placebo-controlled study. Thirty-six subjects were recruited and broken into two groups of 18. One group received the Sativex and the other group received placebo. The primary efficacy endpoint was the time to treatment failure (TTF), with the null hypothesis that the TTF would be the same in subjects randomized to either the placebo or Sativex. The secondary endpoint had a range of secondary measures assessed that included daily spasticity severity score, daily sleep disruptions score, and Ashworth scale score, among a few others. Limitations include the small sample size and the possibility of those in the placebo group knowing they were not receiving the Savitex. The two groups were well matched for age, gender, duration and type of multiple sclerosis, and disability score. Seventeen of the 36 subjects completed the 4-week treatment period, with the other 19 withdrawing. At the end of the 4-week study, 17 of the 18 subjects (94%) from the placebo group had failed treatment compared to 8 of 18 subjects (44%) from the Savitex group. Primary outcome was significantly in favor of Sativex (p=0.013). Results The results of both studies indicated a benefit of cannabis in the treatment of muscle spasticity with those individuals with multiple sclerosis. Study 1 showed more cognitive impact due to smoking the cannabis compared with Study 2, in which Savitex is an oromucosal spray derivative of cannabis. Study 1 noted a decrease in pain level with the use of cannabis. Further studies of cannabis and/or forms of cannabis use to treat spasticity is recommended due to short length of studies and small sample sizes. Clinical Bottom Line Evidence from these two studies suggests a benefit from cannabis in treating muscle spasticity, especially for those suffering from this with multiple sclerosis. In Study 1, smoking cannabis THE USE OF CANNABIS IN TREATING MUSCLE SPASTICITY reduced visual analog, but did not significantly affect patient perceptions of fatigue or deficits. Neither study had any serious adverse events during trial. Further studies would be of benefit in determining if other forms of cannabis-oral pills, spray-would be safer with less cognitive effects and still reduce spasticity. Also noted, that pain level had declined in Study 1 participants, brings up questioning with cognition playing a role in this aspect. Both studies incorporated individuals who were failing their current treatment. Implications for Practice After review of the above studies, I would recommend using cannabis to treat muscle spasticity. I would add stipulations though to this. The individual would need to have noted medical trials of other medications to treat spasticity, such as baclofen, tizanidine, benzodiazepines, anticonvulsants. After noted failures from these medications, then the option of cannabis should be introduced. One needs to be open to the fact of cannabis being misused and sold, along with dependence and withdrawal effects. THE USE OF CANNABIS IN TREATING MUSCLE SPASTICITY References Corey-Bloom, J., Wolfson, T., Gamst, A., Jin, S., Marcotte, T., Bentley, H., & Gouaux, B. (2012). Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebocontrolled trial. Canadian Medical Association Journal, 184, 1143-1150. doi: 10.1503/cmaj.110837 Notcutt, W., Langford, R., Davies, P., Ratcliffe, S., and Potts, R. (2012). A placebocontrolled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex (nabiximols). Multiple Sclerosis Journal, 18, 219-228. doi: 10.1177/1352458511419700