Journal Club May 2014

Medical Marijuana Iowa legalizes medicinal marijuana oil for use in treatment of childhood seizures (May 2014) Patients must have a registration card from the Iowa Dept. of Public Health Patients must have a prescription from an Iowa neurologist Patients can only have a maximum of 32 oz of oil There is no provision to buy, sell or manufacture

Cannabis questions Claims seen all the time on medical benefits of marijuana States legalizing medicinal uses, some recreational uses What evidence exists for a medical benefit from marijuana? How significant are the benefits if they really exist?

Literature Review JABFM July-August 2011 Cannabis and Its Derivatives: Review of Medical Use Lawrence Leung Systematic review: Efficacy and safety of medical marijuana in selected neurologic disorders - Report of the Guideline Development Subcommittee of the American Academy of Neurology Both reviews of studies in the literature. JABFM – 25 trials reviewed, 15 level A evidence

JABFM Level A Studies Tourette’s syndrome – two placebo-controlled RCTs with reduction of symptom score but not examiner rating scores: 36 total patients (9-thc) HIV – two blinded placebo-controlled RCTs with decrease chronic pain scales : 78 pts, smoking for 1-2 weeks; one placebo-controlled RCT, twice daily oral for 6 weeks, change in mood, appetite and nausea in pts with anorexia and weight loss Pain – fibromyalgia, peripheral neuropathic, MS RCTs all improvement in pain scores using synthetic/extracts (40, 125, 66 pts)

JABFM Level A Studies Spasticity – MS 5 RCTs studies, 2 cannabis oral and 2 9-THC oral; 1 combo extract for bladder spasms – all symptoms reduction (377, 343, 15 pts); 1 study oral for 12 spinal cord injury patients with reduction of symptom scale Level B studies significant reduction intraocular pressure in 18 glaucoma pts, capsaicin induced pain reduction at medium dose short term 15 volunteers, single oral dose to acute inflammatory pain volunteers (18) no effect, no effect postop pain pod#2 & trend toward behavior improvement in Alzheimers 15 pts

So…. What about epilepsy? Systematic review by Neurology association for several types of neurology illnesses : 34 studies, 8 high-quality Spasticity in MS: OCE is established as effective for reducing patient-reported scores (2 Class I studies). OCE is probably ineffective for reducing objective measures at 12–15 weeks (1 Class I study) but possibly effective at 1 year (1 Class II study). THC is probably effective for reducing patient reported scores (1 Class I study). THC is probably ineffective for reducing objective measures at 15 weeks (1 Class I study) but possibly effective at 1 year (1 Class II study). Nabiximols is probably effective for reducing patient-reported symptoms at 6 weeks (1 Class I study) and probably ineffective for reducing objective measures at 6 weeks (1 Class I study).

So…. What about epilepsy? Systematic review by Neurology association for several types of neurology illnesses Still in MS – Nabiximols effective for bladder spasms, OCE, nabiximols and THC probably effective for central pain, not enough evidence for tremors. Smoking – no evidence for any treatment in MS. Others: Probably no effect in dyskinesias in Parkinson’s (OCE); Tourette’s too small of numbers to conclude effective or not (THC); cervical dystonia – one study inconclusive Finally – EPILEPSY No class I, II, or III studies. Two class IV studies – no benefit and no adverse effect over 3-18 weeks

Adverse Side Effects Systematic review by Neurology association for several types of neurology illnesses Overall 1619 patients treated for < 6 months 6.9% discontinued compared to 2.2% placebo Inhibits P450, so interacts with some meds Incomplete reporting – nausea, behavior/mood changes, SI/hallucinations, dizziness, fatigue, and intoxication. No serious adverse events in studies

Why is it a big deal? 20 states/D.C. approved medicinal use before Iowa & 2 decriminalized marijuana Lots of case reports, media stories, anecdotes and political pressures Despite only small studies with only symptom score improvements (blinding) Possibly a lack of data of adverse events overcame a lack of data of efficacy In Iowa, several families with children with epilepsy at the state house testifying and lobbying Fortunately in Iowa – it has to be prescribed by a neurologist for pediatric epilepsy