Clinical Studies of Cannabis and Its Derivatives with SORT Level of Recommendation56
| Agent | Condition Indicated | Form of delivery | Nature of Study | Patients (n) | Outcome Measures | Outcome | SORT Level of Recommendation | Reference |
|---|---|---|---|---|---|---|---|---|
| Cannabis | Gilles de la Tourette Syndrome | Smoking | Case report | 3 | Self-reported frequency of motor tics | 50% to 70% remission | C | Sandyk et al57 |
| Cannabis | Gilles de la Tourette Syndrome | Smoking | Case report | 1 | Self-reported symptoms | 100% remission | C | Hemming et al58 |
| Cannabis | Glaucoma | Smoking single dose | Double-blinded cross-over placebo-controlled RCT | 18 | Intraocular pressure | Significant reduction | B | Merritt et al59 |
| Cannabis | Neuropathic pain in HIV patient | Smoking 5 days a week for 2 weeks | Prospective placebo-controlled RCT | 28 | Pain intensity using Descriptor Differential Scale | Improvement in pain (P = .016) | A | Ellis et al49 |
| Cannabis | Sensory neuropathic pain in HIV patient | Smoking 3 times a day for 5 days | Double-blinded cross-over placebo-controlled RCT | 50 | Chronic pain ratings | Reduction of pain by 34% (P = .03) | A | Abrams et al48 |
| Cannabis | Capsaicin-induced pain in volunteers | Smoking single dose at various concentrations | Double-blinded cross-over placebo-controlled RCT | 15 | Pain scores and McGill Pain Questionnaire | Pain reduction at medium dose within a certain time frame only | B | Wallace et al60 |
| Cannabis | Acute inflammatory pain in volunteers | Single oral dose of encapsulate extract | Double-blinded cross-over placebo-controlled RCT | 18 | Threshold to heat and electricity in areas with UV-induced sunburnt | No effect on pain thresholds | B | Kraft et al61 |
| Cannabis | Spasticity due to multiple sclerosis | Escalating dose of oral encapsulate extract | Double-blinded cross-over placebo-controlled RCT | 50 | Spasms frequency and mobility | Improvement in spasms frequency (P = .013) and mobility (P = .01) | A | Vaney et al62 |
| Cannabis | Spasticity caused by multiple sclerosis | Titrating oral dose of cannabis extract | Double-blinded placebo-controlled RCT | 327 | Ashworth score and self-reported spasticity | Improvement of self-report ratings of pain and spasticity (P = .003) | A | Zajicek et al63 |
| Δ9-THC | Gilles de la Tourette Syndrome | Single oral dose | Cross-over placebo-controlled RCT | 12 | TSSL, STSS, YGTSS scores | Significant reduction in TSSL score (P = .015), nil for STSS and YGTSS | A | Müller-Vahl et al64 |
| Δ9-THC | Gilles de la Tourette Syndrome | Daily oral dose for 6 weeks | Placebo-controlled RCT | 24 | TSSL,TS-CGI, STSS; YGTSS | Significant reduction in TSSL score using ANOVA (P = .037), nil for TS-CGI, STSS, YGTSS | A | Müller-Vahl et al65 |
| Δ9-THC | Spasticity caused by multiple sclerosis | Escalating dose for 5 days | Double-blinded cross-over placebo-controlled RCT | 13 | Subjective rating and objective measure of spasticity | Significant in both scores | A | Ungerleider et al66 |
| Δ9-THC | Spasticity due to multiple sclerosis | Titrating oral dose of Δ9-THC | Double-blinded placebo-controlled RCT | 330 | Ashworth score and self-reported spasticity | Improvement of self-report ratings of pain and spasticity (P = .003) | A | Zajicek et al63 |
| Δ9-THC | Postoperative pain | Single oral dose on postoperative day 2 | Double-blinded placebo-controlled RCT | 40 | Summed pain intensity difference 6 hours after administration | No significant difference | B | Buggy et al67 |
| Δ9-THC | Refractory neuropathic pain | Titrating oral dose | Open label pilot | 8 | Neuropathic pain score and quality of life | No apparent effect | C | Attal et al68 |
| Δ9-THC | Glioblastoma multiforme | Daily intracranial tumour injection up to 64 days | Phase I cohort pilot study | 9 | Safety of intracranial route of administration | Intracranial route seems to be safe and may slow down tumour growth | C | Guzman et al69 |
| Dronabinol (synthetic Δ9-THC) | Alzheimer’s disease | Twice-daily oral dose for 6 weeks | Double-blinded cross-over placebo-controlled RCT | 15 | Body weight, triceps skin fold, disturbed behavior, affect | A trend of improvement reported but no significance quoted | B | Volicer et al70 |
| Dronabinol (synthetic Δ9-THC) | Alzheimer’s disease | Daily oral dose for 2 weeks | Open label pilot | 6 | Nocturnal motor activity score and Neuropsychiatric Inventory | Significant improvement in both (P = .028 and P = 0027) | C | Walther et al71 |
| Dronabinol (synthetic Δ9-THC) | Anorexia and weight loss in AIDS | Twice-daily oral dose for 6 weeks | Placebo-controlled RCT | 139 | VAS for appetite, mood, and nausea | Significant change in appetite (38%; P = .015); mood (10%; P = .06); and nausea (20%; P = .05) | A | Beal et al72 |
| Nabilone | Spasticity caused by spinal cord injury | Twice-daily oral dose for 4 weeks | Double-blinded cross-over placebo-controlled RCT | 12 | Ashworth Scale, Total Ashworth Score | Significant reduction, P = .003 and 0.001 respectively | A | Pooyania et al73 |
| Nabilone | Pain caused by fibromyalgia | Oral dose for 4 weeks | Double-blinded placebo-controlled RCT | 40 | VAS and Fibromyalgia impact questionnaire | Significant reduction in both scores (P < .02) | A | Skrabek et al74 |
| Sativex (extract of cannabis containing Δ9-THC and cannabidiol) | Peripheral neuropathic pain | Self-titrating dose of oromucosal spray for 5 weeks | Double-blinded placebo-controlled RCT | 125 | Various pain intensity scores | Significant reduction, (P = .001 to P = .04) | A | Nurmikko et al75 |
| Sativex (extract of cannabis containing Δ9-THC and cannabidiol) | Intractable neurogenic symptoms | Self-titrating dose of oromucosal spray for 2 weeks | Double-blinded cross-over placebo-controlled RCT | 20 | Self-report symptoms and adverse effects | Significant relief in pain with certain domains reaching significance of P < .05 | A | Wade et al76 |
| Sativex (extract of cannabis containing Δ9-THC and cannabidiol) | Central pain in multiple sclerosis | Self-titrating dose of oromucosal spray for 4 weeks | Double-blinded placebo-controlled RCT | 66 | 11-point scale for pain and sleep disturbance | Significant reduction of pain (P = .005) and sleep disturbance (P = .003) | A | Rog et al77 |
| Sativex (extract of cannabis containing Δ9-THC and cannabidiol) | Bladder dysfunction in multiple sclerosis | Single daily dose for 8 weeks | Open label pilot study | 15 | Occurrence of urinary incontinence, frequency, nocturia | Significant reduction in all 3 domains (P < .05) | A | Brady et al78 |
RCT, randomized controlled trial; UV, ultraviolet; TSSL,; STSS,; YGTSS,; TS-CGI, ANOVA, analysis of variance; VAS, Visual Analog Scale; THC, tetrahydrolcannabinol.