Cannabis Extract Capsules Reduced Spasticity in MS Patients Who Took Enough of the Medication

In a crossover trial of 57 MS patients, cannabis extract capsules showed no benefit in the full group, but the 37 patients who took at least 90% of their prescribed dose had significantly fewer spasms and improved mobility.

Vaney, C et al.·Multiple sclerosis (Houndmills·2004·Moderate EvidenceRandomized Controlled Trial
RTHC-00181Randomized Controlled TrialModerate Evidence2004RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Randomized Controlled Trial
Evidence
Moderate Evidence
Sample
N=57

What This Study Found

Researchers enrolled 57 MS patients with poorly controlled spasticity into a randomized, double-blind, placebo-controlled crossover study during inpatient rehabilitation. Patients received capsules standardized to 2.5 mg THC and 0.9 mg CBD each, escalated from 15 to a maximum of 30 mg THC per day.

In the full intention-to-treat analysis of 50 patients, there were no statistically significant differences between cannabis extract and placebo. However, trends favoring active treatment appeared for spasm frequency, mobility, and getting to sleep.

In the 37 patients who took at least 90% of their prescribed dose (the per-protocol analysis), improvements in spasm frequency (P = 0.013) and mobility (P = 0.01) reached statistical significance. Minor adverse events were slightly more frequent during active treatment but were generally mild.

Key Numbers

57 patients enrolled. 50 included in intention-to-treat analysis. 37 completed per-protocol analysis (took 90%+ of dose). Capsules contained 2.5 mg THC and 0.9 mg CBD each. Spasm frequency improvement P = 0.013 in per-protocol set. Mobility improvement P = 0.01 in per-protocol set.

How They Did This

This was a prospective, randomized, double-blind, placebo-controlled crossover study conducted during inpatient rehabilitation. Fifty-seven MS patients received standardized cannabis extract capsules (2.5 mg THC and 0.9 mg CBD each) with dose escalation from 15 to 30 mg THC daily. Outcomes included daily self-reported spasm frequency, Ashworth Scale, Rivermead Mobility Index, 10-m timed walk, nine-hole peg test, and cognitive tests.

Why This Research Matters

The split between intention-to-treat and per-protocol results highlights a common challenge in cannabis research: dosing compliance matters. When patients took enough of the medication, measurable benefits emerged. This distinction is important for understanding how cannabis-based medicines might work in clinical practice.

The Bigger Picture

This trial is part of a body of research from the early 2000s testing cannabis-based medicines for MS spasticity. The finding that benefits only reached significance in compliant patients is a pattern seen across several cannabis trials, suggesting that adequate dosing is necessary for therapeutic effects to emerge.

What This Study Doesn't Tell Us

The intention-to-treat analysis did not show significant benefits. The per-protocol analysis, while positive, excludes patients who could not tolerate the full dose, potentially inflating the apparent benefit. The crossover design during inpatient rehabilitation may not reflect real-world use. Sample size was relatively small.

Questions This Raises

  • ?Why did some patients not complete the full dosing regimen?
  • ?Would longer treatment periods or different dosing schedules produce significant benefits in the full treatment group?

Trust & Context

Key Stat:
Spasm frequency improved significantly (P = 0.013) in patients who took at least 90% of prescribed dose
Evidence Grade:
Randomized, double-blind, placebo-controlled crossover trial, but the primary intention-to-treat analysis was not significant. Positive results come from the per-protocol subset.
Study Age:
Published in 2004. Cannabis-based medicines for MS have continued to be studied, with Sativex (nabiximols) receiving approval in several countries since this trial.
Original Title:
Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.
Published In:
Multiple sclerosis (Houndmills, Basingstoke, England), 10(4), 417-24 (2004)
Database ID:
RTHC-00181

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled TrialGold standard for testing treatments
This study
Cohort / Case-Control
Cross-Sectional / Observational
Case Report / Animal Study

Participants are randomly assigned to treatment or placebo groups to test cause and effect.

What do these levels mean? →

Frequently Asked Questions

Did the cannabis extract help all MS patients with spasticity?

Not in the full analysis. When all patients were included regardless of how much medication they took, no statistically significant benefit was found. Benefits only reached significance in the subset who took at least 90% of their prescribed dose.

What side effects did patients experience?

Minor adverse events were slightly more frequent during active treatment, and toxicity symptoms were more pronounced during the active phase, but effects were generally described as mild.

Read More on RethinkTHC

Cite This Study

RTHC-00181·https://rethinkthc.com/research/RTHC-00181

APA

Vaney, C; Heinzel-Gutenbrunner, M; Jobin, P; Tschopp, F; Gattlen, B; Hagen, U; Schnelle, M; Reif, M. (2004). Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.. Multiple sclerosis (Houndmills, Basingstoke, England), 10(4), 417-24.

MLA

Vaney, C, et al. "Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.." Multiple sclerosis (Houndmills, 2004.

RethinkTHC

RethinkTHC Research Database. "Efficacy, safety and tolerability of an orally administered ..." RTHC-00181. Retrieved from https://rethinkthc.com/research/vaney-2004-efficacy-safety-and-tolerability

Access the Original Study

Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.

This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.