Largest MS Cannabinoid Trial Found Small But Significant Spasticity Benefit After 12 Months

The 12-month follow-up of 630 MS patients from the CAMS study found THC produced a small but statistically significant reduction in spasticity on the Ashworth scale (P = 0.01 adjusted), suggesting a longer-term treatment effect beyond what the initial 15-week study showed.

Zajicek, J P et al.·Journal of neurology·2005·Strong EvidenceRandomized Controlled Trial
RTHC-00210Randomized Controlled TrialStrong Evidence2005RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Randomized Controlled Trial
Evidence
Strong Evidence
Sample
N=154

What This Study Found

This was the 12-month follow-up to the main Cannabinoids in Multiple Sclerosis (CAMS) study, the largest RCT of cannabinoids for MS at the time. Six hundred thirty patients from 33 UK centers had been randomized to oral THC, cannabis extract, or placebo in the initial 15-week study, which had not found significant Ashworth score changes.

Eighty percent of patients continued into this blinded follow-up. At 12 months, intention-to-treat analysis revealed a small but significant treatment effect for THC on the Ashworth spasticity scale (mean reduction 1.82 for THC vs. -0.23 for placebo, P = 0.01 adjusted for ambulatory status and center). Cannabis extract showed a smaller, non-significant effect.

There were suggestive findings for THC benefits on some aspects of disability. No major safety concerns emerged over the 12-month period. Patients generally reported feeling the drugs were helpful.

Key Numbers

630 patients from 33 UK centers. 80% followed for 12 months. THC Ashworth reduction: 1.82 (n=154). Cannabis extract: 0.10 (n=172). Placebo: -0.23 (n=176). P = 0.01 adjusted. No major safety concerns.

How They Did This

Double-blind follow-up study extending the original 15-week CAMS trial. Six hundred thirty MS patients from 33 UK centers originally randomized to oral THC, cannabis extract, or placebo. Eighty percent followed for 12 months. Primary outcome: change in Ashworth spasticity scale. Secondary outcomes: Rivermead Mobility Index, timed walk, disability scores, quality of life.

Why This Research Matters

The finding that THC produced a significant spasticity benefit at 12 months, when the initial 15-week study had not, suggests that cannabinoid effects on spasticity may take time to develop or that the Ashworth scale may be insensitive to early changes. This result was important for the broader case that cannabinoids have a role in MS management.

The Bigger Picture

The CAMS study and its follow-up remain among the largest and most rigorous RCTs of cannabinoids for MS. The delayed treatment effect raises important questions about how and when to assess cannabinoid efficacy. The results contributed to the eventual approval of cannabis-based medicines for MS spasticity.

What This Study Doesn't Tell Us

The treatment effect, while statistically significant, was small. Cannabis extract did not show a significant effect, complicating interpretation. Eighty percent follow-up means 20% were lost, potentially biasing results. The Ashworth scale has known limitations as a measure of spasticity.

Questions This Raises

  • ?Why did THC but not cannabis extract show a significant effect?
  • ?Does the delayed onset of benefit reflect disease modification rather than just symptom relief?
  • ?How does the clinical significance of the spasticity improvement translate to patients' daily functioning?

Trust & Context

Key Stat:
THC showed significant spasticity reduction at 12 months (P = 0.01) after the initial 15-week study was negative
Evidence Grade:
Large, multi-center, double-blind RCT with 12-month follow-up. Strongest evidence level, though the treatment effect was small and cannabis extract was not significant.
Study Age:
Published in 2005. The CAMS study remains one of the most cited cannabinoid-MS trials and contributed to subsequent regulatory approvals.
Original Title:
Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up.
Published In:
Journal of neurology, neurosurgery, and psychiatry, 76(12), 1664-9 (2005)
Database ID:
RTHC-00210

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 cannabinoids help with MS spasticity in this trial?

THC produced a small but statistically significant reduction in spasticity at 12 months (P = 0.01), though the initial 15-week study had been negative. Cannabis extract did not show a significant effect. The delayed benefit suggests cannabinoid effects on spasticity may take time to develop.

Was this trial large enough to be reliable?

With 630 patients from 33 centers and 80% completing 12 months, this was one of the largest and most rigorous cannabinoid trials ever conducted. The small effect size was statistically significant but the clinical meaningfulness has been debated.

Read More on RethinkTHC

Cite This Study

RTHC-00210·https://rethinkthc.com/research/RTHC-00210

APA

Zajicek, J P; Sanders, H P; Wright, D E; Vickery, P J; Ingram, W M; Reilly, S M; Nunn, A J; Teare, L J; Fox, P J; Thompson, A J. (2005). Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up.. Journal of neurology, neurosurgery, and psychiatry, 76(12), 1664-9.

MLA

Zajicek, J P, et al. "Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up.." Journal of neurology, 2005.

RethinkTHC

RethinkTHC Research Database. "Cannabinoids in multiple sclerosis (CAMS) study: safety and ..." RTHC-00210. Retrieved from https://rethinkthc.com/research/zajicek-2005-cannabinoids-in-multiple-sclerosis

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.