Sativex Spray Significantly Reduced MS Spasticity But Not Other Symptoms in 160-Patient Trial
In a randomized trial of 160 MS patients using Sativex oromucosal spray, spasticity scores improved significantly compared to placebo (P = 0.001), but the primary outcome measuring each patient's most troublesome symptom did not reach significance.
Quick Facts
What This Study Found
Researchers recruited 160 MS outpatients experiencing significant problems with spasticity, spasms, bladder issues, tremor, or pain across three centers. Patients received either matched placebo or whole-plant cannabis extract (Sativex) containing equal amounts of THC and CBD at doses of 2.5 to 120 mg each daily via oromucosal spray.
The primary outcome, a visual analogue scale (VAS) score for each patient's most troublesome symptom, improved in both groups but did not reach statistical significance between them.
However, spasticity VAS scores were significantly reduced by Sativex compared to placebo (P = 0.001). There were no significant adverse effects on cognition or mood, and intoxication was generally mild.
Key Numbers
160 MS patients across three centers. Sativex dose range: 2.5-120 mg THC and CBD daily. Primary symptom VAS: not significant between groups. Spasticity VAS: significantly reduced (P = 0.001). No significant cognitive or mood adverse effects.
How They Did This
Parallel group, double-blind, randomized, placebo-controlled study across three centers. One hundred sixty MS outpatients experiencing problems with spasticity, spasms, bladder issues, tremor, or pain received oromucosal spray of placebo or Sativex (equal THC and CBD, 2.5-120 mg daily). Primary outcome was VAS score for each patient's most troublesome symptom. Secondary outcomes included VAS scores for other symptoms, disability, cognition, mood, sleep, and fatigue.
Why This Research Matters
While the primary outcome was negative, the significant improvement in spasticity specifically (P = 0.001) suggested that Sativex may be effective for this particular MS symptom. This trial contributed to the evidence base that eventually led to Sativex receiving regulatory approval for MS spasticity in multiple countries.
The Bigger Picture
This trial is part of a series of studies that built the case for Sativex as a treatment for MS spasticity. The pattern of significant improvement in spasticity specifically, but not across all MS symptoms, helped refine the therapeutic target for cannabis-based medicines in MS treatment.
What This Study Doesn't Tell Us
The primary endpoint did not reach significance. The wide dose range (2.5-120 mg) means individual dosing varied substantially. The study grouped patients with different primary symptoms together, which may have diluted the overall treatment effect.
Questions This Raises
- ?Would a trial focused exclusively on MS spasticity patients show stronger overall results?
- ?What is the optimal dose range for spasticity specifically?
Trust & Context
- Key Stat:
- Spasticity VAS scores significantly reduced by Sativex vs. placebo (P = 0.001)
- Evidence Grade:
- Multi-center randomized controlled trial with adequate sample size, though the primary endpoint was negative. The significant spasticity finding was a secondary outcome.
- Study Age:
- Published in 2004. Sativex has since been approved for MS spasticity in over 25 countries based on this and subsequent trials.
- Original Title:
- Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.
- Published In:
- Multiple sclerosis (Houndmills, Basingstoke, England), 10(4), 434-41 (2004)
- Authors:
- Wade, Derick T(2), Makela, Petra(2), Robson, Philip(4), House, Heather, Bateman, Cynthia
- Database ID:
- RTHC-00183
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
Did Sativex help with all MS symptoms?
No. The primary outcome measuring each patient's most troublesome symptom was not significantly better than placebo. However, spasticity specifically showed significant improvement (P = 0.001). Other symptoms like pain, tremor, and bladder problems did not show significant benefits.
Did Sativex cause cognitive problems?
No significant adverse effects on cognition or mood were found. Intoxication was generally described as mild.
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Cite This Study
https://rethinkthc.com/research/RTHC-00183APA
Wade, Derick T; Makela, Petra; Robson, Philip; House, Heather; Bateman, Cynthia. (2004). Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.. Multiple sclerosis (Houndmills, Basingstoke, England), 10(4), 434-41.
MLA
Wade, Derick T, et al. "Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.." Multiple sclerosis (Houndmills, 2004.
RethinkTHC
RethinkTHC Research Database. "Do cannabis-based medicinal extracts have general or specifi..." RTHC-00183. Retrieved from https://rethinkthc.com/research/wade-2004-do-cannabisbased-medicinal-extracts
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.