PMID- 17355549
OWN - NLM
STAT- MEDLINE
DCOM- 20070510
LR  - 20220408
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Linking)
VI  - 14
IP  - 3
DP  - 2007 Mar
TI  - Randomized controlled trial of cannabis-based medicine in spasticity caused by 
      multiple sclerosis.
PG  - 290-6
AB  - Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be 
      difficult to treat. We have investigated the efficacy, safety and tolerability of 
      a standardized oromucosal whole plant cannabis-based medicine (CBM) containing 
      delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. 
      A total of 189 subjects with definite MS and spasticity were randomized to 
      receive daily doses of active preparation (n = 124) or placebo (n = 65) in a 
      double blind study over 6 weeks. The primary endpoint was the change in a daily 
      subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints 
      included a measure of spasticity (Ashworth Score) and a subjective measure of 
      spasm. The primary efficacy analysis on the intention to treat (ITT) population 
      (n = 184) showed the active preparation to be significantly superior (P = 0.048). 
      Secondary efficacy measures were all in favour of active preparation but did not 
      achieve statistical significance. The responder analysis favoured active 
      preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals 
      were attributed to adverse events (AEs); six were on active preparation and two 
      on placebo. We conclude that this CBM may represent a useful new agent for 
      treatment of the symptomatic relief of spasticity in MS.
FAU - Collin, C
AU  - Collin C
AD  - Department of Neurorehabilitation, Royal Berkshire and Battle NHS Trust, Reading, 
      UK. christine.collin@rbbh-tr.nhs.uk
FAU - Davies, P
AU  - Davies P
FAU - Mutiboko, I K
AU  - Mutiboko IK
FAU - Ratcliffe, S
AU  - Ratcliffe S
CN  - Sativex Spasticity in MS Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Cannabinoids)
RN  - 0 (Placebos)
RN  - 0 (Plant Extracts)
RN  - 19GBJ60SN5 (Cannabidiol)
RN  - 7J8897W37S (Dronabinol)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Cannabidiol/administration & dosage/adverse effects
MH  - Cannabinoids/*administration & dosage/adverse effects
MH  - Central Nervous System/drug effects/physiopathology
MH  - Double-Blind Method
MH  - Dronabinol/administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/complications/*drug therapy/physiopathology
MH  - Muscle Spasticity/*drug therapy/etiology/physiopathology
MH  - Placebos
MH  - Plant Extracts/*administration & dosage/adverse effects
MH  - Treatment Outcome
EDAT- 2007/03/16 09:00
MHDA- 2007/05/11 09:00
CRDT- 2007/03/16 09:00
PHST- 2007/03/16 09:00 [pubmed]
PHST- 2007/05/11 09:00 [medline]
PHST- 2007/03/16 09:00 [entrez]
AID - ENE1639 [pii]
AID - 10.1111/j.1468-1331.2006.01639.x [doi]
PST - ppublish
SO  - Eur J Neurol. 2007 Mar;14(3):290-6. doi: 10.1111/j.1468-1331.2006.01639.x.