Smoked Cannabis For Spasticity In Multiple Sclerosis: A Randomized, Placebo-Controlled Trial.

[Mr Stoned]

Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial.

Abstract

BACKGROUND:

Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom.

METHODS:

We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11 days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients' perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue.

RESULTS:

Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabisresulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial.

Trinta e sete participantes foram escolhidos aleatoriamente para começar o estudo, trinta deles completaram o teste. Tratamento com cannabis fumada resultou em uma redução nos pontos da escla modificada de Ashworth em uma media de 5.28 pontos, mais que o placebo ( p = 0.008). Pontuação para a escala de caminhada não mudou significativamente entre tratamento e placebo (p=0.2). Pontuação no Paced Auditory Serial Addition Test abaixou 8.67 pontos mais com o tratamento do que com o placebo ( p=0.003). Nenhum evento adverso serio ocorreu durante o teste.

INTERPRETATION:

Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact.

'/http://www.ncbi.nlm.nih.gov/pubmed/22586334

Cannabis fumada para espastividade na esclerose multipla: um aleatoria, teste placebo - controlado.

Espasmos é um sintoma comum e mau controlado da esclerose multipla. Nosso objetivo foi determinar os curtos efeitos da cannabis fumada neste sintoma.

Nos conduzimos um controle com placebo, trocando pacientes adultos escolhidos com esclerose multipla e espasmos. Nós recrutamos participantes de uma clinica regional ou por indicação de especialistas. Nos escolhemos aleatoriamente participantes para as duas intervenções ( Fumar cannabis, uma vez por dia por três dias) ou controle ( cigarro idêntico de placebo, uma vez por dia por três dias). Cada paciente foi checado um dia antes e um dia depois do tratamento. Depois de um intervalo de onze dias de desintoxicação, os pacientes mudaram para o grupo oposto. Nossa primeira medida foi trocar as espastividade por medidas de postos dos pacientes através da escala modificada de Ashworth. Nossa segunda medida inclui a percepção de dor do paciente (medida usando uma escala análoga visual), um tempo de caminhada e efeitos nas funções cognitivas ( medidas nas performances dos pacientes no Paced Auditory Serial Addition Test), adicionando notas para fadiga.

Trinta e sete participantes foram escolhidos aleatoriamente para começar o estudo, trinta deles completaram o teste. Tratamento com cannabis fumada resultou em uma redução nos pontos da escla modificada de Ashworth em uma media de 5.28 pontos, mais que o placebo ( p = 0.008). Pontuação para a escala de caminhada não mudou significativamente entre tratamento e placebo (p=0.2). Pontuação no Paced Auditory Serial Addition Test abaixou 8.67 pontos mais com o tratamento do que com o placebo ( p=0.003). Nenhum evento adverso serio ocorreu durante o teste.

Fumar cannabis foi superior que o placebo nos sintomas e redução da dor nos pacientes tratamento-resistencia da espastividade. Futuros estudos deveriam examinar como as diferentes doses podem resultar em um efeito similar com menores impactos cognitivos

[sujeito]

interessante... estudos duplo cegos controlados com placebo são sempre os que resultam em evidências mais confiáveis...

fiquei só em dúvida de como se consegue um "identical placebo cigarrette"...

[fuck_off]

interessante... estudos duplo cegos controlados com placebo são sempre os que resultam em evidências mais confiáveis...

fiquei só em dúvida de como se consegue um "identical placebo cigarrette"...

boa pergunta msm.....acredito q seria facil diferenciar....

pq sera que usaram cannabis "fumada" e nao vap ou ingerida?

nao fala tbem se o trabalho eh duplo/triplo cego EDIT- eh duplo cego

[fuck_off]

AQUI TA O TRABALHO COMPLETO

http://www.cmaj.ca/c...maj.110837.long

Spasticity is a common and disabling symp tom that remains a substantial problem for many patients with multiple sclerosis.

Some patients have adverse effects from conventional antispasticity medications; for others, spasticity persists despite treatment. A report

from the Institute of Medicine in the United States concluded that the active compounds of cannabis (marijuana) are potentially effective in

treating neurologic conditions and “should be Tested rigorously in clinical trials.”1 There is evidence that the cannabinoid receptors CB1 and

CB2 may be involved in the control of spasticity in multiple sclerosis2 and that the endogenous ligand of CB1, anandamide, is itself an effective

antispasticity agent.3 CB1 receptors are primarily presynaptic; their activation inhibits calcium influx and glutamate release, and reduces neuronal

excitability by activating somatic and dendritic potassium channels.4 Although many patients with multiple sclerosis

endorse smoking cannabis as therapy, evidence that it relieves spasticity is largely anecdotal, as most trials focus on orally ad min istered cannabinoids.

We sought to assess the safety and efficacy of smoked cannabis versus placebo in patients with multiple sclerosis who have treatmentresistant spasticity.

Methods

Participants

We recruited participants from a regional multiple sclerosis clinic and by referral from special- ists. Our eligibility criteria were spasticity and at

least moderate increase in tone (score ≥ 3 points on the modified Ashworth scale5 at the elbow,

hip or knee). Participants were allowed to continue other treatments for spasticity, with the exception of benzodiazepines, if they had been

taking stable doses for three months or longer. Participants could continue disease -modifying therapy (e.g., interferon β-1a, interferon β-1b, gla tiramer) if they had been on a stable regimen for at least six months. We prohibited any changes to medications that were expected to affect spasticity scores during the trial. Participants could be cannabis-naive or cannabisexposed; if the participants had been previously exposed to can nabis, we asked that they refrain

from smoking cannabis for one month before screening and during the trial. We excluded patients with a history of major psychiatric disorder (other than depression) or substance abuse, substantial neurologic disease other than multiple sclerosis (e.g., epilepsy, head trauma) and severe or unstable medical illnesses, known pulmonary disorders (tuberculosis, asthma), patients who used benzodiazepines to control spasticity or high doses of narcotic medications

for pain, and women who were pregnant or breastfeeding. Our study was approved by the Human Re - search Protections Program at the University of

California, San Diego, the Research Advisory Panel of California, the Drug Enforcement Administration, the US Food and Drug Administration and the National Institute on Drug

Abuse. Our study was monitored by an independent

data safety monitoring board through the

University of California Center for Medicinal

Cannabis Research.

Study design

We used a randomized, double-blind, placebocontrolled

crossover design. We evaluated participants

during eight visits over a period of two

weeks. Visit 1 was a screening visit during which

the participants gave their informed consent. At

this time, we took medical/medication histories,

screened participants for substance abuse (using

urine toxicology) and psychiatric disorders, and

determined spasticity using the modified Ashworth

scale.5 Participants with a positive toxicological

screening result (e.g., presence of delta-9

tetrahydrocannabinol, amphetamines, benzodiazepines,

cocaine and/or benzoylecgonine) were

excluded.

A second screening visit took place within

seven days of the first. At this time, we completed

the expanded disability status scale,

determined spasticity again using the modified

Ashworth scale and conducted a battery

of cognitive tests to reduce practise effects.

During this second visit, participants were

given a “practise session” with a placebo cigarette,

although they were not told that it was

a placebo.

Treatment began within seven days of the

second screening visit, including randomization

to placebo or smoked cannabis. Phase 1 was

followed by an 11-day washout period, after

which participants crossed over to the opposite

treatment group for phase 2. We assessed each

patient before and after treatment for three consecutive

days during each phase. The examiner

was blind to the treatment group to which each

patient was assigned. We assessed patients

using the modified Ashworth scale, a visual

analog scale for pain, a timed walk and cognitive

tests such as the Paced Auditory Serial

Addition Test (PASAT). We as sessed treatment -

emergent effects about 45 minutes after treat-

ment. We collected urine for toxicological

screening at the beginning (baseline) of each

phase.

We assessed participants at the same time of

day to regulate food, medication and time of

cannabis intake. Participants smoked either a

placebo or a cannabis cigarette, using the Foltin

uniform puff procedure (inhalation for 5 s, followed

by a 10-s breath-hold and exhalation, with

a 45-s wait between puffs),6 under supervision in

a ventilated room. Participants completed an

average of four puffs per cigarette.

Prerolled cannabis and placebo cigarettes

with identical appearances and weight (about

800 mg) were provided by the National Institute

on Drug Abuse. Cannabis cigarettes contained

about 4% delta-9-tetrahydrocannabinol (delta-9-

THC) by weight; placebo cigarettes had the

same base material but with the delta-9-THC

removed. We chose to use the 4% delta-9-THC

cigarette available from the National Institute on

Drug Abuse because it most closely resembled

the strength of cigarettes available in the community

at the time of the study (typically

between 5% and 6%).7

We assessed safety and adverse effects by

monitoring participants’ vital signs in addition to

self-report by participants.

[fuck_off]

nao excluiram do estudo aqueles que ja tinha experimentado maconha.

entao o cara pensa : se eu fiquei HIGH , tinha THC, entao era maconha.

o problema eh que aposto q mto neguim q usou placedo juraria por Deus que ficou HIGH.......hahaahahah

e os outros cannabinoides????