Beware the power of placebo
Posted: Wed Nov 09, 2005 1:22 pm
My favorite part of the article about Sativex below, "Three patients (11 percent) withdrew from the placebo group after experiencing adverse events they associated with treatment."
I think this is promising because they also noticed a reduction in relapses in one of the the MS trials they did for Sativex, although the trial wasn't designed to look at relapses and the numbers were too small to draw firm conclusions. This is actually a case where I hope the researchers use Bromley's favorite conclusion and say more study is required. I'm not sure if they are considering Sativex for any additional MS trials.
Cannabis drug promising in rheumatoid arthritis
Nov 9, 2005 - Reuters Health - A company-sponsored trial of GW Pharma's cannabis-based medicine, Sativex, in rheumatoid arthritis patients, shows the drug works as a painkiller and may also slow disease progression, according to research published online in Rheumatology on Wednesday.
In the first ever controlled trial of a cannabis-based medicine (CBM) in rheumatoid arthritis, significant pain-relieving effects were observed and disease activity was significantly suppressed following Sativex treatment, according to researchers
"Whilst the differences are small and variable across the population, they represent benefits of clinical relevance and show the need for more detailed investigation in this indication", researchers led by the Royal National Hospital for Rheumatic Diseases, in Bath, England concluded.
Of the 56 patients in the five-week randomized study, 31 were given Sativex daily by fixed delivery oromucosal spray and 27 received placebo.
Each spray of Sativex delivers Tetrahydrocannabinol (2.7mg) and cannabidiol (2.5mg).
Assessment of pain on movement, pain at rest, morning stiffness and sleep quality was measured using a numerical scale, the Short-Form McGill Pain Questionnaire (SF-MPQ) and the DAS28 measure of disease activity.
The cannabis-based drug produced statistically significant improvements in pain of movement, pain at rest, quality of sleep, and disease activity.
Co-author Philip Robson, Director of Cannaboid Research Institute, Oxford told APM: "It's a preliminary study but you would have to say it's a promising start. Pain relief was over and above the standard treatment already being taken in a stabilized way.
The so-called DAS scale is supposed to reflect the inflammatory effect of the disease and this improvement might suggest that the drug is affecting the process of the disease, "although this remains very speculative," Robson added.
The large majority of side effects were mild or moderate and the treatment group showed no serious adverse effects or withdrawals due to side effects.
Three patients (11 percent) withdrew from the placebo group after experiencing adverse events they associated with treatment.
Adverse events reported with CBM included mild dizziness, light-headedness, and dry mouth.
The study was funded by GW pharmaceuticals, which with Bayer, has launched Sativex for multiple sclerosis patients in Canada but which has so far failed to secure marketing authorization in Europe.
I think this is promising because they also noticed a reduction in relapses in one of the the MS trials they did for Sativex, although the trial wasn't designed to look at relapses and the numbers were too small to draw firm conclusions. This is actually a case where I hope the researchers use Bromley's favorite conclusion and say more study is required. I'm not sure if they are considering Sativex for any additional MS trials.
Cannabis drug promising in rheumatoid arthritis
Nov 9, 2005 - Reuters Health - A company-sponsored trial of GW Pharma's cannabis-based medicine, Sativex, in rheumatoid arthritis patients, shows the drug works as a painkiller and may also slow disease progression, according to research published online in Rheumatology on Wednesday.
In the first ever controlled trial of a cannabis-based medicine (CBM) in rheumatoid arthritis, significant pain-relieving effects were observed and disease activity was significantly suppressed following Sativex treatment, according to researchers
"Whilst the differences are small and variable across the population, they represent benefits of clinical relevance and show the need for more detailed investigation in this indication", researchers led by the Royal National Hospital for Rheumatic Diseases, in Bath, England concluded.
Of the 56 patients in the five-week randomized study, 31 were given Sativex daily by fixed delivery oromucosal spray and 27 received placebo.
Each spray of Sativex delivers Tetrahydrocannabinol (2.7mg) and cannabidiol (2.5mg).
Assessment of pain on movement, pain at rest, morning stiffness and sleep quality was measured using a numerical scale, the Short-Form McGill Pain Questionnaire (SF-MPQ) and the DAS28 measure of disease activity.
The cannabis-based drug produced statistically significant improvements in pain of movement, pain at rest, quality of sleep, and disease activity.
Co-author Philip Robson, Director of Cannaboid Research Institute, Oxford told APM: "It's a preliminary study but you would have to say it's a promising start. Pain relief was over and above the standard treatment already being taken in a stabilized way.
The so-called DAS scale is supposed to reflect the inflammatory effect of the disease and this improvement might suggest that the drug is affecting the process of the disease, "although this remains very speculative," Robson added.
The large majority of side effects were mild or moderate and the treatment group showed no serious adverse effects or withdrawals due to side effects.
Three patients (11 percent) withdrew from the placebo group after experiencing adverse events they associated with treatment.
Adverse events reported with CBM included mild dizziness, light-headedness, and dry mouth.
The study was funded by GW pharmaceuticals, which with Bayer, has launched Sativex for multiple sclerosis patients in Canada but which has so far failed to secure marketing authorization in Europe.
