Sequoiacrone
June 29th, 2008, 11:50 AM
IACM Bulletin 4-13-08 Sativex studies, OCD, neuropathic pain
--------------------------------------------------------
IACM-Bulletin of 13 April 2008
--------------------------------------------------------
* Spain: Positive results of a study with the cannabis extract
Sativex in Catalonia
* Science: THC effective in obsessive compulsive disorder
according to case reports
* Science: Preliminary results of a study with Sativex in
neuropathic pain due to multiple sclerosis
* Germany: Lead poisoning due to adulterated cannabis
1.
Spain: Positive results of a study with the cannabis extract
Sativex in Catalonia
On 9 April the government of Catalonia published positive
results of its pilot programme to evaluate the oral cannabis
extract Sativex as a treatment in different patient groups.
According to the press release almost half of the patients who
received Sativex responded well by reporting improvement of
their symptoms. A total of 207 patients were included with the
following therapeutic indications: 32 with neuropathic pain due to
multiple sclerosis, 54 with spasticity due to MS, 47 with
neuropathic pain due to different medical conditions (other than
MS), 41 with diagnosed anorexia-cachexia syndrome due to
cancer or AIDS, and 33 with nausea and vomiting due to
chemotherapy treatment.
The pilot programme commenced in January 2006 by order of
the Head of the Catalan Health Department and was finished in
December 2007. The project has involved the participation of
over 40 doctors in 6 hospitals in the Barcelona Area. According
to Marina Geli, the head of the Catalan health department, in the
case of patients suffering from anorexia-cachexia associated with
AIDS up to 53 per cent of these regained their appetite. The
number of patients in the study suffering from multiple sclerosis
who went from having unbearable pain to suffering tolerable pain
went down from 66 per cent to 35 per cent.
More at:
http://production.investis.com/gwp/pressreleases/currentpress/20 (http://production.investis.com/gwp/pressreleases/currentpress/20)
08-04-09/
http://www.420magazine.com/forums/international-cannabis (http://www.420magazine.com/forums/international-cannabis)-
news/74830-study-spain-underlines-therapeutic-use-
cannabis.html
(Sources: Press release of GW Pharmaceuticals of 9 April
2008, www.420magazine.com (http://www.420magazine.com/) of 11 April 2008)
2.
Science: THC effective in obsessive compulsive disorder
according to case reports
Researchers from Berlin, Germany, reported two cases of
obsessive compulsive disorder successfully treated with oral
THC to the American Journal of Psychiatry. Both patients, a 38-
year-old woman and a 36-year-old man, were refractory to
conventional treatment such as neuroleptics and antidepressants.
After the first patient had informed her physicians that smoking
of cannabis relieved her symptoms, 10 mg THC three times
daily was added to the ongoing treatment with clomipramine,
which resulted in a significant decrease of symptoms within 10
days. The second patient received dronabinol, which was slowly
increased up to a dose of 10 mg THC twice daily, also in
addition to his ongoing treatment. A significant reduction of
symptoms was observed within two weeks.
Obsessive compulsive disorder is a psychiatric anxiety disorder
most commonly characterized by a subject's obsessive,
distressing, intrusive thoughts and related compulsions (tasks or
"rituals") which attempt to neutralize the obsessions. Many
patients do not respond well to conventional medications, which
also may cause significant side effects. Based on the observation
that THC is effective in treating tics in Tourette's syndrome and
the observation that Tourette's syndrome may be genetically
linked to obsessive compulsive disorder, researchers
hypothesized that THC might also reduce their symptoms.
The short article (a letter to the editor) is available at:
http://ajp.psychiatryonline.org/cgi/content/full/165/4/536?maxtosh (http://ajp.psychiatryonline.org/cgi/content/full/165/4/536?maxtosh)
ow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Schin
dler&searchid=1&FIRSTINDEX=0&sortspec=relevance&re so
urcetype=HWCIT
(Source: Schindler F, Anghelescu I, Regen F, Jockers-Scherubl
M. Improvement in refractory obsessive compulsive disorder
with dronabinol. Am J Psychiatry. 2008 Apr;165(4):536-7.)
3.
Science: Preliminary results of a study with Sativex in
neuropathic pain due to multiple sclerosis
On 8 April GW Pharmaceuticals announced preliminary results
of a Phase III placebo-controlled study of its cannabis extract
Sativex in 339 patients with central neuropathic pain due to
multiple sclerosis, who have achieved inadequate pain relief with
existing therapies. The primary efficacy endpoint in the study
was the proportion of patients whose pain reduced by at least
30 per cent as measured on a 0-10 numerical rating scale. 50
per cent of Sativex patients experienced a pain reduction of at
least 30 per cent. However, although the difference between the
Sativex and placebo groups was clearly in favour of Sativex, it
failed to reach statistical significance due to an unexpectedly
large placebo response.
After the negative results were announced, shares of GW
Pharmaceuticals lost more than a quarter of their value within
one day. This study is one of three Phase III trials for Sativex
underway in 2008, each of which targets a distinct indication.
The other European Phase III study in MS spasticity, requested
last year by the UK regulator in order to gain approval in this
indication is on track to report later this year. According to the
press release GW's regulatory strategy is to file Sativex for
approval in MS spasticity in Europe and cancer pain in the
United States.
(Sources: Press release of GW Pharmaceuticals of 8 April
2008, Independent of 9 April 2008)
4.
Germany: Lead poisoning due to adulterated cannabis
In recent months several cases of lead poisoning were observed
in Germany, mainly in the region of Leipzig. Some cases also
occurred in other places, such as Munich and Vienna, Austria.
According to a report published in the New England Journal of
Medicine 29 patients were admitted to four different hospitals in
the greater Leipzig area with classic signs and symptoms of lead
intoxication, which had not occurred in Germany in recent
decades. All patients were regular cannabis users and lead was
detected in cannabis of some patients.
A criminal investigation was begun to find the causer of the lead
adulteration. Lead was obviously added to the drug by drug
traffickers to increase weight and profit. An anonymous
screening program for cannabis users was started and further 95
subjects were found, who had blood levels of lead that required
treatment. The Drug Commissioner of the Federal Government,
Sabine Baetzing, issued a warning on cannabis that may be
adulterated by lead. Several German organisations called for the
possibility for cannabis users to grow their own for personal use
to reduce the risks of cannabis use.
The article is available at:
http://content.nejm.org/cgi/content/full/358/15/1641 (http://content.nejm.org/cgi/content/full/358/15/1641)
(Source: Busse F, Omidi L, Leichtle A, Windgassen M, Kluge
E, Stumvoll M. Lead poisoning due to adulterated marijuana. N
Engl J Med 2008;358(15):1641-2.)
5.
News in brief
***The Netherlands: Maastricht
On 1 April a district court in Maastricht overturned a municipal
decree stating that cannabis bars must refuse foreigners as
clients. French, Belgians and Germans must now be allowed in.
A distinction by 'residency' is not permitted on grounds of the
ban on discrimination in Article 1 of the constitution unless there
are reasonable, objective grounds justifying it. There was no
question of this here, the judge found. (Source: NIC News
Bulletin of 2 April 2008)
***Science: Fibromyalgia
Compared with healthy subjects 22 patients with primary
fibromyalgia had increased blood levels of anandamide.
Researchers assume that patients with fibromyalgia "might
benefit from pharmacologic manipulation of endocannabinoid
signalling." (Source: Kaufmann I, et al.
Psychoneuroendocrinology. 2008 Apr 4 [Electronic publication
ahead of print])
***Science: Dependency
Researchers of the Columbia University in New York reported
on two cases of cannabis dependence, who were treated with
oral THC. They conclude that given "that agonist agents have
been found to be effective for opiate and nicotine dependence,
the clinical utility of dronabinol for cannabis dependence is a
reasonable approach." (Source: Levin FR & Kleber HD. Am J
Addict 2008;17(2):161-4.)
***Science: Neuropathic pain
British researchers conclude from animal studies that the
cannabinoid-2 receptor in the thalamus, a brain region, may have
a functional role in neuropathic pain. (Source: Jhaveri MD, et al.
Eur J Neurosci 2008;27(7):1722-30.)
***Science: Neuropathic pain
It was shown in animal studies that activation of the CB2
receptor in the spinal cord may reduce pain after nerve injury.
(Source: Romero-Sandoval A, et al. Anesthesiology
2008;108(4):722-34.)
6.
ONE YEAR AGO:
- Italy: Government wants to allow the use of cannabis-based
medicines
- Science: The use of cannabis does not influence the efficacy of
two anti-cancer drugs, a clinical study finds
TWO YEARS AGO:
- Science: Cannabinoids reduce inflammation of the bowel in
animal model
(More at the IACM-Bulletin archives: http://www.cannabis (http://www.cannabis/)-
med.org/)
International Association for Cannabis as Medicine (IACM)
Am Mildenweg 6
D-59602 Ruethen
Germany
Phone: +49 (0)2952-9708571
Fax: +49 (0)2952-902651
Email: info@cannabis-med.org (info@cannabis-med.org)
http://www.cannabis-med.org (http://www.cannabis-med.org/)
If you want to be deleted from or added to the IACM-Bulletin
mailing list or if you want to change your e-mail address please
visit
www.cannabis-med.org/english/subscribe.htm (http://www.cannabis-med.org/english/subscribe.htm). You may choose
between different languages (English, German, French, Dutch,
Italian and Spanish).
The articles of the IACM-Bulletin can be printed, translated and
distributed freely for any non-commercial purposes, provided
the original work is properly cited. The source of the IACM-
Bulletin is "IACM, www.cannabis-med.org (http://www.cannabis-med.org/)".
__________________
--------------------------------------------------------
IACM-Bulletin of 13 April 2008
--------------------------------------------------------
* Spain: Positive results of a study with the cannabis extract
Sativex in Catalonia
* Science: THC effective in obsessive compulsive disorder
according to case reports
* Science: Preliminary results of a study with Sativex in
neuropathic pain due to multiple sclerosis
* Germany: Lead poisoning due to adulterated cannabis
1.
Spain: Positive results of a study with the cannabis extract
Sativex in Catalonia
On 9 April the government of Catalonia published positive
results of its pilot programme to evaluate the oral cannabis
extract Sativex as a treatment in different patient groups.
According to the press release almost half of the patients who
received Sativex responded well by reporting improvement of
their symptoms. A total of 207 patients were included with the
following therapeutic indications: 32 with neuropathic pain due to
multiple sclerosis, 54 with spasticity due to MS, 47 with
neuropathic pain due to different medical conditions (other than
MS), 41 with diagnosed anorexia-cachexia syndrome due to
cancer or AIDS, and 33 with nausea and vomiting due to
chemotherapy treatment.
The pilot programme commenced in January 2006 by order of
the Head of the Catalan Health Department and was finished in
December 2007. The project has involved the participation of
over 40 doctors in 6 hospitals in the Barcelona Area. According
to Marina Geli, the head of the Catalan health department, in the
case of patients suffering from anorexia-cachexia associated with
AIDS up to 53 per cent of these regained their appetite. The
number of patients in the study suffering from multiple sclerosis
who went from having unbearable pain to suffering tolerable pain
went down from 66 per cent to 35 per cent.
More at:
http://production.investis.com/gwp/pressreleases/currentpress/20 (http://production.investis.com/gwp/pressreleases/currentpress/20)
08-04-09/
http://www.420magazine.com/forums/international-cannabis (http://www.420magazine.com/forums/international-cannabis)-
news/74830-study-spain-underlines-therapeutic-use-
cannabis.html
(Sources: Press release of GW Pharmaceuticals of 9 April
2008, www.420magazine.com (http://www.420magazine.com/) of 11 April 2008)
2.
Science: THC effective in obsessive compulsive disorder
according to case reports
Researchers from Berlin, Germany, reported two cases of
obsessive compulsive disorder successfully treated with oral
THC to the American Journal of Psychiatry. Both patients, a 38-
year-old woman and a 36-year-old man, were refractory to
conventional treatment such as neuroleptics and antidepressants.
After the first patient had informed her physicians that smoking
of cannabis relieved her symptoms, 10 mg THC three times
daily was added to the ongoing treatment with clomipramine,
which resulted in a significant decrease of symptoms within 10
days. The second patient received dronabinol, which was slowly
increased up to a dose of 10 mg THC twice daily, also in
addition to his ongoing treatment. A significant reduction of
symptoms was observed within two weeks.
Obsessive compulsive disorder is a psychiatric anxiety disorder
most commonly characterized by a subject's obsessive,
distressing, intrusive thoughts and related compulsions (tasks or
"rituals") which attempt to neutralize the obsessions. Many
patients do not respond well to conventional medications, which
also may cause significant side effects. Based on the observation
that THC is effective in treating tics in Tourette's syndrome and
the observation that Tourette's syndrome may be genetically
linked to obsessive compulsive disorder, researchers
hypothesized that THC might also reduce their symptoms.
The short article (a letter to the editor) is available at:
http://ajp.psychiatryonline.org/cgi/content/full/165/4/536?maxtosh (http://ajp.psychiatryonline.org/cgi/content/full/165/4/536?maxtosh)
ow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Schin
dler&searchid=1&FIRSTINDEX=0&sortspec=relevance&re so
urcetype=HWCIT
(Source: Schindler F, Anghelescu I, Regen F, Jockers-Scherubl
M. Improvement in refractory obsessive compulsive disorder
with dronabinol. Am J Psychiatry. 2008 Apr;165(4):536-7.)
3.
Science: Preliminary results of a study with Sativex in
neuropathic pain due to multiple sclerosis
On 8 April GW Pharmaceuticals announced preliminary results
of a Phase III placebo-controlled study of its cannabis extract
Sativex in 339 patients with central neuropathic pain due to
multiple sclerosis, who have achieved inadequate pain relief with
existing therapies. The primary efficacy endpoint in the study
was the proportion of patients whose pain reduced by at least
30 per cent as measured on a 0-10 numerical rating scale. 50
per cent of Sativex patients experienced a pain reduction of at
least 30 per cent. However, although the difference between the
Sativex and placebo groups was clearly in favour of Sativex, it
failed to reach statistical significance due to an unexpectedly
large placebo response.
After the negative results were announced, shares of GW
Pharmaceuticals lost more than a quarter of their value within
one day. This study is one of three Phase III trials for Sativex
underway in 2008, each of which targets a distinct indication.
The other European Phase III study in MS spasticity, requested
last year by the UK regulator in order to gain approval in this
indication is on track to report later this year. According to the
press release GW's regulatory strategy is to file Sativex for
approval in MS spasticity in Europe and cancer pain in the
United States.
(Sources: Press release of GW Pharmaceuticals of 8 April
2008, Independent of 9 April 2008)
4.
Germany: Lead poisoning due to adulterated cannabis
In recent months several cases of lead poisoning were observed
in Germany, mainly in the region of Leipzig. Some cases also
occurred in other places, such as Munich and Vienna, Austria.
According to a report published in the New England Journal of
Medicine 29 patients were admitted to four different hospitals in
the greater Leipzig area with classic signs and symptoms of lead
intoxication, which had not occurred in Germany in recent
decades. All patients were regular cannabis users and lead was
detected in cannabis of some patients.
A criminal investigation was begun to find the causer of the lead
adulteration. Lead was obviously added to the drug by drug
traffickers to increase weight and profit. An anonymous
screening program for cannabis users was started and further 95
subjects were found, who had blood levels of lead that required
treatment. The Drug Commissioner of the Federal Government,
Sabine Baetzing, issued a warning on cannabis that may be
adulterated by lead. Several German organisations called for the
possibility for cannabis users to grow their own for personal use
to reduce the risks of cannabis use.
The article is available at:
http://content.nejm.org/cgi/content/full/358/15/1641 (http://content.nejm.org/cgi/content/full/358/15/1641)
(Source: Busse F, Omidi L, Leichtle A, Windgassen M, Kluge
E, Stumvoll M. Lead poisoning due to adulterated marijuana. N
Engl J Med 2008;358(15):1641-2.)
5.
News in brief
***The Netherlands: Maastricht
On 1 April a district court in Maastricht overturned a municipal
decree stating that cannabis bars must refuse foreigners as
clients. French, Belgians and Germans must now be allowed in.
A distinction by 'residency' is not permitted on grounds of the
ban on discrimination in Article 1 of the constitution unless there
are reasonable, objective grounds justifying it. There was no
question of this here, the judge found. (Source: NIC News
Bulletin of 2 April 2008)
***Science: Fibromyalgia
Compared with healthy subjects 22 patients with primary
fibromyalgia had increased blood levels of anandamide.
Researchers assume that patients with fibromyalgia "might
benefit from pharmacologic manipulation of endocannabinoid
signalling." (Source: Kaufmann I, et al.
Psychoneuroendocrinology. 2008 Apr 4 [Electronic publication
ahead of print])
***Science: Dependency
Researchers of the Columbia University in New York reported
on two cases of cannabis dependence, who were treated with
oral THC. They conclude that given "that agonist agents have
been found to be effective for opiate and nicotine dependence,
the clinical utility of dronabinol for cannabis dependence is a
reasonable approach." (Source: Levin FR & Kleber HD. Am J
Addict 2008;17(2):161-4.)
***Science: Neuropathic pain
British researchers conclude from animal studies that the
cannabinoid-2 receptor in the thalamus, a brain region, may have
a functional role in neuropathic pain. (Source: Jhaveri MD, et al.
Eur J Neurosci 2008;27(7):1722-30.)
***Science: Neuropathic pain
It was shown in animal studies that activation of the CB2
receptor in the spinal cord may reduce pain after nerve injury.
(Source: Romero-Sandoval A, et al. Anesthesiology
2008;108(4):722-34.)
6.
ONE YEAR AGO:
- Italy: Government wants to allow the use of cannabis-based
medicines
- Science: The use of cannabis does not influence the efficacy of
two anti-cancer drugs, a clinical study finds
TWO YEARS AGO:
- Science: Cannabinoids reduce inflammation of the bowel in
animal model
(More at the IACM-Bulletin archives: http://www.cannabis (http://www.cannabis/)-
med.org/)
International Association for Cannabis as Medicine (IACM)
Am Mildenweg 6
D-59602 Ruethen
Germany
Phone: +49 (0)2952-9708571
Fax: +49 (0)2952-902651
Email: info@cannabis-med.org (info@cannabis-med.org)
http://www.cannabis-med.org (http://www.cannabis-med.org/)
If you want to be deleted from or added to the IACM-Bulletin
mailing list or if you want to change your e-mail address please
visit
www.cannabis-med.org/english/subscribe.htm (http://www.cannabis-med.org/english/subscribe.htm). You may choose
between different languages (English, German, French, Dutch,
Italian and Spanish).
The articles of the IACM-Bulletin can be printed, translated and
distributed freely for any non-commercial purposes, provided
the original work is properly cited. The source of the IACM-
Bulletin is "IACM, www.cannabis-med.org (http://www.cannabis-med.org/)".
__________________