FIBROMYALGIA and cannabis studies completed
Science & Research
Undated - Study - Cannabis Sativa (Marijuana) for Fibromyalgia.
2012 - News ~ One in 8 with fibromyalgia uses cannabis as medicine.
2012 - News ~ Pot Popular for Pain in Fibromyalgia.
2010 - News ~ Medical marijuana may help fibromyalgia pain.2009 - News ~ Medical Marijuana and Fibromyalgia.
2008 - Study - Nabilone for the treatment of pain in fibromyalgia.
2008 - Study ~ Anandamide and neutrophil function in patients with fibromyalgia.
2008 - Study ~ Marijuana-Based Drug Reduces Fibromyalgia Pain, Study Suggests.
2008 - News - Fibromyalgia and Medical Marijuana.
2008 - News ~ Two New Approaches for Fibromyalgia.
2008 - News - Marijuana Ingredient May Cut Fibromyalgia Pain.
2008 - News - Marijuana Derivative Called Effective in Fibromyalgia.
2007 - Study ~ Study of analgesic effects of oral THC in Germany.
2007 - News - Fibromyalgia: Effective Treatment with Medical Marijuana.
2007 - News - Synthetic Cannabis for Fibromyalgia Pain?
2006 - News - THC Reduces Pain in Fibromyalgia Patients.
Recommended Cannabis Strains for Fibromyalgia
Clinical Endocannabinoid Deficiency
Ethan B. Russo
Senior Medical Advisor, GW Pharmaceuticals, 2235 Wylie Avenue, Missoula, MT 59802, USA
Correspondence to: Ethan B. Russo, M.D.
Senior Medical Advisor, GW Pharmaceuticals
2235 Wylie Avenue
Missoula, MT 59802, USA
VOICE: +1 406-542-0151
FA X: +1 406-542-0158
EMAIL : [email protected]
Submitted: December 1, 2003
Accepted: February 2, 2004
Abstract OBJECTIVES: This study examines the concept of clinical endocannabinoid deficiency
(CECD), and the prospect that it could underlie the pathophysiology of
migraine, fibromyalgia, irritable bowel syndrome, and other functional conditions
alleviated by clinical cannabis.
METHODS: Available literature was reviewed, and literature searches pursued
via the National Library of Medicine database and other resources.
RESULTS: Migraine has numerous relationships to endocannabinoid function.
Anandamide (AEA) potentiates 5-HT1A and inhibits 5-HT2A receptors
supporting therapeutic efficacy in acute and preventive migraine treatment.
Cannabinoids also demonstrate dopamine-blocking and anti-inflammatory
effects. AEA is tonically active in the periaqueductal gray matter, a migraine
generator. THC modulates glutamatergic neurotransmission via NMDA receptors.
Fibromyalgia is now conceived as a central sensitization state with secondary
Cannabinoids have similarly demonstrated the ability to
block spinal, peripheral and gastrointestinal mechanisms that promote pain in
headache, fibromyalgia, IBS and related disorders.
The past and potential clinical
utility of cannabis-based medicines in their treatment is discussed, as are
further suggestions for experimental investigation of CECD via CSF examination
CONCLUSION: Migraine, fibromyalgia, IBS and related conditions display
common clinical, biochemical and pathophysiological patterns that suggest an
underlying clinical endocannabinoid deficiency that may be suitably treated with cannabinoir medicines.
|Treatment Ratings for FMS Symptoms|
Based on 70 rating(s) & review(s).
makes me feel tired 04/04/11
Reviewed by: Location Not Given
I sleep well and am relaxed but feel worse fybro pain the next day and next few days
The best medicine I've used so far. 02/08/11
Reviewed by: painfullyaware Location Not Given
Was diagnosed with FMS, and CPS in 2000 and have had (3) knee surgeries along the way.
I tried cannabis at a young age but migrated away from it but rediscovered it as a medicine in 1990-91 due to undiagnosed FMS, CPS as at that time FMS and CFS were not even identified.
I think I've tried every prescription medication on the market with limited relief but nothing works like Marijuana.Prescription Meds turn toxic over time and make one sicker as I got much sicker off of them and lost my gall bladder along the way and have a bad stomach as well.Marijuana is a god send of sorts cause it helps my symptoms but has cost me as well in the long run due to getting caught growing my own for medicinal use.
Politician's need to make this type of medicine available to sick people that need it.
Instead some of us are forced to use this remarkable medicine illegally and being forced into a criminal lifestyle due to it's use.I've tried for 11 years to find a doctor that would see me and sign the forms to get legal MMJ but can't find one as my doctor is approaching 70 years of age and appears to be an old fashioned type of doctor.
I've cried a million tears over my situation that continues after all these years and I still can't get this medicine legally and I think this is just terrible and at times unbearable.
I Hope and pray that every FMS patient finds some relief from this dreaded disease as the symptoms can be more than one can take.
Hash oil & my experience 02/03/11
Reviewed by: Location Not Given
Hash oil capsules 3 times a day allowed me to be free of all symptoms. Down side is that I can't get much of a head change when I toke...I used to like to smoke "pot" that is why I was open to trying it in my food as a medicine. It was quite a relief eating it in a brownie, but when I made the hash oil capsules and took them 3 times a day I was amazed! I am now finally able to get around and do some things!
Marijuana does help. 01/07/11
Reviewed by: Chelle Location Not Given
I have found that it does really help. Especially sleep and depression. Helps with energy as well.
I was a real skeptic but have been converted. 01/03/11
Reviewed by: Location Not Given
If you found this your probably wondering if the drug will help you. Well I am a 48 yr old male and started getting sick about 7 years but doctors didn't know what it was. It wasn't until about a year ago that I was finally diagnosed with Fibromyalgia.
I was put on all kinds of medications including Methadone, Morphine, Norco (Vicodin), Fentanyl, Lyrica, Neurontin, Celexa... in all over 50 different medications. Some things helped but even the strong opiates didn't do the trick and most of the medications had some serious side effects including death!
After loosing my 100K a yr job and declaring bankruptcy I was desperate to find something so I could return to a semi-normal life. I should point out that I avoided all drugs and for the most part alcohol all my life.
It was simply something I didn't want to like. Then I stumbled upon this page and read EVERY review regarding medical marijuana. I was reluctant to try and very much opposed to smoking anything.
First time out I tried nothing more than an edible (fudge). I have since bought a vaporizer and am happy to say that on average I get between a 50% and 80% reduction in pain.
Granted I don't care much for the "high" feeling which is loosely similar to a couple glasses of wine but other than that, the only other side effect seems to be bad dry mouth. These I can live with.
I've been able to drastically reduce my reliance on Norco (basically strong Vicodin). I am now tapering off Lyrica which caused me to gain 60lbs in just a few months.
If your doctors have you on and they are just not cutting it and you live somewhere that you can try it without the risk of legal prosecution, I have to recommend you give Medical Marijuana a try.
Keep in mind this is coming from an anti-drug skeptic so I am not posting this simply to push a political agenda. In short, this really helps. DA
1 out of 1 people found this review useful.
Flush the Vicodin. 11/16/10
Reviewed by: Location Not Given
Used Marijuana to cease using Vicodin out of concern to Opiate addiction.
Doctors loved giving more.Marijuanas mild spacey/stoned feeling on onset is the only side effect,wears off quickly.
I was never one to smoke it because of social stigma,but drank for years with massive consequences.
To the naysayers on this,open your little minds.This has been a godsend to me to function again,I wish I had opened my mind a long time ago.
1 out of 1 people found this review useful.
It really works! 10/27/10
Reviewed by: Location Not Given
I'm 52 with no small children @ home anymore & I've had fibro for 14 yrs.
I've been smoking for about the past month, only at night and I've been really surprised at the outcome, which is Great! Only problem is trying to get it. It's not leagal at all in our state so I worry about getting caught.
Seems to me if the other states have legalized medical marijuana, then ALL the states should HaVe to follow suit! haha!
1 out of 1 people found this review useful.
I finally tried it 10/21/10
Reviewed by: Location Not Given
And it works! I have tried Lyrica - which made me feel zoned out of my mind with not much pain relief, Gabapentin, Darvocet, Ultram, Flexeril, Hydrocodone, etc. over the last 10 years or so since my fibro dx and which only helped maybe with 30-40% of the pain or less.
Also, that amount of relief is only when I took the meds at a higher dosage than rxd. Even that amount of pain relief was of course better than none at all but it is pretty much impossible to get more than a few pills from drs that I have seen.
They all say that those meds are too addictive for long term use. Nothing has helped nearly as much as MJ, but it took me all this time to try it for several reasons.
Its illegal, difficult to aquire, and I am mother to 4 kids that I did not want them to find out that their mother is smoking weed. I know after all my "don't do drugs" talks that they would think I am a hypocrit or worse.
So I really was desperate enough due to increasing pain to try it and I am so glad knowing that I will at least have periods of being pretty much pain-free several times a week. I don't smoke during the day, only evenings after my husband is home, and never if I even might have to drive.
It is truly a shame that I have to sneak to obtain this, sneak to use it and worry about being caught by police or my kids, since this is the only thing that makes me feel close to normal again.
Relief, but kind of a hassel 09/02/10
Reviewed by: Location Not Given
Difficult to obtain and take, but it definitely helps!
Lifelong user, only relief I get. 08/19/10
Reviewed by: Woodbridge, Virginia, USA
There was a time, way back before I developed the pain symptoms and other associated issues related to FMS, when marijuana was simply a recreational thing that I did with my friends;
I could take it or leave it at any time. Then, lo and behold, several years later I developed symptoms of the FMS that runs rampant through my maternal line and nothing I tried had any effect. I can take over the counter medications all day long and none of them have more than the slightest of slight positive effects on my FMS symptoms.
Even the prescription medications I have been given generally only have slight effect (except for maybe the opiate based drugs, such as vicoden and fentanyl and that sort of meds, all of which come with SEVERE side effects, including nausea and constipation).
It was during this time that I first tried smoking marijuana to try to find some relief of the pain that I experience every day and found that marijuana seemed to be effective to manage the worst of my pain symptoms.
I have continued to use marijuana (primarily in the smoked form as that is the easiest to procure means of delivery; vaporizers are expensive) over the last 14 years as the primary medication to manage my various FMS symptoms, including the nausea that seems to be an every day thing with some FMS patients, the pain that fluctuates from day to day, the moderate insomnia that I deal with, and other issues that I have including major depression (that is at least partly due to the fact that I do have a chronic pain issue that I cannot get adequately treated by the medical profession).
There have been times in my life where the pain has been so severe that I have literally wished to die, if only that would stop the pain. Times like those, marijuana has quite literally served as a life saver for me. I don't know what part of the MMJ that I have consumed over the years is responsible for the benefits that I have received from it but the effects that MMJ has had on my physical and mental state over the years are undeniable.
There is an aspect that it seems that some patients forget to mention when discussing the part that MMJ plays in our lives and that is namely the fact (and yes, I do say fact) that even if smoking MMJ does not relieve ALL of the pain and other symptoms of FMS, it does tend to put one into a mental state in which I am more capable of coping with what is.
Also, I would love to see some research and others experiences with such preparations as hemp oil for pain relief. The couple of experiences I have had with hemp oil (applied to a cigarette as a means of delivery) produced no "high" but, and this is a big but, for the first time in many years, after the first time I was exposed to this particular so-called drug, I know I experienced the first time in many years of absolutely no pain and this lasted for several hours (upwards of 4 or 5 hours) with absolutely no side effects that I could tell. I wish that this medicine would be made available to the general public as I believe it is much more effective than many of the pharmaceutical preparation that are commonly prescribed for what ails us.
Currently the only downside that I see to the use of marijuana for the management of my FMS is the legality of it. I would love to be able to acquire my medicine legally and with the full knowledge and supervision of a trained medical professional and look forward to the day that this government gets its head out of its own ass and smells the bud, so to speak.
Marijuana is medicine and is much safer even as a "nightcap" type of thing than alcohol ever was. May the goddess Mary Jane bring her enlightenment to the medical establishment and may the government stop persecuting those who are only trying to feel better.
Displaying 1-10 of 70 ratings and reviews.
THC Reduces Pain in Fibromyalgia Patients
Mannheim, Germany: Oral administration of THC significantly reduces both chronic and experimentally induced pain in patients with fibromyalgia, according to clinical trial data to be published in the June 2006 issue of the journal Current Medical Research and Opinion. The study is the first-ever clinical trial assessing the efficacy of cannabinoids in the treatment of fibromyalgia.
Investigators at Germany's University of Heidelberg assessed the analgesic effects of oral THC in nine patients with fibromyalgia over a 3-month period. Subjects in the trial were administered daily doses of 2.5 to 15 mg of THC, but received no other pain medication during the trial. Among those participants who completed the trial, all reported a significant reduction in daily recorded pain and electronically induced pain, investigators found.
"All patients who completed the delta-9-THC therapy ... experienced pain relief of more than 50
percent," authors concluded. Investigators recommended that follow up placebo-control trials be
conducted assessing the use of cannabinoids on fibromyalgia.
Previous trials have shown that both naturally occurring and endogenous cannabinoids hold analgesic qualities, particularly in the treatment of cancer pain and neuropathic pain, both of
which are poorly treated by conventional opiates.
Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain,
fatigue, and multiple tender points in the neck, spine, shoulders, and hips. An estimated 3 to
6 million Americans are afflicted by the disease, which is often poorly controlled by standard
Full text of the study, "Delta-9-THC based monotherapy in fibromyalgia patients on experimentally induced pain, axon reflex flare, and pain relief," will be available in the June 2006 issue of Current Medical Research and Opinion.
Fibromyalgia: Effective Treatment with Medical Marijuana
Dr. Phil Leveque Salem-News.com
(MOLALLA, Ore.) - Fibromyalgia is a very painful, complex disease causing spasm of muscles and accompanying nerves and has been a contentious puzzle to both victims and their doctors.
It seems nobody has the slightest idea what causes it and its symptoms and signs can be so diverse that it has been called the "invisible disease" with no specificity except the victim's typical statements that, "I hurt all over."
Most doctors reaction or response to a patient presenting with the above just responded with "It's all in your head," or alternatively "You just want drugs." This is and was incorrect, they wanted relief!
The self-hypnosis of many doctors was usually that depression causes fibromyalgia. This decries the fact that chronic pain does cause depression. One very prominent doctor in Oregon made an international reputation for himself by treating hundreds of patients with a very widely used anti-depressant, amitriptyline (Elavil). It helped their depression but it didn't help much for their fibromyalgia pain and spasms.
Another of the attempts to treat the painful muscle spasms was with cyclobenzaprine (Flexaril) which my patients told me just made them dopey or feel stupid. This is just not too good for someone who has to work.
Anti-seizure drugs such as gabapentin (Neurontin) have been tried. I tried this myself for causalgia, severe burning pain in my feet caused from damage to my sacral nerves. It made me so dopey and dysfunctional I called my neurosurgeon and told him I wouldn't prescribe it to my worst enemy. I do have a former patient who takes it in high doses for severe discogenic disease. His wife says he is now completely disabled AND dysfunctional.
Some other medications have been tried, success has been minimal.
It was not a surprise to me to read of successful trials in Germany for fibromyalgia with THC, the medicinal chemical in cannabis/marijuana. I have about 100 fibromyalgia patients using marijuana/cannabis very effectively. It is known that cannabis has good analgesic, antispasmodic and euphoriant actions.
It is also known also that the body produces endocannabinoids, anandamide and 2AG also produce analgesia, antispasm and euphoriant actions, and that plant and natural cannabinoids are better than any other chemical/pharmaceutical trial drug or combination.
It is estimated that 5% to 7% of the population has fibromyalgia. This means that several million patients in the U.S. are afflicted. I note that Eli Lilly & Company are advertising a new drug for fibromyalgia. Three years ago they ballyhooed a drug for ADD. It was a bust. Eli Lilly was once a leading producer of cannabis medicines. I think they should go back to that, it works.
You can email your questions to the doctor: [email protected]
More information on the history of Leveque can be found in his book, General Patton's Dogface Soldier of Phil Leveque about his experiences in WWII. Order the book by mail by following this link: salem-news.com/pages/Dogface_soldier.
If you are a World War Two
histsry fan, you don't want to miss it.
Fibromyalgia and Medical Marijuana
And Andrea Hecht
Fibromyalgia, a chronic pain syndrome, is hard to treat and impossible to cure. With pain so debilitating, patients may wonder about trying medical marijuana to ease their discomfort.
Still widely controversial, "medical marijuana" refers to the smoked form of the drug. It does not refer to the synthesized version of THC, one of the active chemicals in marijuana, that's available in a medication called Marinol. The FDA first approved Marinol (dronabinol) in 1986 for nausea and vomiting from chemotherapy. It later approved its use for nausea and weight loss from AIDS.
The history of medical marijuana
Medical marijuana was prescribed by doctors until 1942. That's when it was taken off the U.S. pharmacopoeia, the list of commonly available drugs.
"Marijuana has been a medicine for 5,000 years," says Donald I. Abrams, MD. "That's a lot longer than it hasn't been a medicine." Abrams, who is an oncologist and director of clinical research programs at the Osher Center for Integrative Medicine at the UCSF School of Medicine in San Francisco, is one of a handful of top-flight doctors in the country researching medical marijuana. "The war on drugs is really a war on patients," he says.
So why research medical marijuana when a pill, Marinol, is now available?
Marijuana -- the plant's Latin name is cannabis -- has a host of components called cannabinoids. These components may have medicinal properties.
"There are 60 or 70 different cannabinoids in marijuana," says Abrams. Marinol contains only one cannabinoid -- delta-9 THC. When THC is isolated from the plant, other ingredients are lost, including those that might be buffering any adverse effects of taking "straight" THC. "In Chinese medicine," Abrams says, "they prescribe whole herbs and usually combinations of herbs."
Abrams goes on to point out that, "In 1999 the Institute of Medicine did a report -- Marijuana and Medicine. And they said, in fact, that cannabinoids have benefit in relief of pain, increase in appetite, and relief of nausea and vomiting."
Is medical marijuana legal?
The federal government, in the Controlled Substances Act of 1970, placed drugs into five groups called "schedules," driven by three criteria:
- potential for abuse or
- medical usefulness
- dangers of abuse or addiction, both physically and psychologically
Marijuana, LSD, and heroin were all initially placed in Schedule I -- the most addictive, and least medically useful, category.
To further entangle the legal issues, several states have passed their own controlled substance laws that conflict with federal laws. That includes drug policy reforms and "compassionate use" laws that allow patients with terminal and debilitating diseases to use medical marijuana. In order to be able to use it, a patient needs to have documentation from a doctor.
The American Chronic Pain Society says in ACPA Medications & Chronic Pain, Supplement 2007: "Some states allow the legal use of marijuana for health purposes including pain, while the federal government continues to threaten physicians with prosecution for prescribing it."
Nabilone for the treatment of pain in fibromyalgia
J Pain. 2008 Feb;9(2):164-73. Epub 2007 Nov 5
Section of Physical Medicine and Rehabilitation, University of Manitoba, Rehabilitation Hospital, Health Sciences Centre, Winnipeg, Manitoba, Canada. [email protected]
A randomized, double-blind, placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia. After a baseline assessment, subjects were titrated up on nabilone, from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo.
At the 2- and 4-week visits, the primary outcome measure, visual analog scale (VAS) for pain, and the secondary outcome measures, number of tender points, the average tender point pain threshold, and the Fibromyalgia Impact Questionnaire (FIQ), were evaluated.
After a 4-week washout period, subjects returned for reassessment of the outcome measures.
There were no significant differences in population demographics between groups at baseline. There were significant decreases in the VAS (-2.04, P < .02), FIQ (-12.07, P < .02), and anxiety (-1.67, P < .02) in the nabilone treated group at 4 weeks.
There were no significant improvements in the placebo group. The treatment group experienced more side effects per person at 2 and 4 weeks (1.58, P < .02 and 1.54, P < .05), respectively.
Nabilone appears to be a beneficial, well-tolerated treatment option for fibromyalgia patients, with significant benefits in pain relief and functional improvement. PERSPECTIVE: To our knowledge, this is the first randomized, controlled trial to assess the benefit of nabilone, a synthetic cannabinoid, on pain reduction and quality of life improvement in patients with fibromyalgia.
As nabilone improved symptoms and was well-tolerated, it may be a useful adjunct for pain management in fibromyalgia.
Marijuana Ingredient May Cut Fibromyalgia Pain
WebMD Health News
Feb. 19, 2008 -- Nabilone, a pain drug based on marijuana's active ingredient, may ease fibromyalgia pain.
So say Canadian researchers, based on a preliminary, short-term study.
The study included 40 fibromyalgia patients. First, they did three things:
- Rate the intensity of their fibromyalgia pain. The rating scale ranged from 0 (no pain) to 10 (the worst pain imaginable). Their average rating was about 6.
- Rate their quality of life. The rating scale ranged from 0 to 100, with higher scores indicating worse quality of life. Their average rating was 66.
- Get a check of their tender points -- parts of the body that are often sensitive in fibromyalgia patients.
The researchers then split the patients into two groups.
For a month, one group of patients took nabilone daily. The other group took a placebo pill. The patients didn't know which pill they were taking.
After a month of nabilone treatment, fibromyalgia pain was less intense and quality of life had improved. No such changes were seen with the placebo.
Nabilone treatment didn't affect the patients' number of tender points. And it didn't cure fibromyalgia pain -- when patients stopped taking nabilone, their fibromyalgia pain returned to its former intensity.
Nabilone was well tolerated, but side effects were more commonly reported in the nabilone group. Those side effects -- which included drowsiness, dry mouth,, and movement problems -- were "generally mild," write the researchers.
Longer studies are needed to track the long-term effects, note the University of Manitoba's Ryan Quinlan Skrabek, MD, and colleagues.
Their study appears in the February edition of The Journal of Pain.
Synthetic Cannabis for Fibromyalgia Pain?
Karen Lee Richards’ career as a writer and patient advocate grew.
The first randomized clinical trial of nabilone for the treatment of fibromyalgia pain was recently conducted at the University of Manitoba in Canada. Nabilone (pronounced NAB ill own) is a synthetic cannabinoid that mimics the main ingredient of marijuana (THC). It is marketed in the U.S., Canada, the United Kingdom and Mexico under the brand name Cesamet. Nabilone is approved by the FDA for use as an antiemetic for chemotherapy-induced nausea and vomiting that cannot be controlled by other medications.
A randomized, double-blind, placebo-controlled trial was conducted to determine whether nabilone would improve pain management and quality of life for fibromyalgia patients. Forty FM patients were divided into two groups. Over a four-week period, one group received nabilone, titrated up from 0.5 mg at bedtime to 1 mg twice a day, and the other group received a corresponding placebo. Subjects in both groups were allowed to continue taking their regular medications.
Subjects were assessed after two weeks and again after four weeks using the visual analog scale (VAS) [0 = no pain; 10 = worst pain imaginable], the number of tender points, the average tender point pain threshold, and the Fibromyalgia Impact Questionnaire (FIQ) [evaluates the impact FM is having on the subject’s functionality and quality of life].
After four weeks, the group receiving nabilone showed significant decreases in the VAS score and in the FIQ anxiety levels, but there was no significant improvement in either number of tender points or tender point pain thresholds. The control group receiving the placebo showed no significant improvement in any area.
Subjects returned after eight weeks, following a four-week washout period. At that time the outcome measures for both groups showed no significant difference from their original baseline scores, indicating that Nabilone does not have any lasting benefit when treatment is discontinued. The reported side effects of Nabilone were generally mild, and it did not seem to have any adverse interactions with the medications subjects were already taking.
Researchers reported that nabilone appeared to be a beneficial, well-tolerated treatment option for fibromyalgia patients, offering significant benefits in pain relief and functional improvement. However, since this is the first study of nabilone for FM, the duration of the study was short, and there were a limited number of participants, researchers concluded that future studies are necessary to accurately assess whether nabilone is an effective treatment for fibromyalgia.
Marijuana Derivative Called Effective in Fibromyalgia
WINNIPEG, Manitoba, Feb. 15 -- Pain, anxiety, and disability were significantly reduced with the marijuana derivative nabilone (Cesamet) used for fibromyalgia, researchers here said.
In a small trial, four weeks of off-label nabilone reduced mean scores on the 10-point Visual Analog Scale of pain by 2.0 points from baseline (P=0.02), reported Ryan Q. Skrabek, M.D., and colleagues at the University of Manitoba, in the February issue of the Journal of Pain.
Nabilone is a synthetic analog of tetrahydrocannabinol, a key component of marijuana. It is FDA-approved for chemotherapy-induced nausea and vomiting.
Forty patients were enrolled in the randomized, double-blind, placebo-controlled trial, the first such trial of nabilone in fibromyalgia, according to the investigators.
The 20 patients given nabilone also showed improvement of 12.0 points from baseline (P=0.02) on the 100-point Fibromyalgia Impact Questionnaire. The instrument evaluates physical function, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being in fibromyalgia patients.
On the Fibromyalgia Impact Questionnaire's 10-point anxiety component, mean scores declined 2.2 points from baseline (P<0.01) with nabilone.
No significant improvements from baseline were seen with the 20 placebo controls in any outcome measure at any time point in the study, Dr. Skrabek and colleagues reported.
At four weeks, there were statistically significant differences between nabilone and placebo in Visual Analog Scale pain scores (-1.43, P<0.05), Fibromyalgia Impact Questionnaire scores (-10.76, P<0.01), and the latter's anxiety scale (-2.20, P<0.01).
Nabilone treatment began at 0.5 mg orally at bedtime during the first week of treatment and was increased by 0.5 mg/day each week until patients were receiving 1 mg twice daily during the fourth week of treatment. A four-week washout period followed.
Patients were included in the trial if they met American College of Rheumatology criteria for fibromyalgia and had continued pain despite other oral medications. They could continue on other medications during the study.
The mean baseline score on the Fibromyalgia Impact Questionnaire was 66.5 in both treatment arms. On the pain scale, mean scores were 6.9 in the nabilone group and 6.2 in the placebo group.
Patients were evaluated at weeks two and four, and again at week eight after patients had been off treatment for four weeks.
After the washout period, pain and fibromyalgia impact scores returned to near baseline values in the nabilone group.
The assessments included tender point counts and the average pain threshold associated with tender points. These did not change significantly with nabilone treatment, with respect either to baseline or to placebo, Dr. Skrabek and colleagues said.
Side effects were more common in the nabilone group. Many of these were consistent with what is reported with smoked marijuana, Dr. Skrabek said. They included drowsiness, dry mouth, vertigo, confusion, and disassociation.
On the other hand, only one patient reported feeling euphoria, and no one said they felt "stoned," he said.
Five patients assigned to nabilone dropped out within the study's first two weeks, compared with two discontinuations in the placebo group.
However, Dr. Skrabek pointed out that two of the nabilone patients gave no reason for withdrawing.
He added that fibromyalgia patients are sensitive to side effects of medications and that the investigators were concerned that the dropout rate might be even higher.
Nevertheless, he said nabilone was well-tolerated. Taken with the evidence for efficacy, he said, the drug deserves additional study for treating fibromyalgia.
The investigators pointed out that "subjects were only trialed on nabilone for a total of four weeks, of which only the last week of treatment was at 1mg twice a day. The long-term effect of nabilone in alleviating pain and improving quality of life in patients with fibromyalgia cannot be determined based on the short duration of the study."
"Future studies are still necessary to assess the long-term benefit of nabilone on pain and quality of life, and secondary outcome measures such as anxiety, depression, and fatigue should be further explored with validated assessment tools," the researchers concluded.
Nabilone is regulated as a Class II controlled substance, and its label includes warnings about potential psychotropic effects and a precaution referring to abuse potential.
Dr. Skrabek characterized nabilone's price for chronic use as "prohibitive." He said a year of treatment at the dosage studied in the trial would cost $4,000.
In the United States, the average wholesale cost of a single 1-mg capsule is about $20, according to the University of Utah Hospital in Salt Lake City.
Primary source: Journal of Pain
Skrabek R, et al "Nabilone for the treatment of pain in fibromyalgia" J
The Effects of Nabilone on Sleep in Fibromyalgia: Results of a Randomized Controlled Trial
|Author(s)||Ware MA, Fitzcharles MA, Joseph L, Shir Y|
|Institution||Pain Clinic, McGill University Health Centre, Montreal, Quebec, Canada. [email protected]|
|Source||Anesth Analg 2010 Feb; 110(2):604-10.|
BACKGROUND: Sleep disorders affect many patients with chronic pain conditions. Cannabis has been reported by several patient populations to help sleep. We evaluated the safety and efficacy of nabilone, a synthetic cannabinoid, on sleep disturbance in fibromyalgia (FM), a disease characterized by widespread chronic pain and insomnia.
The primary outcome was sleep quality, measured by the Insomnia Severity Index and the Leeds Sleep Evaluation Questionnaire. Secondary outcomes included pain, mood, quality of life, and adverse events (AEs).
|Pub Type(s)||Journal Article|
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Delta-9-THC based monotherapy in fibromyalgia patients on experimentally induced pain, axon reflex flare, and pain relief
by M Schley, et al
September 13, 2006
Journal: Curr Med Res Opin. 2006 Jul;22(7):1269-76. Author and Affiliation: Schley M, Legler A, Skopp G, Schmelz M, Konrad C, Rukwied R; Department of Anaesthesiology and Intensive Care Medicine, Faculty of Clinical Medicine Mannheim, University of Heidelberg, Mannheim, Germany.
OBJECTIVE: Fibromyalgia (FM) is a chronic pain syndrome characterized by a distinct mechanical hyperalgesia and chronic pain. Recently, cannabinoids have been demonstrated as providing anti-nociceptive and anti-hyperalgesic effects in animal and human studies.
Here, we explored in nine FM patients the efficacy of orally administered delta-9-tetrahydrocannabinol (THC) on electrically induced pain, axon reflex flare, and psychometric variables. Research design and methods: Patients received a daily dose of 2.5-15 mg of delta-9-THC, with a weekly increase of 2.5 mg, as long as no side effects were reported.
Psychometric variables were assessed each week by means of the West Haven-Yale Multidimensional Pain Inventory (MPI), Pittsburgh Sleep Quality Index (PSQI), Medical outcome survey-short form (MOS SF-36), the Pain Disability Index (PDI), and the Fibromyalgia Impact Questionnaire (FIQ). In addition, patients recorded daily, in a diary, their overall pain intensity on a numeric scale.
Each week, pain and axon reflex flare was evoked experimentally by administration of high intensity constant current pulses (1 Hz, pulse width 0.2 ms, current increase stepwise from 2.5-12.5 mA every 3 minutes) delivered via small surface electrodes, attached to the volar forearm skin.
MAIN OUTCOME MEASURES: Daily pain recordings by the patient, experimentally induced pain, and axon reflex flare recorded by a laser Doppler scanner.
RESULTS: Five of nine FM patients withdrew during the study due to adverse side effects.
Delta-9-THC had no effect on the axon reflex flare, whereas electrically induced pain was significantly attenuated after doses of 10-15 mg delta-9-THC (p < 0.05). Daily-recorded pain of the FM patients was significantly reduced (p < 0.01). CONCLUSIONS: This pilot study demonstrated that a generalized statement that delta-9-THC is an analgetic drug cannot be made.
However, a sub-population of FM patients reported significant benefit from the delta-9-THC monotherapy. The unaffected electrically induced axon reflex flare, but decreased pain perception, suggests a central mode of action of the cannabinoid.