Welcome to Higher Learning LV's Study Summary series. This series reviews and summarizes peer-reviewed research studies and was developed specifically for cannabis industry professionals. These study summaries provide easily digested quick reads for a variety of important issues regarding the commerce and chemistry of legal cannabis.
A 2019 clinical study involving hundreds of human participants entitled "Safety and Efficacy of Medical Cannabis in Fibromyalgia" that was published in the Journal of Clinical Medicine explored the potential therapeutic role of cannabis and two of its primary chemical classes, cannabinoids and terpenes, in the treatment of fibromyalgia.
"Fibromyalgia is a common syndrome of chronic pain, often accompanied by sleeping disturbances, cognitive impairment, and psychiatric symptoms," reported the study. This disease affects up to eight percent of the population and is "the most common reason for generalized pain among working age women worldwide."
"Fibromyalgia is a common syndrome of chronic pain, often accompanied by sleeping disturbances, cognitive impairment, and psychiatric and somatic symptoms."
The scientists noted that cannabis may offer "a promising therapeutic option" for fibromyalgia sufferers "due to its effectiveness and relatively low rate of serious adverse effects." They also reported that "only a handful of studies" conducted in the past have investigated the effect of cannabis for fibromyalgia patients.
"These [previous] studies had rather small sample sizes (31–40 subjects) and a short duration of follow up, which makes the generalizability of the results questionable," noted the study. "In the current analysis of the prospective registry, we aim to investigate the safety and effectiveness of fibromyalgia patients receiving medical cannabis," reported the study's authors.
The Study
The scientists noted the unique nature of their research. "To the best of our knowledge, this is the first [human clinical] trial to use herbal cannabis in fibromyalgia patients," they noted.
This study collected data that included "all patients with a diagnosis of fibromyalgia (primary or secondary to other conditions) who initiated treatment with medical cannabis from Tikun-Olam Ltd., the largest medical cannabis provider in Israel."
This study collected data that included "all patients with a diagnosis of fibromyalgia (primary or secondary to other conditions) who initiated treatment with medical cannabis from Tikun-Olam Ltd., the largest medical cannabis provider in Israel," between January 2015 and December 2017. This selection criteria resulted in 367 patient participants featuring a mean age of 53. 301 of the participants (82 percent) were female.
"Twenty eight patients (7.6 percent) stopped the cannabis treatment prior to the six month follow-up. The six months response rate was 71 percent," reported the study. Patients who participated in the research "were referred to cannabis treatment by ether the family physician, pain physician, or specialized rheumatologist after receiving [conventional non-cannabis] treatment for at least a year without improvement."
Additional metrics involving study participants are available in the study schematic below.
"The study was approved by the Soroka University Medical Center (SUMC) institutional ethics committee and was conducted by the SUMC Clinical Cannabis Research Institute," disclosed the study's authors.
The research investigation involved education of participants by a certified nurse in various areas of cannabis use, including "instructions on route of administration, delivery methods (drops, flowers, capsules, or cigarettes [joints]), and possible adverse effects." This participant education also included an explanation of regulatory and legal issues of potential concern to cannabis consumers in Israel.
"Study participants were permitted to select the consumption avenue of their choice, with the options being smoking loose-leaf, smoking joints, capsules (containing oil), or a tincture involving an oil."
This education included information regarding the varying effects of different cultivars ("strains") of cannabis within the context of the 14 varieties available via Tikun-Olan Ltd., including a detailed titration protocol that helped participants determine a dosing schedule.
Study participants were permitted to select the consumption avenue of their choice, with the options being smoking loose-leaf cannabis (such as in a bowl or bong) or "cigarettes," capsules containing oil, or a tincture involving an oil. For smoking cigarettes, patients were given joints involving 0.75 grams of loose-leaf cannabis and "instructed to [inhale] one breath every three to four hours and to increase the amount gradually...until therapeutic effect is reached."
The study employed "a gradual titration process rather than a fixed dose.""Initially, all patients received a low dose of cannabis, below the therapeutic effect," it reported. Mixing of consumption avenues involving use of both the oil tincture or capsules and smoked loose-leaf cannabis or joints "was not recommended."
For those using the oil-based tincture, the scientists employed a dosing schedule involving "a [single] drop of 15 percent THC." Patients were instructed to increase the dosage "gradually in small intervals" involving a single drop per day until they achieved a therapeutic effect. Therapeutic effect was defined as "subjective relief of their pain" or "significant improvement in their quality of life."
"The majority of the patients were 40–60 years old," reported the study, which noted that 45 percent of participants reported previous experience with recreational cannabis. The median duration of fibromyalgia symptoms for the participants was seven years. 320 of the patients reported "constant daily pain."
For 283 of the patients (77 percent), "fibromyalgia was the primary pain-related indication to initiate medical cannabis therapy."
For 283 of the patients, "fibromyalgia was the primary pain-related indication to initiate medical cannabis therapy." Fibromyalgia was the secondary indication to initiate cannabis therapy in 35 (10 percent) of the patients who also suffered cancer, 22 (six percent) of those with Post-traumatic Stress Disorder, and 27 (seven percent) of those with other diseases or conditions.
In terms of dosing, "the median THC and CBD dosages at six months were 140 mg/day and 39 mg/day, respectively," reported the study.
The Results
The scientists reported that "overall treatment success was achieved in 194 out of 239 patients (81 percent)" and defined this success as "at least moderate improvement in their condition while still receiving medical cannabis without experiencing serious adverse events."
"Overall treatment success was achieved in 194 out of 239 patients (81 percent)" and was defined as "at least moderate improvement in their condition while still receiving medical cannabis without experiencing serious adverse events."
The researchers noted that 73 percent of participants who reported sleep problems at the beginning of the study (196 patients) experienced improvement and that sleep disorders "completely disappeared" in 26 participants. Of the patients who reported depression-related symptoms at intake (125, or 59 percent), the study noted that 101 (81 percent) experienced improvements.
193 study participants (53 percent), prior to treatment initiation, "reported a high level of pain" (eight out of 10 on the pain scale). After six months of treatment, "only 19 patients (eight percent) reported similar pain intensity." Overall, after six months of cannabis consumption, the pain suffered by study participants "reduced from a median of 9.0...to 5.0."
At the start of treatment, only 10 patients reported "good or very good" quality of life (QOL), whereas 148 patients reported the same after six months of cannabis treatment.
At the start of treatment, only 10 patients reported "good or very good" quality of life (QOL), whereas 148 patients reported the same after six months of cannabis treatment.
"When analyzing QOL components, sleep quality, appetite, and sexual activity significantly improved" for participants after six months of cannabis treatment. However, the study also noted that other components of QOL, including "mobility, dressing, and concentration" did not improve after six months of cannabis consumption.
Decrease in Opioid Use
The study noted that a significant percentage of participants (22 percent) who had been prescribed opioids for pain relief "reduced or ceased the use of these medications [after] six months" of cannabis therapy.
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The scientists reported that this is significant because of the potential (and well documented) negative side effects associated with regular opioid consumption. "Considering that opioid use is coupled with a complex titration process, higher risk for dependency, and a higher rate of serious adverse effects, medical cannabis may pose a reasonable therapeutic alternative," they wrote.
Conclusions
The study's authors concluded that their human trial data demonstrate "that medical cannabis is an effective and safe option for the treatment of fibromyalgia patients' symptoms." They noted what they called "significant improvement [reduction]" in pain intensity and "significant improvement in patients' overall quality of life and fibromyalgia-related symptoms" after six months of medical cannabis therapy.
"Medical cannabis is an effective and safe option for the treatment of fibromyalgia patients' symptoms" that involves "significant improvement [reduction]" in pain.
The scientists noted that "there were relatively minor adverse effects [from cannabis] with a small number of patients," all of whom discontinued cannabis treatment at six months.
The research also noted that "previous studies have shown that medical cannabis use was more prevalent among young adults and males," but that their participant population ("cohort") was composed of mostly middle aged women between the ages of 40 and 60 years, "representing the population most affected by fibromyalgia."
View the original study.
