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OCTOBER 8, 2019

Medical Cannabis Found Safe and Effective for Treating Fibromyalgia

Medical cannabis to treat fibromyalgia symptoms was found safe and effective, according to a prospective, observational study.

However, the authors noted that standardization of treatment compounds and regimens is needed.

“Fibromyalgia is one of the most common reasons for chronic pain, which physicians encounter daily in their clinical practice, yet the current treatments for fibromyalgia are very limited to improve efficacy,” said co-principal investigator Iftach Sagy, MD, PhD, a physician at the Rheumatology Unit and Clinical Research Center, Soroka University Medical Center, in Beersheba, Israel. “The recommended guidelines to manage fibromyalgia are based on pharmacological and nonpharmacological treatments. But many patients do not achieve sufficient control of disease burden.”

Of the 367 patients with fibromyalgia (mean age, 52.9 years; 82% women) who participated in the study, 45.2% reported previous experience with recreational cannabis.

The median length of fibromyalgia symptoms was seven years, and 87.2% of patients reported constant daily pain. Furthermore, 77.1% of patients said pain from fibromyalgia was the primary reason they sought medical cannabis therapy.

Patients were educated by a certified nurse on the use of medical cannabis; instructions on route of administration (oil vs. inflorescence); delivery methods (drops, flowers, capsules or cigarettes); and potential adverse effects. The nurse also advised individual patients on selecting one of 14 strains of medical cannabis.

A gradual titration process was used instead of a fixed dose. Initially, all patients received a low dose of cannabis below the therapeutic effect, and then the dosage was gradually increased—for instance, to a single daily drop—until a therapeutic effect was achieved: a subjective relief of pain or a significant improvement in quality of life.

For patients opting for inflorescence, each cigarette contained 0.75 g of cannabis, for which patients were instructed to inhale one breath every three to four hours, and then increase the amount gradually until a therapeutic effect was reached. Mixing of oil and inflorescence during the same usage time was dissuaded.

The cannabis provider also operated a 24/7 call center to address any patient concerns.

The median cannabis approved dosage was 670 mg per day at initiation and 1,000 mg per day at six months. The median THC and cannabidiol (CBD) dosages at six months were 140 and 39 mg per day, respectively.

All patients had one- and six-month follow-up telephone interviews during the span of the study, which lasted from 2015 to 2017. Overall, 7.6% of participants stopped treatment before six months.

At six months, 81.1% of the remaining cohort achieved a treatment response of at least moderate to significant improvement in disease control, with pain intensity (scale 0-10) reduced from a median of 9.0 at baseline to 5.0 (P<0.001).

Treatment failure was more likely to occur in patients over 60 years of age and those who voiced concerns about cannabis treatment, whereas spasticity at treatment initiation and previous use of cannabis strongly correlated with treatment success.

There were no major adverse events. The three most common mild effects were dizziness (7.9%), dry mouth (6.7%) and gastrointestinal symptoms (5.4%).

“None of these results surprise me because previous small, short-term studies have demonstrated the same findings,” Dr. Sagy said. “Medical cannabis is effective for fibromyalgia, due to centralized pain reduction on the brain, which relates to the two major active components of cannabis: THC and CBD.”

To increase the efficacy and safety of medical marijuana, Dr. Sagy recommends “start low and go slow; in other words, a gradual titration process with the minimal dosage possible.”

Among the advantages of the current study are a large cohort of patients with fibromyalgia; a prolonged follow-up period, compared with only two to four weeks for previous studies; and the use of herbal cannabis, compared with synthetic cannabis that is often used in studies.

“Future randomized controlled trials should be conducted to repeat our findings in order to establish the proper place of cannabis in the treatment of fibromyalgia,” Dr. Sagy said.

Michael Schatman, PhD, the director of research and network development at Boston PainCare, said the results of the study are definitely promising. “However, to draw any hard conclusions is difficult,” he said. “Fortunately, the authors did not draw any hard conclusions either, which is appropriate.”

Dr. Schatman, who is also a Pain Medicine News advisory board member, said the Israeli researchers are able to perform better research than others in the United States because of a superior type of medical cannabis grown in Israel. “All of the medical cannabis used in research in the United States has come from the University of Mississippi School of Agriculture,” he said. “It is very low in delta-9-THC and you do not know the specific constituents, so it is impossible to do good medical cannabis research in the United States.”

But as the researchers pointed out, they did not separate the high THC strains from the high CBD strains. “Thus, we do not know what strains the study subjects were using and how it impacted fibromyalgia outcomes,” Dr. Schatman said.

The key to effectively manage chronic pain from fibromyalgia with medical cannabis is to maintain the lowest possible level of THC and highest possible level of CBD, which is exactly the opposite of what is done in the United States, Dr. Schatman said. “High THC leaves patients incapacitated, whereas CBD is anti-inflammatory, neuroprotective, non-euphoriant and definitely the most medically relevant cannabinoid in cannabis.”

The study results were published in the Journal of Clinical Medicine (2019;8[6]. pii: E807).

—Bob Kronemyer

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