It is always difficult to talk about medical cannabis, as it is a highly debated and sensitive topic. Legalization and the differentiation between medical and recreational use pose a real problem. There are certainly significant controversies related to culture and social norms, and not just negative ones: often, its proponents argue that it is healthier because it is a “natural” product rather than being synthesized in a laboratory like many other medications, although from a chemical standpoint, this is not a completely sensible argument. On the other hand, many patient associations support the use and legalization of cannabis as a drug, a position that stems from the positive experiences gathered daily among patients treated with this medication.
The purpose of this article is to clarify the characteristics of this plant from a pharmacological, legal, and bureaucratic perspective, concluding with a note on the latest scientific data collected regarding its use in fibromyalgia syndrome (FM).
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The compounds known to be associated with the cannabis plant are THC (tetrahydrocannabinol) and CBD (cannabidiol). These substances are part of the large family of “cannabinoids,” which includes not only THC and CBD but also dozens of other compounds found in cannabis (cannabicyclol, cannabichromene, cannabitriol, and many others). THC and CBD are the most important and studied cannabinoids. In addition to cannabinoids, cannabis contains hundreds of other substances, such as flavonoids and terpenes, which are at the center of many recent studies and also seem to have beneficial properties. It is particularly important to emphasize this concept in order to distinguish the two main classes of medications: synthetic cannabinoids and medications based on the whole inflorescence of cannabis, which we will discuss in this article. Synthetic cannabinoids are pure compounds: nabilone, for example, consists of pure THC. These pure substances can be synthesized in a laboratory or directly extracted from the plant. In any case, they contain far fewer active ingredients than the whole inflorescence of cannabis.
The different types of cannabis are differentiated by their THC and CBD content (for example: Bedrocan 19% THC), which are the most studied compounds, but one should not forget the entire array of active ingredients contained in the plant. In Italy, medications based on the whole inflorescence come from Holland (such as Bedrocan or Bedrolite) and Canada (Pedanios). Italy also began producing cannabis plants a few years ago, in two varieties called FM1 or FM2. Why choose one variety over another, with the same percentage of THC or CBD? The inflorescences are chemically equivalent; FM1 and FM2 may exhibit greater variability in the percentage of contained cannabinoids (the THC value ranges from 13 to 20% in FM1, while Bedrocan guarantees a titration of about 19 to 22%).
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From a legislative perspective, medical cannabis has been legal in Italy since 2013. It must be used, in Italy, as a supportive treatment for standard treatments when (I quote the website of the Ministry of Health, salute.gov.it) “the latter has not produced the desired effects, has caused intolerable side effects, or requires dose increases that should lead to side effects.” Medical cannabis can be prescribed by any doctor registered with the Medical Association, using a non-reproducible white prescription (in accordance with the Di Bella law), on which the patient’s name should not be written but a unique alphanumeric code. By presenting this prescription at the pharmacy, any patient suffering from the diseases indicated by the ministry can purchase the cannabis-based medication; however, the reimbursement of the medication itself (i.e., whether the medication is “category A”) is at the discretion of each region or autonomous province. Reimbursement requires both a red prescription, which can also be issued by the family doctor, and a treatment plan, which can only be filled out by the specialist and is valid for a maximum of 6 months (as is the case, for example, for oral anticoagulant treatment). Finally, cannabis prescriptions are magistral, meaning they are prepared by the pharmacist. In short: the pharmacist receives the whole inflorescence, which must be transformed into a medication that can be taken by the patient. The pharmacist, through a series of chemical preparations and extractions of the active ingredients, will prepare the oil, capsule, decoction, etc., according to the doctor’s prescription. These complex steps explain not only why not all pharmacies prepare medical cannabis but also its high cost.
As FM is a chronic disease, the preferred route of administration is oral, which facilitates slow absorption and thus prolongs the effect. As with all other medications, you should start taking it at a minimal dose and then gradually increase the dose to avoid side effects while maximizing effectiveness. It is important to remember that cannabis has low interaction with other medications, so it can generally be added to your baseline treatment and has a lower frequency of serious adverse effects: when compared with opioids (codeine, morphine, oxycodone, fentanyl), we see that cannabis results in much less intolerance and dependence.
Cannabis is a natural drug that has been used for hundreds of years, particularly in India and China, to treat various ailments, including pain. In recent years, many scientific studies have confirmed its effectiveness in treating chronic pain. FM is a very complex disease for which cannabis could be an asset, especially for patients who do not find benefit from conventional treatments or who would need to increase the dosage at the risk of causing side effects. The data in the scientific literature regarding cannabis and FM are still controversial, especially due to the lack of well-structured long-term studies confirming their effectiveness. Preliminary data and especially the subjective impressions of patients are encouraging. Some of this data has been collected at our center, the “Luigi Sacco” University Hospital in Milan. In a study published this year, we followed 100 patients with fibromyalgia for 6 months of cannabis treatment, which had been added to their baseline treatment. 30% of patients achieved significant improvement in sleep and quality of life, while many patients experienced moderate improvement in anxiety and depression (results were recorded using questionnaires). Nearly half of the patients reduced their concomitant analgesic treatment. Two other studies published last year highlight that, on average, the impression of the effectiveness of cannabis treatment in patients with fibromyalgia is high.
What conclusions can we draw? First of all, it is important to emphasize the significance of subjective perception when measuring the effectiveness of a medication, a fundamental aspect for both the patient with FM in cannabis and for any other type of pathology or medication. The placebo effect is known, which is an improvement induced by the patient’s positive expectations, while few are aware of the nocebo effect, which is an aggravation of symptoms caused by negative expectations. This is particularly relevant for cannabis, which carries an emotional burden related to culture, expectations, education, and moral values, which can significantly affect the drug’s effect. On the other hand, while it is essential to overcome cultural doubts and hesitations, it is also true that medical cannabis should not be considered a “definitive remedy” for FM. It may be effective in 30 to 50% of patients (a percentage that corresponds to that of other medications used for FM, such as duloxetine), and only for certain symptoms. However, it can be considered a safer alternative to opioids. In general, the therapeutic strategy should be based on gradualness, clinical experience, and the physician-patient alliance.
Dr. Valeria Giorgi
Researcher at the “Luigi Sacco” University Hospital in Milan
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