First time a randomised, placebo-controlled four-way cross-over study conducted into the therapeutic effects of inhaling company products

A study out of the Netherlands found that standardised pharmaceutical-grade cannabis with a high tetrahydrocannabinol (THC) content was effective in treating the musculoskeletal pain caused by fibromyalgia.

Conducted by Leiden University Medical Centre (LUMC) in co-operation with Bedrocan International, the study involving the pharmaceutical-grade cannabis provided by the company further found “cannabis flos with only cannabidiol (CBD) did not provide the patients with relief.”

The research involved a total of 20 patients treated at four distinct moments, as well as the administration of three different cannabis products provided by Bedrocan and placebo (cannabis without the main active substances THC and CBD) by a vaporizer.

All subjects were exposed to externally inflicted pain by applying increasing pressure, reports the company, a producer of legal medicinal cannabis that provides standardised medical cannabis capable of being used as an active pharmaceutical ingredient (API) to the Dutch government. With two of the company products, “patients experienced significantly less pressure pain compared to the placebo,” the company statement notes.

Tjalling Erkelens, founder and CEO of Bedrocan, sees the results as encouraging for patients. “The outcome is very important for patients who suffer from fibromyalgia. Now we have the serious clinical evidence that medical doctors are asking for when prescribing our products and that health insurance companies want to have, to legitimize reimbursement,” Erkelens points out.

It is believed this is the first “scientific proof that at least two of Bedrocan’s products are effective in treating the pain symptoms caused by fibromyalgia,” says Professor Albert Dahan, head of LUMC’s Anaesthesia & Pain Research Unit.

“The study is the first time that a randomised, placebo-controlled four-way cross-over study is conducted into the therapeutic effects of inhaling Bedrocan’s medicinal cannabis products,” the statement explains. Noting that “fibromyalgia patients experience pressure pain on muscles and tendons especially,” Dahan concludes “THC is effective in this specific condition.”

Both Bedrocan and Dahan believe that “investigation is now required to determine whether the same results on pain relief can be reproduced in a long-term study with fibromyalgia patients,” the statement notes.

“The next study takes place with patients at home,” he says. “I want to investigate whether THC can be used as an opiate-saving drug. Many people use, and abuse opiates, such as oxycodone. We think that you do not have to prescribe much oxycodone if you also allow patients to use THC,” he adds.

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