Welcome to Study of the Week from Patient Worthy. In this segment, we select a study we posted about from the previous week that we think is of particular interest or importance and go more in-depth. In this story we will talk about the details of the study and explain why it’s important, who will be impacted, and more.

If you read our short form research stories and find yourself wanting to learn more, you’ve come to the right place.

This week’s study is…

Topical cannabidiol in the treatment of digital ulcers in patients with scleroderma: comparative analysis and literature review

We previously published about this research in a story titled “Topical Cannabidiol Improved Wound Healing in Patients with Scleroderma” which can be found here. The study was originally published in the research journal Advances in Skin & Wound Care. You can read the full text of the study here. 

This research team was affiliated with the University Hospital of Modena.

What Happened?

A frequent and painful symptom that is found in scleroderma are digital ulcers. These ulcers are often very slow to heal, leading to a significant negative impact on the quality of life of patients. Opioids and NSAIDs, two classes of pain relievers, are often used, but they aren’t always effective or are limited by the risk of serious side effects. In this study, a research team decided to test a topical Cannabis sativa CBD seed oil as a therapy for digital ulcers.

The study included a total of 45 patients. 40 of them were female and the patient group had a mean age of 53 years and 10.68 years mean disease duration. 35 patients had limited scleroderma, while the remainder had diffuse scleroderma. These patients had ulcers that were resistant to opioid therapy, even at the maximum tolerable dose level. The patients were also being treated with a number of systemic and local therapies, depending on the presence of co-existing disorders and other symptoms.

These patients were also treated with advanced dressings and surgical debridement. 25 patients were treated with the CBD oil, while the remainder served as a control group. Over a period of two months, patients received four drops of CBD oil each day. These drops were applied directly to the wound and covered with a nonadhesive gauze. 

Patients treated with CBD reported lower wound pain scores, dropping from 8.4 to 6 after receiving the treatment for one month. Pain as a result of voluntary actions (volitional incident pain) dropped from 9.32 to 6.8. Meanwhile, the control group reported a wound pain change of 8.44 to 7.88. The researchers found that this degree of change was not statistically significant. 

In the group that was treated with CBD, 12 patients required additional pain treatment, such as acetaminophen (four patients), morphine (two patients), acetaminophen plus codeine (four patients), or oxycodone (four patients). All patients in the control group required additional pain medications. Treatment with CBD also improved mean hours of sleep, increasing from 2.56 to 5.67. These patients also saw a reduction in their Health Assessment Questionnaire Disability Index, with mean score dropping from 2.19 to 0.79. This means that patients reported improved quality of life. Meanwhile, the control group saw no appreciable change.

None of the participants discontinued treatment with CBD, and aside from seven patients reporting redness and itching at the wound site, no adverse effects were reported. The research team concluded that topical CBD could be a useful therapy for the treatment of digital ulcers in scleroderma, and called for further study of this treatment.

About Scleroderma

Scleroderma, which is also referred to as systemic sclerosis, describes a group of autoimmune diseases that can cause system-wide effects in the most severe cases. The mechanism of this disease is believed to be an autoimmune response in which the immune system mistakenly attacks body tissue. Some factors that may contribute to triggering the autoimmune response include mutations of the HLA genes and exposure to certain materials, such as certain solvents, white spirits, ketones, and silica. Symptoms are broad ranging and systemic, including kidney failure, erectile dysfunction, fatigue, stroke, headaches, facial pain, congestive heart failure, skin abnormalities, high blood pressure, chest pain, indigestion, and many more. Treatments are varied and depend on the symptoms, but most patients take medications in an attempt to suppress the autoimmune response. In severe cases, life expectancy is around 11 years from onset. To learn more about scleroderma, click here.

Why Does it Matter?

The findings from this study appear to indicate that topical CBD oil could be an effective treatment for scleroderma digital ulcers. Furthermore, the treatment appears to have advantages over current methods, such as greater pain relief and a relative lack of serious side effects.

“The results of this preliminary report encourage further exploration of CBD oil as a potentially helpful topical treatment in the management of SSc-DUs, having no major adverse effects and few minor adverse effects.”