Botox Found to Be Effective for Treating Raynaud’s in Small Study

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by Marta Figueiredo PhD |

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Local injection with botulinum toxin A (BTX-A) safely and effectively reduces Raynaud’s phenomenon (RP) and nailfold small blood vessel, or capillary, abnormalities in women with scleroderma, according to data from a small study in China.

Treatment also led to significant improvements in upper limb function in women with limited scleroderma, but not in those with diffuse disease — a more severe form.

While larger studies are needed to confirm these preliminary findings, they highlight BTX-A’s potential to treat RP in scleroderma patients, particularly in those with limited disease, the researchers noted.

The study, “The efficacy of Botulinum toxin A in the treatment of Raynaud’s phenomenon in systemic sclerosis: A randomized self-controlled trial,” was published in the journal Dermatologic Therapy.

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Scleroderma, also known as systemic sclerosis, is an autoimmune disease characterized by extensive blood vessel dysfunction and tissue scarring that may affect multiple organs, but most commonly the skin.

As such, most patients show nailfold capillary abnormalities and Raynaud’s phenomenon, a condition in which the fingers and toes become numb and cold in response to low temperatures or stress. RP is often accompanied by pain and digital ulcers.

The current conservative and surgical treatments are not fully effective for RP secondary to scleroderma, and there is a need for new treatments, the researchers wrote.

Botulinum toxin A, commonly known as Botox, has been shown to promote blood vessel widening and suppress pain. While there is evidence that BTX-A can help ease RP, most of these studies were case reports or case series, and “large randomized controlled trials are lacking,” the researchers wrote.

To address this, a team of researchers in China conducted a randomized controlled trial to evaluate the safety and effectiveness of BTX-A in treating RP in 16 women with scleroderma.

The women’s mean age was 44.8 years and half of them had limited scleroderma, while the other half had diffuse scleroderma. They all had been living with the disease for more than six months, and pharmacological treatment proved ineffective.

In each participant, a hand was randomly assigned to receive a BTX-A injection, with the other receiving no injection and serving as a control.

RP, fingertip temperature before and after cold water stimulation, upper limb disability, pain, digital ulcers, skin involvement, and nailfold capillary abnormalities were assessed through validated measures on both hands before treatment and four weeks later.

Results showed that BTX-A treatment led to a significant reduction in RP and nailfold capillary manifestations, and a significant improvement in temperature recovery after the cold water stimulation.

The therapy was also associated with a significant increase in resting fingertip temperature in diffuse scleroderma patients, and a significant reduction in upper limb disability and in the staging of nailfold capillary damage in those with limited scleroderma.

While there were no significant changes in digital ulcers, “four weeks of follow-up might not be long enough to observe ulcer healing,” the team wrote.

Non-treated hands showed no significant changes in all measures.

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BTX-A injections were generally well-tolerated, with the most common adverse event being temporary mild-to-moderate pain at the injection site. No infections, large bruises, hand muscle weakness, allergic reactions, or nerve injury were reported.

These findings highlight that “local injection of BTX-A can reduce the activity of RP, improve fingertip blood supply, and improve nailfold capillary manifestations” in scleroderma patients, particularly in those with the limited form of the disease, the investigators wrote.

As such, BTX-A may be a safe and effective approach to treat RP secondary to scleroderma.

Larger studies, involving repeated injections as well and longer follow-up, are needed to confirm these findings, the team noted.