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A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin in Treating Scleroderma-Associated Raynaud's Phenomenon
Ricardo J. Bello, MD, MPH; Carisa M. Cooney, MPH, CCRP; Eitan Melamed, MD; Keith Follmar, MD; Scott D. Lifchez, MD, FACS
Johns Hopkins University, Baltimore, MD

Introduction: Raynaud's phenomenon is a painful and often debilitating condition which can lead to digital ulcers, loss of function, and partial amputations. A promising new treatment option for Raynaud's phenomenon uses local injections with Botulinum Toxin Type-A (Btx-A) into the perivascular space of the affected digits and has been reported in case series to provide significant symptoms relief. However, researchers have noted anecdotally that this effect could not be demonstrated in patients with advanced scleroderma. As most patients with scleroderma (approximately 90%) suffer from Raynaud's phenomenon, we conducted a randomized, double-blinded, placebo-controlled clinical trial to assess the therapeutic efficacy of Btx-A in treating scleroderma-associated Raynaud's phenomenon.

Materials and Methods: Eligible patients are enrolled and their hands randomized to receive 7 injections each either with Btx-A (50 units in a total volume of 2.5 mL) or sterile saline (2.5 mL in total). Patients are followed-up 1 month and 4 months post-injection using laser Doppler imaging (LDI) of the hands to assess blood flow, patient-reported outcome questionnaires to assess quality-of-life, and a physical exam to assess digital ulcers. Paired t-test or paired signed rank test are used as appropriate to compare outcomes.

Results: Blinded analysis of 40 patients was performed using 1-month post-injection data. Twenty-three (57.5%) patients have limited scleroderma, 14 (35%) diffuse scleroderma, and 2 (5%) mixed connective tissue disease; 31 patients (79.5%) are female. Mean age is 52 years (range: 21-75) and the median time since diagnosis is 14 years (range: 1-35). Twenty eight patients (70%) are being treated with calcium channel blockers, 7 with phosphodiesterase-5 inhibitors (17.5%), 6 with fluoxetine (15%), and 5 with losartan (12.5%). Paired t-test using 1-month post-injection LDI data showed only weak statistical evidence for a change in blood flow on average (difference: -27.99, 95% CI: -59.12 to 3.15, p-value: 0.075), which did not achieve our level of significance set a priori (p=0.049). Differences in secondary outcomes were also not statistically significant (Table 1).

Conclusions: This study has found insufficient statistical evidence demonstrating the average efficacy of locally injected Botulinum toxin Type-A for scleroderma-associated Raynaud's phenomenon. Further ongoing analysis will reveal which patients with scleroderma may still benefit from this treatment and will occur after 4-month post-injection data collection is completed and unblinding has occurred (September 2015).


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