Efficacy of local oxygen–ozone therapy for the treatment of digital ulcer refractory to medical therapy in systemic sclerosis: A randomized controlled study

Abstract

Background This study aimed to investigate the efficacy of local oxygen-ozone therapy in systemic sclerosis (SSc) patients with digital ulcers (DUs) who were resistant to medical therapy and had impairment in activities of daily living. Methods Participants’ demographic data, medical treatment, and clinical parameters (duration and number of Reynaud’s Phenomenon (RP) attacks, ulcer pain, grade, and diameter) were recorded. Twenty-five SSc patients with DUs were randomized to the ozone group (I) (n = 13) to receive medical treatment plus local oxygen-ozone therapy and the control group (II) (n = 12) to receive medical treatment only. Hand functions were assessed using the Health Assessment Questionnaire (HAQ) and Modified Hand Mobility in Scleroderma (HAMISm) test. Ulcer grade, clinical parameters, HAQ, mHAMIS scores were re-evaluated in all participants 4 weeks after the initiation of treatment. Results Demographic and clinical characteristics of the two groups showed no significant differences. At 4 weeks after the initial treatment, the efficacy rate was significantly higher in the ozone group than in the control group (92% versus 42%, p = 0.010). Clinical parameters, HAQ, and HAMISm scores were significantly improved in the treatment group compared to the control group (p < 0.05). Conclusion Local oxygen-ozone therapy was effective in the treatment of SSc patients with resistant DUs and improved clinical parameters and functional disability.

Rapid and Sustained Effect of Ozone Major Autohemotherapy for Raynaud and Hand Edema in Systemic Sclerosis Patient: A Case Report

“…To the best of my knowledge, this is the first evidence that ozone autohemotherapy could significantly and rapidly modify the microcirculation of patients with scleroderma, especially in the early stages, reducing digital edema and RP attacks, which results in less pain and recovery of hand function. The improvement of the microcirculation induced by ozone therapy could finally lead to a reduced incidence of digital ulcers or at least to their faster healing, as previously reported [9,10].…”

Effectiveness and Safety of Ozone Therapy for Dermatological Disorders

“…Figure 2 presents an overview of the included clinical trials and Table 1 summarizes the most relevant data and main results from each study. [ 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 ]…”

“…A general analysis of clinical trials results suggests a positive response to the use of ozone therapy in the investigated dermatological conditions. The patients received ozone therapy by gaseous ozone[ 18 19 20 23 24 25 26 ] or incorporated in different vehicles such as water,[ 22 28 30 ] gel[ 24 ] and oil. [ 21 27 28 29 30 31 33 34 ] Only in three clinical trials ozone was not used topically, but were used through subcutaneous,[ 35 ] intralesional,[ 22 ] intravenous[ 22 32 ] and rectal[ 32 ] routes.…”

“…Considering the outcomes of effectiveness presented in Table 1 , ozone therapy has achieved significantly superior results in statistical analyzes when compared to control groups in the treatment of the following dermatological disorders: Diabetic foot ulcers,[ 19 20 24 ] chronic venous leg ulcers,[ 21 ] digital ulcers,[ 23 26 ] onychomycosis,[ 27 ] atopic dermatitis,[ 29 30 ] balanitis xerotica obliterans[ 33 ] and multiple common warts. [ 35 ] Besides, the studies conducted by Menéndez et al .…”

“…In spite of a few clinical trials report the occurrence of adverse effects, in 7 of the 18 studies analyzed, the authors appear not to evaluate the occurrence of unwanted effects during ozone treatment. [ 18 20 22 23 25 26 32 ] Thereby, there is a lack of complete data regarding the safety of ozone therapy in these seven investigated clinical trials.…”