Efficacy of ozone therapy as an add-on treatment in fibromyalgia: A randomized double-blind placebo-controlled study

BACKGROUND: Fibromyalgia (FM) is a chronic disease that causes widespread pain, fatigue, and sleep disturbance. There is still no effective definitive treatment method; therefore, the search for treatment continues. OBJECTIVE: The purpose of this study is to investigate the effectiveness of ozone therapy (OT), which has been used in FM treatment in recent years, as an additional treatment. METHODS: The patients were divided into OT (n = 26) and placebo control (PC) (n = 28) groups. Both groups received OT in the form of major autohemotherapy (MaAHT) and minor autohemotherapy (MiAHT) for two sessions per week for a total of 10 sessions. The fibromyalgia impact questionnaire (FIQ), Pittsburgh sleep quality index (PSQI), and 12-item short-form health survey (SF-12) were used for evaluation pre- and post-intervention. RESULTS: In the between-group comparison, the OT group showed significant post-treatment improvements in FIQ subscales (feel good, fatigue) and PSQI total score and subscales (subjective sleep quality, sleep latency and sleep disturbances) compared to the PC group (p < 0.05). Although there were improvements in the FIQ total score post-treatment in both groups, there was no significant difference between the groups ( p > 0.05). CONCLUSION: OT, which is applied as an additional treatment with the autohemotherapy method, simultaneously improves the subscale scores (feel good and fatigue) of FM and sleep quality in the treatment period. However, changes in the post-treatment FIQ total score were not different in the ozone therapy group from the placebo control group.