Ozone Therapy as Add-On Treatment in Fibromyalgia Management by Rectal Insufflation: An Open-Label Pilot Study

Background: the search for options in hard-to-treat fibromyalgia

Fibromyalgia causes widespread pain, fatigue, poor sleep and low mood, and it can be difficult to manage with standard treatments alone. That has prompted interest in complementary approaches used alongside usual care. Ozone therapy - here delivered by rectal insufflation, a needle-free way of introducing an oxygen-ozone mixture into the body - has been proposed as one such add-on. This pilot study set out to take an early look at whether it might help.

Study design: an open-label pilot, 24 rectal ozone sessions over 12 weeks

This was an open-label pilot study, meaning everyone taking part received ozone therapy and both patients and researchers knew it - there was no placebo or comparison group. Patients with fibromyalgia were given ozone by rectal insufflation at a dose of 8 mg, across 24 sessions over 12 weeks, on a tapering schedule (five times a week at first, then twice weekly, then weekly). The team tracked the Fibromyalgia Impact Questionnaire (FIQ, a standard measure of how much the condition affects daily life) along with sleep quality, depression, anxiety and general health.

Findings: improved fibromyalgia impact, physical symptoms and depression

Total FIQ scores fell significantly over the study, with most of the improvement seen in the first four weeks. The authors reported that the physical symptoms of fibromyalgia improved, as did depression scores. The main side effect was temporary gas production from the rectal insufflation. Because there was no control group, these before-and-after changes cannot be separated from other influences such as the natural course of symptoms or the placebo effect.

What the authors concluded

The authors concluded that, at the dose and number of sessions used, ozone therapy by rectal insufflation seemed to be beneficial mainly for the physical symptoms and depression associated with fibromyalgia. They framed this as an encouraging early signal and called for further evaluation, ideally with a controlled study design, to test whether the effect holds up.

Limitations of this study

As a pilot study this was small and, importantly, open-label with no placebo or control group. Fibromyalgia is known to respond strongly to placebo, so uncontrolled improvements should be interpreted with real caution. The outcomes were self-reported questionnaires, the follow-up was short, and the study was not designed to show that ozone caused the changes observed. The authors themselves flagged the need for a controlled trial - which is exactly the right next step before drawing firm conclusions.