Ozone Therapy and Lower Back Pain

We read with interest Bonetti et al’s article “Intraforaminal O₂–O₃ Versus Periradicular Steroidal Infiltrations in Lower Back Pain: Randomized Controlled Study,” which appeared in the May issue of the AJNR.¹ We came across this paper as we were searching for the possible beneficial effects of ozone therapy in fibromyalgia, which had been pointed out to us at a recent European meeting. The conclusions from this paper are that oxygen-ozone treatment is highly effective in relieving acute and chronic lower back pain and sciatica and that this treatment can be administered as a first option rather than epidural steroids. The authors support their conclusions with percentages and P values noted in the text as well as in the abstract, but not in the Table. In examining the actual data shown in the Table, we realized that the statistical analyses performed were flawed, given that the outcomes (excellent, good, or poor) are not independent observations. Therefore, the comparisons cannot be limited to those patients in one category with the exclusion of those in the others, but rather have to be performed with the entire data in a classic 2 (treatment type) by 3 (outcome type) format (2 df). The data would then read as noted in Tables 1 (for the intermediate outcomes) and 2 (for the long-term outcomes) that accompany this letter. None of the derived χ² values shown in these tables reached 5.991, which would be the required value for a significance of 0.05. The conclusions reached in this paper are, therefore, not supported by the data presented.

Table 1:

Medium-term follow-up in patients with and without disk disease as a function of treatment type

Treatment Group	Outcome
	Excellent	Good	Poor	Total
Patients with disk disease
O2–O3	67	9	10	86
Steroid	54	14	12	80
Total	121	23	22	166 χ2 = 2.42
Patients without disk disease
O2–O3	55	9	6	70
Steroid	49	10	11	70
Total	104	19	17	140 χ2 = 1.86

Table 2:

Long-term follow-up in patients with and without disk disease as a function of treatment type

Treatment Group	Outcome
	Excellent	Good	Poor	Total
Patients with disk disease
O2–O3	64	9	13	86
Steroid	46	16	18	80
Total	110	25	31	166 χ2 = 5.51
Patients without disk disease
O2–O3	53	11	6	70
Steroid	44	11	15	70
Total	97	22	21	140 χ2 = 4.68

In light of the possible implications these data may have in supporting the role of ozone therapy for the treatment of back pain (and other painful musculoskeletal disorders), this clarification is essential.