Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study
Shen W, Liu N, Ji Z, et al. Pain Research & Management, 2022.
- Study type
- Randomized controlled trial
- People studied
- 118 people
- Population
- Patients with comorbid insomnia and myofascial pain syndrome
- Published
- 2022, Pain Research & Management
- Identifiers
- PMID 37214227, DOI 10.1155/2022/3562191
What the authors reported
No adverse complications were observed in either group of this randomized trial, in which 118 patients were randomized and 103 completed follow-up. Compared with the control group, the group given ozonated autohemotherapy with the same drugs had significantly improved sleep quality, pain, and negative mood at different time points.
What limits this result
Single-center trial. Controls had blood drawn without ozone and a sham infusion, and only the operator giving the infusions knew each patient's group, but the authors state that double blinding was not used. Of 118 randomized, 103 (50 control, 53 ozone) completed follow-up and are the ones reported. Harms were checked against a list of possible complications, and follow-up ended at 6 months.
Harms reported after ozone therapy, and studies of how ozone exposure affects health. One study rarely settles a medical question; our guides weigh each paper against the rest of the evidence.
How the study was done
- Design
- Prospective randomized controlled study
- Setting
- Department of Pain, Shanghai East Hospital Affiliated Tongji University, Shanghai, China (author affiliation)
- Read from
- Read from the full text of the paper. Read on September 28, 2026.
Source: Abstract on PubMed
Study arms
| Group | Participants | What they received |
|---|---|---|
| Control group (completed follow-up) | 50 | The same pharmacological management as the other group, plus a sham infusion (source sentences in notes) |
| O3-AHT group (completed follow-up) | 53 | Ozonated autohemotherapy (O3-AHT; ozone concentrations in the protocol fields) plus the same pharmacological management (source sentence in notes) |
Source: Full text on Europe PMC
Procedure as reported
- Ozone concentration
- 20 µg/ml in the first week, 30 µg/ml in the second week, and 40 µg/ml in the third week
- Blood volume
- 100 ml of blood
A special operator collected 100 ml of blood via the median cubital vein
- Sessions
- Three times a week for 3 weeks
Patients received ozonated autohemotherapy three times a week for 3 weeks.
- Anticoagulant
- 10 ml of 3.8% sodium citrate
In the paper's own units, not converted.
Source: Full text on PubMed Central
What it measured
- Insomnia and pain symptoms, both groups versus pretreatment
- Relieved significantly in both groups
- Insomnia severity index (ISI), primary outcome
- O3-AHT group significantly lower than control at each time point after treatment
- Visual analogue scale (VAS) for pain, primary outcome
- O3-AHT group significantly lower than control at each time point after treatment
- Epworth sleepiness scale (ESS)
- Control group scores higher than O3-AHT group scores at each time point
- Polysomnography (TST, SOL, WASO, SE, NOA)
- O3-AHT group significantly improved compared with control at posttreatment, 1-month and 6-month follow-up
- Beck depression inventory (BDI)
- Control group significantly higher than O3-AHT group at each time point after treatment
- Effective rate 6 months after treatment
- 44% in the control group and 84.90% in the O3-AHT group
- Patients invited and randomized
- 176 invited; 118 randomized (103 completed each follow-up, per the group sizes above)
Sources: Abstract on PubMed, Full text on Europe PMC, Full text on PubMed Central
Safety as reported
No adverse complications (such as allergic reaction, puncture point infection, hypotension, myocardial infarction, blood contamination, or abnormal blood potassium) occurred in either group during treatment and follow-up
Source: Full text on PubMed Central
Follow-up
Outcomes examined at pretreatment, posttreatment, 1 month and 6 months
Source: Abstract on PubMed
Funding and conflicts
Supported by the National Natural Science Foundation of China (No. 8217010632)
Source: Full text on PubMed Central
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