Efrati2
Unblinded hyperbaric oxygen therapy was associated with symptomatic improvement in fibromyalgia symptoms.
Clinical Bottom Line:
1. Patients undergoing HBOT demonstrated improvements in symptomatology and quality of life,2. A participation effect may explain these findings and a blinded random comparison is required to quantify any such effect.
Citation/s: 1. Efrati S, Golan H, Bechor Y, Faran Y, Daphna-Tekoah S, Sekler G, Fishlev G, Ablin JN, Bergan J, Volkov O, Friedman M. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome–prospective clinical trial. PloS one. 2015 May 26;10(5):e0127012.
Lead author's name and email:Shai Efrati efratishai@013.net
'Three-part Clinical Question:'For adult patients diagnosed with fibromyalgia syndrome, does treatment with hyperbaric oxygen compared to no treatment, improve the symptoms?
Search Terms: Fibromyalgia Syndrome; placebo; SPECT
The Study: Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Female adult patients with a two year history of established FMS symptoms and diagnosed by pain above and below the waist and at least 11 of 18 tender points.
Control group (N = 30; 26 analysed): No treatment
Experimental group (N = 30; 24 analysed): 100% oxygen breathing at 2 ATA for 90 minutes daily (Monday to Friday) to a total of 40 treatments
The Evidence:
| Measure | Control Group | HBOT Group | Difference | 95% CI | ||
| Mean | SD | Mean | SD | |||
| Dolorimeter threshold (kg) after 40 treatment period | 0.58 | 0.46 | 1.65 | 0.81 | 1.07 | -0.70 to 1.44 |
| Tender points after 40 treatment period | 17.2 | 1.2 | 8.9 | 6.0 | 8.4 | 5.9 to 10.80 |
| Fibromyalgia Impact Questionnaire (0 worst to 10) | 3.7 | 1.15 | 2.51 | 1.14 | 1.19 | 0.54 to 1.84 |
Comments:
1. In summary, the outcome measures in the control group did not change, while the same measures improved over the period of the HBOT in the active group. The same improvements were evident after the control group was treated. No change in the control group is unsurising and it is not clear what this group achieves versus treating everyone.
2. Because of the unblinded nature of this trial, the question of any changes being due to a participation effect cannot be answered. This trial is a cohort study of two different groups treated with HBOT at different times rather than a true RCT as commonly understood.
3. Rheumatologist assessing tender point count and pain was blinded to allocation but could easily be aware of that allocation if the individual mentioned the chamber or lack of it.
4. SPECT scanning suggested symptom improvements were accompanied by changes in brain activity. It remains unclear if this is cause or effect and does not preclude a participation effect.
Appraised by: Mike Bennett m.bennett@unsw.edu.au; Thursday, 10 January 2019
Kill or Update By: June 2020
