1. Sign our petition calling on Cochrane to withdraw their review of Exercise Therapy for CFS here.
    Dismiss Notice
  2. Guest, the 'News in Brief' for the week beginning 15th April 2024 is here.
    Dismiss Notice
  3. Welcome! To read the Core Purpose and Values of our forum, click here.
    Dismiss Notice

Meditative-based diaphragmatic breathing vs. vagus nerve stimulation in the treatment of fibromyalgia—A randomized controlled trial 2022 Paccione

Discussion in ''Conditions related to ME/CFS' news and research' started by Andy, Nov 28, 2022.

Tags:
  1. Andy

    Andy Committee Member

    Messages:
    21,944
    Location:
    Hampshire, UK
    Importance: Vagus nerve innervation via electrical stimulation and meditative-based diaphragmatic breathing may be promising treatment avenues for fibromyalgia.

    Objective: Explore and compare the treatment effectiveness of active and sham transcutaneous vagus nerve stimulation (tVNS) and meditative-based diaphragmatic breathing (MDB) for fibromyalgia.

    Design: Participants enrolled from March 2019–October 2020 and randomly assigned to active tVNS (n = 28), sham tVNS (n = 29), active MDB (n = 29), or sham MDB (n = 30). Treatments were self-delivered at home for 15 min/morning and 15 min/evening for 14 days. Follow-up was at 2 weeks.

    Setting: Outpatient pain clinic in Oslo, Norway.

    Participants: 116 adults aged 18–65 years with severe fibromyalgia were consecutively enrolled and randomized. 86 participants (74%) had an 80% treatment adherence and 107 (92%) completed the study at 2 weeks; 1 participant dropped out due to adverse effects from active tVNS.

    Interventions: Active tVNS is placed on the cymba conchae of the left ear; sham tVNS is placed on the left earlobe. Active MDB trains users in nondirective meditation with deep breathing; sham MDB trains users in open-awareness meditation with paced breathing.

    Main outcomes and measures: Primary outcome was change from baseline in ultra short-term photoplethysmography-measured cardiac-vagal heart rate variability at 2 weeks. Prior to trial launch, we hypothesized that (1) those randomized to active MDB or active tVNS would display greater increases in heart rate variability compared to those randomized to sham MDB or sham tVNS after 2-weeks; (2) a change in heart rate variability would be correlated with a change in self-reported average pain intensity; and (3) active treatments would outperform sham treatments on all pain-related secondary outcome measures.

    Results: No significant across-group changes in heart rate variability were found. Furthermore, no significant correlations were found between changes in heart rate variability and average pain intensity during treatment. Significant across group differences were found for overall FM severity yet were not found for average pain intensity.

    Conclusions and relevance: These findings suggest that changes in cardiac-vagal heart rate variability when recorded with ultra short-term photoplethysmography in those with fibromyalgia may not be associated with treatment-specific changes in pain intensity. Further research should be conducted to evaluate potential changes in long-term cardiac-vagal heart rate variability in response to noninvasive vagus nerve innervation in those with fibromyalgia.

    Open access, https://www.frontiersin.org/articles/10.3389/fneur.2022.1030927/full
     
    Andy, Nov 28, 2022
    #1
    oldtimer, Hutan, Sean and 4 others like this.
  2. alex3619

    alex3619 Senior Member (Voting Rights)

    Messages:
    2,142
    Diaphragmatic breath meditation was what I was doing in the 80s. I found it induced PEM. I had to stop. However I had massive lung capacity back then, and could easily hold my breath for 5 minutes.
     
    alex3619, Nov 28, 2022
    #2
    ContraindiKate, oldtimer, Hutan and 5 others like this.
  3. Hutan

    Hutan Moderator Staff Member

    Messages:
    26,889
    Location:
    Aotearoa New Zealand
    This looks like a decent study - two treatments (vagus nerve stimulation and meditative breathing) each with a fairly reasonable sham version.

    So:
    None of the treatments changed heart rate variability
    None of the treatments performed better than the others with respect to pain
    Changes in heart rate variability didn't correlate with changes in pain


    Note that the abstract doesn't say which treatments performed best for overall FM severity. Here are the results for changes from baseline and after treatment:

    Overall FM severity (0-31). The sham tVNS treatment gave the best result! (although it wasn't very different to the active tVNS)
    Active tVNS -2.82
    Sham tVNS (on the earlobe) -2.90
    Active meditative breathing -1.28
    Sham meditative breathing -1.37

    Average pain intensity over the last week (0-10). Again, the sham tVNS treatment gave the best result
    Active tVNS -0.57
    Sham tVNS (on the earlobe) -0.86
    Active meditative breathing -0.59
    Sham meditative breathing -0.33

    Current pain intensity (0-10). Again, the sham tVNS treatment gave the best result
    Active tVNS -0.82
    Sham tVNS (on the earlobe) -0.86
    Active meditative breathing -0.07
    Sham meditative breathing -0.21

    Widespread pain index (0-19). Again, the sham tVNS treatment gave the best result
    Active tVNS -1.50
    Sham tVNS (on the earlobe) -1.69
    Active meditative breathing -0.79
    Sham meditative breathing -0.63

    Symptom severity (0-12). Here the real tVNS treatment gave the best result, although not by much. The confidence intervals look pretty much the same
    Active tVNS -1.32 (-1.91 to -0.74)
    Sham tVNS (on the earlobe) -1.21 (-1.78 to -0.63)
    Active meditative breathing -0.48
    Sham meditative breathing -0.73


    This was a reasonably powered trial - there were 21 people providing data in each treatment. I think it should be the end of ideas about vagus nerve stimulation fixing fibromyalgia - it really really doesn't.

    It should also be noted that all of the treatments, sham and all, produced a small subjective improvement - more evidence that open label trials with only subjective outcomes are worse than a waste of time and effort because they produce misleading results.
     
    Hutan, Nov 29, 2022
    #3
    Peter Trewhitt, Trish, Andy and 1 other person like this.
  4. Hutan

    Hutan Moderator Staff Member

    Messages:
    26,889
    Location:
    Aotearoa New Zealand
    That was interesting. I think there has been a lot of speculation about HRV's relationship with vagal activity.


    This trial should be a nail in the coffins of the ideas that meditation or diaphragmatic breathing help fibromyalgia.


    Good on the authors for devising a reasonable trial and for reporting the null results (although some of the text has a bit of spin and obfuscation).
     
    Hutan, Nov 29, 2022
    #4
    ContraindiKate, Peter Trewhitt, Trish and 1 other person like this.
  5. Trish

    Trish Moderator Staff Member

    Messages:
    52,283
    Location:
    UK
    I agree it looks like a well designed study. But the abstract conclusion makes no sense. Surely the conclusion should be that neither TVNS nor mediative breathing have any beneficial effect when compared to sham versions.
     
    Trish, Nov 29, 2022
    #5
    ContraindiKate and Peter Trewhitt like this.

Share This Page