The last 50 years we have seen an increase in published biomedical science on acupuncture, how it works and for which conditions. Our analysis considers if persistence of treatment effect may be related to continued treatment after study completion. Our data comes from a completed Army-funded Randomized Controlled Trial “The Effectiveness of Acupuncture in the Treatment of Gulf War Illness (Army grant W81XWH-09-2-0064)”. This pragmatic RCT applied acupuncture treatment in a therapeutically informed dose determined in focus groups with expert practitioners. We followed the advice of the practitioners and designed a treatment protocol of Individualized acupuncture treatments administered by practitioners in the community for a possible treatment window of 6 months. Using data from our focus groups we designed the study to compare the dose that our acupuncture focus group experts told us would be necessary for effect (twice per week) to once per week treatment. Treatment protocols individualized or personalized to the patient are standard of care in acupuncture therapy. Put another way, a standardized treatment protocol was not used; instead experienced licensed practitioners were given training in the known medical information of GWI, and encouraged to treat with discretion while keeping detailed treatment records. The Importance of Measuring Context to Study Whole Person Health: Healing and Persistence of Clinical Effect in Acupuncture Science
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT01305811
Funding StatementThis work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The New England Institutional Review Board approved this research protocol on September 4, 2009. All human participants gave written informed consent. All of our study processes were approved and oversight is provided by: 1) The New England Institutional Review Board (http://www.neirb.com/), 2) United States Army Human Research Protection Office (https:// mrmc-www.army.mil/rodorphrpo.asp).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors
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