Wolf E Mehling1, Zelda DiBlasi, Frederick Hecht. 1. Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, USA. mehling@itsa.ucsf.edu
Abstract
OBJECTIVE: To review and summarize the methodological challenges in clinical trials of bodywork or handson mind-body therapies such as Feldenkrais Method, Alexander Technique, Trager Work, Eutony, Body Awareness Therapy, Breath Therapy, and Rolfing, and to discuss ways these challenges can be addressed. DESIGN: Review and commentary. METHODS: Search of databases PubMed and EMBASE and screening of bibliographies. Published clinical studies were included if they used individual hands-on approaches and a focus on body awareness, and were not based on technical devices. RESULTS: Of the 53 studies identified, 20 fulfilled inclusion criteria. No studies blinded subject to the treatment being given, but 5 used an alternative treatment and blinded participants to differential investigator expectations of efficacy. No study used a credible placebo intervention. No studies reported measures of patient expectations. Patient expectations have been measured in studies of other modalities but not of hands-on mind-body therapies. Options are presented for minimizing investigator and therapist bias and bias from differential patient expectations, and for maintaining some control for nonspecific treatment effects. Practical issues with recruitment and attrition resulting from volunteer bias are addressed. CONCLUSIONS: Rigorous clinical trials of hands-on complementary and alternative therapy interventions are scarce, needed, and feasible. Difficulties with blinding, placebo, and recruitment can be systematically addressed by various methods that minimize the respective biases. The methods suggested here may enhance the rigor of further explanatory trials.
OBJECTIVE: To review and summarize the methodological challenges in clinical trials of bodywork or handson mind-body therapies such as Feldenkrais Method, Alexander Technique, Trager Work, Eutony, Body Awareness Therapy, Breath Therapy, and Rolfing, and to discuss ways these challenges can be addressed. DESIGN: Review and commentary. METHODS: Search of databases PubMed and EMBASE and screening of bibliographies. Published clinical studies were included if they used individual hands-on approaches and a focus on body awareness, and were not based on technical devices. RESULTS: Of the 53 studies identified, 20 fulfilled inclusion criteria. No studies blinded subject to the treatment being given, but 5 used an alternative treatment and blinded participants to differential investigator expectations of efficacy. No study used a credible placebo intervention. No studies reported measures of patient expectations. Patient expectations have been measured in studies of other modalities but not of hands-on mind-body therapies. Options are presented for minimizing investigator and therapist bias and bias from differential patient expectations, and for maintaining some control for nonspecific treatment effects. Practical issues with recruitment and attrition resulting from volunteer bias are addressed. CONCLUSIONS: Rigorous clinical trials of hands-on complementary and alternative therapy interventions are scarce, needed, and feasible. Difficulties with blinding, placebo, and recruitment can be systematically addressed by various methods that minimize the respective biases. The methods suggested here may enhance the rigor of further explanatory trials.
Authors: Wolf E Mehling; Judith Wrubel; Jennifer J Daubenmier; Cynthia J Price; Catherine E Kerr; Theresa Silow; Viranjini Gopisetty; Anita L Stewart Journal: Philos Ethics Humanit Med Date: 2011-04-07 Impact factor: 2.464
Authors: Wolf E Mehling; Viranjini Gopisetty; Jennifer Daubenmier; Cynthia J Price; Frederick M Hecht; Anita Stewart Journal: PLoS One Date: 2009-05-19 Impact factor: 3.240