Problems of scientific methodology related to placebo control in Qigong studies: A systematic review

Author: Mário Gonçalves1, Luís Carlos Matos2, Leonel Duarte3, Jorge Machado4, Henry Johannes Greten5, Giovanna Franconi6
Affiliation: <sup>1</sup> ICBAS - Institute of Biomedical Sciences, University of Porto, 4050-313, Porto, Portugal; DGTCM - German Society of Traditional Chinese Medicine, 69126, Heidelberg, Germany; HSCM - Heidelberg School of Chinese Medicine, 69126, Heidelberg, Germany. Electronic address: mrgoncalves@aol.com. <sup>2</sup> Faculdade de Engenharia da Universidade do Porto, Rua Dr. Roberto Frias, s/n, 4200-465, Porto, Portugal; Centro Transdisciplinar de Estudos da Consciência da Universidade Fernando Pessoa (CTEC-UFP), 4249-004, Porto, Portugal. <sup>3</sup> ICBAS - Institute of Biomedical Sciences, University of Porto, 4050-313, Porto, Portugal. <sup>4</sup> ICBAS - Institute of Biomedical Sciences, University of Porto, 4050-313, Porto, Portugal; LABIOMEP - Biomechanics Laboratory of Porto, University of Porto, 4200-450, Porto, Portugal. <sup>5</sup> ICBAS - Institute of Biomedical Sciences, University of Porto, 4050-313, Porto, Portugal; DGTCM - German Society of Traditional Chinese Medicine, 69126, Heidelberg, Germany; HSCM - Heidelberg School of Chinese Medicine, 69126, Heidelberg, Germany. <sup>6</sup> ICBAS - Institute of Biomedical Sciences, University of Porto, 4050-313, Porto, Portugal; Department of Systems Medicine, University of Rome Tor Vergata, 00133, Rome, Italy.
Conference/Journal: J Bodyw Mov Ther
Date published: 2020 Oct 1
Other: Volume ID: 24 , Issue ID: 4 , Pages: 261-270 , Special Notes: doi: 10.1016/j.jbmt.2020.06.035. , Word Count: 262


Introduction:
Qigong is widespread in the West and used for preventive care, stress-induced conditions, emotional and vegetative symptoms like migraine and hypertension, as well as for better coordination in the elderly and quality of life enhancement in severe disease such as cancer. Adequate controls for Qigong research are lacking, compromising the level of efficacy evidence. Adequate Qigong placebo control exercises should match clear and standardized criteria.

Methods:
Three computerized databases were assessed in January 2018 (Scopus, Web of Science and MEDLINE on PubMed) using the following keywords or their combinations: (Qigong OR Qi Gong OR Gong Qi OR Chi Kung OR Kung Chi OR Kiko OR Ki Gong OR Ki Kong) AND placebo. In addition, all reference lists were scanned for further relevant articles. Literature was examined for the effects of Qigong as compared to a control intervention.

Results:
110 articles were found, 78 of which were excluded after examining the title and abstract, and 16 because they were duplicates. Four more articles were found by searching in the bibliographies of published papers. A total of 20 studies were included in this systematic review. We found that, to the best of our knowledge, no criteria for placebo controls have been published in peer-reviewed journals so far.

Conclusion:
Placebo controls should be developed by the usage of vegetative functional assessments such as heart rate variability, thermography, and electrophysiological measurements, thus excluding major vegetative effects of the exercise, as well as by the usage of psychometric tests and other quantitative evaluations.

Keywords: Control group; Methodology; Placebo; Qigong; Randomised controlled trial (RCT); Traditional Chinese medicine (TCM).

PMID: 33218521 DOI: 10.1016/j.jbmt.2020.06.035