Miho Takayama1,2,3,4, Hiroyoshi Yajima5,6,7,8, Akiko Kawase9,10,11, Ikuo Homma12,13,14, Masahiko Izumizaki15, Nobuari Takakura16,17,18,19. 1. Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan. takayama@tau.ac.jp. 2. Department of Physiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan. takayama@tau.ac.jp. 3. Japan School of Acupuncture, Moxibustion and Physiotherapy, 20-1 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. takayama@tau.ac.jp. 4. The Foundation for Oriental Medicine Research, 28-9 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. takayama@tau.ac.jp. 5. Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan. yajima@tau.ac.jp. 6. Department of Physiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan. yajima@tau.ac.jp. 7. Japan School of Acupuncture, Moxibustion and Physiotherapy, 20-1 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. yajima@tau.ac.jp. 8. The Foundation for Oriental Medicine Research, 28-9 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. yajima@tau.ac.jp. 9. Department of Physiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan. kawase@hanada.ac.jp. 10. Japan School of Acupuncture, Moxibustion and Physiotherapy, 20-1 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. kawase@hanada.ac.jp. 11. The Foundation for Oriental Medicine Research, 28-9 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. kawase@hanada.ac.jp. 12. Department of Physiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan. hommai@tau.ac.jp. 13. The Foundation for Oriental Medicine Research, 28-9 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. hommai@tau.ac.jp. 14. Department of Nursing, Faculty of Nursing, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan. hommai@tau.ac.jp. 15. Department of Physiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan. masahiko@med.showa-u.ac.jp. 16. Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, 2-9-1 Ariake, Koto-ku, Tokyo 135-0063, Japan. takakura@tau.ac.jp. 17. Department of Physiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan. takakura@tau.ac.jp. 18. Japan School of Acupuncture, Moxibustion and Physiotherapy, 20-1 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. takakura@tau.ac.jp. 19. The Foundation for Oriental Medicine Research, 28-9 Sakuragaokacho, Shibuya-ku, Tokyo 150-0031, Japan. takakura@tau.ac.jp.
Abstract
BACKGROUND: Whether acupuncture treatment employing multiple penetrating, skin-touch placebo, or no-touch placebo needles designed for double blinding actually do blind practitioners and patients has not been investigated. We aimed to investigate this question. SUBJECTS:120 patients with functional neck/shoulder stiffness but in otherwise healthy condition were randomly assigned to a treatment using four penetrating, four skin-touch placebo, or four no-touch placebo needles. Each of six acupuncturists applied four needles to four acupoints in the neck/shoulder of 20 patients. Acupuncturists and patients were asked to guess the treatment mode and their confidence in their guesses on 100 mm visual analog scales. RESULTS: The kappa coefficients between practitioner guesses and treatment type and between patient guesses and treatment type were 0.15 and 0.44, respectively. The median score of practitioner confidence was 46.8, and no significant difference in confidence between correct and incorrect guesses was revealed for any treatment. The median score of patient confidence for correct guesses was 77.6. The kappa coefficient between practitioner and patient guesses was 0.06. CONCLUSIONS: The practitioners were blinded to the nature of treatment using the same multiple needles, but patient blinding was insufficient. Further improvement is necessary to achieve satisfactory patient blinding with these acupuncture needles.
RCT Entities:
BACKGROUND: Whether acupuncture treatment employing multiple penetrating, skin-touch placebo, or no-touch placebo needles designed for double blinding actually do blind practitioners and patients has not been investigated. We aimed to investigate this question. SUBJECTS: 120 patients with functional neck/shoulder stiffness but in otherwise healthy condition were randomly assigned to a treatment using four penetrating, four skin-touch placebo, or four no-touch placebo needles. Each of six acupuncturists applied four needles to four acupoints in the neck/shoulder of 20 patients. Acupuncturists and patients were asked to guess the treatment mode and their confidence in their guesses on 100 mm visual analog scales. RESULTS: The kappa coefficients between practitioner guesses and treatment type and between patient guesses and treatment type were 0.15 and 0.44, respectively. The median score of practitioner confidence was 46.8, and no significant difference in confidence between correct and incorrect guesses was revealed for any treatment. The median score of patient confidence for correct guesses was 77.6. The kappa coefficient between practitioner and patient guesses was 0.06. CONCLUSIONS: The practitioners were blinded to the nature of treatment using the same multiple needles, but patient blinding was insufficient. Further improvement is necessary to achieve satisfactory patient blinding with these acupuncture needles.
Entities:
Keywords:
acupuncture; complementary and alternative medicine; double blind; placebo; randomized controlled study
Authors: Hanns-Peter Scharf; Ulrich Mansmann; Konrad Streitberger; Steffen Witte; Jürgen Krämer; Christoph Maier; Hans-Joachim Trampisch; Norbert Victor Journal: Ann Intern Med Date: 2006-07-04 Impact factor: 25.391
Authors: Jongbae Park; Adrian R White; Martin A James; Anthony G Hemsley; Paul Johnson; John Chambers; Edzard Ernst Journal: Arch Intern Med Date: 2005-09-26
Authors: Judith M Schlaeger; Nobuari Takakura; Hiroyoshi Yajima; Miho Takayama; Alana D Steffen; Elizabeth M Gabzdyl; Robyn A Nisi; Kathleen McGowan Gruber; Jason M Bussell; Diana J Wilkie Journal: Pilot Feasibility Stud Date: 2018-04-13