title: Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder: A nonrandomized controlled pilot study.
abstract: BACKGROUND
  Depression presents a significant burden to both patients and society. One treatment that has emerged is vagus nerve stimulation (VNS), an FDA-approved physical treatment for depressive disorders. However, the application of this intervention has been limited by the involvement of surgery and potential side effects. The aim of this study is to explore the effectiveness of stimulating the superficial branches of the vagus nerve as a solo treatment for MDD.
  
  
  METHODS
  This is a nonrandomized, controlled study. The first cohort of patients (n=91) only received transcutaneous auricular VNS (taVNS) for 12 weeks. In the second cohort (n=69), patients first received 4 weeks of sham taVNS followed by 8 weeks of taVNS. All treatments were self-administered by the patients at home after they received training from the hospitals. The primary outcome measurement was the 24-item Hamilton Depression Rating Scale measured at weeks 0, 4, 8, and 12. Data analysis included a timelag analysis comparing (1) real and sham taVNS groups at week 4; (2) the real taVNS group at week 4 vs the sham taVNS group at week 8 (fourth week of real taVNS following 4 weeks of sham); and (3) the real taVNS group at week 8 vs the sham taVNS group at week 12 (eighth week of real taVNS following sham).
  
  
  RESULTS
  After four weeks of treatment, MDD patients in the taVNS group showed greater improvement than patients in the sham taVNS group as indicated by Hamilton score changes as well as response and remission rates at week four. In addition, we also found that the clinical improvements continued until week 12 during taVNS.
  
  
  CONCLUSIONS
  Patients were not randomized in this study.
  
  
  CONCLUSIONS
  Our results suggest that taVNS is a promising, safe, and cost-effective therapeutic method for mild and moderate MDD.
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China. Electronic address: rongpj@hotmail.com.
authors.forename: Peijing
authors.initials: P
authors.lastname: Rong
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Liu
authors.affiliation: Huguosi TCM Hospital, Beijing University of TCM, Beijing, 100035, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Wang
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Rupeng
authors.initials: R
authors.lastname: Liu
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China; Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Jiliang
authors.initials: J
authors.lastname: Fang
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Jingjun
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Yufeng
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Honghong
authors.initials: H
authors.lastname: Wang
authors.affiliation: Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Vangel
authors.affiliation: Psychiatry Department, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Sun
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Ben
authors.affiliation: Psychiatry Department, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Park
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Shaoyuan
authors.initials: S
authors.lastname: Li
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Meng
authors.affiliation: Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Zhu
authors.affiliation: Psychiatry Department, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: kongj@nmr.mgh.harvard.edu.
authors.forename: Jian
authors.initials: J
authors.lastname: Kong
mesh_terms: D000328:Adult; D015331:Cohort Studies; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D054644:Ear Auricle / Q000294:innervation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D012074:Remission Induction; D012646:Self Administration; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*
keywords: Depression; Hamilton depression rating scale; Major depressive disorder; Transcutaneous auricular vagus nerve stimulation; Transcutaneous vagus nerve stimulation