title: Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study.
abstract: OBJECTIVE
  To determine if injection of vitamin K3 in an acupuncture point is optimal for the treatment of primary dysmenorrhoea, when compared with 2 other injection treatments.
  
  
  METHODS
  A Menstrual Disorder Centre at a public hospital in Shanghai, China.
  
  
  METHODS
  Chinese women aged 14-25 years with severe primary dysmenorrhoea for at least 6 months not relieved by any other treatment were recruited. Exclusion criteria were the use of oral contraceptives, intrauterine devices or anticoagulant drugs, pregnancy, history of abdominal surgery, participation in other therapies for pain and diagnosis of secondary dysmenorrhoea. Eighty patients with primary dysmenorrhoea, as defined on a 4-grade scale, completed the study. Two patients withdrew after randomisation.
  
  
  METHODS
  A double-blind, double-dummy, randomised controlled trial compared vitamin K3 acupuncture point injection to saline acupuncture point injection and vitamin K3 deep muscle injection. Patients in each group received 3 injections at a single treatment visit.
  
  
  METHODS
  The primary outcome was the difference in subjective perception of pain as measured by an 11 unit Numeric Rating Scale (NRS). Secondary measurements were Cox Pain Intensity and Duration scales and the consumption of analgesic tablets before and after treatment and during 6 following cycles.
  
  
  RESULTS
  Patients in all 3 groups experienced pain relief from the injection treatments. Differences in NRS measured mean pain scores between the 2 active control groups were less than 1 unit (-0.71, CI -1.37 to -0.05) and not significant, but the differences in average scores between the treatment hypothesised to be optimal and both active control groups (1.11, CI 0.45 to 1.78) and (1.82, CI 1.45 to 2.49) were statistically significant in adjusted mixed-effects models. Menstrual distress and use of analgesics were diminished for 6 months post-treatment.
  
  
  CONCLUSIONS
  Acupuncture point injection of vitamin K3 relieves menstrual pain rapidly and is a useful treatment in an urban outpatient clinic.
  
  
  BACKGROUND
  NCT00104546; Results.
authors.affiliation: Richard & Hinda Rosenthal Center for Complementary and Alternative Medicine Research, College of Physicians and Surgeons, Columbia University, New York, New York, USA Institute of East West Medicine, New York, New York, USA.
authors.forename: C
authors.initials: C
authors.lastname: Wade
authors.affiliation: Obstetrics and Gynecology Hospital, Fudan University, Shanghai, Shanghai, China.
authors.forename: L
authors.initials: L
authors.lastname: Wang
authors.affiliation: Obstetrics and Gynecology Hospital, Fudan University, Shanghai, Shanghai, China.
authors.forename: W J
authors.initials: WJ
authors.lastname: Zhao
authors.affiliation: Agenzia Sanitaria e Sociale Regionale dell'Emilia Romagna, (Healthcare and Social Agency of Emilia Romagna Region), Viale Aldo Moro, 21, 40127 Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Cardini
authors.affiliation: Richard & Hinda Rosenthal Center for Complementary and Alternative Medicine Research, College of Physicians and Surgeons, Columbia University, New York, New York, USA Department of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Palo Alto, California, USA.
authors.forename: F
authors.initials: F
authors.lastname: Kronenberg
authors.affiliation: Obstetrics and Gynecology Hospital, Fudan University, Shanghai, Shanghai, China.
authors.forename: S Q
authors.initials: SQ
authors.lastname: Gui
authors.affiliation: Department of Statistics, Columbia University, New York, New York, USA.
authors.forename: Z
authors.initials: Z
authors.lastname: Ying
authors.affiliation: Department of Statistics, School of Public Health, Fudan University, Shanghai, Shanghai, China.
authors.forename: N Q
authors.initials: NQ
authors.lastname: Zhao
authors.affiliation: Richard & Hinda Rosenthal Center for Complementary and Alternative Medicine Research, College of Physicians and Surgeons, Columbia University, New York, New York, USA Osher Center for Integrative Medicine, University of California at San Francisco, San Francisco, California, USA.
authors.forename: M T
authors.initials: MT
authors.lastname: Chao
authors.affiliation: Obstetrics and Gynecology Hospital, Fudan University, Shanghai, Shanghai, China.
authors.forename: J
authors.initials: J
authors.lastname: Yu
mesh_terms: D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000379:methods*; D000293:Adolescent; D000328:Adult; D002681:China; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006801:Humans; D007267:Injections; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management; D011247:Pregnancy; D024483:Vitamin K 3 / Q000008:administration & dosage / Q000627:therapeutic use*; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D014815:Vitamins; D024483:Vitamin K 3
keywords: acupuncture; dysmenorrhea; menstruation; pain; vitamin k