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BMJ Open. 2016 Jan 5;6(1):e008166. doi: 10.1136/bmjopen-2015-008166.

Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study.

Author information

1
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.
2
Obstetrics and Gynecology Hospital, Fudan University, Shanghai, Shanghai, China.
3
Agenzia Sanitaria e Sociale Regionale dell'Emilia Romagna, (Healthcare and Social Agency of Emilia Romagna Region), Viale Aldo Moro, 21, 40127 Bologna, Italy.
4
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.
5
Department of Statistics, Columbia University, New York, New York, USA.
6
Department of Statistics, School of Public Health, Fudan University, Shanghai, Shanghai, China.
7
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.

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.

SETTING:

A Menstrual Disorder Centre at a public hospital in Shanghai, China.

PARTICIPANTS:

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.

INTERVENTIONS:

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.

PRIMARY AND SECONDARY OUTCOME MEASURES:

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.

TRIAL REGISTRATION NUMBER:

NCT00104546; Results.

KEYWORDS:

acupuncture; dysmenorrhea; menstruation; pain; vitamin k

PMID:
26733563
PMCID:
PMC4716272
DOI:
10.1136/bmjopen-2015-008166
[Indexed for MEDLINE]
Free PMC Article

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