Contact information
Type
Scientific
Primary contact
Prof Jiang Zhu
ORCID ID
Contact details
Beijing University of Chinese Medicine
11 Bei San Huan Dong Lu
Chao Yang District
Beijing
100029
China
+86 (0)10 8456 0099
603005@bucm.edu.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006CB504503
Study information
Scientific title
Analgesic effect of acupuncture compared with sham acupuncture in primary dysmenorrhoea: a multi-centre randomised controlled clinical trial-II
Acronym
AAEPD-II (Acupuncture Analgesia Effect in Primary Dysmenorrhoea-II)
Study hypothesis
Some recent randomised controlled trials (RCTs) suggested that acupuncture was no more effective than sham acupuncture. Because of small sample size in the previous study (50 patients in each arm) (ISRCTN84496835), we have a design for a larger sample of trial to evaluate the point specificity of analgesic effect of acupuncture at SP6 in primary dysmenorrhoea. For the primary outcome measure the Visual Analogue Scale (VAS) score for pain at baseline and 30 minutes after the first intervention, the previous study (ISRCTN84496835) suggested a 47.58% improvement for acupoint group, compared with 40.71% for non-acupoint group. We used these findings as the basis for our power calculation. At 5% significance and 80% power, 145 patients are required in each arm. Taking into consideration a 15% dropout rate, at least 167 patients in each arm are needed.
Ethics approval
Medical Ethics Committee of the Beijing University of Chinese Medicine, approved on 10/11/2008
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary dysmenorrhoea
Intervention
1. Acupuncture
2. Sham acupuncture
Acupuncture and sham acupuncture were administered once-daily for 3 days with acupuncture at Sanyinjiao (SP6) that was specifically designed to treat primary dysmenorrhoea, or 1 of 2 sham acupuncture treatments: acupuncture for an unrelated acupoint (Xuanzhong, GB39), or needle insertion at non-acupoint locations (lateral side of lower leg, 3 inches above the tip of external malleolus, 1.5 inches behind anterior crest of the bibia).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. VAS score for pain at baseline, 5, 10, 30, and 60 minutes after the first intervention
2. Cox Retrospective Symptom Scale (RSS) during 3 menstrual cycles (before the treatment, during the treatment, and in 1 subsequent cycle after intervention)
3. Verbal Rating Scale (VRS) during 3 menstrual cycles (before the treatment, during the treatment, and in 1 subsequent cycle after intervention)
Secondary outcome measures
1. Pain, as measured by VAS, before the second intervention, before the third intervention, and during 3 menstrual cycles
2. The changes in assigned analgesic medication usage that each participant reported using during 2 menstrual cycles (during the treatment and in 1 subsequent cycle after intervention), and proportion of participants in each group who were using analgesics in addition to their assigned treatment during 2 menstrual cycles (during the treatment and in 1 subsequent cycle after intervention)
Overall trial start date
01/12/2008
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women aged 18 to 30 years
2. A history of regular menstruation (28-day cycle +/- 7 days)
3. Primary dysmenorrhoea (onset greater than or equal to 3 years after menarche)
4. Menstrual cramping pain of moderate or severe intensity, varying from 4.0 to 10.0 on VAS, and for at least 6 months before study entry
5. Not pregnant
6. Good general health
7. Agree to refrain from the use of any analgesics 24 hours before the first intervention
8. Provide written informed consent prior to enrolment
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
501
Participant exclusion criteria
1. Dysmenorrhoea secondary to organic pathology
2. A history of term pregnancy or possible current pregnancy
3. Severe gastrointestinal, gynaecological or autoimmune diseases, or gynaecological surgery
4. They have previously received acupuncture (to maximize blinding)
Recruitment start date
01/12/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
China
Trial participating centre
Beijing University of Chinese Medicine
Beijing
100029
China
Sponsor information
Organisation
Ministry of Science and Technology (China)
Sponsor details
15B
Fuxing Road
Beijing
100862
China
+86 (0)10 5888 1072
jcc973@vip.sina.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Science and Technology (China) - National Basic Research Programme (ref: 2006CB504503)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21166767
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24555788
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24636695
Publication citations
-
Results
Liu CZ, Xie JP, Wang LP, Zheng YY, Ma ZB, Yang H, Chen X, Shi GX, Li SL, Zhao JP, Han JX, Li JD, Wang YX, Tang L, Xue XO, Li M, Wang Y, Sun AP, Xing JM, Cao HJ, Zhu J, Liu JP, Immediate analgesia effect of single point acupuncture in primary dysmenorrhea: a randomized controlled trial., Pain Med, 2011, 12, 2, 300-307, doi: 10.1111/j.1526-4637.2010.01017.x.
-
Results
Shi GX, Li QQ, Liu CZ, Zhu J, Wang LP, Wang J, Han LL, Guan LP, Wu MM, Effect of acupuncture on Deqi traits and pain intensity in primary dysmenorrhea: analysis of data from a larger randomized controlled trial., BMC Complement Altern Med, 2014, 14, 69, doi: 10.1186/1472-6882-14-69.
-
Results
Liu CZ, Xie JP, Wang LP, Liu YQ, Song JS, Chen YY, Shi GX, Zhou W, Gao SZ, Li SL, Xing JM, Ma LX, Wang YX, Zhu J, Liu JP, A randomized controlled trial of single point acupuncture in primary dysmenorrhea, Pain Med, 2014 , 15, 6, 910-920, doi: 10.1111/pme.12392.