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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial

Authors: Siyi Yu, Yueqiang Wen, Wanting Xia, Mingxiao Yang, Zhengtao Lv, Xiaoji Li, Wenyao Li, Sha Yang, Youping Hu, Fanrong Liang, Jie Yang

Published in: Trials | Issue 1/2018

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Abstract

Background

Primary dysmenorrhea (PD), is one of main gynecological complaints in women of child-bearing age. Common medications for PD do not always achieve satisfactory outcome of pain relief. Hence, both health professionals and patients are seeking help from complementary and alternative medicine. The acupoint herbal plaster (AHP), which appears to be a safe and effective way to alleviate menstrual pain, as well as to improve other PD-related symptoms. Despite similar clinical studies for this condition in the past, no high-quality methodology-based clinical trial has been reported to date. The current study aims to assess the efficacy of the AHP compared with the acupoint placebo plaster (APP) and being placed on a waiting-list control group in patients with primary dysmenorrhea.

Methods/design

This study is a randomized, single-center, placebo-controlled clinical trial. A total of 180 women with PD will be included and randomly allocated to the AHP, APP and waiting-list (WL) groups in a 1:1:1 ratio. Patients in the AHP group will be provided with herbal plasters (Shaofuzhuyu decoction) on various acupoints: Shenque (CV8), Guanyuan (CV4), Qihai (CV5), Ciliao (BL32) and Zigong (EX-CA1). Women in the APP group will receive placebo plasters on the same acupoints, and no intervention will be given to the WL group until completion of the study. The primary outcome will be pain intensity reduction measured by a Visual Analog Scale (VAS), with other outcome measurements including the Cox Menstrual Symptom Scale (CMSS), the 12-Item Short Form Health Survey (SF-12) and the Participant Global Impression of Change (PGIC). All assessments will be performed at baseline, each menstrual cycle during the treatment course and the follow-up course. Any adverse events will be recorded throughout the study.

Discussion

This is the first study to compare the changes in menstrual pain after three different interventions: the active intervention (AHP), the placebo intervention (APP), and a period of no intervention (WL). This three-arm randomized controlled trial (RCT) aims to investigate the relative contributions of the specific (AHP vs. APP) and non-specific (APP vs. WL) effects to the overall clinical effects of the active AHP on women with PDM. The scientific and rigorous methodology design of this trial should gather good evidence to assess the curative effects and safety of the AHP on PD. Moreover, the results of this study may provide evidence-based references for the treatment of menstrual pain in future.

Trial registration

Chinese Clinical Trial Registry, ID: ChiCTR-TRC-16008701. Registered on 22 July 2016.
Appendix
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Literature
1.
Kennedy S. Primary dysmenorrhoea. Lancet. 1979;56:1116.
2.
Yang J, Chen J, Lao L, Yang M, Chen J, Bo L. Effectiveness study of moxibustion on pain relief in primary dysmenorrhea: study protocol of a randomized controlled trial. Evid Based Complement Alternat Med. 2014;2014:1–6.
3.
Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104–13.PubMedCrossRef
4.
Grandi G, Ferrari S, Xholli A, Cannoletta M, Palma F, Romani C, Volpe A, Cagnacci A. Prevalence of menstrual pain in young women: what is dysmenorrhea? J Pain Res. 2012;2012:169–74.CrossRef
5.
Zahradnik HP, Groth BK. Nonsteroidal anti-inflammatory drugs and hormonal contraceptives for pain relief from dysmenorrhea: a review. Contraception. 2010;81:185–96.PubMedCrossRef
6.
Harel Z. Dysmenorrhea in adolescents. Menarche Transit Girl Woman. 2008;1135:185–95.
7.
Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015;21:17.CrossRef
8.
9.
Ruoff G, Lema M. Strategies in pain management: new and potential indications for COX-2 specific inhibitors. J Pain Symptom Manag. 2003;25:21–31.CrossRef
10.
Jun E-M, Chang S, Kang D-H, Kim S. Effects of acupressure on dysmenorrhea and skin temperature changes in college students: a non-randomized controlled trial. Int J Nurs Stud. 2007;44:973–81.PubMedCrossRef
11.
Lefebvre G, Pinsonneault O, Antao V, Black A, Burnett M, Feldman K, Lea R, Robert M. Primary dysmenorrhea consensus guideline. J Obstet Gynaecol Can. 2005;27:1117.PubMedCrossRef
12.
Park J-S, Park S, Cheon C-H, Go H-Y, Sun S-H, Shin Y-C, Jang B-H, Ko S-G. Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial. Trials. 2012;13:6.CrossRef
13.
14.
15.
Sriprasert I, Suerungruang S, Athilarp P, Matanasarawoot A, Teekachunhatean S. Efficacy of acupuncture versus combined oral contraceptive pill in treatment of moderate-to-severe dysmenorrhea: a randomized controlled trial. Evid Based Complement Alternat Med. 2015; https://​www.​doi.​org/​10.​1155/​2015/​735690.
16.
Liu CZ, Xie JP, Wang LP, Liu YQ, Song JS, Chen YY, Shi GX, Zhou W, Gao SZ, Li SL. A randomized controlled trial of single point acupuncture in primary dysmenorrhea. Pain Med. 2014;15:910–20.PubMedCrossRef
17.
Yang M, Chen X, Bo L, Lao L, Chen J, Yu S, Yu Z, Tang H, Yi L, Wu X. Moxibustion for pain relief in patients with primary dysmenorrhea: a randomized controlled trial. PLoS One. 2017;12:17.
18.
Smith CA, Zhu X, He L, Song J. Acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2011;40:132.
19.
Cho SH, Hwang EW. Acupuncture for primary dysmenorrhoea: a systematic review. BJOG Int J Obstet Gynaecol. 2010;117:509–21.CrossRef
20.
Wang L, Pang L, Bai X, Zhao L, Liu F, Lv X. Clinical efficacy on pediatric recurrent pneumonia treated with point application in summer for the prevention in winter. Chin Acupunct Moxibust. 2016;36:261.
21.
Li JS, Li SY, Yu XQ, Xie Y, Wang MH, Li ZG, Zhang NZ, Shao SJ, Zhang YJ, Zhu L. Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: a randomized, double-blind, double-dummy, active-controlled, 4-center study. J Ethnopharmacol. 2012;141:584–91.PubMedCrossRef
22.
Lai X, Li Y, Fan Z, Zhang J, Liu B. An analysis of therapeutic effect of drug acupoint application in 209 cases of allergic asthma. J Tradit Chin Med. 2001;21:122–6.PubMed
23.
Peng J, Wu X, Hu J, Fang Y, Zi M, Liu B. Influencing factors on efficacy of summer acupoint application treatment for allergic rhinitis: a retrospective study. J Tradit Chin Med. 2012;32:377–81.PubMedCrossRef
24.
Ge H, Chen B. Clinical observation of acute pancreatitis treated with acupoint application combined with medicine. Chin Acupunct Moxibust. 2012;32:602–4.
25.
Peng S, Zheng Y, Zheng K, Lin K, Wu J, Zheng W, Li Y. Effect of a comprehensive therapy plus Gushenyutai plaster administered at Guanyuan (CV 4) on male infertility associated with semen non-liquefaction. J Tradit Chin Med. 2014;34:666–72.PubMedCrossRef
26.
Wang S, Lu D, Li Y. Observation on therapeutic effect of acupoint application on dysmenorrhea of excess syndrome and effect on prostaglandins. Chin Acupunct Moxibust. 2009;29:265–8.
27.
Feng X, Li X, Huang Y. Observation on 60 cases of primary dysmenorrheal treated with acupoint-application. Liaoning J Tradit Chin Med. 2013;6:1225–6.
28.
Yang Y. Observation on primary dysmenorrhea treated with acupoint-application. Hubei J Tradit Chin Med. 2017;1:32–3.
29.
Liu LY, Qiao M, Gao F, Wang HS, Sun JH. Effect of acupiont sticking therapy with Kechuanting paste on expression of T-bet and GATA-3 mRNA in lung for chronic asthma airway inflammation rats. J Nanjing Univ Tradit Chin Med. 2014;6:550–3.
30.
Chen J, Chen JQ, Huang Y, Zhang JL, Tang CZ. Study of traditional Chinese medicine acupoint sticking ultrafine effect on the TGF-β 1 and IL-17 content in allergic rhinitis rats. Chin J Basic Med Trad Chin Med. 2014;9:1218–21.
31.
Ding Y, Wang Y. The effects of acupoint sticking therapy in summer for winter disease on inflammation mediator in patients with chronic bronchitis. Int J Laboratory Med. 2014;17:2289–90.
32.
Yao H, Tong J, Zhang P, Wang Z. Effect of acupoint application on inflammatory cells level in patients with bronchial asthma. J Guangzhou Univ Tradit Chin Med. 2007;4:289–92.
33.
Huang X, Su S, Duan J, Sha X, Zhu KY, Guo J, Yu L, Liu P, Shang E, Qian D. Effects and mechanisms of Shaofu-Zhuyu decoction and its major bioactive component for Cold – Stagnation and Blood – Stasis primary dysmenorrhea rats. J Ethnopharmacol. 2016;186:234–43.PubMedCrossRef
34.
Wang L, Huang S, Chen B, Zang XY, Su D, Liang J, Xu F, Liu GX, Shang MY, Cai SQ. Characterization of the anticoagulative constituents of Angelicae Sinensis Radix and their metabolites in rats by HPLC-DAD-ESI-IT-TOF-MSn. Planta Med. 2016;82:362–70.PubMedCrossRef
35.
Xin Y, Liu S. Quantitative assessment of the influence of Rhizoma Zingiberis on the Level of aconitine in rat gut sacs and qualitative analysis of the major influencing components of Rhizoma Zingiberis on aconitine using UPLC/MS. PLoS One. 2015;10:16.
36.
Tian Y, Li J, Li Y, Dong Y, Yao F, Mao J, Li L, Wang L, Luo S, Wang M. Effects of Bufei Yishen granules combined with acupoint sticking therapy on pulmonary surfactant proteins in chronic obstructive pulmonary disease rats. Biomed Res Int. 2016;2016:1–8.
37.
Fan M. Clinical observation of Shaofu Zhuyu decotiong for treating primary dysmenorrhea of cold coagulation and blood stasis. Beijing J Tradit Chin Med. 2011;30:455–6.
38.
Cheng Q, Zhu Y. Clinical study on primary dysmenorrheal of blood—stasis of cold-coagulation syndrome treated with modified Shaofu Zhuyu decoction. J Chin Med. 2011;26:1249–50.
39.
Ye X, Wang H, Le J. Effects of Shaofuzhuyu Tang on uterine convulsion and anti-inflammatory action in rodent. Chin J Hosp Pharm. 2002;22:329–31.
40.
41.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krležajerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158:200–7.PubMedPubMedCentralCrossRef
42.
43.
Zhang X, Zhang S, Xu C. Jiawei Shaofu Zhuyu decoction combined with moxibustion therapy in treating primary dysmenorrhea—55 cases. Chin J Exp Tradit Med Formulae. 2014;20:192–5.
44.
Wang N, Li P. Analysis of therapeutic effects of modified Shaofu Zhuyu decoction for dysmenorrhea caused by coagulation and blood stasis. J Clin Med Pract. 2013;5:036.
45.
Lee H, Choi T-Y, Myung C-S, Lee JA, Lee MS. Herbal medicine (Shaofu Zhuyu Decoction) for treating primary dysmenorrhea: a systematic review of randomized clinical trials. Maturitas. 2016;86:64–73.PubMedCrossRef
46.
Lin D. The acupoint application of Shaofu Zhuyu Tang on navel. J Extern Ther TCM. 2000;9:36–7.
47.
Li J, Zhang M, Wang X. The clinical observation on the treatment of chronic pelvic inflammatory disease by oral and external application of Shaofu Zhuyu Tang. J Qinghai Med. 2014;44:53–4.
48.
Fu J, Xia Y. The clinical observation on oral and external application of Shao Xue Tong Yu decoctionon for treating chronic pelvic inflammatory disease. Mod J Integrat Trad Chin Western Med. 2012;21:1513–4.
49.
Price DD, Mcgrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17:45–56.PubMedCrossRef
50.
Cox DJ, Meyer RG. Behavioral treatment parameters with primary dysmenorrhea. J Behav Med. 1978;1:297–310.PubMedCrossRef
51.
Bourion-Bédès S, Schwan R, Laprevote V, Bédès A, Bonnet JL, Baumann C. Differential item functioning (DIF) of SF-12 and Q-LES-Q-SF items among French substance users. Health Qual Life Outcomes. 2015;13:1–8.CrossRef
52.
Pagé I, Abboud J, O᾽Shaughnessy J, Laurencelle L, Descarreaux M. Chronic low back pain clinical outcomes present higher associations with the STarT Back Screening Tool than with physiologic measures: a 12-month cohort study. BMC Musculoskelet Disord. 2015;16:1–10.CrossRef
53.
Smeets RJ, Beelen S, Goossens ME, Schouten EG, Knottnerus JA, Vlaeyen JW. Treatment expectancy and credibility are associated with the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. Clin J Pain. 2008;24(4):305–15.PubMedCrossRef
54.
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86.PubMedCrossRef
55.
US Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE) version 4.0[J]. National Cancer Institute. 2009;(09-5410).
56.
Wu X, Jin P, Li G, Wei Z, Liu G, Liu B. Efficacy evaluation of summer acupoint application treatment on asthma patients: a two-year follow-up clinical study. J Tradit Chin Med. 2015;35:21–7.PubMedCrossRef
57.
Wu XQ, Peng J, Li GQ, Su HP, Liu GX, Liu BY. Association between skin reactions and efficacy of summer acupoint application treatment on chronic pulmonary disease: A prospective study. Chin J Integr Med. 2016;22:284–92.PubMedCrossRef
58.
Chow SC, Shao J, Wang H. Sample size calculations in clinical research. Boca Raton: Chapman & Hall/CRC Biostatistics; 2003.
59.
Irnich D, Salih N, Offenbächer M, Fleckenstein J. Is sham laser a valid control for acupuncture trials? Evid-Based Complement Altern Med. 2011;2011(27):485945.
Metadata
Title
Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial
Authors
Siyi Yu
Yueqiang Wen
Wanting Xia
Mingxiao Yang
Zhengtao Lv
Xiaoji Li
Wenyao Li
Sha Yang
Youping Hu
Fanrong Liang
Jie Yang
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2682-8

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