The role of treatment timing and mode of stimulation in the treatment of primary dysmenorrhea with acupuncture: An exploratory randomised controlled trial

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Abstract

Objectives

We examined the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea.

Methods

A randomised controlled trial was performed with four arms, low frequency manual acupuncture (LF-MA), high frequency manual acupuncture (HF-MA), low frequency electro acupuncture (LF-EA) and high frequency electro acupuncture (HF-EA). A manualised trial protocol was used to allow differentiation and individualized treatment over three months. A total of 74 women were randomly assigned to one of the four groups (LF-MA n = 19, HF-MA n = 18, LF-EA n = 18, HF-EA n = 19). Twelve treatments were performed over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.

Results

During the treatment period and nine month follow-up all groups showed statistically significant (p < .001) reductions in peak and average menstrual pain compared to baseline but there were no differences between groups (p > 0.05). Health related quality of life increased significantly in six domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups (p = 0.02). HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups (p<0.05).

Conclusion

Acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

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Most cited references 60

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Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations.

Robert H Dworkin, Dennis C Turk, Michael McDermott … (2009)

An essential component of the interpretation of results of randomized clinical trials of treatments for chronic pain involves the determination of their clinical importance or meaningfulness. This involves two distinct processes--interpreting the clinical importance of individual patient improvements and the clinical importance of group differences--which are frequently misunderstood. In this article, we first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. We then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors. The clinical importance of individual patient improvements can be determined by assessing what patients themselves consider meaningful improvement using well-described methods. In contrast, the clinical meaningfulness of group differences must be determined by a multi-factorial evaluation of the benefits and risks of the treatment and of other available treatments for the condition in light of the primary goals of therapy. Such determinations must be conducted on a case-by-case basis, and are ideally informed by patients and their significant others, clinicians, researchers, statisticians, and representatives of society at large.

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Primary dysmenorrhea: advances in pathogenesis and management.

Reham M Dawood (2006)

Primary dysmenorrhea is painful menstrual cramps without any evident pathology to account for them, and it occurs in up to 50% of menstruating females and causes significant disruption in quality of life and absenteeism. Current understanding implicates an excessive or imbalanced amount of prostanoids and possibly eicosanoids released from the endometrium during menstruation. The uterus is induced to contract frequently and dysrhythmically, with increased basal tone and increased active pressure. Uterine hypercontractility, reduced uterine blood flow, and increased peripheral nerve hypersensitivity induce pain. Diagnosis rests on a good history with negative pelvic evaluation findings. Evidence-based data support the efficacy of cyclooxygenase inhibitors, such as ibuprofen, naproxen sodium, and ketoprofen, and estrogen-progestin oral contraceptive pills (OCPs). Cyclooxygenase inhibitors reduce the amount of menstrual prostanoids released, with concomitant reduction in uterine hypercontractility, while OCPs inhibit endometrial development and decrease menstrual prostanoids. An algorithm is provided for a simple approach to the management of primary dysmenorrhea.

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WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity

Pallavi Latthe, Manish Latthe, Lale Say … (2006)

Background Health care planning for chronic pelvic pain (CPP), an important cause of morbidity amongst women is hampered due to lack of clear collated summaries of its basic epidemiological data. We systematically reviewed worldwide literature on the prevalence of different types of CPP to assess the geographical distribution of data, and to explore sources of variation in its estimates. Methods We identified data available from Medline (1966 to 2004), Embase (1980 to 2004), PsycINFO (1887 to 2003), LILACS (1982 to 2004), Science Citation index, CINAHL (January 1980 to 2004) and hand searching of reference lists. Two reviewers extracted data independently, using a piloted form, on participants' characteristics, study quality and rates of CPP. We considered a study to be of high quality (valid) if had at least three of the following features: prospective design, validated measurement tool, adequate sampling method, sample size estimation and response rate >80%. We performed both univariate and multivariate meta-regression analysis to explore heterogeneity of results across studies. Results There were 178 studies (459975 participants) in 148 articles. Of these, 106 studies were (124259 participants) on dysmenorrhoea, 54 (35973 participants) on dyspareunia and 18 (301756 participants) on noncyclical pain. There were only 19/95 (20%) less developed and 1/45 (2.2%) least developed countries with relevant data in contrast to 22/43 (51.2%) developed countries. Meta-regression analysis showed that rates of pain varied according to study quality features. There were 40 (22.5%) high quality studies with representative samples. Amongst them, the rate of dysmenorrhoea was 16.8 to 81%, that of dyspareunia was 8 to 21.8%, and that for noncyclical pain was 2.1 to 24%. Conclusion There were few valid population based estimates of disease burden due to CPP from less developed countries. The variation in rates of CPP worldwide was due to variable study quality. Where valid data were available, a high disease burden of all types of pelvic pain was found.

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Author and article information

Contributors

Roberta W. Scherer: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 12 July 2017

Publication date Collection: 2017

Volume: 12

Issue: 7

Electronic Location Identifier: e0180177

Affiliations

[1 ] The National Institute of Complementary Medicine, Western Sydney University, Sydney, Australia

[2 ] School of Nursing and Midwifery, Western Sydney University, Sydney, Australia

[3 ] Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand

Johns Hopkins University Bloomberg School of Public Health, UNITED STATES

Author notes

Competing Interests: MA is the director of an acupuncture clinic in New Zealand and has recently been engaged in integrative medicine clinical practice. MA, CS and XZ are part of NICM. As a medical research institute, NICM receives research grants and donations from foundations, universities, government agencies, individuals and industry. Sponsors and donors provide untied funding for work to advance the vision and mission of the Institute. The project that is the subject of this article was not undertaken as part of a contractual relationship with any organisation other than the funding declared in the Acknowledgments. It should also be noted that NICM conducts clinical trials relevant to this topic area, for which further details can be provided on request. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Conceptualization: MA CS HD XZ CF.
Data curation: MA.
Formal analysis: MA CS CF.
Investigation: MA.
Methodology: MA CS HD XZ CF.
Project administration: MA CS HD.
Resources: MA CS HD XZ.
Supervision: CS HD XZ CF.
Visualization: MA CS CF.
Writing – original draft: MA.
Writing – review & editing: MA CS HD XZ CF.

* E-mail: m.armour@ 123456westernsydney.edu.au

Author information

Mike Armour http://orcid.org/0000-0001-7539-9851

Article

Publisher ID: PONE-D-16-38118

DOI: 10.1371/journal.pone.0180177

PMC ID: 5507497

PubMed ID: 28700680

SO-VID: 61972923-aa5d-490c-9d61-2a71cb5b5356

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 22 September 2016

Date accepted : 18 May 2017

Page count

Figures: 2, Tables: 5, Pages: 20

Funding

Funded by: Australian Postgraduate Award

Award ID: PhD candidature funding

Award Recipient :

ORCID: http://orcid.org/0000-0001-7539-9851

Mike Armour

This study was funded in part by the Australian federal government via their Australian postgraduate award to MA. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Data Availability All relevant data are within the paper and its Supporting Information files.

The role of treatment timing and mode of stimulation in the treatment of primary dysmenorrhea with acupuncture: An exploratory randomised controlled trial

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Abstract

Objectives

Methods

Results

Conclusion

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PLOS Climate

Most cited references 60

Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations.

Primary dysmenorrhea: advances in pathogenesis and management.

WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity

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