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

Date Published: July 12, 2017

Publisher: Public Library of Science

Author(s): Mike Armour, Hannah G. Dahlen, Xiaoshu Zhu, Cindy Farquhar, Caroline A. Smith, Roberta W. Scherer.

http://doi.org/10.1371/journal.pone.0180177

Abstract

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

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.

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). 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.

Partial Text

Primary dysmenorrhea is defined as menstrual pain in the absence of any organic cause and is most common in women under the age of 25. Primary dysmenorrhea’s characteristic symptom is crampy, colicky spasms of pain in the suprapubic area, occurring within 8–72 hours of menstruation and peaking within the first few days as menstrual flow increases[1]. In addition to painful cramps, many women with primary dysmenorrhea experience other menstrual-related symptoms, including back and thigh pain, headaches, diarrhoea, nausea and vomiting[1]. Pain commonly starts within three years of menarche[2] and results in life time world-wide prevalence rates ranging from 17–81%[3] with 71% of Australian women suffering from dysmenorrhea in a given year[4]. Primary dysmenorrhea is the most common cause for school absenteeism in women [5] and in 10–30% of women causes regular absence from work, school or university each month [6, 7]. In addition to absenteeism primary dysmenorrhea causes a reduction in academic performance [8, 9], reduced participation in sport and social activities[8] and an overall significant decrease in women’s quality of life [9, 10]. Despite the significant negative impact and disruption to daily living that primary dysmenorrhea has on women most do not seek medical treatment [11, 12].When women do present to their doctor with primary dysmenorrhea, the most commonly prescribed treatments are non-steroidal anti-inflammatories (NSAIDs) and the combined oral contraceptive (COC) pill. These treatments are effective for many women [2, 13], however approximately 25% of women have pain that is refractory to either or both of these standard treatments[14].

A total of 106 women expressed interest in the study (See Fig 1). Seventy-four women met the eligibility criteria and were randomised to one of the four groups. Sixty-three (85%) women completed the treatment phase of the trial. Ten participants withdrew during the treatment phase of the trial. Withdrawal from the trial was equally distributed across groups, with none of the women citing any group-related concerns as reason for withdrawal.

Acupuncture treatment, regardless of group, using a manualised acupuncture protocol, showed significant clinical improvements in all menstrual pain scores recorded; ‘peak pain’ over the first three days of the menstrual period and ‘average pain’ over the entire menstrual period, and that reduction was sustained for twelve months. This was supported by a similar significant reduction across all other measures of menstrual impact; duration of pain, analgesic usage, secondary menstrual symptoms and a high self-rated improvement score. Electro-acupuncture did not deliver greater pain reduction than manual acupuncture. Manual acupuncture groups tended to have a higher responder rate, significantly greater reduction in secondary symptoms, and lower analgesic usage. With respect to health related quality of life six domains improved from baseline in the HF groups, with only two improving from baseline in the LF groups. There was no difference between manual and electro-acupuncture in terms of domains improved.

This exploratory study suggests acupuncture administered over three menstrual cycles gave both statistically and clinically significant reductions in menstrual pain compared to baseline and persisted for 12 months, however there was no significant difference in pain intensity between groups. Electro-acupuncture was well tolerated but did not always provide the same magnitude of improvements as manual acupuncture in reducing secondary menstrual symptoms and analgesic medication intake. Manual acupuncture provided the same or greater pain relief as electro-acupuncture, but with less analgesic medication required to achieve this pain reduction. Treatment timing appears to play a small role, with high frequency of treatment providing greater improvements in health-related quality of life. This exploratory trial suggests that there may be an effect of both treatment timing and mode of stimulation, but possibly only of small clinical benefit. Future adequately powered studies are needed to confirm the role of both mode of stimulation and treatment timing and to provide a more accurate indication of the clinical impact of altering these dose components on menstrual pain.

 

Source:

http://doi.org/10.1371/journal.pone.0180177

 

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