Abstract
Introduction: Dysmenorrhea constitutes one of the most frequent disorders in women of a fertile age. The present study was conducted to evaluate the efficacy of acupuncture in the management of primary dysmenorrhea.Materials and methods: Sixty females aged 17-23 years were randomly assigned to either a study group or a control group. The study group received acupuncture for the duration of 20 minutes/day, for 15 days/month, for the period of 90 days. The control group did not receive acupuncture for the same period. Baseline, during, and post assessments of both the groups were taken on day 1; day 30 and day 60; and day 90, respectively. Statistical analysis was per-formed by repeated measures of analysis of variance followed by post hoc analysis with Bon-ferroni adjustment for multiple comparisons, independent samples test for visual analog scale score, and ManneWhitney U test for rest of the variables using statistical package for the social sciences。
Results: This study showed a significant reduction in all the variables such as the visual analog scale score for pain, menstrual cramps, headache, dizziness, diarrhea, faint, mood changes,tiredness, nausea, and vomiting in the study group compared with those in the control group.
Conclusion: Acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea
1. Introduction
Dysmenorrhea is one of the commonest health problems[1] found in 25e50% of adult women [2]. It is characterized by severe uterine pain during menstruation [1], crampy pelvic pain radiating to lower back or anterior
thigh,nausea,vomiting,diarrhea,headache,fatigue,nervous-ness, and dizziness which begins shortly before or at the onset of menstruation, lasting 1e3 days [3]. About 75% of adolescents experience pain with menstruation, whereas 20% report severe dysmenorrhea or pain that prevents them from participating in their usual activities [2].Complementary and alternative approaches such as ex-ercise, acupuncture, heat, behavioral interventions, and dietary/herbal supplements are commonly used by women to relieve symptoms of dysmenorrhea. Acupuncture, a Traditional Chinese Medicine, is well tolerated, free of relevant side effects, and has been approved by the Food and Drugs Act. It is commonly used to treat chronic pelvic pain and has also been recommended by the National
Institute of Health for the treatment of several diseases,including dysmenorrhea [4]. Although acupuncture is shown to be effective in various painful conditions, there is a lack of randomized controlled trial in evaluating its efficacy on pain and its associated symptoms in primary dysmenorrhea.We hypothesized that acupuncture may be effective in the management of pain and its’ associated symptoms in
women with primary dysmenorrhea. Hence, the present study was conducted to evaluate the efficacy of acupunc-ture in the management of primary dysmenorrhea.
2. Materials and methods
2.1. Study design
This is a parallel-group randomized controlled trial.Participants were randomly allocated to either the study group or control group. The study group participants received acupuncture, whereas the control group participants did not receive it, and they were in their
normal routine. Baseline, during, and post assessments of both the groups were taken on the 1st day; 30th and 60th
day; and 90th day, respectively (Fig. 1).
2.2. Participants
Sixty participants aged 17-23 years were recruited from a residential college. Female participants with the history of primary dysmenorrhea at least for the past 1 year, regular menstruation with periods varied from 21 to 35 days,and no history of use of oral contraceptive pills,intrauterine devices, and any particular medicine for primary dysmenorrhea for the past 6 months before the
commencement of the study were included in the study.Female participants with the history of secondary dysmenorrhea, any systemic and/or psychiatric illness,and regular use of medication for any disease were excluded from the study. The study was conducted in
the Department of Acupuncture, SDM College of Naturopathy and Yogic Sciences, Karnataka. Institutional ethics committee approved the study protocol, and a written informed consent was obtained from each participant.
2.3. Intervention
Study group: Participants received clinical acupuncture in Traditional Chinese Medicine style of acupuncture for symptomatic relief of dysmenorrhea. Needling was performed at 12 acupuncture points, such as KI-3, SP-8, ST-25,ST-29, ST-30, ST-36, CV-4, CV-6, BL-62, HT-7, LI-4, and PC-6 [5]. Of the 12 acupuncture points, two acupuncture points,i.e., CV-4 and CV-6, were needled using single needle for each point, whereas the rest of the 10 acupuncture points were needled bilaterally. Detailed description of these acupuncture points are provided in Table 1. Participants were informed about the procedure, sensations of needle insertion, and response sought. All needles were left undisturbed for a duration of 20 minutes without any stimulation for each session. We used 0.2 30 mm locally
manufactured stainless steel needles. Each participant received a total of 45 sessions of acupuncture [1 session (20 minutes)/day, 15 sessions/30 days, for the period of 90 days]. Needling was started on the 6th day of menstrual cycle and was not performed during menstruations. Along with acupuncture, participants did not receive other treatments. Acupuncture was given by an institutionally
qualified physician who has experience of more than 15 years in clinical acupuncture (see Table 2).
Control group: Participants did not receive acupuncture and continued with their normal routine during the study period.
2.4. Outcomes
The primary outcome variable of the study was pain intensity that was measured on a numerical rating scale,with scores ranging from 0 to 10. On this scale, a score of 1-3 Z mild pain, 4-7 Z moderate pain, and 8-10 Z severe pain. The secondary outcome variable such
as muscle cramping was assessed using a 4-point numerical rating scale that indicates four stages of the intensity of cramps, ranging from 0 to 3 (0 Z none; 1 Z mild;2 Z moderate; and 3 Z severe). The systemic symptoms such as headache, dizziness, diarrhea, faint, mood change,tiredness, nausea, and vomiting were also carried out using a 4-point numerical rating scale [6] graded from 0 to 3
(0 Z no symptoms; 1 Z symptoms exist only mildly and do not interfere with routine activities; 2 Z symptoms exist moderately and interfere with routine activities but are not debilitating; 3 Z symptoms exist severely and are completely debilitating). Baseline, during, and post as-sessments were taken on the 1st day; 30th and 60th day; and 90th day, respectively.
2.5. Sample size
Sixty participants aged from 17 to 23 years were recruited. Sample size calculation was not made based on any previous study or pilot study, and that is one of the limitations of the study.
154 G.B. Shetty et al.
[1][2][1][3][2][4]Fig. 1[5][6]
2.6. Randomization
All the participants were randomly allocated to either the study group or control group using the papers with the words “study” and “control” which were put in an envelope, and the paper each participant drew out determined the group [7]. The randomization was done by one of the authors involved in the intervention, but did not in any part of the investigation.
2.7. Blinding/masking
The investigator who involved in the data collection was blind to the study group and control group.
2.8. Statistical analysis
All the data were tested for normality using KolmogoroveSmirnov and ShapiroeWilk tests. Within-group statistical analysis was performed using repeated measures of analysis of variance followed by post hoc analysis with Bonferroni adjustment for multiple comparisons.Between-group analysis was performed using independent samples t test for normally distributed data (visual analog
scale score) and ManneWhitney U test for non-normally distributed data with the use of Statistical Package for the Social Sciences,version 16. The p value < 0.05 was considered significant.
3. Results
Baseline was comparable, and there was no significant difference between the study and control groups. Results of this study showed a significant reduction in all the variables at during (30th and 60th days) and postintervention assessments, except headache, for which the significant reduction was observed only after intervention and not during intervention compared to the control group. In within-
Post assessment (n = 30)
Acupuncture and during assessment
(30th & 60th day) (n = 30)
Baseline assessments (n = 30)
Study group (n = 30)
Normal routine and during
assessment (30th & 60th day) (n = 30)
Post assessment (n = 30)
Baseline assessment (n = 30)
Assessed for eligibility (n = 320)
Randomization (n = 60)
Exclusion (n = 260)
did not fulfill the
criteria
Recruited participants (n = 60)
Control group (n = 30)
Data analysis (n = 60)
Figure 1 Trial profile.
Efficacy of Acupuncture 155
[7]
group analysis, the study group showed a significant reduction in all the variables, except faint, but no such significant changes were observed in the control group(Table 1). None of the participants reported any adverse effects during the study period.
4. Discussion
Results of the present study showed a significant reduction in pain severity, muscle cramps, and systemic symptoms in the study group compared with the control group. Reduction in pain was also found in the previous studies on acupuncture in dysmenorrhea which supports the study findings [8, 9]. Improvement in the pain and other symptoms of dysmenorrhea could be possibly through the
central analgesic effect of acupuncture [10, 11] and its reflex effects on the tissues such as changes in blood flow[12]. A previous study with animals has identified biochemical and neuroanatomical substrates of acupuncture analgesia [13]. From a biochemical perspective, it appears that acupuncture may alter the metabolism of substrates involved in the ascending facilitatory pathways,viz., N-methyl-D-aspartate receptors [14], substance P[15], and interleukin-1 [16] and the descending inhibitory pain pathways, viz.,endogenous opioids [17], serotonin[18], and norepinephrine [19]. From a neuroanatomical standpoint, several central nervous system structures are involved in acupuncture analgesia, including peri-aqueductal gray, nucleus raphe magnus, locus coeruleus,
arcuate nucleus, amygdala, and nucleus accumbens [13,20]. In a previous study, stimulation of acupuncture points through needling was shown to trigger the release of enkephalins and endorphins in the periaqueductal gray,arcuate nucleus, and caudate nucleus [21]. These structures send projections to the spinal dorsal horn via dorsal lateral funiculi [22]. Increases in serotonin release at nucleus raphe magnus and norepinephrine release in locus ceruleus are also crucial for acupuncture-induced analgesia [19] in dysmenorrhea and other painful conditions.Animal studies have shown that acupuncture may help toreduce symptoms of dysmenorrhea by regulating neuroen-docrine activities and the related receptor expression ofthe hypothalamus-pituitary-ovary axis [23]. The role of vascular changes in the causation of dysmenorrhea is well documented. A previous study suggested that menstrual pain is caused by reduced blood flow due to uterine hyperactivity. This can occur when the menstrual flow isconstricted and can be relieved by increased blood circulation and antispasmodics [24]. Acupuncture needling was reported to stimulate the nerves in the local tissues and
cause the release of neuropeptides resulting in vasodilation[25] and increased blood circulation around the target area
[26]. This increase in blood circulation causes a dilution of intravascular prostaglandins, bradykinins, and histamines (pain-inducing molecules); an increased tissue oxygenation[27]; a facilitated drainage and a “wash-out” effect; and purging of the tissues of debris and by-products of tissue injury. Acupuncture was also shown to increase nitric oxide levels which relaxes smooth muscle and helps in inhibiting uterine contractions that might reduce cramps and the other symptoms of dysmenorrhea [28]. Strength of the study: Randomized controlled trial; All the participants were kept under supervision under same atmosphere and
diet conditions. None of the participants reported any adverse effects throughout the study period. Limitations
Table 1 Description of acupuncture points.Needling point Location Depth of needling; method KI-3 (Taixi)* Mid way between the tip of the medial malleolus and medial border of tendoachilles.1 cun; perpendicular needling LI-4 (Hegu)* Highest point of the muscles on the back of the hand when the forefinger and thumb are adducted 0.5e1 cun; perpendicular needling HT-7 (Shenmen)* On the radial side of the tendon of flexor carpi ulnaris muscle at the wrist crease0.5 cun; perpendicular needling PC-6 (Neiguan)* 2-cun proximal to the midpoint of the wrist crease,between the tendons of palmaris longus and flexor carpi radialis muscles,1 cun; perpendicular needling
SP-8 (Diji)* On the posterior border of the tibia 3-cun distal to inferior end of medial condyle of the tibia 1 cun; perpendicular needling
ST-25 (Tianshu)* 2-cun lateral to the umbilicus 0.5e1 cun; perpendicular needling ST-29 (Guilai)* 4-cun below and 2-cun lateral to the umbilicus 0.5e1 cun; perpendicular needling ST-30 (Qichong)* 5-cun below and 2-cun lateral to the umbilicus in the
inguinal region.0.5e1 cun; perpendicular needling ST-36 (Zusanli)* One finger breadth lateral to the inferior end of tibial tuberosity
1 cun; perpendicular needling BL-62 (Shenmai)* 0.5-cun inferior to the tip of the lateral malleolus 0.3e0.5 cun; perpendicular needling
CV-4 (Guanyuan){ In the front midline 3-cun below the umbilicus 1 cun; perpendicular needling CV-6 (Qihai){ In the front midline 1.5-cun below the umbilicus 1.5 cun; perpendicular needling Note: * Z bilateral needling; { Z single needling.KI Z kidney; LI Z large intestine; HT Z heart; PC Z pericardium; SP Z spleen; ST Z stomach; BL Z urinary bladder; CV Z conception.vessel; cun Z the breadth of the distal phalanx of the thumb at its widest point.
Source: Anton Jayasuriya. Clinical Acupuncture. 1st Ed (revised). India: B Jain Publishers (P) Ltd; 2005.
156 G.B. Shetty et al.[8, 9][10, 11][12][13][14][15][16][17][18][19][13,20][21][22][19][23][24][25][26][27][28]
of the study: Objective measures such as changes in the level of uterine blood flow, biochemical and neurotrans mitters were not performed to find out the mechanisms behind the effect of this study. The participants were not followed up to see whether or not the effect was persisting.Hence, further studies are required with a large sample,longer follow up, and more objective measures to explain
the possible mechanisms.
5. Conclusion
Results of this study suggest that acupuncture could be considered an effective treatment modality for the management of primary dysmenorrhea.
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VAS for pain 7.29 1.22 4.43 2.46* 2.54 1.78* 2.53 1.68* 7.12 1.44 6.73 1.91 6.83 1.38 7.17 1.42 MC 1.90 .80 0.70 0.88* 0.47 0.51* 0.30 0.54* 1.53 0.97 1.63 0.89 1.70 0.92 1.63 0.81
Headache 0.83 1.05 0.40 0.68! 0.37 0.56! 0.33 0.55* 0.73 0.83 0.70 0.75 0.63 0.67 0.70 0.70
Dizziness 1.17 1.18 0.33 0.76* 0.17 0.53* 0.17 0.53* 1.07 0.98 0.97 0.93 1.10 0.89 1.13 0.86
Diarrhea 0.63 0.76 0.17 0.38* 0.10 0.31* 0.07 0.25* 0.63 0.67 0.83 0.87 0.70 0.75 0.83 0.79
Faint 0.43 0.89 0.03 0.18{ 0.03 0.18{ 0.00 0.00{ 0.43 0.68 0.40 0.68 0.27 0.45 0.53 0.73
Mood changes 1.97 0.81 0.97 0.81* 1.07 0.64* 1.00 0.79* 1.77 1.01 1.73 0.91 1.60 0.77 1.67 0.76
Tiredness 2.17 0.70 1.17 0.99* 0.90 0.76* 0.90 0.85* 1.87 0.68 1.83 0.83 1.83 0.83 1.63 0.76
Nausea 0.90 0.80 0.20 0.41* 0.17 0.38* 0.03 0.18* 0.87 0.82 0.80 0.96 1.00 0.83 1.03 0.76
Vomiting 0.50 0.82 0.03 0.18* 0.03 0.18* 0.03 0.18* 0.50 0.73 0.53 0.86 0.57 0.77 0.50 0.63
*Note: All values are in mean standard deviation. ! Z p < 0.05 (only in within-group analysis), { Z p < 0.05 (only in between-groups analysis), and * Z p < 0.05 (within- and betweengroups analyses). VAS Z visual analog scale; MC Z menstrual cramps.
Efficacy of Acupuncture 157
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