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Effect of acupressure at the Sanyinjiao point on primary dysmenorrhea: A randomized controlled trial
Complementary Therapies in Clinical Practice 16 (2010) 198e202
Contents lists available at ScienceDirect
Complementary Therapies in Clinical Practice journal homepage: www.elsevier.com/locate/ctnm
Effect of acupressure at the Sanyinjiao point on primary dysmenorrhea: A randomized controlled trial Farzaneh Kashefi a, *, Samaneh Ziyadlou b, Marjan Khajehei c, Ali Reza Ashraf d, Ali Reza Fadaee e, Peyman Jafari f a
Faculty Member, Northern Khorasan University of Medical Sciences, Bojnoord, Iran Faculty Member, Department of Midwifery, Fatemeh(P.B.U.H) College of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran Curtin Business School, Curtin University of Technology, Perth, Western Australia, Australia d Faculty Member, Physical Medicine and Rehabilitation, Department of Rehabilitation, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran e Faculty Member, Fellow of Pain Management, Azad University of Mashhad, Mashhd, Iran f Faculty Member, Department of Statictics, Shiraz University of Medical Sciences, Shiraz, Iran b c
a b s t r a c t Keywords: Primary dysmenorrhea Acupressure San Yin Jiao Acupoint Menstrual pain
Objective: We conducted this study to assess the effect of acupressure at the Sanyinjiao point on primary dysmenorrhea. Methods: Eighty-six students participated in the study. All participants met the inclusion criteria. The study group received acupressure at Sanyinjiao point, while the control received sham acupressure. The severity of dysmenorrhea was assessed at the following time periods: prior to the intervention, 30 min, 1, 2 and 3 h following the intervention. Data were analyzed using SPSS. Results: The acupressure caused decline in the severity of dysmenorrhea immediately after intervention in both groups during their first menstrual cycle, although, there difference was not significant (p > 0.05). In addition, during the same cycle, the severity of the dysmenorrhea decreased more in study group rather than control group at 30 min, 1, 2 and 3 h after intervention (p < 0.05). During the second menstrual cycle, acupressure made dysmenorrhea reduced in both study and control groups; however, the decline was more salient among participants of the study group at all stages after the intervention (p < 0.05). Conclusions: Acupressure at Sanyinjiao point can be an effective, feasible, cost-effective intervention for improving primary dysmenorrhea. Ó 2010 Elsevier Ltd. All rights reserved.
1. Introduction Dysmenorrhea is a common problem in women of reproductive age.1 Fifty percent of women suffer dysmenorrhea, and 10% are in capacitated for 1 to 3 days each month.1,2 Various symptoms may accompany painful menstruation3 and can be disruptive to life at school, work, or home and might be responsible for economic burdens.4 For many years, several chemical remedies have been used to relief this disabling pain. Nonsteroidal anti-inflammatory medicines are the established therapy of choice in women with primary dysmenorrhea5; however, they are associated with many side effects, such as diarrhea, stomachache and nausea.6
* Corresponding author. Tel.: þ98 09355992409. E-mail addresses: kashefi[email protected] (F. Kashefi), [email protected] (S. Ziyadlou), [email protected] (M. Khajehei). 1744-3881/$ e see front matter Ó 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.ctcp.2010.04.003
On the other hand, alternative treatment options such as herbs, dietary supplements, and vitamins and minerals have been seek to treat women’s health issues. Although a recent review found promising evidence supporting the use of Chinese herbal medicine for primary dysmenorrhea, in order to skip the side events of chemical drug, results are limited by the poor study design.7 Furthermore, several techniques have been used to subside menstrual pain, including nerve ablation,8 spinal manipulation,9 static magnet application,10 transcutaneous electrical nerve stimulation ear point tapping and pressing therapy,11 acupuncture,12 and acupressure.13 According to previous studies acupuncture is effective for pain relief,14 and dysmenorrhea has been palliated due to acupuncture of specific sites such as the San Yin Jiao (SP6) point.15 The SP6 acupoint is the junction point of the liver, spleen, and kidney meridians, and based on principles of traditional Chinese medicine it is proposed to strengthen the spleen, resolve and expel dampness, and restore balance to the Yin and blood, liver, and kidneys.16 Notwithstanding
F. Kashefi et al. / Complementary Therapies in Clinical Practice 16 (2010) 198e202
these scientific relationships, the evidence for acupressure intervention in women with dysmenorrhea is unclear. Therefore, we set out the present study to investigate clinicaland cost- effectiveness of acupressure compared with sham pressure in women suffering dysmenorrhea.
2. Method A single-blind clinical trial was conducted in Medical University of Sciences in Iran. The protocol received institutional review board approval. Permission to conduct the study and access to the female students were obtained from the director of the Medical University. Eighty-six students, presenting previous history of repeated dysmenorrhea, participated in this study. Having suffered moderate to severe pain, participants were given a detailed description of the intervention protocol. Recruited participants in the two groups received a written description of the research purposes, and given written informed consent after the procedures had been fully explained. They were randomly assigned to the study group (n ¼ 43) and control group (n ¼ 43). The inclusion criteria were:(a) female college students between the ages of 18e28 years, (b) had regular menstrual cycles, (c) single were students Iranian (d), dysmenorrhea with pain scoring higher than four on the Pain Visual Analogue Scale (PVAS: range 0e10), (e) no prior history of gynecological disease or secondary dysmenorrhea, (f) no pain medication taken before the expected onset of each menstrual period and 3 h after intervention, (g) signature testimonial about intervention. These were eight demographic measures, four questions about dysmenorrhea, one scale about dysmenorrhea, and one question each about likelihood for self-managing future dysmenorrhea and expectations of acupressure. PVAS was used for assessing the intensity of the dysmenorrhea pain. It is a reliable and valid tool and is shown to be useful in the evaluation of menstrual pain.4 The PVAS consists of a 10 cm horizontal scale with verbal descriptors, such as “no pain” on one end and “worst possible pain” on the other. Moreover, a Short-Form of the McGill Pain Questionnaire (SFMPQ) was used in this study. The McGill Pain Questionnaire was developed in 1975 and has been widely used to assess postoperative, chronic, and dysmenorrhea pain.13 The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) that are rated on an intensity scale as 0 ¼ none, 1 ¼ mild,
199
2 ¼ moderate, and 3 ¼ severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective, and total descriptors. Ten experts examined the content validity of questionnaires. In order to determine the exact area of SP6 on the leg of participants in the study group, a portable battery-powered pointscope Unit was placed on the lower area of leg’s skin, 5 cm above medical Malleolus (SEVESA model, Germany). The red lamp was turning on, if the SP6 was right under the Unit. The specialized physician trained researcher to perform acupressure on the SP6 point. Then, the researcher conducted acupressure therapy during each person’s menstrual cycle. The study group received acupressure at Sanyinjiao point (above the ankles). Moreover, control group (n ¼ 43) received acupressure on the sham point.4 This point is located in the dorsal compartment of the leg and is not situated upon the Achilles tendon. According to the specialists in acupressure and acupuncture and with regard to the text books, this point is not placed on the especial meridian.17 During the first 24 h of their initial menstrual cycle, the participants were placed in the prone position on an intervention table, with a pillow under their head, shoulders and knees. Study group received acupressure alternately on each leg at the Sanyinjiao (SP6) acupoint (above the ankle). The force applied to the acupoint was initially 1.21 kg, increasing to 3.53 kg at the end of therapy for each pressure cycle on each side. SP6 was pressed with the researcher’s thumb for 6 seconds and released for 2 seconds without pressure, and this was continued for 30 min and repeated for two menstrual cycles. For Control group the researchers pressed with thumb on the sham point. After receiving the 30-min acupressure intervention, both groups completed the VAS immediately after, 30 min, 60 min, 120 min, and 180 min following the intervention.
The demographic and menstrual data summarized with descriptive statistics such as frequencies, percentage and testmeans were used to analyze the homogeneity between the two groups. Five participants (acupressure ¼ 3, control group ¼ 2) failed to complete the study for one of the following reasons: sought medical advice elsewhere, withdrawal, and vacation. Repeated Measure Analyses of Variance was used by two groups. The accepted level of significance for all analyses was p < 0.05.For computation Data statistical soft ware package for the social sciences (SPSS), version 13. 3. Results A total of eighty-six participants suffering primary dysmenorrhea enrolled in the study. Three participants dropped out during the first month and two during the second month of the intervention (respectively, 2 and 1 in the SP6 acupressure group; 1 and 1 in the control group). The analysis was thus based on 81 participants during the study (39 in the SP6 acupressure group and 41 in the control
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F. Kashefi et al. / Complementary Therapies in Clinical Practice 16 (2010) 198e202
Assessed for eligibility (n= 100)
Not meeting inclusion Criteria (n=14)
Enrollmen
Allocated to sp6 acupressure: (n=43)
Allocated to control group: (n=43)
Discontinued intervention because of treatment ineffectiveness: - in the first month (n= 2) - in second month (n=1)
Discontinued intervention because of adverse effects - in the first month (n= 1) - in second month (n=1)
Analysis
Follow-up
Allocation
Randomized (86)
Analyzed (n=40)
Analyzed (n=41)
Fig. 1. The flow diagram of participants through each stage of the randomized trial.
group) (Fig. 1). Sociodemographic and psychometric status were not statistically different between those who finished the study and those who did not. The mean age of those who completed the study was 20.84 1.64 years (range, 18e26 years). They weighed between 39 and 72 kg (mean SD, 55.59 5.7 kg) and their mean age at menarche was 13.3 1.44 years (range, 12e17 years). According to Table 1, prior to the study, participants in both study and control groups had similar severe dysmenorrhea and there were not any statistically significant differences between groups (p > 0.05). After conducting acupressure during the first menstrual cycle, the severity of dysmenorrhea in both study and control groups reduced immediately after intervention; although, there was not any statistically significant difference between groups (p > 0.05). Table 1 Menstrual information of the subjective
Time since menarche (years) Age of the first Dysmenorrhea Duration of menstruation
SP6 Acupressure M*SD**
Sham M SD
P-value
13 14 1/2 6/1 1
12/8 14 1/2 6/7 1
0/18 0/5 0/16
M* ¼ mean, SD** ¼ standard deviation.
However, the severity of dysmenorrhea decreased dramatically in study group and it was more obvious in the first hour after intervention and there were statistically significant differences within group after intervention (p < 0.001). On the other hand, the decline of the severity of dysmenorrhea in control group occurred just immediately after intervention; however, it was not statistically significant in comparison with prior to the study (p > 0.05). Moreover, there were statistically significant differences between groups after intervention and in all stages of evaluation (p < 0.05) (Table 2). During the second menstrual cycle, the severity of dysmenorrheal was similar in both groups (p > 0.05) (Table 3). Unlike first menstrual cycle, the differences between groups regarding the severity of dysmenorrhea immediately after intervention were statistically significant during the second menstrual cycle (p < 0.05). Moreover, the improvement of dysmenorrhea was more salient among participants of the study group in all stages of the intervention; both the within group and between groups differences were statistically significant (p < 0.05) (Table 3). 4. Discussion This study investigated the effectiveness of SP6 acupressure on reliving dysmenorrhea.
F. Kashefi et al. / Complementary Therapies in Clinical Practice 16 (2010) 198e202 Table 2 Comparison of the severity of dysmenorrheal in different stages of the intervention between study and control groups within their first menstrual cycle. Stages of the intervention
Study group M* SD**
Control group M SD
P value
Before Immediately after 30 min after 1 h after 2 h after 3 h after
6.86 1.35 5.34 1.21 4.90 1.30 4.38 1.21 4.55 1.60 5.34 1.47
6.67 1.35 5.81 1.02 6.06 1.35 6.23 1.52 6.34 1.57 6.81 1.56
NS NS <0.001 <0.001 <0.001 <0.001
M*¼mean, SD** ¼ standard deviation.
RCTs are considered the gold standard for assessing effects of intervention because they control most threats to internal validity.18 The reason, why the target population in this study was nursing and midwifery students, was that they were more accessible in this study. In addition, dysmenorrhea is more likely to occur during the second and third decades of life among females of reproductive age13; therefore, we chose this group of people because of the high probability of occurrence of dysmenorrheal among them. Previous research recommended acupuncture for in patient with pain due to dysmenorrhea but patients were reported many side effects after receiving acupuncture such as minor local bleeding or hematoma, needling pain, vegetative symptoms, and other.19 The Taiwanese study found that 20 min of acupressure at SP6 was effective for reducing menstrual pain and anxiety levels during menstruation. The experimental group received acupressure at Sanyinjiao (above the ankle), while the control group rested for 20 min for 4e6 weeks session. VAS for pain and for anxiety were used to collect pre-test and post-test data at each session. This study design had a limitation in that it had been obvious to participants that acupressure was being tested for its efficacy, while the control groups rest was merely an ordinary alternative. The acupressure group, having read about the purpose of the study and about acupressure, must have had heightened expectations relative to the control group. therefore, the placebo effect could not be excluded in this study design. However, because these studies stated blinding of outcome assessment, there did not seem to be relative potential bias with regard to investigators.13Our researcher are significant as they show that SP6 acupressure was effective in alleviating dysmenorrhea, this study is random assignment of participants. Sixty-one women were assigned to the standard treatment. Control group or acupressure device after one pre-treatment menses, with 58 women reporting the effect on the pain during two post-treatment menstrual cycles in the U.S. study. The acupressure device is a cotton Lycra panty brief with a fixed number of lower abdominal and lower back latex foam acupads that provide pressure to dysmenorrhoea-relieving acupressure points. The strength
Table 3 Comparison of the severity of dysmenorrheal in different stages of the intervention between study and control groups within their second menstrual cycle. Stages of the intervention
Study group M* SD**
Control group M SD
P value
Before Immediately after 30 min after 1 h after 2 h after 3 h after
7.14 1.47 5 1.21 4.86 1.30 4.72 1.36 4.60 2.02 5.67 1.64
6.86 1.20 6.16 1.47 6.04 1.21 6.44 1.46 6.58 1.60 7.04 1.58
NS <0.001 <0.001 <0.001 <0.001 <0.001
M* ¼ mean, SD** ¼ standard deviation.
201
of a placebo response in the experimental group in this study could not be determined either. Especially, a longer study with a crossover design or an alternative treatment control group such as briefs without acupads will be necessary to eliminate the possibility of the presence of a placebo effect. Use of sham control is an important consideration in acupressure research. Without a sham control group, it is still difficult to determine whether the achieved acupressure effect is a true effect or a placebo effect.18 Our finding suggested that the reduction of menstrual pain severity happened immediately after intervention during the second menstrual cycle but not in the first cycle. The results of our study were in agreement with previous research studies showing a reduction in the scores of PVAS after the initial application of 20 min acupressure on SP6.4 It supports the results of other studies on the effectiveness of the SP6 acupressure in alleviating pain within reproductive age, such as labor pain in women.20 In our study, acupressure was applied within the first 24 h of the participants’ menstrual cycle when dysmenrrhea pain was most intense and it caused salient diminution in the severity of dysmenorrhea in the study group. Our findings were similar to the study conducted by Chung et al.20 in which the researchers found statistically significant differences between the study and control groups regarding the reduction in pain using acupressure. It could represent a strong relationship between the acupressure points in the body and the relief of the discomfort. On the other hand, Melzack et al.21 declared that conducting acupressure on the feckless spots can have similar effects and result in the alleviation of pain; as we showed the reduction in the severity of dysmenorrheal in the control group after committing acupressure, however, there was statistically significant differences between the control and study groups (Tables 2 and 3). The results of the present study also corroborate the finding of previous literature in which there was significant reduction in the intensity of dysmenrrhea after a 20-min acupressure intervention.13 However, the results of that study were not to be generalized due to a lack of random assignment of participants. Our study failed to show the SP6 acupressure having an immediate effect in reliving menstrual pain during the first menstrual cycle (Table 2), because the scores on PVAS did not achieve significant differences between the study and control groups. It might be because of the gradual release of the endogenous opioid peptides, such as enkephalin, b-endorphin and endomorphin, in the central nervous system.22 It seems that these neuroactive agents need more times to work properly. The results of our study showed that the reduction of pain intensity was extended to 30-min after, and 1 h, 2 h r and 3 h after the SP6 acupressure intervention; The reduction of pain’s score may be due to the SP6 acupoint stimulation, which causes the activation of an endogenous opioid system and facilitates the release of specific neuropeptide, in the central nervous system; in effect, achieving pain relief.23 Our study not only examined the immediate effect of acupressure in relieving pain, but further investigated the effect of acupressure for a longer period (up 3 months) and its applicability as a self-care measure for adolescents in reliving dysmenorrhea. We found that the participants had difficulty identifying various acupoint for self-intervention. Our study therefore focused on a single acupoint, which was easily applied by the women, themselves, and which can achieve a fairly long-term effect of reducing menstrual pain. However, there was several potential limitation in this study: a)one limitation of this study was not using sonographic evaluation for ruling out the secondary dysmenorrhea and we used only selfreport questionnaires in order to exclude those suffering secondary dysmenorrhea, as it is known as a disease that needs medical
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investigation and proper treatment; b) physiologically, the pain tolerance among people is different. Thus, it is expected that the student’s reaction to pain reduction method was not the same. Controlling of the perception of participants in terms of pain tolerance was impossible for researcher; c) using questionnaire for data gathering, we excluded those who had recent stressful events in their lives; however, it was out of our control if any of the participants had intrapersonal stress during the study. Despite study limitation, the finding are significant as they show that SP6 acupressure was effective in alleviating dysmenorrhea, this study is random assignment of participants. This study was the first to investigate the effect of SP6 acupressure on dysmenorrhea in adult girls, testing of the physiological outcome, heart rates, respiration rates and blood pressure. The acupressure group returned very positive evaluations: 39 participants (100%) reported that acupressure was more than moderately helpful, and were more than moderately satisfied with acupressure during dysmenorrhoea. This study conveniently sampled only university nursing and midwifery students, the results of which may have limited generalizability to other population such as adolescents or young women with lower educational levels. Further studies with a larger sample, which is not limited to university nursing and midwifery students and a longer follow-up period, are recommended. 5. Conclusion This study presented preliminary findings that acupressure at the San Yin Jiao (SP6) acupoint may be an effective way to alleviate primary dysmenorrhea among young college women. The SP6 acupressure protocol used in this study consisted of a simple set of non-invasive actions applied for 30 min and can be integrated into clinical practice as an inexpensive and easy-to-learn midwifery intervention for women experiencing dysmenorrhea. Studies testing the feasibility of SP6 acupressure as a self-care measure as well as alternative acupressure methods may also be of significance, such as developing and testing pressure patches or pressure bands to be applied to the SP6 acupoint. Conflict of interest statement There is no conflict of interest. Acknowledgements The authors would like to thank the students studying Medical University of Science for their cooperation. We also wish to express
our sincere gratitude to Deputy for Research of Shiraz University of Medical Science for financial supports we received (grant 86-3652). References 1. Break JS. Berek & Novaks gynecology. 4th ed. Philadelphia, USA: Lippincott Williams,; 2007. p. 516. 2. Dawood MY. Dysmenorrhea and prostaglandins pharmacological and therapeutic considerations. Drugs 1988;22:43e56. 3. Speroff L, Glass Robert H, Kase Nathan G. Clinical gynecology endocrinology and infertility. 5th ed. USA: Willims & Wilkins;; 2005. 321. 4. Chen HM, Chen CH. Effets of acupressure at the Sanyinjiao point on primary dysmenorrhea. J Adv Nurs 2004;48:380e7. 5. Dawood MY. Nonsteroidal anti-inflammatory drugs and changing attitudes toward dysmenorrhea. Am J Med 1988;84:23e9. 6. Howard FM, Perry CP, Carter JE, Minawl AE, Li RZ. Dysmenorrhea, pelvic pain diagnosis and management. Philadelphia, USA: Lippincot Williams Wilkins; 2003. pp. 100e5. 7. Namavar Jahromi B, Tartifizadeh A, Khabnadideh S. Comparison of fennel and mefnamic acid for the treatment of primary dysmenorrhe. Int J Gynaecol Obstet 2003;80:153e7. 8. Lin JA, Wong CS, Lee MS, Ko SC, Chan SM, Chen JJ, et al. Successful treatment of Primary dysmenorrhea by collateral meridian acupressure therapy. J Manipulative Physiol Ther 2010;33:70e5. 9. Wang CL, Lai KY, Tesee HM. Effect of SP6 acupressure on pain and menstrual distress in young women with dysmenorrheal. Complement Ther Clin Pract 2010 May;16(2):64e9. 10. Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol 2008;198:166e98. 11. Tugay N, Akbayrak T, Demirturk F, Karakaya IC, Kocaacar O, Tugay U, et al. Effectiveness of transcutaneous electrical nerve stimulation and interferential current in primary dysmenorrheal. Pain Med 2007;8:295e300. 12. Krapp K, Jacquelin L. The Gale encyclopedia of alternative medicine, Gale Group 2001;vol. I. pp. 10e19. 13. Jun E, Chang S, Hee Kang D, Kim S. Effect of acupressure on dysmenorrhea and skin temperature changes in college students: a non- randomized controlled trial. Int J Nurs Stud 2007 Aug;44(6):973e81. 14. Tournaire M, Theau-Yonneau A. Complementary and alternative approaches to pain relief during labor. Evid Based Complement Alternat Med 2007 Dec;4 (4):409e17. 15. Kotani N, Sato Y, Yoshioka H, Yasuda T, Matsuki A. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology 2001;95 (2):349e56. 16. Kim MA, Bak SH, Kang HS. Literature review of acupuncture therapy on dysmenorrheal. J EasteWest Med 1993;23(2):25e40. 17. Navidi A, Khedmat H, Heli Saz M. Base of acupuncture. Tehran: Teymoorzadeh; 2000. p. 245. 18. Cho SH, Hwang EW. Acupressure for primary dysmenorrheal: Systematic review. J Complement Therap Med 2010;18:49e56. 19. Lian YL, Chen CY, Hammes M, Kolster BC In: Ogal HP, Stör W, editors. The seirin pictorial atlas of acupuncture. Cologne: Könemann; 2000. p. 86e7. 20. Chung UL, Hung LC, Kuo SC, Huang CL. Effect of L14 and BL67 acupressure on labor pain and uterine contraction in the first stage of labor. Nurs Res 2003;11:187e91. 21. Melzack R, Wall PD. Pain mechanisms:a new theory. Science 1965;699:971e9. 22. Han JS. Acupuncture and endorphins. Neurosci Lett 2004 May;361 (1e3):258e61. 23. Zhan C. Treatment of 32 cases of dysmenorrhea by puncturing hegu and sanyinjiao acupoints. J Tradit Chin Med 1990;10(1):33e5.
Contents lists available at ScienceDirect
Complementary Therapies in Clinical Practice journal homepage: www.elsevier.com/locate/ctnm
Effect of acupressure at the Sanyinjiao point on primary dysmenorrhea: A randomized controlled trial Farzaneh Kashefi a, *, Samaneh Ziyadlou b, Marjan Khajehei c, Ali Reza Ashraf d, Ali Reza Fadaee e, Peyman Jafari f a
Faculty Member, Northern Khorasan University of Medical Sciences, Bojnoord, Iran Faculty Member, Department of Midwifery, Fatemeh(P.B.U.H) College of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran Curtin Business School, Curtin University of Technology, Perth, Western Australia, Australia d Faculty Member, Physical Medicine and Rehabilitation, Department of Rehabilitation, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran e Faculty Member, Fellow of Pain Management, Azad University of Mashhad, Mashhd, Iran f Faculty Member, Department of Statictics, Shiraz University of Medical Sciences, Shiraz, Iran b c
a b s t r a c t Keywords: Primary dysmenorrhea Acupressure San Yin Jiao Acupoint Menstrual pain
Objective: We conducted this study to assess the effect of acupressure at the Sanyinjiao point on primary dysmenorrhea. Methods: Eighty-six students participated in the study. All participants met the inclusion criteria. The study group received acupressure at Sanyinjiao point, while the control received sham acupressure. The severity of dysmenorrhea was assessed at the following time periods: prior to the intervention, 30 min, 1, 2 and 3 h following the intervention. Data were analyzed using SPSS. Results: The acupressure caused decline in the severity of dysmenorrhea immediately after intervention in both groups during their first menstrual cycle, although, there difference was not significant (p > 0.05). In addition, during the same cycle, the severity of the dysmenorrhea decreased more in study group rather than control group at 30 min, 1, 2 and 3 h after intervention (p < 0.05). During the second menstrual cycle, acupressure made dysmenorrhea reduced in both study and control groups; however, the decline was more salient among participants of the study group at all stages after the intervention (p < 0.05). Conclusions: Acupressure at Sanyinjiao point can be an effective, feasible, cost-effective intervention for improving primary dysmenorrhea. Ó 2010 Elsevier Ltd. All rights reserved.
1. Introduction Dysmenorrhea is a common problem in women of reproductive age.1 Fifty percent of women suffer dysmenorrhea, and 10% are in capacitated for 1 to 3 days each month.1,2 Various symptoms may accompany painful menstruation3 and can be disruptive to life at school, work, or home and might be responsible for economic burdens.4 For many years, several chemical remedies have been used to relief this disabling pain. Nonsteroidal anti-inflammatory medicines are the established therapy of choice in women with primary dysmenorrhea5; however, they are associated with many side effects, such as diarrhea, stomachache and nausea.6
* Corresponding author. Tel.: þ98 09355992409. E-mail addresses: kashefi[email protected] (F. Kashefi), [email protected] (S. Ziyadlou), [email protected] (M. Khajehei). 1744-3881/$ e see front matter Ó 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.ctcp.2010.04.003
On the other hand, alternative treatment options such as herbs, dietary supplements, and vitamins and minerals have been seek to treat women’s health issues. Although a recent review found promising evidence supporting the use of Chinese herbal medicine for primary dysmenorrhea, in order to skip the side events of chemical drug, results are limited by the poor study design.7 Furthermore, several techniques have been used to subside menstrual pain, including nerve ablation,8 spinal manipulation,9 static magnet application,10 transcutaneous electrical nerve stimulation ear point tapping and pressing therapy,11 acupuncture,12 and acupressure.13 According to previous studies acupuncture is effective for pain relief,14 and dysmenorrhea has been palliated due to acupuncture of specific sites such as the San Yin Jiao (SP6) point.15 The SP6 acupoint is the junction point of the liver, spleen, and kidney meridians, and based on principles of traditional Chinese medicine it is proposed to strengthen the spleen, resolve and expel dampness, and restore balance to the Yin and blood, liver, and kidneys.16 Notwithstanding
F. Kashefi et al. / Complementary Therapies in Clinical Practice 16 (2010) 198e202
these scientific relationships, the evidence for acupressure intervention in women with dysmenorrhea is unclear. Therefore, we set out the present study to investigate clinicaland cost- effectiveness of acupressure compared with sham pressure in women suffering dysmenorrhea.
2. Method A single-blind clinical trial was conducted in Medical University of Sciences in Iran. The protocol received institutional review board approval. Permission to conduct the study and access to the female students were obtained from the director of the Medical University. Eighty-six students, presenting previous history of repeated dysmenorrhea, participated in this study. Having suffered moderate to severe pain, participants were given a detailed description of the intervention protocol. Recruited participants in the two groups received a written description of the research purposes, and given written informed consent after the procedures had been fully explained. They were randomly assigned to the study group (n ¼ 43) and control group (n ¼ 43). The inclusion criteria were:(a) female college students between the ages of 18e28 years, (b) had regular menstrual cycles, (c) single were students Iranian (d), dysmenorrhea with pain scoring higher than four on the Pain Visual Analogue Scale (PVAS: range 0e10), (e) no prior history of gynecological disease or secondary dysmenorrhea, (f) no pain medication taken before the expected onset of each menstrual period and 3 h after intervention, (g) signature testimonial about intervention. These were eight demographic measures, four questions about dysmenorrhea, one scale about dysmenorrhea, and one question each about likelihood for self-managing future dysmenorrhea and expectations of acupressure. PVAS was used for assessing the intensity of the dysmenorrhea pain. It is a reliable and valid tool and is shown to be useful in the evaluation of menstrual pain.4 The PVAS consists of a 10 cm horizontal scale with verbal descriptors, such as “no pain” on one end and “worst possible pain” on the other. Moreover, a Short-Form of the McGill Pain Questionnaire (SFMPQ) was used in this study. The McGill Pain Questionnaire was developed in 1975 and has been widely used to assess postoperative, chronic, and dysmenorrhea pain.13 The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) that are rated on an intensity scale as 0 ¼ none, 1 ¼ mild,
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2 ¼ moderate, and 3 ¼ severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective, and total descriptors. Ten experts examined the content validity of questionnaires. In order to determine the exact area of SP6 on the leg of participants in the study group, a portable battery-powered pointscope Unit was placed on the lower area of leg’s skin, 5 cm above medical Malleolus (SEVESA model, Germany). The red lamp was turning on, if the SP6 was right under the Unit. The specialized physician trained researcher to perform acupressure on the SP6 point. Then, the researcher conducted acupressure therapy during each person’s menstrual cycle. The study group received acupressure at Sanyinjiao point (above the ankles). Moreover, control group (n ¼ 43) received acupressure on the sham point.4 This point is located in the dorsal compartment of the leg and is not situated upon the Achilles tendon. According to the specialists in acupressure and acupuncture and with regard to the text books, this point is not placed on the especial meridian.17 During the first 24 h of their initial menstrual cycle, the participants were placed in the prone position on an intervention table, with a pillow under their head, shoulders and knees. Study group received acupressure alternately on each leg at the Sanyinjiao (SP6) acupoint (above the ankle). The force applied to the acupoint was initially 1.21 kg, increasing to 3.53 kg at the end of therapy for each pressure cycle on each side. SP6 was pressed with the researcher’s thumb for 6 seconds and released for 2 seconds without pressure, and this was continued for 30 min and repeated for two menstrual cycles. For Control group the researchers pressed with thumb on the sham point. After receiving the 30-min acupressure intervention, both groups completed the VAS immediately after, 30 min, 60 min, 120 min, and 180 min following the intervention.
The demographic and menstrual data summarized with descriptive statistics such as frequencies, percentage and testmeans were used to analyze the homogeneity between the two groups. Five participants (acupressure ¼ 3, control group ¼ 2) failed to complete the study for one of the following reasons: sought medical advice elsewhere, withdrawal, and vacation. Repeated Measure Analyses of Variance was used by two groups. The accepted level of significance for all analyses was p < 0.05.For computation Data statistical soft ware package for the social sciences (SPSS), version 13. 3. Results A total of eighty-six participants suffering primary dysmenorrhea enrolled in the study. Three participants dropped out during the first month and two during the second month of the intervention (respectively, 2 and 1 in the SP6 acupressure group; 1 and 1 in the control group). The analysis was thus based on 81 participants during the study (39 in the SP6 acupressure group and 41 in the control
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Assessed for eligibility (n= 100)
Not meeting inclusion Criteria (n=14)
Enrollmen
Allocated to sp6 acupressure: (n=43)
Allocated to control group: (n=43)
Discontinued intervention because of treatment ineffectiveness: - in the first month (n= 2) - in second month (n=1)
Discontinued intervention because of adverse effects - in the first month (n= 1) - in second month (n=1)
Analysis
Follow-up
Allocation
Randomized (86)
Analyzed (n=40)
Analyzed (n=41)
Fig. 1. The flow diagram of participants through each stage of the randomized trial.
group) (Fig. 1). Sociodemographic and psychometric status were not statistically different between those who finished the study and those who did not. The mean age of those who completed the study was 20.84 1.64 years (range, 18e26 years). They weighed between 39 and 72 kg (mean SD, 55.59 5.7 kg) and their mean age at menarche was 13.3 1.44 years (range, 12e17 years). According to Table 1, prior to the study, participants in both study and control groups had similar severe dysmenorrhea and there were not any statistically significant differences between groups (p > 0.05). After conducting acupressure during the first menstrual cycle, the severity of dysmenorrhea in both study and control groups reduced immediately after intervention; although, there was not any statistically significant difference between groups (p > 0.05). Table 1 Menstrual information of the subjective
Time since menarche (years) Age of the first Dysmenorrhea Duration of menstruation
SP6 Acupressure M*SD**
Sham M SD
P-value
13 14 1/2 6/1 1
12/8 14 1/2 6/7 1
0/18 0/5 0/16
M* ¼ mean, SD** ¼ standard deviation.
However, the severity of dysmenorrhea decreased dramatically in study group and it was more obvious in the first hour after intervention and there were statistically significant differences within group after intervention (p < 0.001). On the other hand, the decline of the severity of dysmenorrhea in control group occurred just immediately after intervention; however, it was not statistically significant in comparison with prior to the study (p > 0.05). Moreover, there were statistically significant differences between groups after intervention and in all stages of evaluation (p < 0.05) (Table 2). During the second menstrual cycle, the severity of dysmenorrheal was similar in both groups (p > 0.05) (Table 3). Unlike first menstrual cycle, the differences between groups regarding the severity of dysmenorrhea immediately after intervention were statistically significant during the second menstrual cycle (p < 0.05). Moreover, the improvement of dysmenorrhea was more salient among participants of the study group in all stages of the intervention; both the within group and between groups differences were statistically significant (p < 0.05) (Table 3). 4. Discussion This study investigated the effectiveness of SP6 acupressure on reliving dysmenorrhea.
F. Kashefi et al. / Complementary Therapies in Clinical Practice 16 (2010) 198e202 Table 2 Comparison of the severity of dysmenorrheal in different stages of the intervention between study and control groups within their first menstrual cycle. Stages of the intervention
Study group M* SD**
Control group M SD
P value
Before Immediately after 30 min after 1 h after 2 h after 3 h after
6.86 1.35 5.34 1.21 4.90 1.30 4.38 1.21 4.55 1.60 5.34 1.47
6.67 1.35 5.81 1.02 6.06 1.35 6.23 1.52 6.34 1.57 6.81 1.56
NS NS <0.001 <0.001 <0.001 <0.001
M*¼mean, SD** ¼ standard deviation.
RCTs are considered the gold standard for assessing effects of intervention because they control most threats to internal validity.18 The reason, why the target population in this study was nursing and midwifery students, was that they were more accessible in this study. In addition, dysmenorrhea is more likely to occur during the second and third decades of life among females of reproductive age13; therefore, we chose this group of people because of the high probability of occurrence of dysmenorrheal among them. Previous research recommended acupuncture for in patient with pain due to dysmenorrhea but patients were reported many side effects after receiving acupuncture such as minor local bleeding or hematoma, needling pain, vegetative symptoms, and other.19 The Taiwanese study found that 20 min of acupressure at SP6 was effective for reducing menstrual pain and anxiety levels during menstruation. The experimental group received acupressure at Sanyinjiao (above the ankle), while the control group rested for 20 min for 4e6 weeks session. VAS for pain and for anxiety were used to collect pre-test and post-test data at each session. This study design had a limitation in that it had been obvious to participants that acupressure was being tested for its efficacy, while the control groups rest was merely an ordinary alternative. The acupressure group, having read about the purpose of the study and about acupressure, must have had heightened expectations relative to the control group. therefore, the placebo effect could not be excluded in this study design. However, because these studies stated blinding of outcome assessment, there did not seem to be relative potential bias with regard to investigators.13Our researcher are significant as they show that SP6 acupressure was effective in alleviating dysmenorrhea, this study is random assignment of participants. Sixty-one women were assigned to the standard treatment. Control group or acupressure device after one pre-treatment menses, with 58 women reporting the effect on the pain during two post-treatment menstrual cycles in the U.S. study. The acupressure device is a cotton Lycra panty brief with a fixed number of lower abdominal and lower back latex foam acupads that provide pressure to dysmenorrhoea-relieving acupressure points. The strength
Table 3 Comparison of the severity of dysmenorrheal in different stages of the intervention between study and control groups within their second menstrual cycle. Stages of the intervention
Study group M* SD**
Control group M SD
P value
Before Immediately after 30 min after 1 h after 2 h after 3 h after
7.14 1.47 5 1.21 4.86 1.30 4.72 1.36 4.60 2.02 5.67 1.64
6.86 1.20 6.16 1.47 6.04 1.21 6.44 1.46 6.58 1.60 7.04 1.58
NS <0.001 <0.001 <0.001 <0.001 <0.001
M* ¼ mean, SD** ¼ standard deviation.
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of a placebo response in the experimental group in this study could not be determined either. Especially, a longer study with a crossover design or an alternative treatment control group such as briefs without acupads will be necessary to eliminate the possibility of the presence of a placebo effect. Use of sham control is an important consideration in acupressure research. Without a sham control group, it is still difficult to determine whether the achieved acupressure effect is a true effect or a placebo effect.18 Our finding suggested that the reduction of menstrual pain severity happened immediately after intervention during the second menstrual cycle but not in the first cycle. The results of our study were in agreement with previous research studies showing a reduction in the scores of PVAS after the initial application of 20 min acupressure on SP6.4 It supports the results of other studies on the effectiveness of the SP6 acupressure in alleviating pain within reproductive age, such as labor pain in women.20 In our study, acupressure was applied within the first 24 h of the participants’ menstrual cycle when dysmenrrhea pain was most intense and it caused salient diminution in the severity of dysmenorrhea in the study group. Our findings were similar to the study conducted by Chung et al.20 in which the researchers found statistically significant differences between the study and control groups regarding the reduction in pain using acupressure. It could represent a strong relationship between the acupressure points in the body and the relief of the discomfort. On the other hand, Melzack et al.21 declared that conducting acupressure on the feckless spots can have similar effects and result in the alleviation of pain; as we showed the reduction in the severity of dysmenorrheal in the control group after committing acupressure, however, there was statistically significant differences between the control and study groups (Tables 2 and 3). The results of the present study also corroborate the finding of previous literature in which there was significant reduction in the intensity of dysmenrrhea after a 20-min acupressure intervention.13 However, the results of that study were not to be generalized due to a lack of random assignment of participants. Our study failed to show the SP6 acupressure having an immediate effect in reliving menstrual pain during the first menstrual cycle (Table 2), because the scores on PVAS did not achieve significant differences between the study and control groups. It might be because of the gradual release of the endogenous opioid peptides, such as enkephalin, b-endorphin and endomorphin, in the central nervous system.22 It seems that these neuroactive agents need more times to work properly. The results of our study showed that the reduction of pain intensity was extended to 30-min after, and 1 h, 2 h r and 3 h after the SP6 acupressure intervention; The reduction of pain’s score may be due to the SP6 acupoint stimulation, which causes the activation of an endogenous opioid system and facilitates the release of specific neuropeptide, in the central nervous system; in effect, achieving pain relief.23 Our study not only examined the immediate effect of acupressure in relieving pain, but further investigated the effect of acupressure for a longer period (up 3 months) and its applicability as a self-care measure for adolescents in reliving dysmenorrhea. We found that the participants had difficulty identifying various acupoint for self-intervention. Our study therefore focused on a single acupoint, which was easily applied by the women, themselves, and which can achieve a fairly long-term effect of reducing menstrual pain. However, there was several potential limitation in this study: a)one limitation of this study was not using sonographic evaluation for ruling out the secondary dysmenorrhea and we used only selfreport questionnaires in order to exclude those suffering secondary dysmenorrhea, as it is known as a disease that needs medical
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investigation and proper treatment; b) physiologically, the pain tolerance among people is different. Thus, it is expected that the student’s reaction to pain reduction method was not the same. Controlling of the perception of participants in terms of pain tolerance was impossible for researcher; c) using questionnaire for data gathering, we excluded those who had recent stressful events in their lives; however, it was out of our control if any of the participants had intrapersonal stress during the study. Despite study limitation, the finding are significant as they show that SP6 acupressure was effective in alleviating dysmenorrhea, this study is random assignment of participants. This study was the first to investigate the effect of SP6 acupressure on dysmenorrhea in adult girls, testing of the physiological outcome, heart rates, respiration rates and blood pressure. The acupressure group returned very positive evaluations: 39 participants (100%) reported that acupressure was more than moderately helpful, and were more than moderately satisfied with acupressure during dysmenorrhoea. This study conveniently sampled only university nursing and midwifery students, the results of which may have limited generalizability to other population such as adolescents or young women with lower educational levels. Further studies with a larger sample, which is not limited to university nursing and midwifery students and a longer follow-up period, are recommended. 5. Conclusion This study presented preliminary findings that acupressure at the San Yin Jiao (SP6) acupoint may be an effective way to alleviate primary dysmenorrhea among young college women. The SP6 acupressure protocol used in this study consisted of a simple set of non-invasive actions applied for 30 min and can be integrated into clinical practice as an inexpensive and easy-to-learn midwifery intervention for women experiencing dysmenorrhea. Studies testing the feasibility of SP6 acupressure as a self-care measure as well as alternative acupressure methods may also be of significance, such as developing and testing pressure patches or pressure bands to be applied to the SP6 acupoint. Conflict of interest statement There is no conflict of interest. Acknowledgements The authors would like to thank the students studying Medical University of Science for their cooperation. We also wish to express
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