Acupunture For The Treatment Of Vulvodynia

Vulvodynia is described by the International Society for the Study of Vulvovaginal Disease (ISSVD) as "vulvar discomfort, most often described as burning pain, occurring in the absence of relevant visible findings or a specific, clinically identifiable, neurologic disorder". Pain of the vulva is described as burning and sharp stabbing. Often there is an accompanying dyspareunia rendering sexual intercourse virtually impossible. Vulvodynia has further been subdivided based upon location of the pain," generalized or localized" and whether the pain is "provoked or unprovoked or both". The incidence of this potentially life altering condition has been reported to be as high as16%of the adult female population.The aim of my research study was to evaluate the effectiveness of acupuncture for the treatment of vulvar pain and dyspareunia in women with vulvodynia. This is a debilitating pain syndrome that often prevents women from carrying out activities of daily living. Additionally, vulvodynia often negatively impacts upon how women perceive themselves to be sexual people. They may feel inadequate as women. Because of pain with sexual intercourse, they may not be able to perform sexually. Up to50%of women with vulvodynia may avoid intercourse. Furthermore, women with vulvodynia had lower levels of sexual desire, arousal, lubrication, and orgasm. They also had lower levels of sexual satisfaction and greater pain with vaginal penetration as compared to controls. Additionally, women suffering from vulvodynia have an increase incidence of anxiety as well as hypervigilance.57%of women with vulvodynia reported at least a mild level of depression.17%of women developed a major depressive disorder (MDD).This was a randomized controlled trial. Participation by the research subjects was completely voluntary. The study was approved by an Institutional Review Board (IRB). All subjects were given informed written consent prior to participating in the study. Subjects participating in the study did not receive any monetary compensation. However, they were given a$20.00gift card for each of2sets of questionnaires they completed.Results from a test of power dictated that the study have36total participants. Eighteen subjects were required to be in the active acupuncture group and18subjects were required to be in the wait-list control group(p<0.05).There are2prominent TCM patterns underlying the diagnosis of vulvodynia:1) liver qi stagnation and spleen/kidneydeficiency with damp cold obstruction in the lower jiao; and,2) liver qi stagnation and blood stasis with heat in the liver channel. Regardless of pattern, subjects were randomized into either the active acupuncture group or the wait-list control group.Each subject received one acupuncture treatment two times per week for five weeks, for a total of10weeks. Each treatment was30minutes in duration.The pattern presentation descriptions as found in the textbook Chinese Acupuncture and Moxibustion were used to differentiate symptomatology, tongue and pulse. Diagnosis in TCM can be subjective; two experienced TCM practitioners may see the same patients and diagnose them differently. This can be a complicating factor in doing standardized research. For this reason, several attempts have been made to standardize diagnosis by creating and validating some standardized criteria (tongue, pulse, primary complaint, secondary complaints, etc.). To date, no measure has been validated, so for this study the author relied upon her years of experience and professional judgment along with the criteria described in Chinese Acupuncture and Moxibustion.Research on the treatment of vulvodynia suggests that there is no consistently effective standardized western medical treatment protocol for vulvodynia. Furthermore, there is no western medical treatment that consistently is effective with more than50%of vulvodynia patients. Often different treatments are chosen based upon varying physician preferences. From my literature review, there are no randomized controlled studies that evaluated the use of acupuncture for treating vulvar pain and dyspareunia associated with vulvodynia. I believe acupuncture has the potential to positively impact upon the treatment of this debilitating pain syndrome.The review of the acupuncture literature suggested that there are very few studies that examine the effectiveness of acupuncture in the treatment of vulvodynia. Methodological problems were found in those studies that have been conducted. Depending upon which study was reviewed, these problems included:lack of randomization, absence of a control or comparison group, small sample size, non-standardized acupuncture treatment protocols (e.g., points individualized based upon the acupuncturist’s assessment), and subjects’ low rates of completing the research measures. Because of these methodological issues, the effects of acupuncture on symptoms of vulvodynia remain unsubstantiated. The present study attempted to improve upon the previous research examining the effectiveness of acupuncture treatment in reducing symptoms of vulvodynia by:1) randomly assigning subjects to experimental conditions;2) increasing the sample size;3) creating a standardized acupuncture treatment protocol which will be developed by the Chairman of Acupuncture at Guangzhou University of Chinese Medicine, Dr. Xu Nengui and this researcher;4) using standardized research measures with demonstrated reliability and validity;5) using incentives to increase the likelihood of subjects completing the research measures; and,6) minimizing bias by having the research interviewer remain blind as to the subjects’ experimental condition.The objective of this study was to develop an effective standardized acupuncture treatment for vulvar pain and other symptoms associated with vulvodynia; including generalized vulvodynia, provoked vestibulodynia, and mixed vulvodynia (both generalized and provoked vulvodynia). Subject Recruitment, Selection, and Assignment:A total of36female subjects with generalized vulvodynia, provoked vestibulodynia, or mixed vulvodynia (generalized plus provoked vulvodynia)were recruited for participation in the study through several avenues. About one-third of the subjects answered an announcement to participate in this research study placed on the National Vulvodynia Association website, http://www.nva.org. A weekly classified advertisement was placed in the " volunteers wanted " section in the " Chicago Reader ", a free weekly newspaper that is distributed throughout the Chicagoland area; about one-sixth of the study subjects responded to this advertisement. The rest of the referrals were from physician and certified nurse midwife referrals generated from a packet that included a recruitment letter (Appendix D), a recruitment flyer (Appendix E), and a business card to every board certified obstetrician-gynecologist, every urogynecologist, and every certified nurse midwife (CNM) in Chicago and the Chicagoland area.Women contacted the study’s principle investigator and acupuncturist by email or telephone if they were interested in participating in the study. Using the criteria listed below, she determined if a woman was eligible to participate in the study. The study’s inclusion and exclusion criteria are listed below.Research MethodsInclusion CriteriaSubjects were:1) between18years old and menopause; and2) diagnosed with generalized vulvodynia and/or provoked vestibulodynia. Subjects could continue to take their medications for the treatment of these and/or any other medical conditions.To date, the literature does not suggest western medications taken for other medical indications have as a possible side effect an increased risk of vulvodynia, except for oral contraceptives. It is postulated the younger a woman begins oral contraceptives, the longer she stays on them and the higher the progestogenic/androgenic effect of the particular formulation of oral contraceptive she is on, the more at risk a women is for developing vulvodynia. This study acknowledged this as a possibility. The data intake sheets specifically asked all study participants whether they have or were currently taking oral contraceptives or any other western medications. The incidence of oral contraceptive use as well as any trends in taking certain medications was examined during the data analysis. Exclus ion Criter iaSubjects could not:1) be pregnant;2) be in menopause;3) be diagnosed with interstitial cystitis;4) be diagnosed with irritable bowel syndrome;5) have any untreated vaginitis, cervicitis, or pelvic inflammatory disease; or,6) have any other pelvic pathology which may cause pain. While enrolled in the study, subjects could not receive physical therapy, biofeedback, massage, or additional acupuncture treatments.Those patients who were eligible to participate in the study were scheduled for an appointment to review and sign the informed consent form. The study monitor explained to potential subjects the nature of the study, the possible benefits and risks of participating in the study, the voluntary nature of participation, and the ability to discontinue their participation without consequences at any time. Those subjects who were interested in participating in the study signed the Informed Consent Form. After informed consent was obtained, subjects were randomly assigned either to the acupuncture treatment group or to the wait-list control group. Treatment groups were assigned via a computer generated random numbers table. Each number, one through36and its computer assigned group, was written on an index card which was placed in a sealed envelope. All36sealed envelopes were placed into a box. The subject then picked a sealed envelope with the enclosed index card with the subject number and corresponding treatment group on it.Subjects assigned to the acupuncture treatment group received a schedule of their acupuncture treatment visits (2treatments per week for5weeks). Immediately after the completion of the tenth acupuncture treatment, subjects in the acupuncture treatment group completed the second set of the same4questionnaires that they had filled out just prior to their first acupuncture treatment.Subjects in the wait-list control group were informed that10free acupuncture treatments were available to them at the conclusion of the five week wait-list control period. They then met with the study monitor to complete baseline research measures. After the5week, no treatment, waiting period was finished, the wait-list control subjects completed the second set of the same4questionnaires that they had filled out at the beginning of the5week wait-list control period. These subjects had then completed the study and were eligible for10free acupuncture treatments. All18wait-list control subjects elected to begin and complete10free acupuncture sessions.Acupuncture Treatment ProtocolThe18subjects assigned to the acupuncture treatment group received active acupuncture two times per week for five weeks for a total of10sessions. All acupuncture treatments were administered at no cost to the study participants.The following acupuncture points were used:GV20, LI4bilaterally, CV4, CV2, KD11bilaterally, ST30bilaterally, SP6bilaterally, and LV3bilaterally. Needles were inserted using the standards of clean needle technique established by the Council of Colleges of Acupuncture and Oriental Medicine. All subjects urinated prior to the insertion of the needles to prevent bladder injury.Selection of Acupuncture Treatment Points:Some of the acupuncture points were selected because of their ability to strengthen qi. Other points were selected to move qi and blood. Several points relax the pelvic muscles and genitals. Some points warm the lower pelvis and genitals. Other points drain heat. Other points drain damp. The overarching treatment principle is to reduce the energetic imbalance which should relieve vulvar pain.1size of acupuncture needle,0.25diameters x40mm length, will be used. All acupuncture needles will be made of surgical stainless steel with stainless steel wound heads. They will be sterile and disposable.Research ProtocolAfter informed consent was obtained, the subject number and treatment group was determined. This number was used on all research instruments completed by the subject. Only the study monitor had access to the list showing subjects’names correlating with their numbers. The study monitor then administered four questionnaires to obtain baseline measures of sexual response/function and vulvar pain to both treatment groups:The Vulvar Pain Functional Questionnaire (VQ), The Female Sexual Distress Scale-Revised (FSDS). The Short Form McGill Pain Questionnaire (SF-MPQ), and The Female Sexual Function Index (FSFI). The Vulvar Pain Functional Questionnaire (VQ) is an11item self-report measure of the physical dimensions of vulvar pain. The Female Sexual Distress Scale-Revised (FSDS) measures how often sexual problems have bothered the subject or caused personal distress. The Short Form McGill Pain Questionnaire (SF-MPQ) is a five part measure which captures sensory and affective descriptors of pain and the intensity of pain. It includes a Present Pain Intensity Scale (PPI) and a Visual Assessment Scale (VAS) scale. The Female Sexual Function Index (FSFI) is a19-item, multi-dimensional self-report measure which examines six areas of sexual response:desire, arousal, lubrication, orgasm, satisfaction, and pain.The research interviewer re-administered The Vulvar Pain Functional Questionnaire (VQ), The Female Sexual Distress Scale-Revised (FSDS), The Short Form McGill Pain Questionnaire (SF-MPQ), and, The Female Sexual Function Index (FSFI) to subjects in the acupuncture treatment group at the completion of their tenth acupuncture treatment and to the subjects in the wait-list control group at the end of the5week waiting period. Subjects received a$20gift card upon completion of the4questionnaires at baseline, and again upon completion of the second set of four questionnaires5weeks later.Theoretical AnalysisThe severity of pain was measured using The Short Form McGill Pain Questionnaire (SF-MPQ) and the Pain subscale of The Female Sexual Function Index (FSFI). Dimensions of vulvar pain were quantified through The Vulvar Pain Functional Questionnaire (VQ). Ability to function sexually was measured via the Female Sexual Function Index (FSFI). Level of personal distress over sexual problems was measured with The Sexual Distress Scale-Revised.Data AnalysisThe independent variables were:1) active acupuncture treatments; and,2) wait-list control no treatments. The dependent variables were:1) female genital pain and2) dyspareunia (vulvar pain with intercourse).Null hypothesis:There is no difference in outcomes in female genital pain and dyspareunia between the active acupuncture treatment group and the wait-list control no treatment group. Alternative hypothesis:The active acupuncture treatment group will have less genital pain and less dyspareunia than the wait-list control no treatment group.Statistical AnalysisStatistical analysis was done using an unpaired t-test. In the unpaired t-test, the means of two independent groups are compared to one another. There are three assumptions that must be fulfilled in order to use the unpaired t-test:1) there must be a normal distribution in the population being studied;2) the samples must be completely independent; and,3) the variances (the distribution of subjects) in the populations must be the same.DiscussionDemographicsIt was previously determined using an unpaired t-test that there were no differences between the acupuncture group and the wait-list control group regarding the3subtypes of vulvodynia groups:provoked, generalized, and mixed. It was also determined that there were no differences between the acupuncture group and the wait-list control group in the2TCM pattern groups:hot(liver qi stagnation and blood stasis with heat in the liver channel) and cold(liver qi stagnation and spleen/kidney deficiency with damp cold obstruction in the lower Jiao).However, analysis of the demographics revealed30(83.3%) of the study subjects had the TCM pattern liver qi stagnation and blood stasis with heat in the liver channel.6(16.3%) of the subjects had liver qi stagnation and spleen/kidney deficiency with damp cold obstruction in the lower jiao.At the time of the study,9subjects (25%) were taking several different antidepressants for pain. They were taking tricyclics, ProzacTM, or Buproprion.7subjects (19.4%) had a history of Gabapentin use for vulvar pain but discontinued it because of side effects;1(2.8%) subject at the time of the study was taking Gabapentin, but felt sedated from it.3previously had used LyricaTM (pregabalin) for the pain of vulvodynia but discontinued it.2subjects (5.6%) took codeine to manage their pain.2subjects (5.6%) used lidocaine gel. Other medications used to manage the pain of vulvodynia included topical steroids and topical ketamine. 3(8.3%) subjects, even though they were not in menopause, were given estrogen intravaginal therapy by their physicians (2estrogen cream, and1an e-string placed intravaginally for time released estrogen). It is well established within the field of gynecology that unopposed (not combined with progesterone) exogenous estrogen preparations given to a subject in menopause increases her risk of developing breast and uterine cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction, and cerebral vascular accident. It is a dangerous practice to prescribe additional estrogen therapy to a non-menopausal, menstruating subject.0subjects received BotoxTM (Botulinum toxin) injections to the genitals. Likewise,0subjects previously underwent vestibulectomy. Both treatments are highly invasive; vestibulectomy, skinning of the vestibule is a radical step. However, there are no studies in the literature that examine the feelings of subjects with provoked (localized vulvodynia) about having vulvectomy.6(16.7%) subjects had a concomitant diagnosis of fibromyalgia or another chronic pain syndrome. Specifically,5(13.9%) subjects had fibromyalgia and1(2.8%) subject had psoriatic arthritis. The incidence of fibromyalgia in subjects in this current study is consistent with a2006NIH investigation by Arnold et al. which examined the incidence of co-morbid conditions associated with vulvodynia. They found a significant correlation between vulvodynia and fibromyalgia of15.6%which is similar to this researcher’s findings.As the Literature Review revealed, there is no increased incidence of vulvodynia in subjects who have a history of sexually transmitted diseases including chlamydia, gonorrhea, genital herpes, and human papilloma (HPV) virus. Therefore, the fact that there were four condom users in the acupuncture group and0condom users in the wait-list control group is an incidental finding.The7subjects who were no longer taking Gabapentin still had pain from vulvodynia. Either the Gabapentin did not lessen the pain, or the side effects such as fatigue rendered it impossible for the subjects to continue the medication. The study intake form did not ask subjects why medications were discontinued. Discussion of the DataThe Data strongly shows that the hallmark signs of vulvodynia, genital pain and dyspareunia (painful intercourse), are reduced by the acupuncture protocol developed for this study. Every scale that measured sensory pain, revealed a statistically significant difference in reduction of sensory pain in the acupuncture treatment group as compared to the wait-list control group.However, the acupuncture subjects did not have as great of reduction in their negative feelings about their pain (affective) as they did an overwhelming reduction in pain (sensory). Emotions subjects have surrounding their chronic pain is a complex issue. Several factors may account for not as great a reduction in affective pain as sensory pain in the study population.It may take longer after there is a reduction in pain to trust that the pain will stay reduced, that the severe vulvar pain will not return soon, or will not return with such vengeance. The subjects acknowledged they felt better, but perhaps they were afraid their pain relief would not last. Or perhaps they were afraid their pain relief wasn’t real, that they just had one or two good days and then the pain would return.Perhaps the subjects still remembered their pain, how they suffered, their physical limitations, how it affected their ability to have sex. The literature supports partners of women with vulvodynia leave them at greater rates because they may not be able to have sex. The emotional trauma may still be very strong and very real for them. For some of the subjects, the pain of vulvodynia dictated the parameters of their lives. They were imprisoned by their disease. Until some time has passed, the strong emotions surrounding their pain may not lessen even though the physical pain has.The literature shows subjects with vulvodynia have a higher incidence of anxiety, depression, and tend to catastrophize. Because of the influences of these emotional states, the mind may not be able to adjust to the reduced physical pain and still perceives the body is in great pain. Some studies point to a higher incidence of a history of childhood abuse in subjects with vulvodynia. Perhaps vulvodynia is the somatization of trapped emotional trauma and until past emotional issues are dealt with in psychotherapy, subjects’emotions regarding their pain may remain high. Perhaps as adults, subjects have had long-standing stressful periods in their lives, that in the United States, they have too many demands from home and work. Until their stress is reduced, the subjects will not feel differently towards their pain even though it has lessened.In terms of the Vulvar Pain Functional Questionnaire (VQ), which measures subjects’ability to function in their daily lives with chronic vulvar pain across time,1in4statistical analyses showed statistically significant differences. Therefore, the acupuncture group showed greater improvement in ability to function in daily life with chronic vulvar pain as compared to the wait-list control group. Consequently, the acupuncture protocol developed for this study for the treatment of vulvodynia did increase the subject’s ability to function in their daily lives across time.Then the Female Sexual Function Index desire, arousal, orgasm, and sexual satisfaction scales were examined. The acupuncture group had no increased sexual desire, no increased ability to be aroused, no increased ability to orgasm, and had no increased sexual satisfaction.0of4statistical analyses were statistically significant in all subscales.However, in the lubrication subscale, there was an increase in vaginal lubrication. The items on these scales measure the emotional feelings and problems people report about their sexuality. The determinants of how people feel about their sexuality are complex and not likely impacted by acupuncture. It is possible by virtue of reducing the heat and indirectly nourishing the yin, more vaginal lubrication was made by the subjects with the heat pattern.