Abstract
Abstract
Background:
Female sexual dysfunction (FSD) includes disturbances in the sexual response cycle resulting in marked distress and interpersonal difficulty capable of altering quality of life adversely. FSD is a common phenomenon affecting up to 26%–71% of the general female population worldwide. The umbrella term FSD subsumes four disorders: (1) hypoactive sexual desire disorder; (2) female sexual arousal disorder; (3) orgasmic disorder; and (4) sexual pain disorder.
Objective:
The aim of this pilot study was to assess immediate and longer-term effects of acupuncture quantitatively on symptoms related to female sexual dysfunction, using global- and specific-symptom instruments.
Design:
This was a time series study in a self-selected population of nonrandomized patients.
Setting
: The pilot study was conducted at a private women's health clinic in Reno, NV.
Patients:
Seventeen sequential subjects between ages 40 and 66 and clinically diagnosed with FSD were assessed at baseline and followed through time.
Intervention:
The intervention examined was a series of four acupuncture treatments. Patients were also administered five instruments to measure symptoms related to FSD before acupuncture treatment, just before the final treatment, and 3 weeks after the final treatment.
Main Outcome Measures:
Using internal controls, changes in symptoms over time were measured using multivariate analysis of variance for repeated measures.
Results:
Acupuncture promoted reductions in multidimensional symptoms related to FSD. Sexual desire improved as identified by two instruments, the Sexual Interest and Desire Inventory–Female (p=0.01 for short- and long-term) and the desire subscale of the Female Sexual Function Index (short-term p=0.002 and long-term p=0.04). Psychological symptoms were also reduced, as measured by two separate instruments, the Greene Climacteric Scale (short-term p=0.03, long-term p=0.008) and the Menopause Rating Scale (short-term p=0.04, long-term p=0.008). Acupuncture reduced anxiety in the short (p=0.03) and long term (p=0.01), reduced sexual dysfunction over the long-term (p=.03), improved urogenital symptoms over the short-term (p=.04) and somato-vegatative symptoms over the short (p=.01) and long-term (p=0.03).
Conclusions:
Acupuncture was effective for reducing some FSD problems, compared to baseline. Active research on nonpharmaceutical alternatives—including acupuncture—for treating symptoms related to FSD are ongoing, and preliminary results are promising.
Introduction
Female sexual arousal disorder (FSAD) is the “persistent or recurrent inability to attain or maintain sufficient sexual excitement, causing personal distress. It may be expressed as a lack of subjective excitement or a lack of genital lubrication/swelling or other somatic response.” 4 Pharmaceuticals that have been shown to be effective for treating sexual dysfunction in men have not demonstrated efficacy in women and have been accompanied by a range of unwanted side-effects. 5
Orgasmic disorder has been defined as “the persistent or recurrent difficulty, delay in, or absence of, attaining orgasm following sufficient sexual stimulation and arousal, which causes personal distress.” 1 The presence of a normal excitement phase is critical to this diagnosis. 3
Sexual pain disorder includes dyspareunia, vaginismus, and noncoital sexual pain, any of which can be a side-effect of medications or a comorbidity of other physical or psychological issues.3,6 Dyspareunia is much more prevalent in postmenopausal women (12%–45%) than in premenopausal women (5%), 3 most commonly because of vaginal atrophy. Dyspareunia can also result from tenderness at the vaginal cuff scar after hysterectomy.
To meet diagnostic criteria for any of these disorders, the symptoms must result in personal distress. Recent literature addressing female sexual dysfunction tends to focus on the definition, prevalence, etiology, and current standard of care.6–10
Pharmaceutical treatment typically consists of medications, such as hormones, antidepressants, 8 and, most recently, Type 5 phosphodiesterase inhibitors (e.g., sildenafil), all of which may pose risks 6 that are unacceptable to patients. Stinson 9 points out that female sexual disorder (FSD) treatment efficacy research is not in keeping with the needs of women with this problem and calls for studies that elucidate more treatment options, address the multidimensional nature of FSD, and follow a biopsychosocial approach that incorporates individual circumstances and definitions of success. Unlike male sexual issues, such as erectile dysfunction (ED), symptoms of FSD have either become an accepted consequence of the normal aging process or are considered temporary. Studies suggest, however, that many patients with FSD want, and, in fact, can find, relief with nonpharmacological therapies. 9
Many people turn to complementary and alternative medicine in an effort to avoid side-effects and risks of pharmaceuticals. Acupuncture involves stimulation of the body's energy flow channels with unassisted or assisted (e.g., by electric currents) needling of organ and function-specific acupuncture points, which redirect and restore the natural balance of blocked systems. This may involve activation of corresponding neuroendocrine-, vasoactive-, and immune-modulators, 11 all of which play a role in female sexual physiology. 3 Several studies have demonstrated the efficacy of acupuncture for treating various symptoms that are common to postmenopausal women. Reductions in somatic, psychological, and vasomotor symptoms were found in a Turkish population of postmenopausal women who were treated with acupuncture. 12 Vasomotor symptoms were reduced in two postmenopausal Korean women 13 and in postmenopausal women from a rural area of Eastern Oregon. 14 Depression was reduced in a Norwegian population treated with acupuncture. 15 While the literature addressing FSD has recently expanded, little attention has been focused on the potential efficacy of acupuncture as a treatment modality for FSD.
Several controlled and uncontrolled trials examining the efficacy of acupuncture for treating male, rather than female, sexual dysfunction 16 have shown promising results. A prospective, crossover, randomized, controlled pilot study 11 examined acupuncture specific to ED as an intervention versus acupuncture targeted at headache (control) in patients with psychogenic ED (pED). Of the 20 subjects who completed the study, more than one third responded to the intervention acupuncture as measured by pre- and post-trial criteria, which included serum sex-hormone levels and erectile response.
Recently, a group of Polish researchers 17 investigated the effects of acupuncture on symptoms of decreased libido in menopausal women. Subjects were assessed using Greene's Climacteric Scale 18 as well as being asked to rate themselves on a 3-point scale designed to measure decrease in libido (no decrease, slight decrease, or significant decrease). Treatment consisted of two series of 10 twice-weekly sessions, with a 2-week break between the series.
The percentage of subjects rating themselves as having experienced significant decreases in libido went from 79% to 17% following treatment. While no subjects rated themselves as having experienced no loss of libido before treatment, 33% put themselves in this category after receiving the therapy. The percentage of the sample scoring below a cutoff of 21 points on Greene's Climacteric Scale doubled (from 19% to 58%) after acupuncture therapy.
The current study expands on these promising results by using measures designed to capture the range of symptoms associated with FSD more fully.
Many researchers have recommended more investigations into the impact of acupuncture on women's health.13,19–22 The aim of this study was to test the hypothesis that acupuncture treatment would reduce symptomatology in pre- and post-menopausal women diagnosed with FSD.
Methods
The study used a repeated-measures design, with assessments taken at threetime points: (1) pretreatment baseline; (2) just prior to the last (fourth) session; and (3) at follow-up 3 weeks post-treatment. Thus, the immediate effects of acupuncture on FSD were evaluated as well as the maintenance of symptom reduction over time. All data were collected between June 17, 2009, and September 23, 2010.
Subjects
A cohort of 17 women between the ages of 40 and 66, with a diagnosis of FSD, was sequentially recruited from a private women's health clinic to test the hypothesis that acupuncture reduces FSD symptoms. None of the participants had an associated medical condition and/or were on any medications known to be associated with FSD. All but 3 women were postmenopausal with no menstruation in the past year (however, it should be noted that it is common to see an overlap between menopausal and FSD symptoms). Potential participants were provided a description of all treatment options available, and patients who elected to undergo acupuncture treatment were recruited into the study and given therapy free of charge. Subjects were given 1 week to contact the acupuncture clinic to schedule four consecutive acupuncture visits, one per week. Patients' clinical symptoms were identified at baseline, and patients were followed throughout acupuncture therapy until 3 weeks after therapy was completed. All subjects agreed not to modify their medication intakes, including hormone therapy, for the duration of the study. The investigators chose to use a time-series study design instead of a case-control study design with the control group receiving sham acupuncture (placing needles away from known verum points and meridians, and inserted to a superficial depth) because of research documenting that sham acupuncture is not inert, and, in fact, appears to offer a significant therapeutic effect that is often similar to verum application (placing the needles at points and depths specified by traditional Chinese techniques). The protocol was approved by the University of Nevada, Reno, institutional review board.
Measures
Before receiving the acupuncture intervention, subjects completed five questionnaires designed to measure aspects of each of the four FSD disorders. These same questionnaires were administered again before the last acupuncture treatment and at follow-up 3 weeks after the final treatment.
A variety of instruments were chosen, because there is currently no validated instrument to assess changes in FSD symptoms in response to therapy. The Female Sexual Function Index (FSFI) 23 is a 19-item questionnaire designed to assess global sexual function in women. Higher scores indicate better sexual functioning. The Sexual Interest and Desire Inventory–Female (SIDI-F) 24 is a 13-item scale developed as a clinician-administered assessment tool to quantify the severity of symptoms in women diagnosed with HSDD (reduction in libido). The SIDI-F was validated to measure change in response to treatments of HSDD. 2 Higher scores indicate better functioning.
The Greene Climacteric Scale (GCS) 18 is designed to provide a score for psychological, vasomotor, and somatic symptoms along with depression and anxiety. This is a standard scale for measuring climacteric symptoms. 18 Each symptom is rated by the subject according to its severity using a 4-point rating scale, with higher scores indicating greater symptomatology. Construct validity has been demonstrated in relation to psychological treatment, hormone-replacement therapy (HRT), and breast-cancer therapy.25–28 The Menopause Rating Scale (MRS) 29 was developed as a menopause-specific health related quality-of-life scale (QoL) to measure changes in response to HRT. Higher scores are related to higher degree of problems. The three domains in the MRS include psychological symptoms, such as depression, irritability, anxiety, and exhaustion; somato-vegetative symptoms, such as sweating, feeling flushed, and cardiac, sleeping, and joint and muscle problems; and urogenital symptoms, including sexual problems, urinary problems, and vaginal dryness. The MRS is known for its ability to measure treatment effects independent of severity of symptoms. 30 Furthermore, the scale fits well with the subjective assessment of treatment by the clinician.
The Quality of Life Scale (QoLS) was originally developed by Flanagan and colleagues, and consists of 16 summed items, each evaluated on a 7-point scale.31,32 Higher scores are related to better QoL. The QoLS is an individual satisfaction instrument that focuses on a wide range of domains that are not directly health-related. Scores on the QoLS have been shown to vary more in response to mood and other psychological states than to physical functioning. 32
The methodology used in this study allowed for three points of data collection (prior to initiation of the study, after three treatments, and 3 weeks beyond the last acupuncture session), providing important information related to efficacy and duration of treatment.
Intervention
A Western medical acupuncture protocol (used at all four visits) was developed, incorporating meridian points known to be effective for all four of the disorders. The certified medical acupuncturists for the study were a medical doctor and nurse–practitioner. During the initial 1.5-hour visit, each subject was given the questionnaires to complete in a private room in the clinic. Upon completion of the questionnaires, an acupuncturist met with each subject to review the protocol and health history. Following this discussion, acupuncture points were located and needling completed. The following acupuncture points (FSD protocol) were chosen using Helm's text 33 and reference materials, and were used consistently for each visit on all subjects: Spleen 4, 6, and 9; Stomach 29, 30, 36, and 43; Gallbladder 41; Heart 3,7, and 9; Triple Heater 5 and 10; Large Intestine 4; and Conception Vessel 3, 4, and 6. Sterile, single-use 0.16–0.20-mm×30–40 mm Seirin (Weymouth, MA) needles were used with insertion tubes initially. After the insertion tubes were removed, the needles were inserted to an appropriate depth (maximum insertion=1″) depending on the location on the body of the point and body habitus (weight or depth of adipose tissue). During needle insertion, a clockwise rotating motion was used to determine the presence of Qi (energy flow). No other needle stimulation was performed.
Subjects were asked to lie supine on the table with shoes and socks removed; and arms, lower legs, abdomen, and scalp accessible for needling. Needles were left in place for ∼30 minutes. During this time, subjects were left alone in the treatment room with the lights low and soft music playing in the background. If the patients wished, they were covered with a light blanket. All subjects were provided with a bell to ring in case they needed assistance.
Upon completion of the treatment the subjects were discharged from the clinic. The acupuncture treatment was repeated at three subsequent visits, each 1 week apart. Additional questionnaire data were collected just prior to the final (fourth) treatment, and at follow-up three weeks post-treatment.
Statistical Analysis
Data were analyzed using SAS statistical software. A multivariate analysis of variance (MANOVA) for repeated measures was used to test the hypothesis regarding the impact of acupuncture on sexual dysfunction symptoms and QoL. The Wilk's Lambda test statistic was used to evaluate statistical significance of our results. 34 It was hypothesized that fewer FSD symptoms would be observed over time. A Bonferroni-type adjustment was not used, because the objective of this pilot study was to provide evidence of promising treatments for FSD, not to assess many hypotheses definitively.
Power
Adequate sample size was necessary to reduce the possibility of failing to detect any changes in symptoms resulting from the acupuncture treatment. Using published data for the mean SIDI-F score for women with HSDD, the 95% confidence interval (CI) was 11.4, 18.3. 2 To have 80% power, a sample size of 11 subjects was needed. 35 As 17 subjects were recruited, this suggested that this study was adequately powered.
Results
Of the 17 women who agreed to participate, all completed the treatment phase of the study, and there was no attrition at follow-up. No adverse events were reported by any of the participants during or after treatment. Table 1 shows the mean scores for the SIDI-F, the FSFI, the four domains of the GCS, the three domains of the MRS, and the QoLS at baseline, during acupuncture, and 3 weeks after treatment ended. Table 1 also shows the 95% CIs and significance levels for each analysis performed. Although the 0.05 level of significance was adopted, the actual p-values are provided in that table, and it is left to the reader to decide what would provide adequately convincing evidence of the efficacy of acupuncture for symptom relief.
Immediate effects are univariate within-subjects comparison between baseline and during acupuncture.
Longer-term effects are univariate within-subjects comparison between baseline and 3 weeks after acupuncture.
SIDI-F scores increased significantly over time, indicating improved sexual functioning (p=0.01 during treatment and at follow-up). Total FSFI scores also increased, indicating better sexual functioning, although this improvement did not reach statistical significance. Interestingly, the increase was primarily driven by the desire domain, in which scores increased significantly during treatment (p=0.002) and at follow-up (p=0.04). The results for arousal, lubrication, orgasm, satisfaction, and pain were not statistically significant.
Psychological problems as measured by the GCS decreased during treatment (p=0.03) and at follow-up (p=0.008). This result appears to be driven by the anxiety subdomain of this scare, which was statistically significant during (p=0.03) and after (p=0.01) treatment and the sexual functioning question, which approached significance during (p=0.06) and reached significance after (p=0.03) treatment. Although there was a decrease in depression scores over time, this did not reach statistical significance.
Scores in all three domains of the MRS decreased over time (indicating fewer problems) and most changes were statistically significant during treatment and at follow-up. Improvement in the psychological domain was significant both during treatment (p=0.04) and at follow-up (p=0.008). Similarly, improvement in the urogenital domain was significant during (p=0.04) and approached significance after (p=0.07) treatment. Statistically significant improvement was also seen in the somato-vegatative domain during treatment (p=0.01) and at follow-up (p=0.03).
There was a trend for QoLS scores to improve over time. The mean score before treatment was 87.8, prior to the last acupuncture treatment, the mean score was 88.2, and 3 weeks after treatment the mean score was 89.3. However, this result was not statistically significant.
Discussion
Overall, subjects reported that acupuncture improved sexual desire, decreased psychological symptoms (especially anxiety), and reduced urogenital and somato-vegatative symptoms. Improvements were observed in general QoL and in global sexual functioning although these improvements did not reach statistical significance. (It is possible that more-significant improvements in these measures would have been seen at a later point in time, as reduced symptomatology may not have immediate effects on more global measures of functioning.) While the literature addressing FSD has recently expanded, acupuncture has received little attention as a treatment modality for FSD. This pilot study suggests that acupuncture can be an efficacious approach for reducing many FSD symptoms, indicating the need for further study of acupuncture as a low-risk alternative to pharmacotherapy and other less-efficacious treatments for each of the four diagnoses subsumed under FSD.
Testosterone is a commonly prescribed treatment for HSDD, but Food and Drug Administration approval has been delayed because of efficacy and risk issues. Undesirable masculinization side-effects are common at effective doses, and testosterone's relative effectiveness is dependent on a low androgen level being the sole cause of the disorder. 1 Other current treatment options include lifestyle changes and sex therapy. 36 The current study found that sexual desire increased over time after acupuncture as assessed with two instruments, the SIDI-F and the desire sub-domain of the FSFI.
Effective treatment options for arousal disorder in women are lacking. Sildenafil was not found to be effective for subjective improvement of sexual response in either estrogenized (n=577) or nonestrogenized (n=204) women, 5 although the drug might be helpful for arousal disorder secondary to selective serotonin reuptake inhibitor (SSRI) use. Furthermore, adverse effects of sildenafil were mild-to-moderate and included headache, nausea, visual impairment, and gastrointestinal distress. The current study indicated a nonstatistically significant improvement in arousal (FSFI subdomain) with acupuncture therapy. The impact of acupuncture on female arousal disorder warrants further study.
Treatment of orgasmic disorder using pelvic-floor muscle exercises has met with varying degrees of success, indicating the need to establish more consistently efficacious treatment protocols. 37 The results of the current study were inconclusive regarding changes in the orgasm subdomain of the FSFI. Given that the FSFI instrument is a global instrument, it may not have enough sensitivity to detect changes in the subdomains. Instruments specifically measuring orgasm and impact of treatment or changes over time need to be used to assess this symptom. However, frequency of orgasm is less likely to correlate with sexual satisfaction in women than in men.
Regarding sexual pain disorder, vaginal estrogen-replacement therapy is often, but not always, an effective treatment for postmenopausal dyspareunia. Pelvic-floor physical therapy and biofeedback are effective in some cases. 38 In the current study, changes in the MRS urogenital subscale—which measures symptoms such as sexual problems, urinary problems, and vaginal dryness—indicated significant improvement during treatment and a trend toward improvement at follow-up. This suggests that acupuncture may be beneficial for patients who have urogenital symptoms and sexual pain. It is essential to note here that all subjects received the same acupuncture protocol regardless of symptomatology. However, most acupuncture providers would treat pain quite differently from other aspects of FSD. Anecdotally, 1 subject with severe posthysterectomy dyspareunia had no improvement from the study protocol but improved dramatically with follow-up acupuncture treatment directed at her pain. Female sexual pain syndromes may be investigated better separately from other FSD disorders, and further study for sexual pain is warranted.
Strengths and Limitations
Although this was a small pilot study, it was sufficiently powered to detect the benefits of acupuncture in many domains (e.g., psychological, vasomotor, and urogenital symptoms, and desire disorders). The small sample size, however, leaves the study vulnerable to other Type II errors (e.g., potentially failing to detect significant changes in the subdomains, rather than the total score, of the FSFI instrument; arousal, lubrication, orgasm, satisfaction, and pain).
To circumvent the problematic confounding effect of partial improvement with sham acupuncture as a control, a repeated-measures design was used. There is no standardized control protocol for acupuncture studies. Because of the lack of a satisfactory control group, placebo and other psychological effects of acupuncture are difficult to quantify and may have affected the results. Future studies could use a wait-list control group or a group receiving a theoretically inert intervention, such as massage, to control for nonspecific therapy effects thought to result from contact with a caring and listening healthcare provider. In addition, other design elements from time-series methodology (such as multiple baselines) could be used to control for threats to validity such as history or maturation.
According to Chinese medical theory, a standardized acupuncture protocol, such as the one used in this study, may not be as beneficial as individually tailored treatment, a factor that which tend to lead to underestimating the benefit of treatment. Finally, a nonprobability sampling method (sequential sampling) from a limited population was used, potentially restricting generalizability.
Conclusions
This pilot study suggests benefit from acupuncture treatment for several aspects of FSD, warranting further study. Clinicians should be aware that, for women who do not want or who cannot tolerate hormone therapy, lifestyle changes, or counseling for FSD, acupuncture may be an acceptable alternative treatment. Furthermore, declines in mental health associated with FSD may also be responsive to acupuncture. Despite the aforementioned limitations, the current study provides preliminary support for the efficacy of acupuncture for treating FSD. Future research should concentrate on improving internal validity through inclusion of control groups and implementing randomization. It is the hope of the current authors that this pilot study will serve to generate new research questions aimed at increasing understanding of the efficacy, and, ultimately, the effectiveness, of acupuncture as an alternative treatment option for women with FSD.
Footnotes
Disclosure Statement
No competing financial interests exist.
