Study Overview
Objective. To examine the effects of acupuncture on vasomotor symptoms (VMS) and quality of life in perimenopausal and postmenopausal women.
Design. Pragmatic randomized controlled trial.
Setting and participants . Participants were perimenopausal and postmenopausal women aged 45 to 60 years who had 4 or more VMS episodes a day. Women were excluded if they had initiated or changed a dose of any VMS treatment in the 4 weeks prior to the study, initiated or changed the dose of an antidepressant in the prior 3 months, had received acupuncture in the prior 4 weeks, self-reported their health as poor or fair, or had a diagnosis of hemophilia. The study was conducted at the Wake Forest School of Medicine and the Chapel Hill Doctors Healthcare Center in North Carolina with women recruited from the community. Potential participants completed a 2-week hot flash diary to establish that they met the eligibility criteria of 4 or more hot flashes a day.
Intervention. Eligible participants were randomized to either the experimental group, who received up to 20 acupuncture treatments over a 6-month period, or a waitlist control group who received usual care for 6 months followed by the same 6 months of acupuncture treatment received by the experimental group. The researchers decided not to use sham acupuncture in the control group because outside of the experiment women would not receive sham acupuncture and because it has been shown to have an effect on menopausal symptoms in other studies.
Participants could receive up to 20 acupuncture treatments from 1 of the 4 study licensed acupuncturists over a period of 6 months. The acupuncturist assessed the participant and made a traditional Chinese medicine diagnosis to guide treatment at the initial and each subsequent visit. During treatment, acupuncture needles were inserted 0.5 to 3 cm through the skin to achieve a “de Qi” sensation, which is a sensation of heaviness, numbness, soreness, or distention at the insertion site. Acupuncturists were permitted to administer additional acupuncture-related treatments with the exception of the use of Chinese herbal remedies. Additionally, participants were permitted to start other treatments, and 11 women in the acupuncture group and 2 women in the control group started other behavioral treatments during the study.
Main outcome measures . The primary outcome measure was the frequency and severity of hot flashes and night sweats, measured using the Daily Diary of Hot Flashes (DDHF). Secondary measures were the following quality of life indicators: hot flash interference (the degree to which hot flashes interfered with specific daily activities), measured using the Hot Flash-related Daily Interference Scale; sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the PROMIS Sleep Disturbance short form; menopause related symptoms other than VMS, measured using the Women’s Health Questionaire (WHQ); depression, measured using the short form of the Center for Epidemiologic Studies Depression scale (CESD-10); anxiety, measured using the General Anxiety Disorder (GAD-7) and the PROMIS Anxiety short form; perceived stress, measured using the Perceived Stress Scale (PSS); and health-related quality of life (HRQOL), measured using a global visual analog scale (VAS) and the Physical and Mental Health Component scores of the Medical Outcomes Study short form health survey (SF-36).
Main results . The final sample size was 209 women, with 170 randomized to the acupuncture group and 39 to the control group. There were no significant differences between the groups at baseline. The retention rate was 89% at 6 months and 84% at 12 months. At 6 months there was a 36.7% decrease VMS frequency in the acupuncture group compared to a 6.0% increase in the control group ( P < 0.001). At 12 months the decrease in VMS frequency was 29.5% in the acupuncture group. The control group began acupuncture at 6 months and by 12 months the frequency of VMS in this group was 31.0% less than at baseline ( P < 0.001). Overall, the maximal effect was achieved at week 7 with a median of 8 acupuncture treatments. Sensitivity analysis indicated that there were no differences in effect in those who started other behavioral treatments during this period. There were also significant improvements in scores on the hot flash interference scale ( P < 0.001), fewer sleep problems on the sleep measures, and fewer symptoms on the WHQ for women in the acupuncture group and these effects were maintained at 12 months. In addition, similar results were found in the control group after they initiated acupuncture at 6 months.
Conclusion. Overall, acupuncture resulted in significant and sustained improvements in VMS and quality of life measures.
Commentary
More than half of women will experience frequent VMS beginning with the menopause transition [1] and lasting an average of 7.4 years [2]. The effect of VMS on women’s quality of life is considerable, including anxiety, stress, decreased energy, sleep disruption and interference with leisure, social, and work activities [3,4]. Estrogen therapy remains the most effective therapy for VMS; however, its use is contraindicated in many women and duration of use is limited [5]. Therefore, safe and effective alternate therapies are needed.
Acupuncture is a traditional Chinese medicine therapy that has gained popularity in recent years for therapeutic management of many conditions, including pain, nausea related to pregnancy or chemotherapy, anxiety, headache, and addiction. Evidence regarding effectiveness has been equivocal, with studies of its effectiveness in some conditions, such as nausea and dental pain, showing strong positive results while evidence for its use in other conditions is lacking or inconsistent [6]. There have been consistent positive findings in prior research of the use of acupuncture to reduce the severity and frequency of VMS, however, according to the authors of this study, little is known about the long-term effects or the effect on quality of life. Additionally, most studies use sham acupuncture in the control group, which would not be offered to women outside a study protocol and has been shown to have a physiological effect of its own. Therefore, the authors conducted a pragmatic randomized control trial; designing the intervention so that it more closely reflected what happens in a real world clinical setting, to examine the overall effects and effect on quality of life measures.
The results of this study were a significant positive effect of acupuncture on the frequency and severity of VMS in the acupuncture group that was sustained over 12 months and improvements on all quality of life measures. There was also a significant effect in the control group when they received the intervention after the initial 6-month period. As the authors note, it is unclear if improvements in the quality of life indicators were a direct effect of the acupuncture or secondary to the relief of the vasomotor symptoms. Its use in women who experience other menopause-related symptoms, such as mood disorders or sleep disruption, in the absence of VMS needs further study.
The authors compare their results with that of research on the use of selective serotonin reuptake inhibitors (SSRIs) for VMS, one of the more efficacious alternatives to hormone therapy. As they note, though the reduction was somewhat less than that found with SSRIs (for example 35% for acupuncture vs. 47% with escitalopram), the risk of adverse effects is much lower with acupuncture. The only reported adverse effects in this study were 2 women who reported pain during treatment and 1 who reported numbness while SSRIs are known to have significant adverse effects. In addition, the results in this study were sustained longer, until the final follow-up at 6 months, while women who used escitalopram relapsed three weeks after discontinuing the medication.
The use of a pragmatic design allows for more confidence that the findings will translate to the real world setting. The number and timing of acupuncture treatments were determined by each woman with the acupuncturist as would happen in the clinical setting. In addition, the initiation of other therapies during the treatment stage was allowed, with 11 women in the acupuncture group and 2 women in the treatment group starting other behavioral interventions during that time. Though this approach has a small chance of introducing confounding variables, sensitivity analysis indicated it did not. As such, this design results in a study that is an accurate reflection of the experience of women receiving acupuncture in the clinical setting and thus good external validity.
There were 2 limitations of note. Though retention was excellent, 89% and 84% for the acupuncture and control group respectively, it is unknown if the women who dropped out did so due to lack of improvement, in which case the actual reduction in VMS would have been less than reported. Additionally, the use of self-report (diaries) of VMS can be unreliable and biased.
Applications for Clinical Practice
The results of this study indicate that acupuncture offers women a safe and effective therapy for VMS. The optimal dose appears to be 8 treatments. Clinicians should consider it as a first-line treatment for women with moderate to severe VMS who have contraindications to hormone therapy and before prescribing SSRI therapy, which carries the potential for significant adverse effects.
—Karen Roush, PhD, RN