Acupuncture

Acupuncture

PEP Topic 
Hot Flashes
Description 
Acupuncture is a  method of producing analgesia or altering the function of a body system by inserting fine, wire-thin needles (about the diameter of a strand of hair) into acupoints along a specific meridian. (Meridians are channels in the body that transport energy.) The needles are twirled or energized electronically or are warmed and left in place for 20–30 minutes. The acupuncture point P6 is most commonly used for treatment of nausea and vomiting (Gamaluddin & Kirchner, 2006). Acupuncture has been evaluated in regard to treatment of anxiety, chemotherapy-induced nausea and vomiting, dyspnea, pain, hot flashes, depression, lymphedema, sleep-wake disturbances, peripheral neuropathy, and fatigue.
 
Gamaluddin, S., & Kirchner, J.T. (2006). Acupuncture: What the evidence shows now. Family Practice Recertification, 28(9), 26–28,33–37.

Effectiveness Not Established

Research Evidence Summaries

Ashamalla, H., Jiang, M. L., Guirguis, A., Peluso, F., & Ashamalla, M. (2011). Acupuncture for the alleviation of hot flashes in men treated with androgen ablation therapy. International Journal of Radiation Oncology, Biology, Physics, 79(5), 1358-1363.

doi:10.1016/j.ijrobp.2010.01.025
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Study Purpose:

To study the effect of acupuncture on hot flashes in men with prostate cancer treated with androgen deprivation

Intervention Characteristics/Basic Study Process:

Men with hot flashes occurring at least 3 or more times per day for at least three days before enrollment were enrolled. They completed hot flash diaries with resulting hot flash scores at baseline, daily for at least 6 weeks, and then monthly for 8 months (targeted time was 36 months). Acupuncture was administered by same acupuncturist twice a week for 4 weeks to the same 10 points with electro stimulation applied to 8 of the 10 points per protocol.

Sample Characteristics:

  • N = 14  
  • AGE:  mean 68 years
  • MALES (%)  100%     FEMALES (%)  0
  • KEY DISEASE CHARACTERISTICS:   Locally advanced prostate cancer
  • OTHER KEY SAMPLE CHARACTERISTICS:   Advanced local disease managed with androgen deprivation therapy

The study enrolled men with locally advanced prostate cancer, who had been treated with androgen deprivation therapy as an adjuvant to radiation therapy, radical prostatectomty, or brachytherapy. All men must have had hot flashes occurring at least 3 or more times per day for at least three days before enrollment. Patients could not be receiving medications for hot flashes nor have a history of acupuncture treatment.

Setting:

  • SITE: Single site   
  • SETTING TYPE: Outpatient setting   
  • LOCATION: United States

Phase of Care and Clinical Applications:

PHASE OF CARE: Active Treatment

APPLICATIONS: Late effects & survivorship; Elderly care

Study Design:

Prospective single arm trial

Measurement Instruments/Methods:

  • Hot Flash Diaries    
  • Hot Flash Score - calculated as frequency x severity.

Results:

Mean initial Hot Flash Score (HFS) was 28.3, which decreased to 10.3 (p= 0.0001) at 2 weeks post-treatment, 7.5 (p = 0.0001) at 6 weeks post-treatment, and 7.0 (p= 0.0001) at 8 months post-treatment. Clinical improvement for each patient was defined as the percent decrease in the mean HFS at each time point. The mean improvement at weeks 2 and 6 was 68.4% and 89.2%.

Conclusions:

In this limited sample size, acupuncture appeared to reduce hot flash symptoms experienced by men treated with androgen deprivation for their locally advanced prostate cancer.

Limitations:

  • Small sample <30
  • The study clearly defined the participant group; however it failed to define further the acupuncture points used within the study. It also did not define which of the 8 out of  10 points had electro stimulation applied in order to determine if these were exact points used in each participant.  
     

Nursing Implications:

Further research is needed in larger sample sizes to determine effectiveness, and  the reproducibility of the study when using multiple providers. The study explored the long term benefits of using acupuncture and suggested (demonstrated) an 80.3% decrease in HFS at the 8-month follow-up.

Beer, T. M., Benavides, M., Emmons, S. L., Hayes, M., Liu, G., Garzotto, M., . . . Eilers, K. (2010). Acupuncture for hot flashes in patients with prostate cancer. Urology, 76, 1182–1188.

doi: 10.1016/j.urology.2010.03.033
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Study Purpose:

 To determine the effect of acupuncture on hot flash (HF) frequency and intensity, quality of life, and sleep quality in patients undergoing hormonal therapy for prostate cancer.

Intervention Characteristics/Basic Study Process:

Men with HF scores greater than four who received androgen-depriving therapy underwent acupuncture with electrostimulation biweekly for four weeks then weekly for six weeks using a predefined treatment plan. Patients completed a Hot Flash Diary daily for seven days prior to treatment then daily throughout the study.

Sample Characteristics:

  • The sample was comprised of 22 males with prostate cancer.  
  • Median age was 71 years.
  • Patients were undergoing androgen deprivation therapy.

The study enrolled men with prostate cancer who were treated with bilateral orchiectomy, gonadotropin-releasing hormone agonist, or antagonists with or without antiandrogen therapy. The sample group reported at least four HFs per day. They could not be receiving concurrent chemotherapy, estrogens, progesteronal agents, or gabepentin. They had to be off of selective serotonin reuptake inhibitor (SSRI) class antidepressants for at least two weeks; however, the SSRI prohibition was removed after 16 patients were enrolled to speed accrual. Patients with pacemakers or other electrical devices were excluded.

Setting:

  • Single site   
  • Outpatient   
  • Sweden

Phase of Care and Clinical Applications:

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability for late effects and survivorship and elderly care.

Study Design:

The study used an open-label, single arm, phase II design.

Measurement Instruments/Methods:

  • Hot Flash Related Daily Interference Scale (HFDIS)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Short Form 36-item Health Survey (SF-36)
  • Blood samples plasma calcitonin gene-related peptide (CGRP)
  • Urine samples 5-HIAA
  • Hot Flash Diary

Results:

Acupuncture treatment was administered twice weekly, with an attempt to use the same practitioner throughout the treatment period. Specific acupuncture sites were used in all patients. The HF score was calculated from the Hot Flash Diary, and each HF was calculated to determine severity. The severity-adjusted HF scores were summed for seven days. Biomarkers were assessed at baseline; 2, 4, 6, and 10 weeks of treatment; and again after 6 weeks. The mean HF score was reduced after four weeks of therapy, then reduced to 52% of baseline at eight weeks. The HFDISs were available for 21 of the improved patients. The PSQI was available for 19 patients, but there was no statistical significance noted from baseline to after 10 weeks of treatment. No improvement in overall vitality was measured by the SF-36. No significant adverse effects were noted. Regarding the biomarkers, no change in the serum serotonin levels was noted for any patient. Urinary 5-HIAA had a nonsignificant trend toward reduced 5-HIAA concentrations, with the nonresponders (two patients) having an increase over time. The nonresponders' 5-HIAA concentrations were 129% of baseline, whereas the responders at week 10 showed 73.3% of baseline concentrations. The CGRP levels baseline sample results were so diverse that subsequent samples obtained during and posttreatment detected no meaningful differences. The variability in the CGRP samples reduced the statistical power of the study to detect differences.

Conclusions:

The study suggested that acupuncture may be an active nonpharmacologic option for patients with prostate cancer experiencing HFs while undergoing hormonal treatment.

Limitations:

  • The study had a small sample size, with less than 30 patients.
  • Hot flash Diaries were incomplete beyond week 8, so the severity of hot flashes was not calculable past the time point proposed.
  • The variability in the CGRP samples reduced the statistical power of the study to detect differences.

Nursing Implications:

Further research is needed in the use of acupuncture in reducing HF scores and improving sleep quality in prostate cancer survivors. Further research may also be needed  to determine if differences exist between genders for HF distress/occurrence and sleep quality, which may provide some direction for extrapolating research results with either gender group.

Bokmand, S., & Flyger, H. (2013). Acupuncture relieves menopausal discomfort in breast cancer patients: A prospective, double blinded, randomized study. The Breast, 22, 320–323. 

doi: 10.1016/j.breast.2012.07.015
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Study Purpose:

To investigate the therapeutic effect of acupuncture on hot flashes and disturbed sleep in patients with breast cancer, the possible side effects of this treatment, and the effect on plasma estradiol levels

Intervention Characteristics/Basic Study Process:

Two experienced acupuncturists provided either true acupuncture or sham acupuncture in the predetermined points. Group 1 had manual acupuncture in pre-determined bilateral points for 15–20 minutes once a week for five consecutive weeks. These points were Hc6, Ki3, Sp6, and Lr3, which are located on the wrist, ankle, and foot. Group 2 had sham acupuncture in four predetermined bilateral non-acupuncture points outside the meridian but within the same region as the true points. The treatment was given once a week for five weeks. Group 3 received no acupuncture. All groups completed a log book. Plasma estradiol levels were measured in blood samples obtained just prior to the first treatment and 30 minutes after. It was measured again at five weeks later and 30 minutes after the final treatment. Group 3 had plasma estradiol levels obtained at allocation and five weeks later.

Sample Characteristics:

  • N = 94
  • MEAN AGE = 61 years (45–76 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Self-estimation of troublesome hot flashes and disturbed night sleep

Setting:

  • SITE: Single site    
  • SETTING TYPE: Outpatient area   
  • LOCATION: Denmark

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Post-surgical and survivorship
  • APPLICATIONS: Elder care

Study Design:

  • Double-blinded, randomized (double-blind only applied to Groups 1 and 2 for the investigator and participants)

Measurement Instruments/Methods:

  • Completion of a logbook using a subjective visual analog scale to rate extent of symptoms
  • Obtained plasma estradiol levels prior to first treatment, 30 minutes after that treatment, at five weeks and 30 minutes after final treatment
  • The control group had the levels drawn at allocation and five weeks later.
  • Analysis performed using Roche Modular Immunochemistry, Electrochemical Luminescent Immuno Assay

Results:

The researchers reported that a significant relief occurred in the acupuncture group after the second treatment, lasting until 6 weeks post-treatment (p < 0.05), as compared to the sham acupuncture and no treatment groups, which lasted for at least 12 weeks. A decrease in sleep disturbance also was noted in the same group as compared to the others. Side effects were reported as mild and temporary. Reported side effects included fatigue, pruritus, and nausea. No effect on the plasma estradiol levels in all groups occurred. Eleven women from all groups reported using concurrent treatments including clonidine and/or venlafaxine, mirtazapine with clonidine, and hormone replacement.

Conclusions:

The acupuncture group reported a decrease in hot flashes versus the other groups. No formal validation of the visual analog scale occurred. The concurrent use of other therapies may influence the reported outcomes. Restrictions of concurrent therapies for hot flashes during participation and validation of the self-reporting tool were needed.

Limitations:

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: 11 participants used other forms of treatment in conjunction with their study participation to control hot flashes. Participants were Caucasian. No other groups were included in the sample.

Nursing Implications:

A large randomized trial exploring acupuncture versus placebo is needed that restricts concurrent therapy usage during trial participation and includes women with breast cancer having similar hot flash interventions such as tamoxifen or aromatase inhibitors with hot flash occurrence. True acupuncture may benefit, but further study is indicated.

de Valois, B. A., Young, T. E., Robinson, N., McCourt, C., & Maher, E. J. (2010). Using traditional acupuncture for breast cancer-related hot flashes and night sweats. Journal of Alternative and Complementary Medicine, 16, 1047–1057.

doi:10.1089/acm.2009.0472
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Study Purpose:

To determine if traditional acupuncture (TA) could reduce hot flashes and night sweats (HF&NS) frequency, improve physical and emotional well-being, and improve perceptions of HF&NS in women receiving tamoxifen after active breast cancer treatment.

Intervention Characteristics/Basic Study Process:

Women with a diagnosis of breast cancer receiving tamoxifen who reported experiencing HF&NS for more than three months underwent eight sessions of TA, delivered once weekly. They were monitored for 30 weeks, during which there were five measurement points. Data were collected using a paper-based hot flash diary. Physical and emotional well-being were measured using two questionnaires:  the Women’s Health Questionnaire (WHQ) and the Hot Flashes and Night Sweats Questionnaire (HFNSQ).

Sample Characteristics:

  • The sample was comprised of 47 female patients.  
  • Mean age was 54.3 years (range 37–68). 
  • Patients
    • Were women taking tamoxifen as adjuvant treatment for early breast cancer
    • Were six or more months postsurgery, chemotherapy, or radiotherapy
    • Were taking tamoxifen for at least six months
    • Reported HF&NS for at least 3 months.
    • Had no recurrent or metastatic disease
    • Could be receiving concomitant preparations for relieving HF&NS, whether prescription or over the counter, if they had been taking them at least three months and would continue them through the trial period.

Setting:

  • Single site   
  • Outpatient 
  • Mount Vernon Hospital, Middlesex, United Kingdom

Phase of Care and Clinical Applications:

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability for late effects and survivorship.

Study Design:

This was a prospective, single-arm, observational study using before and after measurements.

Measurement Instruments/Methods:

  • Hot Flash Diaries    
  • WHQ
  • HFNSQ

Results:

HF&NS mean frequency was reduced by 49.8% (95% confidence interval [40.5, 56.5]; p < 0.0001; n = 48) at end of treatment (EOT) over baseline. Trends indicated longer-term effects of TA at 4 and 18 weeks after EOT. At EOT, seven WHQ domains showed significant statistical and clinical improvements, including Anxiety/Fears, Memory/Concentration, Menstrual Problems, Sexual Behavior, Sleep Problems, Somatic Symptoms, and Vasomotor Symptoms. Perceptions of HF&NS as a problem were reduced by 2.2 points (standard deviation = 2.15 points; n = 48; t = 7.16; p < 0.0001).

Conclusions:

The study supports using TA to manage HF&NS in women receiving tamoxifen as a breast cancer treatment. In addition, it suggests that the women received the added benefit of improved emotional and physical well-being with few side effects.

Limitations:

  • The study lacked an appropriate control group.
  • The study lacked control over the therapeutic relationship that was established between the practitioner and the patient, which could have contributed to the placebo effect.
  • Concomitant medication was used for managing hot flashes.

Nursing Implications:

Nurses should recognize that tamoxifen continues to pose distressing side effects in women with breast cancer, even after prolonged use. This study suggests that, through the use of TA, women receiving tamoxifen may be able to control some of these distressing side effects. Randomized, controlled trials using larger samples are warranted to validate TA as a tool for reducing these common side effects. Future studies, if including concomitant medications for hot flash symptoms, may want to control the types of concomitant medication usage for further analysis of results or have a randomized group to TA alone to TA plus a specific concomitant medication to note if hot flash symptoms are further controlled.

Deng, G., Vickers, A., Yeung, S., D’Andrea, G.M., Xiao, H., Heerdt, A.S., … Cassileth, B. (2007). Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. Journal of Clinical Oncology, 25, 5584–5590.

doi:10.1200/JCO.2007.12.0774
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Study Purpose:

Compare the immediate and long-term effects of true acupuncture versus sham acupuncture on hot flash frequency in women with breast cancer

Sample Characteristics:

The study included 72 women with breast cancer experiencing three or more hot flashes per day.

Study Design:

Patients were randomly assigned to receive either true or sham acupuncture.

Measurement Instruments/Methods:

The primary outcome measurement was hot flash frequency. Participants completed a hot flash diary for one day at days 7, 14, 21, 28, and 35.

Results:

The mean number of hot flashes per day was reduced from 8.7 to 6.2 in the true acupuncture group. The mean number of daily hot flashed was reduced from10.0 to 7.6 in the sham group. The true acupuncture was associated with 0.8 fewer hot flashes per day when compared to the sham at six weeks. This difference was not statistically significant. During the cross-over phase, participants in the sham group who received true acupuncture reported a further reduction in the frequency of hot flashes. The overall reduction in hot flash frequency persisted for up to 6 months after the completion of treatment.

Limitations:

The study was limited by a reliance on self-report instruments and recall. No physiologic measurements were used. The study may not have been of a sufficiently long duration and employed a modest sample size.

Filshie, J., Bolton, T., Browne, D., & Ashley, S. (2005). Acupuncture and self-acupuncture for long-term treatment of vasomotor symptoms in cancer patients—Audit and treatment algorithm. Acupuncture in Medicine, 23, 171–180.

doi:10.1136/aim.23.4.171
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Study Purpose:

Describe the effects of acupuncture and self-accupuncture on hot flash frequency and intensity

Sample Characteristics:

The study enrolled 182 females ages 35 to 83 and 12 men ages 49 to 79 years of age.

Study Design:

Researchers performed a retrospective audit of electronic charts.

Measurement Instruments/Methods:

The primary outcome measurement was hot flash frequency and intensity. Participants used both traditional acupuncture and self-accupuncture.

Results:

The average pre-treatment hot flash count was 16 per day. When acupuncture was added, the chart audit showed that 114 (79%) subjects achieved a 50% or greater reduction in hot flashes.

Limitations:

  • Data was not collected prospectively; the study relied on data available in the charts.
  • Data was missing in 27 charts.
  • The study reviewed only 24 weeks of charts.

Frisk, J., Carlhall, S., Kallstrom, A.C., Lindh-Astrand, L., Malmstrom, A., & Hammar, M. (2008). Long-term follow-up of acupuncture and hormone therapy on hot flushes in women with breast cancer: A prospective, randomized, controlled multicenter trial. Climacteric, 11, 166–174.

doi:10.1080/13697130801958709
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Study Purpose:

To evaluate the effects of electro-acupuncture (EA) and hormone therapy (HT) on vasomotor symptoms in women with a history of breast cancer

Sample Characteristics:

Twenty-seven women were randomized to EA for 12 weeks, 18 received  HT for 24 months. The total population was 45.

Setting:

This was an international, multicenter study, HABITS19, involving patients from three centers in Sweden between April 1998 and December 2002.

Study Design:

Randomized, controlled study

Measurement Instruments/Methods:

The patients were monitored with daily entries made in a log book, recording the numbers of hot flashes during day and night and how disturbing they were (range 0 for no distress to 10 for worst possible distress). The log books were completed daily for 1–3 weeks before treatment, continuously during the first 12 weeks of treatment, and thereafter for 1 week per month; altogether for 24 months. The measuring points were baseline, the 12th week of treatment, and at 1 week and 6, 9, 12, 18, and 24 months after start of treatment.

Results:

In 19 women who completed 12 weeks of EA, the median number of hot flashes per 24 hours decreased from 9.6 at baseline to 4.3 at 12 weeks of treatment. At 12 months after start of treatment, 14 women with only the initial 12 weeks of EA had a median number of flashes per 24 hours of 4.9, and at 24 months 7. Women with no other treatment than EA had 2.1 hot flashes per 24 hours.

Limitations:

Limitations included small sample size and relatively large attrition rate.

Frisk, J., Källström, A. C., Wall, N., Fredrikson, M., & Hammar, M. (2012). Acupuncture improves health-related quality-of-life (HRQoL) and sleep in women with breast cancer and hot flushes. Supportive Care in Cancer, 20, 715–724.

doi: 10.1007/s00520-011-1134-8
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Study Purpose:

To evaluate the effectiveness of electroacupuncture (EA) and hormone therapy (HT) on health-related quality of life (HRQoL) and sleep in breast cancer survivors with vasomotor symptoms.

Intervention Characteristics/Basic Study Process:

Women who had completed treatment for breast cancer were randomized to receive EA for 12 weeks or HT for 24 months. They completed the Psychological and General Wellbeing Index (PGWI) and Women’s Health Questionnaire (WHQ) pretreatment for vasomotor symptoms; during treatment; and at 6, 9, 12, 18, and 24 months after the start of treatment.

Sample Characteristics:

  • The sample was comprised of 18 female patients.  
  • Mean age was 54.1 years (range 47–69). 
  • Patients had completed treatment for breast cancer in situ for a T1 or T2 tumor with a maximum of four metastatic lymph nodes or T3 tumors without metastatic lymph nodes.
  • Patients also had:
    • Vasomotor symptoms 
    • Been seen by a breast surgeon or oncologist within the last three months and were not receiving active treatment for breast cancer  
    • No clinical or mammographic signs of recurrence.

Women were excluded if they were receiving ongoing breast cancer treatment other than tamoxifen; had other malignancies; or had a history of thromboembolic, cereverbrovascular, or liver disease; porphyria; or active cardiovascular disease.

Setting:

  • Multisite   
  • Outpatient
  • Sweden

Phase of Care and Clinical Applications:

  • Patients were undergoing the long-term follow-up phase of care.
  • The study has clinical applicability for late effects and survivorship and elderly care.

Study Design:

The study was a multicenter, randomized, prospective trial.

Measurement Instruments/Methods:

  • WHQ
  • PGWI
  • Log books for hot flushes and for sleep data, specifically the number of hours slept and times woken

Results:

Nineteen women completed 12 weeks of EA. Eleven women were excluded due to changes in treatment. About 40% of the patients had no other treatment. The HT group had 11 women complete the 24 months of treatment. In both groups, reduction of hot flushes was noted. The EA group had a decrease in the median number of flushes/24 hours of 55% (p < 0.001) after 12 weeks. The decrease was 29% (p = 0.026) after 24 months. In the HT group, the median number of hot flushes/24 hours decreased by 100% (p = 0.001) after 12 weeks of treatment with no further changes. Sleep parameters improved significantly in both groups from baseline, with a WHQ sleep score in the EA group at baseline of 0.50 and at 24 months 0.33; in the HT group, the baseline score of 0.33 to declined 0.00 at 24 months.

The study showed improvement in sleep scores of both groups up to 21 months. The numbers of hours slept per night did not increase, but the numbers of flushes and distress caused by them decreased, resulting in fewer times woken, with overall improvement in HRQoL. Both groups also showed a significant decrease in the number of HF experienced, which was maintained up to 21 months after treatment was stopped.

Conclusions:

EA, compared to HT for management of hot flashes in breast cancer survivors, shows some potential benefit in reducing numbers of hot flashes/24 hours, improving overall WHQ scores.

Limitations:

  • The study had a small sample size, with less than 30 patients.
  • There was a high number of drop-outs in EA group.

Nursing Implications:

HT is not recommended as a safe treatment for vasomotor symptoms for breast cancer survivors. Thus, the value of using that group to compare with a group that received EA is of concern. EA needs further investigation in larger sample sizes. Further research is needed for efficacy of EA in hot flash management for breast cancer survivors and in women treated with aromatase inhibitors experiencing hot flash distress, as this study did not address that phenomenon. 

Hammar, M., Frisk, J., Grimås, O., Höök, M., Spetz, A.C., & Wyon, Y. (1999). Acupuncture treatment of vasomotor symptoms in men with prostatic carcinoma: A pilot study. Journal of Urology, 161, 853–856.

doi:10.1016/S0022-5347(01)61789-0
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Study Purpose:

Evaluate acupuncture treatment 30 minutes twice weekly for 2 weeks and once a week for 10 weeks for the relief of hot flashes

Sample Characteristics:

Seven men with vasomotor symptoms due to castration underwent the prescribed acupuncture regimen.

Measurement Instruments/Methods:

Hot flashes were recorded in logbooks.

Results:

Of the seven men, six completed at least 10 weeks of acupuncture therapy, and all had a substantial decrease in the number of hot flashes (average 70% after 10 weeks). At three months after the last treatment, the number of flashes was 50% lower than before therapy. Therapy was discontinued after 10 weeks because of a femoral neck fracture in one man and after three weeks due to severe back pain in another subject.

Limitations:

Study limitations included very small sample size, short study duration, and use of a convenience sample

Harding, C., Harris, A., & Chadwick, D. (2008). Auricular acupuncture: A novel treatment for vasomotor symptoms associated with luteinizing-hormone releasing hormone agonist treatment for prostate cancer. British Journal of Urology International, 103, 186–190.

doi:10.1111/j.1464-410X.2008.07884.x
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Study Purpose:

To evaluate the role of auricular acupuncture (AA) in men receiving luteinizing-hormone releasing hormone (LHRH) analogues for prostate cancer on hot flash incidence and severity

Sample Characteristics:

The study enrolled 60 consecutive men with prostate cancer who were receiving on LHRH agonist treatment.  Their median age was74 years, and they received weekly AA for 10 weeks.

Measurement Instruments/Methods:

Patients recorded the frequency of hot flash episodes during the day and at night at 0, 4, and 10 weeks. Participants were asked to grade the intensity of their hot flashes on a 0–6 scale, with 6 representing maximum intensity, and they recorded these data at 0, 4, and 10 weeks.

Results:

95% of patients reported a decrease in the severity of symptoms, from a mean of 5.0 to 2.1 (Student’s test, p < 0.01).

Limitations:

Limitations of this study included using a convenience sample and absence of a control group.

Hervik, J., & Mjåland, J. (2009). Acupuncture for the treatment of hot flashes in breast cancer patients, a randomized, controlled trial. Breast Cancer Research and Treatment, 116, 311–316.

doi:10.1007/s10549-008-0210-3
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Study Purpose:

To examine the efficacy of acupuncture in women with breast cancer experiencing hot flashes as a result of anti-estrogen medication

Intervention Characteristics/Basic Study Process:

Patients were randomized to either 10 weeks of traditional Chinese acupuncture or sham acupuncture.

Sample Characteristics:

The trial reported on a sample of 59 women with breast cancer.

Study Design:

A prospective, controlled trial design was used.

Measurement Instruments/Methods:

  • Mean number of hot flashes at day and night were recorded prior to treatment, during the treatment period, and during the 12 weeks following treatment.
  • Kupperman Index was completed at baseline, at the end of the treatment period, and at 12 weeks following treatment.

Results:

During the treatment period, the mean number of hot flashes at day and night was significantly reduced by 50% and almost 60%, respectively, from baseline in the acupuncture group, and was further reduced by 30% both at day and night during the next 12 weeks. In the sham acupuncture group, a significant reduction of 25% in hot flashes at day was seen during treatment, but was reversed during the following 12 weeks. No reduction was seen in hot flashes at night. Kupperman Index was reduced by 44% from baseline to the end of the treatment period in the acupuncture group, and largely maintained 12 weeks after treatment ended. No corresponding changes were seen in the sham acupuncture group.

Limitations:

  • A placebo effect may have occurred.
  • The study had a small sample size.

Nursing Implications:

Longer studies are needed to see if effect continues.

Jeong, Y.J., Park, Y.S., Kwon, H.J., Shin, I.H., Bong, J.G., & Park, S.H. (2013). Acupuncture for the treatment of hot flashes in patients with breast cancer receiving antiestrogen therapy: A pilot study in Korean women. Journal of Alternative and Complementary Medicine, 19, 690–696. 

doi: 10.1089/acm.2012.0347
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Study Purpose:

To determine if acupuncture administered to Korean women receiving tamoxifen or anastrozole for breast cancer can be safe and feasible in controlling their hot flashes during eight weeks of intervention

Intervention Characteristics/Basic Study Process:

Each intervention session lasted 40 minutes and consisted of 20 ± 5 minutes of acupuncture. Patients received three sessions per week for four weeks for a total of 12 sessions. The following acupuncture points were selected for the intervention: GV 20, M-HN-3, HT 8, KI 10, and LV 2. Acupuncture was administered by a physician with three years of experience.  After appropriate skin preparation, eight needles were inserted 10-20 mm deep into the skin and were manipulated to obtain De Qi.  Needles were rotated after 10 minutes.  Data were recorded at baseline, weekly during the intervention (visits 5, 8, 11, and 13), and four weeks post study.

Sample Characteristics:

  • N = 10 
  • MEAN AGE = 46.60 years ± 4.93 (range = 38–53 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer diagnosis; pre-menopause = 80% and post-menopause = 20%
  • OTHER KEY SAMPLE CHARACTERISTICS: Previous treatments were surgery, radiotherapy, and chemotherapy in different proportions; any participant took dietary supplements concomitant to the study.

Setting:

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: East-West Medical Center at Daegu Catholic University Center in Daegu, Korea

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care, palliative care, and supportive care

Study Design:

Interventional study in a nonrandomized series of cases enrolled prospectively

Measurement Instruments/Methods:

Data was self-reported using a hot-flash diary to record number and severity of hot flashes. A visual analogue scale was used to record severity of hot flashes. A total score was calculated by multiplying the severity and frequency of hot flashes.

Results:

ANOVA was performed to analyze the differences from initial to final scores for hot flashes severity, frequency, and total hot flash score. 
 
The 10 women participants reported a significant decrease from initial to the last measure (F = 30.261, p < 0,001) in their mean VAS severity score of their hot flashes, and the benefit persists for four weeks after finalizing acupuncture intervention. Hot flashes frequency mean per day also shows a significant detriment from initial means 9.30 ± 9.72 to 2.80 ± 0.79 at final point. 
 
Facial temperature scores are not reported in the study, although authors describe this in the intervention. 

Conclusions:

Findings are limited in explaining completely the efficacy of acupuncture to decrease hot flashes in women receiving tamoxifen or anastrozole to treat breast cancer. Although safety and statistical significance result from the study, the sample size, the lack of a random design, and the lack of a control group limit the generalization of data.

Limitations:

  • Small sample of < 30
  • Baseline sample/group differences of import
  • Risk of bias from no control group
  • Risk of bias from no blinding
  • Risk of bias from no random assignment
  • Risk of bias from no appropriate attentional control condition
  • Risk of bias related to sample characteristics
  • Selective outcomes reporting
  • Key sample group differences that could influence results 
  • Findings not generalizable
  • Other limitations/explanation: Previous cancer treatments in the sample group, such as chemotherapy or radiotherapy, can also affect the final outcome. Pre- and post-menopausal women should not be in the same group in the sample. No control group is the main limitation. Follow-up described to eight weeks is limited. Subjective measures self-reported by participants may differ from other objective ways of measuring the symptom. Comparison with other references in the literature shows that Korean technic and Chinese technic are performed differently.

Nursing Implications:

Implications for cancer nurses are limited since applying this intervention requires professional training. However, oncology nurses are vital in providing information to patients about complementary treatments that are safe and feasible in controlling hot flashes related to hormone cancer treatments. No related adverse events were described.

Liljegren, A., Gunnarsson, P., Landgren, B. M., Robeus, N., Johansson, H., & Rotstein, S. (2012). Reducing vasomotor symptoms with acupuncture in breast cancer patients treated with adjuvant tamoxifen: a randomized controlled trial. Breast Cancer Research and Treatment, 135, 791-798.

doi:10.1007/s10549-010-1283-3
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Study Purpose:

The study evaluated the value of true acupuncture in management of hot flashes in women with breast cancer receiving tamoxifen.

Intervention Characteristics/Basic Study Process:

Patients  on tamoxifen who experienced vasomotor symptoms were randomly assigned to true acupuncture or control acupuncture groups.  All patients were treated for 20 minutes twice weekly for 5 weeks in an outpatient clinic.  In the true acupuncture group, 8 needles were inserted at defined points.  In the control group, needles did not penetrate the skin, but were rotated until the patient felt a superficial sensation on the skin.  In the control group, the needles were placed at 8 sites, as well.   Study data were collected at baseline, week 6, and week 18.

Sample Characteristics:

The study enrolled 74 women with a mean age of 58 years. 

  • KEY DISEASE CHARACTERISTICS: All had breast cancer  and were receiving tamoxifen.
  • OTHER KEY SAMPLE CHARACTERISTICS:
    • 70% were post menopausal
    • 69% had received previous estrogen replacement therapy
    • 22% were also receiving SSRIs
    • 41% in the treatment group and 38% in the control group had received previous acupuncture therapy

Setting:

The study was conducted in an outpatient clinic in Sweden.

Phase of Care and Clinical Applications:

PHASE OF CARE: Transition phase after active treatment

Study Design:

The study was a single-blind, randomized, sham-controlled trial.

Measurement Instruments/Methods:

Instruments/measures included:

  • Vasomotor symptom intensity – 5 point self-report scale
  • Hot flush diary

Results:

There were no significant differences between groups in frequency of hot flushes and sweating over time.  The acupuncture group reported less severity of symptoms of sweating at night ( p = .03).    Both groups demonstrated significant improvement in symptoms over time.  Of those who received true acupuncture, 69.4% thought they had receiving true acupuncture, while 63.9% of those in the control group thought they had received true acupuncture, suggesting that patient blinding was accomplished.  One adverse event of bleeding and bruising was reported in 1 control patient.

Conclusions:

Findings suggest little difference in symptoms between those who received acupuncture versus those who received sham acupuncture.  Acupuncture may have some benefit, but it is unclear if this also reflects a placebo effect from the intervention.

Limitations:

Study limitations included:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement/methods not well described 
  • Measurement validity/reliability questionable 
  • It is unclear how a control patient could have experienced the adverse event of bleeding at a sham acupuncture site when the sham needles did not puncture the skin.  This raises questions about fidelity to the sham procedure used. 
  • Investigators who collected the data were not blinded. 
  • It is unclear how the frequency of night sweatings was actually measured and what was used for the analysis – the measurement method described does not specify frequency of episodes and does not specify time of day of episodes. There was no analysis of significance of  baseline symptom differences between groups, or correction of changes over time with baseline symptom levels

Nursing Implications:

This study provides limited evidence regarding the effect of acupuncture for vasomotor symptoms in women with breast cancer treated with tamoxifen.  It does demonstrate questions regarding potential placebo effects of acupuncture or placebo effects of sham acupuncture procedures that complicate research design in this area. Appropriate placebo or comparison control groups for this type of research need to be identified.

Otte, J. L., Carpenter, J. S., Zhong, X., & Johnstone, P. A. (2011). Feasibility study of acupuncture for reducing sleep disturbances and hot flashes in postmenopausal breast cancer survivors. Clinical Nurse Specialist, 25, 228–236.

doi: 10.1097/NUR.0b013e318229950b
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Study Purpose:

To evaluate the feasibility of acupuncture as a treatment for concurrent hot flashes (HFs) and sleep disturbances.

Intervention Characteristics/Basic Study Process:

  • This was an eight-week study using certified community acupuncture providers for three acupuncture treatments over a two-week period per patient.
  • Wrist actigraphy and sternal skin conductance was used for measuring HF occurrence and duration.
  • Completion of questionnaires was required at baseline and weeks 5 and 8.
  • Self-reported symptom data were gathered during treatment and each week at follow-up.

Sample Characteristics:

  • The sample was comprised of 10 female patients. 
  • Patients were 18 years or older; mean age was 53 years.
  • Patients had breast cancer stage 1; a possible other stage was not defined.
  • Patients were perimenopausal/postmenopausal.
  • Patients could not change sleep or HF medication during study.

Patients were included if they

  • Reported sleep disturbances over the past month
  • Had daily HFs
  • Lived within a 100-mile radius of the study site
  • Spoke English
  • Were diagnosed with nonmetastatic breast cancer
  • Had no history of other cancers
  • Were at least three months postcompletion of surgery, radiotherapy, and chemotherapy.

Setting:

  • Multisite   
  • Outpatient   
  • University

Phase of Care and Clinical Applications:

  • Patients were undergoing the transition phase after initial treatment.
  • The study has clinical applicability for late effects and survivorship.

Study Design:

The study used a quasiexperimental, single-group, nonrandomized design.

Measurement Instruments/Methods:

  • Protocol for acupuncture points
  • Demographic questionnaire
  • Disease and treatment information
  • Acupuncture session notes
  • 6-item Devilly and Borkovec Outcome/Expectancy Credibility Questionnaire (DBO/ECQ)
  • Wrist Actigraphy and Sternal Skin Conductance Monitoring Biolog model 3991
  • Sleep diary

Results:

Ten breast cancer survivors (BSCs) completed baseline, and two withdrew after the last baseline assessment. The remaining eight BSCs completed all time points. There was no significant difference among acupuncture points used per patient for the three treatments or the four providers. Sessions were mainly conducted at a single clinic. The study described patients as having high outcome expectations for acupuncture effectiveness and its acceptability. Sleep patterns were affected:  sleep latency increased and time spent awake after sleep onset decreased. The average number of HFs decreased.

Conclusions:

Expectations for and credibility and acceptability of acupuncture in managing vasomotor and sleep symptoms were high for the BSCs.The study demonstrated minimal improvement in total sleep time and some sleep latency improvement immediately following completion of acupuncture sessions but not at week 8 (not a sustainable effect); waking after sleep onset improved.

Limitations:

  • The study had a small sample size, with less than 30 patients.
  • The majority of the patients enrolled were not taking a hormone modulator at the time of enrollment; therefore, the authors were unable to extrapolate the results found here to apply to BSCs using aromatase inhibitors or tamoxifen in treating their breast cancer.
  • The number of acupuncture treatments was limited to three over two weeks.
  • Reproducible results were limited because the study mainly occurred at one site with one acupuncturist.
  • No control group was used for comparison to the intervention of acupuncture.

Nursing Implications:

The study showed that women may be amenable, especially highly motivated women, to pursuing acupuncture as a nonpharmacological approach to managing HFs. Further investigations with larger sample sizes are needed to note if there are any correlations with socioeconomic/cultural influences for the acceptability of acupuncture and to compare acupuncture to another intervention for the control of HFs/sleep quality.

Walker, E.M., Rodriguez, A.I., Kohn, B., Ball, R.M., Pegg, J., Pocock, J.R., … Levine, R.A. (2010). Acupuncture versus venlafaxine for the management of vasomotor symptoms in patients with hormone receptor-positive breast cancer: A randomized controlled trial. Journal of Clinical Oncology, 28, 634–640.

doi:10.1200/JCO.2009.23.5150
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Intervention Characteristics/Basic Study Process:

The study compared acupuncture tovenlafaxine for 12 weeks with health measurements for one year.

Sample Characteristics:

The enrolled 50 women, with 25 randomized to each arm. 

Inclusion criteria:

  • Stage 0–III pre- or postmenopausal patients with breast cancer on hormone therapy with tamoxifen or arimidex
  • 14 hot flashes per week
  • 18 years of age
  • May have been treated locally with surgery or radiation and must have completed chemotherapy
  • May be receiving radiation therapy but otherwise must be within five years after treatment
  • Must be on a stable dose of hormone therapy for four weeks or more without plans to discontinue therapy for the duration of the study
  • Karnofsky performance status
  • Life expectancy of at least six months

Study Design:

This was a randomized, controlled trial.

Measurement Instruments/Methods:

Participants completed:

  • Hot Flash Diary (number and severity of hot flashes
  • Menopause- Specific Quality of Life Questionnaire (MenQOL)

Results:

By two weeks after treatment, the venlafaxine group experienced significant decreases in hot flashes, and hot flashes in the acupuncture group remained at low levels. The venlafaxine group experienced 18 incidences of adverse effects (e.g., nausea, dry mouth, dizziness, anxiety), whereas the acupuncture group experienced no negative adverse effects. Acupuncture had the additional benefit of increased sex drive in some women, and most reported an improvement in their energy, clarity of thought, and sense of well-being.

Conclusions:

Both groups exhibited significant decreases in hot flashes, depressive symptoms, and other QOL symptoms. Acupuncture was as effective as venlafaxine.

Limitations:

The study was limited by its small sample size.

Systematic Review/Meta-Analysis

Dodin, S., Blanchet, C., Marc, I., Ernst, E., Wu, T., Vaillancourt, C., . . . Maunsell, E. (2013). Acupuncture for menopausal hot flushes. The Cochrane Database of Systematic Reviews, 7, CD007410. 

doi: 10.1002/14651858.CD007410.pub2
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Purpose:

STUDY PURPOSE: To determine whether acupuncture is effective and safe for reducing hot flashes and improving the quality of life of menopausal women with vasomotor symptoms

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: Cochrane Menstrual Disorders and Subfertility Group Specialised Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, CINAHL, PsycINFO, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC), China National Knowledge Infrastructure (CNKI), VIP database, Dissertation Abstracts International, Current Controlled Trials, Clinicaltrials.gov, National Center for Complementary and Alternative Medicine (NCCAM), BIOSIS, AMED, Acubriefs, and Acubase
 
KEYWORDS: Acupuncture; hot flashes; hot flushes
 
INCLUSION CRITERIA: Randomized controlled trials comparing any type of acupuncture to no treatment/control or other treatments for reducing menopausal hot flashes and improving the quality of life in symptomatic perimenopausal and postmenopausal women
 
EXCLUSION CRITERIA: Qualitative and observational research; case history and abstracts of annual meeting with no further scientific publication of their results; insufficient data information related to vasomotor symptoms in order to meet the review inclusion criteria; duplication studies; and no randomization

Literature Evaluated:

TOTAL REFERENCES RETRIEVED = 384
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Identified and screened 384 references; excluded 322 references based on the title and abstract, and retrieved 62 references for more detailed evaluation

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 16
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,155 women 
  • KEY SAMPLE CHARACTERISTICS: Mean participant age 51–57 years; experiencing hot flashes at baseline including perimenopausal, menopausal, and postmenopausal women

Phase of Care and Clinical Applications:

PHASE OF CARE: Mutliple phases of care

Results:

When acupuncture was compared with sham acupuncture, there was no evidence of any difference in their effects on hot flashes. When acupuncture was compared with no treatment, there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than hormonal therapy. In assessing quality of life measures, acupuncture was significantly less effective than hormonal therapy, but traditional acupuncture was significantly more effective than no intervention. One small study compared acupuncture with relaxation and showed no significant difference between the groups. Five studies included women with breast cancer; one study excluded them. No significant difference existed between acupuncture and other interventions on quality of life. Data on adverse effects was lacking. The diary of vasomotor symptoms was the most commonly used tool to quantify hot flash frequency and severity.

Conclusions:

Studies that compared acupuncture versus sham acupuncture did not provide sufficient evidence to show whether acupuncture is an effective treatment for vasomotor symptoms. A debate exists about whether sham acupuncture is a placebo intervention or possesses an active effect related to peripheral sensory stimulation. Currently, insufficient evidence exists to determine whether acupuncture is effective as a treatment for hot flashes. Data on adverse effects were not included. Further high-quality studies are needed to determine the effect of acupuncture on vasomotor symptoms. An exclusion of the one study with breast cancer survivors comparing acupuncture with sham acupuncture had shown no difference related to hot flush severity.

Limitations:

The evidence was of low or very low quality, and the studies comparing acupuncture versus no treatment or hormone therapy were not controlled with sham acupuncture or placebo hormone therapy. Most had small sample sizes and questionable methodological quality. Many had an inadequate level of blinding and no intention-to-treat analysis.

Nursing Implications:

This review included menopausal women and women with breast cancer. Risk of infection should be considered in immunosuppressed patients. Studies with larger sample sizes of women with breast cancer are needed to determine the effectiveness of acupuncture for treating hot flashes in this group.

Garcia, M. K., McQuade, J., Haddad, R., Patel, S., Lee, R., Yang, P., . . . Cohen, L. (2013). Systematic review of acupuncture in cancer care: a synthesis of the evidence. Journal of Clinical Oncology, 31, 952–960.

doi: 10.1200/JCO.2012.43.5818
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Purpose:

To evaluate the effectiveness of acupuncture for symptom control in patients with cancer.

Search Strategy:

Databases searched were MEDLINE, EMBASE, CINAHL, Cochrane Collaboration, Scopus, and PubMed through December 2011.

Search keywords were acupuncture, electroacupuncture, moxibustion, Chinese medicine, Asian medicine, and keywords that included cancer and cancer symptoms.

Studies were included in the review if they

  • Were randomized, clinical trials (RCTs)
  • Involved acupuncture with needle insertion
  • Compared acupuncture to control, placebo, or sham acupuncture.

Studies were excluded from the review if they

  • Compared two active acupuncture forms, acupressure, or other interventions similar to acupuncture that did not involve needle insertion
  • Did not measure the effect of acupuncture on symptoms
  • Were considered gray literature (i.e., not generally accessible).

Literature Evaluated:

In total, 3,494 references were retrieved and evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions.

Sample Characteristics:

  • The final number of studies included was 41.
  • The authors did not provide the sample range across studies, total number of patients, disease types, or characteristics.

Results:

Studies addressed potential management of the following symptoms:

  • Pain:  Eleven RCTs met the criteria for analysis. No large trials reported positive results or were of good quality.
  • Chemotherapy-Induced Nausea and Vomiting (CINV):  Eleven RCTs met the criteria for analysis. One large study with a low risk of bias showed between-group effect sizes for acupuncture versus sham (0.80) and for acupuncture versus usual care (1.10).
  • Fatigue:  Three RCTs met the criteria for analysis. All had high risks of bias, and two had negative outcomes.
  • Hot Flashes:  Seven RCTs met the criteria for analysis. None had a low risk of bias.
  • Anxiety or Depression:  Five of the six RCTs analyzed showed positive results. All five had high risks of bias.
  • Sleep:  Three RCTs met the criteria for analysis, and all three reported positive outcomes and had high risks of bias.

Conclusions:

The strongest evidence that the study produced showed that acupuncture may be effective for the management of CINV. The study did not show acupuncture to be efficacious in the treatment of other symptoms.

Limitations:

The studies included were of low quality.

Nursing Implications:

Available evidence, which was limited, did not support the claim that acupuncture is effective in alleviating various adverse symptoms in adults with cancer. Additional research is needed to determine the efficacy. The findings of this analysis suggested that patients with uncontrolled CINV may be appropriate candidates for acupuncture referral. For the treatment of other symptoms, the efficacy is undetermined.


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