Effectiveness Not Established

Acupuncture/Electroacupuncture

for Fatigue

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). Electroacupuncture involves the application of a pulsating electrical current to acupuncture needles to stimulate the acupoint via an electrode that is attached to the acupuncture needles. The electrical current substitutes for maneuvering the needles by hand. The P6 acupuncture point is most commonly used for nausea and vomiting. Acupuncture and electroacupuncture have been evaluated for their effects on anxiety, chemotherapy-induced nausea and vomiting, dyspnea, pain, depression, lymphedema, hot flashes, sleep–wake disturbances, peripheral neuropathy, and fatigue in patients with cancer.

 

Systematic Review/Meta-Analysis

Finnegan-John, J., Molassiotis, A., Richardson, A., & Ream, E. (2013). A systematic review of complementary and alternative medicine interventions for the management of cancer-related fatigue. Integrative Cancer Therapies, 12, 276–290.

Purpose

To appraise the evidence of the effectiveness of complementary and alternative medicine (CAM) interventions in reducing cancer-related fatigue (CRF).

Search Strategy

Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, British Nursing Index, and Evidence-Based Medicine Reviews (EBMR).

The specific MEDLINE search strategy was provided.

Studies were included in the review if

  • They were published in the English language
  • They used a randomized, controlled trial or quasiexperimental design
  • Patients were older than 18 years
  • They tested at least one CAM as defined by the National Center for Complementary and Alternative Medicine (NCCAM)
  • They measured fatigue and had CRF as primary or secondary outcome.

Studies were excluded from the review if they were psychosocial interventions.

Literature Evaluated

In total, 2,398 references were retrieved. The Jadad scale was used to appraise study quality.

Sample Characteristics

  • The final number of studies included was 20. 
  • The total sample included 1,560 patients (sample range 13–200).
  • The majority of studies were performed in patients during treatment. 
  • Most studies were performed in women with breast cancer.

Phase of Care and Clinical Applications

Patients were undergoing multiple phases of care.

Results

During treatment, the intervention that seemed to be the most effective was hypnosis (one study), whereas ginseng provided promising results (one study). Massage, multivitamins, herbs, yoga, relaxation therapy, and combined education and acupuncture were less effective. Sound and reliable conclusions could not be drawn due to the poor quality of the studies and varying interventions, timings, and dosages. Most studies did not describe processes to ensure intervention integrity, and the “dose” was often not well reported.

Conclusions

Evidence from the trials reviewed was not sufficient to support the use of the interventions examined.

Limitations

  • Studies were of low quality. 
  • The appraisal method did not include consideration of factors such as sample size and power or difference between single and multisite studies.

Nursing Implications

Current evidence suggests a very limited role of CAM to contribute to improvement in fatigue among patients with cancer.

Print

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.

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.

Print

He, X.R., Wang, Q., & Li, P.P. (2013). Acupuncture and moxibustion for cancer-related fatigue: A systematic review and meta-analysis. Asian Pacific Journal of Cancer Prevention, 14, 3067–3074.

Purpose

STUDY PURPOSE: To evaluate the auxiliary effectiveness of acupuncture and moxibustion in the treatment of cancer-related fatigue (CRF)

TYPE OF STUDY: Systematic review and meta analysis

Search Strategy

DATABASES USED: PubMed, EMBASE, Cochrane Library, ISI Web of Knowledge, Chinese Biomedical Literature Database, Chinese Journal Full-test Database, Chinese Scientific Journal Full-text Database, and Wanfang Data
 
KEYWORDS: acupuncture, moxibustion, acupressure, cancer, carcinoma, neoplasm, fatigue
 
INCLUSION CRITERIA: Adults older than age 18 with cancer, without bleeding disorders or other comorbid disease that would effect the data, who were scheduled to receive chemotherapy or radiation during the study.
 
EXCLUSION CRITERIA: Patients with cancer who did not receive chemotherapy or radiation and/or have hematological issues

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 357 studies were initially retrieved.
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: 167 articles received in-depth “sifting.”

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED =  7 prospective RCT
  • TOTAL PATIENTS INCLUDED IN REVIEW = 804
  • KEY SAMPLE CHARACTERISTICS: Patients with cancer, mean age 55 years in five trials; mean age 70 years in two trials. Two studies concentrated on breast cancer; for other studies, the cancers varied.

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Results

Fatigue declined over time for all groups: true acupuncture, sham acupuncture, and controls. However, no significant difference between groups was noted. Three studies looked at moxibustion lacking information on adverse effects and inadequate methodology.

Conclusions

The authors concluded that data is currently insufficient to recommend as an intervention for CRF other than when traditional interventions fail. No data exist to recommend this over conventional interventions, which are not described in this article.

Limitations

  • The article did not describe enhanced/routine care.
  • The authors described patient’s interest in interventions but never described physiology of effect for acupressure/puncture or moxibustion in CRF.

Nursing Implications

Insufficient date to recommend.

Print

Ling, W., Lui, L.Y.Y., So, W.K.W., & Chan, K. (2014). Effects of acupuncture and acupressure on cancer-related fatigue: A systematic review. Oncology Nursing Forum, 41, 581–592. 

Purpose

STUDY PURPOSE: To critically examine the evidence for acupuncture and acupressure in the management of cancer-related fatigue (CRF) in adult patients with cancer
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: AMED, British Nursing Index, CINAHL, Evidence-Based Medicine Reviews, Embase, Journals@Ovid, MEDLINE, Physiotherapy Evidence Database, ProQuest, PubMed, ScienceDirect, SpringerLink, TRIP, Wiley Online Library, China Academic Journals Full-Text Database, and Wanfang Data China Online Journals
 
KEYWORDS: Fatigue, cancer, acupuncture, and acupressure
 
INCLUSION CRITERIA: Randomized, controlled trials (RCTs) of acupuncture and acupressure for CRF in adult patients with cancer regardless of the type of cancer, duration of disease, and type of treatment received. CRF was a key outcome to be clearly measured and reported. Only studies published in English or Chinese were included.
 
EXCLUSION CRITERIA: Articles whose sole target participants were patients with fatigue other than CRF were excluded. Studies using shiatsu or reflexology for therapeutic intervention also were excluded.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 716
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two reviewers independently appraised the methodologic quality of the full texts of all potentially eligible articles by means of the standard checklist for RCTs developed by the Scottish Intercollegiate Guidelines Network ([SIGN], 2014). The 10 appraisal criteria for internal validity in the SIGN checklist were equally weighted. Most studies were underpowered or consisted of small sample sizes.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 11
  • TOTAL PATIENTS INCLUDED IN REVIEW = 731
  • SAMPLE RANGE ACROSS STUDIES: 13–302 patients
  • KEY SAMPLE CHARACTERISTICS: Age range was 20–81 years; average age was 52–59 years; variety of diagnoses but mainly breast cancer

Phase of Care and Clinical Applications

PHASE OF CARE: All phases

Results

Seven out of eight acupuncture studies showed improvement in CRF, but only four reached statistic significance. All four acupressure studies showed significant improvement. The four studies that showed improvement during initial treatment determined that results could be maintained for as many as 12 weeks. However, the maintenance study did not determine any extra benefit. Three studies reported no side effects. In other studies, adverse events were identified as minor and transient. Four studies used acupressure. These showed positive results. However, three studies were underpowered, and the comparability of study groups was questionable.

Conclusions

Acupuncture and acupressure may be helpful in reducing fatigue. However, because of multiple methodologic flaws in studies reviewed, no firm conclusions can be made regarding the effectiveness of these interventions.

Limitations

  • Heterogeneity of the samples, sizes, types of cancer, treatments administered, length, dose, and intensity of treatment
  • Studies had multiple flaws

Nursing Implications

Acupuncture and acupressure appear to be safe and may be effective. Therefore, this intervention may be suggested for patients with CRF. Additional research is needed to confirm their effectiveness.

Print

Posadzki, P., Moon, T. W., Choi, T. Y., Park, T. Y., Lee, M. S., & Ernst, E. (2013). Acupuncture for cancer-related fatigue: a systematic review of randomized clinical trials. Supportive Care in Cancer, 21, 2067–2073.

Purpose

To review the evidence regarding acupuncture for cancer-related fatigue (CRF).

Search Strategy

Databases searched were PRISMA, AMED, CINAHL, EMBASE, MEDLINE, PsycINFO, Cochrane Collaboration, one Chinese, three Japanese, and four Korean databases.

Search keywords were acupuncture therapy or electroacupuncture, cancer, and fatigue. A full listing of search terms used was provided.

Studies were included in the review if they were randomized, controlled trials (RCTs) investigating the effect of acupuncture treatments on CRF.

The exclusion criteria were not specified.

Literature Evaluated

In total, 2,419 references were retrieved. The Cochrane tool was used to assess research method quality.

Sample Characteristics

  • The final number of studies included was seven RCTs (548 patients).
  • The sample range across studies was not provided.

Results

Of the seven RCTs found for inclusion, four favored acupuncture and three showed no effect. Most studies had serious limitations and methodological flaws. Of the two studies that were of relatively high quality, one showed no benefit over sham acupuncture and one favored the intervention over sham and wait-list control. Three of the four studies that controlled for placebo effect showed no benefit of acupuncture.

Conclusions

The evidence for acupuncture in the management of CRF is ambiguous, conflicting, and inconclusive.

Limitations

  • The review included a small number of studies.
  • The included studies were of low quality. 
  • Heterogeneity among studies precluded meta-analysis.

Nursing Implications

Findings showed that evidence is lacking in support of acupuncture for the management of CRF.

Print

Zeng, Y., Luo, T., Finnegan-John, J., & Cheng, A.S. (2013). Meta-analysis of randomized controlled trials of acupuncture for cancer-related fatigue. Integrative Cancer Therapies, 13, 193–200.

Purpose

STUDY PURPOSE: To examine effects of acupuncture on cancer-related fatigue

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Medline, CINAHL®, Scopus, Cochrane Library, and CAJ full-text database
 
KEYWORDS: acupuncture, acupuncture therapy, fatigue, cancer-fatigue, cancer, carcinoma, tumour or tumor, malignance
 
INCLUSION CRITERIA: Articles published in English or Chinese, RCTs of acupuncture for the treatment of cancer-related fatigue; initially cancer survivors expanded to patients with cancer undergoing treatment
 
EXCLUSION CRITERIA: Studies of acupuncture that did not involve needle insertion, such as laser acupuncture or electro-acupuncture

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 488 records screened; 349 records excluded; 139 full-text articles assessed for eligibility
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Data extracted by two authors; methodological quality of included studies assessed by two authors independently; risk of bias of methodological quality assessed using the Cochrane Assessment Tool

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 7
  • TOTAL PATIENTS INCLUDED IN REVIEW = 689
  • SAMPLE RANGE ACROSS STUDIES: 12–302
  • KEY SAMPLE CHARACTERISTICS: 568 were female; 121 unknown; primarily diagnosed with breast cancer. No other demographic information provided.

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care

Results

Three of seven trials had high risk of bias; one trial (combination of acupuncture with educational interventions compared to usual care) showed significant differences but could not parse out if acupuncture or education caused the effects; pooled analysis showed no difference in acupuncture compared to sham acupuncture or usual care in cancer-related fatigue, although forest plots indicate in favor of acupuncture; pooled analysis also showed no significant difference in quality of life and functioning.

Conclusions

The meta-analysis did not provide evidence to support the use of acupuncture in reducing cancer-related fatigue. There was no evidence that acupuncture was harmful.

Limitations

  • Small number of studies
  • Primarily women with breast cancer
  • Methodological bias in many studies

Nursing Implications

No evidence to recommend acupuncture for cancer-related fatigue, although no evidence indicates that it is harmful either. Rigorously designed RCTs are needed.

Print

Research Evidence Summaries

Balk, J., Day, R., Rosenzweig, M., & Beriwal, S. (2009). Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue. Journal of the Society for Integrative Oncology, 7, 4–11.

Study Purpose

To obtain feasibility and effect size data for the intervention of true acupuncture on cancer-related fatigue (CRF) in patients receiving radiation therapy.

Intervention Characteristics/Basic Study Process

Participants were randomized to receive acupuncture or sham acupuncture; there were three real intervention assignments for every two sham assignments. Needles were in place for 30 minutes per session, and participants had treatments once or twice per week during the four to six weeks of the trial. Needle placement for true and sham interventions were specifically described in the report.

Sample Characteristics

  • In total, 27 females receiving radiation therapy completed the study:  11 were randomized to the sham procedure and 16 were randomized to acupuncture.
  • Mean age was 54.1 years (standard deviation = 9.4 years).
  • All but one participant had breast cancer.
  • Of the sample, 44% had also received chemotherapy (74% of the acupuncture group versus 44% of the sham group).

Setting

  • Single site
  • Magee Womens’ Hospital, Pittsburgh, PA

Study Design

The study was a double-blind, placebo-controlled, randomized trial.

Measurement Instruments/Methods

  • The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale was measured at baseline and three, six, and 10 weeks.
  • Quality of life (QOL) was measured with the Short Form 36 (SF-36) Health Survey at baseline and six and 10 weeks.
  • The Cancer-Related Fatigue Distress Scale (CRFDS) was measured at baseline and six and 10 weeks.
  • Confounding variables measured included:  Brief Symptom Inventory (BSI-18) and Center for Epidemiologic Studies Depression Scale (CEDS).

Results

FACIT-F scores in the true acupuncture group improved more over time than those in the sham group, but the differences were not significant. QOL and depression scores improved in both groups over time significantly but were not different between the groups. Observations regarding feasibility during the study included:  there was difficulty getting patients enrolled; changes in staff, staffing, and procedures made protocol use difficult; and due to procedures to maintain blinding and use of sham procedures, therapists felt that there was less needle manipulation possible with the protocol used for true acupuncture and felt it was difficult to determine the actual depth of needle insertion. It was also felt that the sham procedure was actually more than sham, although less than true acupuncture, due to skin and pressure stimulation.

Conclusions

It was concluded that feasibility to conduct this type of trial in a large group of patients was low. Findings of this study did not support the use of acupuncture to reduce fatigue in patients receiving radiation therapy.

Limitations

  • The study had a small sample size.
  • It was not clear, or discussed, how many patients in either group received one or two sessions per week during the trial or whether any differences were associated with the frequency of treatment.
  • It was noted that the sham/placebo control procedures were inadequate to provide a true control.
  • There was no standard care comparison group.
  • Improvements in fatigue, QOL, and depression over time may have been associated with increased attention from trial participation rather than any effect from study interventions.
  • The study was not sufficiently powered, and the sample size was too small to differentiate between the groups and identify the associated effect size.
Print

Deng, G., Chan, Y., Sjoberg, D., Vickers, A., Yeung, K.S., Kris, M., . . . Cassileth, B. (2013). Acupuncture for the treatment of post-chemotherapy chronic fatigue: a randomized, blinded, sham-controlled trial. Supportive Care in Cancer, 21, 1735–1741.

Study Purpose

To determine if acupuncture reduced cancer-related fatigue (CRF) more effectively than did sham acupuncture.

Intervention Characteristics/Basic Study Process

Patients were randomized to an acupuncture or sham control group. Treatments were given once a week over six weeks. In the acupuncture group, a total of 14 needles were inserted at defined points during each session. The needles were stimulated manually and retained for 20 minutes. Sham needles, used in the control group, were blunt-tipped, moved up inside their handles when pressed against the skin, and did not penetrate the skin. In the control group, sham needles were applied in the same number and using the same technique as were the needles in the acupuncture group. Outcome measures were obtained at two weeks and at one week prior to the start of interventions and again at 42 and 49 days after completion.

Sample Characteristics

  • The study reported a sample of 74 patients (82% female, 18% male).
  • Mean patient age was 53.5 years (range 45–59).
  • Patients had multiple tumor types, and more than half had breast cancer.
  • All had completed a course of chemotherapy at least 60 days prior to the study.

Setting

  • Single site
  • Outpatient
  • Memorial Sloan Kettering Cancer Center, New York City, NY

Phase of Care and Clinical Applications

Patients were undergoing the transition phase after initial treatment.

Study Design

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

Measurement Instruments/Methods

  • Brief Fatigue Inventory (BFI)
  • Hospital Anxiety and Depression Scale (HADS)
  • Functional Assessment of Cancer Therapy-General (FACT-G)

Results

  • At least 87% of participants completed all sessions.
  • In both groups, total fatigue scores declined by approximately one point between baseline and follow-up.
  • There were no differences between groups.
  • Neither HADS nor FACT-G measures showed significant differences between groups.

Conclusions

The study showed that acupuncture had no effect on the symptoms of fatigue, anxiety, or depression.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • The drop-out rate was greater than 24%.
  • The authors performed an intention-to-treat analysis, but they did not report their exact procedures.

Nursing Implications

The study did not demonstrate that acupuncture had an effect on fatigue, anxiety, or depression. The study contributes to a growing body of research that shows conflicting results regarding the effectiveness of this intervention for the management of fatigue. It has been shown that symptoms such as fatigue and anxiety tend to decline over time among patients with cancer. It is unclear if the timing in this study affected the results; symptoms may have declined with or without the intervention.

Print

Johnston, M. F., Hays, R. D., Subramanian, S. K., Elashoff, R. M., Axe, E. K., Li, J. J., . . . Hui, K. K. (2011). Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complementary and Alternative Medicine, 11, 49.

Study Purpose

This small pilot study had two objectives:  (1) to design a strategy for recruitment tailored to the institutional environment and therapeutic intervention and (2) to collect evidence of preliminary effects.

Intervention Characteristics/Basic Study Process

In a two-part intervention, patients were first taught to improve self-care with regard to exercise, nutrition, and cognitive-behavioral techniques over a four-week period. They were then provided with eight weekly 50-minute acupuncture sessions. This therapeutic protocol references a conceptual framework derived from two theories—Social Cognitive Theory and Integrative Medicine Theory—but did not provide a description of the theory to match the interventions (exercise, nutrition, cognitive therapy, or acupuncture) with conceptual variables in the model.

Sample Characteristics

  • The sample was comprised of 13 women with breast cancer.   
  • Mean age was 54 years (range 18–65). 
  • About two-thirds of the patients were white.

Setting

  • Single site  
  • University of California Los Angeles Center for East-West Medicine
     

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 randomized, controlled feasibility study.

Measurement Instruments/Methods

  • Brief Fatigue Inventory (BFI) to assess cancer-related fatigue (self-reported)
  • Functional Assessment of Cancer Therapy–Cognitive Function, version 2 (FACT-COGv2) to measure three dimensions of perceived cognitive impairment:  cognitive problems, impact on functioning, and impact on health-related quality of life (self-assessment without objective measures)

Results

Failure of the recruitment methods led to the development of a tailored recruitment strategy. The intervention was said to be associated with a 2.38-point decline in fatigue (BFI) (90% confidence interval [0.586, 5.014]; p < 0.10). Differences in perceived cognitive dysfunction outcomes were not statistically significant between the two groups over time. The authors talked about using a pooled standard deviation for the BFI at baseline to compare the means of the two groups to determine the effect size.

Conclusions

An effective recruitment strategy is necessary for the execution of any randomized, controlled trial. The conceptual framework integrating social cognitive theory and integrative medicine was not effectively operationalized.

Limitations

  • The pooled standard deviation was not reported. It was unclear how the Cohen’s D metric was applied to this small study.
  • The study had a small sample size, with less than 30 patients; 13 patients were randomized of 40 recruited.
  • The study had a poor design.
  • Numerous confounding variables were not controlled for in the first part of the intervention in which patients were taught to improve self-care by optimizing exercise routines, improving nutrition, and implementing various cognitive-behavioral techniques.
  • The tailored recruitment strategy of two two-hour recruitment sessions is labor intensive to yield only 5 interested patients.
  • One patient assigned to the control group actually received acupuncture and patient education, but his/her results were calculated with the control group.
  • The study was nonblinded.

Nursing Implications

Investigation into outcomes attributed to specific patient education interventions might first be warranted before blending such an educational intervention with a complimentary/alternative therapy studying efficacy on cancer-related fatigue.

Print

Mao, J.J., Farrar, J.T., Bruner, D., Zee, J., Bowman, M., Seluzicki, C., . . . Xie, S.X. (2014). Electroacupuncture for fatigue, sleep, and psychological distress in breast cancer patients with aromatase inhibitor-related arthralgia: A randomized trial. Cancer, 23, 3744–3751. 

Study Purpose

To examine electroacupuncture (EA) compared to sham acupuncture (SA) and a waitlist control (WLC) group to determine effectiveness on fatigue, sleep disturbance, depression, and anxiety in postmenopausal breast cancer survivors who reported joint pain, or arthralgia, related to aromatase inhibitors (anastrazole, letrozole, exemestane)

Intervention Characteristics/Basic Study Process

Acupuncture interventions were administered by two licensed acupuncturists (not physicians). Ten treatments were administered over eight weeks with two treatments during each of the first two weeks followed by one treatment per week for the following six weeks. The EA and SA treatments were administered by the same two acupuncturists. Procedures for the two groups differed in the placement of the acupuncture needles and actual versus sham electrical stimulation using a transcutaneous electrical nerve stimulation (TENS) unit. The same timing and duration of treatments was used for each group.

Sample Characteristics

  • N = 67 (159 were screened; 76 were enrolled; 9 were excluded during the next round of evaluations; 4 were lost to follow-up by time 2 [4 weeks] and 4 more were lost to follow-up by time 3 [12 weeks])  
  • MEAN AGE: 59.7 years (range = 41–76 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer survivors being treated with aromatase inhibitors (AIs) for 3–56 months. 66% of participants were being treated with an AI at the time of the study. At baseline, there were significant correlations between baseline pain (as measured by the Brief Pain Inventory) and fatigue, sleep, and depression, but there was no correlation with anxiety. Most participants (71.6%) were white and 23.9% were black; greater than 75% reported college education. Disease: 48%–50% were at disease stage I, 30–36 % were at disease stage II, and 14%–22 % were at disease stage III.  
  • OTHER KEY SAMPLE CHARACTERISTICS: Most participants (71.6%) were white and 23.9% were black; greater than 75% held some college education. Inclusion criteria: Women with histories of stages I–III breast cancer currently taking an AI, current complaints of joint pain times three months, attributes pain to AI, current-week pain rating of 4 or greater on an 11-point rating (0–10), complaints of pain at least 15 days within the last 30 days. 

Setting

  • SITE: Single-site    
  • SETTING TYPE: Not specified    
  • LOCATION: The Abramson Cancer Center of the Hospital of the University of Pennsylvania

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS:  Elder care, palliative care 

Study Design

Three-group randomized controlled trial comparing EA, SA, and WLC.

Measurement Instruments/Methods

Four measurement tools were used: the Brief Pain Inventory (BPI); the Brief Fatigue Inventory (BFI); the Pittsburgh Sleep Quality Index (PSQI); and the Hospital Anxiety and Depression Scale (HADS). A priori primary outcome reported pain intensity and interference. A priori secondary outcome reported fatigue, sleep, and psychological distress (anxiety, depression).

Results

Measurements were repeated at weeks 4, 8, and 12. There was significant (p = 0.0095) improvement in the fatigue score after EA, no improvement with SA, and greater reduction in fatigue than the WLC group. There were nonsignificant improvements in sleep in the EA and SA groups compared to the WLC group. There was significant (p = 0.04) improvement in the EA group but the SA group on the HADS anxiety score compared to the WLC group; a nonsignificant improvement continued in the EA group at week 8, whereas week 12 showed a significant (p = 0.006) improvement in the EA and WLC groups. EA and SA group improvements in depression scores were significant (p = 0.015 and p = 0.0088, respectively) compared with the WLC group; EA and SA significantly (p = 0.0031m and p = 0.0056, respectively) improved scores at week 8, and scores did not change at week 12.

Conclusions

EA produced improvements by reducing fatigue, anxiety, and depression scores. SA produced improvements in depression scores only. Acupuncture with electronic stimulation may be an effective treatment for pain and the nonpain symptoms of fatigue, sleep disturbance, and depression associated with AIs. Additional research is encouraged.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding). There was no blinding but the risk of bias is low because each arm of the study required specific treatment limited to administration by just two acupuncturists.

 

Nursing Implications

Acupuncture with electrical stimulation should be considered a viable treatment option for patients with breast cancer taking AIs who complain of joint pain. Large, randomized, controlled research studies are needed to develop evidence for the efficacy of EA in breast and other cancers. Drug and symptom cluster correlations must be deconstructed.

Print

Molassiotis, A., Bardy, J., Finnegan-John, J., Mackereth, P., Ryder, D. W., Filshie, J., . . . Richardson, A. (2012). Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. Journal of Clinical Oncology, 30, 4470–4476.

Study Purpose

To assess the effectiveness of acupuncture for cancer-related fatigue (CRF) in women with breast cancer.

Intervention Characteristics/Basic Study Process

Women were randomly assigned to acupuncture or enhanced usual care groups. Usual care enhancement consisted of providing a booklet about CRF, diet, exercise, and sleep. The intervention group was offered six acupuncture treatments over six weeks. Sessions lasted 20 minutes each and involved unilateral or bilateral needles at three points. No rotation or flicking of needles was performed. Patients were followed for 18 weeks. Outcome measures were recorded at six weeks.

Sample Characteristics

  • The sample was comprised of 246 participants.
  • Mean age was 52.5 years (range 25–80).
  • All participants were female.
  • All participants had breast cancer with no distant metastases. 
  • All participants had completed antitumor treatment within one month to five years prior to enrollment. 
  • All participants had a baseline fatigue of at least 5 on an 11-point screening scale. 
  • Average time since diagnosis was 20.5 months.
  • Mean duration of fatigue was 16.5 months.
  • Participants were predominantly white, married, and had at least a college education.

Setting

  • Multisite
  • Outpatient
  • United Kingdom

Phase of Care and Clinical Applications

The study has clinical applicability for late effects and survivorship.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Multidimensional Fatigue Inventory (MFI)
  • Hospital Anxiety and Depression Scale (HADS)
  • Functional Assessment of Cancer Therapy-Breast (FACT-B)
     

Results

The difference score between the control and acupuncture groups for fatigue was –3.11 (95% confidence interval [CI] [–3.97, –2.25]; p < 0.001). Intention-to-treat (ITT) analysis, using an assumption of no improvement for patients whose week six outcome data were missing, continued to show a significant difference (–2.49; p < 0.001). Week six outcomes, as reflected in HADS and FACT-B scores, were significantly improved from baseline in patients who received acupuncture (p < 0.001).

Conclusions

Findings showed that acupuncture as provided was effective in reducing fatigue over a six-week period among survivors of breast cancer.

Limitations

  • The study had a risk of bias due to no blinding.
  • Data were missing for 20.3% of the acupuncture group and 13.3% of the control group. The authors performed conservative ITT analysis to account for the missing data. For the intervention group, the authors reported complete data only.
  • The authors did not discuss data relative to anxiety or depression.

Nursing Implications

Findings showed that acupuncture was helpful in reducing fatigue in patients with breast cancer who had completed antitumor treatment. The study supports the effectiveness of acupuncture for the treatment of fatigue.

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Molassiotis, A., Bardy, J., Finnegan-John, J., Mackereth, P., Ryder, W. D., Filshie, J., . . . Richardson, A. (2013). A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture. Annals of Oncology, 24, 1645–1652.

Study Purpose

To determine if maintenance acupuncture is beneficial in sustaining improvements in fatigue after a course of acupuncture.

Intervention Characteristics/Basic Study Process

Patients in a previous six-week acupuncture trial were rerandomized to three groups:  maintenance self-acupuncture, therapist-delivered maintenance acupuncture, or a control group receiving usual care. Maintenance therapy lasted for four weeks. Standard acupuncture points were used, and sessions were weekly. Data were collected at the end of four weeks and at 12 weeks after rerandomization.

Sample Characteristics

  • The study reported a sample of 151 women with breast cancer.
  • Mean age was 53 years.
  • Patients had undergone surgery, and the majority had received prior chemotherapy and radiotherapy.
  • Mean time since completion of treatment was 20 months.
  • The majority of patients were married and employed full- or part-time.

Setting

  • Single site
  • Multiple settings
  • United Kingdom

Phase of Care and Clinical Applications

Patients were undergoing the transition phase of care after active treatment.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Multidimensional Fatigue Inventory (MFI)
  • Hospital Anxiety and Depression Scale (HADS)
  • Functional Assessment of Cancer Therapy-Breast (FACT-B)
  • Patients' logs of self-needling

Results

Results showed a trend of fatigue improvement in the combined acupuncture groups compared to the control; the trend was not significant. In regard to results reflecting anxiety or depression, the study showed no differences between groups. Patients' logs indicated that patients performed self-needling as planned.

Conclusions

Findings suggested that it is feasible for patients to maintain acupuncture treatment through self-needling. Compared to symptom improvement in patients in the control group, symptom improvement in patients undergoing maintenance acupuncture through self-needling or through delivery by a therapist was not significant.

Limitations

  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • The authors did not discuss other treatments or interventions aimed at fatigue. If the authors used additional management approaches, the approaches are unknown.

Nursing Implications

The study showed that patients can be taught to deliver their own acupuncture treatments effectively by self-needling. The study did not demonstrate that ongoing acupuncture, or maintenance acupuncture, had any effect on fatigue, anxiety, or depression.

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Molassiotis, A., Sylt, P., & Diggins, H. (2007). The management of cancer-related fatigue after chemotherapy with acupuncture and acupressure: a randomised controlled trial. Complementary Therapies in Medicine, 15, 228–237.

Intervention Characteristics/Basic Study Process

The study was a randomized, controlled trial of acupuncture (n = 15); acupressure (n = 16); and sham acupressure (n = 16). Acupuncture included six 20-minute sessions over two weeks. Acupressure involved self-applying pressure to the same points daily. Sham acupressure involved self-applying pressure to nonenergy points. The selected acupuncture points were energy points that have been used for more than 2,000 years.

Sample Characteristics

  • The study included 47 patients with cancer who experienced moderate to severe fatigue (greater than 5 on a 1–10 scale) who were at least one month postchemotherapy.
  • Of the participants, 32 of 47 were female and all but one were Caucasian.
  • Mean age was 53.4 years (range 20–76).
  • Patients were excluded if they had needle phobia, platelets less than 50,000, hematocrit (HCT) less than 30, Karnofsky Performance Status (KPS) less than 70, or were on steroids.

Setting

Patients were recruited from an outpatient clinic, an acupuncture treatment setting in a hospital in the United Kingdom, or in their own homes.

Study Design

The study was a small randomized, controlled trial with blinding between two acupressure conditions.

Measurement Instruments/Methods

  • Multidimensional Fatigue Inventory (MFI) pretreatment and at two and four weeks
  • Daily log for acupressure groups

Results

The study included an intention-to-treat (ITT) analysis. Significant improvements existed in general fatigue (p < 0.001), physical fatigue (p = 0.016), activity (p = 0.004), and motivation (p = 0.024). Patients showed 36% improvement in acupuncture, 19% in acupressure, and 0.6% in sham acupressure. The effect was not sustained at the same level after two weeks.

Limitations

  • The drop-out rate was 15%.
  • It was not possible to blind the acupuncture group.
  • Travel to the clinical site to receive acupuncture or acupressure treatment was a barrier.

Nursing Implications

Spot bleeding was observed in two cases. Trained acupuncturists are necessary. A detailed description of acupuncture was given using Standards of Reporting Interventons of Controlled Trials of Acupuncture (STRICTA) guidelines.

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Robertshawe, P. (2008). Cancer-related fatigue managed with acupuncture and acupressure. Journal of the Australian Traditional-Medicine Society, 14, 229–229.

Study Purpose

To determine whether a larger trial using acupuncture and acupressure therapies would be feasible.

Intervention Characteristics/Basic Study Process

Patients were randomized into three groups. The acupuncture group received three 20-minute sessions per week for two weeks using the same points. The acupressure group was taught self-treatment techniques for the same points. Pressure was held for one minute every day for two weeks. The sham group was taught to hold pressure on three points not related to energy for one minute each day for two weeks.

Sample Characteristics

  • Mean age was 54 years.
  • Patients were reported as being “predominantly female.” 
  • Patients were at least one month from completing chemotherapy and reported a fatigue score of at least 5 on a 0-to-10 scale.

Setting

Not reported

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Patients completed the Multidimensional Fatigue Inventory (MFI) before randomization, at the completion of treatment, and two weeks after.
  • Patients in the acupressure and sham groups also filled out a diary reporting whether they had applied pressure to the points each day.

Results

Improvements were noted in fatigue scores in the acupuncture and acupressure groups in general fatigue, physical fatigue, reduced activity, and motivation. The sham group showed no significant improvements.

Conclusions

The use of acupuncture may be helpful for fatigue. Because such little data was provided, it is difficult for readers to make this same conclusion. The report of significant improvements was not cited with statistical methodologies. A larger, multicenter trial is needed.

Limitations

  • The study examined a small, homogenous population with limited data collection.
  • The results were poorly reported.
  • The implementation of these two treatments in practice may be difficult for smaller institutions.
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Smith, C., Carmady, B., Thornton, C., Perz, J., & Ussher, J. M. (2013). The effect of acupuncture on post-cancer fatigue and well-being for women recovering from breast cancer: a pilot randomised controlled trial. Acupuncture in Medicine, 31, 9–15.

Study Purpose

To evaluate the feasibility and acceptability of acupuncture in managing fatigue and well-being in women with breast cancer.

Intervention Characteristics/Basic Study Process

Patients were randomized to acupuncture, sham control, or wait-list control groups. Six acupuncturists provided the interventions. All needles were inserted with a Park device for both the sham and actual groups. Treatments were performed twice weekly for three weeks and then weekly for another three weeks. Acupuncture was administered at five points, and the needles were stimulated manually. Needles were retained for a maximum of 20 minutes, and sessions lasted 45 minutes. Women in the wait-list control were contacted every four days during the study. Women in the acupuncture group were also interviewed to explore the perceived impact of the intervention.

Sample Characteristics

  • In total, 30 patients (100% female) were included.
  • Mean age was 55 years.
  • All patients had breast cancer.
  • No patients were receiving treatment during the study.
  • Prior treatments received were not described.
  • All patients had fatigue scores between 4 and 6, which were considered moderate levels at baseline.

Setting

  • Single site  
  • Outpatient 
  • Australia

Phase of Care and Clinical Applications

  • Patients were undergoing the transition phase after active treatment.
  • The study has clinical applicability for palliative care.

Study Design

The study used a randomized, sham-controlled trial, with a mixed method.

Measurement Instruments/Methods

  • Brief Fatigue Inventory (BFI)
  • Well-Being Questionnaire (W-BQ12)
  • Measure Yourself Concerns and Wellbeing Questionnaire (MyCaW)

Results

Fatigue declined over time in all three groups. It was reported that fatigue declined significantly in the acupuncture group after two weeks; however, no statistical results were provided. Almost half of the women recruited declined participation, mainly due to the travel distance required. Well-being scores improved in all women, with no differences between groups. Findings from interviews showed that women who received acupuncture experienced improved sleep and relaxation with treatments and improved mood.

Conclusions

Findings suggested that acupuncture treatment is feasible in this group of patients and may be of benefit in improving fatigue.

Limitations

The study had a small sample size, with less than 100 patients.

Nursing Implications

The study suggested that acupuncture was feasible as provided and might have benefit in the management of fatigue; however, the study did not provide strong evidence to support the efficacy of acupuncture to improve fatigue.

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Vickers, A. J., Straus, D. J., Fearon, B., & Cassileth, B. R. (2004). Acupuncture for postchemotherapy fatigue: a phase II study. Journal of Clinical Oncology, 22, 1731–1735.

Intervention Characteristics/Basic Study Process

Traditional Chinese acupuncture was performed twice per week for four weeks or once per week for six weeks. The acupuncturists used points commonly used for fatigue.

Sample Characteristics

  • Thirty-seven adults (68% female) were included.
  • Mean age was 61 years (range 43–78).
  • Patients were ambulatory.
  • Patients were at least three weeks posttreatment.
  • Patients had a Brief Fatigue Inventory (BFI) score of 4 or greater. 
  • Race/ethnicity were not reported.
  • Patients were excluded if they had severe anemia, a Karnofsky Performance Status (KPS) score of less than 70, or an anticipated survival of less than 3 months.

Setting

Acupuncture was delivered in an Integrative Medicine clinic.

Study Design

The study used a single-arm, phase II, pilot design.

Measurement Instruments/Methods

  • BFI was measured at baseline pretreatment and one and two weeks posttreatment.
  • Anxiety and depression were covariates, not outcomes.

Results

Mean improvement was 31.1% (confidence interval [CI] [20.6%, 41.5%]); 39% of patients improved by greater than 40%. Younger and less depressed patients showed a greater response.

Conclusions

Acupuncture may affect serotonin pathways. No adverse events occurred.

Limitations

  • No control group or randomization was used.
  • There was no control for exercise.
  • Travel to the site was a barrier.

Nursing Implications

Certified acupuncturists are needed. Once weekly treatment was preferable. The intervention seemed to show benefits that suggest it is worthy of further study.

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Guideline / Expert Opinion

Bower, J.E., Bak, K., Berger, A., Breitbart, W., Escalante, C.P., Ganz, P.A., . . . American Society of Clinical Oncology. (2014). Screening, assessment, and management of fatigue in adult survivors of cancer: An American Society of Clinical Oncology clinical practice guideline adaptation. Journal of Clinical Oncology, 32, 1840–1850. 

Purpose & Patient Population

PURPOSE: To present screening, assessment, and treatment procedures for adult survivors of cancer who have completed treatment
 
TYPES OF PATIENTS ADDRESSED: Cancer survivors diagnosed at age 18 or older who completed curative treatment, are considered in remission, or are disease-free and on maintenance therapy.

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Consensus-based guideline  
 
PROCESS OF DEVELOPMENT: Two content experts reviewed and recommended use of pan-Canadian guideline; the ASCO panel suggested use of National Comprehensive Cancer Network (NCCN) articles. The Appraisal of Guidelines for Research and Evaluation (AGREE) II subscale was then used on three articles. Experts issued recommendations based on guidelines and modified based on local context and practice beliefs.
 
DATABASES USED: MEDLINE and Embase
 
KEYWORDS: Fatigue, cancer, survivor, post-treatment, late effects, long-term effects
 
INCLUSION CRITERIA: Cancer survivors diagnosed at age 18 or older who completed curative treatment, are considered in remission, or are disease-free and on maintenance therapy.
 
EXCLUSION CRITERIA: None

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results Provided in the Reference

Adapted from three guidelines by multidisciplinary experts using supplementary evidence and clinical experience. Most recommendations listed verbatim but some modified to include updated evidence or current practice beliefs.

Guidelines & Recommendations

Recommendations focused on patients who have completed active treatment or are considered in clinical remission. Treat underlying causes, moderate physical activity after cancer treatment with PT and lymphedema referrals as needed (meta-analysis, systematic review, [randomized controlled trial [RCT]; 10 cited), cognitive behavioral therapy (meta-analysis, RCT, systematic reviews; 6 cited), psychoeducational therapies (systematic, RCT; 3 cited), psychosocial services, mindfulness-based interventions (RCT; 3 cited), yoga (RCT; 2 cited), acupuncture (RCT; 2 cited), psychostimulants/wakefulness agents (limited evidence in patients who are post-treatment disease-free). Additional areas in which research needed include biofield therapies, massage, music therapy, relaxation, Reiki, Qigong, ginseng, and vitamin D.

Limitations

Guidelines were tailored to survivors with current evidence as not all evidence done is survivors.

Nursing Implications

Screening, assessment, and treatment guidelines summarized for use in cancer survivors.

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