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Bao et al (2013) Outcomes Breast Cancer Effect Acupuncture

Bao et al (2013) Outcomes Breast Cancer Effect Acupuncture

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Bao et al (2013) Outcomes Breast Cancer Effect Acupuncture
Bao et al (2013) Outcomes Breast Cancer Effect Acupuncture

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Published by: LF619513 on Dec 27, 2013
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New Study Exposes Acupuncture As Pseudoscience
Lauren F Friedman, provided byPublished 12:48 pm, Thursday, December 26, 2013
 Acupuncture has been practiced for thousands of years — but that doesn't mean it actually  works. A new study published online in the journal Cancer suggests that
any relief acupuncture brings may be the result of a placebo effect.
Researchers followed a group of 47 women being treated with aromatase inhibitors, a breast cancer medication that can cause menopause-like side effects (hot flashes, nightsweats) as well as joint and muscle pain. Twenty-three of the women received eight weeksof acupuncture; the rest received eight weeks of something called "sham acupuncture," where needles are placed on the skin somewhat randomly — not at traditionalacupuncture points — and then not actually inserted.The result?
 All of the patients reported that their side effects had improved
,especially the severity of their hot flashes.
The power of the placebo
There was no significant difference between the group that had received real acupunctureand the group that had received "sham acupuncture." So why the improvement in both?"You could conclude," study author Ting Bao of the University of Maryland, Baltimore toldHealthDay , "that it's a placebo effect."Traditional Chinese Medicine practitioners explain acupuncture as a way to rebalance theenergy, or "qi," that flows through specific pathways in the body by applying needles todesignated points along these pathways."Sham acupuncture" is notoriously difficult to design. Unlike a sugar pill given in place of a real medicine, it's more complicated to convince patients that they are actually undergoing acupuncture without doing anything that might affect them physically. Theauthors of the new study caution that even fake acupuncture might yield some unknownphysical effect. While some studies show a "possible positive effect" when acupuncture is used to treatconditions like lower back pain and menstrual cramps, most research on acupuncture isinconclusive. Still, while there's no evidence that energy flows are involved,
a placeboeffect is not the same as no effect.
Steve Silberman, in an investigation for Wired, documented how the mind can be sopowerful that promising drugs end up looking ineffective when they're stacked up againstplacebo pills. And that's not necessarily a bad thing. All of the patients in the new Cancer study reportedthat their symptoms had improved, so the takeaway is not necessarily that acupuncture is worthless — it's that the power of the mind to mediate physical symptoms is anything butimaginary.  As Bao told The New York Times, if you think acupuncture could help you and you're notforegoing conventional treatments, there's no real harm in giving it a try: “It has a minimalrisk and potentially significant benefits.”
 
12/27/13 4:22 AMhttp://www.sfgate.com/technology/businessinsider/article/New-Study-Exposes-Acupuncture-As-Pseudoscience-5094637.php
 
Patient-Reported Outcomes in Women With Breast CancerEnrolled in a Dual-Center, Double-Blind, Randomized ControlledTrial Assessing the Effect of Acupuncture in Reducing AromataseInhibitor-Induced Musculoskeletal Symptoms
Ting Bao, MD
1
; Ling Cai, PhD, MS
1
; Claire Snyder, PhD
2
; Kelly Betts, BS
1
; Karineh Tarpinian, BS
2
; Jeff Gould, LAc
2
;Stacie Jeter, CCRP
2
; Michelle Medeiros, MA, MS, CCRP
1
; Saranya Chumsri, MD
1
; Aditya Bardia, MD
2
; Ming Tan, PhD
1
;Harvinder Singh, MD
1
; Katherin H. R.Tkaczuk, MD
1
; and Vered Stearns, MD
2
BACKGROUND:
 Aromatase inhibitors (AIs) have been associated with decrements in patient-reported outcomes (PROs). The objec-tive of this study was to assess whether real acupuncture (RA), compared with sham acupuncture (SA), improves PROs in patientswith breast cancer who are receiving an adjuvant AI.
 METHODS:
 Postmenopausal women with a stage 0 through III breast cancerwho received an AI and had treatment-associated musculoskeletal symptoms were randomized to receive 8 weekly RA versus SA in adual-center, randomized controlled trial. The National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptomsquestionnaire, the Center for Epidemiological Studies Depression (CESD) scale, the Hospital Anxiety and Depression Scale (HADS),the Pittsburgh Sleep Quality Index (PSQI), the hot flash daily diary, the Hot Flash-Related Daily Interference Scale (HFRDI), and theEuropean quality-of-life survey (EuroQol) were used to assess PROs at baseline and at 4weeks, 8 weeks, and 12 weeks.
 RESULTS:
 Theintention-to-treat analysis included 23 patients in the RA arm and 24 patients in the SA arm. There were no significant differences inbaseline characteristics between the 2 groups. Compared with baseline, scores in the RA arm improved significantly at week 8 on theCESD (
5
.022), hot flash severity (
5
.006), hot flash frequency (
5
.011), the HFRDI (
5
.014), and NSABP menopausal symptoms(
5
.022); scores in the SA arm improved significantly on the EuroQol (
5
.022),the HFRDI (
5
.043), and NSABP menopausal symp-toms (
5
.005). Post-hoc analysis indicated that African American patients (n
5
9) benefited more from RA than SA compared withnon-African American patients (n
5
38) in reducing hot flash severity (
<
.001) and frequency (
<
.001) scores.
 CONCLUSIONS:
 BothRA and SA were associated with improvement in PROs among patients with breast cancer who were receiving AIs, and no significantdifference was detected between arms. Racial differences in response to acupuncture warrant further study.
 Cancer 
 2013;000:000-000
.
V
C
 2013 American Cancer Society 
.
KEYWORDS:
 acupuncture, aromatase inhibitor, musculoskeletal symptoms, patient-reported outcomes.
INTRODUCTION
 Aromatase inhibitors (AIs) are the recommended primary adjuvant endocrine therapy for postmenopausal women withhormone-receptor-positive breast cancer.
1
 AIs have been associated with worsening patient-reported outcomes (PROs),such as musculoskeletal symptoms and vasomotor symptoms.
2-6
One study demonstrated that 59% of women with early stage breast cancer who were receiving AIs experienced hotflashes, with 32% reporting moderate-to-severe hot flashes and25% reporting significantly worsening hot flashes after the initiation of AI therapy.
6
The current treatments for AI-associated musculoskeletal and vasomotor symptoms arelimited and may lead to drug discontinuation. Treatmentfor hotflashes include nonhormonal pharmacologic agents, such as clonidine, venlafaxine, gabapentin, and pregabalin; however,their use is limited because of suboptimal efficacy and potential side effects.
7,8
Improved treatment of vasomotor symp-toms inbreastcancerpatientsis needed. Acupuncture is a traditional Chinese medicine technique that involves inserting filiform stainless steel needles intospecific pointsin the body to achievetherapeutic effect. Acupuncturereportedly alleviatesvasomotor symptoms, decreases
Corresponding author:
 Ting Bao MD, DABMA, 22 South Greene Street, N9E24, Baltimore, MD 21201-1595; Fax: (410) 328-2578; tbao@umm.edu
1
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland;
 2
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MarylandWe thank Dr. Xiaobu Ye for statistical support and Drs. N. Lynn Henry and Richard Harris for helpful discussions regarding study design.Aditya Bardia’s current address: Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts.Ming Tan’s current address: Department of Biostatistics, Bioinformatics, and Biomathematics, Georgetown Lombardi Comprehensive Cancer Center, Washington,DC.
DOI:
 10.1002/cncr.28352,
 Received:
 May 13, 2013;
 Revised:
 July 29, 2013;
 Accepted:
 August 2, 2013,
 Published online
 in Wiley Online Library(wileyonlinelibrary.com)
Cancer 
 Month 00, 2013
 1
Original Article
 
depression, and improves quality of life (QoL) in post-menopausal women, poststroke patients, and breast can-cer survivors who are receiving tamoxifen.
9-12
To the bestof our knowledge, no research has been conducted tostudy the effect of acupuncture in alleviating such symp-toms inbreastcancersurvivors whoreceiveAIs. We previously conducted a dual-center, random-ized, sham acupuncture (SA) (placebo)-controlled trial toassess the efficacy of real acupuncture (RA) in improving PROs in breast cancer patients who were receiving AIs.The primary endpoint of that study was the improvementof AI-associatedmusculoskeletal symptoms(AIMSS),andno statistically significant difference between the RA andSA arms was observed, although both groups reportedimprovement.
13
Prospective secondary endpointsincluded the effect of RA versus SA on other PROs thatmay be related to estrogen deprivation, such as menopau-sal symptoms, mood (depression, anxiety), sleep quality,and overallQoL,whicharereportedhere.
MATERIALS AND METHODS
Patients
Postmenopausal women with stage 0 through III hor-monereceptor-positivebreastcancerwhohadbeenreceiv-ing AI therapy for
1 month, who reported AIMSS, andwho had not received acupuncture within the past 12months were included. Patients were treated at the JohnsHopkins Sidney Kimmel Comprehensive Cancer Centerand the University of Maryland Greenebaum CancerCenter, and all provided informed consent before ran-domization. This clinical trial protocol was approved by the institutional review board of both institutes and is reg-isteredatclinicaltrials.gov(NCT00641303).
Interventions
Patients were randomized to an 8-weekly RA group or SA group. The randomization lists were generated by the trialstatistician using specialized randomization softwarebefore the start of the trial. Randomization assignmentswere providedto the centeracupuncturists. Therewerenodeviations from the randomization lists. Although therandomization sequence was not concealed, the acupunc-turistswere notawareof thenextassignment. Although the acupuncturists were not blinded to theassignment, in an effort to minimize the introduction of bias, the acupuncturists followed a prepared script whenengaging in conversation with the participants. All otherindividuals involved in the care of participants wereblinded, including the treating oncologist(s), nurses, andstudy team members. The participants also were blindedtotheirtreatmentassignment.Details of the RA and SA interventions have beenreported previously.
13
Briefly, patients in the RA groupreceived acupuncture in the conception vessel 4 (CV4),CV6, and CV12 points; the bilateral large intestine 4(LI4) points; the Master of Heart 6 point (MH6); gallbladder point 34 (GB34); stomach point 36 (ST36);kidney point 3 (KI3); and urinary bladder point 65(BL65). Patients in the SA group received nonpenetrating,retractable needles placed in 14 sham acupoints located atthe midpoint of the line connecting 2 real acupoints.
Outcome Measures
 We collected weekly hot flash diaries during weeks 0through 8 and in week 12; and other PRO questionnaireswere collected at baseline and at 4 weeks, 8 weeks, and 12weeks. All questionnaires were in paper form, and thepatients either completed the questionnaires in the clinicor completed them at home and returned them to theclinic during study visits. PROs that may have beenrelatedto estrogendeprivation,suchas menopausalsymp-toms, mood (depression, anxiety), sleep quality, and over-all QoL, were measured by using the PRO questionnairesdescribed below: these instruments are commonly usedamong breast cancer survivors. In all but the EuropeanQoL (EuroQol) questionnaire, higher scores indicateworsesymptoms.Menopausal symptoms were assessed using the re-vised National Surgical Adjuvant Breast and Bowel Pro- ject (NSABP) menopausal symptoms questionnaire,which assesses 47 common symptoms. Respondents wereaskedtocircleyesornotoindicatewhethertheyhadexpe-rienced the symptom during the previous week. If themenopausal symptom was present, then they were askedtorateitsseverityusingascalefrom0to4.AtotalNSABPmenopausal symptoms score was computed by summing items and ranged from 0 to 188. Reliability and validity havebeenpreviouslyreported.
14
The Hot Flash-Related Daily Interference Scale(HFRDI) and the hot flash daily diary were used to assessthe severity of hot flashes. The HFRDI is a 10-item scalemeasuring the degree to which hot flashes interfere withdailylifeactivities, includingwork,socialactivities,leisureactivities, sleep, mood, concentration, relations withothers, sexuality, enjoyment of life, and overall QoL.
15
Participants rated the degree to which hot flashes hadinterfered with each item during the previous week using a scale from 0 (do not interfere) to 10 (completely inter-fere). A total score was computed by summing items and
Original Article
2
 Cancer 
 Month 00, 2013

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