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Feasibility Trial of Electro-acupuncture for Aromatase Inhibitor Related Arthralgia in Breast Cancer Survivors

Identifieur interne : 003463 ( Pmc/Curation ); précédent : 003462; suivant : 003464

Feasibility Trial of Electro-acupuncture for Aromatase Inhibitor Related Arthralgia in Breast Cancer Survivors

Auteurs : Jj Mao [États-Unis] ; Dw Bruner [États-Unis] ; C. Stricker [États-Unis] ; Jt Farrar [États-Unis] ; Sx Xie [États-Unis] ; Ma Bowman [États-Unis] ; D. Pucci [États-Unis] ; X. Han [États-Unis] ; A. Demichele [États-Unis]

Source :

RBID : PMC:3569528

Abstract

Background

Arthralgia affects postmenopausal women receiving aromatase inhibitors (AI) for breast cancer. Given the existing evidence for electro-acupuncture (EA) for treatment of osteoarthritis in the general population, this study aims to establish the feasibility of studying EA for treating AI-related arthralgia.

Patients and Methods

Postmenopausal women with stage I-III breast cancer who reported AI-related arthralgia were enrolled in a single arm feasibility trial. EA was provided twice a week for two weeks followed by six weekly treatments. The protocol was based on Chinese medicine diagnosis of “Bi” syndrome with electro-stimulation of needles around the painful joint(s). Pain severity of the modified Brief Pain Inventory was used as the primary outcome. Joint stiffness, Joint interference, and Patient Global Impression of Change (PGIC) were secondary outcomes. Paired-t tests were used for analysis.

Results

Twelve women were enrolled and all provided data for analysis. From baseline to the end of intervention, patients reported reduction in pain severity (5.3 to 1.9), stiffness (6.9 to 2.4), and joint symptom interference (4.7 to 0.8), all P<0.001; 11/12 considered joint symptoms “very much better” based on PGIC. Subjects also reported significant decrease in fatigue (4.4 to 1.9, p=0.005) and anxiety (7.1 to 4.8, p=0.01). No infection or development or worsening of lymphedema was observed.

Conclusion

Preliminary data establishes the feasibility of recruitment and acceptance as well as promising preliminary safety and effectiveness. A randomized controlled trial is warranted to establish the efficacy of EA for AI-related arthralgia in breast cancer survivors.


Url:
DOI: 10.1177/1534735409332903
PubMed: 19679620
PubMed Central: 3569528

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PMC:3569528

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<title>Background</title>
<p id="P1">Arthralgia affects postmenopausal women receiving aromatase inhibitors (AI) for breast cancer. Given the existing evidence for electro-acupuncture (EA) for treatment of osteoarthritis in the general population, this study aims to establish the feasibility of studying EA for treating AI-related arthralgia.</p>
</sec>
<sec id="S2">
<title>Patients and Methods</title>
<p id="P2">Postmenopausal women with stage I-III breast cancer who reported AI-related arthralgia were enrolled in a single arm feasibility trial. EA was provided twice a week for two weeks followed by six weekly treatments. The protocol was based on Chinese medicine diagnosis of “Bi” syndrome with electro-stimulation of needles around the painful joint(s). Pain severity of the modified Brief Pain Inventory was used as the primary outcome. Joint stiffness, Joint interference, and Patient Global Impression of Change (PGIC) were secondary outcomes. Paired-t tests were used for analysis.</p>
</sec>
<sec id="S3">
<title>Results</title>
<p id="P3">Twelve women were enrolled and all provided data for analysis. From baseline to the end of intervention, patients reported reduction in pain severity (5.3 to 1.9), stiffness (6.9 to 2.4), and joint symptom interference (4.7 to 0.8), all P<0.001; 11/12 considered joint symptoms “very much better” based on PGIC. Subjects also reported significant decrease in fatigue (4.4 to 1.9, p=0.005) and anxiety (7.1 to 4.8, p=0.01). No infection or development or worsening of lymphedema was observed.</p>
</sec>
<sec id="S4">
<title>Conclusion</title>
<p id="P4">Preliminary data establishes the feasibility of recruitment and acceptance as well as promising preliminary safety and effectiveness. A randomized controlled trial is warranted to establish the efficacy of EA for AI-related arthralgia in breast cancer survivors.</p>
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<name>
<surname>Mao</surname>
<given-names>JJ</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
<xref ref-type="aff" rid="A2">2</xref>
<xref ref-type="aff" rid="A3">3</xref>
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<name>
<surname>Bruner</surname>
<given-names>DW</given-names>
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<name>
<surname>Stricker</surname>
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</contrib>
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<name>
<surname>Farrar</surname>
<given-names>JT</given-names>
</name>
<xref ref-type="aff" rid="A2">2</xref>
<xref ref-type="aff" rid="A3">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Xie</surname>
<given-names>SX</given-names>
</name>
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<name>
<surname>Bowman</surname>
<given-names>MA</given-names>
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<xref ref-type="aff" rid="A1">1</xref>
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<contrib contrib-type="author">
<name>
<surname>Pucci</surname>
<given-names>D</given-names>
</name>
<xref ref-type="aff" rid="A3">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Han</surname>
<given-names>X</given-names>
</name>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>DeMichele</surname>
<given-names>A</given-names>
</name>
<xref ref-type="aff" rid="A2">2</xref>
<xref ref-type="aff" rid="A3">3</xref>
<xref ref-type="aff" rid="A4">4</xref>
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<aff id="A1">
<label>1</label>
Department of Family Medicine and Community Health, University of Pennsylvania Health System, PA</aff>
<aff id="A2">
<label>2</label>
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Health System, PA</aff>
<aff id="A3">
<label>3</label>
Abramson Cancer Center, University of Pennsylvania Health System, PA</aff>
<aff id="A4">
<label>4</label>
Department of Medicine, University of Pennsylvania Health System, PA</aff>
<author-notes>
<corresp id="cor1">
<bold>CORRESPONDING AUTHOR</bold>
Jun J Mao, MD, MSCE, Department of Family Medicine and Community Health, University of Pennsylvania, 3400 Spruce Street / 2 Gates, Philadelphia, Pennsylvania 19104, Phone: 215-615-4330; Fax: 215-662-3591;
<email>jun.mao@uphs.upenn.edu</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted">
<day>30</day>
<month>1</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="ppub">
<month>6</month>
<year>2009</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>11</day>
<month>2</month>
<year>2013</year>
</pub-date>
<volume>8</volume>
<issue>2</issue>
<fpage>123</fpage>
<lpage>129</lpage>
<abstract>
<sec id="S1">
<title>Background</title>
<p id="P1">Arthralgia affects postmenopausal women receiving aromatase inhibitors (AI) for breast cancer. Given the existing evidence for electro-acupuncture (EA) for treatment of osteoarthritis in the general population, this study aims to establish the feasibility of studying EA for treating AI-related arthralgia.</p>
</sec>
<sec id="S2">
<title>Patients and Methods</title>
<p id="P2">Postmenopausal women with stage I-III breast cancer who reported AI-related arthralgia were enrolled in a single arm feasibility trial. EA was provided twice a week for two weeks followed by six weekly treatments. The protocol was based on Chinese medicine diagnosis of “Bi” syndrome with electro-stimulation of needles around the painful joint(s). Pain severity of the modified Brief Pain Inventory was used as the primary outcome. Joint stiffness, Joint interference, and Patient Global Impression of Change (PGIC) were secondary outcomes. Paired-t tests were used for analysis.</p>
</sec>
<sec id="S3">
<title>Results</title>
<p id="P3">Twelve women were enrolled and all provided data for analysis. From baseline to the end of intervention, patients reported reduction in pain severity (5.3 to 1.9), stiffness (6.9 to 2.4), and joint symptom interference (4.7 to 0.8), all P<0.001; 11/12 considered joint symptoms “very much better” based on PGIC. Subjects also reported significant decrease in fatigue (4.4 to 1.9, p=0.005) and anxiety (7.1 to 4.8, p=0.01). No infection or development or worsening of lymphedema was observed.</p>
</sec>
<sec id="S4">
<title>Conclusion</title>
<p id="P4">Preliminary data establishes the feasibility of recruitment and acceptance as well as promising preliminary safety and effectiveness. A randomized controlled trial is warranted to establish the efficacy of EA for AI-related arthralgia in breast cancer survivors.</p>
</sec>
</abstract>
<kwd-group>
<kwd>Acupuncture</kwd>
<kwd>breast neoplasm</kwd>
<kwd>clinical trial</kwd>
<kwd>Aromatase inhibitors/*adverse effects</kwd>
<kwd>joint diseases</kwd>
</kwd-group>
<funding-group>
<award-group>
<funding-source country="United States">National Center for Complementary and Alternative Medicine : NCCAM</funding-source>
<award-id>K23 AT004112 || AT</award-id>
</award-group>
</funding-group>
</article-meta>
</front>
</pmc>
</record>

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