Review of Clinical Acupuncture Research Protocols on Cancer in the USA

(1)

서 론

,

1-2)

30~

2007 8 3 2007 8 5

2007 8 30

: Sanghoon Lee, 550 N Broadway Suite 107, Baltimore, Maryland, 21205, USA

(Tel : 1-410-502-2466, Fax : 1-410-502-3624 E-mail : [email protected])

2006

This research was supported by the Kyung Hee University Research Fund in 2006.

이상훈

^1,2

, Adrian S Dobs

²

원 저

Review of Clinical Acupuncture Research Protocols on Cancer in the USA

Sang-hoon Lee, KMD, PhD

^1,2

, Adrian S Dobs, MD, MHS

²

1

Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Korea

2

The Johns Hopkins University Center for Complementary and Alternative Medicine, Baltimore, Maryland, USA

Objective : To overview the protocols of clinical acupuncture research on cancer in the USA.

Methods : Using “acupuncture” and “cancer” as keyword search terms in Clinical Trials. gov, 28 clinical studies were found. Three studies by non-American institutions were excluded and 25 studies were analyzed. Analytic parameters were cancer condition, primary outcome, research institution, study design, and acupuncture intervention.

Results : Breast cancer was the most frequent single condition in the searched protocols. Pain and quality of life were the primary outcomes in many studies. Memorial Sloan-Kettering Cancer Centerin New York has performed the largest number of acupuncture cancer studies. The majority of studies were randomized controlled trials with active controls or placebo/sham controls. Total enrollment varied between the range of 10 and 700 subjects and ages of these subjects were at least above 18 years old (except one protocol). Most protocols had strict exclusion criteria for acupuncture needling such as bleeding disorders, infection, heart disorder, and central nervous system disorder.

Conclusions : Clinical acupuncture studies for cancer patients have focused on pain, quality of life, and side effects induced by anti-cancer therapies. Re-evaluation and cautions for strict exclusion criteria in foreign countries are required to perform multi-national acupuncture trials.

Key Words : Acupuncture, cancer, clinical trials, USA

28 3 (2007 9 )

J Korean Oriental Med 2007;28(3):116-125

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연구 방법

(National Institutes of Health, NIH)

ClinicalTrials.gov 2007 5

“Acupuncture”

“Cancer”

28 3

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2 25 .

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“Not Mentioned”

. (623)

Condition

Cancer 5

Breast 6*

Colon & Rectum 4

Head & Neck 2

Ovary 2

Pancreas 2

Prostate 2

Lung 2*

Liver 1

Total 26

* included one study for both breast and lung cancer.

(3)

28 3 (2007 9 )

연구 결과

1.

연구 대상 암의 종류

5 , 6

, 4 , , ,

, , 2 , 1

,

. (Table 1)

2.

주 평가 항목

,

Research Institution (State)

Memorial Sloan-Kettering Cancer Center (New York) 9

MD Anderson (Texas) 3*

Dana-Farber Cancer Institute (Massachusetts) 2

University of Pittsburgh (Pennsylvania) 2

Emory University (Georgia) 1

Legacy Health System (Oregon) 1

James. P. Wilmot Cancer Center (New York) 1

NCCAM (Maryland) 1

National Cancer Institute (Maryland) 1

New York Methodist Hospital (New York) 1

Oregon Health and Science University (Oregon) 1

Southern California University of Health Sciences (California) 1

University of New Mexico (New Mexico) 1

Total 25

* Recruiting site of two studies is Fudan University in Shanghai, China. Multi-site trial (624)

Study Indications

Pain 8*

Quality of Life 4*

Hot Flashes 4

Nausea/Vomiting 3

Ileus 3

Fatigue 2

Anxiety 1

Shortness of Breath 1

Xerostomia 1

Total 27

* included two studies for both pain and QOL.

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8 ,

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3.

주관 연구 기관

Memorial Sloan-Kettering Cancer Center 9

,

1-3 . (Table 3)

4.

임상 연구 디자인

19 6

, (placebo) (sham)

12 Total Enrollment Ages for Study (years)

10~19 3* 10~35 1

20~29 2* 18 and above 16

30~39 2 18~64 1

40~49 3 18~75 1

50~59 4 21 and above 3

60~69 2 Not Mentioned 3

70~79 0

80~89 4

90~99 0

100~110 4

146 1

700 1

Total 26 Total 25

* included one study with 10~29 subjects.

Study Design

Non-Randomized (Single Arm) 6

Randomized 19

2 Groups (Active Control) 7

2 Groups (Placebo Control) 11

3 Groups (Real, Sham, Usual Care) 1

Total 25

(5)

28 3 (2007 9 )

. (Table 4)

5.

연구 대상 모집 규모와 연령

10 , 10 700

, 50 , 80 , 100 4

, 146 700

1 .

1 (10~35 )

18 ,

64 75 1

. (Table 5)

6.

연구 시기 및 현황

1999 1 , 2001 2 , 2002 3 , 2003 5 , 2004 2 , 2005 4

, 2006 6 , 2007 5 2

2004

. ,

Start Year Current Status

1999 1 Recruiting or Not yet recruiting 13

2001 2 Completed or No longer recruiting 12

2002 3*

2003 5*

2004 2*

2005 4*

2006 6

2007 2

Total 25 Total 25

*included some cases according to the date of “Record first received” if study start date is not mentioned.

Tx Time/Visit Intervention Frequency Intervention Duration

20 min 2 2 times/day 1 3 days 1

20~30 min 1 1~2 times/day 1 5 days 1*

>25 min 1 1 time/day 2 1 week 2

30 min 2 3 times/week 3 4 weeks 2

> 30min 2 2 times/week 4 5 weeks 1

Continuously 1* 1~2 times/week 1 6 weeks 1

1 time/week 1 7 weeks 1

8 weeks 2

10 weeks 1

until pain is resolved 1

* Patients wore an acupressure or acustimulation wrist band continuously for five consecutive days.

included one study of 1 week treatment during the first week of each chemotherapy course.

(625)

(626)

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13 , 12 . (Table 6)

7.

침치료 방법 1)

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고 찰

ClinicalTrials.gov 1997 11

(FDA Modernization Act)

NIH FDA

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12,000,000 31,000

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. 2007 5 260

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Exclusion for Prior Acupuncture Experience

Not Mentioned 7

At the moment 2

4 weeks 3

6 weeks 6*

3 months 1

6 months 1

Any time 5

Total 25

*included one study of 6-week prior acupuncture experience, but 6 month for the main outcome-related acupuncture therapy.

(627)

(7)

28 3 (2007 9 )

“Acupuncture” “Cancer”

28 ,

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, MD Anderson 2

.

5 ,

6 , 4 , ,

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Acupuncture-Related Exclusion Criteria

Bleeding 11*

Platelet <20,000/mm^3 2

<50,000 3

<25,000 1

<75,000 1

INR >2.5 2

PT,PTT abnormal 2

Bleeding history 1

Anticoagulant therapy 4

Hemophilia 2

Von Willebrand disease 1

Infection 12*

ANC <500/mm^3 3

<1,000 3

Skin Infection 6

Cardiac disorder 11*

Pace maker 9

Endocarditis 2

Implantable electrical device 3

CNS disorder 3*

CVA 3

Spinal cord injury 3

Others Previous adverse effect with acupuncture 2

Allergy to stainless steel 2

Contraindicated for phlebotomy 1

Extremity deformities 1

Metal implants 1

Needle phobia 1

Not mentioned 5

*Multiple items of one criteria are counted as one per protocol.

(628)

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Memorial Sloan-Kettering Cancer Center 9

, U.S. News & World Report

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