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Articles and Resources of Interest
Acupuncture for Fibromyalgia
Technology Assessment
Excerpted from a report from: US. Department of Health and Human Services
-Public Health Service, June 5, 2003
Table of Contents
Introduction
Background
-Fibromyalgia
-Description of Acupuncture
-Adverse events associated with acupuncture
Methodology
Results
Conclusions
Tables 1-4
References
Introduction
The Centers for Medicare and Medicaid Services (CMS)
commissioned an expedited review of the literature on acupuncture for
fibromyalgia from the Agency for Healthcare Research and Quality (AHRQ).
In order to expedite the review, CMS requested that the
review be based on systematic reviews that are published by other groups.
Therefore this review contains:
- a) A review of recent (1995 to present) systematic reviews on the
use of acupuncture for fibromyalgia, updated with any RCTs published
since the date of the last systematic review (2000 to present).
- b) Information available in the literature on training for persons
performing this therapy and the number of physicians certified to
perform this therapy.
Background
Fibromyalgia
Fibromyalgia is a syndrome with features that include
chronic, widespread musculoskeletal pain and stiffness and associated with
fatigue, poor sleep and the presence of discrete tender points. Fibromyalgia
affects ~3.7 million people in the U.S.; 75% of patients are women between
the ages of approximately 35 to 55 .1 One small survey estimated that
approximately 20% of fibromyalgia patients treated at a university-based
clinic in the United States tried acupuncture within 2 years of diagnosis.2
Description of Acupuncture
In its original form acupuncture was based on the principles
of traditional Chinese medicine.3-5 The general theory of acupuncture is
based on the premise that there are patterns of energy flow through the body
that are essential for health. Traditional acupuncturists understand health
in terms of a vital force of energy called Qi which circulates between the
organs along channels called meridians. The traditional Chinese medicine
acupuncture practitioner seeks to identify the nature of any imbalance in Qi, and then selects the
appropriate acupuncture points from among approximately 360 points
distributed along the meridians.4, 6, 7
Acupuncture involves the stimulation of the specific
acupuncture points (acupoints) on the skin, usually by the insertion of
needles ranging in length from 1 cm to 10 cm. Between 5 and 15 needles are
used in a typical treatment, with the point combinations varying during a
course of sessions. The acupoints can be chosen based on a standardized
"formulary" involving a fixed menu of consistent points for each disease or
condition or selected for each patient individually based on a patients
specific symptoms and Qi balance. Depth of puncture can be up to 5 cm.
Other forms of acupuncture include electroacupuncture, heat
(including moxibustion), pressure, and laser-generated light.5, 6, 8. A
glossary of these procedures is found in Appendix A. Generally, studies have
addressed either manual needling or electroacupuncture because the
stimulation parameters of these procedures are easiest to control.4, 6, 7
Adverse events associated with acupuncture
Serious adverse events associated with acupuncture include
transmission of infectious disease, pneumothorax, other problems associated
with organ punctures, spinal lesions, cardiac tamponade, and broken needles
with remnants migrating to other locations.7, 8 Minor adverse events
include forgotten needles, exacerbation of symptoms, minor bleeding,
hematoma, fatigue, sweating, severe nausea, fainting, and headache.4, 7, 8
Adverse events may be associated with practitioner competence and
training.4, 14, 15
There have been several studies quantifying the rates of
adverse events. A few studies compiled case reports. One Japanese systematic
review of case reports found 25 cases of pneumothorax, 18 cases of spinal
cord injury, 11 cases of acute hepatitis B and two fatalities from
infections.16 This study and other similar studies establish that serious
adverse events are possible, but they were not able to measure the frequency
of these complications.17
Two large prospective studies in the U.K. provided estimates
of the rates of adverse events. White and colleagues conducted a prospective
survey of 32000 treatments and found that the rate of "significant" events
were 14 per 10,000 acupuncture visits. 18 None of these were deemed to be
serious. A total of 671 minor events (such as bleeding or needling pain) per
10,000 acupuncture visits were reported in this study. MacPherson and
colleagues conducted a prospective survey of 34000 treatments and found that
there were no reports of serious adverse events that required hospital
admission or led to permanent disability or death. 19 Minor adverse events
such as severe nausea and vomiting occurred in 1.3 out of 1000 visits. Mild
transient reactions such as pain or bleeding occurred in 15% of the visits.
Methodology
-
We reviewed two recent Technology Assessments to provide a
synopsis of systematic reviews as of 2001 (Table 1).
We updated the initial review by searching and listing systematic
reviews and other reviews on the use of acupuncture for fibromyalgia
from 2000 to the present (Table 2).
We further updated the review by searching for all RCTs published
since the last systematic review.
We reviewed the abstracts of all RCTs identified.
We searched for ongoing acupuncture clinical trials to treat
fibromyalgia from the clinicaltrials.gov web site (Table 3).
The search strategy used to identify studies listed in all
Tables is summarized in Appendix D.
Results
Literature search
To evaluate the current evidence for the efficacy of
acupuncture in treating fibromyalgia we identified two recent
methodologically sound Technology Assessments:
"Alberta":
Alberta
Health Technology Assessment, Acupuncture: Evidence from Systematic
Reviews and Meta-analyses (2002) 8
"NHS": United
Kingdom National Health Service Center for Reviews and
Dissemination: Effective Health Care on Acupuncture (2001)7
These reviews systematically assessed available systematic
reviews and meta-analyses on acupuncture. Both of these cited only a single
systematic review on fibromyalgia by Berman and colleagues.20 The Alberta
report rated the Berman systematic review as "Satisfactory" (on a 3 point
rating system from "Good" to "Poor"). The Alberta report criticized the
Berman systematic review because it failed to identify the style of
acupuncture (e.g. whether the points were individualized to the patient or
chosen based on a formula), appropriateness of treatment, or the
qualification of the practitioner.
In order to find more recent literature, we searched for
reviews or RCTs published since 2000. Two reviews were found: Berman and
Bandolier; these did not include any new RCTs. 21,22 There were no RCTs
identified in our search that were published since the last systematic
review.
We searched the clinicaltrials.gov website to find current
clinical trials on the use of acupuncture for fibromyalgia. Two clinical
trials are currently underway (Table 3).
Issues in evaluating acupuncture for fibromyalgia
In addition to standard design issues such as the number of
patients needed for adequate statistical power, the randomization
procedures, and the appropriateness of outcome measures, the Alberta report
summarized specific issues in designing a study for acupuncture including:
- Selection of control technique: Placebo or "sham" acupuncture in
studies of acupuncture typically use non-traditional acupuncture points,
superficial puncturing of the skin, or for electroacupuncture, the use
of electrical stimulators without connecting the cables. Some
researchers believe that inserting a needle anywhere in the body or
applying pressure to any site evokes a response.
- Complexities of acupuncture: There are many choices in designing a
study including different types of acupuncture, different systems for
choosing sites and variability in the technique of needle insertion and
manipulation.
In addition, it is important to consider that fibromyalgia
is a chronic disease characterized by recurring pain over a period of many
months or longer. Long term follow-up would be critical to determine the
effectiveness of the treatment.
Clinical data
The Berman review, which is the basis for all the other
reviews of acupuncture for fibromyalgia, cites 7 primary studies 23-29
, of which 3 are RCTs (Table 4). 25, 27, 28
Berman and colleagues considered the Deluze RCT to be the
only one of high methodological quality. 28 The other two RCTs were
considered to be of lower quality because the designs precluded the ability
to blind patients to group assignment and the method of randomization
concealment was unclear.
The NHS report included fibromyalgia together with the use
of acupuncture for other types of chronic pain, and criticized the
literature based on three points:
- Quality of the studies was related to study outcomes: lower
quality studies were more likely to favor acupuncture.
- Most RCTs of acupuncture in chronic pain have few patients and may
be underpowered.
- Active acupuncture and sham techniques may be inadequate;
including too few numbers of points, too few treatment sessions, and
placement of sham needles in the same body segment as the active
needles.
Deluze and colleagues studied 70 patients with
electroacupuncture compared to sham. They found statistically significant
improvements on several outcome measures such as pain relief. They did not,
however, follow patients beyond the three week study period. The two other
RCTs had longer term follow-up. Berman et al. reviewed the results of the
Lautenschlager et al. study of 50 patients and stated that no significant
difference of effect was found between acupuncture and placebo at 3 month
follow-up (the translation of the abstract is ambiguous and we could not
therefore confirm this statement by Berman et al.) Berman et al. also noted
that the data from the RCT was combined with data from a nonrandomized pilot
study.27 Cassisi and colleagues studied 21 patients and found a long term
pain relief benefit at 6 months, but this benefit was quantitatively less
than the initial pain relief. 25
Conclusions
There is only one RCT (Deluze et al. 28) on the use of
acupuncture for fibromyalgia that was considered to be of high quality by
Berman et al, the primary reviewer of fibromyalgia. This study of 70
patients found statistically significant benefits for acupuncture using
several outcome measures such as pain relief. This study used
electroacupuncture rather than the more traditional needling technique. More
importantly, however, Deluze et al. only followed patients for three weeks.
Studies of lower methodological quality include two other randomized studies
and several other nonrandomized studies.
The reviews interpret the strength of this body of evidence
somewhat differently (Table 1 and 2). None of the reviews concluded that the
evidence was sufficient to use acupuncture as a first line treatment,
although two concluded that the evidence supported the use of acupuncture as
adjunctive or second line treatment for fibromyalgia. Even though the study
by Deluze et al. found a statistically significant benefit for acupuncture,
it only followed patients for three weeks, which is not long enough to draw
conclusions about health outcomes for patients with this long-term chronic
condition. Longer term studies are necessary to determine the benefit of any
treatment for fibromyalgia.
At this time, therefore, there is insufficient evidence to
conclude that acupuncture has efficacy for the treatment of fibromyalgia.
Two randomized controlled clinical trials with a follow-up of at least 13
weeks are currently underway and should provide more useful data about this
treatment for fibromyalgia.
Table 1: Acupuncture for Fibromyalgia: A Review of
Systematic Reviews*
|
Systematic Review |
Conclusion |
Systematic Reviews Included (Quality Rating)
|
|
Alberta |
The robustness of the effect of acupuncture is
debatable and its clinical value questionable. |
Berman BM et al.
1999 18 (Satisfactory) |
|
NHS |
Current levels of evidence from RCTs of acupuncture
for chronic pain (including fibromyalgia) are probably sufficient to
justify the use of acupuncture as second or third line treatment for
a patient who is not responding to conventional management, not
tolerating medication or experiencing recurrent pain; however, there
is insufficient evidence to warrant first-line treatment of chronic
pain. |
Berman BM et al. 1999 18 |
* The
Alberta Health
Technology Assessment, Acupuncture: Evidence from Systematic Reviews and
Meta-analyses (2002)8and the
United Kingdom
National Health Service Center for Reviews and Dissemination: Effective
HealthCare on Acupuncture (2001) 7 systematically assessed available
systematic reviews and meta-analyses on acupuncture. This Table provides the
systematic review for fibromyalgia.
Table 2: Acupuncture for Fibromyalgia Reviews: 2000-
Present*
|
Clinical condition |
Reference |
Abstract Conclusions of SR Findings |
|
Fibromyalgia |
Berman BM, Swyers JP, Ezzo J. The
evidence for acupuncture as a treatment for rheumatic conditions.
Rheu Dis
Clin North Am. 2000;26(1):103-15,ix-x 21 |
Not yet definitive evidence from large-scale
randomized controlled trials; moderately strong evidence supports
the use of acupuncture as an adjunctive therapy for fibromyalgia.
|
|
Bandolier. Acupuncture for fibromyalgia.
22 |
There is little or no evidence of benefit |
*An update of acupuncture systematic reviews found in Table
1 for fibromyalgia: 2000 to the present.
Table 3. Acupuncture Clinical Trials for Fibromyalgia
|
Acupuncture Clinical Trial |
Condition |
Study Duration |
Target Number of Patients |
|
Acupuncture for Fibromyalgia
Principal investigator: Thomas R. Cupps, MD
|
Fibromyalgia Pain |
13 weeks active treatment; no mention of longer term
follow-up |
Phase III trial* |
|
Efficacy of Acupuncture in the Treatment of
Fibromyalgia
Principal Investigator: Debra S. Buchwald, MD
|
Fibromyalgia |
12 week treatments;
follow up at 1 and 6 months post treatment |
96 |
* Phase III trials typically involve >1000 patients (see clinicaltrials.gov)
Table 4: RCTs cited by Berman, et al. 1999
|
Trial |
Number of Patients |
Treatment |
Duration |
Results |
|
Cassisi 199425 |
21
(7 patients per group) |
Mianserine
Acupuncture
Mianserine plus acupuncture |
10 weeks treatment
6 month follow-up |
Huskisson test, McGill pain questionnaire, pressure
alometry, Krug and Laughlin test for depression, electric algometry
and daily analysis of pain and sleep were all used in evaluating
efficacy. All three groups showed improvement from baseline. Six of
7 in the acupuncture group, 3 of 7 in the mianserine group and 6 of
7 in the combined group showed improvement. Six month follow-up
showed lasting but decaying efficacy. |
|
Deluze 199228 |
70 |
Sham electro-acupuncture
Electro-acupuncture |
3 weeks |
Seven of 8 outcomes parameters showed a significant
improvement in the active treatment group compared to sham group.
Differences were significant for 5 of 8 parameters. Parameters
included pain threshold, analgesia use, sleep quality, and morning
stiffness. |
|
Lauten-schlager 198927 |
50 |
6 placebo acupuncture treatments (sham-disconnected
laser equipment)
6 acupuncture treatments |
3 months |
Change in pain threshold was documented before and
after treatment using pain scales (visual analog scale and
dolorimetry). Significant differences between treatment and sham in
all 3 methods of pain evaluation were found. Three month follow-up
found no changes in the effect of treatment, despite upward trends
in the treatment group (however, the meaning of the translation is
ambiguous). |
References
. Leventhal LJ. Management of Fibromyalgia.
Annals of
Internal Medicine. 7 December 1999 1999;131(11):850-858.
2. Bombardier CH, Buchwald D. Chronic fatigue,
chronic fatigue syndrome, and fibromyalgia. Disability and
health-care use. Med Care.
1996;34(9):924-930.
3. National Institutes of Health. Acupuncture. NIH
Consensus statement Online. 1997 Nov 3-5;15(5):1-34.
4. Kaptchuk T. Acupuncture: theory, efficacy, and
practice. Ann Intern Med. 2002 Mar;136(5):374-383.
5. National Center for Complementary and Alternative
Medicine. Acupuncture Information and Resources. Available at: http://nccam.nih.gov/health/acupuncture.
6. Mayer DJ. Acupuncture: an evidence-based review
of the clinical literature.
Annu Rev
Med. 2000;51:49-63.
7. United Kingdom National Health Service Center for
Reviews and Dissemination. Effective Health Care on Acupuncture.
Effective
Health Bulletins. Vol 7; 2001 Nov:1-12.
8. Alberta Heritage Foundation for Medical Research
Health Technology Assessment Unit.
Acupuncture: Evidence from systematic reviews and meta-analyses
2002 Mar.
9. Lytle CD. History of the food and drug
administration's regulation of acupuncture devices.
J Altern
Complement Med. 1996;2(1):253-256.
10. Turner JS. The regulation of acupuncture needles
by the United States food and drug administration.
J Altern
Complement Med. 1995;1(1):15-16.
11. GuidePoints. ACU Field Crosses Fingers on N.I.H.
Panel Outcome. Guidepoints: Acupuncture in Recovery, 1997 Sep 30;Health
Watch, Nexis: 1.
12. Center for Devices and Radiological Health
USFaDA. List of Devices for Third Party Review under the FDA
Modernization Act of 1997. Feb 7, 2002. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdparty/current.cfm?panel=HO.
13. Center for Devices and Radiological Health
USFaDA. Code of Federal Regulations Title 21 Food and Drugs
Database.
14. Norheim AJ. Adverse effects of acupuncture: a
study of the literature for the years 1981-1994.
J Altern
Complement Med. 1996;2(2):291-297.
15. Vickers A, Zollman C. ABC of Complementary
Medicine. Acupuncture.
BMJ. 1999;319:973-976.
16. Yamashita H, Tsukayama H, White AR, Tanno Y,
Sugishita C, Ernst E. Systematic review of adverse events following
acupuncture: the Japanese literature.
Complement
Ther Med. 2001;9(2):98-104.
17. Vincent C. The safety of acupuncture.
BMJ. 2001;323(7311):467-468.
18. White A, Hayhoe S, Hart A, Ernst E. Adverse
events following acupuncture: prospective survey of 32 000
consultations with doctors and physiotherapists.
BMJ. 2001;323(7311):485-486.
19. MacPherson H, Thomas K, Walters S, Fitter M. A
prospective survey of adverse events and treatment reactions
following 34,000 consultations with professional acupuncturists.
Acupunct
Med. 2001;19(2):93-102.
20. Berman BM, Ezzo J, Hadhazy V, et al. Is
acupuncture effective in the treatment of fibromyalgia.
J Fam
Pract. 1999;48(3):213-218.
21. Berman BM, Swyer J, Ezzo J,. The evidence for
acupuncture as a treatment for rheumatologic conditions.
Rheum Dis
Clin North Am. 2000;26(1):103-115, ix-x.
22. Bandolier. Acupuncture for fibromyalgia:
Bandolier; 2003.
23. Sprott H, Franke S, Kluge H, Hein G. Pain
treatment of fibromyalgia by acupuncture (abstract).
Arthritis
Rhuem. 1996;39:S91.
24. Radaelli E, Buzzi GP. Trattamento mediante
agopuntura delle fibromiositi del tratpezio.
Min Med.
1978;69:3017-3019.
25. Cassisi G, Roncaglione A, Ceccherelli F,
Donolato C, Gagliardi G, Todesco S. Trattamento agopunturale della
fibromyalgia primiria. Confronto con mianserina.
G. Ital.
Riflessot. Agopunt. 9-10 September 1994 1995;7(1):33-35.
26. Pasotti D, Montanari E, Capobianchi B.
Lagopuntura nella Syndrome Fibromyalgia primaria.
G Ital
Riflessot Agopunt. 1990;2:23-31.
27. Lautenschlager J, Schnorrenberger CC, Muller W.
Akupunktur bei generalisierter Tendomyopathie (Fibromyalgie-Syndrom).
Deutsche
Zeitschrift fur Akupunktur. 1989 1989;6:122-128.
28. Deluze C, Bosia L, Zirbs A, Chantraine A,
Vischer TL. Electroacupuncture in fibromyalgia: results of a
controlled trial. BMJ. 1992;305(6864):1249-1252.
29. Waylonis G.W. Long-term follow-up on patients
with fibrocytis treated with acupuncture.
Ohio State
Medical Journal. 1977;17:299-302.
30. An Overview Of Medical Acupuncture, American
Academy of Medical Acupuncture, June 2, 2003. Available at:
http://www.medicalacupuncture.org/acu_info/articles/helmsarticle.html
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