Acupuncture and Knee Osteoarthritis

July 4, 2006

Another study that finds AP is effective, but with no difference between

real AP and sham AP. From the abstract we do not know how the sham AP was

done. Does anyone have access to this article (Annals of Int Medicine)?

http://tinyurl.com/ns7ye

Acupuncture and Knee Osteoarthritis

A Three-Armed Randomized Trial

Hanns-Peter Scharf, MD; Ulrich Mansmann, PhD; Konrad Streitberger, MD;

Steffen Witte, PhD; Jürgen Krämer, MD; Christoph Maier, MD; Hans-Joachim

Trampisch, PhD; and Norbert Victor, PhD

4 July 2006 | Volume 145 Issue 1 | Pages 12-20

Background: Despite the popularity of acupuncture, evidence of its efficacy

for reducing pain remains equivocal.

Objective: To assess the efficacy and safety of traditional Chinese

acupuncture (TCA) compared with sham acupuncture (needling at defined

nonacupuncture points) and conservative therapy in patients with chronic

pain due to osteoarthritis of the knee.

Design: Randomized, controlled trial.

Setting: 315 primary care practices staffed by 320 practitioners with at

least 2 years' experience in acupuncture.

Patients: 1007 patients who had had chronic pain for at least 6 months due

to osteoarthritis of the knee (American College of Rheumatology [ACR]

criteria and Kellgren–Lawrence score of 2 or 3).

Interventions: Up to 6 physiotherapy sessions and as-needed

anti-inflammatory drugs plus 10 sessions of TCA, 10 sessions of sham

acupuncture, or 10 physician visits within 6 weeks. Patients could request

up to 5 additional sessions or visits if the initial treatment was viewed as

being partially successful.

Measurements: Success rate, as defined by at least 36% improvement in

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

at 26 weeks. Additional end points were WOMAC score and global patient

assessment.

Results: Success rates were 53.1% for TCA, 51.0% for sham acupuncture, and

29.1% for conservative therapy. Acupuncture groups had higher success rates

than conservative therapy groups (relative risk for TCA compared with

conservative therapy, 1.75 [95% CI, 1.43 to 2.13]; relative risk for sham

acupuncture compared with conservative therapy, 1.73 [CI, 1.42 to 2.11]).

There was no difference between TCA and sham acupuncture (relative risk, 1

01 [CI, 0.87 to 1.17]).

Limitations: There was no blinding between acupuncture and traditional

therapy and no monitoring of acupuncture compliance with study protocol. In

general, practitioner–patient contacts were less intense in the conservative

therapy group than in the TCA and sham acupuncture groups.

Conclusions: Compared with physiotherapy and as-needed anti-inflammatory

drugs, addition of either TCA or sham acupuncture led to greater improvement

in WOMAC score at 26 weeks. No statistically significant difference was

observed between TCA and sham acupuncture, suggesting that the observed

differences could be due to placebo effects, differences in intensity of

provider contact, or a physiologic effect of needling regardless of whether

it is done according to TCA principles.

July 5, 2006

Selection from Methods section included below. Also see file uploaded to

this group ( " AnnInternMed_Scharf_et_al_145_1_12_table1.gif " at

http://health.Chinese Medicine)

which summarizes acu/sham protocols.

.........................

Ann Intern Med Scharf et al. 145 (1): 12.

METHODS

Participants

A total of 1039 eligible patients were enrolled in the

study between April 2002 and March 2004. The 320 physicians

were selected from a group of experienced primary

care practitioners participating in a large cohort study on

acupuncture (www.gerac.de). The ethics committees of the

University of Heidelberg and the University of Mannheim

and all involved local ethics committees approved the

study. The study protocol was consistent with the principles

of the Declaration of Helsinki.

The inclusion criteria were signed declaration of consent;

age 40 years and older; chronic pain in the knee joint

for the last 6 months, according to American College of

Rheumatology (ACR) criteria (8); radiologic confirmation

of osteoarthritis in 1 or both knees (Kellgren–Lawrence

score 2 or 3 [9]); Western Ontario and McMaster Universities

Osteoarthritis Index (WOMAC) (10, 11) score of at

least 3 points; and a chronic pain score of at least 1, according

to the criteria of von Korff and colleagues (12).

Patients with other diseases affecting the knee, neurologic

and psychiatric diseases, severe coagulopathy, pregnancy,

or previous acupuncture treatment for osteoarthritis of the

knee were excluded. A detailed list of eligibility criteria was

reported by Streitberger and colleagues (13).

The physicians checked the patients’ eligibility criteria

during a screening examination. A screening telephone interview

was done to record baseline WOMAC values, quality

of life (12-item Short-Form Health Survey [sF-12])

(14), von Korff scores (15), and use of analgesics. Finally,

patients were randomly assigned into 3 treatment groups.

Interventions

Conservative therapy involved 10 visits to practitioners

with consultation and a prescription for diclofenac, up to

150 mg/d, or rofecoxib, 25 mg/d, as needed until week 23.

The protocol permitted 5 additional visits in weeks 7 to 13

if patients were graded as having a “partially successful”

result (10% to 50% reduction in pain after 6 weeks based

on the von Korff pain intensity scale) during a telephone

interview. If a patient fulfilled the criterion for additional

visits, the interviewer informed the patient during the interview

and informed the related investigator by fax. The

patient could choose whether to participate in the 5 additional

visits.

In the TCA and sham acupuncture groups, 10 acupuncture

sessions administered over a 6-week period began

2 weeks after screening. Patients receiving acupuncture

who met the criterion for partial success were also entitled

to 5 additional treatment sessions.

The defined TCA program followed recommendations

for optimized acupuncture treatment in clinical studies

(16). According to the traditional Chinese theory of the Bi

syndrome to treat knee pain, the most important local acupuncture

points were included as obligatory points (17–

19). In addition, according to traditional Chinese diagnosis

(including meridian theory and the most common syndrome

differentiation of qi stagnation, kidney deficiency,

and dampness and cold), 2 of 16 defined acupuncture

points could be chosen. A maximum of 4 Ahshi points was

also allowed (Table 1).

Sham acupuncture was standardized as minimal-depth

needling without stimulation at 10 points at defined distances

from TCA points. One point was between the gallbladder

and stomach meridian on the distal part of the

fibula, 2 cun above the malleolus lateralis toward the knee

(cun is a patient-related measure that is the width of a

thumb, approximately 1.5 cm, and is used in TCM). Two

points were 2 cun and 6 cun, respectively, above the malleolus

medialis in the center of the tibia surface area, intracutaneous,

without periosteum contact and in the direction

of the knee. One point was in the center of the thigh

on the connecting line from the center of the patella to theanterior

superior iliac spine, in the direction of the hip.

One point was on the highest spot of the tightened musculus

biceps brachii. This control technique was chosen to

minimize any supposed nonspecific antinociceptive physiologic

effects of deep needling and strong stimulation, including

the typical acupuncture sensation of deqi. Noninvasive

sham devices, such as the placebo needle (20), were

not used. The protocol prescribed the same general procedure,

diagnostics, and communication with patients in the

TCA and sham acupuncture groups.

The same types of acupuncture needles were used for

TCA and sham acupuncture, and all investigators were

trained in both techniques. Both knees were treated if affected.

When acupuncture did not reduce the pain to a

level the patient found acceptable, patients could take up

to 150 mg of diclofenac per day during the first 2 treatment

weeks and up to a total of 1 g until week 23.

Each of the 3 treatment groups had up to 6 physiotherapy

sessions. Corticosteroids and other analgesics besides

diclofenac and rofecoxib were explicitly excluded for

all patients. Injections, infiltrations, moxibustion, cupping,

and electroacupuncture were also prohibited. Additional

details are shown in Table 1 and in the protocol published

by Streitberger and colleagues (13).

The patients knew whether they were in the conservative

therapy group but were blinded to TCA versus sham

acupuncture. The investigators were not blinded to treatment

group, but the person doing the telephone interviews

for end point measurement was blinded to treatment assignment.

.........................

> Another study that finds AP is effective, but with no difference between

> real AP and sham AP. From the abstract we do not know how the sham AP was

> done. Does anyone have access to this article (Annals of Int Medicine)?

>

> http://tinyurl.com/ns7ye

> Acupuncture and Knee Osteoarthritis

> A Three-Armed Randomized Trial

> Hanns-Peter Scharf, MD; Ulrich Mansmann, PhD; Konrad Streitberger, MD;

> Steffen Witte, PhD; Jürgen Krämer, MD; Christoph Maier, MD; Hans-Joachim

> Trampisch, PhD; and Norbert Victor, PhD

__________________________

Michael Short, Lic. Ac.

Confidentiality: The information herein may contain confidential

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July 13, 2006

Thank you to Michael Short and Chinesedoc2000 for providing info about this

important study.

The conclusion of the trial is that both true and sham AP were more

effective than standard physiotherapy and anti-inflammatory drugs.

Miller and Kaptchuck have written an interesting response to this article

here: http://tinyurl.com/pt3xw

The conclusions of this trial are biased against acupuncture because the

sham intervention, that in this trial was used as a placebo control, is not

completely inert.

In addition, non-specific effects of true AP have not been accounted for.

See this quote from an article by Stephen Birch*:

" ...it has been postulated that the principal purpose of the traditionally

based diagnoses and treatments in acupuncture is to target a specific

improvement in the innate healing abilities of each patient, which may

employ the same mechanisms of action as those harnessed by placebo. There is

growing evidence for the claim that placebo harnesses self-healing

mechanisms. Because the traditionally based acupuncture treatment targets

improvement of these mechanisms, controlling for this in placebo-controlled

trials of acupuncture may thus require attempting to control for the

specific mechanisms and effects of the therapy being investigated, which

contradicts the reasons for conducting placebo-controlled trials. "

We're probably going to get bad press from this trial like " AP just a

placebo treatment " . Articles like the one written by Stephen Birch need to

get more airplay, including in the medical circles that use the so-called

sham needles or sham-acupuncture. Again from Birch: " ...there is general

agreement that any invasive sham acupuncture cannot be inert. "

I just came across this study: " Immediate effect of Fu’s subcutaneous

needling for low back pain " (pdf @ http://tinyurl.com/lcxae)

Whilst the scientific rigour of this study is very low, it again illustrates

that even very superficial (subcutaneous) needling without eliciting deqi,

like the sham-AP used in the " Acupuncture and Knee Osteoarthritis " trial

(uploaded to this group) can be used to treat conditions like low back pain

and, why not, knee osteoarthitis.

In conclusion, I find that the conclusions of the trial are not completely

valid and underestimate the effect of the AP because of the non-inertia of

its placebo method.

Tom.

* Birch S. A Review and Analysis of Placebo Treatments, Placebo Effects,

and Placebo Controls in Trials of Medical Procedures When Sham Is Not Inert.

THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, Volume 12, Number 3,

2006, pp. 303–310

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July 13, 2006

Tom

Most of the references to the article i have seen in medical communications such

as medscape etc., were " acupuncture may be affective for osteoarthritis of the

knee. " So the press is not completely negative

Oakland, CA 94609

-

Tom Verhaeghe

Chinese Medicine

Thursday, July 13, 2006 8:20 AM

Re: Acupuncture and Knee Osteoarthritis