Acupuncture in patients with osteoarthritis of the knee: a randomised trial

doi:10.1016/S0140-6736(05)66871-7

The Lancet

Volume 366, Issue 9480, 9–15 July 2005, Pages 136-143

https://doi.org/10.1016/S0140-6736(05)66871-7 Get rights and content

Summary

Background

Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee.

Methods

Patients with chronic osteoarthritis of the knee (Kellgren grade ≤2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat.

Results

294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26·9 (SE 1·4) in the acupuncture group, 35·8 (1·9) in the minimal acupuncture group, and 49·6 (2·0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture −8·8, [95% CI −13·5 to −4·2], p=0·0002; acupuncture vs waiting list −22·7 [−27·5 to −17·9], p<0·0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0·08).

Interpretation

After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.

Introduction

Osteoarthritis most frequently affects the knee joint.¹ Anti-inflammatory drugs used to treat the symptoms of this disorder are associated with various side-effects.² Furthermore, for patients for whom these drugs do not lead to an adequate response, replacement surgery is often recommended.³ Patients with chronic pain are increasingly using acupuncture for pain relief.⁴ There is some evidence that acupuncture can be effective in treating pain and dysfunction in patients with osteoarthritis of the knee. In a systematic review including seven randomised controlled trials with a total of 393 patients, acupuncture was more effective than sham acupuncture in reducing pain, whereas for joint function the results were inconclusive.⁵ These previous studies, however, were based on small sample sizes and the follow-up period was never longer than 3 months.

We aimed to investigate the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with pain and dysfunction due to osteoarthritis of the knee.

Section snippets

Patients

Patients were included in our study if they were aged 50–75 years, had been diagnosed with osteoarthritis according to the American College of Rheumatology criteria, had documented radiological alterations in the knee joint of grade 2 or more according to Kellgren-Lawrence criteria,6, 7 had an average pain intensity of 40 or more on a 100 mm visual analogue scale in the 7 days before baseline assessment, and if they gave written informed consent. The exclusion criteria were one or more of the

Results

Between March 6, 2002, and January 17, 2003, about 1100 patients with osteoarthritis of the knee applied to participate in the study. Figure 2 shows the trial profile. Of 300 patients randomised six were excluded from the intention-to-treat population because no baseline data were available, and they did not receive the study intervention. All the remaining 294 patients treated in a total of 28 outpatient centres were included in the intention-to-treat population. Three patients in the

Discussion

In this study, patients with osteoarthritis of the knee who received acupuncture had significantly less pain and better function after 8 weeks than did patients who received minimal acupuncture or no acupuncture. After 26 and 52 weeks, exploratory analysis indicated that the differences between acupuncture and minimal acupuncture were no longer significant.

The present study is, to date, one of the largest and most rigorous trials of the efficacy of acupuncture available. Its strengths include a

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Cited by (516)

The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: A systematic review and network meta-analysis
2024, Heliyon
In sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis.
Ten databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated.
A total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate.
For knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.
Effect of acupuncture duration in patients with knee osteoarthritis: A secondary analysis of a multi-center randomized controlled trial
2023, World Journal of Acupuncture - Moxibustion
To explore the influence of acupuncture duration on the effect of acupuncute for patients with knee osteoarthritis (KOA).
This secondary analysis was conducted based on the data of a randomized controlled trial about acupuncture on KOA. A total of 480 patients were recruited at nine centers. Only data from the manual acupuncture (MA) group and electroacupuncture (EA) group were included in this secondary analysis. The needles were retained for 30-min each time and treatment was given three times a week for 8 weeks. The follow-up visit lasted until week 26. Outcomes were numerical rating scale (NRS) on pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function and the response rate.
The NRS and WOMAC function at week 8 were lower than those at week 4 (P<0.05), and were no significant difference compared with those at week 26 in MA and EA groups (P>0.05). Greater changes were observed in NRS and WOMAC function during 0–4 weeks compared with those during 4–8 weeks (P<0.05) in both groups. The response rate at week 8 was higher than it at week 4 (P<0.05), and was no significant difference compared with it at week 26 (P>0.05) in both groups. Association was found between BMI and changes of NRS (P<0.05), but not between BMI and WOMAC function (P>0.05) in MA group, while no asscoaition was found between BMI and NRS or WOMAC function in EA group (P>0.05). There was no association found between other factors and NRS or WOMAC function in both groups (P>0.05).
For KOA patients, 8-week acupuncture was more effective than 4-week acupuncture in relieving pain and improving joint function, but growth rate of the effect slowed down with increasing duration of intervention. It was uncertain whether the long-term effect of 8-week acupuncture was better than that of 4-week acupuncture. Further studies are required to further determine the effect of duration of intervention.
Electroacupuncture combined with extracorporeal shock wave therapy improves pain symptoms and inflammatory factor levels in knee osteoarthritis patients
2023, Heliyon
To compare the clinical efficacy and safety of electroacupuncture combined with extracorporeal shock wave therapy (EESWT) and extracorporeal shock wave therapy (ESWT) in the treatment of knee osteoarthritis (KOA).
A total of 135 KOA patients who received EESWT treatment were selected as the EESWT group, and 135 KOA patients who received extracorporeal shock wave therapy (ESWT) were selected as the ESWT group. The clinical efficacy, inflammatory factors in joint synovial fluid and adverse events during treatment were compared before and after treatment.
The clinical effective rate of patients in the EESWT group (89.63 %) after treatment was significantly higher than that of the ESWT group (74.81 %) (p < 0.01). The lysholm kness (LKSS) score and range of motion (ROM) of the patients in the EESWT group after treatment were higher than those of the ESWT group, while Lequesne index score, visual analogue scale (VAS) score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) were lower than those of the ESWT group (p < 0.01). Compared with ESWT group, the changes in the expression levels of nitric oxide (NO), superoxide dismutase (SOD), interleukin 1β (IL-1β), tumor necrosis factor-α (TNF-α), matrix metalloproteinase-3 (MMP-3), and transforming growth factor β1 (TGF-β1) in the synovial fluid of the EESWT group after treatment were significantly greater than those of the ESWT group (p < 0.01). No significant difference in the incidence of adverse events between the EESWT group and the ESWT group (p > 0.05).
EESWT significantly improves pain symptoms and inflammatory factor levels in KOA patients and is an optional KOA treatment option worthy of clinical attention.
Economic evaluation of acupuncture as an adjunctive treatment with usual care for mild-to-moderate knee osteoarthritis: A Markov model-based analysis
2023, Integrative Medicine Research
Collaborative care (CC), in which acupuncture is combined with usual care (UC), improves clinical outcomes and increases costs in knee osteoarthritis (KOA). We evaluated the economic feasibility of CC for Korean female patients with mild-to-moderate KOA by using a cost-effectiveness approach.
Two alternatives for KOA (1. UC as a comparator; and 2. CC as an intervention) were defined based on clinical guidelines, official Korean statistics, and expert validation. Each alternative was simulated in a Markov model every 6 months for 10 years. Estimates of costs, utilities, and transition probabilities were obtained from official statistics and previous studies. The effectiveness of CC was synthesized from randomized controlled trials. A base-case analysis of a limited societal perspective, univariate sensitivity analysis, and probability sensitivity analysis were performed. An annual discount rate of 4.5% and threshold of 20,000 United States dollar per Quality-adjusted life year (USD/QALY) were applied.
Every incremental cost-effectiveness ratio (ICER) of CC calculated from the analyses was sub-threshold. In the base-case analysis, with a limited societal perspective, the ICER was 11,085 USD/QALY. The ICERs from the univariate sensitivity analyses were -2,577–16,748 USD/QALY. The average ICER in the probability sensitivity analysis was 12,412 USD/QALY. When the threshold surpassed 8,000 USD/QALY, the cost-effectiveness of CC exceeded 50%. The probability was 70.27% when the threshold was 20,000 USD/QALY.
CC for Korean female patients with mild-to-moderate KOA was generally cost-effective. Considering the limitations of the evidence, we propose a re-evaluation using further clinical studies in the future.
Acupuncture out, dogma in: The U.K. National Institute for Health and Care Excellence guideline for osteoarthritis 2022
2023, European Journal of Integrative Medicine
The recently published National Institute for Health and Care Excellence (NICE) guideline for osteoarthritis (NG226) does not recommend acupuncture. However, high-quality evidence exists that indicates acupuncture is effective for osteoarthritis and not simply a placebo. NICE clinical guidelines, such as NG226, provide recommendations for the National Health Service (NHS) in the U.K. In this opinion article the author examines the rationale and evidence set out in the guideline NG226 and the supporting documentation.
Two interrelated issues are identified: problems of interpretation and problems of definition. The problems of interpretation have been discussed in relation to previous NICE guidelines, these include: the evidence review erroneously analyses sham acupuncture as inert; the minimal important difference criterion for efficacy trials is not applied consistently; insufficient weight is given to pragmatic comparative effectiveness evidence. The problems of definition have not been discussed to the same degree. The evidence review employs no operational definitions of acupuncture or sham acupuncture. As a result, highly similar procedures are classified as sham in one trial but verum in another. This is illogical and unscientific.
The guideline rationale fails to engage with the scientific debate regarding acupuncture research and repeats the mistakes of earlier guidelines. The interpretation of the evidence is erroneous as it is based on the dogma that sham acupuncture is inert. This is compounded by a failure to have clear definitions for acupuncture or sham acupuncture. The committee's interpretation of the acupuncture evidence will have negative consequences for patients in practice and for those enrolled in future clinical trials.
Attenuation of skeletal muscle atrophy via acupuncture, electro-acupuncture, and electrical stimulation
2023, Integrative Medicine Research
Accelerated skeletal muscle wasting is a shared trait among many pathologies and aging. Acupuncture has been used as a therapeutic intervention to control pain; however, little is known about its effects on skeletal muscle atrophy and function. The study's purpose was to compare the effects of acupuncture, electro-acupuncture, and electrical stimulation on cast-induced skeletal muscle atrophy.
Forty female Sprague Dawley rats were randomly divided into groups: Control, casted (CAST), CAST+Acupuncture (CAST-A), 4) CAST+Electro-acupuncture (CAST-EA), and CAST+Electrical stimulation (CAST-ES) (n = 8). Plaster casting material was wrapped around the left hind limb. Acupuncture and electro-acupuncture (10 Hz, 6.4 mA) treatments were applied by needling acupoints (stomach-36 and gallbladder-34). Electrical stimulation (10 Hz, 6.4 mA) was conducted by needling the lateral and medial gastrocnemius muscles. Treatments were conducted for 15 min, three times/week for 14 days. Muscle atrophy F-box (MAFbx), muscle RING finger 1 (MuRF1), and contractile properties were assessed.
Fourteen days of cast-immobilization decreased muscle fiber CSA by 56% in the CAST group (p = 0.00); whereas, all treatment groups demonstrated greater muscle fiber CSA than the CAST group (p = 0.00). Cast-immobilization increased MAFbx and MuRF1 protein expression in the CAST group (p<0.01) while the CAST-A, CAST-EA, and CAST-ES groups demonstrated lower levels of MAFbx and MuRF1 protein expression (p<0.02) compared to the CAST group. Following fourteen days of cast-immobilization, peak twitch tension did not differ between the CAST-A and CON groups (p = 0.12).
Skeletal muscle atrophy, induced by 14 days of cast-immobilization, was significantly attenuated by acupuncture, electro-acupuncture, or electrical stimulation.

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ArticlesAcupuncture in patients with osteoarthritis of the knee: a randomised trial

Summary

Background

Methods

Results

Interpretation

Introduction

Section snippets

Patients

Results

Discussion

Lancet

Pain

Osteoarthritis Cartilage

Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines

Arthritis Rheum

Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey

JAMA

Acupuncture for osteoarthritis of the knee: a systematic review

Arthritis Rheum

Radiolocical Assessment of Osteo-Arthrosis

Ann Rheum Dis

Scoring prevalence and severity in gonarthritis: the suitability of the Kellgren & Lawrence scale

Clin Rheumatol

Acupuncture Randomized Trials (ART) in patients with chronic low back pain and osteoarthritis of the knee: design and protocols

Forsch Komplementarmed Klass Naturheilkd

A manual of acupuncture

Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee

J Rheumatol

Evaluation of a German version of WOMAC (Western Ontario and McMaster Universities) Arthrosis Index

Z Rheumatol

Entwickling und empirische Überprüfung des Deutschen Schmerzfragebogens der DGSS

Schmerz

Behinderungseinschätzung bei chronischen Schmerzpatienten

Schmerz

Die Schmerzempfindungsskala (SES)

Allgemeine Depressionsskala (ADS). Die deutsche Version des CES-D

Articles
Acupuncture in patients with osteoarthritis of the knee: a randomised trial