acetaminophen (Tylenol): nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Motrin, Nuprin, Advil); and exercises to restore joint movement and strengthen the knee. Losing excess weight can also help people with osteoarthritis.
(Tukmachi, E.S.A., Dempsey, E., Jubb, R.W. (2004); Tukmachi, E.S.A. (2000); Tukmachi, E.S.A. (1990); Jubb RW, Tukmachi ES, Jones PW, Dempsey E, Waterhouse L, Brailsford S. (2008)). The future research should address the following key questions:
when compared with placebo or another treatment modality using a double-blind controlled trial and a strictly defined protocol. Papers should describe enrolment procedures, eligibility criteria, description of the clinical characteristics of the subjects, methods for diagnosis, and a description of the protocol (i.e., randomization method, specific
definition of treatment, and control conditions, including length of treatment and number of acupuncture sessions). Optimal trials should also use standardized outcomes and appropriate statistical analyses. This assessment of efficacy focuses on high-quality trials comparing acupuncture with sham acupuncture or placebo.
2. What is known about the biological effects of acupuncture that helps us understand how it works in knee osteoarthritis?
Assessing the usefulness of a medical intervention in practice differs from assessing formal efficacy. In conventional practice, clinicians make decisions based on the characteristics of the patient, clinical experience, potential for harm, and information from colleagues and the medical literature. In addition, when more than one treatment is possible, the clinician may make the choice taking into account the patient's preferences.
While it is often thought that there is substantial research evidence to support conventional medical practices, this is frequently not the case. This does not mean that these treatments are ineffective.
The data in support of acupuncture are as strong as those for many accepted Western medical therapies. one of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted medical procedures used for the same conditions. As an example, among painful diseases, knee osteoarthritis is a condition for which acupuncture may be beneficial. The condition is often treated with, among other things, anti-inflammatory medications (aspirin, ibuprofen, etc.). This medical intervention has a potential for deleterious side effects but is still widely used and considered as an acceptable treatment. The evidence supporting this type of therapy is no better than that for acupuncture.
3.What issues need to be addressed so that acupuncture can be appropriately incorporated into today's health care system?
Many studies in animals and humans have demonstrated that acupuncture can cause multiple biological responses. These responses can occur locally, i.e., at or close to the site of application, or at a distance, mediated mainly by sensory neurons to many structures within the central nervous system. This can lead to activation of pathways affecting various physiological systems in the brain as well as in the periphery. A focus of attention has been the role of endogenous opioids in acupuncture analgesia. Considerable evidence
supports the claim that opioid peptides are released during acupuncture and that
the analgesic effects of acupuncture are at least partially explained by their actions. That opioid antagonists such as naloxone reverse the analgesic effects of acupuncture further strengthens this hypothesis. Stimulation by acupuncture may also activate the hypothalamus and the pituitary gland, resulting in a broad spectrum of systemic effects. Alteration in the secretion of neurotransmitters and neurohormones and changes in the regulation of blood flow, both centrally and peripherally, have been documented. There is also evidence of alterations in immune functions produced by acupuncture. Which of these and other physiological changes mediate clinical effects is at present unclear. Although much remains unknown regarding the mechanism(s) that might mediate the therapeutic effect of acupuncture in osteoarthritis, the current pilot and future studies benefit from a number of significant acupuncture-related biological changes can be identified and carefully delineated. Further research in this direction is not only important for elucidating the phenomena associated with acupuncture, but also has the potential for exploring new pathways in human physiology not previously examined in a systematic manner.
4.What are the directions for future research
Mechanisms that provide a Western scientific explanation for some of the effects of acupuncture are beginning to emerge. This is encouraging and may provide novel insights into neural, endocrine, and other physiological processes. Research should be supported to provide a better understanding of the mechanisms involved, and such research may lead to improvements in osteoarthritis treatment.
Acupuncture Approach And Mechanism In Osteoarthritis
Many research reports show that acupuncture can be helpful for reducing the pain, inflammation, and muscle spasm associated with osteoarthritis (Tukmachi, 1991a, 1999, Tukmachi, 1999a). This type of arthritis most commonly affects large joints such as the hips, knees, and the back, and is related to ongoing wear and tear. While there is no strong evidence that cartilage can be rebuilt, there is a suggestion that electrical currents applied around joints, can be of some benefit to cartilage, at least by reducing ongoing damage. Electrical stimulation is beneficial to joint tissue, at least in part by increasing blood flow and joint nutrition, possibly allowing for some repair. Acupuncture may be able to enhance effects of glucosamine sulfate because by improving joint blood flow, local delivery of glucosamine can increase.
In western medicine, the fact that to date so much of the related research has been performed, and the commentary dominated, by poorly trained and insufficiently practised acupuncturists must not only reflect badly on traditional Chinese acupuncture but also undermines the profession's authority and expertise.
Melzack and Wall's gate control theory ( Melzack and Wall, 1965) had to be revised on a number of occasions because it didn't fit in with (well established) clinical reality. The popular endorphin theory itself (Tukmachi, 1991) can only be maintained with difficulty in view of the studies that demonstrate long-term benefits (two months to two years follow up) of acupuncture. Therefore, many of the theories on the mechanism of acupuncture so far proposed have been incapable of completely addressing the clinical portrait of acupuncture in osteoarthritis.
In traditional Chinese acupuncture medicine, osteoarthritis is a subgroup of Bi-syndrome in Chinese medicine (Tukmachi, 1999a). Bi-syndrome is a classical example of how a disease is caused by the invasion of external pathogenic factors such as Wind, Cold, or Dampness. According to these external pathogenic factors, the following four patterns of arthritis are differentiated and the leading herbs to address these patterns are discussed.
Exposure to wind is an important cause of the Wind pattern of arthritis. The Wind pattern of arthritis is characterized by joint soreness and pain. The pain moves from joint to joint like wind. Movement of joints is limited. Aversion to wind and fever is experienced. Thin and white tongue coating and a floating pulse is read by Chinese medicine practitioners.
The Cold pattern of arthritis is characterized by a severe pain in a joint or muscle. The pain has a fixed location. The pain is reduced by warmth and increased by cold. Movement of joints is limited. Thin and white tongue coating and a wiry and tight pulse are read.
The Damp pattern of arthritis is characterized by pain, soreness, and swelling in muscles and joints with a feeling of heaviness and numbness of the limbs. The pain has a fixed location and is aggravated by damp weather. White and sticky tongue coating and soggy and slow pulse are read.
The Heat pattern of arthritis is originated from any of the above three patterns. It is characterized by a severe pain and hot-red-swollen joints. The pain is reduced with cold. Aversion to wind, fever, thirsty and anxiety might be experienced. Yellow and dry tongue coating and slippery and rapid pulse are read.
It is believed that the meridians (energy pathways) are blocked with arthritis, or generally Bi-syndrome indicating pain, soreness or numbness of muscles, tendons and joints in traditional Chinese medicine. As a result, the Chi and Blood in the meridians are obstructed. Acupuncture helps open the blockage, balance the energy, and harmonize the Chi and Blood.
OF ACUPUNCTURE CLINICAL RESEARCH TRIALS
In clinical trials patients with a specific disease condition are randomly assigned to either a treatment group or control group. In designing the trial, one must consider the nature of the control group - this may comprise patients who are not treated at all, who are treated by another therapy, or who are treated by some sham method such as shallow puncture of non-meridian areas.
The "gold standard" for clinical trials of drug treatments is the double-blind study. It is generally accepted that double-blind trials of acupuncture are practically impossible, since it is inevitable that the practitioner will know whether or not they are giving a true acupuncture treatment. However, this problem is not unique to acupuncture, since the same issues arise in assessing surgical procedures or physiotherapy treatments for example, and it is still possible to design "single-blind" studies.
Thus, in all trials, and regardless of the nature of the control group, the design should always employ "blinded evaluation". Also, when the control group is treated using "sham acupuncture", patients should not be aware of being in the control group as opposed to the group receiving true acupuncture. Therefore, single-blind trials with independent assessment are adequate, provided efforts are made to monitor independently the impact of non-specific effect and/or ensure that they do not vary between groups.
Much of the work that discusses the clinical effectiveness of acupuncture is descriptive and of a limited value. Therefore, it is essential that clearly controlled, randomised clinical trials become available in this area before the acupuncture techniques are accepted or rejected. Usually in acupuncture research, researchers used a real versus sham acupuncture models in order to evaluate its effects (Co et al 1979, Gaw, et al 1975, Godfrey and Morgan 1978, Moor and Berk 1976). The real acupuncture involves the use of acupuncture needles inserted into acupuncture points supposed therapeutically effective, for the condition being treated, and can be considered to be properly performed acupuncture. On the other hand, the sham acupuncture is the insertion of needles into parts of the body supposed therapeutically ineffective for the condition being treated and can be considered to be improperly performed acupuncture. Most of the clinical trials using a real versus sham acupuncture model showed that sham acupuncture is effective in relieving pain of approximately 50% of patients and real acupuncture is shown to be effective in approximately 75% of patients with chronic pain. While the placebo (no acupuncture treatment) was effective in only 35% of patients with chronic pain (Co et al 1979, Gaw et al 1975, Godfrey and morgan 1978).
Despite these results, there is a considerable debate about the desirable approach to acupuncture methodology, point selection and the methods of needle stimulation. It is apparent that the vast majority of the published reports have a very low power and consequently very few conclusions about the efficacy of acupuncture (Moor and Berk 1976). Godfrey and Morgan (1978) suggested that the real acupuncture is no more effective than sham acupuncture. However, their analysis has not accounted for possible imbalances of primary diagnosis and site of pain between the treatment arms.
Indeed many researchers have indicated the need for appropriate numbers of patients to be recruited to clinical trials (Altman , 1980, Feinstein, 1977, Freiman et al 1978, Gore, 1981). Altman (1980) has emphasised the ethical problems of performing trials, which are of an unsatisfactory statistical design.
With regard to placebo effects, Lewith and Machin (1983) reported that a physical placebo resulted in 30% of patients experiencing significant pain relief, random needling in a 50% response and acupuncture in a 70% response. It is not surprising that most studies on this subject did not produce a statistically significant results as only small numbers of patients were involved into each individual clinical trial ( for example, Gaw, et al 1975, calculated only a one in three chance of detecting a significant difference between acupuncture and random needling if we assume that the predicted 70% and 50% response rate is correct).
Finally, well designed and carefully conducted clinical trials will produce measures of the value of acupuncture treatment which are comparable to those produced for other treatments such as physiotherapy or drug therapy.
Does the trial include a normal acupuncture practice?
Many acupuncture reports give few details of treatment procedures stating only, for example, that, "acupuncture sites were selected after consultation with established acupuncturists (Gaw, et al 1975)". There are as yet not clearly established principles concerning which style of acupuncture is best suited to a particular complaint or a particular individual. It is important that any report should specify as clearly as possible what was done. This might include the following:
1.Number of sessions.
2.Mode of stimulation (electrical, manual or both).
3.Duration and frequency of stimulation.
4.Whether "Teh-chi" sensation (e.g. numbness, tingling, sore¬ness...etc) were sought.
5.Point classification (the classical Chinese points, motor points, trigger points, points
within the dermatome...etc).
Diagnosis (Western and, if appropriate, traditional Chinese acupuncture diagnosis).
Individual treatment variability.
The trial is a pragmatic randomised controlled trial. A pragmatic trial seeks to evaluate acupuncture as it is actually practised in order to make comparison between treatment options thereby aiding decision-making. Therefore, the trial should involve randomisation of the patients in three groups: the first group is treated with acupuncture and the second group B is treated with both acupuncture and conventional medicine while the third group C is treated with conventional medicine only (served as a no-acupuncture treatment control group) and later crossed over to acupuncture.
Cost effectiveness is to be evaluated
Since the efficient use of resources is a major concern of those planning the nation's health policies, there is a very good case for gathering data concerning the cost-effectiveness of acupuncture treatment. The argument here would be that a course of acupuncture can yield long-lasting benefits and may therefore enable a patient to avoid years of taking expensive drugs and seeing their doctor at frequent intervals. Indeed, a course of acupuncture may even remove the need for surgical intervention. The possibility of long-lasting benefits from acupuncture is one reason why measures of long-term outcome of treatment are important.
The future trial will break new ground because it will get to grips with the cost issue. The trial will include an assessment of treatment costs in both acupuncture and conventional medicine together with the cost of staff and of medication whether prescribed or over the counter. There are three outcomes that would be positive for the future of acupuncture: firstly that acupuncture is more effective and cheaper; secondly that acupuncture is more effective but not cheaper; and thirdly that the acupuncture is as effective and cheaper. Whatever the outcome, costing all the economic dimensions will help answer the question as to whether acupuncture should be more widely available as an option in treatment of osteoarthritis of the knee.
Exploring the perspective of patients
The future trial will include patient interviews in order to capture the patient’s
experience of acupuncture. We are also interested in the coping strategies that people
with knee osteoarthritis employ, and the extent that patients take on the lifestyle and
dietary advice given by the acupuncturist. At a more subtle level, we want to know
what deeper changes might be taking place when someone receives acupuncture. Do
patients make fundamental changes in their relationship to themselves and their health
and do their attitudes and behaviours change over time? These areas of interest do not
lend themselves to quantitative analysis, hence the qualitative nature of the enquiry in
Acupuncture as a therapeutic intervention is widely practised in the United Kingdom.
While there have been many studies of its potential usefulness, many of these studies
provide equivocal results because of inadequate design, small sample size and other
factors. The issue is further complicated by inherent difficulties in the use of
appropriate controls, such as placebos and sham acupuncture groups. However,
promising results have emerged, for example, showing efficacy of acupuncture in
non-painful conditions (Tukmachi, 199b) as well as painful conditions such as low
back pain (Tukmachi, 1992) and osteoarthritis (Tukmachi, 1991a, 1999, 1999a). They
have showed that acupuncture may be useful as an adjunct treatment or an acceptable
alternative or be included in a comprehensive management program. Further research
is likely to uncover additional areas where acupuncture interventions will be useful.
There is sufficient evidence of acupuncture's value to expand its use into conventional
medicine and to encourage further studies of its physiology and clinical value.
The main goal of our acupuncture research is to promote wide access to traditional
acupuncture within our nation’s health care system. This type of research fits with our
goal in that an objective of the trial is to explore the benefits that will make a
contribution to the evidence based on acupuncture for knee osteoarthritis. The future
research trial will offer an opportunity to promote acupuncture as effective, affordable
and safe. The patient-centred nature of the future trial will be one of its strengths, with
the primary rationale of the research that it furthers the interest of patients and their
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