Acupuncture in Medicine

To undertake a pragmatic randomised controlled trial to test the hypothesis that a population of patients with persistent low back pain, when given access to an acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost.

The study is a pragmatic randomised controlled trial (n=241). Suitable patients are identified by their general practitioners. Patients randomised to the experimental arm are offered the option of referral for up to 10 individualised treatments from one of six qualified acupuncture practitioners. The control group continues to receive usual management from their general practitioner. The primary scale used for measuring change is the Bodily Pain (SF–36) at 3 months and 12 months post randomisation. The main outcome is cost-effectiveness at 12 months.

A total of 43 general practitioners participated in the trial and 241 patients were randomised. All patients randomised to the option of acupuncture chose to receive treatment. Clinical outcomes at 3 months show that the SF-36 Bodily Pain scores improved by 29.4 and 24.9 points in the acupuncture and normal management group respectively (p=0.125). Patients in the acupuncture group reported lower levels of worry at three months (p<0.001).

It is possible to conduct a large pragmatic randomised controlled trial of acupuncture in a primary care setting. Acupuncture is seen as an acceptable treatment by patients with low back pain. Clinical outcomes at three months suggest that the acupuncture group are in less pain than the control group.

Response of Chinese acupuncture compared to conservative orthopaedic treatment and unspecific needling in pain treatment on CSP.

Prospective, randomized controlled trial with three blinded parallel groups; follow up three months.

Outpatients of 26 orthopaedists, who have attended a 140 hours training course on acupuncture.

Four hundred and twenty seven out-patients with a history of CSP ≥ six weeks, VAS ≥ 50 mm were selected; three random groups, six weeks treatment. 308 patients reported after three months follow up. Two strata: age 25–45 and age 46–65.

Group 1: VAP: 15 treatments of verum acupuncture (VAP). Group 2: SHM: 15 treatments of non-specific needling, sham acupuncture (SHM). Group 3: COT: conventional conservative orthopaedic treatment (COT). Patients were blinded to allocation between verum and sham acupuncture.

Primary endpoint: pain reduction ≥ 50% on VAS three months after the end of the treatment protocol. Secondary endpoints: global assessments on a 4-score scale directly after the end of the treatment protocol.

The results after three months follow up are: Highly significant effect of CAP over SHM and COT in the whole sample (P<0.0001) and in Stratum1 (P<0.001) and Stratum2 (P<0.001).

Acupuncture is an important supplement in the management of CSP.

BMBF grant: 01KT9411/9

For clinical trials of acupuncture, it would be desirable to have a sham procedure that is indistinguishable from the real treatment, yet inactive. A sham needle has been designed which telescopes instead of penetrating the skin. The Park Sham Device involves an improved method of supporting the sham needle and requires validation.

To test whether the sham procedure using the new device is: 1. Indistinguishable from real needles, and 2. Inactive.

Two subject and assessor-blind, randomized controlled trials. Study samples: Study 1: 58 patients included in a clinical trial of acupuncture for acute stroke. Study 2: 63 healthy, acupuncture naïve, adult volunteers.

Intervention: Real or sham acupuncture using the Park Sham Device. Settings: 1. District general hospital, 2. University laboratory. Measurements: 1. The form of treatment that patients believed they had received 2. Experience of de-qi, as judged by three acupuncture experts.

Study 1: No patient in either group believed s/he had been treated with the sham needle. Study 2: In 40 volunteers for whom experts achieved consensus, the relative risk of experiencing de-qi with real acupuncture to that with sham acupuncture was 15.38 (95% CI 2.26 to 104.86). The inter-rater reliability of all 13 experts, calculated from their judgements on 10 subjects selected by randomisation, was 0.52 (95% CI 0.19 to 0.61).

Results suggest that the procedure using the new Park Sham Device is both indistinguishable from real acupuncture and inactive. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de-qi, a major concept underlying traditional Chinese acupuncture.

Notalgia paraesthetica is a condition associated with itching, and unassociated with a rash, that affects a segment of the body innervated by T2-T6 dorsal spinal nerves. It is believed to be a type of neuropathy. This single-handed practice reports one such case. It also describes a further eight cases of “neurogenic” pruritus which share similar characteristics to this condition but are in segments of the body innervated by cervical and lumbar spinal nerves. Traditional acupuncture has been described to help with skin conditions and this study was performed to see if it was successful in this type of pruritus.

Over a nine-year period in a practice with an average list size of 2000 patients, nine patients aged 41 to 79 years presenting with segmental itching were identified. Other causes of pruritus were excluded by clinical examination, as well as by haematological and biochemical tests. Drug induced causes were also excluded. Duration of pruritus was six weeks (range 4 – 52 weeks). In eight patients itching was restricted to dermatomes innervated by the spinal nerves of the cervical spine, in two by the dorsal spine and in two by the lumbar spine. In three patients pruritus occurred in dermatomes innervated by two separate areas of the spine. Clinical examination revealed restricted cervical or lumbar movements in seven patients. Paravertebral tenderness and/or spasm of the paravertebral muscles was found in the areas of pruritus in seven patients. Skin changes associated with sympathetic nerve over-activity were noted in five patients. Six of the nine patients had x-ray evidence of degeneration of the spine.

All nine patients were treated by deep intramuscular stimulation of the paravertebral muscles in the dermatomes affected by pruritus. In total a median of three treatments (range 2 – 5) was required to resolve the pruritus. Recurrence of symptoms occurred in four patients within 8 to 12 months of their last treatment over a period of follow-up of 0.5 – 9 years (median one year). Repeat acupuncture treatment resolved the pruritus.

The term neurogenic pruritus describes and encompasses all conditions associated with segmental itching unassociated with a rash. The clinical signs of this condition are suggestive of an early neuropathy as a result of a degenerative condition of the spine. This is the first report of symptoms of such a condition being treated successfully by acupuncture.

Traditional Chinese medicine (TCM) has long recognised the use of acupuncture in psychological medicine. Classically the acupuncture meridians or channels are each linked to particular emotions, for example, joy and sadness (heart channel), panic and anxiety (kidney channel), anger and frustration (liver channel). By correct diagnosis, acupuncture intervention can be useful in the restoration of emotional well-being. Today it is realised that this restoration of emotional health is due to neuromodulation at the higher centres. Results of the NIH funded depression study by Allen, Hitt and Schnyer (1998) were encouraging. The study demonstrated acupoint specificity (p < 0.05) for mood disorders. Unfortunately, the study was single blinded. This study is based on the NIH study. The research team hoped to reproduce the significant results achieved then. With laser as the modality, the advantages were obvious: non-invasive modality, randomised double blind control achievable, no infection risk and ease of training community-based doctors to utilise the technique.

This pilot study utilised laser acupuncture in an outpatient population with mild to moderately severe depression with Beck Depression Inventory (BDI) scale of 12 to 30.

Normal was less than or equal to BDI of 10. Recruitment was through family practices (called general practices in Australia) and newspapers. Recruits were each screened by a psychiatrist to confirm their suitability. They were then randomised into sham laser and true laser groups. Each patient received twice a week sessions for a month, followed by once a week sessions for another month. BDI scores were taken fortnightly to ensure none of the patients deteriorated. The acupuncturist was also blinded. BDIs were repeated at one month and three months post laser.

Thirty patients were recruited and randomised into true and sham laser. Four patients were withdrawn, two from each arm of the study. The rest completed the laser sessions. Of those who completed the study, one patient did not respond to any of the post laser follow up BDI requests. Another patient did not complete the three-month follow up BDI. Results showed a markedly significant improvement in the active group (p< 0.001) at the end of the course of treatment with a sustained difference one month after treatment (p<0.05).

The markedly significant results were unexpected. They do however make laser acupuncture a serious contender as a third standard management option in the treatment of depression in the community. Laser acupuncture could stand alone, or be used together with counselling, psychotherapy or drug therapy. These latter areas of mixed management need to be explored. In the National Institute of Mental Health Treatment of Depression Collaborative Research Programme over 30% of participants terminated treatment early due to adverse effects, lack of improvement or desire to change therapies. These were based on psychological and/or pharmacological treatments. Patients were obviously searching for more satisfactory treatments, non-chemical in nature and without adverse effects. An important point to note from this laser study is that the series of treatments maintained their significance for the month after completion. This suggested that follow-up or maintenance laser acupuncture sessions were important for patient well-being and the one month mark could be indicative of appropriate timing.

The research team recommends larger and more specific studies to confirm these findings and explore the wider clinical implications. The team is keen to perform a multicentre study but is restricted by funding issues.