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Summary: The efficacy of any treatment is inherently bound up with the delivery system employed to provide that treatment and its associated non-specific effects. We propose to investigate the patient/ practitioner interaction and context of acupuncture treatment within a randomised controlled trial (RCT). This will involve 2 practitioners, treating patients with osteoarthritic pain, specifically investigating the clinical effects, on pain, of real acupuncture and different currently available acupuncture placebo controls. The results of this study may have broad implications for other physical treatments employed in painful conditions.
Aims: 1) To investigate the relative effects of different currently used acupuncture placebo controls, 2) To evaluate the specific effects of acupuncture on pain, in a population of patients with severe OA knee or hip, awaiting joint replacement. 3) To evaluate the effects of patient/ practitioner interaction on outcome.
Hypotheses: Primary. A) Needles cause an enhanced placebo effect in acupuncture treatment which will affect clinical outcome. B) Acupuncture is more effective than placebo in the treatment of O.A. hip/ knee. Secondary: Empathic consultations are more effective than non-empathic consultations
Background: Complementary and Alternative Medicine (CAM) is widely used, Thomas et al indicate that 10% of the U.K. population use CAM annually and 47% are lifetime users, whilst Ernst and White suggests a U.K annual expenditure of  £1.6 billion. Acupuncture is one of the most widely used CAM therapies and 0.6 million individuals received this treatment in 1998. This popularity is not sustained by a strong evidence base, as indicated by the recent House of Lords report.

This study will contribute to the development of a model of the psychosocial predictors of treatment effects, using acupuncture as a treatment model. Therapeutic effects have two components: specific effects and non-specific effects (including the natural history of the disease). Specific effects are a direct result of the particular therapeutic agent involved in a treatment, while non-specific effects result from the context within which the specific therapeutic effect is provided. In complex interventions such as acupuncture, specific and non-specific effects and the factors that might cause or facilitate these effects are difficult to identify and distinguish. Previous research has investigated individual factors including expectancy and the therapeutic relationship. The aim of this project is to identify the psychosocial context factors that might contribute to treatment outcomes in acupuncture. The objective of this study is to identify and describe factors that form part of patients’ experiences of acupuncture. The study uses qualitative methods (individual semi-structured interviews with patients, Framework Analysis).

Benefits the proposed investigation will bring to acupuncture/physiotherapy / patient care
A clearer understanding of the mechanisms involved in the response to acupuncture.
Purpose
The aim of this study is to assess cutaneous blood flow responses to acupuncture and to investigate whether there is a difference in blood flux between a commonly used acupuncture point (UB 23) and a non acupuncture point, both without producing  Deqi (needling sensation) and with needle manipulation designed to elicit Deqi on purpose.

Our primary research questions are:
1.   Is baseline blood flux different at a commonly used acupuncture point (UB 23) compared with a non acupuncture point?
2.   Are there differences in blood flux between an acupuncture and non acupuncture point when an acupuncture needle is inserted?
3.   Are there differences in blood flux between an acupuncture point and a non acupuncture point when acupuncture needling designed to elicit Deqi occurs?
Our secondary research question is:
4.   Is there a relationship between the blood flux responses and the beliefs and expectations of the individual?
We aim to test the hypothesis that there is a difference in the cutaneous blood flow response to acupuncture at an acupuncture site compared with a non acupuncture site and that these differences may vary when Deqi occurs.
The outcome of this study will be a better understanding of a safe and non invasive technique through which we can investigate the underlying vaso-responsive mechanisms of acupuncture as well as the various physiological and psychological factors that may predict and influence the clinical response to treatment.

Our primary objectives are to use fMRI to:(i) investigate the effects of the “placebo” (retractable) Streitberger needle to ascertain if it is a true acupuncture placebo, (ii) to identify the specific neurological components that are activated/deactivated by real acupuncture alone and that correlate with clinical improvement and (iii)  to ascertain if we should use patients in chronic pain or healthy volunteers  to research the effects of acupuncture in pain. Implicitly these studies will impact on imaging/pain research. Obtaining answers to these questions will be essential to enhance our understanding of acupuncture’s underlying neural mechanisms which in turn will enable us to design better and more meaningful clinical trials, thus allowing scarce clinical research resources to be used in a more efficient manner.

Acupuncture involves fine needles being inserted into the body. It is safe alongside conventional medicine for pain relief, nausea/vomiting and to maintain health and promote well-being. Acupuncture for pregnant women may reduce vomiting, improve pain and mobility and lessen the overdue pregnancy rate thereby reducing the rate of labour induction and possibly caesarean sections. It can alleviate anxiety and so reduce the need for pethidine and epidurals. Users report great satisfaction. Direct written quotes (Whittington) say: “I found this treatment very useful and resulted in less medical intervention, I would recommend it to my friends”; “Feel that this is a great option and is effective – excellent value for my tax. Please continue”; “I am really grateful that this service is available. I’m feeling relaxed and in great hands”. We would like to investigate if birth preparation as a consequence of using our demand-led acupuncture service can improve our maternity service, reduce our intervention rate, is cost effective and whether it enhances women’s experience of pregnancy and birth. We recognize that an RCT would be valuable in this area, but we know from respected journals that observational studies such as this proposal can also provide valuable evidence, while taking into account vital and clinically relevant aspects of client choice and expectation. This is an ideal opportunity to pragmatically evaluate a current service. Research into complementary medicine within the NHS is under funded so this is also a unique opportunity to improve the evidence as well as provide feasibility data for the methodology required for a definitive trial involving patient preference. This type of study approach involves maternal choice - an important factor in optimising the outcomes and experiences of pregnancy. The Whittington Hospital serves a very diverse community, a further reason to provide services respecting client choice.

We are in the process of developing a pragmatic randomised clinical trial evaluating the use of acupuncture as an additional therapy in the treatment of sub-acute low back pain referred to physiotherapy.This will involve evaluating the cost effectiveness of adding acupuncture to the already existing protocol for treatment of back pain and will also evaluate whether dose of acupuncture is important.

We aim to combine raw data from high quality randomized trials of acupuncture for chronic pain to create an individual patient level data set. This data set will be analyzed to determine the effect size of acupuncture and modifiers thereof. After publication of the principal results of these analyses, a de-identified (i.e. anonymized) raw data set will be posted on an Open Access website for the benefit of the acupuncture research community as a whole.

Back pain has severe consequences and affects 36% of the UK population.  Acupuncture is a popular and effective back pain treatment, but its mechanism is poorly understood.  This research develops psychological theory to investigate the determinants of patient outcomes of acupuncture for back pain.  The purpose is to improve our understanding of the psychological mechanisms involved.  Three linked studies are planned.  A prospective postal longitudinal questionnaire study will test theoretically grounded hypotheses concerning the predictors of outcome in acupuncture.  A nested qualitative interview study will analyse patients’ unsuccessful experiences of acupuncture.  A booklet will be designed to alter patients’ beliefs about acupuncture and back pain, and a randomised controlled trial of the booklet will determine whether patients’ beliefs have a causal role in acupuncture outcomes and whether the booklet is effective in improving patient outcomes.  There will be implications for understanding and researching related conditions and treatments.

Aim of study
1 Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
2 Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.
Study results will support the design of future research; including a Phase III randomised controlled trial1 that combines rigorous research methodology with an authoritative and well-defined intervention and outcomes that assess the effect of acupuncture care for this group of patients.

Objectives This pilot study explores the methodological implications of evaluating the use of acupuncture in the treatment of disabling breathlessness.
Design A randomized, controlled trial involving three treatments that were used on one occasion, each in random order.
Settings The study was designed to evaluate the feasibility of providing acupuncture treatment on a domiciliary basis, in Southampton (United Kingdom) to patients with disabling breathlessness.
Subjects Sixteen (16) subjects with disabling breathlessness caused by chronic lung disease (primarily chronic obstructive pulmonary disease [COPD]) were recruited from the respiratory medicine clinics of Southampton University Hospitals Trust.
Interventions The treatments were real acupuncture, dummy acupuncture, and mock trans-electrical nerve stimulation (TENS).
Outcomes To evaluate the respiratory outcome measures, to look at the credibility of the three treatments (using a previously validated Borkovec and Nau scale), and to calculate the sample size for a larger, more definitive study.
Results Twelve (12) subjects completed the study. The acupuncture was a predefined point prescription that had been found previously to be of value in this condition, an approach that could be taught to health professionals and provided on a domiciliary basis. The treatment was provided only on one occasion, therefore, we did not expect a clear therapeutic benefit to emerge, but some non-significant benefit was noted as a consequence of acupuncture treatment. The shuttle test that we used as an objective measure of breathlessness was impractical in a domiciliary environment and will not be used in further studies. Each of the three treatments was equally credible at the outset, although real and dummy acupuncture were considered by the patients to be preferable choices after the completion of treatment.
Conclusions It was possible to carry out this study on a domiciliary basis. The information obtained will allow us to design a much clearer definitive study and the small, but statistically insignificant, response to acupuncture has allowed us to estimate sample size.

Study objectives The management of disabling breathlessness is poor, and a standardized form of acupuncture has been reported as offering benefit. This study was designed to evaluate the efficacy of standardized acupuncture treatment.
Design A single-blind, randomized, crossover study.
Setting This study was carried out on a domiciliary basis in Southampton (UK).
Interventions This study evaluated a standardized acupuncture technique vs an appropriately validated placebo/control (mock transcutaneous electrical nerve stimulation [TENS]) for disabling, nonmalignant breathlessness (largely COPD). The acupuncture was provided by an appropriately trained nurse acupuncturist. Each patient received six treatments in each phase of the study, with an intervening 2-week washout period.
Measurements and results The primary outcome was worst breathlessness (visual analog scale, 0 to 100 mm), with the sample size based on an 80% power to detect a 10-mm difference between treatment means. Secondary outcomes included the St George’s respiratory questionnaire score and treatment credibility.
Results Thirty-six patients were entered into the study (33 with COPD), and 24 patients completed both treatment phases. The primary outcome improved significantly during the course of the study, but there were no significant treatment differences between acupuncture and the placebo/control of mock TENS for either primary or secondary outcomes. The placebo was shown to be a credible control. There was no evidence of a carryover effect from the first to second phase of the study.
Conclusion This standardized acupuncture technique does not show specific efficacy in disabling nonmalignant breathlessness, but those entered into the study did experience clinically significant benefit from both treatments.

Introduction The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research. In order to provide an effective placebo, the control procedure must be convincing and should mimic, in all respects, apart from a physiological effect, the real active treatment. To be truly credible, the placebo should be visible to the patient and it should appear as though the skin is being penetrated, The ‘Streitberger’ needle might fulfil these criteria and this paper reports on a validation study.
Method: This was a single blind, randomised (to practitioner and treatment sequence), cross-over pilot study and subjects were stratified for gender and joint type. Patients were drawn from the orthopaedic hip and knee, joint replacement waiting list. Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo, or vice versa. The prime outcome was a needle sensation questionnaire and there was a range of secondary outcomes.
Results 37 patients were randomised and completed treatment. Groups were well balanced at baseline. No significant differences between groups or needle type were found for any of the sensations measured. Most patients were unable to discriminate between the needles by penetration however nearly 40% were able to detect a difference in treatment type between needles.
Conclusion No major differences in outcome between real and placebo needling could be found. The fact that nearly 40% of subjects did not find that the two interventions were similar however, raises some serious concerns with regard to the wholesale adoption of this instrument as a standard acupuncture placebo. Further work on intertester reliability and standardisation of technique is highly recommended before we can be confident about using this needle in further studies.

Introduction The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research. In order to provide an effective placebo, the control procedure must be convincing and should mimic, in all respects, apart from a physiological effect, the real active treatment. To be truly credible, the placebo should be visible to the patient and it should appear as though the skin is being penetrated, The ‘Streitberger’ needle might fulfil these criteria and this paper reports on a validation study.
Method This was a single blind, randomised (to practitioner and treatment sequence), cross-over pilot study and subjects were stratified for gender and joint type. Patients were drawn from the orthopaedic hip and knee, joint replacement waiting list. Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo, or vice versa. The prime outcome was a needle sensation questionnaire and there was a range of secondary outcomes.
Results 37 patients were randomised and completed treatment. Groups were well balanced at baseline. No significant differences between groups or needle type were found for any of the sensations measured. Most patients were unable to discriminate between the needles by penetration however nearly 40% were able to detect a difference in treatment type between needles.
Conclusion No major differences in outcome between real and placebo needling could be found. The fact that nearly 40% of subjects did not find that the two interventions were similar however, raises some serious concerns with regard to the wholesale adoption of this instrument as a standard acupuncture placebo. Further work on intertester reliability and standardisation of technique is highly recommended before we can be confident about using this needle in further studies.

Objective To investigate the efficacy of acupuncture on stroke recovery compared to an inert placebo.
Design Placebo-controlled, randomised, clinical trial.
Setting Post-stroke rehabilitation wards in five NHS hospitals in the UK.
Subjects Patients between 4 and 10 days after their first stroke.
Interventions and outcome measures  The patients received 12 acupuncture or placebo treatments over four weeks,
Acupuncture with electrical stimulation was compared with mock TENS, and assessments continued for 12 months after entry. Primary outcome was the Barthel Index, (BI). Secondary outcomes were muscle power, Motricity Index (MI), mood, Nottingham Health Profile (NHP) and treatment credibility.
Results 92 patients completed data sets.  Data were analysed using both t tests and a structural equation based on longitudinal analysis of both BI and MI, using generalised estimating equations with an exchangeable correlation structure.
While both acupuncture and placebo (mock TENS) appeared to have had an equal effect on stroke recovery, there is no significant difference between the two interventions at 12 (p=0.737, 95% CI -2.00 to 2.81) and 52 weeks (p=0.371, 95% CI -3.48 to1.32).
An apparently accelerated improvement in the MI scores in the acupuncture group at 3 weeks, (p= 0.009, 95% CI 1.55 to 10.77), is interesting.

Conclusions Acupuncture did not demonstrate specific efficacy over placebo and both groups did as well as normally expected with this condition.

This paper examines some of the problems specifically associated with conducting research into acupuncture and how this can lead to further problems with subsequent systematic reviews. Studies for the treatment of chronic neck pain have been used as examples of how presented information can be misleading to an acupuncture-naive reader and how researchers must be sensitive to these problems when compiling their inclusion and exclusion criteria. The problems associated with scoring trials are discussed and further work to increase the scope of scoring mechanisms is recommended in order to produce meaningful systematic reviews in the future.

Background Despite substantial increases in its popularity and use, the efficacy of acupuncture for chronic mechanical neck pain remains unproved.
Objective To compare acupuncture and placebo for neck pain.
Design A randomized, single-blind, placebo-controlled, parallel-arm trial with 1-year follow-up.
Setting The outpatient departments of 2 major hospitals in the United Kingdom, 1999 to 2001.
Patients 135 patients 18 to 80 years of age who had chronic mechanical neck pain. Eleven patients withdrew from treatment, and 124 completed the primary end point.
Measurements The primary outcome was pain 1 week after treatment, according to a visual analogue scale. Secondary outcomes were pain at other time points, score on the Neck Disability Index and the Short Form-36, and use of analgesic medications.
Interventions Patients were randomly assigned to receive, over 4 weeks, 8 treatments with acupuncture or with mock transcutaneous electrical stimulation of acupuncture points using a decommissioned electroacupuncture stimulation unit.
Results Both groups improved statistically from baseline, and acupuncture and placebo had similar credibility. For the primary outcome (weeks 1 to 5), a statistically significant difference in visual analogue scale score in favor of acupuncture (6.3 mm [95% CI, 1.4 to 11.3 mm]; P = 0.01) was observed between the 2 study groups, after adjustment for baseline pain and other covariates. However, this difference was not clinically significant because it demonstrated only a 12% (CI, 3% to 21%) difference between acupuncture and placebo. Secondary outcomes showed a similar pattern.
Limitations All treatments were provided by 1 practitioner. Although the control was credible, it did not mimic the process of needling. A nonintervention group was not present to control for regression to the mean.
Conclusions Acupuncture reduced neck pain and produced a statistically, but not clinically, significant effect compared with placebo. The beneficial effects of acupuncture for pain may be due to both nonspecific and specific effects.

Both specific and non-specific factors may play a role in acupuncture therapy for pain. We explored the cerebral consequences of needling and expectation with real acupuncture, placebo acupuncture and skin-prick, using a single-blind, randomized crossover design with 14 patients suffering from painful osteoarthritis, who were scanned with positron emission tomography (PET). The three interventions, all of which were sub-optimal acupuncture treatment, did not modify the patient's pain. The insula ipsilateral to the site of needling was activated to a greater extent during real acupuncture than during the placebo intervention. Real acupuncture and placebo (with the same expectation of effect as real acupuncture) caused greater activation than skin prick (no expectation of a therapeutic effect) in the right dorsolateral prefrontal cortex, anterior cingulate cortex, and midbrain. These results suggest that real acupuncture has a specific physiological effect and that patients' expectation and belief regarding a potentially beneficial treatment modulate activity in component areas of the reward system.

Objective To investigate the efficacy of acupuncture on stroke recovery compared to an inert placebo.
Design Placebo-controlled, randomised, clinical trial.
Setting Post-stroke rehabilitation wards in five NHS hospitals in the UK.
Subjects Patients between 4 and 10 days after their first stroke.
Interventions and outcome measures The patients received 12 acupuncture or placebo treatments over four weeks,
Acupuncture with electrical stimulation was compared with mock TENS, and assessments continued for 12 months after entry. Primary outcome was the Barthel Index, (BI). Secondary outcomes were muscle power, Motricity Index (MI), mood, Nottingham Health Profile (NHP) and treatment credibility.
Results 92 patients completed data sets.  Data were analysed using both t tests and a structural equation based on longitudinal analysis of both BI and MI, using generalised estimating equations with an exchangeable correlation structure.
While both acupuncture and placebo (mock TENS) appeared to have had an equal effect on stroke recovery, there is no significant difference between the two interventions at 12 (p=0.737, 95% CI -2.00 to 2.81) and 52 weeks (p=0.371, 95% CI -3.48 to1.32).
An apparently accelerated improvement in the MI scores in the acupuncture group at 3 weeks, (p= 0.009, 95% CI 1.55 to 10.77), is interesting.
Conclusions Acupuncture did not demonstrate specific efficacy over placebo and both groups did as well as normally expected with this condition.

Background Acupuncture has been suggested as a treatment for stroke rehabilitation, but the question whether it is effective has not been answered satisfactorily.
Purpose To summarise and critically review all randomised controlled trials of the effectiveness of acupuncture as a treatment for stroke.
Methods Four independent computerised literature searches (in MEDLINE, Cochrane Controlled Trials Register, Embase, and CISCOM data bases) were conducted in June 1999. All randomised-controlled trials that compared any form of needle insertion acupuncture to any form of non-acupuncture control intervention in the treatment of human stroke patients were included. Data were extracted independently by two authors and arbitrated by a third. The methodological quality of the included studies was assessed using the Jadad score.
Results Nine randomised controlled trials with a total sample size of 538 patients were included. Two studies were assessor blind, one was subject blind, and one was assessor and subject blind. Two studies exclusively used manual acupuncture, five only electroacupuncture, and two used both. Outcome measures used were Scandinavian Stroke Scale, Chinese Stroke Scale or Recovery Scale, Barthel index, Nottingham Health Profile, Motor function, balance, and days in hospital. Of the nine studies, six yielded a positive result suggesting that acupuncture is effective, and three produced a negative finding implying that acupuncture is not superior to control treatment. Only two studies obtained a Jadad score of more than
3. These methodologically best trials showed no significant effect of acupuncture.
Conclusion Based on the evidence of rigorous randomised controlled trials, there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation. Further, better-designed studies are warranted.

This short speculative report describes the outcome of three studies looking at the effect of acupuncture on stroke recovery and the subsequent place of residence of the subjects entered. It is not a systematic review and does not endeavor to provide comprehensive data on the effect of acupuncture on poststroke recovery. Our observations demonstrate that patients may be more likely to remain independent and in their own homes one year post stroke if they receive acupuncture. This conclusion is supported by our study and two previous trials. It may be that acupuncture improves poststroke perception, thereby enhancing independence.

Sustained and subtle hyperventilation can result in a wide variety of symptoms, leading to a chronic condition which has been termed hyperventilation syndrome (HVS). Treatment options include physiotherapy, in the form of breathing retraining (BR), but additional approaches aim to reduce the anxiety which is recognised as being a frequent component of this condition.
Objectives: The aim of this study was to evaluate whether acupuncture is an appropriate treatment for HVS to reduce anxiety, and whether a crossover trial is an appropriate study design to evaluate acupuncture in this condition.
Design: A single-blind crossover trial was carried out comparing the effects of 4 weeks (twice weekly) acupuncture and BR on patients with HVS.
Subjects: Ten(10) patients diagnosed with HVS were recruited to the trial and randomised into two groups. Both groups received acupuncture and BR with a washout period of 1 week.
Outcome measures: The primary outcome measure used was the Hospital Anxiety and Depression Scale (HAD). Other outcome measures used were the Nijmegen questionnaire and Medical Research Council Dyspnoea scale.
Results: The results showed statistically significant treatment differences between acupuncture and breathing retraining, in favour of acupuncture. Reductions were found in the HAD A (anxiety) (p = 0.02) and Nijmegen (symptoms) (p = 0.03) scores. There was no statistical evidence of any carryover effects. However, when graphically examining individual anxiety scores, in those who received acupuncture first, there was a reduction in anxiety levels which persisted through the wash out period, suggesting that there may have been some carry over effect from this treatment.
Conclusions: This study suggests that acupuncture may be beneficial in the management of HVS in terms of reducing anxiety levels and symptom severity.  However, there may be some carry over effect, after acupuncture treatment, which went undetected due to the small sample size. This preliminary study provides the basis for a larger, sufficiently powered and methodologically sound trial.