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Research and clinical trials

These articles are taken from LymphLine, the LSN's quarterly newsletter available to all LSN members. All articles are for interest only and are read by the LSN Medical Advisor prior to publication, but fall outside the scope of the Information Standard. All articles contain their publication date and will be removed after three years.

- Using Acupuncture in the Management of Lymphoedema - Spring 2011
- ‘Management of Cellulitis in Lymphoedema’ -
    An update on the development of the revised consensus document
- Summer 2010

- Final update on the HOT Trial - Summer 2010



     

Using Acupuncture in the Management of Lymphoedema

By Beverley de Valois PhD LicAc MBAcC, Research Acupuncturist,
Lynda Jackson Macmillan Centre, Mount Vernon Cancer Centre, Northwood, Middlesex

Acupuncture is not usually considered a treatment option for lymphoedema. It is assumed to involve needling the affected area, raising concerns about aggravating the lymphoedema or increasing the risk of cellulitis. Consequently, many lymphoedema specialists advise patients to avoid this form of complementary medicine.

Funding from the National Institute of Health Research (NIHR) allowed us to explore using acupuncture in the management of lymphoedema. This research was carried out at the Lynda Jackson Macmillan Centre, a cancer support and information centre associated with Mount Vernon Cancer Centre (MVCC), in close collaboration with the Lymphoedema Service at MVCC. Approved by Hertfordshire Research Ethics Committee, the study began in April 2008 and was recently completed.

Acupuncture, a form of traditional medicine used widely throughout East Asia, involves the insertion of very fine solid metal needles to stimulate points on the body called acupuncture points. Moxibustion is a process that uses heat to warm the acupuncture points. Both needling and moxibustion are common in the clinical practice of acupuncture in Asia and the West, and I will refer to these two modes as acu/moxa.

There has been little research into using acu/moxa in the management of lymphoedema. Small studies from Japan and Brazil report promising results for prevention and treatment in gynaecological cancer patients1, and for increasing arm mobility in breast cancer patients2. Because of the lack of evidence, we chose to focus on using acu/moxa to promote wellbeing and improve quality of life in cancer patients with upper body lymphoedema (specifically breast cancer and head and neck cancers). It was not an aim to treat the lymphoedema itself: the aim was to treat the person, not the condition. We wished to investigate whether acupuncture was 1) acceptable, 2) helpful, and 3) safe.

To do this, we designed a three-step study. In Step 1, cancer survivors with lymphoedema and their healthcare professionals participated in focus groups to discuss whether acu/moxa was an acceptable intervention if used in addition to usual care. Participants were almost unanimous in agreeing that this could be a beneficial approach, provided needling was avoided in the affected area. For breast cancer patients, this meant not only avoiding needling in the affected arm, but in the torso on the affected side as well.

This agreement was the green light to continue to Step 2, the treatment phase. The Lymphoedema Nurse Specialist referred breast cancer and head and neck cancer patients who had been managed by the service for a minimum of 2 months. These patients had mild to moderate lymphoedema, had completed cancer treatment at least 3 months previously, and had no active cancer disease. Participants were offered a series of 7 acu/moxa treatments (Series 1), followed by the option of a further 6 sessions (Series 2). It was the participant’s decision whether to continue to Series 2. Two experienced members of the British Acupuncture Council administered treatments, which were given once a week and were individualised according to the needs of the participant. Needling was avoided in the affected area, including the torso on the affected side of breast cancer participants.

Participants set their own treatment priorities using a questionnaire called the Measure Yourself Medical Outcome Profile (MYMOP). Change in MYMOP scores at the end of each Series was the main measurement for the study. Quality of life was measured using the SF-36, another questionnaire. Reducing volume was not an aim of this study; however, the Lymphoedema Nurse Specialist measured breast cancer patients at intervals throughout the study to ensure there were no adverse reactions.

Of the 35 participants in this step, 30 chose to complete both Series (13 treatments) and 3 completed Series 1 only (7 treatments). Two participants withdrew from the study, but did not find acu/ moxa unacceptable.

MYMOP scores for all participants showed both statistical and clinical significance at the end of each Series. SF-36 scores for Bodily Pain and Vitality showed significant improvement at the end of each Series and at 4-week follow up. No serious adverse effects were observed or reported, and there were no volume changes outside the normal range for each participant.

In Step 3, we conducted a further series of focus groups to gain insight into the experience of having acu/ moxa treatment. Participants discussed a range of physical and emotional benefits including reductions in pain, discomfort, and heaviness; improved sleep; increased energy levels; reduced stress levels; and reduced medication. Benefits were experienced in a variety of ways, and the effects could be short-term or long-lasting. Overall, participants were enthusiastic about acu/moxa, and several reported increased motivation to manage their long-term health issues.

Further research is warranted, as well as changing perceptions about the use of acupuncture by people with lymphoedema. This study makes no claims about acupuncture’s suitability to treat lymphoedema itself. However, it opens the door to reassuring people with lymphoedema that it is possible to use acupuncture safely to manage a range of physical and emotional conditions. This increases their options in managing their healthcare, and allows them to share in the same experiences as people without lymphoedema, as discussed in a recent article in LymphLine3.

For the acupuncture community, it provides evidence that acupuncture treatment can be effective even if large areas of the body are inaccessible for needling. This study also demonstrates that acupuncturists and lymphoedema specialists can work together to bring about improved healthcare for patients. In the words of one breast cancer participant:

“I think we were always made aware from the very beginning, that it wasn’t going to cure lymphoedema... And I think we’ve had such incredible results from it for other things that it almost overshadowed what was happening with the lymphoedema... It wasn’t such a dominating factor in your life.”

Acknowledgements:

Thank you to my colleagues and collaborators: Teresa Young, Rosemary Lucey and Professor Jane Maher (Lynda Jackson Macmillan Centre), Professor Christine Moffatt (International Lymphoedema Framework), Anita Wallace (Lymphoedema Support Network), Elaine Melsome (Mount Vernon Lymphoedema Service); Anthea Asprey and Dr Charlotte Paterson (University of Exeter), and Rachel Peckham MSc LicAc MBAcC. Very special thanks to the women and men who participated in this study.

“This paper presents independent research commissioned by the National Institute for Health Research (NIHR) under its Research for Innovation, Speculation and Creativity (RISC) Programme (Grant Reference Number PB-PG-0407-10086). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.”

For further information, contact Dr Beverley de Valois at beverley.devalois@nhs.net. To find out more about acupuncture, contact the British Acupuncture Council: Telephone 020 8735 0400 website: www.acupuncture.org.uk.

References

1. Kanakura Y, Niwa K, Kometani K, et al. Effectiveness of acupuncture and moxibustion treatment for lymphedema following intrapelvic lymph node dissection: a preliminary report. American Journal of Chinese Medicine 2002;30(1):37-43.

2. Alem M, Gurgel MSC. Acupuncture in the rehabilitation of women after breast cancer – a case series. Acupuncture in Medicine 2008;26(2):86-93.

3. Hansard S. Lymphoedema and complementary therapy – how to make an informed choice. LymphLine: newsletter of the Lymphoedema Support Network 2010;Summer:7-9.


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‘Management of Cellulitis in Lymphoedema’ – An update on the development of the revised consensus document

By Katie Riches, Research Nurse, Derby

The original consensus document was developed in October 2005 by a group of lymphoedema therapists, doctors and LSN representatives. The group came together at the instigation of LSN Chair, Anita Wallace, as it was felt that cellulitis in people with lymphoedema was not well recognised by health care professionals, nor appropriately managed.
The consensus document was, therefore, designed to be used by health care professionals as guidance for treating cellulitis in lymphoedema. It was distributed by the LSN to patients and lymphoedema clinics, and patients would show it to their doctor if they experienced cellulitis.

The consensus document was audited and 400 people completed a questionnaire detailing the symptoms experienced, treatment received and the time taken to recover. Some of the findings of this audit were; the importance to receive prompt antibiotic treatment when first experiencing the signs and symptoms of cellulitis and the need to take a longer course of antibiotics, suggested as at least 14 days, to ensure the infection resolves completely.

The consensus group meets annually to review the use of the guideline, feedback from therapists and patients, current research and practice development. It was at this meeting that the decision was made to update and revise the original document.
Changes in the revised consensus document reflect some of the research that has been undertaken in the time since the production of the original document and the problems associated with courses of antibiotics causing infections such as clostridium difficile (C.Diff). Flucloxacillin has been shown to be an effective antibiotic in the treatment of cellulitis infections and some hospitals and GPs use this and not the antibiotic recommended in the consensus document, amoxicillin. Amoxicillin remains the antibiotic of choice of the consensus group; however, flucloxacillin is a reasonable alternative.

There is evidence that Decongestive Lymphatic Drainage (DLT) therapy reduces the frequency of attacks. Control of the swelling is therefore important. The revised consensus document is currently being reviewed by different microbiologists from around the UK and it is planned that the final version will be available by the end of June. The LSN’s fact sheet, ‘Management of Cellulitis in Lymphoedema’ will subsequently be updated.

The audit that we undertook previously resulted in some very useful information being collected about how cellulitis affects people with lymphoedema. Because of this we plan to repeat this audit looking at the impact of the revised consensus document from October 2010. To do this we will be asking for your help again. The next issue of LymphLine will contain a post card. If you experience an episode of cellulitis between October 2010 and October 2011 we would like you to complete the post card and send it to me. I will then telephone you and ask you some questions about having had cellulitis and the treatment you received.


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Final update on the HOT Trial

By Lone Gothard, Trial coordinator
Randomised phase II trial of Hyperbaric Oxygen Therapy in patients with chronic arm lymphoedema after radiotherapy for cancer

The HOT Trial has now been analysed and a manuscript describing the study in detail has been accepted for publication in the European Journal of Radiotherapy and Oncology. HOT closed accrual in December 2007 and a 12-month follow period began. Fifty six women and 2 men entered the study, and the majority of people randomised to receive high pressure oxygen therapy completed their 6 weeks of treatment. Apart from temporary changes in eyesight, which is an expected side effect from hyperbaric oxygen (HBO), no toxicities were reported from the treatment.

We collected and analysed a very large set of data generated by the fifty eight volunteers in the study. Although some individuals recorded an improvement in arm volume, lymphoscintigraphy and water content after high pressure oxygen treatment, similar improvements were seen in a minority of volunteers who did not have treatment. The small overall difference between the two groups cannot be said to result from high pressure oxygen; they could be due to small differences in the volunteers allocated to each group. We didn’t detect any differences in the quality of life scores reported by volunteers in the two groups, either.

We therefore have to conclude, that there is no overall benefit from high pressure oxygen therapy in a population of individuals, although we cannot rule out the possibility that some individuals benefited.

On behalf of all of my colleagues involved in the trial, I would like to take the opportunity to thank you again for your tremendous help and commitment to this research and to wish you all the best in the future.


 
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