VOL: 103, ISSUE: 32, PAGE NO: 32-33
Janet Richardson, PhD, RN, CPsychol; Karen Pilkington, MSc, MRPharmS
Janet Richardson is reader in nursing and health studies, Faculty of Health and Social Work, University of Plymouth; Karen Pilkington is senior research fellow, School of Integrated Health, University of Westminster.
This article reports on a systematic review of literature on complementary and alternative medicine
AbstractRichardson, J., Pilkington, K. (2007) An overview of research on complementary therapies in life-limiting conditions, www.nursingtimes.netIntroduction:The public is increasingly relying on the internet for information about complementary and alternative medicine. Much of this information is anecdotal or commercial and therefore unreliable. Method: Comprehensive searches were undertaken to identify published studies on the use of CAM, which were then evaluated. Results: Published systematic reviews covered cancer, mental health, heart disease, stroke and long-term conditions. Positive findings were found in relation to the effectiveness of hypnosis and meditation in cancer care, yoga in diabetes and mental health, acupuncture, St John’s Wort and massage in mental health, and T’ai chi and meditation in multiple sclerosis. Conclusion: Nurses will benefit from being able to access evaluated evidence of CAM when assessing its potential benefits and harm. The literature from this review is being intergrated into the National Library for Health’s CAM Specialist Library (www.library.nhs.uk/cam). IntroductionThe general public increasingly relies on the internet for health information, in particular information about complementary and alternative medicine (CAM). Finding reputable information is not a simple matter. There are two main reasons for this. The first problem is related to lack of an agreed definition for CAM. It is comprised of a diverse range of different disciplines, practices and even philosophies. A whole spectrum of therapies exist, ranging, from widely used and relatively accepted therapies such as osteopathy and acupuncture to those for which there is limited research, such as crystal therapy and dowsing. All can be considered to be complementary or alternative. The second problem in finding reliable information is the extensive number of web sites addressing CAM, many of which are commercial sites or are based on personal anecdote. In searches conducted in 2003, the number of hits obtained using the search term ‘alternative medicine’ in a general search engine (Google) was more than 800,000, while using the search term ‘complementary medicine’ resulted in approximately 150,000 hits (Pilkington and Richardson, 2003). When these searches were rerun in July 2007, there were more than nine million hits for ‘complementary medicine’ and over 64 million hits for ‘alternative medicine’. Searching for information on a specific therapy does not solve the problem. In the more recent searches, nearly 15 million web pages were listed for ‘acupuncture’, a situation mirrored for ‘chiropractic’while for’yoga’nearly 70 million hits were retrieved. The Research Council for Complementary Medicine (RCCM) recognised the challenges of searching for evidence in CAM more than 10 years ago by producing a comprehensive guide to searching for published information in complementary medicine and developing a specialist complementary therapy database (CISCOM) and search service. A source of information developed by the National Centre for Complementary and Alternative Medicine (NCCAM) in the US and the National Library of Medicine (NLM) is CAM on PubMed. This is a subset of the NLM bibliographic citations including MEDLINE citations and it offers computer links to more than 2,700 journals. However, a search of this subset may produce irrelevant articles that will need to be filtered out on the basis of the titles or abstracts. Furthermore, health professionals require information that has been synthesised and appraised so it is quick and easy to access. Researchers (and funders) need to know where the evidence gaps are in order to plan and conduct relevant research. In order to advise and support patients who choose CAM, practitioners require a readily accessible, user-friendly database that includes details of safety issues as well as evidence for effectiveness and ineffectiveness. They also need to be able to access simple and straightforward information that provides details of study types as well as a synopsis of the research and its relevance to clinical practice. The House of Lords Select Committee on Science and Technology report on Complementary and Alternative Medicine (House of Lords Select Committee on Science and Technology, 2000) pointed to the need for research evidence, as well as wider access to research-based information. This project was a result of recommendations that ‘the NHS Centre for Reviews and Dissemination work with the RCCM, the UK Cochrane Centre and the British Library to develop a comprehensive information source with the help of the CISCOM database, in order to provide a comprehensive and publicly available information source on CAM research’ (House of Lords Select Committee on Science and Technology, 2000). Discussions with the Department of Health’s research and development directorate guided the focus of the project towards areas of health that were of particular concern to government policy at the time: cancer; mental health; heart disease and stroke; and chronic conditions (arthritis, asthma, chronic back pain, diabetes and multiple sclerosis). Therapies were selected on the basis of those frequently sought by patients (House of Lords Select Committee, 2000), and those that have the potential to provide a component of self-management: acupuncture; Alexander technique; herbalism (Western); homeopathy; hypnotherapy; massage and aromatherapy; meditation; osteopathy/chiropractic; reflexology; and yoga. The final list was agreed with DH representatives. Aims of the projectThe aims were:
- To carry out a detailed review and critical appraisal of the published research in specific complementary therapies, focusing on key areas of NHS priority: cancer; mental health; heart disease and stroke; and chronic conditions (arthritis, asthma, chronic back pain, diabetes, multiple sclerosis);
- To make this information available to healthcare professionals, researchers and the public via the internet;
- To maintain an evidence-based information resource that reflects up-to-date research evidence and to establish an ongoing process for updating this information.
MethodA project advisory group was established to provide advice to the whole project on strategic issues including the relationship of the project data to other information management systems, the development of appropriate links with other information systems and sustainability of the information. This group included representatives from the NHS Centre for Reviews and Dissemination, NHS National Library for Health, Cochrane Collaboration and a patient organisation as well as CAM practitioners. Specialist advisers were consulted on aspects of the project related to the specific topics; clinicians and therapists with expertise in the specific clinical area were involved in working with the project team to produce the reviews. For each individual review, one or more specialists in the therapy and/or condition were identified and provided comments on the clinical relevance of each study. For the majority of reviews, the clinical commentators were also involved in co-authoring the review.A number of external experts provided advice or support on specific aspects, for example statistics, or commented on completed reviews. Following significant preliminary work to develop and test the search and critical appraisal strategies and clarify the topicsfor reviews, comprehensive searches of a range of databases were conducted for each review. Major biomedical databases:
- - ClNAHL;
- - Cochrane CENTRAL Register of Controlled Trials;
- Cochrane Database of Systematic Reviews;
- DARE (Database of Abstracts of Reviews of Effects);
- - EMBASE;
- MEDLINE (and PubMed);
Specialist CAM databases:
- Cochrane Complementary Medicine Field Registry.
Specialist therapy databases as appropriate to the topic:
- Acubriefs (acupuncture reviews);
- HerbMed (herbal reviews);
- Hom-Inform (homeopathy reviews);
- - International Association of Yoga Therapists (yoga reviews);
- - Yoga Biomedical Trust (yoga reviews).
Specialist condition-based databases and sources as appropriate to the topic:
- Specialist mental health websites: MIND, Mental Health Foundation;
- Cochrane Collaborative Group on Depression, Anxiety and Neurosis register;
- Cochrane Pain, Palliative and Supportive Care Group Register;
- Cochrane Stroke Group Register;
- Cochrane Musculoskeletal Group Register.
Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field where possible.Lists of the sources used for each review are specified in the methods section of each review. Search strategies included terms relevant to the condition (and symptoms where necessary) and to the therapy. Potential research articles were noted for retrieval and given a preliminary ‘study type’ category according to the flow-chart developed for this project. The basic study type categories included systematic reviews, randomised controlled trials, controlled clinical trials, uncontrolled studies and qualitative studies. Animal research and basic laboratory-based research were not included in the categorisation process. No language limitations were imposed at the filtering stage. Two reviewers carried out this process independently, notes were compared and, in cases of disagreement, these articles were also retrieved. Where filtering identified only a small number of studies, all research studies that included clinical outcome measures, with the exception of single case reports, were selected for inclusion in a review. Data extraction and appraisalStudies were appraised and their methodological quality assessed using standardised data extraction and critical appraisal forms. Data extracted included details of selection criteria and procedure, the participants, the intervention and any comparison or control intervention, aspects of the methodology and outcome measures and results. Clinical trials were appraised using a standardised appraisal framework developed specifically for this project based on a template published by the Centre for Reviews and Dissemination (CRD, 2001). Systematic reviews were appraised using a standardised template based on Oxman and Guyatt’s index of the scientific quality of research overviews (Shea et al, 1995; Oxman and Guyatt, 1988), while qualitative studies were appraised using a combination of the quality criteria recommended by the Critical Appraisal Skills Programme (CASP, 2002) and Mays and Pope (2000; 1995). Full details of methods are available at www.rccm.org.uk/cameol. Data extraction and appraisal were conducted independently by two researchers for each study and any disagreements or discrepancies were resolved by discussion. Where consensus could not be obtained, a third reviewer was available for consultation. Database developmentOne of the main deliverables of the project was to make the information available to health professionals, researchers and the public via the internet. In order to achieve the objectives, the information was organised in relational data storage and published on the web via dynamic web interfaces. A demonstration interface was developed based on the initial specification and presented to the advisory groups and representatives of two patient organisations for comments. A pilot version of the database was then developed and tested by the project team and by members of the advisory groups. The online database CAMEOL (CAM Evidence OnLine) was subsequently developed and tested and the information was then uploaded. This became openly available via the Internet at the end of May 2005 (www.rccm.org.uk/cameol).
ResultsA series of systematic reviews was carried out over a four-year period, covering the evidence base for CAM in cancer, mental health, heart disease and stroke and chronic conditions (arthritis, asthma, chronic back pain, diabetes and multiple sclerosis). Each review was written up either for publication in a peer-reviewed journal or for direct entry onto the CAMEOL website. CancerFour systematic reviews on CAM and cancer were published in peer-reviewed journals. Studies of hypnosis report positive results including statistically significant reductions in anticipatory and chemotherapy-induced nausea and vomiting. Meta-analysis has demonstrated that hypnosis could be a clinically valuable intervention for anticipatory and chemotherapy-induced nausea and vomiting in children with cancer (Richardson et al, 2006a). Richardson et al (2006b) reported positive results including statistically significant reductions in pain and anxiety for children undergoing bone marrow aspirations or lumbar punctures when hypnosis was used. Studies were small but included comparisons against other therapies and no treatment. It was concluded that hypnosis has the potential to be a clinically useful intervention for procedure-related pain and distress in paediatric cancer patients. Aloe vera gel is clear jelly-like substance that is obtained from the thin-walled sticky cells of the inner portion of the leaf. It is commonly used to treat a number of skin complaints. Studies of aloe vera for radiation-induced skin reactions showed mixed results or no benefit, while two studies found aloe vera gel to be less effective than other creams (Richardson et al, 2005). Mindfulness-based stress reduction (MBSR) is a specific, highly structured psycho-educational and skill-based therapy package that combines mindfulness meditation with hatha yoga exercises and is traditionally delivered as an eight-week programme. Studies report positive results, including improvements in mood, sleep quality and reductions in stress. Mindfulness-based stress reduction has potential as a clinically valuable self-administered intervention for cancer patients (Smith et al, 2005). Further reviews were published on the CAMEOL website. These reviews suggest that evidence to support the use of acupuncture in breathlessness and therapy-induced dry mouth is limited and further research is required. Acupuncture might be useful in relieving hot flush symptoms resulting from tamoxifen use but the evidence supporting the effectiveness of black cohoshandhomeopathy for this is limited. There is some evidence to suggest meditation can increase positive coping and optimism, reduce the severity and duration of chemotherapy nausea, and that yoga can reduce sleep disturbance and increase emotional well-being. Previously published reviews ofaromatherapy and massageandacupuncturein cancer pain were also located and summaries of these included on the CAMEOL database. We also identified one ongoing systematic review of acupuncture in nausea and vomiting that has subsequently been published (Ezzo et al, 2006). DiabetesSystematic reviews were conducted on acupuncture, homeopathy, hypnotherapy, meditation, reflexology and yoga in diabetes (Pilkington et al, in press). More trials of acupuncture were found than of other therapies: seven randomised controlled trials and one non-randomised controlled trial were found. Acupuncture was used in the treatment of hyperglycaemia, neuropathy, gastroparesis, cerebral infarction-complicating diabetes and lipodystrophy. All studies reported an improvement in at least one measurable outcome but there was a general lack of research robustness; the studies were almost exclusively conducted in China using traditional approaches and methodological details were limited. Several trials were found on yoga in diabetes. Two small randomised controlled trials conducted in the UK reported conflicting results. In the first, a significant difference in blood glucose control (p<0.05) between the groups was observed and the majority of the yoga group described subjective improvements. In the second, no difference was observed between the groups in glycaemic control or quality-of-life measures but insulin requirements remained stable for the yoga group while increasing in the control group. An randomised controlled trial conducted in India assessed a complex six-day intervention consisting of Sudarshan kriya yoga, pranayama (breathing exercises), asanas (postures and stretches) and meditation alongside interactive discussion on stress-free living by a specialist teacher and nutritional counselling. Beneficial effects on a range of measures were reported but a large proportion of participants failed to complete the programme. The final study reported improvement in diabetic neuropathy with yoga asanas but there were many limitations to this study. Overall, the trials were considered to provide some limited evidence on beneficial effects of yoga and as virtually all participants in the two UK randomised controlled trials elected to continue with yoga. Further investigation of the potential role of yoga in diabetes was recommended. For most other therapies, research evidence was limited to one or two studies: one small uncontrolled trial of hypnotherapy reported improved compliance while two studies on reflexology reported improvements in foot care and general condition. However, data from well-designed randomised controlled trials is limited and results are difficult to translate into clinical practice. For most therapies, well-designed robust studies replicating small preliminary studies in diabetes are required. Mental healthIn mental health, the focus was on anxiety, depression and related problems including specific anxiety disorders. The therapies addressed included acupuncture, aromatherapy, massage, reflexology, homeopathy, meditation and yoga. An overview of previously published systematic reviews and qualitative research on St John’s wort was also carried out. This overview, together with the reviews of homeopathy and yoga, has been published in full elsewhere (Pilkington et al, 2006a; 2006b; 2005a; 2005b; Kirkwood et al, 2005). Efficacy of acupuncture in depression has been addressed previously (Mukaino et al,2005; Smith and Hay, 2005). The CAMEOL review of acupuncture in anxiety succeeded in locating 10 randomised controlled trials (Pilkington et al, 2007). Four RCTs focused on acupuncture in generalised anxiety disorder or anxiety neurosis and positive findings were reported but there was insufficient good-quality research evidence for firm conclusions to be drawn. No trials of acupuncture for panic disorder, phobias or obsessive-compulsive disorder were located. Some limited evidence was found in favour of auricular acupuncture from six trials focusing on anxiety in the perioperative period. A comprehensive search for published and unpublished studies demonstrated that evidence is limited for homeopathy in anxiety and anxiety disorders (Pilkington et al, 2006a). A number of studies were located but the randomised controlled trials reported contradictory results, were underpowered or provided insufficient details of methodology. Only two RCTs on homeopathy in depression were identified and one of these demonstrated problems with recruitment of patients in primary care (Pilkington et al, 2005a). Several uncontrolled and observational studies reported positive results including high levels of patient satisfaction in both anxiety and depression but, because of the lack of a control group, it is difficult to assess the extent to which any response is due to specific effects of homeopathy. It was, therefore, not possible to draw firm conclusions on the efficacy or effectiveness of homeopathy for anxiety or depression, although surveys suggest that homeopathy is quite frequently used by people suffering from these problems so further research would be worthwhile. Five RCTs of yoga in depression reported positive findings although some methodological details were missing (Pilkington et al, 2005b). No adverse effects were reported with the exception of fatigue and breathlessness occurring in participants in one study. As the interventions and severity of depression varied and reporting of trial methodology was inconsistent, the findings must be interpreted with caution. Furthermore, several interventions may not be feasible for people with reduced or impaired mobility. However, initial indications were of potentially beneficial effects of yoga interventions on depressive disorders. Eight studies of yoga were found in which participants were anxious or had a diagnosed anxiety disorder (Kirkwood et al, 2005). Various styles of yoga were used. The eight studies reported positive results but, because of the variation in conditions treated and the poor quality of the majority of the studies, it was not possible to say that yoga is effective in treating anxiety or anxiety disorders in general. Nevertheless, there are encouraging results, particularly with obsessive-compulsive disorder. The herb St John’s wort has received the greatest attention in the field of mental health because of its potential effectiveness in depression. More than 25 systematic reviews have been published with varied estimates of effectiveness but, overall, findings have been positive compared with placebo for mild to moderate depression (Pilkington et al, 2006b). One qualitative study focusing on St John’s wort in depression was also retrieved. The focus now appears to be moving to safety, particularly potential adverse effects and interactions, although numerous studies are still ongoing to address effectiveness and mechanism of action. The reviews of aromatherapy, massage, reflexology and meditation were published on the CAMEOL website. Massage appeared superior to no treatment or relaxation-based control, based on self-assessment in a range of anxiety-related situations (anxious elderly, post-traumatic stress disorder in children, premenstrual dysphoria disorder and pre-operatively). There was limited evidence of positive effects of massage therapy in depression, although there is insufficient research evidence on any single intervention or patient group for firm conclusions on effectiveness, potential role or long-term outcomes to be drawn. One small study suggested that combining massage with aromatherapy was more effective than massage alone but the results for aromatherapy without massage were not convincing. The added benefits of incorporating essential oils into massage treatment suggested by the single study require further evaluation. Safety considerations relate to the selection of appropriate massage techniques and of suitable essential oils. These aspects of treatment also require further evaluation. There is a lack of evidence on the effectiveness or otherwise of reflexology in the treatment of anxiety disorders or depressive disorders but several studies are ongoing. Limited evidence for the efficacy of meditation in anxiety and anxiety disorders was found. Most of the trials located found no difference between meditation and other relaxation techniques. This could be because of equivalent effectiveness or the result of poor methodology. Where positive results were reported (post-traumatic stress disorder, performance anxiety, anxious elderly), support for the findings from further studies is required before any conclusions can be drawn. Due to a general lack of research on the topic, it was not possible to draw conclusions on either the effectiveness of meditation in easing depression or its potential to exacerbate depression. A Cochrane review has since been published (Krisanaprakornkit et al, 2006). Mindfulness-based cognitive therapy which includes a meditation-type component may be useful in preventing relapse among people who have recovered from depression. Multiple sclerosisSeven systematic reviews examining the evidence for the effectiveness of CAM in multiple sclerosis (MS) were undertaken (see www.rccm.org.uk/cameol for full details). The results of the small t’ai chi studies suggest that this form of meditation exercise shows promise in alleviating MS symptoms. Meditation requires active participation that may improve body awareness and empowerment but may also adversely affect study attrition rates. Evidence to support the use of acupuncture, aromatherapy, massage, osteopathy and yoga in the treatment of MS-specific symptoms is not available due to a lack of well-conducted studies. However, some small studies have demonstrated improvements worthy of further investigation. For example, one small randomised controlled trial of massage without essential oils demonstrated benefits on measures of anxiety, depression and self-esteem. A small uncontrolled study found improved strength and endurance when osteopathic manipulative treatment was combined with exercises using a specific exercise machine. One well-designed randomised controlled trial found yoga and exercise improved vitality and fatigue, but this study was limited by a small sample size. StrokePreviously published systematic reviews, including Cochrane reviews, were found on acupuncture and herbal therapies in stroke, although the evidence from controlled trials of the effectiveness of acupuncture in stroke patients is not conclusive. In acute stroke, acupuncture ‘appeared to be safe but without clear evidence of benefit’ and trials were too small to be ‘certain whether acupuncture is effective for treatment of acute ischaemic or haemorrhagic stroke’ (Zhang et al, 2005). In addition, there was no clear evidence of benefit in stroke rehabilitation (Wu et al,2006). CAMEOL reviews suggested that little research is available on the effectiveness of homeopathy or homeopathic remedies in stroke patients. Only two randomised controlled trials have been published, both of which assessed the effects of a single remedy, arnica, on mortality and severity of stroke and found no conclusive difference between arnica and a placebo. One small randomised controlled study was found on hypnotherapy in stroke patients but there was insufficient detail of the methods to draw firm conclusions on the overall effectiveness. Similarly,only a single trial of a specific type of massage was located. In this study, positive effects on a range of measures were reported and further assessment of this relatively safe and simple intervention appears warranted. Studies of the potential of massage in stroke are ongoing in the UK. Other conditionsInitial scoping searches indicated that considerable efforts to identify and appraise the evidence in arthritis, asthma and low back pain had been conducted previously as demonstrated by published systematic reviews. Consequently, the CAMEOL project focused on identifying and selecting relevant systematic reviews rather than primary research studies. The methods used and the results of this work were integrated into the development of the National Library for Health CAM Specialist Library (www.library.nhs.uk/cam). Specifically, the literature has supported the preparation for relevant national knowledge weeks, which are initiatives by the specialist libraries that aim to highlight the ‘best current evidence for selected healthcare topics’ (www.library.nhs.uk/specialistlibraries). The evidence on CAM in rheumatoid arthritis is available as part of a national knowledge week on the National Library for Health Musculoskeletal Specialist Library (www.library.nhs.uk/musculoskeletal). Similarly, the work on low back pain has been integrated into the preparation for a national knowledge week in October 2007 while the work on asthma will form the basis of a future annual evidence update or national knowledge week.
ConclusionThe ever-increasing internet resources referring to complementary and alternative therapies provide a challenge for health professionals and the general public. In particular, nurses and other health professionals will require quick access to credible resources that synthesise and appraise the evidence for the safety and effectiveness of complementary therapies. This project has succeeded in bringing together a wide range of research literature on complementary therapies in chronic and life-limiting illnesses in a short time. The main outcome is a new resource, the CAMEOL database, which provides access to summaries and full details of the research on each topic including methodological appraisal and clinical comments and links to relevant evidence. Progress is being made to integrate the work into the development of the National Library for Health Complementary and Alternative Medicine Specialist Library (www.library.nhs.uk/cam). Nurses will benefit from access to such electronic resources when attempting to make assessments about the potential benefits and harm of complementary therapies in order to advise patients who use such therapies. The quality of the evidence base for complementary therapies is diverse, which makes it difficult to draw firm conclusions and make recommendations for clinical practice. However the strongest evidence is in the use of a range of therapies in cancer and mental health, for example hypnosis for chemotherapy-induced nausea and vomiting and painful procedures (specifically bone marrow aspirations and lumber punctures), mindfulness-based stress reduction for better quality of life and stress reduction in cancer, St John’s wort for mild to moderate depression and mindfulness-based cognitive therapy in preventing relapse in depression. However, while mindfulness-based cognitive therapy is included in guidelines on management of depression (NICE, 2004), St John’s wort is not recommended in these guidelines. There are also indications of potential benefits of massage and of yoga in anxiety and mild depression. Integration of complementary therapies into nursing practice will need to be informed by the available evidence and in the context of evaluation/audit programmes that monitor safety and effectiveness. ReferencesCASP(Critical Appraisal Skills Programme) (2002) 10 questions to help you make sense of qualitative research. Milton Keynes: Milton Keynes PCT. Centre for Reviews and Dissemination (CRD) (2001) Report Number 4. Undertaking Systematic Reviews of Research on Effectiveness. York: CRD. Ezzo, J.M. et al (2006).Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database of Systematic Reviews; issue 2, art no CD002285. 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London: BMJ Publishing. Smith,C.A., Hay, P.P.J. (2005) Acupuncture for depression. Cochrane Database of Systematic Reviews, Issue 3, Art No CD004046. [not cited in text] Cited in the textSmith, J. et al (2005) Mindfulness Based Stress Reduction (MBSR) as supportive therapy in cancer care: a systematic review. Journal of Advanced Nursing; 52: 3, 315-327. Wu, H.M. et al (2006) Acupuncture for stroke rehabilitation. Cochrane Database of Systematic Reviews; issue 3, art no 327CD004131. Zhang, S.H. et al(2005) Acupuncture for acute stroke. Cochrane Database of Systematic Reviews; issue 2, art no CD003317. All CAMEOL reviews can be found in full at www.rccm.org.uk/cameolAcknowledgementsThe authors would like to thank Anelia Boshnakova, NLH CAM specialist library for help and advice on search strategies and the CAMEOL project advisory groups for guidance and support during the project. The CAMEOL Project is funded by the Department of Health. The views and opinions expressed are those of the authors and do not necessarily reflect those of the DH.