Complementary Therapies in Medicine

Editorial Board

2012-02-01

Randomised controlled trial with medical leeches for osteoarthritis of the knee

2011-11-16

Summary: Objectives: To evaluate the possible efficacy of medical leeches (Hirudo medicinalis) in the treatment of patients with active osteoarthritis of the knee.Design: Unblinded, randomised controlled trial with outpatients in a crossover design with single interventions of either leeches or transcutaneous electrical nerve stimulation (TENS) as comparator.Main outcome measures: Change in Lequesne's combined index for pain and function and change (L.I.) and overall assessment of complaints by visual analog scale (VAS). Cross-over at day 42, with further observation period of 21 days.Results: 52 out of 72 screened patients were randomised (intent to treat) to initial treatment with either eight leeches (group 1: 27 patients) or TENS (group 2: 25 patients). Due to phase effects, confirmatory evaluation had to be restricted to the first period. Between days 0 and 21, we observed highly significant (p<0.001) improvements for means of Lequesne's index from 12.07 to 9.37 and for VAS from 5.89 to 4.16cm for leeches, but no significant differences for TENS. Effect size as group difference was -2.50 for L.I. (95% confidence interval −3.88 to −1.11), resp. −1.86cm for VAS (95% confidence interval −2.85 to −0.87cm). 12 patients (5 group1, 7 group 2) did not finish the trial, mostly due to non-compliance (6). No serious adverse effects were observed.Conclusions: Single leech therapy showed significant, relevant and sustaining effects, comparable to other trials with leeches. The method deserves further research, esp. into mechanisms of possible specific effects and optimization of dosing by number of leeches and possible repeats.

Measuring possible effect on health-related quality of life by tactile massage or relaxation in patients with type 2 diabetes

2011-10-24

Summary: Objective: The aim was to study the effect of tactile massage versus relaxation exercises on health-related quality of life (HRQoL) in patients with type 2 diabetes, at primary-health-care centres in Stockholm county.Design: The study was carried out as a parallel-arm clinical trial. Patients with type 2 diabetes and HbA1c of 6–8%, aged 35–75, with oral anti-diabetic treatment were included. In all, 26 and 27 attendants in the TM and relaxation group, respectively, entered the study and were included in the intention-to-treat analysis. The attendants were offered one weekly session of TM or the use of relaxation exercises at least once weekly for a total of 10 weeks.Main outcome measures: HRQoL was measured using the SF-36 questionnaire at baseline, after 10 weeks of therapy and 3 months after the completion of the study. Owing to multiple comparisons the level of statistical significance was set at p<0.01, and values of p>0.01 and <0.05 were regarded as borderline values.Results: One difference over time between the groups was reaching a borderline value in favour of the relaxation group, i.e. the scale of “Role functioning, physical” (p<0.05).Conclusions: Based on the findings in this study, we conclude that stress-relieving techniques with TM or relaxation CD have limited, if any, beneficial effects on health-related quality of life in Swedish-born patients with type 2 diabetes. We cannot, however, rule out that specific patient groups with higher levels of perceived stress could show benefits with this kind of treatment.

Osteopathic manipulative treatment effectiveness in severe chronic obstructive pulmonary disease: A pilot study

2011-11-29

Summary: Objectives: Few and contrastingly data are available about use of osteopathic manipulative treatment (OMT) in patients with chronic obstructive pulmonary disease (COPD).Design: Comparing the effects of the combination of pulmonary rehabilitation and OMT compared with pulmonary rehabilitation (PR) in patients with severely impaired COPD.Setting: Rehabilitative pulmonary department.Interventions: Patients underwent exercise training, OMT, educational support and nutritional and psychological counselling.Main outcomes measures: Exercise capacity through 6min walk test (6MWT – primary outcome) and pulmonary function test (secondary outcomes) were evaluated at the beginning and at the end of the training. Patients were randomly assigned to receive PR+soft manipulation (G1) or OMT+PR (G2) for 5 days/week for 4 weeks.Results: 20 stable COPD patients (5 female – mean age, 63.8±5.1 years; FEV1 26.9±6.3% of predicted) referred for in-patient pulmonary rehabilitation were evaluated. Respect to the baseline, 6 MWT statistically improved in both group. In particular, G2 group gained 72.5±7.5m (p=0.01) and G1 group 23.7±9.7m. Between group comparison showed a difference of 48.8m (95% CI: 17 to 80.6m, p=0.04). Moreover, in G2 group we showed a decrease in residual volume (RV – from 4.4±1.5l to 3.9±1.5l, p=0.05). Between group comparison showed an important difference (−0.44l; 95% CI: −0.26 to −0.62l, p=0.001). Furthermore, only in G2 group we showed an increase in FEV1.Conclusions: This study suggests that OMT+PR may improve exercise capacity and reduce RV in severely impaired COPD patients with respect to PR alone.

A network-based analysis of traditional Chinese medicine cold and hot patterns in rheumatoid arthritis

2011-11-04

Summary: Objective: Rheumatoid arthritis (RA) is a heterogeneous disease, and traditional Chinese medicine (TCM) can be used to classify RA into different patterns such as cold and hot based on its clinical manifestations. The aim of this study was to investigate potential network-based biomarkers for RA with either a cold or a hot pattern.Method: Microarray technology was used to reveal gene expression profiles in CD4+ T cells from 21 RA patients with cold pattern and 12 with hot pattern. A T-test was used to identify significant differences in gene expression among RA patients with either cold or hot pattern. Cytoscape software was used to search the existing literature and databases for protein–protein interaction information for genes of interest that were identified from this analysis. The IPCA algorithm was used to detect highly connected regions for inferring significant complexes or pathways in this protein–protein interaction network. Significant pathways and functions were extracted from these subnetworks by the Biological Network Gene Ontology tool.Result: Four genes were expressed at higher levels in RA patients with cold pattern than in patients with hot pattern, and 21 genes had lower levels of expression. Protein–protein interaction network analysis for these genes showed that there were four highly connected regions. The most relevant functions and pathways extracted from these subnetwork regions were involved in small G protein signaling pathways, oxidation–reduction in fatty acid metabolism and T cell proliferation.Conclusion: Complicated network based pathways appear to play a role in the different pattern manifestations in patients with RA, and our results suggest that network-based pathways might be the scientific basis for TCM pattern classification.

Peripheral pulsed electromagnetic fields may reduce the placebo effect in migraine patients that do not respond to the sham intervention in a randomized, placebo-controlled, double-blind, cross-over clinical trial

2011-10-17

Summary: Objective: The purpose of the study was to evaluate the effect of the pulsed electromagnetic fields (PEMF) and its possible modulation of the placebo effect in migraine.Design: Placebo-controlled, randomized, double-blind, cross-over clinical trial.Setting: Government third level hospital.Interventions: Patients with migraine were included. PEMF were applied to the wrist with a bracelet.Main outcome measures: Frequency and intensity of the migraine attacks at baseline and during treatment were recorded. Also, we valuated the possible influence of gender and the presence of aura in the PEMF and placebo responses.Results: Eighteen patients (fifteen women, 30±2 years old) were included. Migraine frequency and intensity was reduced with both PEMF and placebo to a similar extent in the whole population. However, in responders to placebo, migraine intensity was reduced to a median of 100% with the placebo and to 60% with the PEMF, while in non-responders there was only a slight effect of both treatments. Our results do not suggest an influence of gender or presence of aura in the outcomes.Conclusions: Treatment with PEMF may not alter either migraine intensity or frequency compared to baseline, but may reduce the response to placebo in migraine patients.

A pilot study to compare the views of traditionally trained and CAM-trained therapists using the clinical exemplar of the management of neck/upper limb pain to assess barriers to effective integration of approaches

2011-11-30

Summary: Background: In the UK, patients frequently choose complementary (CAM) therapies, particularly for chronic painful musculoskeletal conditions. It is widely agreed that better integration of complementary and traditional healthcare is desirable. We piloted the Benefits and Risks of Treatment Questionnaire to compare the views of different healthcare practitioners about traditional and alternative approaches in one clinical scenario in order to assess barriers to effective integration.Methods: A cross-sectional survey of healthcare practitioners (primary care practitioners, physiotherapists, pharmacists, osteopaths, chiropractors and acupuncturists) in the UK. The views of all healthcare providers were compared using the exemplar of neck, shoulder and upper arm pain to explore the perceived risks and benefits of different types of therapeutic intervention using a mathematical cluster approach.Results: 448/1254 (36%) useable replies were received representing all six professions. A mean of 14.9 years of experience was reported by participants. The cluster analyses revealed distinct clusters of opinion of benefit: primary care physicians, physiotherapists and pharmacists were significantly more likely to rate a cluster including: anti-inflammatory drugs, steroid injections, steroids, physiotherapy, paracetamol and antidepressants as beneficial for neck, shoulder and upper arm pain. In contrast, osteopaths and chiropractors, but not physiotherapists were significantly more likely to rate a cluster including chiropractic, osteopathy and physiotherapy as beneficial.Conclusion: The Beliefs about Risks and Benefits of Treatments Questionnaire can be applied using a postal approach and achieves similar response rates to other surveys amongst healthcare practitioners. Despite widespread agreement that increased integration of traditional and alternative approaches is desirable, the results of this study suggest that experienced practitioners show the strongest belief in the benefit of approaches closest to their own training and background and the most wariness of risk to those therapies furthest from their background.

Factors influencing the use of complementary and alternative medicine and whether patients inform their primary care physician

Patricia Thomson, Jenny Jones, Josie M. Evans, Stephen L. Leslie — 2011-11-04

Summary: Objectives: Use of complementary and alternative medicines (CAMs) is widespread. Several studies have explored why individuals chose to use CAM but there are fewer data to explain how its use ‘dovetails’ with conventional medicine. This study aimed to determine the prevalence of CAM use in the adult population in Australia and the proportion that seek advice or tell their primary care physician after CAM use, and also to investigate which demographic characteristics, health behaviours and health status are associated with CAM use and disclosure.Design: A cross sectional survey. Methods: a random sample of 1261 adults was interviewed as part of 2010 Queensland Social Survey, which contained questions about CAM use, frequency of use, types of CAM used, reasons for use, discussing and reporting CAM use with the doctor and confidence in CAM use. Relationships were explored using bivariate and multiple logistic regression. Main outcome measures: use of CAM; sought advice from doctor before CAM use; informed doctor after CAM use.Results: 61.7% of respondents had used self-prescribed CAM or visited a CAM practitioner. Being female and being younger predicted CAM use. Being male and in better health predicted seeking advice from the doctor before and also after CAM use.Conclusion: Our results confirm the relatively high use of CAM in Queensland, Australia and found that a significant proportion of people did not seek advice from their primary care physician before using CAM, or disclose its use afterwards. These factors should be taken into account in the doctor–patient consultation.

Measuring differential beliefs in complementary therapy research: An exploration of the Complementary and Alternative Medicine Beliefs Inventory (CAMBI)

2011-11-04

Summary: The Complementary and Alternative Medicine Beliefs Inventory (CAMBI) was developed to provide a comprehensive measure of beliefs believed to differentiate complementary therapy (CT) users from nonusers. The initial evaluation of the CAMBI was based on a relatively homogeneous sample of CT users, which raises questions about its applicability in more generalized samples. This study uses data from a community-based sample of older adults (N=200) to evaluate the utility of the CAMBI in more diverse samples. Results indicated substantial variation in responses to items with each of a priori belief domains (i.e., perceived value of natural treatments, preference for participation in treatments, and orientation toward holistic health) and modest inter-correlation among items within each belief domain. Confirmatory factor analysis results indicated the a priori measurement structure provided a poor fit to obtained data. Post hoc analyses indicated that African Americans and those with less education had less consistent responses to items within each belief domain. Revision and additional development of the CAMBI is needed to enable its use in more diverse research samples.

Evaluating the impact of cancer on complementary and alternative medicine use, distress and health related QoL among Australian women: A prospective longitudinal investigation

L.J. Beatty, J. Adams, D. Sibbritt, T.D. Wade — 2011-10-24

Summary: Objectives: While several cross-sectional studies have examined psychological correlates of complementary and alternative medicine (CAM) use and cancer, few prospective longitudinal investigations have been reported. This study examined whether CAM use moderated distress and quality of life (HRQoL) from pre- to post-cancer.Design: A prospective longitudinal national cohort design.Setting: Participants were 718 mid-aged women from the Australian longitudinal study on women's health who did not have cancer at survey 1, but who subsequently developed cancer. For each participant, three waves of data were extracted: the wave prior to diagnosis (‘pre’), at diagnosis (‘cancer’), and after cancer (‘post’).Main outcome measures: CAM use was measured by the question ‘in the past 12 months have you consulted an alternative health practitioner’. Distress was measured by perceived stress (PSS) and depression (CES-D 10), HRQoL was measured by physical and mental health functioning (SF-36).Results: CAM use significantly moderated the change over time in stress [F(561)=3.09, p=0.04], depression [F(494)=3.14, p=0.04], but not HRQoL. CAM-users were significantly more stressed than non-users pre-cancer (p<0.05), but there were no significant differences at subsequent surveys. CAM-users were significantly less depressed post-cancer compared to non-users (p<0.05).Conclusions: Findings indicated that CAM users may be more psychologically vulnerable than non-users with respect to stress, with CAM acting as an effective psychological, but not HRQoL, intervention.

Profile of minority and under-served patients using acupuncture

2011-11-02

Summary: Background: Acupuncture use remains common in the United States, yet little is known of its utilization by minority and underserved populations. Herein we report first visit data capturing patient profiles, types of conditions presented, and self-reports of their experience and satisfaction with acupuncture accessed at a free care clinic with in a large urban safety net hospital.Methods: Sixty-one adult, English-speaking acupuncture patients were given a 20min survey after their first visit to a free care acupuncture clinic.Results: Patients were from 12 different countries. Fifty-six percent of the participants were minorities. Sixty-five percent of respondents were female. Average age was 42.1. Eighty percent were acupuncture naïve. Patients’ health complaints were similar to those of other surveyed mainstream patients with 57% reporting musculoskeletal conditions. Ninety-three percent would recommend a friend or family for acupuncture, 97% rating their overall experience with the acupuncture clinic as either very good or good.Conclusions: When made available to a diverse population of patients, acupuncture is utilized and perceived to be helpful. In this survey, patients sought treatment for musculoskeletal conditions and were satisfied with their first visit. Future research is warranted.

Complementary medicine and safety: A systematic investigation of design and reporting of systematic reviews

Karen Pilkington, Anelia Boshnakova — 2011-11-07

Summary: Objectives: The objective of this study was to examine the methods used in systematic reviews of safety across a range of complementary therapies to assess the variation in approach and the potential for developing guidance on conduct and reporting.Design: Systematic reviews focusing on safety were retrieved from NHS Evidence and searches of major databases. A pre-prepared template was used for data extraction. Information extracted included details of search strategies, sources, participants, interventions, reported adverse event/effect(s) and causality assessment. Data extraction was carried out by one researcher and a check for accuracy by a second researcher. Methods were assessed against criteria based on guidance provided by the Cochrane Adverse Effects Methods Group.Results: A total of 2563 citations were screened and 88 systematic reviews were selected for inclusion. The majority focused on the safety of herbs and nutritional supplements. Approximately half the reviews covered all aspects of safety; other reviews addressed specific adverse effects or interactions. Types of data included in the reviews did not always reflect the focus of the review. Search strategies, sources used, quality assessment and assessment of causality also varied.Conclusions: Detailed examination and comparison of the methods has highlighted several areas in which there is potential for development of guidelines and consensus on standards. These include search strategies, sources of information, data extraction and assessment of causality. The value of systematic reviews in relation to large outcome studies requires further consideration.

Placebo effect was influenced by publication year in three-armed acupuncture trials

Seo Ryang We, Yun Hyung Koog, Min Sun Park, Byung-Il Min — 2011-12-09

Summary: Objectives: We investigated the relationship between the placebo effect and the trial or patient characteristics.Data sources: We identified randomized clinical trials with acupuncture, sham and no-treatment groups in which no-treatment or conventional therapy was applied to the no-treatment group. Thirty-one trials in which no treatment was applied in the no-treatment group were categorised as ‘strict’ trials. Thirty-nine trials in which no-treatment or conventional therapy was applied to the no-treatment group were categorised as ‘less strict’ trials. We calculated the treatment effect, defined as the difference in the effect size between the acupuncture and no-treatment groups, and the placebo effect, defined as the difference in the effect size between the sham and no-treatment groups. Then, a random effect meta-regression analysis was performed on the two effects with respect to trial or patient characteristics.Results: The treatment effect was not found to be associated with any factors in both the strict and less strict trials. However, the placebo effect was found to be associated with the publication year in both the strict and less strict trials (P=0.009 and 0.005, respectively). The placebo effect increased by 0.05 in effect size per year in trials that were published more recently.Conclusion: While the treatment effect was not influenced by any trial or patient characteristics, the placebo effect was associated with the publication year.

Future perspectives of personalized medicine in traditional Chinese medicine: A systems biology approach

Aihua Zhang, Hui Sun, Ping Wang, Ying Han, Xijun Wang — 2011-12-02

Summary: Deconstruction of molecular pathways and advances in enabling technology platforms have opened new horizons for disease management, exploring therapeutic solutions to each individual patient beyond the one-size fits all practice. Application of personalized medicine paradigms aims to achieve the right diagnosis and right treatment for the right patient at the right time at the right cost. With the potential to transform medical practice across global communities, personalized medicine is emerging as the flagship of modern medicine. In recent years, the health care paradigm has shifted from a focus on diseases to a major hot of personalized traditional Chinese medicine (TCM) with holistic approach. TCM focuses on health maintenance, emphasizes on enhancing the body's resistance to diseases and especially showes great advantages in early intervention, personalized and combination therapies, etc. Systems biology, a new science of the 21st century, becomes practically available and resembles TCM in many aspects such as study method and design, and is current key component technologies that serves as the major driving force for translation of the personalized medicine revolution of TCM principles into practice, will advance personalized therapy principles into healthcare management tools for individuals and populations. Such system approach concepts are transforming principles of TCM to modern therapeutic approaches, enable a predictive and preventive medicine and will lead to personalized medicine. To realise the full potential of personalized TCM, we describe the current status of principles and practice of TCM integrated with systems biology platform. Some characteristic examples are presented to highlight the application of this platform to personalized TCM research and development as well as some of the necessary milestones for moving TCM into mainstream health care.

Quality of herbal medicines: Challenges and solutions

Junhua Zhang, Barbara Wider, Hongcai Shang, Xuemei Li, Edzard Ernst — 2011-11-03

Summary: The popularity of herbal medicines has risen worldwide. This increase in usage renders safety issues important. Many adverse events of herbal medicines can be attributed to the poor quality of the raw materials or the finished products. Different types of herbal medicines are associated with different problems. Quality issues of herbal medicines can be classified into two categories: external and internal. In this review, external issues including contamination (e.g. toxic metals, pesticides residues and microbes), adulteration and misidentification are detailed. Complexity and non-uniformity of the ingredients in herbal medicines are the internal issues affecting the quality of herbal medicines. Solutions to the raised problems are discussed. The rigorous implementation of Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) would undoubtedly reduce the risk of external issues. Through the use of modern analytical methods and pharmaceutical techniques, previously unsolved internal issues have become solvable. Standard herbal products can be manufactured from the standard herbal extracts.