Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

Background: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Methods: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture ( up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. Results: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). Conclusion: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain

Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures

BACKGROUND: Central to the development of a sound evidence base for Complementary and Alternative Medicine (CAM) interventions is the need for valid, reliable and relevant outcome measures to assess whether the interventions work. We assessed the specific needs for a database that would cover a wide range of outcomes measures for CAM research and considered a framework for such a database. METHODS: The study was a survey of CAM researchers, practitioners and students. An online questionnaire was emailed to the members of the Canadian Interdisciplinary Network for CAM Research (IN-CAM) and the CAM Education and Research Network of Alberta (CAMera). The majority of survey questions were open-ended and asked about outcome measures currently used, outcome measures' assessment criteria, sources of information, perceived barriers to finding outcome measures and outcome domains of importance. Descriptive quantitative analysis and qualitative content analysis were used. RESULTS: One hundred and sixty-four completed surveys were received. Of these, 62 respondents reported using outcome measures in their CAM research and identified 92 different specific outcomes. The most important barriers were the fact that, for many health concepts, outcome measures do not yet exist, as well as issues related to accessibility of instruments. Important outcome domains identified included physical, psychological, social, spiritual, quality of life and holistic measures. Participants also mentioned the importance of individualized measures that assess unique patient-centered outcomes for each research participant, and measures to assess the context of healing and the process of healing. CONCLUSION: We have developed a preliminary framework that includes all components of health-related outcomes. The framework provides a foundation for a larger, comprehensive collection of CAM outcomes. It fits very well in a whole systems perspective, which requires an expanded set of outcome measures, such as individualized and holistic measures, with attention to issues of process and context

Randomized trial of tapas acupressure technique for weight loss maintenance

<p>Abstract</p> <p>Background</p> <p>Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance.</p> <p>Methods</p> <p>Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT^®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation.</p> <p>Results</p> <p>Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory <it>post hoc </it>tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT.</p> <p>Conclusions</p> <p>The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00526565">NCT00526565</a></p

Reproductive and hormonal factors and mortality among women with colorectal cancer in the NIH-AARP Diet and Health Study

BACKGROUND: Although use of menopausal hormone therapy (MHT) and some reproductive factors have been associated with colorectal cancer (CRC) risk, relations between these factors and survival after CRC diagnosis are unclear. METHODS: Among 2053 post-menopausal women diagnosed with incident CRC in the NIH-AARP Diet and Health Study, we calculated hazard ratios (HRs) and 95% confidence intervals (CIs) using multivariable Cox proportional hazards regression to test associations between oral contraceptive (OC) use, menarche age, age at first birth, parity, menopausal age, and MHT use with all-cause and CRC-specific mortality. RESULTS: There were 759 deaths (332 CRC-related deaths) over a median follow-up of 7.7 years. We observed no statistically significant associations between OC use, menarche age, age at first birth, parity, menopausal age, and mortality. Compared with never MHT use, former use was not associated with mortality, but we found an inverse association among baseline current users, for both all-cause (HR=0.79, 95% CI 0.66–0.94) and CRC mortality (0.76, 0.59–0.99). CONCLUSION: Future studies should further focus on the mechanisms by which exogenous oestrogen exposure might affect tumour progression and CRC survival

A Complex Systems Science Perspective for Whole Systems of Complementary and Alternative Medicine Research

Whole systems complementary and alternative medicine (WS-CAM) approaches share a basic worldview that embraces interconnectedness; emergent, non-linear outcomes to treatment that include both local and global changes in the human condition; a contextual view of human beings that are inseparable from and responsive to their environments; and interventions that are complex, synergistic, and interdependent. These fundamental beliefs and principles run counter to the assumptions of reductionism and conventional biomedical research methods that presuppose unidimensional simple causes and thus dismantle and individually test various interventions that comprise only single aspects of the WS-CAM system. This paper will demonstrate the superior fit and practical advantages of using complex adaptive systems (CAS) and related modeling approaches to develop the scientific basis for WS-CAM. Furthermore, the details of these CAS models will be used to provide working hypotheses to explain clinical phenomena such as (a) persistence of changes for weeks to months between treatments and/or after cessation of treatment, (b) nonlocal and whole systems changes resulting from therapy, (c) Hering\u27s law, and (d) healing crises. Finally, complex systems science will be used to offer an alternative perspective on cause, beyond the simple reductionism of mainstream mechanistic ontology and more parsimonious than the historical vitalism of WS-CAM. Rather, complex systems science provides a scientifically rigorous, yet essentially holistic ontological perspective with which to conceptualize and empirically explore the development of disease and illness experiences, as well as experiences of healing and wellness