Patient Disclosure of Complementary and Integrative Health Approaches in an Academic Health Center.

BACKGROUND: Effective patient-doctor communication about complementary and integrative health (CIH) is crucial to coordinate multimodal treatment for complex conditions. While rates of patient disclosure of CIH use to physicians have increased in the United States over the last 30 years, many patients still do not disclose these facts. Integrating CIH approaches within academic medical centers may enhance the communication, but this has not been explicitly studied. OBJECTIVE: To examine rates of patient disclosure of CIH to physicians and reasons for nondisclosure. METHODS: We surveyed 1177 patients at an academic center's CIH clinic regarding their CIH use and disclosure of CIH use to their physician. RESULTS: Of the 1067 who responded to the disclosure questions, 80.1% had discussed their CIH use with their physician, while 19.9% did not. Of those who did not disclose, lack of physician inquiry was reported by 58% as the principal reason. DISCUSSION: Within an academic center, there is still a need to improve communication about CIH use. Possible strategies might include continued education of both patients and physicians about CIH and communication skills and integration of CIH disclosure into routine patient health questionnaires.

Cost-Effectiveness of a Team-Based Integrative Medicine Approach to the Treatment of Back Pain.

OBJECTIVES: To report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP). DESIGN: Observational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months. SETTINGS/LOCATION: Osher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH. SUBJECTS: CLBP patients seeking care at OCC or non-OCC BWH clinics. INTERVENTIONS: Integrative or conventional care for CLBP as prescribed by the treating clinician(s). OUTCOME MEASURES: Quality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes. RESULTS: Total adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: -1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale. CONCLUSIONS: When adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness.

A Multidisciplinary Integrative Medicine Team in the Treatment of Chronic Low-Back Pain: An Observational Comparative Effectiveness Study.

OBJECTIVES: Chronic low-back pain (CLBP) is burdensome and costly, and a common condition for which adults use integrative therapies. The effectiveness of multidisciplinary integrative approaches has not been well studied. The purpose of this observational study was to compare characteristics and outcomes of CLBP patients treated at the Osher Clinical Center (OCC) versus other clinics at Brigham and Women's Hospital. DESIGN: Observational comparative effectiveness study. SETTING: Tertiary care hospital. SUBJECTS: Patients ≥21 years with 3+ months of CLBP or 6+ months of intermittent low-back pain. INTERVENTION: All patients were observed for 12 months. OCC patients received care at the integrative clinic (7.3 visits on average over 13 weeks); non-OCC patients received usual care at other clinics of the same hospital. OUTCOME MEASURES: Primary outcomes: change from baseline to 6 months in functional status (Roland Disability Questionnaire [RDQ]) and bothersomeness of pain (BOP). SECONDARY OUTCOMES: change in RDQ and BOP at 3 and 12 months, percentages of patients with clinically meaningful (≥30%) improvements. RESULTS: One hundred fifty-six OCC and 153 non-OCC participants were enrolled; follow-up was 90.4 and 98.0%, respectively, at 12 months. There were substantial differences in baseline characteristics between groups. For RDQ, the adjusted mean group difference was nonsignificant at 6 months; for BOP, the differences were significant, but clinically small. At 12 months, the observed benefit on RDQ was significant and clinically meaningful; for BOP, there were significant, but clinically small differences. Percentages of patients with ≥30% improvements in RDQ were significantly greater in the OCC group only at 12 months, and both 6 and 12 months for BOP. CONCLUSIONS: Baseline characteristics can differ between those who select different sources of healthcare for CLBP. While benefits seen in the OCC versus non-OCC clinics were not large, further evaluation through randomized trials might be warranted to provide a more definitive evaluation.

Establishing an Integrative Medicine Program Within an Academic Health Center: Essential Considerations.

Integrative medicine (IM) refers to the combination of conventional and "complementary" medical services (e.g., chiropractic, acupuncture, massage, mindfulness training). More than half of all medical schools in the United States and Canada have programs in IM, and more than 30 academic health centers currently deliver multidisciplinary IM care. What remains unclear, however, is the ideal delivery model (or models) whereby individuals can responsibly access IM care safely, effectively, and reproducibly in a coordinated and cost-effective way.Current models of IM across existing clinical centers vary tremendously in their organizational settings, principal clinical focus, and services provided; practitioner team composition and training; incorporation of research activities and educational programs; and administrative organization (e.g., reporting structure, use of medical records, scope of clinical practice) and financial strategies (i.e., specific business plans and models for sustainability).In this article, the authors address these important strategic issues by sharing lessons learned from the design and implementation of an IM facility within an academic teaching hospital, the Brigham and Women's Hospital at Harvard Medical School; and review alternative options based on information about IM centers across the United States.The authors conclude that there is currently no consensus as to how integrative care models should be optimally organized, implemented, replicated, assessed, and funded. The time may be right for prospective research in "best practices" across emerging models of IM care nationally in an effort to standardize, refine, and replicate them in preparation for rigorous cost-effectiveness evaluations.

Selection for high oridonin yield in the Chinese medicinal plant Isodon (Lamiaceae) using a combined phylogenetics and population genetics approach.

Oridonin is a diterpenoid with anti-cancer activity that occurs in the Chinese medicinal plant Isodon rubescens and some related species. While the bioactivity of oridonin has been well studied, the extent of natural variation in the production of this compound is poorly known. This study characterizes natural variation in oridonin production in order to guide selection of populations of Isodon with highest oridonin yield. Different populations of I. rubescens and related species were collected in China, and their offspring were grown in a greenhouse. Samples were examined for oridonin content, genotyped using 11 microsatellites, and representatives were sequenced for three phylogenetic markers (ITS, rps16, trnL-trnF). Oridonin production was mapped on a molecular phylogeny of the genus Isodon using samples from each population as well as previously published Genbank sequences. Oridonin has been reported in 12 out of 74 species of Isodon examined for diterpenoids, and the phylogeny indicates that oridonin production has arisen at least three times in the genus. Oridonin production was surprisingly consistent between wild-collected parents and greenhouse-grown offspring, despite evidence of gene flow between oridonin-producing and non-producing populations of Isodon. Additionally, microsatellite genetic distance between individuals was significantly correlated with chemical distance in both parents and offspring. Neither heritability nor correlation with genetic distance were significant when the comparison was restricted to only populations of I. rubescens, but this result should be corroborated using additional samples. Based on these results, future screening of Isodon populations for oridonin yield should initially prioritize a broad survey of all species known to produce oridonin, rather than focusing on multiple populations of one species, such as I. rubescens. Of the samples examined here, I. rubescens or I. japonicus from Henan province would provide the best source of oridonin.

Are complementary therapies and integrative care cost-effective? A systematic review of economic evaluations.

OBJECTIVE: A comprehensive systematic review of economic evaluations of complementary and integrative medicine (CIM) to establish the value of these therapies to health reform efforts. DATA SOURCES: PubMed, CINAHL, AMED, PsychInfo, Web of Science and EMBASE were searched from inception through 2010. In addition, bibliographies of found articles and reviews were searched, and key researchers were contacted. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies of CIM were identified using criteria based on those of the Cochrane complementary and alternative medicine group. All studies of CIM reporting economic outcomes were included. STUDY APPRAISAL METHODS: All recent (and likely most cost-relevant) full economic evaluations published 2001-2010 were subjected to several measures of quality. Detailed results of higher-quality studies are reported. RESULTS: A total of 338 economic evaluations of CIM were identified, of which 204, covering a wide variety of CIM for different populations, were published 2001-2010. A total of 114 of these were full economic evaluations. And 90% of these articles covered studies of single CIM therapies and only one compared usual care to usual care plus access to multiple licensed CIM practitioners. Of the recent full evaluations, 31 (27%) met five study-quality criteria, and 22 of these also met the minimum criterion for study transferability ('generalisability'). Of the 56 comparisons made in the higher-quality studies, 16 (29%) show a health improvement with cost savings for the CIM therapy versus usual care. Study quality of the cost-utility analyses (CUAs) of CIM was generally comparable to that seen in CUAs across all medicine according to several measures, and the quality of the cost-saving studies was slightly, but not significantly, lower than those showing cost increases (85% vs 88%, p=0.460). CONCLUSIONS: This comprehensive review identified many CIM economic evaluations missed by previous reviews and emerging evidence of cost-effectiveness and possible cost savings in at least a few clinical populations. Recommendations are made for future studies.

A model of integrative care for low-back pain.

OBJECTIVES: While previous studies focused on the effectiveness of individual complementary and alternative medical (CAM) therapies, the value of providing patients access to an integrated program involving multiple CAM and conventional therapies remains unknown. The objective of this study is to explore the feasibility and effects of a model of multidisciplinary integrative care for subacute low-back pain (LBP) in an academic teaching hospital. DESIGN: This was a pilot randomized trial comparing an individualized program of integrative care (IC) plus usual care to usual care (UC) alone for adults with LBP. SUBJECTS: Twenty (20) individuals with LPB of 3-12 weeks' duration were recruited from an occupational health clinic and community health center. INTERVENTIONS: Participants were randomized to 12 weeks of individualized IC plus usual care versus UC alone. IC was provided by a trained multidisciplinary team offering CAM therapies and conventional medical care. OUTCOME MEASURES: The outcome measures were symptoms (pain, bothersomeness), functional status (Roland-Morris score), SF-12, worry, and difficulty performing three self-selected activities. RESULTS: Over 12 weeks, participants in the IC group had a median of 12.0 visits (range 5-25). IC participants experienced significantly greater improvements at 12 weeks than those receiving UC alone in symptom bothersomeness (p=0.02) and pain (p=0.005), and showed greater improvement in functional status (p=0.08). Rates of improvement were greater for patients in IC than UC in functional status (p=0.02), bothersomeness (p=0.002), and pain scores (p=0.001). Secondary outcomes of self-selected most challenging activity, worry, and the SF-12 also showed improvement in the IC group at 12 weeks. These differences persisted at 26 weeks, but were no longer statistically significant. CONCLUSIONS: It was feasible for a multidisciplinary, outpatient IC team to deliver coordinated, individualized intervention to patients with subacute LBP. Results showed a promising trend for benefit of treating patients with persistent LBP with this IC model, and warrant evaluation in a full-scale study.

Heavy metal and pesticide content in commonly prescribed individual raw Chinese Herbal Medicines.

Heavy metal and pesticide contamination has previously been reported in Chinese Herbal Medicines (CHMs), in some cases at potentially toxic levels. This study was conducted to determine general patterns and toxicological significance of heavy metal and pesticide contamination in a broad sample of raw CHMs. Three-hundred-thirty-four samples representing 126 species of CHMs were collected throughout China and examined for arsenic, cadmium, chromium, lead, and mercury. Of the total, 294 samples representing 112 species were also tested for 162 pesticides. At least 1 metal was detected in all 334 samples (100%) and 115 samples (34%) had detectable levels of all metals. Forty-two different pesticides were detected in 108 samples (36.7%), with 1 to 9 pesticides per sample. Contaminant levels were compared to toxicological reference values in the context of different exposure scenarios. According to a likely scenario of CHM consumption, only 3 samples (1%) with heavy metals and 14 samples (5%) with pesticides were found with concentrations that could contribute to elevated background levels of contaminant exposure. According to the most conservative scenario of CHM consumption, 231 samples (69%) with heavy metals and 81 samples (28%) with pesticides had contaminants that could contribute to elevated levels of exposure. Wild collected plants had higher contaminant levels than cultivated samples. Cadmium, chromium, lead, and chlorpyrifos contamination showed weak correlations with geographic location. Based on our assumptions of the likely mode of consumption of raw CHMs, the vast majority (95%) of the 334 samples in this study contained levels of heavy metals or pesticides that would be of negligible concern. However, given the number of samples with detectable contaminants and the range between the more likely and more conservative scenarios of contaminant exposure, more research and monitoring of heavy metals (especially cadmium and chromium) and pesticide residues (especially chlorpyrifos) in raw CHMs are advised.

Traditional Medicine Collection Tracking System (TM-CTS): a database for ethnobotanically driven drug-discovery programs.

ETHNOPHARMACOLOGICAL RELEVANCE: Ethnobotanically driven drug-discovery programs include data related to many aspects of the preparation of botanical medicines, from initial plant collection to chemical extraction and fractionation. The Traditional Medicine Collection Tracking System (TM-CTS) was created to organize and store data of this type for an international collaborative project involving the systematic evaluation of commonly used Traditional Chinese Medicinal plants. MATERIALS AND METHODS: The system was developed using domain-driven design techniques, and is implemented using Java, Hibernate, PostgreSQL, Business Intelligence and Reporting Tools (BIRT), and Apache Tomcat. RESULTS: The TM-CTS relational database schema contains over 70 data types, comprising over 500 data fields. The system incorporates a number of unique features that are useful in the context of ethnobotanical projects such as support for information about botanical collection, method of processing, quality tests for plants with existing pharmacopoeia standards, chemical extraction and fractionation, and historical uses of the plants. The database also accommodates data provided in multiple languages and integration with a database system built to support high throughput screening based drug discovery efforts. It is accessed via a web-based application that provides extensive, multi-format reporting capabilities. CONCLUSIONS: This new database system was designed to support a project evaluating the bioactivity of Chinese medicinal plants. The software used to create the database is open source, freely available, and could potentially be applied to other ethnobotanically driven natural product collection and drug-discovery programs.

Developing a library of authenticated Traditional Chinese Medicinal (TCM) plants for systematic biological evaluation--rationale, methods and preliminary results from a Sino-American collaboration.

While the popularity of and expenditures for herbal therapies (aka "ethnomedicines") have increased globally in recent years, their efficacy, safety, mechanisms of action, potential as novel therapeutic agents, cost-effectiveness, or lack thereof, remain poorly defined and controversial. Moreover, published clinical trials evaluating the efficacy of herbal therapies have rightfully been criticized, post hoc, for their lack of quality assurance and reproducibility of study materials, as well as a lack of demonstration of plausible mechanisms and dosing effects. In short, clinical botanical investigations have suffered from the lack of a cohesive research strategy which draws on the expertise of all relevant specialties. With this as background, US and Chinese co-investigators with expertise in Traditional Chinese Medicine (TCM), botany, chemistry and drug discovery, have jointly established a prototype library consisting of 202 authenticated medicinal plant and fungal species that collectively represent the therapeutic content of the majority of all commonly prescribed TCM herbal prescriptions. Currently housed at Harvard University, the library consists of duplicate or triplicate kilogram quantities of each authenticated and processed species, as well as "detanninized" extracts and sub-fractions of each mother extract. Each species has been collected at 2-3 sites, each separated geographically by hundreds of miles, with precise GPS documentation, and authenticated visually and chemically prior to testing for heavy metals and/or pesticides contamination. An explicit decision process has been developed whereby samples with the least contamination were selected to undergo ethanol extraction and HPLC sub-fractionation in preparation for high throughput screening across a broad array of biological targets including cancer biology targets. As envisioned, the subfractions in this artisan collection of authenticated medicinal plants will be tested for biological activity individually and in combinations (i.e., "complex mixtures") consistent with traditional ethnomedical practice. This manuscript summarizes the rationale, methods and preliminary "proof of principle" for the establishment of this prototype, authenticated medicinal plant library. It is hoped that these methods will foster scientific discoveries with therapeutic potential and enhance efforts to systematically evaluate commonly used herbal therapies worldwide.

Perceived benefit of Complementary and Alternative Medicine (CAM) for back pain: a national survey.

BACKGROUND: Complementary and alternative medicine (CAM) is commonly used to treat back pain, but little is known about factors associated with improvement. METHODS: We used data from the 2002 National Health Interview Survey to examine the associations between the perceived helpfulness of various CAM therapies for back pain. RESULTS: Approximately 6% of the US population used CAM to treat their back pain in 2002. Sixty percent of respondents who used CAM for back pain perceived a "great deal" of benefit. Using multivariable logistic regression, the factor associated with perceived benefit from CAM modalities was reporting that a reason for using CAM was that "conventional medical treatment would not help" (odds ratio [OR], 1.46; 95% CI, 1.14-1.86). The 2 factors associated with less perceived benefit from CAM modalities were fair to poor self-reported health status (OR, 0.58; 95% CI, 0.41-0.82) and referral by a conventional medical practitioner for CAM (OR, 0.7; 95% CI, 0.54-0.92). Using chiropractic as a reference, massage (OR, 0.62; 95% CI, 0.46-0.83), relaxation techniques (OR, 0.25; 95% CI, 0.14-0.45), and herbal therapy (OR, 0.3; 95% CI, 0.19-0.46) were all associated with less perceived benefit whereas those with similar perceived benefit included yoga/tai chi/qi gong (OR, 0.71; 95% CI, 0.41-1.22) and acupuncture (OR, 0.71; 95% CI, 0.37-1.38). CONCLUSIONS: The majority of respondents who used CAM for back pain perceived benefit. Specific factors and therapies associated with perceived benefit warrant further investigation.

Characteristics of yoga users: results of a national survey.

BACKGROUND: There are limited data on the characteristics of yoga users in the U.S. OBJECTIVE: To characterize yoga users, medical reasons for use, perceptions of helpfulness, and disclosure of use to medical professionals. METHODS: Utilizing cross-sectional survey data from the 2002 National Health Interview Survey (NHIS) Alternative Medicine Supplement (n = 31044), we examined correlates of yoga use for health. The estimated prevalence from 2002 NHIS of yoga for health was 5.1% corresponding to over 10 million adults. RESULTS: In 2002, yoga users were predominately Caucasian (85%) and female (76%) with a mean age of 39.5 years. Compared to non-yoga users, yoga users were more likely female (OR 3.76, 95% CI 3.11-4.33); less likely black than white (OR 0.65, 95% CI 0.53-0.80); tended to be younger; and more likely college educated (OR 2.70, 95% CI 2.37-3.08). Musculoskeletal conditions (OR 1.61, 95% CI 1.42-1.83), mental health conditions (OR 1.43, 95% CI 1.22-1.67), severe sprains in the last 12 months (OR 1.49, 95% CI 1.22-1.81), and asthma (OR 1.27, 95% CI 1.05-1.54) were independently associated with higher yoga use, while hypertension (OR 0.78, 95% CI 0.64-0.95) and chronic obstructive lung disease (OR 0.69, 95% CI 0.48-1.00) were associated with lower use. Yoga was most commonly used to treat musculoskeletal or mental health conditions, and most users reported yoga to be helpful for these conditions. A majority of yoga users (61%) felt yoga was important in maintaining health, though only 25% disclosed yoga practice to their medical professional. CONCLUSIONS: We found that yoga users are more likely to be white, female, young and college educated. Yoga users report benefit for musculoskeletal conditions and mental health, indicating that further research on the efficacy of yoga for the treatment and/or prevention of these conditions is warranted.

Patient expectations as predictors of outcome in patients with acute low back pain.

BACKGROUND: Few studies have evaluated the association between patient expectations for recovery and clinical outcomes, and no study has evaluated whether asking patients to choose their therapy modifies such an association. OBJECTIVE: To evaluate the association between patients' expectations and functional recovery in patients with acute low back pain (LBP), and to determine whether that association is affected by giving patients choice of therapy. DESIGN AND PARTICIPANTS: A secondary analysis of a randomized controlled trial comparing usual care alone to usual care plus choice of chiropractic, acupuncture, or massage in 444 adults with acute LBP, lasting less than 21 days. MEASUREMENTS AND MAIN RESULTS: Primary outcome was functional disability (Roland score) at 5 and 12 weeks. Patients' general expectations for improvement were associated with improvement in functional status (beta = 0.96, 95% CI = 0.56, 1.36). A 1-point increase in general expectations was associated with a 0.96-point improvement in Roland score. The association of expectation with outcome was 2-3 times greater in the usual care group than the choice group. However, these differences did not reach statistical significance. CONCLUSIONS: In patients with acute LBP, higher expectations for recovery are associated with greater functional improvement. Eliciting patient expectations for improvement may be a simple way to identify patients with the highest (or lowest) likelihood of experiencing functional improvement. Incorporating questions about patient expectations in future trials may clarify the role of this important correlate of clinical outcomes.

The relationship between social factors and attitudes toward conventional and CAM practitioners.

CONTEXT: The research results on the relationship between social factors and attitudes toward complementary and alternative medicines (CAMs) and conventional practitioners are equivocal. Some researchers theorize a relationship between social factors and attitudes toward providers, with CAM being more attractive to socially and economically marginalized groups. OBJECTIVES: To evaluate the relationships between selected sociodemographic factors and attitudes toward CAMs in the general US population. DESIGN: A subset of data from a 1997-1998 nationally representative survey was examined using descriptive and univariate analyses. RESULTS: Five outcomes exploring preference for CAM or conventional medical practitioners are considered. Age was positively related to favoring one's conventional medical doctor. Subjects who reported using CAM for wellness/prevention reported significantly less confidence in their conventional doctors than individuals who did not report using CAM for wellness/prevention. Those with low income were also significantly less confident in their medical doctors and less satisfied with their conventional medical practitioners than those with higher incomes. CONCLUSIONS: While more prospective work is needed, this analysis suggests that social factors may be related to practitioner preference. Finding out why these relationships exist is important for the effectiveness of health care.

Factors associated with herbal therapy use by adults in the United States.

OBJECTIVE: To examine the patterns of herbal therapy use among adults in the United States and to describe factors associated with herb use. DESIGN: We examined the use of natural herbs from the 2002 National Health Interview Survey (NHIS). We analyzed factors associated with herb use and reasons for herb use with logistic regression. RESULTS: Factors associated with herb use include the following: age (45-64 years old), being uninsured, being female, having a higher education, living in the West, using prescription medications or over-the-counter (OTC) medications, and self-identified as "non-Hispanic other." Factors associated with no herb use include being non-Hispanic black and living in the South or Midwest. Seventy-two percent of those who used herbs used prescription medications, and 84% of those who used herbs also used an OTC medication in the prior 12 months. Among adults who used herbs, the most commonly mentioned were echinacea (41%), ginseng (25%), gingko (22%), and garlic (20%). The most frequent conditions for herb use were head or chest cold (30%), musculoskeletal conditions (16%), and stomach or intestinal illness (11%). Among those who used herbs in the prior year, factors associated with using herbs because conventional medical treatments were too expensive included being uninsured, having poor health, and being 25-44 years old. CONCLUSIONS: Nearly 1 in 5 people in the US population report using an herb for treatment of health conditions and/or health promotion. More than half did not disclose this information to a conventional medical professional.

Do the dietary supplements epigallocatechin gallate or vitamin e cause a radiomodifying response on tumors in vivo? A pilot study with murine breast carcinoma.

The primary aim of this study was to evaluate a systematic and reproducible assay to examine the potential radiomodifying effects of vitamin E (VE) or epigallocatechin gallate (EGCG), antioxidants commonly consumed by cancer patients as dietary supplements, on tumor control. C3H mice were randomized to a control diet or to the control diet supplemented with VE or EGCG. A tumor control dose 50% (TCD(50)) assay was used to evaluate for a radiomodifying response in stage IV murine cancer (MCa-IV) tumors, implanted in the hindleg of mice, and allowed to grow to 8 mm before receiving a single dose of radiation. The effects of VE and EGCG on intratumoral angiogenesis and apoptosis were evaluated in a group of nonirradiated mice using immunohistochemical staining. Cell proliferation assays were conducted on MCa-IV tumors in vitro. EGCG slowed tumor growth rate by 10%. EGCG and VE slowed tumor regrowth by 24 to 25%. There were no significant differences in TCD(50) values between the groups (control = 73.9 Gy, VE = 77.2 Gy, EGCG = 76.4 Gy); however, normal tissues were protected from late radiation effects (autoamputations) in the VE group. VE and EGCG increased tumor cell apoptosis and decreased tumor cell proliferation but had no effect on microvessel density. In this pilot study, neither VE nor EGCG exerted a significant radiomodifying effect on the MCa-IV tumor. Nonetheless, the suggestion of a small degree of tumor radioprotection by these antioxidant compounds warrants further research. As supplementation with VE radioprotected normal tissue, additional studies on this putative benefit are recommended.

Addition of choice of complementary therapies to usual care for acute low back pain: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVE: To investigate the effectiveness and cost of usual care plus patient choice of acupuncture, chiropractic, or massage therapy (choice) compared with usual care alone in patients with acute low back pain (LBP). SUMMARY OF BACKGROUND DATA: Few studies have evaluated care models with facilitated access to and financial coverage for adjunctive complementary and alternative medicine therapies. METHODS: A total of 444 patients with acute LBP (<21 days) were recruited from 4 clinical sites and randomized into 2 groups: usual care or choice. Outcomes included symptoms (bothersomeness), functional status (Roland), and satisfaction between baseline and 5 weeks, and cost of medical care in the 12 weeks after randomization. RESULTS: After 5 weeks, providing patients with a choice did not yield clinically important reductions in symptoms (median -4, [interquartile range -7, -2] for usual care, and -5 [-7, -3] for choice; P = 0.002) or improvements in functional status (-8 [-13, -2] for usual care, and -9 [-15, -4] for choice; P = 0.15). Although there was a significantly greater satisfaction with care in the choice group, this came at a net increase in costs of 244 dollars per patient. This consisted of a 99 dollars reduction in the average cost to the insurer for medical care but an additional cost of 343 dollars, for an average of 6.0 complementary and alternative medicine treatments per patient. CONCLUSIONS: A model of care that offered access to a choice of complementary and alternative medicine therapies for acute LBP did not result in clinically significant improvements in symptom relief or functional restoration. This model was associated with greater patient satisfaction but increased total costs. Future evaluations of this choice model should focus on patients with chronic conditions (including chronic back pain) for which conventional medical care is often costly and of limited benefit.