Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial.

INTRODUCTION: Chemotherapy-induced peripheral neuropathy (CIPN) is a prominent clinical problem, with limited effective therapies. Preliminary non-randomized clinical trial data support that Scrambler Therapy is helpful in this situation. METHODS: Patients were eligible if they had CIPN symptoms for at least 3 months and CIPN-related tingling or pain at least 4/10 in severity during the week prior to registration. They were randomized to receive Scrambler Therapy versus transcutaneous electrical nerve stimulation (TENS) for 2 weeks. Patient-reported outcomes (PROs) were utilized to measure efficacy and toxicity daily for 2 weeks during therapy and then weekly for 8 additional weeks. RESULTS: This study accrued 50 patients, 25 to each of the 2 study arms; 46 patients were evaluable. There were twice as many Scrambler-treated patients who had at least a 50% documented improvement during the 2 treatment weeks, from their baseline pain, tingling, and numbness scores, when compared with the TENS-treated patients (from 36 to 56% compared with 16-28% for each symptom). Global Impression of Change scores for "neuropathy symptoms," pain, and quality of life were similarly improved during the treatment weeks. Patients in the Scrambler group were more likely than those in the TENS group to recommend their treatment to other patients, during both the 2-week treatment period and the 8-week follow-up period (p < 0.0001). Minimal toxicity was observed. CONCLUSIONS: The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN.

Absent and Discordant Electronic Health Record Documentation of Complementary and Alternative Medicine in Cancer Care.

OBJECTIVES: Many patients with cancer use complementary and alternative medicine (CAM), but the quality of CAM documentation in their electronic health records (EHRs) is unknown. The authors aimed to describe (i) the prevalence and types of CAM used after cancer diagnosis and the influence of oncologists on CAM use, as per patients' self-report, and (ii) the prevalence of CAM documentation in the EHR and its consistency with self-reported usage. DESIGN: Patient and provider surveys and chart review. SETTINGS/LOCATION: Medical oncology practices at one institution. SUBJECTS: Patients with cancer at oncologist visits. OUTCOME MEASURES: Patient self-reported rate of 3-month postvisit CAM use; provider EHR documentation of CAM use or discussion and its concordance with patient self-report. RESULTS: Among 327 patients enrolled, 248 responded to the 3-month postvisit survey. Of these, 158 reported CAM use after diagnosis (63.7%). CAM users were younger (p < 0.001) and had a higher percentage of women (p = 0.03) than nonusers. Modalities most commonly used were supplements (62.6%), special diets (38.6%), chiropractor (28.4%), and massage (28.4%). CAM was used to improve well-being (68.7%), manage adverse effects (35.5%), and fight cancer (22.9%). Oncologists suggested CAM in 22.5% of instances of use. CAM use/discussion was documented for 58.2% of self-reported CAM users. Of the documented modalities, EHR and self-report were concordant for only 8.2%. CAM documentation was associated with physician provider (p = 0.03), older patients (p = 0.01), and treatment with radiation (p = 0.03) or surgery (p = 0.001). After adjusting for other factors, patients with breast cancer or "other" tumor category were four times more likely than patients with gastrointestinal cancer to have CAM use documentation (odds ratio [95% confidence interval]: 4.41 [1.48-13.10]; 3.76 [1.42-9.99], respectively). CONCLUSIONS: Most patients with cancer use CAM after diagnosis, yet EHR documentation is complete for very few. Oncologists should inquire about, document, and discuss CAM benefits and harm or refer patients to CAM specialists.

Noninvasive Ventilation in Patients With Do-Not-Intubate and Comfort-Measures-Only Orders: A Systematic Review and Meta-Analysis.

OBJECTIVES: To assess the effectiveness of noninvasive ventilation in patients with acute respiratory failure and do-not-intubate or comfort-measures-only orders. DATA SOURCES: MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science from inception to January 1, 2017. STUDY SELECTION: Studies of all design types that enrolled patients in the ICU or hospital ward who received noninvasive ventilation and had preset do-not-intubate or comfort-measures-only orders. DATA EXTRACTION: Data abstraction followed Meta-analysis of Observational Studies in Epidemiology guidelines. Data quality was assessed using a modified Newcastle-Ottawa Scale. DATA SYNTHESIS: Twenty-seven studies evaluating 2,020 patients with do-not-intubate orders and three studies evaluating 200 patients with comfort-measures-only orders were included. In patients with do-not-intubate orders, the pooled survival was 56% (95% CI, 49-64%) at hospital discharge and 32% (95% CI, 21-45%) at 1 year. Hospital survival was 68% for chronic obstructive pulmonary disease, 68% for pulmonary edema, 41% for pneumonia, and 37% for patients with malignancy. Survival was comparable for patients treated in a hospital ward versus an ICU. Quality of life of survivors was not reduced compared with baseline, although few studies evaluated this. No studies evaluated quality of dying in nonsurvivors. In patients with comfort-measures-only orders, a single study showed that noninvasive ventilation was associated with mild reductions in dyspnea and opioid requirements. CONCLUSIONS: A large proportion of patients with do-not-intubate orders who received noninvasive ventilation survived to hospital discharge and at 1 year, with limited data showing no decrease in quality of life in survivors. Provision of noninvasive ventilation in a well-equipped hospital ward may be a viable alternative to the ICU for selected patients. Crucial questions regarding quality of life in survivors, quality of death in nonsurvivors, and the impact of noninvasive ventilation in patients with comfort-measures-only orders remain largely unanswered.

Missed Opportunities: A Mixed-Methods Analysis of CAM Discussions and Practices in the Management of Pain in Oncology.

CONTEXT: Treatment of pain in cancer is a clinical priority. Many cancer patients seek and use complementary and alternative medicine (CAM) therapies. OBJECTIVES: The aim of this study was to describe the role CAM plays in oncology, clinicians' approaches to pain management and its alignment with patient preference and self-care. METHODS: We used quantitative criteria to identify patients with high, self-reported pain and reduced quality of life. For these patients, we merged quantitative and qualitative data from encounter audio recordings, patient surveys, and the medical record. RESULTS: We identified 32 patients (72% women, average age 60) experiencing significantly symptomatic pain at enrollment. Merged themes were 1) Restricted and defined roles: Oncology clinicians suggested and documented cancer-specific approaches to pain management. Patients often (17, 53%) used CAM but rarely desired to discuss it in their encounters. 2) Proactive patients in setting of neutrality: Pain management strategies were considered in 22 instances. CAM was mentioned in 4 (18%) of these discussions but only after patient initiation. Clinicians took a neutral stance. 3) Missed opportunities for person-centered CAM discussions and management: Most (88%) patients were receiving conventional pain medications at enrollment or had them added or escalated during follow-up. Some patients in pain expressed preferences for avoiding opioids. One patient reported wishing CAM would have been discussed after an encounter in which it was not. CONCLUSION: Bringing CAM discussions into the oncology encounter may facilitate a stronger patient-clinician partnership and a more open and safe understanding of pain-related CAM use.

Complementary and alternative medicine therapies for chronic pain.

Pain afflflicts over 50 million people in the US, with 30.7% US adults suffering with chronic pain. Despite advances in therapies, many patients will continue to deal with ongoing symptoms that are not fully addressed by the best conventional medicine has to offer them. The patients frequently turn to therapies outside the usual purview of conventional medicine (herbs, acupuncture, meditation, etc.) called complementary and alternative medicine (CAM). Academic and governmental groups are also starting to incorporate CAM recommendations into chronic pain management strategies. Thus, for any physician who care for patients with chronic pain, having some familiarity with these therapies-including risks and benefits-will be key to helping guide patients in making evidence-based, well informed decisions about whether or not to use such therapies. On the other hand, if a CAM therapy has evidence of both safety and efficacy then not making it available to a patient who is suffering does not meet the need of the patient. We summarize the current evidence of a wide variety of CAM modalities that have potential for helping patients with chronic pain in this article. The triad of chronic pain symptoms, ready access to information on the internet, and growing patient empowerment suggest that CAM therapies will remain a consistent part of the healthcare of patients dealing with chronic pain.

Patterns of complementary and alternative medicine use in children with common neurological conditions.

BACKGROUND: Recent literature suggests that one in nine children in the United States uses some type of complementary and alternative medicine (CAM). Children with challenging neurological conditions such as headache, migraine, and seizures may seek CAM in their attempts at self-care. Our objective was to describe CAM use in children with these conditions. METHODS: We compared use of CAM among children aged 3 to 17 years with and without common neurological conditions (headaches, migraines, seizures) where CAM might plausibly play a role in their self-management using the 2007 National Health Interview Survey (NHIS) data. RESULTS: Children with common neurological conditions reported significantly more CAM use compared to the children without these conditions (24.0% vs 12.6%, P<.0001). Compared to other pediatric CAM users, children with neurological conditions report similarly high use of biological therapies and significantly higher use of mind-body techniques (38.6% vs 20.5%, P<.007). Of the mind-body techniques, deep breathing (32.5%), meditation (15.1%), and progressive relaxation (10.1%) were used most frequently. CONCLUSIONS: About one in four children with common neurological conditions use CAM. The nature of CAM use in this population, as well as its risks and benefits in neurological disease, deserve further investigation.

Infectious diseases physicians' attitudes and practices related to complementary and integrative medicine: results of a national survey.

Background. Complementary and alternative medicine (CAM) and integrative medicine (IM) modalities are widely used by patients, including those with infectious diseases (ID). Methods. One thousand randomly selected ID practitioners were surveyed. The survey was divided into domains related to familiarity and recommendation, beliefs and attitudes, and use of CAM/IM modalities. Results. The response rate was 31%. ID physicians were most familiar with vitamin and mineral supplementation (83%), massage (80%), acupuncture (79%), chiropractic (77%), yoga (74%), and herbal medicine (72%). ID physicians most recommended vitamin and mineral supplementation (80%) and massage (62%). Yoga, meditation, and acupuncture were recommended by 52%, 45%, and 46%, respectively. Drug interactions, clinical research, and knowledge of CAM/IM modalities were factors that were considered a major influence. Almost 80% of respondents indicated an interest in IM versus 11% for CAM. Most respondents (75%) felt that IM modalities are useful, and more than 50% believed that they could directly affect the immune system or disease process. Conclusion. ID physicians expressed a markedly greater interest for IM versus CAM. They appear to be familiar and willing to recommend some CAM/IM modalities and see a role for these in the management of certain infectious diseases. Data regarding clinical efficacy and safety appear to be important factors.

Characteristics of exclusive users of mind-body medicine vs. other alternative medicine approaches in the United States.

CONTEXT: Persons using one group of complementary and alternative medicine (CAM) may differ in important ways from users of other CAM therapies. OBJECTIVES: The aim of this study was to characterize the United States (US) adult population using exclusively mind-body medicine (MBM) and to determine if their characteristics differed from those using exclusively non-vitamin natural products. DESIGN/SETTING: Using the 2007 National Health Interview Survey (NHIS) and its periodic supplement on CAM use, descriptive characteristics of exclusive MBM users, as well as those using exclusively non-vitamin natural products were identified. PATIENTS: A total of 75,764 persons completing the 2007 NHIS with adults aged 18 years and older. MAIN OUTCOME MEASURES: Characteristics of MBM users, prevalence of MBM use, and characteristics of exclusive MBM users compared to exclusive non-vitamin natural product users. RESULTS: Among CAM users (N = 83,013,655), 21.8% of the adult population (age 18 or older) reported using exclusive MBM therapy. In multivariate models, exclusive MBM use was associated with female gender, higher educational attainment, younger age, residing in Northeast US, being Asian or black race, and a current smoker compared to those using exclusive non-vitamin natural products. Using bivariate comparisons, individuals that exclusively used MBM were more likely to be white females (60.5%), in a younger age category (18-39 years), educated beyond high school (68.3%), and more likely from the Southern US (32.4%). A greater level of depression in MBM users was noted compared to non-vitamin natural product users (6.6%).

Factors that influence practitioners' interpretations of evidence from alternative medicine trials: a factorial vignette experiment embedded in a national survey.

BACKGROUND: Clinical trial evidence in controversial areas such as complementary and alternative medicine (CAM) must be approached with an open mind. OBJECTIVE: To determine what factors may influence practitioners' interpretation of evidence from CAM trials. RESEARCH DESIGN: In a mailed survey of 2400 US CAM and conventional medicine practitioners we included 2 hypothetical factorial vignettes of positive and negative research results for CAM clinical trials. Vignettes contained randomly varied journal (Annals of Internal Medicine vs. Journal of Complementary and Alternative Medicine) and CAM treatment type (acupuncture, massage, glucosamine, meditation, and reiki). Response items also included randomly varied patient circumstances-chronic refractory symptoms and the patient requesting CAM. MEASURES: All practitioners rated the effectiveness and their willingness to recommend the therapy for a described patient. We used logistic regression to determine the independent influence of the 4 factors on respondents' effectiveness and legitimacy judgments. RESULTS: A total of 1561 practitioners responded (65%). Relative to Reiki, conventional medicine practitioners were most willing to recommend glucosamine (OR = 3.0; 95% CI [1.6-5.4]), than massage (1.9 [1.1-3.3]), acupuncture (1.3 [0.8-2.2]), and meditation (1.2 [0.7-2.0]). CAM practitioners rated acupuncture as effective more than other CAM therapies (OR = 5.8 [2.6-12.8] compared with Reiki), and were more willing to recommend acupuncture (OR = 12.3 [4.8-31.8]). When presented evidence of inefficacy, CAM practitioners were most willing to recommend acupuncture relative to other CAM therapies (OR = 15.5 [9.0-26.9]). CONCLUSIONS: Practitioners' judgments about CAM trial evidence depend on the type of treatments reported. Confirmation bias may play a role in the clinical translation of new evidence from clinical trials.

What rheumatologists in the United States think of complementary and alternative medicine: results of a national survey.

BACKGROUND: We aimed to describe prevailing attitudes and practices of rheumatologists in the United States toward complementary and alternative medicine (CAM) treatments. We wanted to determine whether rheumatologists' perceptions of the efficacy of CAM therapies and their willingness to recommend them relate to their demographic characteristics, geographic location, or clinical practices. METHODS: A National Institutes of Health-sponsored cross-sectional survey of internists and rheumatologists was conducted regarding CAM for treatment of chronic back pain or joint pain. In this study we analyzed responses only from rheumatologists. Response items included participant characteristics and experience with 6 common CAM categories, as defined by the National Institutes of Health. Descriptive statistics were used to describe attitudes to CAM overall and to each CAM category. Composite responses were devised for respondents designating 4 or more of the 6 CAM therapies as "very" or "moderately" beneficial or "very likely" or "somewhat likely" to recommend. RESULTS: Of 600 rheumatologists who were sent the questionnaire, 345 responded (58%); 80 (23%) were women. Body work had the highest perceived benefit, with 70% of respondents indicating benefit. Acupuncture was perceived as beneficial by 54%. Most were willing to recommend most forms of CAM. Women had significantly higher composite benefit and recommend responses than men. Rheumatologists not born in North America were more likely to perceive benefit of select CAM therapies. CONCLUSIONS: In this national survey of rheumatologists practicing in the United States, we found widespread favorable opinion toward many, but not all, types of CAM. Further research is required to determine to what extent CAM can or should be integrated into the practice of rheumatology in the United States.

Religion, clinicians, and the integration of complementary and alternative medicines.

OBJECTIVE: The aim of this study was to compare religious characteristics of general internists, rheumatologists, naturopaths, and acupuncturists, as well as to examine associations between physicians' religious characteristics and their openness to integrating complementary and alternative medicine (CAM). DESIGN: The design involved a national mail survey. The subjects were internists, rheumatologists, naturopaths, and acupuncturists. MEASURES: Physician outcome measures were use of and attitudes toward six classes of CAM. Predictors were religious affiliation, intrinsic religiosity, spirituality, and religious traditionalism. RESULTS: There was a 65% response. Naturopaths and acupuncturists were three times as likely as internists and rheumatologists to report no religious affiliation (35% versus 12%, p < 0.001), but were more likely to describe themselves as very spiritual (51% versus 20%, p < 0.001) and to agree they try to carry religious beliefs into life's dealings (51% versus 44%, p < 0.01). Among physicians, increased spirituality and religiosity coincided with more personal use of CAM and willingness to integrate CAM into a treatment program. CONCLUSIONS: Current and future integrative medicine will be shaped in part by religious and spiritual characteristics of providers.

Alternative medicine research in clinical practice: a US national survey.

BACKGROUND: Little is known about whether federally funded complementary and alternative medicine (CAM) research is translating into clinical practice. We sought to describe the awareness of CAM clinical trials, the ability to interpret research results, the acceptance of research evidence, and the predictors of trial awareness among US clinicians. METHODS: We conducted a cross-sectional mailed survey of 2400 practicing US acupuncturists, naturopaths, internists, and rheumatologists. RESULTS: A total of 1561 clinicians (65%) responded. Of the respondents, 59% were aware of at least 1 major CAM clinical trial; only 23% were aware of both trials. A minority of acupuncturists (20%), naturopaths (25%), internists (17%), and rheumatologists (33%) were "very confident" in interpreting research results (P < .001). Fewer acupuncturists (17%) and naturopaths (24%) than internists (58%) and rheumatologists (74%) rated the results of randomized controlled trials as "very useful" (P < .001). Twice as many internists (53%) and rheumatologists (64%) rated patient preferences as "least important" compared with acupuncturists (27%) and naturopaths (31%) (P < .001). In multivariate analyses, for clinicians aware of at least 1 trial, male sex (odds ratio [OR], 1.30 [95% confidence interval {CI}, 1.05-1.62]), prior research experience (OR, 1.45 [95% CI, 1.13-1.86]), institutional or academic practice setting (ORs, 1.98 [95% CI, 1.01-3.91], and 1.23 [95% CI, 0.73-2.09], respectively), and rating randomized trials as "very useful" (OR, 1.46 [95% CI, 1.12-1.91]) (P < .001) for clinical decision making were positively associated with CAM trial awareness. Acupuncturists, naturopaths, and internists (ORs, 0.15 [95% CI, 0.10-0.23], 0.15 [95% CI, 0.09-0.24], and 0.18 [95% CI, 0.12-0.28], respectively) were all similarly less aware of CAM trial results compared with rheumatologists. CONCLUSION: For clinical research in CAM to achieve its social value, concerted efforts must be undertaken to train clinicians and improve the dissemination of research results.

Herbal medicine research and global health: an ethical analysis.

Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.

Does the evidence make a difference in consumer behavior? Sales of supplements before and after publication of negative research results.

OBJECTIVE: To determine if the public consumption of herbs, vitamins, and supplements changes in light of emerging negative evidence. METHODS: We describe trends in annual US sales of five major supplements in temporal relationship with publication of research from three top US general medical journals published from 2001 through early 2006 and the number of news citations associated with each publication using the Lexus-Nexis database. RESULTS: In four of five supplements (St. John's wort, echinacea, saw palmetto, and glucosamine), there was little or no change in sales trends after publication of research results. In one instance, however, dramatic changes in sales occurred following publication of data suggesting harm from high doses of vitamin E. CONCLUSION: Results reporting harm may have a greater impact on supplement consumption than those demonstrating lack of efficacy. In order for clinical trial evidence to influence public behavior, there needs to be a better understanding of the factors that influence the translation of evidence in the public.

A family's request for complementary medicine after patient brain death.

A 19-year-old woman living with relatives in the United States who was admitted for elective cranial surgery for complications related to a congenital disorder developed an acute intracranial hemorrhage 10 days after surgery. The patient was declared dead following repeat negative apnea tests. The patient's father requested that the treating team administer an unverified traditional medicinal substance to the patient. Because of the unusual nature of this request, the treating team called an ethics consultation. The present article reviews this case and discusses other cases that share key features to determine whether and when it is appropriate to accommodate requests for interventions on patients who have been declared dead.

Associations between home remedy use and a validated self-reported adherence measure in an urban African-American population with poorly controlled hypertension.

OBJECTIVE: To determine associations between home remedy use and self-reported adherence among urban African Americans with poorly controlled hypertension. METHODS: A cross-sectional structured interview of African Americans admitted to medical units for uncontrolled hypertension at an urban academic hospital from 1999-2004. Logistic regression was used to test associations between home remedy use and self-reported adherence. RESULTS: One-hundred-eighty-three of 272 participants completed the study (67%); 39 (21%) reported using home remedies for hypertension. In a multivariate model, home remedy use was independently associated with greater medication adherence (OR for nonadherence=0.32, 95% CI: 0.14-0.75; p<0.01) and dietary adherence (OR for changing diet=3.28, 95% CI: 1.10-9.81; p=0.03), but not lifestyle or appointment adherence. These associations remained strong while controlling for age; sex; employment status; and key covariates, including greater medication side effects (OR=4.31; 95% CI: 1.64-11.3; p<0.01), greater difficulty paying for medications (OR=2.94, 95% CI: 1.25-6.92; p=0.01) and longer duration of diagnosis (OR for log years=1.53; 95% CI: 1.02-2.33; p=0.045). CONCLUSION: Home remedy use may be a marker of positive self-care for some hypertensive African Americans and not a promoter of nonadherence.

Responding to medical pluralism in practice: a principled ethical approach.

The popularity of complementary and alternative medicine (CAM) raises a range of ethical issues for practicing clinicians. Principles of biomedical ethics define obligations of health care professionals, but applying principles in particular cases at the interface of CAM and biomedicine may be particularly challenging. "Recognition of medical pluralism" can help clinicians' ethical deliberations related to CAM. Here we outline a 3-point practical approach to applying basic principles of biomedical ethics in light of medical pluralism: (1) inquiring about CAM use and the scientific evidence related to CAM, (2) acknowledging the health beliefs and practices of patients, and (3) accommodating diverse healing practices. Construed as such, recognition of medical pluralism encourages pragmatic willingness to examine the personal and cultural meaning associated with CAM use, the biases and assumptions of biomedicine, as well as the risk-benefit ratio of CAM practices. In this way, recognition of medical pluralism can help clinicians enhance patient care in a manner consistent with basic ethical principles.