Cuellar Sleep and CAM

The Use of CAM in Sleep: Fact or Fiction?: 

The Use of CAM in Sleep: Fact or Fiction? Dr. Norma Cuellar Assistant Professor School of Nursing University of Pennsylvania

Who’s my audience?: 

Who’s my audience? PROS Do you use CAM? Do you recommend it to your patients? Do you believe it works? CONS Do you think CAM is just a phase? Do you stay away from discussing it with your patient? Do you tell your patients not to use it because nothing is scientifically proven?

What is CAM? (1997): 

What is CAM? (1997) “A broad domain of health resources that encompass health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the dominant health system of a particular society or culture in a given historical period.” “CAM includes all practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being.” “The CAM domain is not always sharp and fixed.”

Who is using CAM?: 

Who is using CAM? Eisenberg Study in 1998 42.1% us some form of CAM Women Well educated In other studies: older adult up to 67% 46.3% use an alternative practitioner Spend $21.2 billion dollars out of pocket This exceeds out of pocket expenses for hospitalizations!

Why are people using CAM? (Stephen Strauss): 

Why are people using CAM? (Stephen Strauss) PUSH Dissatisfaction with health care providers and medical outcomes Side effects of drugs and treatments High health costs Technology Lack of control in their own health care practices Time spent with practitioner

PULL Factors: 

PULL Factors Looking for “cures” Want to use “natural” products Patient feels empowered Focus on spirituality and emotional well-being Health Care Provider provides the 3 T’s: touch, talk, time

Why should you care about CAM?: 

Why should you care about CAM? Health care providers have little knowledge about CAM Not included in health education A more culturally diverse population will bring in different/alternative health care practices Unaware of outcomes of CAM with conventional treatments

Theoretical Perspectives : 

Theoretical Perspectives Medical model (does not focus on prevention or promotion) Acute care Treat disease Reductionism Causality with linear thinking This model has done a very good job in extending our lifespan, aging population, and increased quality of life (contributing to chronic illness)

Model for Health Promotion and Prevention?: 

Model for Health Promotion and Prevention? CAM practices Health promotion Prevent disease (?) Do you ever know what has been prevented? Holistic approach Models to manage chronic disease (using CAM)?

Slide11: 

Health care providers who discredit CAM use can no longer deny the benefits need to respond to the challenges evolving from issues related to the use of CAM It is here to stay……this is a FACT.

Cultural influences in our country: 

Cultural influences in our country Different values and beliefs with every different culture Cultural competence in CAM Have to have a knowledge base about the varying modalities with the skills and abilities to provide culturally competent care including respect, compassion and dignity

Barriers of health care providers related to culture and CAM use: 

Barriers of health care providers related to culture and CAM use lack of knowledge fear and disgust bias ethnocentrism stereotyping ritualistic behaviors by health care providers language barriers differences in perceptions and expectations

Health Disparities in CAM: 

Health Disparities in CAM “Boutique Medicine” (Wayne Jonas) Only people with money can afford CAM If useful CAM modalities become reimbursable, what happens to the uninsured poor? Cost still comes out of their pocket? If we standardize some forms of folklore medicine, are we not taking it out of the realm it was intended to be in?

Research: 

Research Congress established NCCAM (1999) out of concern for the safety and efficacy of the use of CAM. 1992: Office of Alternative Medicine before became a center with 2 million dollar budget 2004 budget: $116.2 million dollars Goals of NCCAM: Safety and efficacy of natural products Pharmacological studies to determine potential interactive effects of CAM with standard treatment medications Evaluation of CAM practices

Research in CAM: 

Research in CAM Done in increasing numbers Lack of extensive, longitudinal studies is a limitation, need large sample sizes to control variability Pharmacodynamics of vitamins, herbs, and natural products is not regulated Shelf life Budget: not enough to study all CAM practices

How is CAM research prioritized?: 

How is CAM research prioritized? Expense of the modality How much people use it Conditions that have not been successfully treated by conventional medicine Cancer and CAM is very popular now Others: fibromyalgia, chronic fatigue syndrome, lower back pain New ideas and concepts

What type of research in CAM is needed?: 

What type of research in CAM is needed? Look at each modality Find the gaps in the literature Meta analysis Qualitative data Observations Subjective interview Descriptive Studies Clinical trials Health services research Cost and reimbursement

CAM Research: 

CAM Research Must stem from clinical and traditional practices Must be evidenced based practice Must be pragmatic How does the modality benefit the person? What are the patients using? What is needed in research to make sure there is safety and efficacy in what people are using?

Research Designs: 

Research Designs Research designs must be consistent with the CAM practice Conceptual Theories match Modalities Mind-body therapies/Psychological Model Manipulation therapies/Physical Therapy Model CAM research does not always require double blind studies Must decide variables to be controlled for Herbs/placebos can be randomized Mind-body therapies cannot be randomized What about Clinical Trials?

NIH Clinical Trials: 

NIH Clinical Trials Dose finding, Side effects, Clinical pharmacology – this is starting point in non-CAM Preliminary evidence of safety and efficacy Comparisons to Standard Therapies Post-marketing surveillance

Funding: 

Funding NIH Funding 67% pre-clinical trials 33% is patient oriented NCCAM 67% is patient oriented 33% is pre-clinical trials

Clinical Trials and CAM – backwards approach?: 

Clinical Trials and CAM – backwards approach? Large portion of people using a product and consider it safe (67% of funding) Has it been compared to other standard therapies? What has been done to determine if it is safe and has efficacy? How does it work? What is the mechanism of action? In CAM, Phase I, II, and III Trials are missing This is starting point

How do we improve the quality of CAM research?: 

How do we improve the quality of CAM research? Taxonomy or definition of CAM Standards of Practice for the modalities Professional bodies are needed to develop standards and update them based on research Address issues of model validity and data quality Train researchers with clinical practice

Funding needs to be broadened: 

Funding needs to be broadened NIH – NCCAM Department of Defense (small amount) NO funding monies AHRQ CDC (CAM will not be used in public health issues) VA Medicare Social Security Disabilities

Integrative Medicine: 

Integrative Medicine Combining the knowledge of old and new ways to treat patients Bringing together the best of conventional and complementary therapies Integration of evidence-based complementary medical therapies and approaches into patient care Example: patient requesting acupuncture

Health Policy: 

Health Policy National Plan to Advance Integrated Health Care White House Commission on CAM Policy National Policy Dialogue to Advance Integrated Health Care The Integrative Health Care Policy Consortium White House Committee on Integrative Medicine

Slide28: 

So what do we know about CAM interventions for sleep? Is it fact or fiction? How can CAM intervene with symptoms that interfere with sleep (e.g. pain)?

5 Domains from NCCAM: 

5 Domains from NCCAM

1800 different CAM modalities: 

1800 different CAM modalities

Alternative Medical Systems: 

Alternative Medical Systems Ayurveda, Chinese, Native American, Aboriginal, African, Middle Eastern, Tibetan, Central and South American cultures, Homeopathy, Naturopathy Acupuncture/Acupressure Decreased awake time and improved quality of sleep Increase in production of melatonin

Mind Body Interventions: 

Mind Body Interventions Cognitive-behavioral approaches, meditation, hypnosis, dance, music, art therapy, prayer, mental healing, autogenic training, biofeedback Cognitive behavior Music therapy Hypnosis

Biological Based Therapies: 

Biological Based Therapies Dietary supplements, herbs, orthomolecular (varying concentrations of chemicals, such as, magnesium, melatonin, and mega-doses of vitamins), individual biological therapies (use of laetrile, shark cartilage, bee pollen). Melatonin (chronobiotic) Valerian KavaKava Passionflower Hop Lavender (aromatherapy)

Manipulative and Body Based Methods: 

Manipulative and Body Based Methods Chiropractic, osteopathic, manipulation, massage massage

Energy Therapies: 

Energy Therapies Qigong, Reiki, therapeutic touch, bioelectromagnetic-based therapies (pulsed fields, magnetic fields, or alternating current or direct current fields) Therapeutic touch Magnetic therapy

Where is CAM research going at PENN?: 

Where is CAM research going at PENN?

Slide37: 

The Efficacy of Acupuncture and Physical Therapy for Treating Patients with Knee Osteo-Arthritis Method for Analysis of Pain Clinical Trials (NIH-NCI) A randomized, double-blind, placebo controlled trial of standardized gugulipid in Americans with moderate hypercholesterolemia Platelet effects of turmeric extract The Safety and Efficacy of Flaxseed in reducing cardiovascular risk in patients with Primary Hypercholesterolemia Specialized Center of Research in Hyperbaric Oxygen Yoga for the Treatment of Osteoarthritis of the Knee Use of complementary medicine by patients receiving primary care Glucosamine, chondroitin sulfate, celecoxib or placebo in treatment of knee OA 1999-2003 Rheumatology-Accupuncture Research Programs at Presbyterian Medical Center (PMC)

PennCam Educationhttp://www.med.upenn.edu/progdev/compmed/education.html: 

PennCam Education http://www.med.upenn.edu/progdev/compmed/education.html Education in Medical School (Why Teach CAM in Medical Schools) Medical School Curriculum Information Graduate Medical Education Curriculum Information: integrating CAM into the Internal Medicine and Primary Care Residency Programs. Educational Resources and Slides: Review chapter outlines and contributors of Medical Nutrition and Disease , a unique case-based textbook developed at Penn. Preview and download CAM-related Power Point slides and resources for educational purposes. Calendar of Events: Identify continuing medical education courses and other programs offered at the School of Medicine and the University of Pennsylvania Community.