Oppositional defiant disorder (ODD) is a pattern of disobedient, hostile, and defiant behavior toward authority figures. To fit this diagnosis, the pattern must persist for at least 6 months and must go beyond the bounds of normal childhood misbehavior.

This disorder is more prevalent in boys than girls. Some studies have shown that 20% of the school-age population is affected. However, most experts believe this figure is inflated due to changing cultural definitions of normal childhood behavior, and other possible biases including racial, cultural, and gender biases.

This behavior typically starts by age 8. Emotionally draining for the parents and distressing for the child, oppositional defiant disorder can add fuel to what may already be a turbulent and stressful family life.

While this is one of the most difficult of behavioral disorders, setting firm boundaries with consistent consequences plus a commitment to improving your relationship with your child can help your family overcome the dominating grip that oppositional defiant disorder may have on your household.

What are the signs and symptoms of Oppositional Defiant Disorder?

Three characteristics of the child who has ODD are: aggression, defiance and the constant need to irritate others. When documenting the child's behavior; characteristics or behavior patterns should be in place for at least 6 months. The behaviors will have a negative impact on social and academic functioning. It is important to look for the following characteristics:

• The child often loses his/her temper

• The child is defiant and doesn't obey rules/routines

• The child argues often with adults and peers

• The child seems to go out of his/her way to annoy others in very bothersome ways

• The child is often lacking accountability and blames others for inappropriate behaviors

• The child often seems angry, resentful, spiteful and vindictive

• The child is often prone to tantrums and will be non-compliant

• The child is constantly in trouble at school

DSM Criteria for Oppositional Defiant Disorder

A pattern of negativistic, hostile, and defiant behavior lasting at least 6 months, during which four (or more) of the following are present:

• often loses temper

• often argues with adults

• often actively defies or refuses to comply with adults' requests or rules

• often deliberately annoys people

• often blames others for his or her mistakes or misbehavior

• is often touchy or easily annoyed by others

• is often angry and resentful

• is often spiteful or vindictive

Note: Consider a criterion met only if the behavior occurs more frequently than is typically observed in individuals of comparable age and developmental level.

The disturbance in behavior causes clinically significant impairment in social, academic, or occupational functioning.

The behaviors do not occur exclusively during the course of a Psychotic or Mood Disorder.

Criteria are not met for Conduct Disorder, and, if the individual is age 18 years or older, criteria are not met for Antisocial Personality Disorder.

What causes someone to develop Oppositional Defiant Disorder?

There's no clear cause underpinning oppositional defiant disorder. Contributing causes may include:

• The child's inherent temperament

• The family's response to the child's style

• A genetic component that when coupled with certain environmental conditions, such as lack of supervision, poor quality daycare or family instability, increases the risk for ODD

• A biochemical or neurological factor

• The child's perception that he or she isn't getting enough of the parent's time and attention

What are the risk factors linked to Oppositional Defiant Disorder?

A number of factors play a role in the development of oppositional defiant disorder. ODD is a complex problem involving a variety of influences, circumstances and genetic components. No single factor alone causes ODD; however, the more risk factors a child has for ODD, the greater the risk for developing the disorder. Possible risk factors include:

• Having a parent with a mood or substance abuse disorder

• Being abused or neglected

• Harsh or inconsistent discipline

• Lack of supervision

• Poor relationship with one or both parents 

• Family instability such as multiple moves, changing schools frequently

• Parents with a history of ADHD, oppositional defiant disorder or conduct problems

• Financial problems in the family

• Peer rejection

• Exposure to violence

• Frequent changes in daycare providers

• Parents who have a troubled marriage or are divorced

In a significant proportion of cases, the adult condition of conduct disorder can be traced back to the presence of oppositional defiant disorder in childhood.

How is Oppositional Defiant Disorder diagnosed?

Psychiatric disorders are diagnosed by a review of medical history, ruling out other disorders, medical tests and ongoing observation. Parents may ask their pediatrician or family physician to refer them to a child and adolescent psychiatrist, who can diagnose and treat ODD and any coexisting psychiatric condition.

A child presenting with ODD symptoms should have a comprehensive evaluation. It is important to look for other disorders which may be present; such as, attention deficit hyperactive disorder (ADHD), learning disabilities, mood disorders (depression, bipolar disorder) and anxiety disorders. It may be difficult to improve the symptoms of ODD without treating the coexisting disorder. Some children with ODD may go on to develop conduct disorder.

Good documentation from both parents and teachers over a period of time about the child's behavior are critical for the practitioner. The onset of the pattern of behaviors often starts early from toddler/pre-school ages and is believed to effect both females and males. Some children will have both ODD and ADD, however, a child with just ODD does have the ability to sit still which isn't the case with the child with ADD or ADHD.

How is Oppositional Defiant Disorder treated?

There are relatively few studies done on the effective treatment for ODD. There is no one way to treat cases of ODD. Sometimes, medication is used to treat some of the symptoms, sometimes psychotherapy and or family therapy is used but more often than anything else, behavior modification is used. The earlier a form of consistent treatment is in place, the greater chance of success.

The best way to treat a child with ODD in and out of the classroom includes behavior management techniques, using a consistent approach to discipline and following through with positive reinforcement of appropriate behaviors. Be fair but be firm, give respect to get respect.

• Develop consistent behavior expectations.

• Communicate with parents so that strategies are consistent at home and school.

• Apply established consequences immediately, fairly and consistently.

• Establish a quiet cool off area.

• Teach self talk to relieve stress and anxiety.

• Provide a positive and encouraging classroom environment.

• Give praise for appropriate behavior and always provide timely feedback.

• Provide a 'cooling down' area/time out.

• Avoid confrontation and power struggles

Treatment of ODD may include: Parent Training Programs to help manage the child's behavior, Individual Psychotherapy to develop more effective anger management, Family Psychotherapy to improve communication, Cognitive Behavioral Therapy to assist problem solving and decrease negativity, and Social Skills Training to increase flexibility and improve frustration tolerance with peers. A child with ODD can be very difficult for parents. These parents need support and understanding. Parents can help their child with ODD in the following ways:

• Always build on the positives, give the child praise and positive reinforcement when he shows flexibility or cooperation.

• Take a time out or break if you are about to make the conflict with your child worse, not better. This is good modeling for your child. Support your child if he decides to take a time out to prevent overreacting.

• Pick your battles. Since the child with ODD has trouble avoiding power struggles, prioritize the things you want your child to do. If you give your child a time out in his room for misbehavior, don't add time for arguing. Say "your time will start when you go to your room."

• Set up reasonable, age appropriate limits with consequences that can be enforced consistently.

• Maintain interests other than your child with ODD, so that managing your child doesn't take all your time and energy. Try to work with and obtain support from the other adults (teachers, coaches, and spouse) dealing with your child.

• Manage your own stress with exercise and relaxation. Use respite care as needed.

Many children with ODD will respond to the positive parenting techniques. Consistency in rules and fair consequences should be practiced in the child's home. Punishments should not be overly harsh or inconsistently applied.

Appropriate behaviors should be modeled by the adults in the household. Abuse and neglect increase the chances that this condition will occur.

Successful treatment also requires committment and follow up on a regular basis from both parents and teachers. Expect setbacks from time-to-time but know that an ongoing consistent approach is in the best interest of the child.

When dealing with a child with Oppositional Defiant Disorder, sometimes parents are pushed to the brink - emotionally - and they consider sending the child to a "boot camp". According to the National Institutes of Health, punitive treatments like boot camps and "behavioral modification" schools which restrict contact with parents, and place the child among other disturbed children, can do more harm than good.

Sources:

• American Psychiatric Association
• Diagnostic and Statistical Manual of Mental Disorders (4th ed.)
• National Institutes of Health
• National Library of Medicine

Editor's Note: Julian Simon passed away in 1998.

Julian L. Simon teaches Business Administration at the University of Maryland and is a Senior Fellow at the Cato Institute. His main interest is the economic effects of population changes. The Ultimate Resource (now The Ultimate Resource 2) and Population Matters discuss trends in the United States and the world with respect to resources, environment, and population and the interactions between them. Simon concludes that there is no reason why material life on earth should not continue to improve, and that increasing population contributes to that improvement in the long run. Those popularly-written books develop ideas introduced in the l977 technical book, The Economics of Population Growth and supported by the 1984 The Resourceful Earth (edited with Herman Kahn), the 1986 Population and Economic Growth Theory, and the 1992 Population and Development in Poor Countries.

The 1989 The Economic Consequences of Immigration provides theory and data which lead to the conclusion that on balance immigrants to the United States make citizens richer rather than poorer.

His most recent books are the edited The State of Humanity (November, 1995), and The Ultimate Resource 2 (November, 1996).

Simon has also written on a variety of other subjects, including statistics, research methods, the economics of advertising, and managerial economics. His other books include How To Start and Operate A Mail Order Business, Basic Research Methods in Social Science, Issues in the Economics of Advertising, The Management of Advertising, Applied Managerial Economics, Patterns of Use of Books in Large Research Libraries (with H. H. Fussler), Effort, Opportunity, and Wealth, and Good Mood: The New Psychology for Overcoming Depression. He is the author of almost two hundred professional studies in technical journals, and he has written dozens of articles in such mass media as Atlantic Monthly, Readers Digest, New York Times, and The Wall Street Journal.

Simon worked in business and ran his own mail-order firm before becoming a professor, and has also been a naval officer. He is the inventor of the airline overbooking plan, in use since 1978 on all U.S. airlines, which solves the overbooking problem by calling for volunteers instead of bumping people involuntarily. He has dis- cussed his work on such programs as Today, Good Morning America, Firing Line, Wall Street Week, National Public Radio, national television in Great Britain, Canada, Australia, Brazil, Israel, and other foreign countries.

next: Living with Depression Homepage
~ back to Good Mood homepage
~ depression library articles
~ all articles on depression

Once upon a time, there was a Prince who was on a great quest.   He was seeking to find the Greatest Treasure Ever Known.   He knew that through finding this magnificent treasure he would be able to once again be united with his other half, with his Twin Soul - with the Princess whom he had been aching for forever - and they would get to go Home.

For many years, he had mistakenly believed that he had to find his Twin Soul in order to find this treasure.   Through the intervention of the Universal Force he was able to discover the Magical Secret Powers contained in the Principles of the Twelve Step Recovery Kingdom.   Using the power of those Principles, he was able to start the healing of his heart, mind, and soul that was necessary for him to start in the right direction to find his True Path.

He showed great courage and faith in his willingness to travel into the abyss of terrifying darkness that is the Realm of Repressed Emotional Demons and Subconscious Monsters

Because of his willingness to face the terror of his own inner grief and rage he was able to heal his wounded soul enough to get more clearly in touch with his Soul.

And it came to pass, that this Prince was given an assignment to go forth and teach others the Magic Powers of the Twelve Step Principles.   It was revealed to him that his quest would be successful if he dedicated his life to Spiritual Service in the name of the Greatest Treasure Ever Known.   Through this Spiritual Service he would serve himself by healing the Karma of Ancient Times to facilitate progress on his Sacred Journey of returning Home to the Greatest Treasure Ever Known.

This heroic chronicle has many chapters which will be related at another place and time.   The story told here is only one short chapter - but one of the most vital passages of this Sacred Journey. This is the Initiation into an inner sanctuary of the Greatest Treasure Ever Known which can only be accomplished by confronting and defeating that ferociously monstrous beast known as The Terror of Intimacy.

And of course, you have already guessed that the Greatest Treasure Ever Known is Love.

This is a chapter in the story of the Sacred Journey of this Prince in his quest to go Home to Love - and to be reunited with his Twin Soul.

next: The Emotional Dynamics of Dysfunctional Romantic Relationships

Someone with depression or mania may use drugs to take away the pain of uncontrollable mood changes associated with Bipolar Disorder (self-medication).

Which came first, the drugs or the mood swings? Too often, I have to figure this out. One child's parents or teachers sent him to see me because he had mood swings, verbal explosions and sleep problems. The drug screen comes back positive for cocaine and marijuana, and the garbage can search reveals empty wine bottles.

He has a problem with drugs and alcohol. He has mood swings. Drugs can cause mood swings. On the other hand, someone with depression or mania may use drugs to take away the pain of uncontrollable mood changes. Figuring out the answer often requires some expert detective work. He needs to open up and give me a detailed, honest history. His family members must also be frank about their own drug and psychiatric histories. No more secrets.

Adolescents may abuse drugs for a variety of reasons. These often include peer group pressure, parental drug and alcohol use, depression or just a desire for a new experience.

No adolescent should use alcohol or illegal drugs. However, there are certain individuals who are at increased risk. These individuals should be cautious even as adults. Some people can drink for quite a while before running into problems. Others have problems after that first drink. If close family members have had problems with drugs or alcohol, you are at increased risk. If you are depressed or already have trouble with mood swings, you are more likely to become addicted, and may have more trouble getting off drugs. There is evidence that drug use may cause an individual with a biological tendency toward bipolar disorder to develop the illness earlier in life. High school is difficult enough; you don't need this too. Talk to a trusted adult and get help early.

About the author: Carol Watkins, M.D. is Board-Certified in Child, Adolescent and Adult Psychiatry and in private practice in Baltimore, MD.

next: Parent Version of the Young Mania Rating Scale
~ bipolar disorder library
~ all bipolar disorder articles

LoveNote. . . To be capable of real love means becoming mature, with realistic expectations of the other person. It means accepting responsibility for our own happiness or unhappiness, and neither expecting the other person to make us happy nor blaming that person for our bad moods and frustrations. ~ John A. Sanford

Maturity, in general, is many things. Maturity in a love relationship is everything! First, it is the ability to base a decision about a love relationship on the big picture - the long haul. In general, it means being able to pass up the fun for the moment and select the course of action which will pay off later.

In a love relationship, it means being able to enjoy the instant gratification that comes with the romance of the moment while knowing the best is yet to be and being patient while you watch your love grow. It is knowing that by working together, the state of unconditional love will present itself in the relationship and will mature with time. It is knowing that you grow into a love relationship. It doesn't happen all at once. Mature love partners seek new ways to help each other grow.

One of the characteristics of infancy is the "I want it now" approach. Grown-up people can wait. And often they don't. Often they allow themselves to slip back into infancy so they can justify rushing into things.

Maturity is the ability to stick with a project or a situation until it is finished. It means doing whatever it takes to make the relationship be one you are proud to be in. The adult who is constantly changing jobs, relationships, and friends, is in a word. . . immature. They cannot stick it out because they have not grown up. Everything seems to turn sour after a while.

LoveNote. . . For a love relationship to mature, both partners must experience a deep feeling, a tacit belief, that there is something quite special about them which would never have happened had each not contributed to its creation. ~ Larry A. Bugen

Mature love partners have learned not to expect perfection in each other. They know that acceptance has its own reward. Each lover's differences test the other's capacity for acceptance, forgiveness and understanding. They never dance around issues. When necessary, they discuss their imperfections, lovingly, with care not to pass judgment with harmful words. Acceptance and tolerance hold hands in the presence of unconditional love.

Mature lovers -- lovers who love unconditionally -- develop a knack for sidestepping resentment and focusing on the good they see in one another. They have evolved to a higher level of understanding, one that transcends taking notice of the imperfections of the other.

Maturity is the capacity to face unpleasantness, frustration, discomfort and defeat without complaint or collapse. Mature love partners know they can't have everything their own way. They are able to defer to circumstances, to other people - and to time, when necessary.

Mature love partners permit each other the freedom to pursue their individual interests and friends without restriction. This is when trust presents itself. Mature love allows this level of separateness to bring lovers closer together. In this scenario separateness is perceived as a bond, not a wedge. It encourages love partners to celebrate their own uniqueness.

LoveNote. . . We can come to realize that mature love equals loving yourself for being what you are, and likewise loving another person for who they are. When we can feel such unconditional no-matter-how-you-act love, we have learned what I call mature love. Mature love allows you fully to be yourself with your loved one. ~ Bruce Fisher, Ed.D.

Maturity is the ability to live up to the responsibilities of a love relationship, and this means being dependable. It means keeping your word; it means living in your relationship like your word really means something. Dependability equates with personal integrity. This means no withholds. It means saying what needs to be said, with love. Do you mean what you say? Do you say what you mean?

The world is filled with people who can't be counted on, people who never seem to come through in the clutches, people who break promises and substitute alibis for performance. They make excuses. They show up late - or not at all. They are confused and disorganized. Their lives are a chaotic maze of unfinished business and uncommitted relationships. Oh, what a tangled web we weave.

LoveNote. . . Mature love offers us our most profound opportunity for regaining wholeness - not because our partners will fill all of our emptiness, but because we can use the embrace of a loving relationship to nurture ourselves toward greater maturation and ripening. ~ Larry A. Bugen

Maturity is the ability to make a decision and stand by it. Immature people spend their lives exploring endless possibilities and then do nothing. Action requires courage. There is no maturity without courage.

Maturity is the ability to harness your abilities and your energies and to do more than is expected in your relationships. The mature person refuses to settle for mediocrity. They would rather aim high and miss the mark than aim low and hit it.

In order to change our relationships with self and life we need to focus on the mental and emotional levels while consciously working to integrate Spiritual Truth into our personal inner process.

Mental Attitudes and Definitions (conscious and unconscious) create Perspective and Expectations which dictate Relationship.

"We learned about life as children and it is necessary to change the way we intellectually view life in order to stop being the victim of the old tapes. By looking at, becoming conscious of, our attitudes, definitions, and perspectives, we can start discerning what works for us and what does not work. We can then start making choices about whether our intellectual view of life is serving us - or if it is setting us up to be victims because we are expecting life to be something which it is not."

From Codependence: The Dance of Wounded Souls

It is kind of like the old joke about three blind men describing an elephant by touch. Each one of them is telling his own Truth, they just have a lousy perspective. Codependence is all about having a lousy relationship with life, with being human, because we have a lousy perspective on life as a human."

"The more we enlarge our perspective, the closer we get to the cause instead of just dealing with the symptoms. For example, the more we look at the dysfunction in our relationship with ourselves as human beings the more we can understand the dysfunction in our romantic relationships".

"As was stated earlier, our perspective of life dictates our relationship with life. This is true for all types of relationships. Our perspective of God dictates our relationship with God. Our perspective of what a man or a woman is, dictates our relationship with ourselves as men or women, and with other men and women. Our perspective of our emotions dictates our relationship with our own emotional process".

"Changing our perspectives is absolutely vital to the growth process".

"We need to be willing to let go of, surrender, our ego's definitions, belief systems, expectations, in order to change our perspective of life. Then we can make the choice to align our beliefs with the concept of an unconditionally Loving God-Force".

"The Truth is that the intellectual value systems, the attitudes, that we use in deciding what's right and wrong were not ours in the first place. We accepted on a subconscious and emotional level the values that were imposed on us as children. Even if we throw out those attitudes and beliefs intellectually as adults, they still dictate our emotional reactions. Even if, especially if, we live our lives rebelling against them. By going to either extreme accepting them without question or rejecting them without consideration we are giving power away".

"In order to stop giving our power away, to stop reacting out of our inner children, to stop setting ourselves up to be victims, so that we can start learning to trust and Love ourselves, we need to begin to practice discernment. Discernment is having the eyes to see, and the ears to hear - and the ability to feel the emotional energy that is Truth."

"We need to change our perspective and learn to practice discernment so that we can change our relationship with life and with ourselves. We need to be pro-active in our own process so that we can stop being the victims of the old tapes and start owning the power to co-create our lives in a healthy, Loving way."

"Recovery involves bringing to consciousness those beliefs and attitudes in our subconscious that are causing our dysfunctional reactions so that we can reprogram our ego defenses to allow us to live a healthy, fulfilling life instead of just surviving. So that we can own our power to make choices for ourselves about our beliefs and values instead of unconsciously reacting to the old tapes. Recovery is consciousness raising. It is en-light-en-ment - bringing the dysfunctional attitudes and beliefs out of the darkness of our subconscious into the Light of consciousness."

Emotional

"On an emotional level the dance of Recovery is owning and honoring the emotional wounds so that we can release the grief energy - the pain, rage, terror, and shame that is driving us".

"That shame is toxic and is not ours - it never was! We did nothing to be ashamed of we were just little kids. Just as our parents were little kids when they were wounded and shamed, and their parents before them, etc., etc. This is shame about being human that has been passed down from generation to generation".

"There is no blame here, there are no bad guys, only wounded souls and broken hearts and scrambled minds".

"Codependence is dysfunctional because it is emotionally dishonest. As long as we are reacting out of childhood wounds and old tapes we are not capable of being in the moment in an emotionally honest, age-appropriate way. It is necessary to be healing the childhood wounds and have an emotionally honest relationship with ourselves internally in order to respond to life honestly in the moment".

"When the role model of what a man is does not allow a man to cry or express fear, when the role model for what a woman is does not allow a woman to be angry or aggressive, that is emotional dishonesty. When the standards of a society deny the full range of the emotional spectrum and label certain emotions as negative - that is not only emotionally dishonest, it creates emotional disease. If a culture is based on emotional dishonesty, with role models that are not honest emotionally, then that culture is also emotionally dysfunctional - because the people of that society are set up to be emotionally dishonest and dysfunctional in getting their emotional needs met. What we traditionally have called normal parenting in this society is abusive - because it is emotionally dishonest".

"We live in emotionally dishonest and Spiritually hostile societies. Trying to get sane in an insane world is crazy-making!"

"We are set up to be emotionally dysfunctional by our role models, both parental and societal. We are taught to repress and distort our emotional process. We are trained to be emotionally dishonest when we are children".

"Attempting to suppress emotions is dysfunctional; it does not work. Emotions are energy: E-motion = energy in motion. It is supposed to be in motion, it was meant to flow. Emotions have a purpose, a very good reason to be even those emotions that feel uncomfortable. Fear is a warning, anger is for protection, tears are for cleansing and releasing. These are not negative emotional responses! We were taught to react negatively to them. It is our reaction that is dysfunctional and negative, not the emotion".

"Emotional honesty is absolutely vital to the health of the being. Denying, distorting, and blocking our emotions in reaction to false beliefs and dishonest attitudes causes emotional and mental disease. This emotional and mental disease causes physical, biological imbalance which produces physical disease".

"Codependence is a deadly and fatal disease because of emotional dishonesty and suppression. It breaks our hearts, scrambles our minds, and eventually kills our physical body vehicles because of the Spiritual dis-ease, because of our wounded souls".

"The key to healing our wounded souls is to get clear and honest in our emotional process. Until we can get clear and honest with our human emotional responses - until we change the twisted, distorted, negative perspectives and reactions to our human emotions that are a result of having been born into, and grown up in, a dysfunctional, emotionally repressive, Spiritually hostile environment - we cannot get clearly in touch with the level of emotional energy that is Truth. We cannot get clearly in touch with and reconnected to our Spiritual Self".

next: Co-dependents and Twelve Step Recovery

Descriptions of Codependence / Codependency

"Codependency at its core is a dysfunctional relationship with self.  We do not know how to Love our self in healthy ways because our parents did not know how to Love themselves.   We were raised in shame-based societies that taught us that there is something wrong with being human."

"This dance of Codependence is a dance of dysfunctional relationships -   of relationships that do not work to meet our needs.   That does not mean just romantic relationships, or family relationships, or even human relationships in general."

"Codependency a particularly vicious form of delayed stress syndrome.   Instead of being traumatized in a foreign country against an identified enemy during a war, as soldiers who have delayed stress are - we were traumatized in our sanctuaries by the people we loved the most."

"Codependency is a dysfunctional emotional and behavioral defense system. Traditionally, in this society, men have been taught that anger is the only acceptable emotion for a man to express, while women are taught that it is not acceptable for them to be angry.   If it is not ok to own all of our emotions then we can not know who we are as emotional beings."

"Codependency could more accurately be called outer or external dependence.     The condition of codependence is about giving power over our self esteem to outside sources/agencies or external manifestations.   We were taught to look outside of our selves to people, places, and things - to money, property and prestige, to determine if we have worth.   That causes us to put false gods before us.   We make money or achievement or popularity or material possessions or the "right" marriage the Higher Power that determines if we have worth."

Codependency Is ... 

There are a variety of ways to describe the condition of codependency.     Here are a few:

Codependency is: at it's core, a dysfunctional relationship with self.   We do not know how to Love our self in healthy ways because our parents did not know how to Love themselves.   We were raised in shame-based societies that taught us that there is something wrong with being human.   The messages we got often included that there is something wrong:   with making mistakes;   with not being perfect;   with being sexual; with being emotional; with being too fat or too thin or too tall or too short or too whatever.   As children we were taught to determine our worth in comparison with others.   If we were smarter than, prettier than, better grades than, faster than, etc. - then we were validated and got the message that we had worth.

In a codependent society everyone has to have someone to look down on in order to feel good about themselves.   And, conversely, there is always someone we can compare ourselves to that can cause us to not feel good enough.

Codependency could: more accurately be called outer or external dependence. The condition of codependence is about giving power over our self esteem to outside sources/agencies or external manifestations. We were taught to look outside of our selves to people, places, and things - to money, property and prestige, to determine if we have worth. That causes us to put false gods before us. We make money or achievement or popularity or material possessions or the "right" marriage the Higher Power that determines if we have worth.

We take our self-definition and self-worth from external manifestations of our own being so that looks or talent or intelligence becomes the Higher Power that we look to in determining if we have worth.

All outside and external conditions are temporary and could change in a moment. If we make a temporary condition our Higher Power we are setting ourselves up to be a victim - and, in blind devotion to that Higher Power we are pursuing, we often victimize other people on our way to proving we have worth.

(I believe that we are all ONE. That we all have equal worth as Spiritual Beings, as sons and daughters of the God-Force / Goddess Energy / Great Spirit - not because of any external manifestation or outside condition.)

Codependency is: a particularly vicious form of delayed stress syndrome. Instead of being traumatized in a foreign country against an identified enemy during a war, as soldiers who have delayed stress are - we were traumatized in our sanctuaries by the people we loved the most. Instead of having experienced that trauma for a year or two as a soldier might - we experienced it on a daily basis for 16 or 17 or 18 years. A soldier has to shut down emotionally in order to survive in a war zone. We had to shut down emotionally because we were surrounded by adults who were emotional cripples of one sort or another.

Codependency is: a dysfunctional emotional and behavioral defense system. When a society is emotionally dishonest, the people of that society are set up to be emotionally dysfunctional. In this society being emotional is described as falling apart, losing it, going to pieces, coming unglued, etc. (Other cultures give more permission to be emotional but then the emotions are usually expressed in ways that are out of balance to the extreme of letting the emotions control. The goal is a balance between emotional and mental - between the intuitive and the rational.)

Traditionally in this society men have been taught that anger is the only acceptable emotion for a man to express, while women are taught that it is not acceptable for them to be angry. If it is not ok to own all of our emotions then we can not know who we are as emotional beings. [Also traditionally, women are taught to be codependent - take their self-definition (including their names) and self-worth - from their relationships with men, while men are taught to be codependent on their work/career/ability to produce, and from their presumed superiority to women.]

Codependency is: a disease of a lost self. If we are not validated and affirmed for who we are in childhood then we don't believe we are worthy or lovable. Often we got validated and affirmed by one parent and put down by the other. When the parent who is "loving" does not protect us - or themselves - from the parent that is abusive, it is a betrayal that sets us up to have low self-esteem because the affirmation we received was invalidated right in our own homes.

And being affirmed for being who we are is very different than being affirmed for who our parents wanted us to be - if they could not see themselves clearly then they sure could not see us clearly. In order to survive, children adapt to whatever behavior will work best in helping them get their survival needs met. We then grow up to be adults who don't know our self and keep dancing the dance we learned as children.

A dysfunctional relationship is one that does not work to make us happy.

Codependency is about having a dysfunctional relationship with self. With our own bodies, minds, emotions, and spirits. With our own gender and sexuality. With being human. Because we have dysfunctional relationships internally we have dysfunctional relationships externally. We try to fill the hole we feel inside of our self with something or someone outside of us - it does not work.

Robert Burney is a codependence counselor, grief therapist, Spiritual teacher, and the author of a Joyously inspirational book of Mystical Spirituality -

Codependence: The Dance of Wounded Souls.

He has pioneered innovative, powerful, life-changing tools and techniques for emotional healing & Spiritual integration. On the Joy to You & Me web site he shares his writings on Spirituality, codependence/codependency, emotional healing, personal empowerment, Twelve Step Recovery, Metaphysical Truth, dysfunctional relationships, the New Age, alcoholism, inner child healing, grief processing, emotional incest, The Human Condition, soul mates, Karma, molecular biology, fear of intimacy, cultural dysfunction, Positive Affirmations and more. He shares quotes and long excerpts of his book, includes columns & articles he has written, and presents material from his next two books. (Joy2MeU Sitemap)

"Codependence deals with the core issues of the human dilemma. Codependence has grown out of the cause from which all symptoms arise. That cause is Spiritual dis-ease: not being at ease, at one with Spiritual Self."

"We are not sinful, shameful human creatures who have to somehow earn Spirituality. We are Spiritual Beings having a human experience."

The following are Joy2MeU recommended links.

There is a ton of information out there, and some sites have links to hundreds of other sites. I am going to try to keep this list fairly short but will add any quality sites as I become aware of them. I have not read everything on these sites so do not necessarily endorse everything - I recommend them because what I have seen has value.

(All of the links on this list open in a new browser window - so that you can explore and when you collapse the window you will be back at this page.)

New Links: *10-3-99*

Co-Dependents Anonymous - The official web site of CoDA. Includes a search for local meetings feature.

New Age Info is another huge resource resource supporting all areas of the New Age Community - including the Spiritual and Theosophical aspects of New Age, also Astrology, Psychic Sciences, Healing, Metaphysical Arts, Occult, Wicca, Magic, UFOs, and Myth.

The About.com guide to urban legends has an interesting page with an up-to-date list of ALL the hoaxes, Urban Legends, and other digital lies.

New Award: *9-25-99*

Our newest award comes from a web site called Recovery with Richard which is a Recovery site focused on NA (Narcotics Anonymous) (Previous Awards are toward the bottom of the page - Looks like I will have to add an awards page pretty soon.)

Links to sites about Codependence, Inner Child Healing, Dysfunctional Dynamics, and Recovery sites with info on those areas:

Dr Irene'sGet With The Program Self-Help & Info Resource - Wonderful site with lots of great info - "Understand the workings of verbal abuse, abusive, addictive and codependent relationships and how to fix them. Bulletin Board, Email questions, and more!"

Codependence Refuge Site - Great site - lots of valuable information on Codependence!

I highly recommend About.com(formerly The Mining Co.) - a directory, like Yahoo. Just check out their A - Z list of topics - it is mind blowing how much varied information is available.

There is a lot of good information about recovery - including codependence - at the Alcoholism section of the About.com and the host Buddy T. is constantly adding new info and links.

The About.com Healing Guide has added a page of Inner Child Net Links that has some really helpful information.

Recovery Online - Self-help recovery groups online and other recovery links. Very comprehensive list of links, including links to 44 different types of Twelve Step Anonymous groups - also to religious and secular groups as well as clubs, stores, treatment programs and periodicals.

Don't Fall Until You See the Whites of Their Lies - "An online autopsy of a dysfunctional family." Part of a large eclectic web site that contains lots of info on lots of topics. This part deals specifically with, and offers a lot of good info for, incest survivors.

Recovery Web - This website is devoted to personal recovery from addictions and trauma. Links, mental health resources and books for recovery. Recovery from addictions, trauma, Post Traumatic Stress Disorder, sexual abuse recovery, alcoholism, codependency, abusive relationships, chemical dependency and relationship recovery issues.

Co-Dependents Anonymous - The official web site of CoDA. Includes a search for local meetings feature.

Laura's "lee" - a beautiful, elaborate site with lots of great information (more info below.)

Links to sites about Healing and Spirituality:

Many Paths contains vast resources for personal and spiritual growth, and specializes in life changing events in people's lives with excerpts from the book, "Life and the Art of Change."

Self Improvement Online - A ton of resources for a multitude of self growth, self improvement topics.

Lisa's Place - Nice site with lots of good stuff including "Mom's Central Station" with thoughts, quotes, prayers and poems, and clubs and webrings for Mommies. Also Marriage, parenting, and children's Links.

New Age Info is another huge resource resource supporting all areas of the New Age Community - including the Spiritual and Theosophical aspects of New Age, also Astrology, Psychic Sciences, Healing, Metaphysical Arts, Occult, Wicca, Magic, UFOs, and Myth.

Links to other Special Sites:

The Hunger Site- this site is actually helping to feed the hungry of the world. There is a button to click on that results in the sites sponsors donating food to international relief efforts. Anyone can visit this site once every day and contribute to fighting world hunger.

back to: Joy2MeU Homepage

Networking is. . . using your creative talents to help others achieve their goals as you cultivate a network of people strategically positioned to support you in your goals. . . expecting nothing in return! ~ Larry James

This #1 business seminar will leave you with a powerful freedom to expand your personal and business network in partnership with others. You will discover your ability to generate long-lasting relationships, ready to act in concert with others, multiplying your own effectiveness.

One seminar participant reported a 38.6% increase in her business in just five short months as a result of Larry's networking seminar! Another reported a $1700 per month increase in income within four months! Too busy to network is too busy!

With the emphasis on personal development and career management, Larry clearly defines his unique version of networking and how to work the system for maximum benefits.

In this seminar you will learn. . .

• The "The 10 "Commitments" of Networking"
• The distinction between networking and prospecting
• How to network for a bigger bottom line!
• How to develop a network of support.
• How to create visibility and get known in a way that will put your career on "Fast Forward!"
• How to create an effective "30 second connection" or self introduction and why it must be a priority.
• How to get more mileage from your business card, plus numerous business card tips.
• How to break through the fear of self-promotion.
• How to commit the perfect "prime." Networking's magic question!
• How to successfully manage network mingling.
• How to network with people, groups of people and networking groups.
• How to put more fun and excitement in your life!
• How to connect with people who make a difference (with a little help from your friends!)
• Why it pays to talk to people in elevators! (One of Larry's personal experiences)
• Networking Do's and Taboos!

continue story below

This high-content seminar is more than a seminar about networking, it's a seminar designed to help people be the very best they can be both personally and professionally.

One participant said, "I thought I knew what networking was until I learned how to power connect the Larry James way!"

Available in a two or three hour seminar format or as a 45 minute keynote called, The 10 "Commitments" of Networking

More on this subject: Making Relationships Work: Personally and Professionally

next: Celebrate Love Homepage

Summary of research on effectiveness of herbal remedies and dietary supplements for treating mental health and health conditions.

Biologically Based Practices: An Overview

On this page

• Introduction
• Scope of the Research
• Summary of the Major Threads of Evidence
• References
• For More Information

Introduction

Definition of Scope of Field
The CAM domain of biologically based practices includes, but is not limited to, botanicals, animal-derived extracts, vitamins, minerals, fatty acids, mino acids, proteins, prebiotics and probiotics, whole diets, and functional foods.

Dietary supplements are a subset of this CAM domain. In the Dietary Supplement Health and Education Act (DSHEA) of 1994, Congress defined a dietary supplement as a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and hey can occur in many forms, such as tablets, capsules, softgels, gelcaps, liquids, or powders.¹

The Food and Drug Administration (FDA) regulates dietary supplements differently than drug products (either prescription or over-the-counter). First, drugs are required to follow defined good manufacturing practices (GMPs). The FDA is developing GMPs for dietary supplements. However, until they are issued, companies must follow existing manufacturing requirements for foods. Second, drug products must be approved by the FDA as safe and efficacious prior to marketing. In contrast, manufacturers of dietary supplements are responsible for ensuring that their products are safe. While the FDA monitors adverse effects after dietary supplement products are on the market, newly marketed dietary supplements are not subject to premarket approval or a specific postmarket surveillance period. Third, while DSHEA requires companies to substantiate claims of benefit, citation of existing literature is considered sufficient to validate such claims. Manufacturers are not required, as they are for drugs, to submit such substantiation data to the FDA; instead, it is the Federal Trade Commission that has primary responsibility for monitoring dietary supplements for truth in advertising. A 2004 Institute of Medicine (IOM) report on the safety of dietary supplements recommends a framework for cost-effective and science-based evaluation by the FDA.²

History and Demographic Use of Biologically Based Practices
Dietary supplements reflect some of humankind's first attempts to improve the human condition. The personal effects of the mummified prehistoric "Ice Man" found in the Italian Alps in 1991 included medicinal herbs. By the Middle Ages, thousands of botanical products had been inventoried for their medicinal effects. Many of these, including digitalis and quinine, form the basis of modern drugs.³

Interest in and use of dietary supplements have grown considerably in the past two decades. Consumers state that their primary reason for using herbal supplements is to promote overall health and wellness, but they also report using supplements to improve performance and energy, to treat and prevent illnesses (e.g., colds and flu), and to alleviate depression. According to a 2002 national survey on Americans' use of CAM, use of supplements may be more frequent among Americans who have one or more health problems, who have specific diseases such as breast cancer, who consume high amounts of alcohol, or who are obese.⁴ Supplement use differs by ethnicity and across income strata. On average, users tend to be women, older, better educated, live in one- or two-person households, have slightly higher incomes, and live in metropolitan areas.

Use of vitamin and mineral supplements, a subset of dietary supplements, by the U.S. population has been a growing trend since the 1970s. National surveys--such as the Third National Health and Nutrition Examination Survey (NHANES III, 1988-1994); NHANES, 1999-2000; and the 1987 and 1992 National Health Interview Surveys--indicate that 40 to 46 percent of Americans reported taking at least one vitamin or mineral supplement at some time within the month surveyed.5-8 Data from national surveys collected before the enactment of DSHEA in 1994, however, may not reflect current supplement consumption patterns.

In 2002, sales of dietary supplements increased to an estimated $18.7 billion per year, with herbs/botanical supplements accounting for an estimated $4.3 billion in sales.⁹ Consumers consider the proposed benefits of herbal supplements less believable than those of vitamins and minerals. From 2001 to 2003, sales of herbs experienced negative growth. This was attributed to consumers' withering confidence and confusion. Within the herbal category, however, formulas led single herbs in sales; products became increasingly condition-specific; and sales of women's products actually increased by approximately 25 percent.¹⁰

References

In contrast to dietary supplements, functional foods are components of the usual diet that may have biologically active components (e.g., polyphenols, phytoestrogens, fish oils, carotenoids) that may provide health benefits beyond basic nutrition. Examples of functional foods include soy, nuts, chocolate, and cranberries. These foods' bioactive constituents are appearing with increasing frequency as ingredients in dietary supplements. Functional foods are marketed directly to consumers. Sales increased from $11.3 billion in 1995 to about $16.2 billion in 1999. Unlike dietary supplements, functional foods may claim specific health benefits.¹¹ The Nutrition Labeling and Education Act (NLEA) of 1990 delineates the permissible labeling of these foods for health claims.^a

^aInformation on NLEA and the scientific review of health claims for conventional foods and dietary supplements is available at vm.cfsan.fda.gov/~dms/ssaguide.html#foot1.

Whole diet therapy has become an accepted practice for some health conditions. However, the popularity of unproven diets, especially for the treatment of obesity, has risen to a new level as the prevalence of obesity and metabolic syndrome among Americans has increased and traditional exercise and diet "prescriptions" have failed. Popular diets today include the Atkins, Zone, and Ornish diets, Sugar Busters, and others. The range of macronutrient distributions of these popular diets is very wide. The proliferation of diet books is phenomenal. Recently, food producers and restaurants have been targeting their marketing messages to reflect commercially successful low-carbohydrate diets.

Public need for information about dietary supplements, functional foods, and selected strict dietary regimens has driven research on the effectiveness and safety of these interventions and the dissemination of research findings.

Scope of the Research

Range of Studies
Research on dietary supplements spans the spectrum of basic to clinical research and includes ethnobotanical investigations, analytical research, and method development/validation, as well as bioavailability, pharmacokinetic, and pharmacodynamic studies. However, the basic and preclinical research is better delineated for supplements composed of single chemical constituents (e.g., vitamins and minerals) than for the more complex products (e.g., botanical extracts). There is an abundance of clinical research for all types of dietary supplements. Most of this research involves small phase II studies.

The literature on functional foods is vast and growing; it includes clinical trials, animal studies, experimental in vitro laboratory studies, and epidemiological studies.12 Much of the current evidence for functional foods is preliminary or not based on well-designed trials. However, the foundational evidence gained through other types of investigations is significant for some functional foods and their "health-promoting" constituents. The strongest evidence for effectiveness is that developed in accordance with the NLEA guidelines for preapproved health claims (e.g., oat bran or psyllium).

An important gap in knowledge concerns the role of diet composition in energy balance. Popular diets low in carbohydrates have been purported to enhance weight loss. Shorter-term clinical studies show equivocal results. In addition, mechanisms by which popular diets affect energy balance, if at all, are not well understood. Although numerous animal studies assessing the impact of diet composition on appetite and body weight have been conducted, these studies have been limited by availability and use of well-defined and standardized diets. The research on weight loss is more abundant than that on weight maintenance.

Primary Challenges
Many clinical studies of dietary supplements are flawed because of inadequate sample size, poor design, limited preliminary dosing data, lack of blinding even when feasible, and/or failure to incorporate objective or standardized outcome instruments. In addition, the lack of reliable data on the absorption, disposition, metabolism, and excretion of these entities in living systems has complicated the selection of products to be used in clinical trials.^13,14 This is more problematic for complex preparations (e.g., botanicals) than for products composed of single chemical moieties (e.g., zinc).

The lack of consistent and reliable botanical products represents a formidable challenge both in clinical trials and in basic research. Most have not been sufficiently characterized or standardized for the conduct of clinical trials capable of adequately demonstrating safety or efficacy, or predicting that similarly prepared products would also be safe and effective in wider public use. Consequently, obtaining sufficient quantities of well-characterized products for evaluation in clinical trials would be advantageous. Several issues regarding the choice of clinical trial material require special attention, for example:

• Influences of climate and soil

• Use of different parts of the plants

• Use of different cultivars and species

• Optimal growing, harvesting, and storage conditions

• Use of the whole extract or a specific fraction

• Method of extraction

• Chemical standardization of the product

• Bioavailability of the formulation

• Dose and length of administration

References

Some nonbotanical dietary supplements, such as vitamins, carnitine, glucosamine, and melatonin, are single chemical entities. Botanicals, however, are complex mixtures. Their putative active ingredients may be identified, but are rarely known for certain. Usually, there is more than one of these ingredients, often dozens. When active compounds are unknown, it is necessary to identify marker or reference compounds, even though they may be unrelated to biological effects. Qualitative and quantitative determinations of the active and marker compounds, as well as the presence of product contaminants, can be assessed by capillary electrophoresis, gas chromatography, liquid chromatography-mass spectrometry, gas chromatography-mass spectrometry, high-performance liquid chromatography, and liquid chromatography-multidimensional nuclear magnetic resonance. Fingerprinting techniques can map out the spectrum of compounds in a plant extract. New applications of older techniques and new analytical methods continue to be developed and validated. However, there remains a paucity of analytical tools that are precise, accurate, specific, and robust. Steps are currently being taken to apply molecular tools, such as DNA fingerprinting, to verify species in products, while transient expression systems, and microarray and proteomic analyses, are beginning to be used to define the cellular and biological activities of dietary supplements.

Particular attention should be paid to the issues of complex botanicals and clinical dosing. Quality control of complex botanicals is difficult, but must be accomplished, because it is not ethical to administer an unknown product to patients. The use of a suboptimal dose that is safe but ineffective does not serve the larger goals of NCCAM, the CAM community, or public health. Although the trial would indicate only that the tested dose of the intervention was ineffective, the public might conclude that all doses of the intervention are ineffective, and patients would be denied a possible benefit from the intervention. Overdosing, on the other hand, might produce unnecessary adverse effects. Phase I/II studies should be conducted first to determine the safety of various doses, and the optimal dose should then be tested in a phase III trial. As a result, maximum benefit would be seen in the trial; also, any negative result would be definitive.

To a great extent, the difference between a dietary supplement and a drug lies in the use of the agent, not in the nature of the agent itself. If an herb, vitamin, mineral, or amino acid is used to resolve a nutritional deficiency or to improve or sustain the structure or function of the body, the agent is considered a dietary supplement. If the agent is used to diagnose, prevent, treat, or cure a disease, the agent is considered a drug. This distinction is key when the FDA determines whether proposed research on a product requires an investigational new drug (IND) exemption. If the proposed investigation of a lawfully marketed botanical dietary supplement is to study its effects on diseases (i.e., to cure, treat, mitigate, prevent, or diagnose a disease and its associated symptoms), then the supplement is more likely to be subject to IND requirements. The FDA has worked with NCCAM to provide direction to investigators and recently created a Botanical Review Team to ensure consistent interpretation of the document Guidance for Industry--Botanical Drug Products.^b Such FDA guidance is currently unavailable for other products (e.g., probiotics).

^bSee www.fda.gov/cder/guidance/index.htm under "Chemistry."

Similarly, little attention has been paid to the quality of probiotics. Quality issues for probiotic supplements may include:

• Viability of bacteria in the product

• Types and titer of bacteria in the product

• Stability of different strains under different storage conditions and in different product formats

• Enteric protection of the product

Therefore, for optimal studies, documentation of the type of bacteria (genus and species), potency (number of viable bacteria per dose), purity (presence of contaminating or ineffective microorganisms), and disintegration properties must be provided for any strain to be considered for use as a probiotic product. Speciation of the bacteria must be established by means of the most current, valid methodology.

Many of the challenges identified for research on dietary supplements, including issues of composition and characterization, are applicable to research on functional foods and whole diets. In addition, challenges of popular diet research include adherence to the protocol for longer-term studies, inability to blind participants to intervention assignment, and efficacy versus effectiveness.

Summary of the Major Threads of Evidence

Over the past few decades, thousands of studies of various dietary supplements have been performed. To date, however, no single supplement has been proven effective in a compelling way. Nevertheless, there are several supplements for which early studies yielded positive, or at least encouraging, data. Good sources of information on some of them can be found at the Natural Medicines Comprehensive Database and a number of National Institutes of Health (NIH) Web sites. The NIH Office of Dietary Supplements (ODS) annually publishes a bibliography of resources on significant advances in dietary supplement research. Finally, the ClinicalTrials.gov database lists all NIH-supported clinical studies of dietary supplements that are actively accruing patients.c

^cThe Natural Medicines Comprehensive Database is accessible at www.naturaldatabase.com. Related NIH Web sites include nccam.nih.gov/health, ods.od.nih.gov, and www3.cancer.gov/occaml. The ODS annual bibliographies can be found at http://ods.od.nih.gov/Research/Annual_Bibliographies.aspx. ClinicalTrials.gov can be accessed at www.clinicaltrials.gov.

For a few dietary supplements, data have been deemed sufficient to warrant large-scale trials. For example, multicenter trials have concluded or are in progress on ginkgo (Ginkgo biloba) for prevention of dementia, glucosamine hydrochloride and chondroitin sulfate for osteoarthritis of the knee, saw palmetto (Serenoa repens)/African plum (Prunus africana) for benign prostatic hypertrophy, vitamin E/selenium for prevention of prostate cancer, shark cartilage for lung cancer, and St. John's wort (Hypericum perforatum) for major and minor depression. The results of one of the depression studies showed that St. John's wort is no more effective for treating major depression of moderate severity than placebo. Other studies of this herb, including its possible value in treatment of minor depression, are under way.

Reviews of the data regarding some dietary supplements have been conducted, including some by the members of the Cochrane Collaboration.d The Agency for Healthcare Research and Quality has produced a number of evidence-based reviews of dietary supplements, including garlic, antioxidants, milk thistle, omega-3 fatty acids, ephedra, and S-adenosyl-L-methionine (SAMe). The following are examples of findings from some of these reviews:

^dThe Cochrane Database is accessible at www.cochrane.org.

• Analysis of the literature shows generally disappointing results for the efficacy of antioxidant supplementation (vitamins C and E, and coenzyme Q10) to prevent or treat cancer. Because this finding contrasts with the benefits reported from observational studies, additional research is needed to understand why these two sources of evidence disagree.¹⁵

• Similarly, the literature on the roles of the antioxidants vitamins C and E and coenzyme Q10 for cardiovascular disease also shows discordance between observational and experimental data. Therefore, the thrust of new research into antioxidants and cardiovascular disease should be randomized trials.¹⁶

• ---

  
  

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  The clinical efficacy of milk thistle to improve liver function is not clearly established. Interpretation of the evidence is hampered by poor study methods or poor quality of reporting in publications. Possible benefit has been shown most frequently, but not consistently, for improvement in aminotransferase levels. Liver function tests are overwhelmingly the most common outcome measure studied. Available evidence is not sufficient to suggest whether milk thistle is more effective for some liver diseases than others. Available evidence does suggest that milk thistle is associated with few, and generally minor, adverse effects. Despite substantial in vitro and animal research, the mechanism of action of milk thistle is not well defined and may be multifactorial.¹⁷

• The review of SAMe for the treatment of depression, osteoarthritis, and liver disease identified a number of promising areas for future research. For example, it would be helpful to conduct (1) additional review studies, studies elucidating the pharmacology of SAMe, and clinical trials; (2) studies that would lead to a better understanding of the risk-benefit ratio of SAMe compared to that of conventional therapy; (3) good dose-escalation studies using the oral formulation of SAMe for depression, osteoarthritis, or liver disease; and (4) larger clinical trials once the efficacy of the most effective oral dose of SAMe has been demonstrated.¹⁸

• Two high-quality randomized controlled trials provide good evidence that cranberry juice may decrease the number of symptomatic urinary tract infections in women over a 12-month period. It is not clear if it is effective in other groups. The fact that a large number of women dropped out of these studies indicates that cranberry juice may not be acceptable over long periods of time. Finally, the optimal dosage or method of administration of cranberry products (e.g., juice or tablets) is not clear.¹⁹

There has been some study of other popular dietary supplements. For example, valerian is an herb often consumed as a tea for improved sleep, and melatonin is a pineal hormone touted for the same purpose.^20-22 Small studies suggest that these two supplements may relieve insomnia, and there may be little harm in a trial course of either one. Echinacea has long been taken to treat or prevent colds; other supplements currently used for colds include zinc lozenges and high doses of vitamin C. As yet, only moderate-sized studies have been conducted with echinacea or zinc, and their outcomes have been conflicting.^23-26 Large trials of high doses of oral vitamin C showed little, if any, benefit in preventing or treating the common cold.^27-30

Because of widespread use, often for centuries, and because the products are "natural," many people assume dietary supplements to be inert or at least innocuous. Yet, recent studies show clearly that interactions between these products and drugs do occur. For example, the active ingredients in ginkgo extract are reported to have antioxidant properties and to inhibit platelet aggregation.³¹ Several cases have been reported of increased bleeding associated with ginkgo's use with drugs that have anticoagulant or antiplatelet effects. St. John's wort induces a broad range of enzymes that metabolize drugs and transport them out of the body. It has been shown to interact with a number of drugs that serve as substrates for the cytochrome P450 CYP3A enzymes responsible for metabolism of approximately 60 percent of current pharmaceutical agents.^32,33 Other dietary supplements shown to potentiate or interfere with prescription drugs include garlic, glucosamine, ginseng (Panax), saw palmetto, soy, valerian, and yohimbe.¹⁴

References

In addition to interacting with other agents, some herbal supplements can be toxic. Misidentification, contamination, and adulteration may contribute to some of the toxicities. But other toxicities may result from the products themselves. For example, in 2001, extracts of kava were associated with fulminant liver failure.^34-36 More recently, the FDA banned the sale of ephedra after it was shown to be associated with an increased risk of adverse events.^37,38

Given the large number of dietary supplement ingredients; that dietary supplements are assumed to be safe in general; and that the FDA is unlikely to have the resources to evaluate each ingredient uniformly, a 2004 Institute of Medicine report offers a framework for prioritizing evaluation of supplement safety.² Among the report's recommendations are:

• All federally supported research on dietary supplements conducted to assess efficacy should be required to include the collection and reporting of all data on the safety of the ingredient under study.

• The development of effective working relationships and partnerships between the FDA and NIH should continue.

• The FDA and NIH should establish clear guidelines for cooperative efforts on high-priority safety issues related to the use of dietary supplements.

The FDA lists warnings and safety information on dietary supplements (e.g., androstenedione, aristolochic acid, comfrey, kava, and PC SPES) as they become available.^e

^eSee www.cfsan.fda.gov/~dms/ds-warn.html.

next: Energy Medicine: An Overview

References

1. Dietary Supplement Health and Education Act of 1994. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Web site. Accessed at www.cfsan.fda.gov/~dms/supplmnt.html on October 1, 2004.
2. Dietary Supplements: A Framework for Evaluating Safety. National Academies Press Web site. Accessed at www.books.nap.edu/books/0309091101/html/R1.html on October 8, 2004.
3. Goldman P. Herbal medicines today and the roots of modern pharmacology. Annals of Internal Medicine. 2001;135(8):594-600.
4. Barnes P, Powell-Griner E, McFann K, Nahin R. Complementary and alternative medicine use among adults: United States, 2002. CDC Advance Data Report #343. 2004.
5. Ervin RB, Wright JD, Kennedy-Stephenson J. Use of dietary supplements in the United States, 1988-94. Vital and Health Statistics Series 11, Data from the National Health Survey. 1999;(244):1-14.
6. Radimer K, Bindewald B, Hughes J, et al. Dietary supplement use by US adults: data from the National Health and Nutrition Examination Survey, 1999-2000. American Journal of Epidemiology. 2004;160(4):339-349.
7. Slesinski MJ, Subar AF, Kahle LL. Trends in use of vitamin and mineral supplements in the United States: the 1987 and 1992 National Health Interview Surveys. Journal of the American Dietetic Association. 1995;95(8):921-923.
8. Subar AF, Block G. Use of vitamin and mineral supplements: demographics and amounts of nutrients consumed. The 1987 Health Interview Survey. American Journal of Epidemiology. 1990;132(6):1091-1101.
9. U.S. Nutrition Industry. Top 70 Supplements 1997-2001. Nutrition Business Journal Web site. Accessed at www.nutritionbusiness.com on October 1, 2004.
10. Madley-Wright R. Herbs and botanicals overview: sales continue to suffer as withering confidence and confusion reign supreme amongst consumers and companies for a little light at the end of this tunnel (Industry overview). Nutraceuticals World. 2003;6(7).
11. Claims That Can Be Made for Conventional Foods and Dietary Supplements. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Web site. Accessed at www.cfsan.fda.gov/~dms/hclaims.html on October 12, 2004.
12. Hasler CM, Bloch AS, Thomson CA, et al. Position of the American Dietetic Association: functional foods. Journal of the American Dietetic Association. 2004;104(5):814-826.
13. Berman JD, Straus SE. Implementing a research agenda for complementary and alternative medicine. Annual Review of Medicine. 2004;55:239-254.
14. De Smet PA. Herbal remedies. New England Journal of Medicine. 2002;347(25):2046-2056.
15. Agency for Healthcare Research and Quality. Effect of the Supplemental Use of Antioxidants Vitamin C, Vitamin E, and Coenzyme Q10 for the Prevention and Treatment of Cancer. Evidence Report/Technology Assessment no. 75. Rockville, MD: Agency for Healthcare Research and Quality; 2003. AHRQ Publication Number 04-E002.
16. Agency for Healthcare Research and Quality. Effect of Supplemental Antioxidants Vitamin C, Vitamin E, and Coenzyme Q10 for the Prevention and Treatment of Cardiovascular Disease. Evidence Report/Technology Assessment no. 83. Rockville, MD: Agency for Healthcare Research and Quality; 2003. AHRQ publication No. 03-E043.
17. Agency for Healthcare Research and Quality. Milk Thistle: Effects on Liver Disease and Cirrhosis and Clinical Adverse Effects. Evidence Report/Technology Assessment no. 21. Rockville, MD: Agency for Healthcare Research and Quality; 2000. AHRQ Publication No. 01-E025.
18. Agency for Healthcare Research and Quality. S-Adenosyl-L-Methionine (SAMe) for Depression, Osteoarthritis, and Liver Disease. Evidence Report/Technology Assessment no. 64. Rockville, MD: Agency for Healthcare Research and Quality; 2002. AHRQ Publication No. 02-E034.
19. Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database of Systematic Reviews. 2004;(2):CD001321. Accessed at www.cochrane.org on October 1, 2004.
20. Donath F, Quispe S, Diefenbach K, et al. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry. 2000;33(2):47-53.
21. Ziegler G, Ploch M, Miettinen-Baumann A, et al. Efficacy and tolerability of valerian extract LI 156 compared with oxazepam in the treatment of non-organic insomnia--a randomized, double-blind, comparative clinical study. European Journal of Medical Research. 2002;7(11):480-486.
22. Kunz D, Mahlberg R, Muller C, et al. Melatonin in patients with reduced REM sleep duration: two randomized controlled trials. Journal of Clinical Endocrinology and Metabolism. 2004;89(1):128-134.
23. Giles JT, Palat CT III, Chien SH, et al. Evaluation of echinacea for treatment of the common cold. Pharmacotherapy. 2000;20(6):690-697.
24. Melchart D, Linde K, Fischer P, et al. Echinacea for preventing and treating the common cold. Cochrane Database of Systematic Reviews. 2003;(3):CD000530. Accessed at www.cochrane.org on October 1, 2004.
25. Taylor JA, Weber W, Standish L, et al. Efficacy and safety of echinacea in treating upper respiratory tract infections in children: a randomized controlled trial. Journal of the American Medical Association. 2003;290(21):2824-2830.
26. Marshall I. Zinc for the common cold. Cochrane Database of Systematic Reviews. 2004;(3):CD001364. Accessed at www.cochrane.org on October 1, 2004.
27. Audera C, Patulny RV, Sander BH, et al. Mega-dose vitamin C in treatment of the common cold: a randomised controlled trial. Medical Journal of Australia. 2001;175(7):359-362.
28. Coulehan JL, Eberhard S, Kapner L, et al. Vitamin C and acute illness in Navajo school children. New England Journal of Medicine. 1976;295(18):973-977.
29. Douglas RM, Chalker EB, Treacy B. Vitamin C for preventing and treating the common cold. Cochrane Database of Systematic Reviews. 2004;(3):CD000980. Accessed at www.cochrane.org on October 1, 2004.
30. Pitt HA, Costrini AM. Vitamin C prophylaxis in marine recruits. Journal of the American Medical Association. 1979;241(9):908-911.
31. Foster S. Herbal medicine: an introduction for pharmacists. Part II. Categories of herbal medicine. National Association of Retail Druggists Journal. 1996;(10):127-144.
32. Yue QY, Bergquist C, Gerden B. Safety of St. John's wort (Hypericum perforatum). Lancet. 2000;355(9203):576-577.
33. Willson TM, Kliewer SA. PXR, CAR and drug metabolism. Nature Reviews Drug Discovery. 2002;1(4):259-266.
34. Anke J, Ramzan I. Kava hepatotoxicity: Are we any closer to the truth? Planta Medica. 2004;70(3):193-196.
35. Centers for Disease Control and Prevention. Hepatic toxicity possibly associated with kava-containing products--United States, Germany, and Switzerland, 1999-2002. MMWR Morbidity and Mortality Weekly Report. 2002;51(47):1065-1067.
36. Gow PJ, Connelly NJ, Hill RL, et al. Fatal fulminant hepatic failure induced by a natural therapy containing kava. Medical Journal of Australia. 2003;178(9):442-443.
37. U.S. Food and Drug Administration. FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products. U.S. Food and Drug Administration Web site. Accessed at www.cfsan.fda.gov/~lrd/fpephed6.html on October 6, 2004.
38. U.S. Food and Drug Administration. Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk. 21 CFR Part 119. February 11, 2004. Top

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NCCAM Clearinghouse

The NCCAM Clearinghouse provides information on CAM and on NCCAM, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

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About This Series

"Biologically Based Practices: An Overview" is one of five background reports on the major areas of complementary and alternative medicine (CAM).

• Biologically Based Practices: An Overview

• Energy Medicine: An Overview

• Manipulative and Body-Based Practices: An Overview

• Mind-Body Medicine: An Overview

• Whole Medical Systems: An Overview

The series was prepared as part of the National Center for Complementary and Alternative Medicine's (NCCAM's) strategic planning efforts for the years 2005 to 2009. These brief reports should not be viewed as comprehensive or definitive reviews. Rather, they are intended to provide a sense of the overarching research challenges and opportunities in particular CAM approaches. For further information on any of the therapies in this report, contact the NCCAM Clearinghouse.

NCCAM has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your primary health care provider. We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy in this information is not an endorsement by NCCAM.

next: Energy Medicine: An Overview