CLINICAL TRIALS AUTISM, ANXIETY, INSOMNIA
"What is the right dosage for Vitamin B6, DMG, and Other nutrients Useful in Autism?", Rimland, Bernard Phd., Autism Research Review International, 1997;11(4):3.
Summary: Vitamin B6 was found helpful in almost half of all autistic children and adults included in 18 consecutive studies between 1965 and 1996. The average amount of B6 found beneficial in the author's own studies was approximately 8 mg. of vitamin B6 per pound of body weight per day. There is a rare harmful side effect from excessive vitamin B6 which is peripheral neuropathy, which presents as a tingling and numbness in the hands. Three to 4 mg. of magnesium per pound of body weight enhances the effect of B6 and protects against a possible n6 induced magnesium deficiency. Dimethylglycine usually comes in tablets of 125 mg. each. Young children tolerate DMG well. One 5 year old boy needed 16 tablets daily. Folic acid at 250 ug per pound of body weight per day, to possibly benefit autism. In 1991, some clinicians gave 8000 mg/day of vitamin C to adolescents and to adult autistic individuals with significant improvements.
"Melatonin: Researchers Say Hormone Markedly Improves Sleep, Behavior of Developmentally Disabled Children", Autism Research Review, 1994;8(3);1-2.
Summary: British and Canadian researchers conducted a double-blind, placebo-controlled study of 15 children with varying disabilities which included autism. these subjects had severe sleep problems. All the children improved while taking melatonin and some had dramatic changes. the improvement was not only in their sleep patterns, but in their behavior. Melatonin in doses ranged from 2 to 10 mg. The Author states that he would try vitamin B6 and magnesium and/or DMG before trying melatonin.
ANXIETY-
"Herbal Anxiolytics Have Novel Mechanisms," Sherman, C, Family Practice News, July 15,1998:30.
ARTICLE REVIEW:
Kava extract is prescribed widely in Germany for anxiety. Valerian is very popular in Europe. It has been approved in Germany for treating anxiety and insomnia. Passion flower is widely used as a sedative, hypnotic and antispasmodic agent.
"Extracts of Kava Kava Can calm Anxiety Disorders," Family Practice News, March 15, 2000Clin Psychopharmacol, 2000;20(1):84-89.
Summary: In 377 subjects evaluated from 7 randomized, placebo-controlled trials, the use of oral kava extract at doses from 150 to400 mg (60-240 mg of kavapyrones), 2-3 times daily, over 1 to 24 weeks showed few adverse side effects. Results showed a significant reduction in anxiety symptoms after taking oral kava compared with placebo.
ARTICLE REVIEW
"Kava-Kava Extract WS Versu Placebo in Anxiety Disorders-A Randomized Placebo-Controlled 25-Week Outpatient Trial," Volz,H.-P., and Keiser, M., Pharmacopsychiatr., 1997;30:1-5.
Summary: In evaluating 101 patients suffering from anxiety of non-psychotic origins in a 25-week multicenter, randomized, placebo-controlled trial using WS 1490, a special extract of kava-kava, there was a significant superiority of this substance starting from week 8 on, compared to placebo. The kava-kava was given in a lipophilic extract containing 90-110 mg. of dry extract (+70 mg. of kava-lactones) per capsule 3 times daily. There were minimal adverse consequences. These data suggest that this particular kava-kava extract is an alternative to tricyclic antidepressants and benzodiazepines in anxiety disorders. WS 1490 has proven long-term efficacy with none of the tolerance problems of these drugs.
ARTICLE REVIEW
"Experiences With L-Tryptophan in a Child and Family Psychiatric Department," Hoyse SE, J Int Med Res,1982;10;157-159.
Summary: In a review of 25 cases of children of varying types of anxiety and behavior disturbances who were between 10 and 16 years of age, with the majority between 14 and 16 years of age, 500 mg of tryptophan was given at dose of 1 or 2 tablets, 2-3 times daily. Results showed improvements in symptoms, especially with anxiety, which were related to behavior problems in school.
INSOMNIA-
"L-Tryptophan: A Possible Natural Hypnotic Substance, "Hartmann E, JAMA, December 23-30,1974;230(12):1680-1681.
Summary: In 10 subjects, 1-15 grams of L-tryptophan produced a significant reduction in sleep latency.
Note: L-tryptophan is a precursor to serotonin and has been found to be useful in the treatment of depression.
"The treatment of sleep disorders with melatonin", Jan, J.E., et al, Developmental Medicine and Child Neurology,1994;36:97-107.
Summary: The article reviews the general role of melatonin in the treatment of sleep disorders in 15 case histories. Melatonin plays an important role in the induction of sleep. Melatonin is produced by the pinealocytes in the pineal gland....Most of the 15 children who were case studies were neurologically multiply disabled with severe, chronic sleep disorders. They were treated with 2 to 10 mg. of oral melatonin given at bedtime. Sleep disturbances include fragmented sleep patterns, delayed sleep onset and non-specific sleep disturbance of unclear etiology. All of these patients had failed conventional treatment. There were no side effects to melatonin therapy and there was a positive benefit, even though not complete in all cases. The authors note that sleep disorders in children who are multiply disabled and are very often neglected and difficult to treat. The study was very rewarding because of the surprisingly good outcome.
ARTICLE; "Herbal Remedies in Psychiatric Practice," Wong AHC, et al, Arch Gen Psychiatry, November, 1998;55:1033-1044.
Summary: Black Cohosh is used for menopausal symptoms at 40-200 mg. daily. Hops is used for sleeping 1 ml. of liquid extract; lemon balm is used in a range of 1-4 grams daily for anxiety and insomnia. Passion flower is used for anxiety and insomnia, 3 times daily at 1 ml of the liquid extract; Skullcap is given 3 times daily at 2-4 ml. of liquid extract for insomnia, anxiety and seizures, kava kava at 100-200 kavalactones daily for insomnia, anxiety, and insomnia. Valerian is taken at a dose of 2-3 grams daily for anxiety. St. John's Wort is taken at as standardized extract of .3% hypericum 300-900 mg. daily for mild and intermediate depressions. German chamomille can be used for anxiety and insomnia. .025% capsicum cream is useful in postherpetic neuralgia pain. .075% capsicum cream is safe and effective for diabetic neuropathy. Siberian Ginseng is the traditional Chinese medicine used for more than 400 years to help with fatigue and stress and to improve endurance. The chaste tree (Vitex Agnus) has been used medicinally for the treatment of premenstrual syndrome, menopause, and menstrual irregularity.
ARTICLE: "Long-Chain Polyunsaturated Fatty Acids in Children With Attention-Deficit Hyperactivity Disorder," Burgess JR, Stevens L, et al, Am J Clin Nutr, 2000:71(Suppl):327S-330S.
Summary: Studies have shown ADHD subjects have reported symptoms indicative of essential fatty acid deficiency and lower proportions of DHA (found in omega-3 fatty acids). Subjects with lower compositions of omega-3 fatty acids had significantly more behavioral problems, temper tantrums, and learning, health and sleep problems than did those with higher proportions of omega-3 fatty acids.
ARTICLE: "Supplementation with flax oil and vitamin C improves the outcome of Attention Deficit Hyperactivity Disorder (ADHD)," Joshi K Lad S et al, Proglastins Leukot Essent fatty Acids,2005;Nov 25.
Summary: In this pilot study, children diagnosed with attention deficit hyperactivity disorder (ADHD) were found to benefit from supplementation with flax oil and vitamin C. Children experienced a reduction total hyperactivity scores, based on the ADHD rating scale.
ARTICLE: "Mentat in Hyperactivity and Attention Deficit Disorders-A Double-Blind Placebo-Controlled Study," Chavda KB, Ind J Psychiatry/Probe April-June 1991;30(3):227-232. (ARYUVEDIC MEDICINE)
Summary: Mentat is a complex of herbs derived from Aryuvedic medicine which is useful in improving memory and has a tranquilizing effect on mental disorders. In 49 boys and 11 girls who were between 3 and 16 years in age with a history of behavioral disor4ders ranging from 3 to 15 years duration, patients were randomly assigned to one of 2 groups to receive either Mentat as a syrup a 1 tsp, 3 times daily, or placebo over a 12 week period. The dose was gradually increased to 2 tsp, 3 times daily, for both the Mentat and placebo diluted group. Evaluation using the Yale Inventory scale at week 0,6, and 12 showed significant improvement following the Mentat treatment compared with placebo and the pretreatment period. Improvement was seen in hyperactivity, attention span, impulsiveness, socialized and aggressive conduct disorders, negative effects and academics. There was some improvement in the placebo group from 0-6 weeks, but no further change from 6-12 weeks.
ARTICLE: "Inositol Treatment of Obsessive-Compulsive Disorder," Fux, Medel, et al, American Journal of Psychiatry, September, 1996;153(9):1219-1221.
Summary: Thirteen patients with obsessive-compulsive disorder completed a double-blind, controlled crossover trial of 18/g per day of inositol or placebo for 6 weeks. Those who took the inositol had significantly lower scores on the Yale-Brown Obsessive Compulsive Scale compared to those taking a placebo. The authors concluded that inositol is effective in depression, panic, post traumatic stress disorder, and obsessive compulsive disorder, which are disorders responsive to serotonin reuptake inhibitors.
ARTICLE: "DMG and Obsessive-Compulsive Behaviors," Autism Research Review International, 1996;10(3);7.
Summary: There have been a number of case reports noting that dimethylglycine has benefited patients with obsessive compulsive disorder. One such case was a 26 year old autistic individual who compulsively squeezed things very hard when frustrated. DMG did not improve speech but it brought noticeable reduction in his compulsive squeezing. Another autistic individual compulsively vomited which lead to very low weight. Drugs were ineffective. The mother put the individual on DMG and the compulsive vomiting stopped, as well as did other symptoms of autism. The mother stated, "Tim is still doing very well on three 125 mg tablets daily. He started out at 5 but became so hyper so they cut the dose to 3 tablets, and improvement was more than anyone hoped for." The editor notes that in some cases DMG produces hyperactivity. Folic acid appears to help neutralize this effect at one or two 800 IU tablets with each DMG tablet.
ARTICLE: "Controlled Trial of Zinc Supplementation in Anorexia Nervosa"' Birmingham, Carl L., et al, International Journal of Eating Disorders, 1994;15(3):251-255.
Summary: This was a randomized, double-blind, placebo controlled trial of 35 female anorexia nervosa patients who either received 100 mg. of zinc gluconate or a placebo. The rate of increase in body mass index of the inc supplemented group of 16 patients was twice that of the placebo group of 19 patients. The difference was statistically significant and the authors concluded that zinc should be considered. Zinc is present in large amounts in those areas of the brain involved in food seeking, weight regulation and serotonin metabolism.
ARTICLE REVIEW: Numerous studies have found that fish oil (EPA/DHA) have beneficial effects in post-partum depression.