1. What do we know about alternative treatments of epilepsy" What do we know about alternative treatments of epilepsy" Enrique Feoli MD North East Regional Epilepsy 2014

2. Alternative Treatments Complementary and Alternative medicines (CAM) Complementary and Alternative medicines (CAM) Non conventional therapies Non conventional therapies

3. Herbs and Epilepsy CAM

4. Complimentary and Alternative CAM CAM On the rise On the rise 42% US 42% US 65% Germany 65% Germany 20% UK 20% UK 1/6 people taking Rx also take Herbal 1/6 people taking Rx also take Herbal > 50 y.o.: 2.66 herbals and 2.26 Rx > 50 y.o.: 2.66 herbals and 2.26 Rx

5. CAM < 40% share their use with Drs. < 40% share their use with Drs. Legislation requiring regulation/licensing of Herbs in Germany, France, Sweden, Australia. Legislation requiring regulation/licensing of Herbs in Germany, France, Sweden, Australia. In US the Dietary Supplement Health and Education Act of 1994 removed these products from FDA jurisdiction In US the Dietary Supplement Health and Education Act of 1994 removed these products from FDA jurisdiction

6. Herbs for Epilepsy Valerian root Valerian root Skullcap Skullcap European Mistletoe European Mistletoe Marijuana Marijuana Black cohosh Black cohosh Lobelia Lobelia Kava Kava Hyssop Hyssop Blue vervain Blue vervain Yarrow Yarrow Geranium Geranium Kelp Kelp Bupleurum Bupleurum Passion flower Passion flower Carline thistle Carline thistle Elderberry Elderberry Mugwort Mugwort Lady’s slipper Lady’s slipper Aloe Aloe Betony Betony European Peony European Peony Ginseng Ginseng Flax seed oil Flax seed oil Ginger Ginger Linden Linden Chrysanthemum Chrysanthemum Forskolin Forskolin Behen Behen Burning bush Burning bush Calotropis Calotropis Gotu Kola Gotu Kola Groundsel Groundsel Lily of the Valley Lily of the Valley Tree of Heaven Tree of Heaven Yew Yew

7. How often do people take herbs? Overall use of complementary and alternative medicines (CAM) in U.S. 1990-1997. Herbal product use increased 4x Herbal product use increased 4x In 1997, adults - 33 million office visits regarding herbal products & high-dose vitamins; spent ~$8 billion In 1997, adults - 33 million office visits regarding herbal products & high-dose vitamins; spent ~$8 billion In 1997, ~15 million adults took prescription medications with herbs and/or high-dose vitamins In 1997, ~15 million adults took prescription medications with herbs and/or high-dose vitamins Eisenberg et al. JAMA 1998;280:1569-75.

8. How often do people take herbs? HerbU.S. sales ($ millions) Gingko biloba150 Echinacea70 Garlic50 Ginseng40 Soy35 Saw palmetto30 St. John’s wort30 Valerian16 Top 10 selling herbs and dietary supplements: 2002

9. How often do persons with epilepsy take herbs? U.S. and England studies: Up to 1 in 3 persons with epilepsy use CAM Up to 1 in 3 persons with epilepsy use CAM Most do not discuss their CAM use with doctors Most do not discuss their CAM use with doctors Herbs taken include ginseng, St. John’s wort, melatonin, gingko biloba, garlic and black cohosh Herbs taken include ginseng, St. John’s wort, melatonin, gingko biloba, garlic and black cohosh Treat seizures ( 70%) Treat seizures ( 70%) Peebles et al. Epilepsy Behav 2000;1:74-7 Easterford et al. Epilepsy Behav 2005;6:59-62

10. Federal regulation of herbs Herbal products are classified by the government as dietary supplements. Herbal products are classified by the government as dietary supplements. Dietary supplements are regulated by the 1994 Dietary Supplement and Health Education Act (DSHEA); prescription drugs - much more rigorous requirements of the Federal Food, Drug, and Cosmetic Act. Dietary supplements are regulated by the 1994 Dietary Supplement and Health Education Act (DSHEA); prescription drugs - much more rigorous requirements of the Federal Food, Drug, and Cosmetic Act.

11. Federal standards by DSHEA Claim -- an effect on bodily structure or function, not against a specific disease. Claim -- an effect on bodily structure or function, not against a specific disease. Label must include a disclaimer that FDA has not evaluated the product Label must include a disclaimer that FDA has not evaluated the product

12. Federal regulation of herbs Not required to be produced under Good Manufacturing Process standards, like drugs Not required to be produced under Good Manufacturing Process standards, like drugs No government agency (eg, FDA) independently verifies the quality/production No government agency (eg, FDA) independently verifies the quality/production Could be contaminated with microbes, pesticides, toxic metals, or adulterated (eg, herbs or drugs) Could be contaminated with microbes, pesticides, toxic metals, or adulterated (eg, herbs or drugs) Potency and amount per pill/capsule may vary significantly within the same bottle or from batch to batch, or from one branded product to another Potency and amount per pill/capsule may vary significantly within the same bottle or from batch to batch, or from one branded product to another

13. Federal regulation of herbs Standards set forth by the DSHEA: Manufacturers are responsible for the truthfulness of labeling claims Manufacturers are responsible for the truthfulness of labeling claims No government agency independently reviews and verifies the claims and supporting evidence No government agency independently reviews and verifies the claims and supporting evidence Only manufacturers control product quality and verify safety Only manufacturers control product quality and verify safety

14. Standardization How much of the active ingredient? How much of the active ingredient? For example, bottle says “carbamazepine 200 mg” For example, bottle says “carbamazepine 200 mg” This is a major problem for herbal products because This is a major problem for herbal products because the active ingredient (s) are usually not known the active ingredient (s) are usually not known the amount of the assumed active ingredient may vary from pill to pill and product to product the amount of the assumed active ingredient may vary from pill to pill and product to product it is usually not possible to measure levels in the blood to guide dosage it is usually not possible to measure levels in the blood to guide dosage

15. ? The active ingredient St. John's wort standardized by its content of hypericin (typically to 0.3% hypericin) St. John's wort standardized by its content of hypericin (typically to 0.3% hypericin) Hypericin not confirmed as the active ingredient Hypericin not confirmed as the active ingredient

16. Case 40 y/o woman with epilepsy well controlled on CBZ Was feeling depressed and began to take St John’s wort. She had multiple recurrent seizures and came to the office for a follow up. She did disclose that she began a over he counter tx. Problem; St john’s W, decreases the effectiveness of CBZ You wonder whether St. John’s wort could affect your carbamazepine or birth control pill, and whether it is safe and actually helps depression

17. Herbal Anticonvulsants: Mechanisms Sedative effect/improved sleep: Valerian, Kava, Lobelia, passion flower. Sedative effect/improved sleep: Valerian, Kava, Lobelia, passion flower. Increase in brain GABA/GABA receptors (Valerian, Kava) Increase in brain GABA/GABA receptors (Valerian, Kava) Agonist of benzodiazepine receptors (Passion flower). Agonist of benzodiazepine receptors (Passion flower). Antioxidants (TJ-960) Antioxidants (TJ-960)

18. Herb/AED Interactions Don’t use Valerian or Kava with alcohol, barbiturates, benzos- sedation/coma. Don’t use Valerian or Kava with alcohol, barbiturates, benzos- sedation/coma. Hemorrhagic complications with Gingko and St. John’s wort. Hemorrhagic complications with Gingko and St. John’s wort. St. John’s wort can lower carbamazepine levels. St. John’s wort can lower carbamazepine levels. Shankapulshpi (Ayurvedic formula) decreases 1/2 life of phenytoin and decreases its efficacy. Shankapulshpi (Ayurvedic formula) decreases 1/2 life of phenytoin and decreases its efficacy. Tell your physician about herb use; anticipate potential for interactions. Tell your physician about herb use; anticipate potential for interactions.

19. Herbs and Seizure Medications Increase Side effects Increase Side effects Valerian Root Valerian Root Kava Kava Kava Kava Passion Flower Passion Flower Chamomile Chamomile

20. Herbs that cause Seizures Kava Kava: GTC from toxicity and withdrawal. Kava Kava: GTC from toxicity and withdrawal. Marijuana: intoxication or withdrawal. Marijuana: intoxication or withdrawal. Skullcap: confusion and convulsions with high doses. Skullcap: confusion and convulsions with high doses. Ma Huang: has ephedrine, pseudoephedrine, lowers threshold. Ma Huang: has ephedrine, pseudoephedrine, lowers threshold. Gamolenic acid lowers seizure threshold: evening primrose oil, borage (starflower). Gamolenic acid lowers seizure threshold: evening primrose oil, borage (starflower). Goldenseal: hydrastine lowers threshold. Goldenseal: hydrastine lowers threshold. Ginseng: lowers threshold. Ginseng: lowers threshold. Ginkgo biloba: GTCs reported. Neurotoxin 4’-o- methylpyridoxine. Ginkgo biloba: GTCs reported. Neurotoxin 4’-o- methylpyridoxine. Thujone-containing herbs: wormwood, sage; lower threshold. Thujone-containing herbs: wormwood, sage; lower threshold.

21. Herbs and seizures Worsen seizures Worsen seizures Ephedra Ephedra Ma Huang Ma Huang Mate Mate Guarana Guarana Borage oil Borage oil ? Ginkgo ? Ginkgo ? Ginseng ? Ginseng

22. Bad Effects on Serum Concentration of AED’s (Herb- Drug interactions) P450 enzymes: Effects on Serum Concentration of AED’s (Herb- Drug interactions) P450 enzymes: St. John’s wort St. John’s wort Garlic Garlic Echinacea Echinacea Pine bark extract Pine bark extract Pygenol Pygenol Milk thistle Milk thistle American hellebore American hellebore Gingko Gingko Mugwort Mugwort Pipissewa Pipissewa

23. Side-Effects of Herbs Natural doesn’t equal safe! Natural doesn’t equal safe! Herbs and herbal preparations contain many compounds. Herbs and herbal preparations contain many compounds. Black cohosh, Valerian, green tea have tannins - can affect absorption of Ca, Cu, Fe, Mg. Black cohosh, Valerian, green tea have tannins - can affect absorption of Ca, Cu, Fe, Mg. Black cohosh can cause miscarriage via uterine stimulation. Black cohosh can cause miscarriage via uterine stimulation. Lobelia - respiratory paralysis and death. Lobelia - respiratory paralysis and death.

25. Samuels et al, 2008

27. What are the Ingredients? What are the Ingredients? Epi-Still is a 100% herbal formula and contains the following ingredients in therapeutic dosage: Passion flower, Skullcap, Cicuta virosa (30C), and Cuprum metallicum (30C). Epi-Still is a 100% herbal formula and contains the following ingredients in therapeutic dosage: Passion flower, Skullcap, Cicuta virosa (30C), and Cuprum metallicum (30C). Hello. I was just wondering if anyone has heard of the herbal medication for seizures called Epistill? I

28. Synergy 02 More than 70 minerals More than 70 minerals More than 18 amino acids More than 18 amino acids Plant source silica Plant source silica Active ingredient? Active ingredient? Is it just water and minerals? Is it just water and minerals? No trails/tests indicating that No trails/tests indicating that is useful is useful

29. Take Home In any given person herbs may be helpful, but in most they likely are not In any given person herbs may be helpful, but in most they likely are not In any given person herbs may worsen epilepsy In any given person herbs may worsen epilepsy Herbs definitely can effect AED levels Herbs definitely can effect AED levels No good studies No good studies Communication between doctors and patients is crucial Communication between doctors and patients is crucial Perspective Perspective

30. Part II Non Conventional Therapies Non Conventional Therapies Yoga Yoga Biofeedback Biofeedback Aromatherapy Aromatherapy Acupuncture Acupuncture

31. Non Conventional Therapies Yoga Yoga Biofeedback Biofeedback Aromatherapy Aromatherapy Acupuncture Acupuncture

32. How effective are alternative or complementary approaches to epilepsy? No scientific research in epilepsy and there is very little evidence of their effectiveness No scientific research in epilepsy and there is very little evidence of their effectiveness Some people who have tried complementary treatments have felt that these have helped their epilepsy and improved their quality of life. Some people who have tried complementary treatments have felt that these have helped their epilepsy and improved their quality of life. Certainly, reducing stress can reduce seizures in some people, and or improve quality of life. Certainly, reducing stress can reduce seizures in some people, and or improve quality of life.

33. Can relaxation, yoga control epilepsy? Some people have found that yoga or meditation helps them prevent stress-induced seizures and improves their quality of life Some people have found that yoga or meditation helps them prevent stress-induced seizures and improves their quality of life

34. Can epilepsy be controlled by acupuncture? Can epilepsy be controlled by acupuncture? the goal is to bring the person's health into a better mental, physical and emotional balance. the goal is to bring the person's health into a better mental, physical and emotional balance. Acupuncture has been used in patients with epilepsy with mixed results. Acupuncture has been used in patients with epilepsy with mixed results.

35. Can epilepsy be controlled using aromatherapy? Aromatherapy uses pure aromatic oils from plants for stimulation and relaxation and to aid the healing process. Dr. Tim Betts, a British researcher, has had some success using oils on patients with epilepsy who can predict an imminent seizure. Aromatherapy uses pure aromatic oils from plants for stimulation and relaxation and to aid the healing process. Dr. Tim Betts, a British researcher, has had some success using oils on patients with epilepsy who can predict an imminent seizure.

36. Can epilepsy be controlled through biofeedback? Biofeedback for epilepsy uses EEG machines to help people identify and alter their own seizure- related brain activity. The person with epilepsy is trained over time to use relaxation or other biofeedback techniques to generate a more normalized brain wave pattern, which may in turn reduce their seizures. Biofeedback for epilepsy uses EEG machines to help people identify and alter their own seizure- related brain activity. The person with epilepsy is trained over time to use relaxation or other biofeedback techniques to generate a more normalized brain wave pattern, which may in turn reduce their seizures.

37. Take Home There are no scientific studies that support the use of non conventional therapies to control seizures. There are no scientific studies that support the use of non conventional therapies to control seizures. Some has shown to improve quality of life (yoga) Some has shown to improve quality of life (yoga) Discuss with your doctor before starting any non conventional therapies Discuss with your doctor before starting any non conventional therapies

38. 38 Thank you for coming! We would like to hear from you Please submit your surveys

39. 39 Please join us 4:15-4:45 Bergen/Ramapo Room Safe and effective core exercises for epilepsy patients Renata Joy