Herbs, germs, and oils: What we know and what we don t. Chelly Dykes, MD

Transcription

1 Herbs, germs, and oils: What we know and what we don t Chelly Dykes, MD

2 What is the cause of IBD? Genetics IBD Immune system Environment

3 What are the outcomes we want? Symptom control Safe Effective (clinical and histologic remission) Few side effects Dosing strategy vs

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5 Why talk about alternative therapies? Herbal preparations are common Patients want to try anything to improve symptoms and heal active disease Our best medicines (biologics) may work in up to 70-80% of patients Wong et al. JPGN 2009.

6 Help us to:

7 We know: Science doesn t know everything Why we sleep How many planets are in the solar system (poor Pluto the scientists can change their minds) How to beat solitaire consistently How many species of animals exist The length of the US coastline Clearly we have work to do

8 But we do know: The highest ideal of cure is the speedy, gentle, and enduring restoration of health by the most trustworthy and least harmful way. Samuel Hahnemann, founder of homeopathy As to diseases, make a habit of two things to help, or at least, to do no harm. Hippocrates

9 Definitions Complementary or alternative medicine (CAM): any treatment (not restricted to herbals) used with or instead of traditional Western medicine If a non-mainstream practice is used together with conventional medicine, it s considered complementary. If a non-mainstream practice is used in place of conventional medicine, it s considered alternative.

10 Definitions Integrative medicine: bringing conventional and complementary approaches together in a coordinated way Herbal: plant or plant part used for its scent, flavor, or therapeutic properties

11 Natural products Botanicals, vitamins, good bacteria Vitamins and minerals Herbals Essential oils Probiotics Natural products are often sold as supplements

12 Mind and body approaches Movement based Yoga Tai chi Mind based Mediation Relaxation techniques Hypnotherapy Physical Chiropractic and osteopathic manipulation Massage therapy Acupuncture Twice as many adults practicing yoga in the last 10 years Variable amount of research depending on the practice and the specific condition

13 HERBALS AND OILS

14 Traditional drugs Herbals and supplements Prescription or OTC OTC only Monitoring through FDA Drug contents accurate and on label Ongoing sideeffect/monitoring Can have good or bad effects Manufacturer in charge of monitoring Label may not reflect contents No planned monitoring Can have good or bad effects

15 How to decide what to talk about Scientific articles Seems reasonable but would discuss with your doctor Selling stuff Seems reasonable but would discuss with your doctor Selling stuff

16 Which herbs are being talked about? Website 1: Vitamins Lemongrass Turmeric Green Tea Website 2: Fish oil Aloe Vera Chamomile Website 3: Withania Wormwood Psyllium seeds

17 In the medical literature: herbs Very few actual studies of herbals More information about: Indian frankincense (Boswellia serrata) Wormwood (Artemisia absinthium) Indian echinacea (Andrographis paniculata) Turmeric (Curcumin) Less information about: Aloe vera Cannabis Germinated barley, Myrrhinil intest, super evening primrose wheat grass juice

18 Traditional Medicine: How Do Doctors Know If Something Works Clinical trial Blinded vs open label Placebo vs experimental drug Standard drug vs experimental drug Large numbers of patients What is the difference compared to placebo? Were there safety concerns? How do you dose it?

19 Boswellia serrata (Indian frankincense) How does it work? anti-inflammatory and immune system effects in laboratory studies For IBD: Small studies (CD and UC) Short study duration, patient drop-out, patient variation, poor study design Seemed to help UC patients in these small studies compared to sulfasalazine Gerhardt et al, Z Gastroenterol 2001 Gupta et al, Planta Med 2001 Gupta et al, Eur J Med Res 1997 Holtmeier et al, IBD 2011 $6.25-$58 per bottle Available as oil, ground, capsule

20 Boswellia serrata (Indian frankincense) Interactions/side-effects: Processed in the liver May interact with many other medications (particularly our common GI meds) Results: short follow-up, seems similar to ASA or placebo Conclusion: Likely doesn t hurt, may help, many possible drug interactions

21 Artemisia absinthium (wormwood) How does it work? May work against the same chemical as infliximab and adalimumab Fun fact: absinthe and vermouth are wormwood derived For IBD (CD): May help IBD symptoms as well as mood Problems: small numbers of patients studied, short study duration no blinding $2.74-$49 Available as oil, ground herb, capsule Krebs et al, Phytomedicine 2010 Omer et al, Phytomedicine 2007

22 Artemisia absinthium (wormwood) Interactions/side-effects: One component (thujone) linked to seizures, mood changes, kidney failure) Allergic reaction for ragweed sensitive people Results: May help, but side-effects may be substantial Conclusion: may help, but side-effects and under-regulation of herbals make it potentially unsafe

23 Andrographis paniculata (Indian echinacea) How does it work? Idea that it boosts the immune system Possibly effective for the common cold For IBD: May help symptoms (has been looked at for 8 weeks active symptoms only) Problems: short duration, unclear randomization procedure or compliance monitoring Tang et al, Aliement Pharmacol Ther 2011 Sandborn et al, Am J Gastro 2013 Available as oil, tea, crushed, capsule. $5-$29

24 Andrographis paniculata (Indian echinacea) Interactions/side-effects: few short-term side-effects. Not likely to interact with most drugs Results: May help short term symptoms (reported use for a variety of other conditions) While it may be helpful, one analysis found that 10% had no Echinacea at all, and up to 50% did not have the amount labeled Conclusion: May be beneficial, but quality of supplements is a problem. Long-term use is unclear

25 Turmeric (Curcumin) How does it work? Common spice, used in foods and as dyes in make-up or foods Claims that it reduces inflammation (most have been unfounded) For IBD: Two studies ranging 8 weeks to 6 months, better in one study no difference in the other Compared to traditional aminosalicilyates Interactions/side-effects: Results: Dose, route (oral or enema), patient selection is unknown. Conclusion: Need more information but appears safe Hanai et al, Int J Mol Med 2004 Singla et al, J Crohns and Colitis 2014 $1.99-$74.95 Usually capsules, also teas, extracts Often combined with Boswellia, ginger

26 On Google Shopping.* Keep out of the reach of children. NOTE: If you have a Form 1: Turmeric extract Curcumin 1000mg medical Helps condition, fight against free are radical pregnant, damage** A lactating, natural supporter trying of the to conceive, liver & gastrointestinal under the system** age of Maximum 18, or potency taking medications, one capsule consult Form 2: your Curcumin healthcare Powerful professional antioxidant (no before dose using given) this Helps maintain cardiovascular health joints extensive scientific product. Curcumin C3 Complex is the registered research on Curcumin has demonstrated its potent antioxidant trademark properties Through of Sabinsa its antioxidant Corporation. mechanisms, *These Curcumin statements supports colon health, exerts neuroprotective activity and helps maintain a healthy have cardiovascular not been system evaluated by the Food and Drug Administration. This product is not intended to diagnose, Form 3: Curcumin 95, 500mg caps treat, Curcumin cure, or 95 helps prevent support any antioxidant disease status Plus 20 other kind

27 How does it work? Cannabis (marijuana) Too many legal restrictions to have good studies available currently Cannabinoids (extracts) are available commercially For IBD: use is common (in up to 20% of adults) for symptom control (particularly pain and appetite) Symptoms seem better but use is a strong predictor of surgery Lal et al. Eur Journal Gastro Hepatology 2011 Stor et al. IBD 2014

28 Cannabis (marijuana) Interactions/side-effects: increased appetite mood changes unclear interactions quality issues depending on supplier Results: Dose, specific compounds that are beneficial remain unstudied Conclusion: Medical use is frequently discussed, seems to improve symptoms but may actually make disease worse

29 Cannabis use in Ohio Medical marijuana legal as of September 2016 Dispensaries and prescribing physicians will not be available for another 1-2 years Have to have a qualifying condition (there are 20) IBD is on the list

30 Cautions There may be a role for some of these herbals As of now, safety and dosing information is unavailable Toxicities and interactions may be underreported due to lack of regulation Companies selling these products do not have to guarantee their quality

31 GERMS

32 Intestinal health and dysbiosis

33 What affects the bacteria in the gut in the first place? Type of birth (c-section vs vaginal) Diet (even during the first years of life) Breastfed or formula fed Antibiotic exposure Surgeries Smoking Obesity

34 Goal of bacterial therapy in IBD Targeted antibiotics Probiotics Prebiotics/diet Fecal transplant

35 Bacterial types differ by diagnosis Haberman et al, JCI 2014

36 Commonly used antibiotics Crohn Disease Metronidazole (Flagyl) and ciprofloxacin Common for perianal disease May help with symptom control for some patients Drawbacks: Issues with resistance, changes large number of bacteria (not just detrimental bacteria), long-term neuropathy Rifaximin (Xifaxan) Not absorbed into the body May be beneficial toward the induction/maintenance of remission Drawbacks: expensive, unclear which patients get the most benefit

37 Commonly used antibiotics Ulcerative colitis Recent suggestion that regimens targeted to fusobacterium may be beneficial Amoxicillin, metronidazole, tetracycline for 14 days Turner et al: 9/15 children with refractory disease improved Oral vancomycin may have a beneficial role in some patients Some antibiotics may trigger flare Turner et al, J of Crohns and Colitis 2014.

38 Antibiotics Not standard of care for either UC or CD, conflicting results, long-term side-effects Sometimes tried for difficult to manage cases No way to target specific bacterial groups Short courses may be worth considering for some patients

39 Probiotics Viewed as beneficial bacteria to replace harmful bacteria Many different strains Lactobacillus Saccromyces E. Coli Nissle VSL #3- probiotic of 8 strains Bifidobacterium breve, B. longum, B. infantis, Lactobacillus acidophilus, L. plantarum, L. paracasei, L. bulgaricus, and Streptococcus thermophilus 8 examples (there are >40) $5-$80

40 Probiotics UC VSL#3 may be recommended for mild patients intolerant to ASA, or as a second therapy for sicker patients Pouchitis: VSL#3 effective for treatment and prophylaxis CD less convincing evidence but still may be beneficial Strains studied: E. Coli Nissle, Lactobacillus GG, S Boulardi Turnet et al. JPGN 2012

41 Diet and bacterial composition More associated with animal fat and saturated fat consumption (Western diet) More associated with carbohydrate consumption (agrarian societies) Wu et al. Science 2011

42 Temporary bacterial shifts with change in diet Shifts within 24 hours of starting a diet At the end of 10 days, there were changes but no real change in types of bacteria Large shifts suggestive of longer term dietary changes Wu et al. Science 2011

43 Diet and Inflammation in IBD Enteral nutrition protocol (80-90% liquid diet) induces remission in up to 80% of patients with Crohn Disease Siblings of people with IBD often have similar bacteria (because similar diet) without the inflammation We do not yet have a diet identified that can sustain long-term changes to inflammation in IBD (especially as a stand alone therapy) Similar to FODMAP diet for IBS, dietary changes might cause shifts in bacteria that affect symptoms

44 What foods should I eat? Crohn Disease: enteral nutrition protocol No specific diet can reduce all of IBD symptoms or inflammation (yet) Coming soon: N of 1 trial looking at specific carbohydrate diet In studies of diet, effects on bacterial composition are reflective of long-term dietary changes For symptom control: Avoid processed foods Increase fiber in diet Limit red meat intake Follow a Mediterranean diet Eat a variety of foods to avoid nutritional deficiencies

45 Fecal transplant: Re-POOPulating the gut Repopulation of healthy bacteria from a well individual to an unwell one Used for recurrent C. Diff refractory to medication Being trialed for IBD treatment Growing number of protocols, modes of delivery, doses, preparations Results: Variable results for UC and CD There may be patient and donor factors which play a role in outcomes Variable protocols So far: experimental and not yet approved except under experimental protocols

46 Sources for transplants

47 Stool is worth a lot, would you buy it World s No. 1 most expensive coffee comes from elephant s No. 2 Coffee made from undigested coffee beans in elephant stool About $60/35 grams (just over an ounce) at Starbuck s?

48 OILS

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50 Essential oils: the new old trend Essential oils Plant based products that get turned into oils Dates back to Biblical times Frankincense and myrrh How are they used? Diffuse (inhale) Apply to skin Swallow

51 Are they helpful? Obvious commercial use Common products containing essential oils Cough drops/decongestants (often menthol, eucalyptus, Vicks vaporub) Topical pain relievers (Icy hot, Bengay) GI relief (peppermint oil capsules) Most seem fine (and they usually smell good)

52 What we know: Pubmed Health

53 Lemon: Essential oils to try (for IBD/GI symptoms): When diffused, seems to help mood and stress hormones (better than lavender which was equivalent to water/placebo) Peppermint oil Helps with stomach upset/ibs Seems safe, no obvious side-effects (might burn if you swallow it as a non-capsule) Kiecolt-Glaser et al. Psychoneuroendocrinology 2008.

54 Problems with essential oils Side-effects Many may be toxic to ingest and some have had hormonal side-effects, particularly in pre-pubertal children Ex: tea tree oil, lavender Many report GI side-effects (or even toxic) if ingested Ex: lavender Sensitivity Breathing or skin problems Price can be quite high

55 Quality and essential oils Look for language indicating purity on the label Expensive oils are frequently diluted with other oils. Other components could add extra side-effects Dilution instructions will be different if you are starting with professional quality essential oils (more concentrated)

56 Sample instructions

57 Essential oil websites: At the intersection of cutting-edge research and traditional wisdom, **** company formulates targeted, essential oil-based wellness solutions that empower you to dodge harmful chemicals, energize your life, ditch stress and negativity, and reclaim your natural radiance If you have a disease or medical condition, or if you are using a prescription medication, it is recommended that you consult with a health advisor who has experience with EOs prior to using an EO. Seek the advice of the prescribing physician and a pharmacist about potential interactions between the medication(s) and the essential oil(s). Traditionally used for general wound healing and for skin cell proliferation. Not to be used on dirty or open wounds. Because of its many health benefits, **** oil is truly a wonderful supplement. It may be taken alone, or can be drizzled on top of salads or other prepared meals. Bloating or abdominal upset may occur from the excessive use of **** oil internally. Modern scientific study and trends toward more holistic approaches to wellness are driving a revival and new discovery of essential oil health applications.

58 If you find a natural therapy you like National Center for Complementary and Integrative Health (NCCIH) 3 long-range goals: Advance the science and practice of symptom management. Develop effective, practical, personalized strategies for promoting health and well-being. Enable better evidence-based decision making regarding use of complementary and integrative therapies and their inclusion in health care and health promotion.

59 Good websites National Center for Complementary and Integrative Health ( Designed for public (there are links for healthcare professionals as well) NIH Office of Dietary supplements ( Natural Medicines Comprehensive Database (naturalmedicinesdatabase.com) Evidenced based reviews Natural Standard ( Multi-institutional, multi-disciplinary

60 Evaluating information sources Social media Evaluate the sponsors website Government agencies have a badge or can be verified Be cautious if: They are selling something Information is old Sounds too good to be true No actual evidence is given

61 Keep in mind Don t rely on online resources only; talk to your doctor Who runs and pays for the Web site?.gov or.edu is usually a decent place to start How does the site support itself (are they advertising or selling things) What is the purpose of the site? What is the source of the information? The reference should not be another website Testimonials, unsupported claims, and opinions are not considered evidence-based Is the information reviewed? How current is it? (there should be a date on the bottom of the page) How does the site handle personal information? You may give access to personal information if you subscribe Guidelines exist (

62 Questions

63 Phases of clinical trials Preclinical Test in cells or animals Stage I Small group of people. Goal: safety, dosage range, side effects Stage II Larger group of people. Goal: see if it is effective, safe Stage III Large groups of people. Goal: effectiveness, side effects, compare to other meds or treatments, make sure it can be used safely Stage IV Post marketing. Goal: see how it works in clinical practice, identify longer term side effects

64 In the medical literature Langhurst et al. J Crohns and Colitis 2015.