Complementary and Alternative Therapies in IBD

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1 Complementary and Alternative Therapies in IBD Ross M. Maltz, MD August 19, 2018 IBD Education Day

2 Objectives Define complementary/alternative medicine (CAM) What are patient s perception of CAM Definitions of Evidence based medicine and types of clinical studies Efficacy of CAM in IBD My approach

3 Defining CAM CAM constitutes a group of diverse medical and healthcare systems, practices, and products that are not presently considered part of conventional medicine

4 CAM Usage in Pediatric IBD Patients CAM used 40-84% The most commonly used CAM therapies megavitamins, dietary supplement, spiritual interventions, and herbal medicine Majority of patients very interested in CAM Heuschkel, et al (2002). AJG Markowitz, et al (2004). Inflamm Bowel Dis Wong, et al (2009). JPGN Serpico, et al (2016). JPGN

5 CAM Usage in Adult IBD Patients 21-60% of adult IBD patients use CAM Number 1 reason for the use of CAM desire for holistic approach Perception that CAM is more natural and less harmful Up to 75% of IBD patients do not discuss the use of CAM with their physician Cheifetz, et al (2017). Gastro Langhorst, et al (2015). J Crohns Colitis Yanai, et al (2016). Curr Gastro Rep Nguyen, et al (2016). Inflamm Bowel Dis Mountifield, et al (2015). World J Gastro Park, et al (2014). Complement Ther Med

6 Definition Evidence Based Medicine Conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients Integrates clinical experience and patient values with the best available research Use of high quality clinical research in clinical decision making

7 Definitions of Clinical Study Designs Case report: reports on 1 patient Case series: reports on a series of patients Retrospective: a look back at a group of patients Prospective study: follows patients over time collecting data Randomized: patients are randomly assigned a treatment (medication or placebo) Blinded experiment: the patient is not sure what therapy they are on placebo or the therapy they are studying Double Blinded experiment: the physicians/researchers and the patient is not sure what therapy they are on

8 What Type of Study is Considered a High Prospective Randomized Double Blinded Placebo controlled Quality Research Study? Published in a well respected journal, that is critiqued by medical peers

9 Dangers of CAM Data mostly not evidence based, rather survey s or case reports, or small sample sizes Medicines are not regulated by the food and drug administration Need to monitor disease

10 Curcumin Active ingredient of turmeric Study mild/moderate UC 5-ASA +/- curcumin for 6 months Relapse of disease 5% vs 21% Study mild/moderate UC 5-ASA +/- curcumin Clinical remission at 4 weeks 53.8% vs 0% Mucosal healing 38% vs 0% Pure curcumin was used not retail brands Hanai, et al (2006). Clin Gastro Hepatol Lang, et al (2015). Clin Gastro Hepatol

11 Aloe Vera gel in IBD Claimed to be anti-inflammatory Placebo controlled study, blinded 44 patients with mild/moderate UC Aloe vera gel or placebo for 4 weeks Clinical remission 30% vs 7% No differences in mucosal healing(endoscopic and histologic) Langmead, et al (2004). Alim Pharm Ther

12 Low-dose Naltrexone in Crohn s disease Used to treat alcohol or opioid dependence May have anti-inflammatory effect Pediatric Crohn s disease mod/severe 12 patients no placebo 53% and 47% achieved clinical remission at 8 and 12 weeks No assessment of mucosal healing Smith, et al (2007). AJG

13 Low-dose Naltrexone in Adult IBD Adult CD and UC, no placebo, not blinded 47 patients 25.5% of patients in clinical remission Did not access mucosal healing Lie, et al (2018). J Translational Med

14 Low-dose Naltrexone in Adult IBD Double blind, randomized placebo-controlled 40 CD patients Clinical remission 63% vs 33% but not statistically significant Accessed mucosal healing, but did not comment on whether patients were healed rather improvement Smith, et al (2011). Dig Dis Sci

15 Alcat Food and Chemical Sensitivity Test Measures leukocyte (white blood cells) reaction to food Over 450 foods, additives, colorings, and chemical substances Zero studies in IBD

16 EnteraGam in IBD Serum immunoglobulin Maintain immune barriers in the gut Data coming from 2 mouse studies A few cases published, one retrospective chart review that assessed improvement based on symptoms 0-4 No prospective studies, no placebo controlled studies Good, et al (2015). J Gastroint Dig Syst Shafran, et al (2015). Therap Adv Gastro Beauerle, et al (2015). Clin Case Rep Rev Awad, et al (2016). J Gastroint Dig Syst

17 How Do I Approach Discussing CAM Ask about CAM usage/interest Complementary vs alternative Importance of assessing disease (symptoms, blood/stool work up, and rescoping) Understand the medical literature We need to do more large scale studies

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