Are adhesions the missing link" in unresolved SIBO? Financial Disclosures

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1 Are adhesions the missing link" in unresolved SIBO? Larry Wurn, LMT, Research Chair Clear Passage Physical Therapy Belinda Wurn, PT, Clinical Director Financial Disclosures Owner, Clear Passage Physical Therapy Treating adhesions with a manual physical therapy we have developed over 30 years. Larry Wurn, LMT, Research Chair Clear Passage Physical Therapy Belinda Wurn, PT, Clinical Director 1

2 Conducting clinical research on decreasing adhesions manually for about 25 years. Larry Wurn, LMT, Research Chair Clear Passage Physical Therapy Belinda Wurn, PT, Clinical Director (2013) SIBO Pt #1: 86 pounds Appendectomy Bowel resection Post-surgical infection Wound left open to heal Developed SIBO Tried: Acupuncture Pelvic floor PT Myofascial Release Visceral Manipulation Facing exploratory surgery 2014 SIBO Pt #1: 86 lbs 110 lbs Canceled surgery 2

3 The abdomen and pelvis are frequent sites for adhesion formation.... do adhesions trap treated SIBO in the small intestine.... is this what is happening with recurrent SIBO symptoms? 3

4 Are adhesions the missing link" in unresolved SIBO? q Why we might think that? q Why and how adhesions form? q How common are bowel adhesions? Are adhesions the missing link" in unresolved SIBO? q Why we might think that? q Why and how adhesions form? q How common are bowel adhesions? q Research on abdominopelvic adhesions Causes Treatments The structure of adhesions Formation Deformation Vulnerable points in adhesions How to assess their presence? 4

5 Take aways Greater understanding of Biomechanics of adhesions in the bowel; Role they may play in patients with recurring SIBO symptoms; What is being done to reverse them. Published data treating ab/pelvic adhesions Surgery Manual therapy Two great tools you can use immediately A scientifically validated test to measure before and after symptoms in your patients with gastro-intestinal symptoms: for clinical notes for conduct research Palpation 101 video: link to a very basic introduction to palpating adhesions in your patients To treat cervical cancer, radioactive cesium (in blue) was placed inside Belinda s pelvis; her organs left unshielded. (Six days; 144 hours). 5

6 1985 Debilitating adhesion pain Couldn t walk or breathe w/o pain Dx: Frozen Pelvis (organs all stuck together) Not a surgical candidate Live with debilitating pain... forever We couldn t accept a diagnosis of nothing can be done so we started studying adhesions.... clearpassage.com Adhesions form naturally as the body s first step in healing from tissue damage. Bowel Adhesions clearpassage.com Ab-pelvic adhesions can decrease bowel motility, and slow or stop the transit of bowel contents. 6

7 Bowel Adhesions clearpassage.com 30 years later: Is this causing recurrent SIBO symptoms? Adhesions form as the first step in healing from: Surgery (any ab-pelvic, back or hip surgery, etc.) Infection (PID, ruptured appendix, etc.) Inflammation (SIBO, endometriosis, Crohns, IBS, etc.) Trauma (fall, abuse, car accidents, repetitive) Radiation therapy (post cancer treatment) 50+ year review of post-surgical adhesions Surgery is a major cause of adhesion formation and the #1 cause of small bowel obstruction. Digestive Surgery,

8 After ab/pelvic surgery, 35% of patients were re-admitted for adhesions.. (n=29,790).. an average of 2.1 times over ten years, most in the 1 st year (n=29,790) Surgeries that cause adhesions C-section, hysterectomy Exploratory surgery (e.g., for pain, infertility) Endometriosis Bowel obstruction/resection Adhesiolysis Appendectomy (worse if burst) NEARLY ALL ABDOMINAL & PELVIC SURGERIES CAUSE ADHESIONS TO FORM 8

9 Once adhesions have formed, they tend to remain or grow. Looking deeper, fibroblasts generate strong collagen fibers to begin the healing process. Crosslinks attach collagen fibers to organs and to each other with a molecular chemical bond. These seemed like vulnerable points; they became our focus when I treated Belinda. 9

10 We opened a tiny clinic to treat people with debilitating, often unexplained chronic pain On the road to treating recurrent SIBO, we documented decreasing adhesions manually in various abdominopelvic conditions.. (will cover three) #1 Blocked fallopian tubes began to open; often full reproductive function returned. 10

11 Physicians were skeptical but curious Richard King, MD, Chief of Staff of a large local hospital called us in. What s behind this claim of opening blocked fallopian tubes? he asked. After he reviewed some charts, he said: You are doing things with your hands I don t think I could do surgically and I m a very good surgeon. We need to investigate this further. Testing the hypothesis with radiographs before therapy..... and after, we documented some significant structural improvements 11

12 Alternative Therapies 61% success rate opening totally in Health blocked and fallopian Medicine tubes (n=28) Alternative Therapies 61% overall success in Health and Medicine 69% -- if no prior tubal surgery 35% -- if patient had prior surgery (n=235) 2015 (n =1392 patients) Alternative Therapies Functional improvements in Health and Medicine (pregs) compared to surgery 12

13 2008 Successful - Alternative subsets Therapies in that study in PCOS Health and Medicine High FSH Endometriosis Pre-IVF (n =1392 patients) #2 Sexual Problems Sexual Problems Medscape General Medicine Pain relief & improved function Functional Improvements 13

14 #3 Women with endometriosis suffered from pain & infertility. We focused on detaching the collagen crosslinks that comprise adhesions 2011 Documented pain relief 14

15 2015 and functional improvements 43% pregnancy rate [n=299] What gives? What gives? While treating one condition, nearby structures showed significant improvements 15

16 What gives? If we could clear blocked fallopian tubes, and improve function of pelvic organs.. What gives?.. could we clear larger tubes the bowel, and improve abdominal organ function? Significant differences Fallopian tubes 4 to 5 inches long Tiny diameter (designed to carry single-cells) Range of adverse conditions is relatively small Bowel 21 feet long Diameter is significantly larger (1+ inch) Range of adverse conditions is enormous 16

17 Formidable tasks: Bowel adhesions can be massive.. and encapsulate neighboring structures in powerful glue-like bonds. Complex Cases Severed duodenum Seven prior SBO surgeries Pelvis split open like a book Gored, then trampled by a bull Neo-bladder created from intestinal tissue We had to reinvent therapy for every patient Seminar techniques didn t really help We had to synthesize a lot. Every applicant is thoroughly screened for contraindications before treating! 17

18 2013 Journal Testing of Clinical results: Medicine Scientific evidence is so important Radiographs on adhesive bowel obstruction.... and on clearing stricture. 18

19 q q Interdisciplinary Meetings with NCNM physicians Confer Allison Siebecker, ND contacted us by Steven Sandberg-Lewis, ND came to confer in Florida Met with us & our MD Research Director Met with our PhD expert in Disease Modeling Interdisciplinary Meetings with NCNM physicians Confer q Allison Siebecker, ND contacted us by q Steven Sandberg-Lewis, ND came to confer in Florida Met with us & our MD Research Director Met with our PhD expert in Disease Modeling Outcome q Protocols to treat patients with recurring SIBO q Conceived Research models, Before and after tests q Now have Early results (towards publishable data) Research models you can use The medical model was surgical lysis cut or burn away adhered tissues.. 19

20 .. we were developing a model to remove adhesions manually crosslink by crosslink (over 30 years). If we could we free structures squeezed by adhesions without surgery.... could that help patients with bowel adhesions, and recurring SIBO? 20

21 Adhesions can create walls of glue.. endogyn.com.. or can bind together to form curtains, ropes or balls. endogyn.com Even so, they are composed of tiny, powerful crosslinks.. endogyn.com 21

22 Once formed, they tend to remain... and sometimes spread to other structures. The body has no way to detach them naturally. endogyn.com They can glue loops of the bowel together.. endogyn.com 22

23 .. or narrow the bowel into a stricture. endogyn.com 2013 Journal of Clinical Medicine We created a scientifically validated questionnaire to measure results Scoring Sheet for Validated Questionnaire We used it to measure pre- vs. post-tx Quality of Life in our patients with SBO 23

24 Published outcomes Return to Normal values Normal Mild Moderate Severe Pre Post Diet Pain GI symptoms QOL Medication Diet Pre Post Pain Pre Post GI Symptoms Pre Post QOL Pre Post Medication Published Outcomes Probability Values Significance at p=<0.025 n=27 Significant in 5 of 7 Measures Pain (presence) p= Sig Pain (severity) p= Sig Quality of life p= Sig Range of motion p< Sig G-I symptoms p= Marg sig Diet p= Medications p= Published outcomes Range of Motion changes Measure (normal ) Pre-treatment mean (s.d.) Post-treatment mean (s.d.) p value* Flexion (80 ) Extension (25 ) Left side bending (45 ) Right side bending (45 ) Left rotation (45 ) Right rotation (45 ) (10.07) (6.17) (7.72) (5.27) (8.95) (7.63) (9.63) (6.82) (10.81) (7.54) (10.54) (7.50)

25 Return to surgery rates 24 and 19 months post-op Validated Questionnaire you can use Monday morning to test before and after results Clear Passage Physical Therapy, 2011 SAMPLE PAIN SCORING DURATION AND INTENSITY X X X MEASURING CHANGES IN PAIN: FDA Significance scales DURATION: 2 column change is significant SEVERITY: 2 point change is significant 25

26 Validated Questionnaire you can use Monday morning to test before and after results Clear Passage Physical Therapy, 2011 Validated Questionnaire you can use Monday morning to test before and after results Validated Questionnaire you can use Monday morning to test before and after results 26

27 Validated Questionnaire you can use Monday morning to test before and after results Validated Questionnaire you can use Monday morning to test before and after results Clear Passage Physical Therapy, 2011 X X X X SAMPLE SCORING: FUNCTION 27

28 SAMPLE SCORING A shift of one column is significant Early Results Treating Patients with Recurring SIBO Ø Constipation Ø Gas / Bloating Ø Diet & Medication Ø Overall Ø Full Body Changes 4/5 4/5 2/2 2/2 0/3 0/3 4/5 80% 100% 2/2 0% 0/3 80% 100% 0% Ø Side Effects Ø Areas Treated 7 Early Results Treating Patients with Recurring SIBO Overall GI Symptom Improvement /5 4/5 2/2 2/2 0/3 0/3 4/5 80% 100% 2/2 0% 0/3 80% 100% 0% Xifaxan Herbal Antibiotics No Antibiotics Xifaxan Herbal No Antibiotics Antibiotics 28

29 Outcomes - GI subdomains Significant Improvement Constipation 3/5 2/2 2/3 60% 100% 67% Xifaxan Herbal No Antibiotics Antibiotics **Must have significant improvement based upon the SBO-Q for GI symptoms Outcomes - GI subdomains Significant Changes Gas / Bloating Better Better Worse Worse 3/5 4/5 2/2 2/3 60% 80% 100% 67% Xifaxan Herbal No Antibiotics Antibiotics Changes based on the SBO-Q for G-I Subdomain Side effects of therapy are transient Summary of reported side effects from CPA treatment over the course of treatment by SBO patients. Reported side effects were assessed daily with conditions present before treatment subtracted to assess the rate of new side effects. [n=31] Side Effect Rate of Observation Abdominal tenderness 19.4% Fatigue 9.7% Headache 12.9% Pelvic or abdominal cramping 9.7% Poor sleep 3.2% Aching 32.3% Bloating 3.2% Nausea 12.9% Diarrhea 12.9% Emotional lability or irritability 9.7% Vaginal spotting 5.0% Skin tear 6.5% Tailbone pain 9.7% Hip or back pain 22.6% 29

30 Range of Motion Head to Toe Musculoskeletal Joint Mobility Biomechanics Organ Mobility Gastrointestinal Urogenital Overall Full Body Changes # Mean improvement: 37.3% (± 7.6%) p = 8.8 x 10-8 [p = ] Mandatory: Thorough review of patient's medical history Due to the wide variety of complex processes and conditions that can occur deep within the abdomen and pelvis, there are significant contraindications to therapy. Screening patients with SIBO Patients must not be responding to overgrowth in an infection or inflammatory manner, based on a Total WBC count no higher than 8x10 3 /μl Neutrophil percent no greater than 60% Must be undergoing concurrent antibiotic treatment; May require a medical clearance letter, based on our review of patient history 30

31 Are adhesions the missing link" in unresolved SIBO? Larry Wurn, LMT, Research Chair Belinda Wurn, PT, Clinical Director Clear Passage Physical Therapy Thank you very much! Handouts & Palpation Video: phone 31