Research 2858167250

Yaron Zeevi

Case# 2841581557 | 20.07.22

Methodology

This is a personal medical meta-research designed to address specific pre-defined questions, based on your expressed needs.
Your personal medical researcher has conducted an extensive search through relevant medical databases, journals, clinical trials databases, and other trusted sources. We have also reviewed additional information such as relevant social media, forums and blogs and similar patients’ descriptions relevant to the situation at hand.
We have analyzed the data, evaluated the reliability of the sources of information and the relevance to the specific case.
Finally, we have assembled all insights into an actionable report for your further use with your doctors.

Patient Summary

The patient is a 35-year-old female who has been suffering from chronic constipation since the age of 10 y/o, refractory to conventional treatment with laxatives.
No specific diagnosis that may point to a cause of such constipation is yet established.
Tests results:

04/2006 Colonoscopy – Melanosis coli; nothing to mention beyond.
05/09/2018 MRI – colonic wall thickening in the area next to hepatic flexure, normal appearance of terminal ileum, high stool content throughout the colon, no colonic distention. No evidence of inflammatory colonic condition.
29/11/2018 Evacuation Proctography – normal position of pelvic floor in rest, good elevation, abnormal descent. During defecation, a small rectocele, enterocele noted. Small amount of residue after defecation.
20/12/2018 Colonoscopy – up to 50 cm – normal
29/11/2018 – Defecography – incomplete emptying
2019 Manometry – Dyssynergy. Elevated basal pressure, normal initiating pressure, normal endurance. RAIR produced. Normal rectal compliance.
2019 – TRUS (Transrectal ultrasound) – Normal anal canal muscle structure, but a huge blocking enterocele is demonstrated, perineal and pelvic floor prolapse noted.
01/05/2022 Anorectal manometry – Normal basal pressure, normal initiating pressure, normal endurance. Preserved sensation, with decreased maximal threshold. Normal relaxation without balloon ejection.
01/05/2022 Anorectal manometry – Normal basal pressure, normal initiating pressure, normal endurance. Preserved sensation, with decreased maximal threshold. Normal relaxation without balloon ejection

The patient is currently suffering from chronic constipation resistant to past treatments. In the past years, the frequency of colonic cleansing as a mode of emptying has increased. The patient reports no urge for defecation (also mentioned at various consultation visits).
Associated conditions diagnosed:

Small Rectocele – 2018
Huge Enterocele – 2018
Anismus [AKA – Dyssynergic defecation] – 2018

Consultations:

21/10/2018 – Dr Yehuda Kariv – suggested Slow transit constipation; suggested to complete formal defecography.
14/11/2018 – Prof Oded Zmora – suggested Colonic inertia and possible treatment with partial resection.
29/01/2019 – Prof Ram Eduard – suggested ruling out Hirschsprung’s disease (HD)
07/03/2022 – Prof Ami Sperber – suggested treatment with Linzess, mentioned SNS (Sacral nerve stimulation) treatment possibility, and finally, surgical treatment.

Treatment history:

The patient was initially treated with conventional methods – laxatives, without long-term response.
Was treated with Lubiprostone; discontinued due to side effects (severe headaches).
Then, the patient received Resolor; discontinued due to side effects.
Psychiatric treatment with Cipralex for 10 months, discontinued due to side effects; no relief of constipation.
Hypnotherapy with Prof Solomonovich – symptomatic relief for 3-4 months, discontinued sessions due to increased anxiety state.

Current treatment:

The patient is currently treated with Hydrocolonic therapy (AKA – colonic cleansing or irrigation) via a medical device placed in her home.
In addition, the patient is practicing alternative methods such as acupuncture, and energetic treatments

Medical background:

Relevant allergies: Augmentin

The patient is seeking additional/alternative treatment options as she is currently advised by her physicians to undergo surgical intervention with stoma placement.
A surgical option is a last resort for her, as she is a dancer and is aware that she’ll be highly restricted and will not be able to proceed with dancing.
During our conversation, I inquired whether a possible diagnosis of Adult Hirschsprung’s disease had been considered. The patient mentioned that this diagnosis was ruled out during her childhood, however, no rectal biopsy was performed. Ruling out of this diagnosis was also suggested by Prof Ram Eduard in 2019.

Research Inquiries

This report addresses the following questions:

What are the conventional and innovative treatment options for chronic refractory constipation for a 35 y/o woman, taking into consideration her treatment history?
What are the alternative treatment options for a chronic refractory constipation for a 35 y/o woman, taking into consideration her treatment history?
Is there any evidence of efficacy of microbiota/fecal transplantation as a relief option for constipation? If so, where in Israel can she receive such treatment?
Is there any evidence of efficacy of sonic frequency therapy as a relief option for constipation? If so, where in Israel can she receive such treatment?
Is there any evidence of efficacy of Intestinal pacemaker/Sacral nerve stimulation as a relief option for constipation? If so, where in Israel can she receive such treatment?
Provide information regarding Linzess treatment option for chronic refractory constipation (efficacy, side effects etc).
Short evaluation of MOTUS-GI company in relation to alleviating symptoms of chronic constipation.
Are there new medical devices that are directed toward alleviating symptoms of chronic constipation?
Who are recommended gastrointestinal surgeons specializing in placing stoma for sportsmen or highly active individuals?
Is there any clinical evidence of efficacy of hyperbaric chamber in treatment of constipation/CIC?

Functional Slow transit constipation – is a condition where the colon can’t move the waste fast enough. The exact cause is unknown, but mostly related to abnormal signaling by the nerves to colonic muscles to move the way they should (affected motility and peristaltic motion). It is characterized by reduced motility of the large intestine, most probably due to abnormalities of the enteric nerves. This type of constipation is more common in young women. Laxatives and a fiber rich diet are usually not effective modes of treatment. This condition usually presents as a lack of urge for defecation, infrequent defecations with dry/hard stool and abdominal bloating. The severity of constipation is highly variable, but may be severe enough to result in complete cessation of spontaneous bowel motions.

Research Information

Conventional and innovative treatment options for chronic refractory/idiopathic constipation
Medications
Bile acid modulation

Elobixibat:
What is it?: It is an inhibitor of ileal bile acid transporter (IBAT) – protein transporter found on ileal epithelium. Mechanism of action: by inhibiting the uptake of bile acids, elobixibat increases the bile acid concentration in the gut, and this accelerates intestinal passage and softens the stool.
Stage of development: It is approved for treatment of chronic constipation in Japan.
Efficacy evidence: A phase IIb clinical trial included 190 patients with CIC assigned patients with 5, 10 and 15 mg dose treatments vs placebo, showed dose dependent increased rates of SBM (spontaneous bowel movements) [in SBM group for week 1 were 1.7 (0.7–2.8) for placebo vs. 2.5 (1.5–3.5), 4.0 (2.9–5.0), and 5.4 (4.4–6.4) for 5 mg, 10 mg, and 15 mg respectively] as well as increased stool frequency which was maintained over 8 weeks.
Side effects: The most common adverse events (AEs) were abdominal pain and diarrhea, which occurred most commonly in the 15-mg dose group.
How to get it?: Not available in Israel. However, some pharmacies, such as Shor Tabachnik pharmacy may supply this drug with special form [29 Gimel] filled by your primary physician.
An ongoing clinical trial NCT04784780 in Japan is currently recruiting patients for evaluation of long term effects on chronic constipation. An e-mail has been sent to study organizers for inquiry of possible Compassionate care with this drug. [Takaomi Kessoku, M.D., PhD. +81-45-787-2800 ext 2640 kessoku-tho@umin.ac.jp] Awaiting response. This drug is manufactured by Ferring Pharmaceuticals, Switzerland.

Guanylate cyclase‐C receptor agonists

Plecanatide: Trulance
What is it?: A compound structurally similar to Uroguanylin, a peptide secreted by the cells lining the intestine. Its function results in increased water content and softening of stools.
Stage of development: FDA approved for treatment of CIC.
Efficacy evidence: A phase III clinical trial included 1394 patients with CIC, received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks. Results showed greater percentage of overall SBM [21.0%, in group receiving 3 mg; 19.5% in group receiving 6 mg] as compared with placebo [10.2%] and general frequency of SBM was increased as well [Complete SBM (CSBM) frequency increased to 2.2/week vs. 1.2/week in placebo group and weekly SMB frequency increased to 3.1/week vs. 1.3/week in placebo group over the 12-week treatment period].
Side effects: The most common side effect reported was diarrhea- 5.9% (3 mg) and 5.7% (6 mg) of patients.
How to get it?: Not available in Israel. However, some pharmacies, such as Shor Tabachnik pharmacy may supply this drug with special form [29 Gimel] filled by your primary physician.
An ongoing clinical trial NCT05151328 in China is currently recruiting patients for evaluation of efficacy on functional constipation. An e-mail has been sent to study organizers for inquiry of possible Compassionate care with this drug. [Mingzhen Gao +86-21-38867466 mingzhengao@luoxin.cn] Awaiting response.

Biofeedback therapy

Biofeedback therapy for dyssynergic defecation = Anismus:
Anismus, also called dyssynergic defecation, is a functional defecation disorder. It occurs when the muscles and nerves in the pelvic floor fail to coordinate correctly to have a bowel movement (pelvic floor dysfunction). It can cause or be caused by chronic constipation. Biofeedback therapy is the most effective treatment.
What is it?: A medical approach that teaches how to change the way our body functions. It is a mind-body therapy that may improve your physical and mental health. The goal is to improve the coordination of the muscles in the abdomen, rectum, pelvic floor and anus that are involved in bowel movements. Using a rectal probe connected to a monitor, patients can visualize their muscles contracting and relaxing.
Stage of development: Accepted approach as part of alternative medicine. Has multiple applications, both in mental health and functional disorders.
Efficacy evidence:
The following study included 69 female patients and showed that 4 to 6 sessions of biofeedback therapy carries an efficacy rate for dyssynergic defecation compared to standard treatment. [ number of stools per week 7.1 vs 5.4 in placebo group; During attempted defecation, the dyssynergic pattern was corrected in 79% of patients who received biofeedback]
Additional study shows long-term sustained effect of biofeedback – included 26 patients, 13 received biofeedback therapy. The results: dyssynergic pattern was corrected in 12/13 subjects who received biofeedback and in none of the subjects who received standard treatment; SBM per week was 7.70 vs 5.71 in standard treatment; CSBM per week was 4.85 vs 1.43 with in standard treatment.
Side effects: No significant side effects are mentioned in clinical trials.
How to get it?: – DRA medical – Tel Aviv and Haifa baised center providing treatment with anorectal biofeedback among other treatments. Contact: contact@dramedical.com +972 (77) 4450-480

Transabdominal/Transcutaneous Electrical (Nerve) Stimulation (TES/TENS)

What is it?: AKA = Transabdominal Interferential Electrical Stimulation. TES is used for treating slow‐transit constipation. TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of the skin. The pad electrodes are placed over the skin surface of the abdomen and the paraspinal regions. Four electrodes are placed, two on the anterior abdominal wall at the level of the umbilicus and two on the paraspinal region in between the distal thoracic and upper lumbar spine.
Stage of development: TES/TENS devices are widely used as pain alleviating assist devices, with a variety of indications, mainly for acute and chronic pain, such as pain relief during labor and many more.
Efficacy evidence:
A clinical trial including 17 women with functional constipation, showed the efficacy of TENS device in reducing constipation score and symptoms by 53%.
A number of studies showed efficacy of this treatment in children. The following study showed: 73% of patients perceived improvement, lasting more than 2 years in 33% and less than 6 months in 25% to 33%. Defecation frequency improved in 30%. Stools got wetter in 62% after stimulation.
Side effects: Serious adverse events from TENS are rare. Skin irritation and contact dermatitis beneath the electrodes may occur. Nausea and feeling faint may occur in some patients.
How to get it?: These devices may be purchased individually or can be borrowed from Yad Sarah. The use is home based.

Alternative treatment options for chronic refractory/idiopathic constipation

Acupuncture

What is it?: Acupuncture with GI specialist.
Stage of development: An alternative mode of treatment.
Efficacy evidence:
A meta-analysis has evaluated the efficacy and safety of acupuncture as treatment for chronic constipation. It included 13 RCT’s with a total of 1,256 patients and concluded that acupuncture for chronic functional constipation seemed as effective as conventional medical therapy.
An additional RCT with total of 1,075 patients evaluated efficacy of Electroacupuncture (EA) showed increase in mean weekly CSBMs during weeks 1 to 8 to 1.76 vs 0.87 in non-therapeutic group; during weeks 9 to 20 to 1.96 vs 0.89 in non-therapeutic group.
Side effects: No obvious adverse event was associated with acupuncture for constipation.
How to get it?: Dana Tzur Shani – Specialist in Chinese medicine and acupuncture with special interest in gastrointestinal problems. [053-4555617 Ramat Aviv]

EMF = electromagnetic field therapy

What is it?: Pulsed EMF therapy sends magnetic energy into the body. These energy waves work with your body’s natural magnetic field to improve healing. The magnetic fields help you to increase electrolytes and ions. This naturally influences electrical changes on a cellular level and influences cellular metabolism.
Stage of development: Available and FDA approved therapy for some conditions, such as bone fractures.
Efficacy evidence: Efficacy was evaluated in a clinical trial that included 24 brain-injured patients with resulting constipation. Results showed decrease in segmental Colon transit time in the left colon [from 22.6 to 14.4 hours] and a significant increase in the frequency of defecation [from 1.7 to 3.2 weekly]; stool softening was noted as well.
Side effects: Generally well tolerated. Reported side effects include post treatment: low blood pressure, low blood glucose, temporary increase in pain, as well as fatigue on exertion and sleep disturbances.
How to get it?: PainFree center with several Israel based sites provides EMF treatment for a number of indications. Contact information: [073-3808899]

Fecal/microbiota transplantation for chronic refractory/ idiopathic constipation

What is it?: Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual.
Stage of development: Decreased colonic motility is an important pathophysiological mechanism of STC. Recently, several studies have suggested that gut microbiota may be involved in the etiology of constipation. Imbalance in composition of stool microbiota has been described in patients with chronic constipation.
Efficacy evidence: An RCT (randomized clinical trial) evaluated effects and safety of FMT for 6 days in 60 patients with SCT. Results were softened stool, speed up transit, and improved symptoms of constipation, with a cure rate of 30% higher than conventional treatment. FMT is a promising cure in 1/3 of adult patients with STC.
Side effects: FMT is usually considered safe, and the common side effects are minor adverse events, including transient diarrhea, abdominal cramps or pain, low-grade fever, bloating, flatulence, and constipation
How to get it?:
Prof Nitsan Maharshak is considered to be a top gastroenterologist in Israel with special interest in research in FMT and bacteriotherapy, based in Ichilov hospital. An email was sent in regards to possible FMT treatment. Awaiting response. [nitsanm@tlvmc.gov.il 03-6974000]
Dr. Milena Pitashny is Head of the Clinical and Research Microbiome Center at Rambam Health Care Campus. An email was sent in regards to possible FMT treatment. Awaiting response. [M_PITASHNY@rmc.gov.il 04-7771108]

Sonic frequency therapy/Infrasound/Shockwave (ESWT) therapy for chronic refractory/idiopathic constipation

No evidence based information was found regarding sonic frequency, infrasound or shockwave therapy for CIC.

Intestinal pacemaker implantation/Sacral nerve stimulation (SNS) for chronic refractory/idiopathic constipation

What is it?: Sacral nerve stimulation involves electrical stimulation of the nerves that control the rectum and rectal nerve and muscle complex. Nerve stimulation can address symptoms of Intractable constipation – inability to pass a spontaneous bowel movement despite use of multiple medical therapies. Sacral nerve stimulation therapy uses a small device (a neurotransmitter), similar to a pacemaker, that is implanted under the skin in the upper buttock area. The device sends mild electrical impulses through a lead that is positioned close to a nerve located in the lower back (the sacral nerve).
Stage of development: Approved by the FDA in 2013 for Incontinence, SNS allows stimulation of appropriate nerves through an implantable device, InterStim by Medtronic.
Efficacy evidence: The following meta-analysis evaluated 13 clinical studies investigating SNS in constipation, and concluded that those patients who proceeded to permanent SNS, up to 87% showed an improvement in symptoms at a median follow-up of 28 months.
Side effects: The following study has evaluated the long-term effects and safety of SNS for incontinence. It is generally well tolerated. The most common device- or therapy-related adverse events throughout 36 months of follow-up included implant site pain (28%), paresthesia (15%), change in the sensation of stimulation (12%), and infection (10%).
How to get it?: Sheba Medical Center – Prof. Edward Ram, director of Pelvic Floor Surgery Services.

Linzess for chronic refractory/idiopathic constipation

Linzess: Linaclotide
What is it?: Mechanism of action – works by
Stage of development: FDA approved for the treatment of constipation associated with IBS (irritable bowel syndrome) and chronic idiopathic (unknown cause) constipation [CIC].
Efficacy evidence: The recommended dosage of linaclotide for CIC is 145 mcg ingested by oral route once a day. The efficacy was evaluated in a clinical trial that included 310 patients, showing significantly improved weekly rate of complete SBM, stool consistency, and quality of life [overall mean weekly SBM frequency showed a linear dose-response with increases of2.6, 3.3, 3.6, and 4.3 for linaclotide doses of 75, 150, 300, and 600 μg, respectively, compared to 1.5 for placebo; overall mean weekly CSBM frequency was dose-responsive with increases of 1.5, 1.6, 1.8, and 2.3 for linaclotide doses of 75, 150, 300, and 600 μg, respectively, compared to 0.5 for placebo]
Side effects: Generally well tolerated. Most commonly reported side effect was diarrhea. In some cases diarrhea may be severe enough to cause dehydration (this warning is more common in children)
How to get it?: Not available in Israel. However, some pharmacies, such as Shor Tabachnik pharmacy may supply this drug with special form [29 Gimel] filled by your primary physician.

MOTUS-GI – Pure-Vu System

This report summarizes the main findings of our research. Our aim is to inform and enhance future decisions. In no circumstances, the information contained in this report or any information given in the process are intended or implied to be a substitute for professional medical advice. It is provided for informative purposes only. We strongly encourage you to use this report and consult your physician before making any medical decisions.
What is it?: A novel device, developed by an Israeli company MOTUS-GI, designed to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation in the setting of inpatient colonoscopy. The device integrates both the function of cleansing (by water stream and air pushed through the device) and suctioning of the debris.
Efficacy evidence: The REDUCE study, which included 94 hospitalized patients showed significant improvements in bowel preparation quality across all evaluable colon segments; adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively.
Side effects: Safety of this device was also evaluated; 1 reported severe event included 1 cm rectal perforation; 3 mild adverse events were also reported including fever, abdominal pain, and a reduction in hemoglobin level.
How to get it?: An email was sent to the company in regards to possibly evaluating the use of this technology for this case. Awaiting response.

Novel medical devices for chronic refractory/idiopathic constipation

Oral Capsule by VIBRANT

What is it?: Vibrant, an Israel based (Yokneam) medical technology company that’s developed a disposable vibrating pill to treat CIC, based on the scientific understanding that when the biological clock is out of synch, people are more likely to experience constipation. The capsule, once ingested, resynchronizes the body’s biological clock to improve daily bowel movement bio-rhythm.
Efficacy evidence: An RCT (phase 3) evaluated the effectiveness of this capsule, including 250 patients. Results showed a significantly higher percentage (50%) of complete spontaneous bowel movements in the active group compared to placebo (sham).
Side effects: Device was well-tolerated barring mild vibration sensation.
How to get it?: An email was sent to the company in regards to assessing treatment possibility and availability. Awaiting response.

MOWOOT II – Pure-Vu System

What is it?: MOWOOT II is a medical device (Spain-based company) that stimulates the large intestine in a non-invasive way (exoperistalsis). Intermittent Colonic Exoperistalsis therapy is inspired by the abdominal massage techniques that are administered by physiotherapists to stimulate the movement of the colon and whose benefits have been clinically proven to solve chronic constipation.
Efficacy evidence: A clinical trial evaluated the safety and efficacy of this device in the treatment of chronic constipation. The trial included 92 patients who underwent daily 20-minute sessions with the ICE (intermittent colonic exo-peristalsis) device for 4 weeks. Results showed an increased number of complete bowel movements per week, reported reduced symptoms of chronic constipation and general improvement of quality of life.
Side effects: No significant adverse events were reported.
How to get it?: This device can be purchased online.

Experts

This list of experts and clinics was assembled by searching for top-rated and recommended doctors and centers from well-known hospitals with special research interest in CIC and various modes of therapy.
*Any further correspondence with the experts presented below will be forwarded to the patient.

Name	Description	Location and Contacts
Dr Yehuda Kariv	Head of General Surgery and Proctology, Head of Advanced Therapy of Rectal and Anal Tumors, Surgical Unit at Ichilov. Senior Surgeon in the Colorectal Unit, Assia Medical, Assuta Ramat Ha-Hayal. An expert in general surgery specializing in colo-rectal surgery. Expert in stoma placement and removal.	Ichilov Medical Center, Tel Aviv yehudaka@tlvmc.gov.il Your last consultation with him was on 21/10/2018.
Dr Roy Dekel	Specialist in internal medicine and gastroenterology, member of the Israeli neurogastroenterology and motility section of the Israeli medical association. His main clinical and research activity is focused on functional and motility disorders of the GI tract. Special interest ןn gastric motility and pelvic floor disorders.	Ichilov Medical Center, Tel Aviv royd@tlvmc.gov.il
Dr Yoav Mazor	Physician and Gastroenterologist at the Gastroenterology and Neuro-Gastroenterology Department. His main fields of interest include heartburn, dysphagia, irritable bowel syndrome, constipation, fecal incontinence, pelvic floor dyssenergia and treatment with biofeedback and neuromodulation. He is part of a multi-disciplinary team of colorectal surgeons, dieticians, physiotherapist and medical technicians dedicated to furthering the diagnostic, treatment and research of these disorders.	Rambam Health Care campus, Haifa y_mazor@rmc.gov.il 04-7772850 An e-mail was sent. Awaiting response.

The following online source can provide some patient-based experiences and information regarding leading an active life/sportmen living and continuing the active lifestyle with a stoma. https://ostomyconnection.com/tag/athletes

Hyperbaric chamber
No evidence-based information was found regarding hyperbaric oxygen therapy in treating CIC. Currently there are no clinical trials evaluating effects of such treatment on gastrointestinal issues. There are only few studies in this field and are focused on effects on bowel dysfunction following radiotherapy. The main indications for the use of Hyperbaric therapy are decompression sickness, carbon monoxide poisoning, traumatic brain injury, various pain syndromes etc.

References

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4553232/

https://www.webmd.com/

סיכום

עצירות פונקציטנלית עם מעבר איטי – מצב שבו המעי הגס לא יכול להזיז את הפסולת מהר מספיק. מצב זה נראה יותר נפוץ בקרב נשים צעירות.

טיפולים קונבציונליים וחדשניים

תרופות

א) ELOBIXIBAT

על ידי עיכוב ספיגת חומצות מרה, ELOBIXIBAT מגביר את ריכוז חומצת המרה במעיים, וזה מאיץ את מעבר המעי ומרכך את הצואה. נבדק במחקר קליני – עם יעילות מוכחת מול פלסבו. ת”ל עיקריות הנרשמו היו כאב בטן ושלשולים. תרופה זו אינה קיימת בישראל. ישנו מחקר קליני ביפן אשר מגייס מועמדים. נשלחה בקשה לבדיקת קבלת תרופה זו במסגרת טיפול חמלה.

ב) Plecanatide: Trulance

פועלת להגברת תכולת המים במעי וריכוך הצואה. מאושרת לשימוש ל-עצירות כרונית. נבדקה קלינית והראתה יעילות אל מול פלסבו. ת”ל הנפוצה אשר דדווחה – שלשולים. תרופה זו ניתן לייבא דרך בית מרקחת שור (טופס 29ג’). כמו כן ישנו מחקר קליני בסין אשר מגייס מועמדים. נשלחה בקשה לבדיקת קבלת תרופה זו במסגרת טיפול חמלה.

טיפול ביו-פידבק

מטרת טיפול זה היא שיפור התיאום של השרירים בבטן, פי הטבעת, רצפת האגן ופי הטבעת המעורבים ביציאות. יעילות טיפול זה נבדקה במספר מחקרים קליניים עם הוכחת יעילות אל מול טיפול פלסבו. לא נרשמו ת”ל משמעותיות.

גירוי חשמלי טרנסבטני (TENS)

אלקטרודות ממוקמות על פני העור של הבטן והאזורים הפאראספינליים. ארבע אלקטרודות סה”כ, שתיים על דופן הבטן הקדמית בגובה הטבור ושתיים באזור הפאראספינלי באזור ע”ש המותני העליון. למכשיר זה ישנם שימושים רבים כולל בזמן לידה אקטיבי לשיפור הכאבים. טיפול זה נבדק במחקרים קליניים עם הוכחת יעילות כנגד טיפול פלסבו. ללא ת”ל משמעותיות. ניתן לרכוש מכשיר זה או להשאיל מיד שרה.

טיפולים אלטרנטיביים

א) דיקור

ישנם מספר מטפלים ברפואה סינית המתמחים בבעיות מערכת העיכול. טיפול זה מקובל כטיפול משלים. יעילותו נבדקה במחקרים קליניים אל מול טיפול המקובל וטיפול פלסבו עם הוכחות יעילות. ללא ת”ל משמעותיות.

ב) טיפול בשדות אלקטרומגנטיים

טיפול EMF שולח אנרגיה מגנטית לתוך הגוף. גלי אנרגיה אלה פועלים יחד עם השדה המגנטי הטבעי של הגוף ע”מ לשפר את תהליך הריפוי. מאושר FDA לטיפול בשברים אך שימוש רב למספר רב של תופעות. נבדק קלינית עם תוצאות יעילות ושיפור העצירות.

השתלת צואה

הזרקה של תסנין נוזלי של צואה מתורם בריא לתוך מערכת העיכול של המקבל. מספר מחקרים מראים קשר פוטנציאלי בין הפלורה החיידיקית לבין הופעת עצירות ועצירות כרונית בפרט. נבדק קלינית עם תוצאות יעילות אל מול טיפול סטנדרטי. נחשבת פרוצדורה בטוחה, ת”ל הנפוצות המדווחות שלשולים, חום נמוך וכאבי בטן.

טיפול בגלי קול

לא נמצא מידע מבוסס ראיות אשר מראה יעילות של טיפול בתדר קולי, אינפרסאונד או טיפול בגלי הלם כנגד CIC

SNS – גירוי עצבי סקראלי

גירוי חשמלי של העצבים השולטים בפי הטבעת ובמתחם העצבים והשרירים של פי הטבעת. מאפשר גירוי של עצבים מתאימים באמצעות מכשיר מושתל (תת-עורי), InterStim של מדטרוניק. יעילות טיפול זה נבדק קלינית עם תוצאות של שיפור בעצירות. ת”ל המדווחות הן כאב מקומי באזור השתלה ושינויים בתחושה.

Linzess: Linaclotide

הגברת הפרשת כלוריד ומים במעיים, שיכולים לרכך את הצואה ולעורר יציאות. מאושר FDA לטיפול בעצירות. נבדק קלינית, עם יעליות מוכחת של מינון 145 mcg כנגד טיפול פלסבו. ת”ל הנפוצות המדווחות שלשולים, בקרב ילדים יכול לגרום להתייבשות. ניתן לייבא תרופה זו דרך בית מרקחת שור בעזרת טופס 29ג’

MOTUS-GI = Pure-Vu System

חברה ישראלית, פיתחה מכשיר המתלבש על קולונוסקופ ועוזר בפינוי צואה לקראת בדיקת קולונוסקופיה. למכישר יכולת הזרמת מים ואוויר יחד עם יכול פינוי הפסולת. יעילות מכשיר זה נבדקה במחקר קליני. נשלחה פניה לחברה בבקשה לקבלת טיפול במכשיר זה כטיפול חמלה או ניסוי קליני עתידי שייפתח בישראל.

מכשור רפואי חדשני

א) קפסולת VIBRANT

גלולת רטט חד פעמית לטיפול ב-CIC, בהתבסס על ההבנה המדעית שכאשר השעון הביולוגי לא מסונכרן, אנשים נוטים יותר לחוות עצירות. הקפסולה, לאחר בליעה, מסנכרנת מחדש את השעון הביולוגי של הגוף כדי לשפר את הביו-קצב של תנועת המעיים. נבדק קלינית עם הוכחת יעילות אל מול טיפול פסלבו. נשלחה פניה לחברה בבקשה לקבלת טיפול זה כטיפול חמלה או ניסוי קליני עתידי שייפתח בישראל.

ב) MOWOOT II

מכשיר רפואי (חברה בספרד) הממריץ את המעי הגס בצורה לא פולשנית (exoperistalsis). חגורה אשר מתלבשת על הבטן וגורם לגירוי חיצוני של מערכת העיכול. יעילות נבדקה קלינית. ניתן לרכוש מכישור זה באתר או-ליין.

תא לחץ

לא נמצא מידע מבוסס ראיות אשר מראה יעילות של טיפול בתא לחץ כנגד CIC