New Therapy for Irritable Bowel Syndrome

Dr. Michele G. Morrow,
Board Certified Family
Physician, Life Extension
Medical Advisor

Barry LeVan

My name is Barry LeVan and I have irritable bowel syndrome (IBS). At 29 years of age I was diagnosed with IBS and began to experience the worst thing that I could ever imagine. My life was in total chaos. Every aspect of my work and social life were being disrupted by a constant dull pain on my lower left side, and multiple other episodes associated with the syndrome. Leaving the house became an ordeal. I was beginning to feel like a prisoner in my own body. The dull pain that I experienced was relentless. It occurred seven days a week, day and night, around the clock. It did not matter what I was doing or if I was not doing anything. By the end of the day, I was so exhausted from the constant dull pain that I couldn't wait to go to sleep hoping to get a little break from the pain, but I was never that fortunate. Some nights I would get up five or six times during the night to take a hot shower to relieve the constant pain.

I always hoped the pain would be gone in the morning, but it never was. What kept me going for five long tortuous years with IBS was the sheer fact that I needed to keep on living. I first sought help and relief from my family physician. After a physical examination and a stool test for cancer, my doctor concluded that I must be having bowel spasms from stress. He prescribed a drug called Bentyl, an anti-spasm drug. I took the drug but it did not help much. I knew that the problem was more than stress and that it could be serious. So, I decided to see a specialist, a gastroenterologist. After a 10-minute consultation about my lifestyle, a physical examination and a stool test, the gastroenterologist determined that I had irritable bowel syndrome. He prescribed another anti-spasm drug called Levsin, and said it was necessary for me to change my daily diet and routine to cope with the syndrome. I started having three meals a day, taking fiber supplements and consuming less caffeine and alcohol (no soda or beer). The changes in my eating habits and the prescription helped ease my IBS symptoms to some extent, but I was still having problems.

With no immediate relief in site, I began to wonder how many other people were also suffering from IBS. After doing some research on this disorder, I found that I was not alone.

Irritable bowel syndrome is the most common intestinal disorder seen by doctors today. Approximately 22 million people in the United States, or 10% to 20% of the world population-two-thirds of them women-suffer from IBS. According to the National Institute for Diabetes, Digestive and Kidney Disease, each year, IBS causes 34,000 hospitalizations; 3.5 million physician office visits; 2.2 million prescriptions; and 400,000 people to become disabled. Knowing this and how I was currently feeling, I knew there had to be something else that I could do for myself. At this point I was willing to try anything.

German Kommission E

In Germany, there is a government authority, the German Kommission E, which regulates and tests herbal remedies. The German Kommission E is similar to the FDA in the United States except they are more involved in testing and regulating herbal remedies. The herbal remedy that is officially endorsed by the German Kommission E as an effective, safe treatment for irritable bowel syndrome is a fixed combination of peppermint/ caraway oil in an enteric-coated capsule.

A fixed combination is a formula containing multiple herbal ingredients. To be approved the combination must show the following: Each active component must make a positive contribution to the evaluation of the whole preparation. Proof of effectiveness should be established by clinical documentation for each component or for the whole preparation. The components of the fixed combination must have a set dosage for appropriate effectiveness. A positive evaluation is given to a fixed combination when it contributes therapeutic effectiveness for a functional disturbance, syndrome or illness. Finally, the safety of all fixed combinations is to be tested by suitable methods. Approved fixed combinations can be advantageous over single herbs if therapeutic effectiveness is increased or if the side effects of a single component are lessened or negated. Currently, the largest category of use for approved fixed combinations is for digestive complaints (35 combinations).

I started doing some research on the Internet to see what other countries were doing to treat irritable bowel syndrome. I found several studies in British medical journals about the use of enteric-coated peppermint oil capsules for this disorder. I discovered that peppermint oil has been used for centuries for its anti-spasmodic properties. When it is delivered into the colon by enteric-coated capsules, the peppermint oil has the ability to relax intestinal smooth muscle. It does this by blocking the influx of calcium into the smooth muscle cells, thus stopping excessive muscle contractions and restoring proper muscle tone. Calcium regulates muscle contractions in the intestinal tract.

The effectiveness of peppermint oil in relieving colonic muscle spasms was demonstrated in one study during a barium enema. The peppermint oil reduced the incidence of spasms by 40%. The enteric-coating allowed the capsule to dissolve in the colon instead of the stomach. The coating prevented the gastric reflux that can be associated with peppermint consumption and also allowed the peppermint to act locally where it is needed: in the colon.

An enteric-coated peppermint-oil formulation called Colpermin was used in a randomized, double-blind, placebo-controlled clinical study in outpatients with irritable bowel syndrome. It included 110, 66 men and 44 women between the ages of 18 and 70 with symptoms of IBS. Each took one capsule of Colpermin or placebo, three or four times daily, 15 to 30 minutes before meals for one month. Fifty-two patients were given the Colpermin and 49 were given placebo. The results: twenty-nine patients on Colpermin became pain free; 41 patients (79%) experienced an alleviation of the severity of abdominal pain; 43 patients (83%) had less abdominal distension; 43 (83%) had reduced stool frequency; and 41 (79%) had less flatulence. Corresponding data for the placebo group: four patients were pain-free, 21 patients (43%) had reduced pain, 14 (29%) had reduced distension, 16 patients (32%) had reduced stool frequency and 11(22%) experienced less flatulence. Overall, symptom improvements after Colpermin were significantly better than after placebo. There were no significant side effects with Colpermin. One patient, however, experienced heartburn due to chewing of the capsules and one developed a mild transient skin rash. There were no significant changes in liver function. Thus, in this trial, Colpermin was an effective and well-tolerated treatment.¹

In a clinical study using a fixed combination of peppermint/caraway oil (see sidebar), 45 patients with non-ulcer dyspepsia and the majority with IBS were studied in a double-blind, placebo-controlled trial. The test group took one capsule taken three times daily for a period of four weeks. While all patients complained of moderate to severe pain before the commencement of therapy, almost one half of the patients (42.1%) in the test group were free from pain in just two weeks after taking the combination therapy. Only one patient (5%) in the placebo group reported freedom from pain. After four weeks of treatment, 63% of the patients were pain-free; 89% showed improvement in the test group, versus 25% in the placebo group. With regard to clinical global impression, 95% of the test group showed overall improvement in their condition.²

diagnosis of exclusion

If you are suffering from irritable bowel syndrome, it is essential that other causes of the cramps are ruled out before treating your symptoms. The syndrome is a diagnosis of exclusion. This means that the diagnosis is made based on other pathological causes of the symptoms being ruled out first. This is accomplished with a good history and physical examination by a well-trained physician and stool tests to rule out parasite or bacterial infection, food poisoning, lactose intolerance, lipid mal-absorption, gastrointestinal bleeding ulcer, polyp or tumor, inflammatory bowel diseases such as colitis or Crohn's disease, and leaky gut syndrome. Depending on the history and physical exam, the doctor may rule out colon cancer as well.

A colonoscopy or rectosigmoidoscopy with a barium enema is often indicated to exclude these disease states before making the diagnosis of irritable bowel syndrome. Since the symptoms of IBS include abdominal cramps, abdominal bloating, flatulence, belching, diarrhea alternating with constipation, that may overlap with other medical problems, blood and imaging tests may be needed as well to exclude other diagnoses that the physician might be considering based on the patient's history and physical examination. Usually, IBS is characterized by either constipation or diarrhea dominance. In both instances, IBS is frequently associated with depression and anxiety. Its symptoms may also be exacerbated by stress.

After reviewing my research on IBS and comparing the clinical studies, I found the fixed combination of peppermint/caraway oil to be the most effective. The fixed combination produced pain-free results in as little as two weeks, and produced the best relief of IBS symptoms after just four weeks of treatment. Not only did it relieve spasms but it also relieved the flatulence and fullness associated with IBS. This was demonstrated by the clinical global impression result of 95% for the test group in the study mentioned earlier. I found that some form of enteric-coated peppermint oil was being used extensively throughout Western Europe and to a certain degree in Canada. After acquiring this knowledge, I wanted to try the peppermint/caraway oil enteric-coated capsules for myself since I was still suffering from IBS. However, none of the nutrition stores in my area were familiar with the therapy.

Peppermint oil is not popular in the United States because it is associated with heartburn and acid reflux. Peppermint has muscle-relaxing properties and when not enteric-coated can relax the sphincter muscle that separates the esophagus from the stomach, producing digestive disorders. After searching extensively throughout the United States, I found an apothecary that specializes in German botanical medicines. I bought a couple bottles of the enteric-coated capsules and started taking one capsule three times daily, about an hour before each meal. After several weeks, I noticed a change for the better. I was still very skeptical because nothing had really worked in the past, and my previous doctors had told me that I would have to live with this disorder for the rest of my life.

As I continued this herbal treatment, I was having less and less symptoms and occasionally no pain. My energy increased; I was no longer tired all the time. I became more confident and motivated. I could not believe that these enteric-coated capsules were giving me my life back.

After being pain free for over six months I stopped taking the enteric-coated capsules. I thought my IBS was gone forever. To my surprise, the IBS symptoms returned several months later. I immediately resumed taking the enteric-coated capsules again. This time, after my IBS was under control, I decided to cut my dosage down to one or two capsules per day to stay symptom free.

Now, at the age of 40, I have been living a life free of IBS symptoms. I am currently married; my wife and I travel on a regular basis. When I leave the house, IBS is no longer an issue that cramps my lifestyle, literally. My secret to having an IBS-free lifestyle is to maintain and schedule three meals a day, eat right, and take one to two enteric-coated capsules of peppermint/caraway oil each and every day.

After having IBS and seeing the results from using the fixed combination of peppermint/caraway oil, I could not understand why such a product did not exist in the United States. Knowing the prevalence of IBS, I began to investigate the possibilities of getting a similar product manufactured in this country. For over a year and half I gathered research and talked to many vendors in the manufacturing sector.

In 1998, I formed a company called Cutting-Edge Herbal Products and began production of a product called Regimint, a peppermint/caraway oil enteric-coated formula. I developed this product in accordance with the recommendations and safety standards set by the German Kommission E. The German Kommission E is a committee of experts in the field of herbs and phyto-medicines that was established in 1978. Its herbal monographs represent the most accurate information available today on the safety and efficacy of herbs and phyto-medicine. To this day, many naturopaths have been prescribing Regimint for IBS and getting the same wonderful results that I did. I have been using Regimint for five years and have been IBS free.

For more information about irritable bowel syndrome, please see "Constipation, Colitis and Irritable Bowel Syndrome" in the Disease Prevention and Treatment book.

References

1. Liu JH, Chen GH, Yeh HZ, et al. J Gastroenterol 1997 Dec 32:6 765-8.
2. May B, Kuntz HD, Kieser M, Kohler S. Arzneim-Forsch Drug Res. 1996; 46(II) 1149-1153.