Irritable Bowel SyndromeIrritable Bowel Syndrome: How Chinese Medicine can help
This is a short research paper I wrote in 2006. It has a lot of information but if you are interested in the cause and treatment of IBS you may find this article to be invaluable. I encourage you to scroll through and just read the sections that you are interested in. Enjoy! - Rebecca Epidemiology and Basic Pathology of IBS The Merck Manual categorizes IBS as a functional bowel disorder and describes IBS as “a motility disorder involving the entire GI tract, causing recurring upper and lower GI symptoms, including variable degrees of abdominal pain, constipation and/or diarrhea, and abdominal bloating.” This means that IBS, unlike Crohn’s or Ulcerative Colitis say, is a problem with the movement of the smooth muscle of the intestines rather than some sort of inflammation along the GI tract. Normally, the smooth muscle of the intestines moves in smooth rolling waves of contraction called peristalsis but in IBS, we experience what’s called “spastic colon” where different portions of the intestines contract at the same time instead of in waves often causing cramping pain and discomfort. The exact cause of IBS is unknown, but emotional stress and dietary factors in particular are known to aggravate symptoms. (Merck 312, 1999) According to UpToDate Patient Information, an official educational program produced in cooperation with the American Gastroenterological Association, IBS is the most commonly diagnosed gastrointestinal condition and is second only to the common cold as a cause of absence from work. An estimated 10 to 20 percent of people in the general population experience symptoms of IBS, that’s over 2 million people in the US, but only about 15 percent of affected people actually seek medical help (UpToDate, 2004; NDDIC, 2004). The National Women’s Health Info Center, a division of the U.S. Department of Health and Human Services, maintains that the majority of people diagnosed with IBS are women, possibly as high as 75% (Nat’l Women’s Health Info Ctr, 2005). Bowel function, Western biomedical diagnosis and treatment The most common site for IBS irritation is the sigmoid colon but it’s important to understand the basic structure and function of the entire Large Intestine before we move on (Merck 313, 1999). The large intestine, or colon, consists of the cecum and ascending colon, the transverse colon, the descending colon, and the sigmoid colon, making a large question-mark shape in the abdomen. The sigmoid colon in turn is connected to the rectum and anus. The cecum, which is at the beginning of the ascending colon, is the point at which the small intestine joins the large intestine and projecting from the cecum is the appendix, which is a small finger-shaped tube that serves no known function but is often removed due to infection, known more commonly as appendicitis. Intestinal contents are liquid when they reach the large intestine but are normally solid by the time they reach the rectum as stool. Therefore the large intestine is largely responsible for the absorption of water along with certain vitamins and nutrients from the stool and is also responsible for the excretion of fecal matter. In addition to the smooth waves of peristalsis we discussed earlier, the large intestine also secretes mucus to help the movement of stool through the bowel. There are also many bacteria in the large intestine that can further digest some intestinal contents and create important substances for the body such as vitamin K, which plays an important role in blood clotting. Healthy gut bacteria or flora and a proper balance of these bacteria are also essential to proper large intestine function. (Merck Manuals Online, 2003) Keeping this in mind, there are three recognized types of Irritable Bowel Syndrome: Constipation type, diarrhea type and alternating between constipation and diarrhea type. Each of these types can be combined in any way (Merck 313, 1999; NDDIC, 2004). There is no test for Irritable Bowel Syndrome, IBS is diagnosed based on clinical symptoms including how often you have abdominal pain, when the pain starts and stops relative to bowel function and how your stool consistency and frequency are altered (NDDIC, 2004). More specifically, IBS is diagnosed using the ROME criteria. The ROME criteria were first published 1990 after a special committee was set up at the 1988 International Congress of Gastroenterology held in Rome, Italy to develop the first classification system for functional gastrointestinal disorders. The ROME criteria were revisited and revised in 2000 by a larger number of committees addressing psychosocial and pediatric issues in addition to the original ROME criteria considerations resulting in what we consider ROME criteria today. A third revision is currently underway that will be released sometime in 2006. (ROME II, 2006) The ROME criteria states that IBS is characterized by at least 12 weeks of abdominal discomfort or pain in the prior year that need not be consecutive and has two of three features: (1) Relieved with defecation; and/or (2) Onset associated with a change in frequency of stool; and/or (3) Onset associated with a change in form (appearance) of stool (ROME II, 2006) Cumulatively, presence of any of these nine additional symptoms are said to support the diagnosis of IBS: • Fewer than three bowel movements a week • More than three bowel movements a day • Hard or lumpy stool • Loose, mushy or watery stool • Straining during a bowel movement • Urgency – having to rush to have a bowel movement • Feeling of incomplete bowel movement • Passing mucus (white material) during a bowel movement • Abdominal fullness, bloating or swelling (ROME II, 2006) In turn, these additional symptoms are used to diagnose diarrhea versus constipation or alternating type IBS. Namely, more hard and lumpy stool with decreased frequency equals constipation type while more loose and watery stool with increased frequency equals diarrhea type and an alternating combination of the two is equivalent with alternating type. (ROME II, 2006) Western biomedical treatment includes dietary therapy and pharmaceutical administration. Common dietary advice is to increase fiber for constipation type IBS, decrease or eliminate dairy for those who show lactose intolerance and decrease or eliminate gluten containing products such as wheat, barley and rye for those with low grade celiac disease, also known as gluten intolerance. (Merck 315, 1999; UpToDate, 2004; IBS Self Help, 2004) There is also a wide range of pharmaceutical approaches to treating IBS and I will briefly summarize them here. At the top of the list are the antispasmodic drugs that are anticholinergic agents that inhibit gastrointestinal propulsive motility, or peristalsis, and decrease gastric acid secretion. They are used to treat diarrhea predominant IBS. Next are the antidiarrheals, also used to manage the symptoms of diarrhea predominant IBS. These include medications such as Immodium AD that you can get both by prescription and over the counter. Antidiarrheals, like antispasmodics, decrease gastrointestinal propulsive motility, inhibiting peristalsis and also affect water and electrolyte movement through the bowel. Moving on, we have fiber supplements to help increase bulk and promote bowel movement for constipation type IBS. (IBS Self Help, 2004; Merck 314-315, 1999; Rx List, 2004) More recently, tricyclic antidepressants and newer SSRI, or selective seratonin reuptake inhibitor-type antidepressants have been used to treat IBS. The exact mechanism of action for tricyclic antidepressants is not known though they show some anticholinergic effects in the body and, like SSRI’s, provide some relief of the stress associated with IBS and decrease spastic colon pain. (IBS Self Help, 2004; Merck 315, 1999; Rx List, 2004) The newest class of IBS pharmaceuticals are the 5-HT4 antagonists such as Tegaserod. These most recently developed drugs focus on constipation type IBS and act on seratonin receptors in the gut to stimulate GI peristalsis and decrease visceral sensitivity. (IBS Self Help, 2004; Rx List, 2004; NDDIC, 2004) As a student and soon to be practitioner of Chinese medicine, I have no experience-based knowledge to share with you about the efficacy of Western pharmaceutical treatments so I must rely on the experience of others. Therefore, I would like to discuss a couple of Randomized Controlled Trials of some of these afore mentioned Western drugs to give you an idea of Western IBS treatment outcomes. Review of biomedical Randomized Controlled Trials The first study I would like to share with you was published in 2004 in the Scandinavian Journal of Gastroenterology. Entitled “A double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome,” this study was completed by a group of eight Scandinavian doctors treating 647 patients who were randomized to 86 different gastroenterological centers spanning Denmark, Finland, Iceland, Norway and Sweden. The treatment group consisted of 327 patients who received 6 mg of tegaserod two times a day while the placebo group consisted of 320 patients receiving two daily doses of a placebo tablet. Patients received treatment for 12 weeks and then were monitored for 4 weeks post treatment. (Nyhlin Bang Elsborg 119-126, 2004) Patients were diagnosed with IBS using the ROME criteria and exclusion criteria included an abdominal pain score equal to or less than one, diarrhea type IBS, as tegaserod is indicated for constipation type IBS only. Exclusion criteria also included severe laxative dependence, other relevant GI conditions, and use of other medications affecting GI motility. To assess efficacy of treatment, patients kept a daily diary for the 12 weeks of treatment and for four weeks beyond treatment recording stool frequency, abdominal pain/discomfort, bloating, loose/watery stool, hard stool, urgency, straining and sense of incomplete evacuation. Patients were also asked weekly to answer yes or no to the question, “Over the past week, do you consider that you have had satisfactory relief of your symptoms of IBS?” Patients were instructed that ‘satisfactory’ meant that in comparison to their typical experience with IBS in the past, the patient felt that their symptoms had been alleviated during that week to the extent that they would take medication to maintain that state. (Nyhlin Bang Elsborg 119-126, 2004) There were no clinically significant differences between the treatment groups in any key demographic areas so the patients were randomized well. Of the 647 randomized patients, 564 completed the treatment period and 544 completed both the treatment and the four-week withdrawal period. There was also no significant difference between the treatment groups with respect to their daily symptoms. Eighty-five percent of the treatment group participants were female. (Nyhlin Bang Elsborg 119-126, 2004) Patients who received tegaserod experienced a significant improvement in satisfactory relief of their IBS symptoms. At four weeks, 26% of the tegaserod group experienced satisfactory relief versus 19% for the placebo group, and by week 12, 34% of the tegaserod group reported satisfactory relief versus only 23% for the placebo group. Over the four- week withdrawal period, the number of patients experiencing satisfactory relief decreased greatly, but the patients who had been in the tegaserod group at 16% still experienced more satisfactory relief than those who had been in the placebo group at only10% during withdrawal. (Nyhlin Bang Elsborg 119-126, 2004) Patients who received tegaserod also experienced no bowel movements or hard stools an average of 3.3 days less than before compared to the placebo group and experienced straining or a feeling of incomplete evacuation of the bowel 3.8 days less than before compared to the placebo group. The decrease in abdominal pain and discomfort, however, was the same in both groups and therefore was not statistically significant. Approximately 55% of the patients in the tegaserod group experienced some adverse event during the course of treatment while 50% of patients in the placebo group experienced the same. The most common adverse event was headache. Just over 9% of the patients in the tegaserod group experienced diarrhea as a side effect of medication, however, while only 1% experienced diarrhea in the placebo group. Overall, the site investigator determined that 23% of the of the patients in the tegaserod group experienced adverse events that were directly related to the study medication versus 13% in the placebo group, but as the frequency and type of adverse events experienced were similar in number and frequency overall, this was considered to be statistically insignificant. In conclusion, this study recommended the use of 6mg of tegaserod twice daily as a safe well-tolerated treatment for constipation type IBS. (Nyhlin Bang Elsborg 119-126, 2004) This next study was published in 2005 in Gut magazine. A study by researchers V. Morgan, D. Pickens, S. Gautam, R. Kessler and H. Mertz, it was entitled “Amitriptyline reduces rectal pain related activation of the anterior cingulate cortex in patients with irritable bowel syndrome.” Building on previous studies showing that the anterior cingulate cortex region of the brain is activated during the experience of irritable bowel syndrome symptoms, the purpose of this study was to observe whether Amitriptyline, a tricyclic antidepressant, is effective in reducing anterior cingulate cortex activation during painful rectal distension in IBS. (Morgan. 601-607, 2005) Nineteen women with painful IBS were enrolled in the study after satisfying the ROME criteria for IBS and being screened and excluded for any other health conditions that could be affecting their IBS symptoms. The women were randomized to receive either 50mg of Amitriptyline once per day or placebo for one month and then, after a three-week washout period, were crossed over to the other treatment. (Morgan. 601-607, 2005) They measured the effects of painful IBS distension of the rectum in the brain by performing functional MRI scans of the brain to measure anterior cingulate cortex activation while inserting a small balloon into the rectum which was inflated to alternating pressures of 4 mm Hg, 15 mm Hg, 30 mm Hg and 50 mm Hg in a random order to decrease the anticipation of painful distension that occurred at the highest pressure. A series of nine distensions were administered for 40 seconds each, followed by a 30 second baseline. While in the MRI, the patients wore headphones to mask the MRI sound that played either the stressful sounds of babies crying or relaxing music. The order of stressful or relaxing conditions was determined randomly and distensions were repeated with the alternate stress condition. (Morgan. 601-607, 2005) At the end of each set of nine distensions, the patients were asked to verbally rate the stimuli on a scale of 0-10 where 0 was non-painful an 10 was the worst pain imaginable. They were also asked to rate their overall experience with the Amitriptyline versus placebo. In addition, blood pressure and heart rate were taken and the functional MRI images were recorded. Distention tests were performed at the end of each one-month treatment period comparing placebo to Amitriptyline treatment. (Morgan. 601-607, 2005) At the conclusion of the study, 13 out of the 19 patients reported that overall their IBS symptoms were better on Amitriptyline, five reported that their IBS symptoms were better on placebo and one reported no change. During rectal distension at 50 mm Hg with the auditory stress of babies crying, pain level was reported as 4.2 on Amitriptyline versus 5.3 on placebo. During relaxing music, pain from 50 mm Hg of distension was reported at 5.7 on Amitriptyline versus 6.0 on placebo. Blood pressure and heart rate were similar during Amitriptyline and placebo with stimuli and at baseline. Activity in the anterior cingulate cortex was decreased by 4.5% during rectal pain from 50 mm Hg distention with auditory stress. In the absence of auditory stress, i.e. during the sound of relaxing music versus babies crying, no decrease in brain activity was observed. (Morgan. 601- 607, 2005) In conclusion, this study reported that Amitriptyline 50mg versus placebo is effective in reducing brain activation and IBS pain during stressful events triggering IBS symptoms. IBS symptoms during non-stressful instances were unchanged. A daily dose of 50mg of Amitriptyline is recommended as a safe and effective dose for stress related IBS pain. (Morgan. 601-607, 2005) All of these treatments are viable and effective but for some people, at 20%-50%, the instances of adverse events are still too high. These medications also treat IBS symptom by symptom. Alternative treatment treats the person as a whole taking into account not only the individual symptoms but also the underlying cause. TCM in particular offers little to no adverse events or side effects to treatment and is a complete system of health care including acupuncture, herbs, dietary and lifestyle advise. With centuries of experienced based practice behind it, it is a viable and successful treatment for IBS. TCM history and approach to medicine. (Maciocia Foundations1-68, 1989; Maciocia Practice 431-492, 1994; Cheng 1-59, 1987) Chinese medicine has a history of over 2,000 years. A holistic form of medicine believing that the body is an organic whole, Chinese medicine maintains that the body must be harmonized and balanced with itself and with nature around it. At the heart of Chinese medicine is Yin-Yang theory, the balance and mutual dependence of light and dark, fullness and vacuity, day and night. They are the greatest of opposites but without one you cannot have the other. As the sun rises, the moon sets but without both crops would fail and the ocean’s tides would be in disarray. The same is true of the body. In Chinese medicine everything can be described by Yin and Yang, organs are even paired in yin-yang, also called zang-fu, pairs such as the Kidney and Bladder, the Spleen and the Stomach, and the Liver and Gallbladder. The substantive or solid organ is Yin in nature, serving primarily to store energy, while the hollow organ is Yang and primarily moves or transports energy. The proper function of these organs and the proper movement of Qi, Blood and Body Fluids through them is essential to health. The concept of Qi is one of the more challenging ideas for those of us in the Western world to grasp, but it too is essential to Chinese medicine. It is important to note here, that without the benefit of detailed internal anatomical knowledge, the Chinese medicine doctors of 2,000 years ago nonetheless gained very accurate knowledge of the body’s workings and how to positively affect the body with acupuncture and herbs. They gained this knowledge through meditation, observation, and trial and error. And what they discovered and specifically learned to manipulate was Qi. Qi is an unseen non-physical energy that courses through the body in channels like rivers that traverse the surface of the body and plunge deep to the internal organs. The internal organs create, store and maintain the flow of Qi throughout these channels that keep the mind and body both healthy and animated. Acupuncture in particular is the stimulation of certain points along these channels on the surface of the body with very fine needles in order to affect and balance the internal organs. The Stomach channel, for instance, begins internally at the Stomach organ, connects to its zang-fu or yin-yang paired organ the Spleen, and emerges on the surface of the body here (point to St-1 on self). It then flows down the head and neck, down the chest and abdomen, and along the lateral aspect of the leg to end at the lateral corner of the nail of the second toe. Points along this channel can affect any pathology that physically manifests along the channel pathway on the exterior of the body and can also affect the energy of the Stomach and Spleen organs harmonizing digestive functions, treating gastric pain and more. There are twelve main channels that traverse the body in this way connecting to twelve main organs. Acupuncture itself is an extension of this channel system. It functions on the premise that by accessing certain acupuncture points along various channels, one can rectify the flow of Qi in those channels as well as rectify the Qi within the organs themselves. By rectifying the Qi within the channels and organs we can work to correct function and imbalance. Acupuncture by itself, however, is not always enough. Herbs are therefore an essential part of Chinese medicine and they too seek to balance the energy of the different organs. Chinese herbs have been part of Chinese medicine for as long as acupuncture, and Chinese herbs have very specific properties to balance the body. Different herbs enter different energetic organs and build or disperse Yin, Yang, Qi, blood, and body fluids. Herbs are mixed together into formulas and while there are traditional formulas that are designed to treat common energetic imbalances, the beauty of Chinese herbal formulas are that they can be modified and individualized for specific people’s individual health concerns. Chinese herbs consist of a wide range of plants – roots, barks, leaves and flowers – as well as some minerals, insects and animal products. In their leaf/twig/root/branch form they are called bulk herbs, and they can be cooked into medicinal teas. In modern times, cooking bulk tea has become cumbersome and often too impractical and while bulk teas are the strongest and sometimes the most affordable form of Chinese herbs, you can also get herbs in a powdered form called granules or pre-formed into pills. The pill or patent form is the weakest and, as the herbs have been made into pills in a factory, the least customizable for the individual patient, but they can still be very effective. Chinese herbal teas, be they bulk or granule, can also be very bitter tasting to the Western palate and basically taste very bad. Sometimes very bad taste makes compliance a problem in the West as we aren’t used to “eating our bitters” as they say in China, but for many people once they try it and really gain relief from their ailments, they can get past the taste to enjoy the benefits. Chinese herbs work in tandem with acupuncture to affect both the physicality of an ailment as well as the energetics of the body. Beyond affecting Yin, Yang and Qi there is also Blood, Body Fluids and the five elements to take into consideration that are additional key features in the Chinese medicine understanding of the body. Blood and body fluids are easier to understand than Qi and the strange workings of Chinese herbs as in Chinese medicine they are still the same substantive fluids we think of in the West. Blood courses through blood vessels and body fluids moisten the skin and lubricate the bowels among other commonly understood functions. In Chinese medicine, however, blood and body fluids also have an energetic component that is maintained by the proper energetic function of certain internal organs. More important for our discussion of IBS, however, is a basic understanding of the five elements, their relation to each other and to certain internal organs. When I talk about organs, however, please remember that I am speaking of the energetic functioning of the organ, not the physicality of the organ. The basis behind Chinese medicine is that affecting the energetics of the body affects the physicality of the body, so Licensed Acupuncturists approach the body from an energetic balance perspective. To continue, the five elements are wood, fire, earth, metal and water. Like Yin and Yang, they too generate and control one another. Wood can come alight to create fire, Fire burns to ash to create earth, earth can be mined for ore creating metal, metal can be shaped into containers to hold water and water can feed the roots of trees giving birth to wood. Each of the five elements corresponds with different seasons, colors, emotions and organs. Wood represents the Liver and Gallbladder, Fire the Heart, Pericardium, Small Intestine and Triple Burner which is a completely non-physical organ responsible for creating an addition connection between the upper middle and lower parts of the body, earth represents the Spleen and Stomach, metal represents the Lungs and the Large Intestine, and water represents the Kidneys and the Bladder. For our discussions of IBS, the most important elements and associated organs to understand are those of Earth and Wood, especially the Spleen and the Liver. Physically, IBS affects the Large Intestine – the metal element – whose job both physically and energetically is eliminating what is no longer needed. IBS, however, has to do with much more than simply elimination. From a Chinese medicine perspective, it has to do with problems transforming and transporting food and drink, a function of the Spleen, and it has to do with stress and emotions, the smooth flow of which is governed energetically by the Liver. You can imagine the Spleen like an industrial factory oven in a production line. It likes to be warm and dry and moving so foods come in, get properly cooked or transformed, and then transported away to be packaged and sent to their various destinations and used accordingly. But imagine if the oven didn’t have enough power, or was frozen by a cold ice storm, or the conveyer belt broke. What would happen? The food would stagnate, it would rot, gunk up the system with damp wet yuk and create problems with distribution and if distribution is disrupted or even if the food goes out but it isn’t properly cooked, everything down the line suffers. You have idle workers who can’t do their jobs and begin smoking and slacking, you have people in the community getting sick and suing the company for food poisoning and a large mess ensues. What we call a Spleen Qi deficiency would be like the power getting cut off or the conveyer belt not moving, what we call cold invading the spleen would be the ice storm, and exactly what happens to the oven is what happens to the body. Without clear differentiation between good food and bad, the Large Intestine doesn’t know when to eliminate and when to hold on creating spasm, pain, constipation and diarrhea. The Liver and the Spleen also have a special relationship. As I mentioned earlier, the five elements and their associated organs have a generating relationship, which I outlined for you, but they also have a controlling relationship. Water controls fire, keeps it from getting out of hand, and wood controls earth the way the roots of trees and grasses bind the soil of a steep hill, keeping the earth from sliding away. Energetically, three of the Liver organ’s main responsibilities are to ensure the smooth flow of energy through the body, to ensure the smooth flow of the emotions and to assist the Spleen and Stomach in digestion, transformation and transportation of Qi and nutrients. It is easy to understand, therefore, that emotional upset can easily disrupt the smooth flow of Qi. When stress in particular affects the mind and body, the smooth flow of Qi in the Liver is disrupted and stagnates. Due to the controlling relationship between wood and earth, representing the Liver and the Spleen, along with the function of the Liver to assist in digestion and move Qi, when emotional upset causes the Liver Qi to stagnate it can build up to a boiling point and overact on the Spleen, essentially controlling it too much. It would be like the foreman at the factory micromanaging the workers who keep the ovens and the conveyer belt going. His constant concern and worry, questions and extra tasks to the workers makes them unable to properly complete their normal jobs and the oven and conveyers can’t function properly and just like in the Spleen Qi deficiency, everything down the line will suffer. We call this Liver overacting Spleen or Wood invading Earth. While the cause for the disruption of the production line is different the result when the disruption goes down the line, i.e. the results in the large intestine, are the same. This brings me to another important concept, that of pattern or syndrome differentiation. Along with the holistic nature of Chinese medicine, we also believe that everyone and every health concern is individual. Each of the three patterns I mentioned above – Spleen Qi Deficiency, Cold invading the Spleen, and Liver Overacting Spleen – can result in IBS symptoms, perhaps even in the same IBS symptoms as far as rectal pain, gas and bloating are concerned, but each of them would be treated in a completely different way by a Chinese medicine practitioner. Which pattern presented would be differentiated by a number of symptoms beyond stool pattern such as one’s subjective sense of body temperature, someone’s energy level, their sleep patterns, as well as other seemingly unrelated questions. Each of these gives the Chinese medicine practitioner valuable information about the individuality of the patient, about the energetic play of the different organs together in the body, and the sum of the whole creates a pattern that gives the same complaint a thousand different treatments tailored to a thousand different individuals. Also essential to this pattern differentiation are tongue and pulse assessment. The pulse is felt in three positions on each wrist, each position corresponding to a different yin-yang or zang-fu organ pair. The tongue is assessed for color, size, shape and coating, which show a snapshot of one’s body constitution. So, if you go see a Chinese medicine practitioner you can expect that he or she will want to feel your pulse, look at your tongue and ask you a lot of questions that may not seem related to the problem you are seeking help with, but they will be invaluable to proper diagnosis and treatment. You can also expect that he or she will put needles in places that can be physically near or physically distant from your area of complaint but you can rest assured that they have a channel connection to whatever is being treated. You can expect that the needles used will be sterile and one-time use only and that while you may feel a pin prick when they go in, there’s a better chance that you will not because the needles are so small they’re often not felt and they rarely hurt. Now that we have a reasonable basic understanding of Chinese medicine theory, let us continue by discussing some research on the treatment of IBS with Chinese medicine. The treatment of IBS with TCM – Review of TCM random controlled trials. Before I get into the details of research proven Chinese medicine IBS treatment, let me first speak a little about the challenge of double-blind placebo when it comes to this medicine. As I mentioned above, the gold standard of Chinese medicine is pattern differentiation and individually tailored treatment where no two people are treated alike, even for the same disease. The gold-standard of Western research, however, is double-blind placebo, where everyone gets the same treatment which is compared to a placebo equivalent to no treatment and herein lies the dilemma. First, how do we treat individuals with stock randomized herbs if their pattern differentiations are different for the same Western medical disease and second, how do we placebo-double blind the act of sticking needles into people? These are big questions and important concerns and some researchers have come up with very elegant solutions that I will share with you as I tell you about the following research studies. I also want to tell you this because it’s important to understand that there is a wide range of Chinese medicine research out there, some which is very good and some which is very bad because people didn’t fully understand these challenges and tried to force the round peg of Chinese medicine into the square hole of placebo-double-blind study and I will share one of these studies with you as well. I urge you, therefore, to read Chinese medicine research carefully and if you are unclear or concerned about whether a new study is good, bad or indifferent ask a Chinese medicine practitioner that you trust to review it with you to help you understand if they have represented our medicine accurately. With that said, first on our list is a very well designed study that was published in the November 1998 issue of the Journal of the American Medical Association, or JAMA, entitled “Treatment of Irritable Bowel Syndrome with Chinese Herbal Medicine: A Randomized Controlled Trial” by an Australian research group headed by Alan Bensoussan. To address the issue of reconciling individualized treatment with the format of double- blind placebo research, a total of 116 patients enrolled in the study were randomized to three different groups. A placebo group, a standard herbal formula group and an individualized herbal treatment group. The standard herbal formula was designed by a group of several Chinese herbalists to address the major Chinese medical pattern differentiations for IBS in a balanced manner. Those patients in the individualized herbal formula group were treated by individual Chinese medicine practitioners. All participants were made to wait 30 minutes to receive their herbal prescriptions, which were powdered and encapsulated, after each consultation to ensure proper blinding. (Bensoussan 1585-1589, 1998) Patients enrolled satisfied the ROME criteria for IBS and were excluded for food allergies, celiac disease, gastric ulcers, and for any other symptoms or current medications that could affect their IBS symptoms. They were not excluded or included for any specific type of IBS – i.e. constipation, diarrhea or alternating predominant. Patients received 5 capsules three times a day. They consulted with a Chinese herbalist every two weeks for one month and every month thereafter for a four-month treatment period. They were assessed by completing questionnaires while they waited for their herbs to be prepared at their Chinese herbal consultations as well as by a follow up questionnaire 14 weeks post treatment. They were also assessed using the Bowel Symptom Scale (BSS) and were each evaluated by a gastroenterologist who was blinded as to which treatment group the patient was randomized to before entering the study, at 8 weeks of treatment, at 16 weeks of treatment, which marked the end of the treatment period, and at a follow up 14 weeks after the completion of the study. (Bensoussan 1585-1589, 1998) Two patients withdrew from the trial because of discomfort associated with treatment. One experienced upper gastrointestinal discomfort from the standard Chinese herbal formulation and a second patient developed headaches from the same but no other major adverse effects were noted by any patients. Liver function tests were also performed regularly on all patients to ensure safety and no Liver tests showed any abnormal values. At the end of the trial, only 33% of the patients on placebo reported that they felt improvement compared to 76% of patients receiving the standard herbal formulation and 64% of patients receiving individualized treatment. As rated by the gastroenterologist, 30% of patients receiving placebo showed improvement on evaluation as compared to 78% of patients on the standard herbal formulation and 50% of patients on the individualized herbal formula. The outcome of this study was very positive, showing clear benefits to Chinese herbal treatment for IBS versus placebo with little to no side effects. Interesting, however, were the statistics for standardized herbal treatment compared to individualized treatment. Individualized treatment is the hallmark of Chinese medicine but in this study, patients who received the standard formulation showed a higher rate of improvement during the treatment period. The interesting part is that after the follow up period, the patients who received the individualized herbal formulas maintained the results of their treatment while those that received the standard herbal formula did not maintain the same rate of symptom improvement. This suggests that while the standard herbal formula may provide more short-term relief, the individualized formulas may have a more long-term effect. (Bensoussan et al. 1585-1589, 1998) The next study I would like to share was published in July 2005 in the World Journal of Gastroenterology and is the most recent study on IBS treatment with Chinese medicine. Entitled “Acupuncture for Irritable Bowel Syndrome: A blinded placebo-controlled trial,” it was completed at St. Mark’s Hospital in the United Kingdom by a group of six researchers. Sixt patients were recruited to participate in the study and were required to have IBS diagnosed by ROME criteria, have no other conditions and use no drugs that would affect their digestion or gastric motility, and also have tried and not responded to conventional Western treatment for IBS. (Forbes et al. 4040-4044, 1998) Two acupuncturists were recruited to treat patients. The first was designated as the “Diagnosing Acupuncturist” or DA who diagnosed an wrote prescriptions for all patients. Patients would meet with the DA before and after treatment when the DA would take case history information, perform tongue and pulse assessment and give patients dietary and lifestyle advice depending on their syndrome differentiation. The second “Treating Acupuncturist” or TA would open a randomization envelope that designated whether the patient was to receive the acupuncture treatment prescribed by the DA or a sham acupuncture treatment and carry out the treatment as prescribed. The TA was the only treater/evaluator who was not blinded. “Real” acupuncture consisted of inserting eight to sixteen needles at 4-8 acupuncture sites bilaterally that were left in place momentarily or retained for up to 25 minutes depending on the patients syndrome differentiation by the DA. “Sham” acupuncture consisted of inserting an unmentioned number of needles in three different areas of the body, namely the anterior thigh, posterior thigh and lateral aspect of the low back, which do not correspond to recognized acupuncture points. Needle technique and length of retention were varied as in genuine treatment though how they were varied was not published in the study. (Forbes et al. 4040-4044, 1998) Outcomes were measured by having the patients complete weekly symptom diaries based on the Bristol scale and by being assessed by a physician at entry and prior to exit. The primary outcome measure was a change in symptom score. Of the sixty enrolled study participants, 59 completed the study and no adverse events were recorded. Overall, the patients receiving true acupuncture showed a 40% improvement in symptom score while the patients receiving sham acupuncture showed a 30% improvement in symptom score. This is not considered to be a statistically significant improvement over placebo treatment and therefore, this study did not recommend acupuncture as a worthwhile treatment for IBS in a European hospital setting. (Forbes et al. 4040-4044, 1998) This, however, is an example of a relatively poor Chinese medicine study but, as the most recently published randomized controlled trial of Chinese medicine treatment for IBS, it warrants reviewing. The most basic criticism is that this study is not reproducible – a requirement of any randomized controlled trial Western or Eastern in nature. It is admirable that they decided to treat patients individually the way Chinese medicine was meant to be practiced, but this is no reason not to explain what points were used, why they were used, what diagnoses were given and how long needles were retained or how the needles were manipulated to elicit what kind of effect. Furthermore, the method of sham acupuncture used still involved inserting needles into the body rather than more accepted placebo versions of sham acupuncture where patients are first of all required never to have experienced acupuncture before so they enter with no expectations, and second, are draped in such a way as to not be able to see where the needles will be (or will not be) inserted. In this way, patients receiving sham acupuncture can have a sharp object such as a pin or toothpick tapped against the skin without puncturing it to mimic the insertion of a needle without ever actually stimulating any sort of acupuncture response anywhere in the body. A third criticism of this study, is that only a single acupuncturist was responsible for diagnosing and prescribing treatment for the entire study rather than having a panel of Chinese medicine practitioners at least choose points, such as in the herbal study discussed earlier. A panel of practitioners rules out, or at least decreases, the possibility of personal error in diagnosis and prescription. Positive and well-derived randomized controlled trials of acupuncture do exist, however, though I could not find any other randomized controlled trials concerning IBS and Chinese medicine in particular. While the exact cause of IBS from a Western medical perspective is poorly understood, as I mentioned at the beginning of this discussion, it is accepted that stress plays a major role in aggravating IBS symptoms. I would like, therefore, to mention another randomized controlled trial entitled “Acupuncture Inhibits Sympathetic Activation During Mental Stress in Advanced Heart Failure Patients,” which was published in the Journal of Cardiac Failure in December 2002. (Middlekauff et al. 399-406, 2002) Mental stress induces a sympathetic nervous response in the body, also knows as a “fight or flight” response. This study measured muscle sympathetic nerve activity, or MSNA, in fifteen advanced heart failure patients during acute mental stress testing before and during real acupuncture, non-acupoint acupuncture and a no-needle acupuncture control. (Middlekauff et al. 399-406, 2002) Fourteen of the fifteen patients were acupuncture naïve. The points chosen for treatment were listed in the study and the specific points were chosen because they were either associated with stress reduction or had been used in previous studies treating heart failure. The same points and stimulation methods were used on each patient receiving real acupuncture. Non-acupoint acupuncture was performed bilaterally in a non-acupuncture point in the anterior deltoid muscle, and no- acupuncture was performed by placing and tapping an empty guide- tube on the skin in an area out of view of the patient. All acupuncture was performed by the same licensed acupuncturist and no adverse affects were reported as a result of acupuncture treatment. (Middlekauff et al. 399-406, 2002) Mental stress testing was performed for 4 minutes by either the Stoop color word test or mental arithmetic. Each patient was asked to assess task difficulty on completion of each task on a scale of 0 to 4 where 0 is not stressful at all and 4 is very, very stressful. Blood pressure and heart rate were also monitored with an automatic blood pressure cuff and an electrocardiogram. (Middlekauff et al. 399-406, 2002) The major finding of this study was that sympathetic activation during mental stress “is virtually eliminated” after acupuncture at the acupoints LI-4, Pc-6 and LR-3 and that this is not a placebo effect because during non-acupoint and no needle acupuncture, sympathetic activation as measured by MSNA was not decreased compared to baseline. (Middlekauff et al. 399-406, 2002) While this study was not directly on Irritable Bowel Syndrome, it does prove that acupuncture is effective in treating stress and decreasing sympathetic fight or flight response. As this is recognized as a major aggravator of IBS symptoms in all types of IBS – constipation, diarrhea and alternating – it stands to reason that acupuncture can be a reasonable treatment to relieve stress associated IBS symptoms. Additional TCM studies/articles While Western randomized controlled trials dealing with the treatment of IBS with Chinese medicine are few and far between, more and more articles about and case study examples of IBS treatment with Chinese medicine are appearing in Chinese medicine journals. This indicates that more IBS patients are seeking out Chinese medical treatment irregardless of how much, or more accurately how little, Western research on IBS treatment efficacy has been done. While none of the Western randomized controlled trials featured a combination of acupuncture and herbal treatment, this is most often the type of treatment prescribed and discussed in the Chinese medicine journal articles that I surveyed when preparing for this discussion. (Lade 10- 16, 1998; Li 16-18, 2004; Lewis 9-12, 1992; Mauer 53-57, 1998; Pagon 28-31, 2002; Yu 27-30, 2005) I have a printed list of these Chinese medicine journal articles available for anyone who is interested in reading more specifics about Chinese medicine treatment of IBS that I will hand out at the end of this discussion. Rather than discuss each of these articles, however, I will just share the highlights of one of them with you because truth to tell, the essence of these articles are all the same – it works. And not only does it work, but the combination of herbs, acupuncture and dietary change can work well enough to be curative in some cases. In an article by Dr. Zhenbo Li, a professor at OCOM with a Ph.D. from Guangzhou University of Traditional Chinese Medicine, that was published in the 2004 issue of The Journal of Chinese Medicine, Dr. Li discusses two main pattern differentiations for IBS. Namely, these are two of the same patterns I mentioned earlier – Spleen Qi Deficiency and Liver Overacting Spleen. For each of these patterns she gives a point prescription and needling protocol along with a basic herbal formula prescription and a series of possible modifications to better tailor the herbal formula to an individual’s personal symptomology. In the end, she discusses three cases from her clinical experience. One patient received a series of eight acupuncture treatments, one a series of fifteen, and one a treatment course lasting two months. Each were also given dietary advice based on their individual constitutional picture and daily Chinese herbs. By the end of each treatment period, each patient was fully recovered and had no more IBS symptoms. (Li 16-18, 2004) Conclusion In conclusion, I feel confident in suggesting that Chinese medicine is a worthwhile adjunctive and or alternative therapy to Western biomedical treatment for irritable bowel syndrome of any type. Both Western pharmaceutical and Traditional Chinese Medicine treatments for irritable bowel have been proven effective in randomized controlled trials. I personally believe that if you had to choose one treatment over the other, Traditional Chinese Medicine treatment has an edge over current Western medical treatment for this disease. Chinese medicine has the benefit of over 2,000 years of experience in treating internal medicine disorders with little to no side effects. While Western medicine does not have a clear understanding of the underlying cause of irritable bowel syndrome, Chinese medicine is able to specifically diagnose IBS using its holistic and energetic understanding of the body and then directly treat both the symptoms and the underlying energetic imbalance. From personal experience and the cases presented in a number of Chinese medicine journals spanning the past ten years, I can say that Chinese medicine can be curative for this condition, but I can’t say that it will cure everyone. If there is one thing Chinese medicine teaches above all, it is that everyone is an individual and that means that not only should everyone be treated specifically and individually, but also that everyone has the potential to respond differently to treatment. I can tell you Chinese medicine cured me, I can tell you that I am confident that it can be an effective alternative and certainly a worthwhile adjunctive therapy to Western medical treatment, but I can’t tell you that Chinese medicine will cure you because I don’t know. We are different and unique, but you will never know unless you try and in light of the information I have shared with you today, I hope that you will at least feel comfortable to try Chinese medicine for the treatment of your own IBS if you suffer from this disorder or recommend it to an affected friend or family member. |
Bibliography
a. Bensoussan, A, NJ Talley, M Hing, et al. “Treatment of irritable bowel syndrome with Chinese herbal medicine: a randomized controlled trial.” JAMA 280.18 11 Nov. 1998: 1585- 1589.
b. Forbes, A, S Jackson, C Walter, et al. “Acupuncture for irritable bowel syndrome: A blinded placebo-controlled trial.” World Journal of Gastroenterology 11.26 14 July 2005: 4040- 4044.
c. IBS Self Help and Support Group. Ed. Jeffrey D. Roberts B.Sc.. 21 Oct. 2005. Irritable Bowel Syndrome Association, The IBS Network-UK, American Self-Help Clearinghouse, Self-Help Resource Center. 26 Oct. 2005. <http://www.ibsgroup.org/main/drugs.html>.
d. Li, Zhenbo. “The Treatment of IBS by Acupuncture.” The Journal of Chinese Medicine 74. 2004: 16-18.
e. Merck & Co., Inc.. Merck Manual 17th Edition. Ed. Mark H. Beers, M.D., Robert Berkow, M.D., Robert M. Bogin, M.D., et al. Whitehouse Station, N.J.: Merck Research Laboratories, 1999.
f. Middlekauff, Holly R, Hui Kakit, Jun L. Yu, et al. “Acupuncture Inhibits Sympathetic Activation During Mental Stress in Advanced Heart Failure Patients.” Journal of Cardiac Failure 8.6 Dec. 2002: 399-406.
g. Morgan, V, D Pickens, S Gautam, et al. “Amitriptyline reduces rectal pain related activation of the anterior cingulate cortex in patients with irritable bowel syndrome.” Gut 54. 2005: 601- 607.
h. National Digestive Diseases Information Clearinghouse (NDDIC). Ed. Alan Spiegel. 14 May 2004. National Institute of Health. 29 Nov. 2005. <http://digestive.niddk.nih.gov/statistics/statistics.htm#specific>.
i. Nyhlin, H, C Bang, L Elsborg, et al. “A double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome.” Scandinavian Journal of Gastroenterology 39.2 Feb. 2004: 119-126.
j. Thompson, W G. ROME II: Diagnostic Criteria for The Functional Gastrointestinal Disorders. n.d. 15 Jan. 2006. <http://www.romecriteria.org/history.html>. The official website of the ROME Criteria.
k. Chinese Acupuncture and Moxabustion. Ed. Xinnong Cheng. Beijing: Foreign Languages Press, 1987.
l. Lade, Heiko. “Irritable Bowel Syndrome.” Pacific Journal of Oriental Medicine n15. 1998: 10-16.
m. Lewis, Peter J. “Irritable Bowel Syndrome: Emotional Factors and Acupuncture Treatment.” The Journal of Chinese
Medicine n40. 1992: 9-12.
n. Maciocia, Giovanni. Foundations of Chinese Medicine. Edinburgh: Churchill Livingstone, 1989.
o. Maciocia, Giovanni. Practice of Chinese Medicine. Edinburgh: Churchill Livingstone, 1994.
p. Mauer, Charles F. “Acupuncture & Irritable Bowel Syndrome.” Oriental Medicine Journal 7.1 1998: 53-57.
q. Pagon, Andrew. “Treatment by Traditional Oriental Medicine: Irritable Bowel Syndrome.” The Journal of Chinese Medicine n58. 2002: 28-31.
r. Yu, Su-Ping, Hui Ye, Nan-Lin Ha, et al. “Effect of Modified Sinisan on Anorectal Manometry of the Constipation Predominant Type of Irritable Bowel Syndrome.” Chinese Journal of Integrative Medicine 11.1 Mar. 2005: 27-30.
s. The Merck Manuals Online Medical Library. 1 Feb. 2003. Merck & Co., Incorporated. 15 Jan. 2006. <http://www.merck.com/mmhe/sec09/ch118/ch118h.html>.
t. Wald, Arnold. UpToDate Patient Information. 30 Aug. 2004. University of Pittsburgh Medical Center. 29 Nov. 2005. <http://patients.uptodate.com/topic.asp?file=digestiv/8576>.
u. Rx List: The Internet Drug Index. 27 Dec. 2004. Rx List Inc. 26 Oct. 2005. <http://www.rxlist.com/cgi/generic3/zelnorm_cp.htm>.
v. The National Women’s Health Information Center. June 2005. U.S. Department of Health and Human Services. 15 Jan. 2005. <http://womenshealth.gov/faq/ibs.htm#2>.
b. Forbes, A, S Jackson, C Walter, et al. “Acupuncture for irritable bowel syndrome: A blinded placebo-controlled trial.” World Journal of Gastroenterology 11.26 14 July 2005: 4040- 4044.
c. IBS Self Help and Support Group. Ed. Jeffrey D. Roberts B.Sc.. 21 Oct. 2005. Irritable Bowel Syndrome Association, The IBS Network-UK, American Self-Help Clearinghouse, Self-Help Resource Center. 26 Oct. 2005. <http://www.ibsgroup.org/main/drugs.html>.
d. Li, Zhenbo. “The Treatment of IBS by Acupuncture.” The Journal of Chinese Medicine 74. 2004: 16-18.
e. Merck & Co., Inc.. Merck Manual 17th Edition. Ed. Mark H. Beers, M.D., Robert Berkow, M.D., Robert M. Bogin, M.D., et al. Whitehouse Station, N.J.: Merck Research Laboratories, 1999.
f. Middlekauff, Holly R, Hui Kakit, Jun L. Yu, et al. “Acupuncture Inhibits Sympathetic Activation During Mental Stress in Advanced Heart Failure Patients.” Journal of Cardiac Failure 8.6 Dec. 2002: 399-406.
g. Morgan, V, D Pickens, S Gautam, et al. “Amitriptyline reduces rectal pain related activation of the anterior cingulate cortex in patients with irritable bowel syndrome.” Gut 54. 2005: 601- 607.
h. National Digestive Diseases Information Clearinghouse (NDDIC). Ed. Alan Spiegel. 14 May 2004. National Institute of Health. 29 Nov. 2005. <http://digestive.niddk.nih.gov/statistics/statistics.htm#specific>.
i. Nyhlin, H, C Bang, L Elsborg, et al. “A double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome.” Scandinavian Journal of Gastroenterology 39.2 Feb. 2004: 119-126.
j. Thompson, W G. ROME II: Diagnostic Criteria for The Functional Gastrointestinal Disorders. n.d. 15 Jan. 2006. <http://www.romecriteria.org/history.html>. The official website of the ROME Criteria.
k. Chinese Acupuncture and Moxabustion. Ed. Xinnong Cheng. Beijing: Foreign Languages Press, 1987.
l. Lade, Heiko. “Irritable Bowel Syndrome.” Pacific Journal of Oriental Medicine n15. 1998: 10-16.
m. Lewis, Peter J. “Irritable Bowel Syndrome: Emotional Factors and Acupuncture Treatment.” The Journal of Chinese
Medicine n40. 1992: 9-12.
n. Maciocia, Giovanni. Foundations of Chinese Medicine. Edinburgh: Churchill Livingstone, 1989.
o. Maciocia, Giovanni. Practice of Chinese Medicine. Edinburgh: Churchill Livingstone, 1994.
p. Mauer, Charles F. “Acupuncture & Irritable Bowel Syndrome.” Oriental Medicine Journal 7.1 1998: 53-57.
q. Pagon, Andrew. “Treatment by Traditional Oriental Medicine: Irritable Bowel Syndrome.” The Journal of Chinese Medicine n58. 2002: 28-31.
r. Yu, Su-Ping, Hui Ye, Nan-Lin Ha, et al. “Effect of Modified Sinisan on Anorectal Manometry of the Constipation Predominant Type of Irritable Bowel Syndrome.” Chinese Journal of Integrative Medicine 11.1 Mar. 2005: 27-30.
s. The Merck Manuals Online Medical Library. 1 Feb. 2003. Merck & Co., Incorporated. 15 Jan. 2006. <http://www.merck.com/mmhe/sec09/ch118/ch118h.html>.
t. Wald, Arnold. UpToDate Patient Information. 30 Aug. 2004. University of Pittsburgh Medical Center. 29 Nov. 2005. <http://patients.uptodate.com/topic.asp?file=digestiv/8576>.
u. Rx List: The Internet Drug Index. 27 Dec. 2004. Rx List Inc. 26 Oct. 2005. <http://www.rxlist.com/cgi/generic3/zelnorm_cp.htm>.
v. The National Women’s Health Information Center. June 2005. U.S. Department of Health and Human Services. 15 Jan. 2005. <http://womenshealth.gov/faq/ibs.htm#2>.
