Keywords: Chinese medicine, Chinese herbal medicine, gastro-enterology, gastro-esophageal reflux disease (GERD)

Gastro-esophageal reflux disease, commonly referred to as GERD, or acid reflux, is a condition in which the liquid content of the stomach regurgitates (backs up, or refluxes) into the esophagus. This results in the subjective sensation of heartburn and may cause inflammation of the esophagus. GERD is a chronic condition. Once it begins, it is usually life-long. If there is injury to the lining of the esophagus (esophagitis), this also is a chronic condition. Moreover, after the esophagus has healed with Western medical treatment and treatment is stopped, the injury will return in most patients within a few months. As many as ten percent of Americans have episodes of heartburn (pyrosis) every day, and 44% have symptoms at least once a month. In all, GERD affects an estimated 25-35% of the US population. Psychological well-being questionnaires have found that patients with GERD can have a worse quality of life than some patients with menopausal symptoms, peptic ulcer disease, angina, or even congestive heart failure. GERD is one of the more popular disorders for research published in Chinese medical journals in the People's Republic of China. Therefore, there is a large body of literature on this subject in Chinese suggesting that Chinese medicine provides safe and effective treatments for this condition. Below are abstracts of recently published Chinese research on GERD.

Clinical Trial #1
On page 53 of issue #5, 2005 of Guang Ming Zhong Yi (Guangming Chinese Medicine), Li Fu-wang published an article titled, "Observations on the Therapeutic Effects of Treating 86 Cases of Gastro-esophageal Reflux Disorder with Chai Hu Shu Gan San Jia Wei (Bupleurum Course the Liver Powder with Added Flavors)."

Cohort Description
Altogether, there were 164 outpatients enrolled in this two-wing comparison study. All met the diagnostic criteria for GERD established at the August 1999 Chinese Gastroenterology Symposium. These 164 were randomly divided into two groups – a treatment group of 86 and a comparison group of 78. In the treatment group, there were 30 males and 56 females with an average age of 41 years. In the comparison group, there were 28 males and 50 females with an average age of 39 years. The average course of disease in both groups was three months. In the treatment group, 72 cases also had a diagnosis of chronic cholecystitis, 25 had a diagnosis of gallstones, 43 had a diagnosis of chronic persistent hepatitis, and six cases had a diagnosis of endohepatic vascular tumor. In the comparison group, the incidence of these accompanying diagnoses were respectively 65, 22, 36, and five.

Treatment Method
All members of the comparison group received 20 milligrams per os b.i.d. of luo sai ke jiao nong (an unidentified, presumably Western pharmaceutical) and one tablet of Ulcerlmin ten minutes before meals. The treatment group took the same Western medicines and, in addition, the following version of Chai Hu Shu Gan San Jia Wei:

Chai Hu (Radix Bupleuri), 12g
Zhi Ke (Fructus Aurantii), 12g
Bai Shao (Radix Paeoniae Albae), 12g
Chen Pi (Pericarpium Citri Reticulatae), 15g
Chuan Xiong (Rhizoma Chuanxiong), 10g
Xiang Fu (Rhizoma Cyperi), 15g
mix-fried Gan Cao (Radix Glycyrrhizae), 10g

One packet of these medicinals was decocted in water two times per day to obtain 600 milliliters of medicinal fluid which was administered in two divided doses morning and evening.

If there was simultaneous qi stagnation, Xiao Yao San (Rambling Powder) was added.

If there was spleen-stomach vacuity weakness, 12 grams of Bai Zhu (Rhizoma Atractylodis Macrocephalae) and 15 grams of Fu Ling (Poria) were added.

If cold dampness was exuberant, 12 grams each of Gao Liang Jiang (Rhizoma Alpiniae Officinari) and Gui Zhi (Ramulus Cinnamomi) were added.

If there was liver-gallbladder damp heat, 20 grams of Long Dan Cao (Radix Gentianae) and Liu Yi San (Six [to] One Powder) were added.

If hiccup and vomiting were severe, 15 grams of Xuan Fu Hua (Flos Inulae) and 20 grams of Dai Zhe Shi (Haemititum) were added.

If there was constipation with dry, bound stools, 10 grams of Da Huang (Radix Et Rhizoma Rhei) were added.

If the disease was mild, the above medicinals were administered until the symptoms disappeared and then continued for one more week. If the symptoms were severe, the medicinals were continued for four weeks.

Study Outcomes
Outcomes were based on a point system for the ranking of endoscopic findings. Cure was defined as zero points. A marked effect was defined as a decrease of two points. Some effect meant that there was a decrease of one point, while no effect meant there was no change or that endoscopic findings worsened by one point or more. Table 1 shows the outcomes based on these criteria.

Table 1: Clinical Trial #1 Outcomes

These outcomes showed that the combined protocol of Chinese and Western medicine was significantly more effective than the Western medical treatment alone (P + 0.05).

Discussion
It is Dr. Li's opinion that this condition's disease mechanism is a mutual binding of phlegm and qi and that it is mostly associated with psycho-emotional dysregulation. The liver governs coursing and discharge. On the one hand, this means the coursing and discharge of bile; on the other, it means the regulation and smoothing of the affects and mind. If the qi mechanism is regulated, the spleen is able to fortify and transport, and the stomach is able to accept and absorb. If the liver qi becomes constrained and depressed, there is loss of coursing and discharge, and the qi mechanism becomes obstructed and stagnant. The liver channel spreads to the rib-sides. Therefore, liver depression manifests as chest and rib-side distention, oppression, and discomfort. Spleen loss of fortification and movement leads to the duct and abdomen developing glomus, congestion, and discomfort. Stomach loss of harmony and downbearing leads to nausea, hiccup, and vomiting. Within the above formula, Chai Hu courses the liver and rectifies the qi, regulates and eases the flow of the qi mechanism. Zhi Ke rectifies the qi and moves the qi. When combined with Chai Hu, the clear is upborne and the turbid is downborne. Bai Shao nourishes yin and restrains yang, emolliates the liver, and relaxes tension or cramping. When combined with Chai Hu, one scatters and the other collects. Together, they rectify the liver qi. Bai Shao plus Gan Cao is able to relax cramping and stop pain. Chen Pi moves the qi and harmonizes the stomach. Chuan Xiong quickens the blood and transforms stasis. When combined with Bai Shao, the qi and blood are both rectified at the same time. Xiang Fu moves the qi within the chest and strengthens the force of the movement of qi. When all these medicinals are used together, their effect is to course the liver and rectify the qi, fortify the spleen and harmonize the stomach, regulate and harmonize yin and yang, free the flow and normalize upbearing and downbearing.

Clinical Trial #2
On pages 544-545 of issue #6, 2005 of the Shi Yong Zhong Yi Nei Ke Za Zhi (Journal of Practical Chinese Medicine Internal Medicine), Liao Mao-jie published an article titled, "The Treatment of 80 Cases of Reflux Gastritis with Self-composed Jia Wei Chai Hu Shu Gan San (Added Flavors Bupleurum Course the Liver Powder)."

Cohort Description
Altogether, there were 160 in-patients enrolled in this two-wing comparison study who were equally and randomly divided into two groups of 80 each – a treatment group and a comparison group. In the treatment group, there were 52 males and 28 females. Forty-four of these were aged 25-40 years, and 36 were 40-55-years-old. These patients had suffered from this condition for one to three years. In the comparison group, there were 53 males and 27 females. Forty-three of these were 26-40, and 37 were 40-54-years-old. These patients had likewise suffered from this disorder for one to three years. Therefore, both groups were judged to be statistically comparable. In terms of diagnostic criteria, there was upper abdominal distention and fullness, pain, burping/belching, upper back and rib-side distention and pain, a bitter taste in the mouth, and torpid intake. In addition, fiber optic endoscopy showed marked hyperemia and edema of the stomach mucosa as well as varying degrees of bile entering the stomach. Patients with other digestive system diseases and duodenal ulcers were excluded from this study.

Treatment Method
All members of the treatment group were administered the following Chinese medicinals:

Yin Chen Hao (Herba Artemisiae Scopariae), 15g
Lian Qiao (Fructus Forsythiae), 15g
Yu Jin (Tuber Curcumae), 15g
Chai Hu (Radix Bupleuri), 15g
Bai Shao (Radix Paeoniae Albae), 15g
Xiang Fu (Rhizoma Cyperi), 15g
Zhi Ke (Fructus Aurantii), 15g
Chen Pi (Pericarpium Citri Reticulatae), 15g
Chuan Xiong (Rhizoma Chuanxiong), 10g
Gan Cao (Radix Glycyrrhizae), 10g

One packet of these medicinals was decocted in water and administered per day in two divided doses, with 30 days equaling one course of treatment.

All members of the comparison group were administered 3.75 g t.i.d. of Wei Kang Ding Pian (Stomach Health Calming Tablets) plus 45 mg t.i.d. of Ma Ding Lin Pian (an unidentifiable Western drug). Likewise, thirty days equaled one course of treatment in this group.

Study Outcomes
Marked effect was defined as the disappearance of subjective symptoms and the basic disappearance or marked improvement in endoscopic findings of inflammation of the gastric mucosa. Improvement meant that the major portion of gastric mucosal inflammation was under control and the bile reflux had basically disappeared. No effect meant that neither of the preceding criteria were met. Table 2 shows the outcomes of these two groups based on the foregoing criteria.

Table 2: Clinical Trial #2 Outcomes

These outcomes show a marked statistical difference in outcomes between these two groups (P + 0.01).

Discussion
According to Dr. Liao, reflux gastritis is relatively difficult to treat, and it has basically two disease mechanisms. On the one hand, there is stomach qi congestion and stagnation with spleen loss of movement and transformation due to unregulated diet or external evils assailing the stomach. If depression transforms heat, this may then burn and damage stomach yin, resulting in inflammation of the gastric mucosa. On the other hand, due to worry, too much thinking, anxiety, and anger, the affects and mind lose their regulation, and the liver qi may become depressed and bound. Then liver wood may check earth. The spleen then loses its movement and transformation, and water and warmth collect internally. This may brew and transform heat, and this warmth and heat may ascend to steam the liver and gallbladder, resulting in loss of the liver's control over coursing and discharge. Hence, the bile is not able to be descended and drained to the small intestine but, instead, erroneously enters the stomach. This then causes even more inflammation of the gastric mucosa. Therefore, in sum, Dr. Liao believes that this condition's disease mechanism is mainly a liver-spleen-stomach disharmony. Jia Wei Chai Hu Shu Gan San is thus designed to course the liver and resolve depression, disperse inflammation and disinhibit the gallbladder, regulate and harmonize the liver and spleen, fortify the spleen and harmonize the stomach. Since the medicinals match the pattern, this treatment is markedly effective.

Clinical Trial #3
Campylobacter pylori has recently been isolated from gastric mucosal biopsy specimens. Campylobacter pylori produces abundant quantities of urease, and this property has been used to develop a rapid diagnostic test. The organism is found predominantly beneath the gastric mucosal layer that lines the surface epithelium of the stomach. Infection with C. pylori causes an acute histologic gastritis which may become chronic. The bacterium is the etiologic agent in type-B gastritis. Prevalence of the organism in asymptomatic persons appears to be age-related. Campylobacter pylori is found commonly in patients with peptic ulcer disease, always in association with chronic gastritis. Eradication of the organism is associated with healing of the gastritis and a lower relapse rate in duodenal ulcer disease. On page 553 of issue #6, 2005 of the Shi Yong Zhong Yi Nei Ke Za Zhi (Journal of Practical Chinese Medicine Internal Medicine), Zhou Qiong published an article titled, "The Treatment of 60 Cases of Gastritis Associated with Campylobacter Pylori with Qing You Tang (Clear the Secluded Decoction)."

Cohort Description
There were 37 males and 23 females enrolled in this study. These patients were 17-68 years of age, with an average age of 45. They had suffered from gastritis for 0.5-28 years, with an average disease duration of 6.3 years. All the patients had had electron gastroscopy, and tests for Campylobacter pylori were positive in all cases. In terms of Chinese medical pattern discrimination, all presented a pattern of spleen-stomach damp heat, the signs and symptoms of which included stomach duct pain, torpid intake, reduced appetite, burping/belching, clamoring stomach, acid eructation, abdominal distention, lack of strength, headache, irregular bowel movements, an abnormal taste in the mouth, a fat, pale red tongue with teeth-marks on its edges and yellow, slimy fur, and a soggy, moderate (i.e., slightly slow) pulse.

Treatment Method
Qing You Tang consisted of the following:

Cang Zhu (Rhizoma Atractylodis), 15g
Hou Po (Cortex Magnoliae), 10g
Chen Pi (Pericarpium Citri Reticulatae), 10g
Gan Cao (Radix Glycyrrhizae), 6g
Huang Lian (Rhizoma Coptidis), 6g
Zhu Ru (Caulis Bambusae In Taeniis), 10g
Pu Gong Ying (Herba Taraxaci), 15g
Zhi Ke (Fructus Aurantii), 15g
Pei Lan (Herba Eupatorii), 10g
Fu Ling (Poria), 10g
Ma Bo (Lasiosphaera/Calvatia), 10g

One packet of these medicinals was decocted in water and administered per day, with one week equaling one course of treatment.

Study Outcomes
Outcomes criteria were based on Shi Yong Zhong Xi Yi Jie He Zhen Duan Zhi Liao Xue (A Study of Practical Integrated Chinese-Western Medicine Diagnosis & Treatment). Cure was defined as disappearance of clinical symptoms one month after treatment, disappearance of signs of active inflammation of the stomach, and extensive improvement in the signs of chronic inflammation. A marked effect was defined as basic disappearance of clinical symptoms, basic disappearance of signs of acute inflammation of the gastric mucosa, and improvement in signs of chronic inflammation after one month. Some effect was defined as a marked decrease in clinical symptoms, shrinkage of the areas of pathological changes of the mucosa by one half or more, and a decrease in the signs of inflammation after one month. No effect meant that none of the above criteria were met after one month. Based on these criteria, 35 cases were judged cured, 19 got a marked effect, four got some effect, and two got no effect, for a total effectiveness rate of 96.7%.

Discussion
According to Dr. Zhou, gastritis associated with Campylobacter pylori is categorized in Chinese medicine as stomach duct pain, glomus and fullness, clamoring stomach, and swallowing acid and is commonly due to either a liver-stomach disharmony, spleen-stomach damp heat, spleen-stomach vacuity cold, or qi stagnation and blood stasis. In Dr. Zhou's experience, most patients present a pattern of spleen-stomach damp heat. Therefore, Dr. Zhou's treatment principles are to clear heat and disinhibit dampness, arouse the spleen and clear the lungs. Within the above formula, Cang Zhu, bitter, warm, and of a dry nature, eliminates dampness and fortifies the spleen. Hou Po moves the qi and transforms dampness, disperses distention and eliminates fullness. When combined with Chen Pi and Gan Cao, these medicinals comprise Ping Wei San (Level the Stomach Powder), which dries dampness and moves the spleen, moves the qi and harmonizes the stomach. When Huang Lian is added, these medicinals then dry dampness and clear heat. Pu Gong Ying clears liver-stomach depressive heat, clears heat and disinhibits dampness. Zhu Ru transforms phlegm and stops vomiting, while Ma Bo clears heat and depurates the lungs. This is based on the fact that the stomach's flow is normal when it is harmonious and downbears and the lungs govern the qi's depuration and downbearing. Zhi Ke is added to simultaneously regulate and rectify the spleen and stomach's qi mechanism. Pei Lan opens depression and arouses the spleen, while Fu Ling disinhibits dampness and fortifies the spleen. This strengthens the spleen and stomach qi in order to dispel evils. When all these medicinals are used together, their effect is to upbear the spleen and downbear the stomach and free the flow of the qi mechanism. In addition, pharmacological research has shown that Hou Po and Huang Lian are both anti-inflammatory and kill Campylobacter pylori. Fu Ling increases the strength of the body's immunity, and Pu Gong Yi disinhibits the bile, protects the liver, and combats ulcers.

Conclusion
As readers hopefully will have seen, the above research suggests that Chinese herbal medicine can be a safe and effective alternative for the treatment of GERD. The three randomized, controlled trials (RCTs) are only a fraction of those published in the last decade in China on the Chinese medical treatment of GERD, and all of these RCTs have shown essentially the same thing: Chinese medicine can treat this common disorder extremely well without any adverse reactions or side effects.

Copyright Blue Poppy Press, 2006. All rights reserved.