THE USE OF JIAN PI LING IN TREATING ULCERATIVE COLITIS

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THE USE OF JIAN PI LING IN TREATING ULCERATIVE COLITIS

Postby herbsandhelpers » Mon Jul 05, 2010 10:32 pm

THE USE OF JIANPILING IN TREATING ULCERATIVE COLITIS
by Subhuti Dharmananda


Background: Ulcerative Colitis and Crohn's Disease

Ulcerative colitis and Crohn's Disease are chronic inflammatory diseases of the intestines that may have similar causes. Crohn's disease produces the main ulcerative sites in the ileum, especially in young people, while ulcerative colitis is mainly confined to the rectal area. Both diseases may cause abdominal pain and diarrhea, but Crohn's is more often characterized by spasms and loss of appetite, while ulcerative colitis is more often characterized by bloody diarrhea. Ulcerative colitis occurs about ten times more frequently than Crohn's, and is, for that reason, more often the subject of clinical study. The causes are not firmly established, but may include chronic infection, allergy responses, autoimmune disease, and genetic predisposition; the condition worsening with emotional stress and poor dietary habits.

Western medical treatments usually focus on steroidal drugs to reduce the inflammation. In severe cases, intestinal portions that are unremittingly inflamed may be surgically removed. It has been noted that nicotine controls ulcerative colitis (the disease flares up when a smoker quits using tobacco), and it has been suggested, though not proven, that the new and safer nicotine delivery systems, such as nicotine patch or nicotine chewing gum, may help manage the disease.

In Chinese medical terms, most ulcerative intestinal disease is classified as spleen deficiency type, because it is believed that the spleen qi is necessary to maintain the health of the intestines. During the Yuan Dynasty, Li Gao developed the "stomach/spleen" school, treating most diseases by administering herbs benefiting these organs. One of his most lasting contributions to Chinese medicine was the prescription Ginseng and Astragalus Combination (Buzhong Yiqi Tang; literally: decoction to tonify the center and regulate the qi), which forms the basis for the majority of therapies for ulcerative colitis and Crohn's disease. The most extensively studied version of this basic formula is the prescription called Jian Pi Ling.

A Proven Formula: Jian Pi Ling

Jian Pi Ling (literally: the effective remedy for supporting the function of the spleen), is a modern prescription for treatment of ulcerative colitis. Its ingredients are:

Astragalus Astragalus membranaceous)
Codonopsis (Codonopsis pilosula)
Atractylodes (Atractylodes macrocephala)
Tang-kuei (Angelica sinensis)
Ginger, roasted (Zingiberis officinalis)
Licorice (Glycyrrhiza uralensis)
Peony (Paeonia lactiflora)
Saussurea (Jurinea souliei)
Mume (Prunus mume)
Catechu (Acacia catechu)
Corydalis (Corydalis bulbosa)


It is prepared as a tablet. The herbs are decocted, dried, and made into tablets of about 0.5 grams each, equivalent to 0.75 grams of crude dried herbs. The formula is a slightly modified version of Ginseng and Astragalus Combination, with codonopsis replacing ginseng (as is standard practice for virtually all such prescriptions in modern China); the first six ingredients are from the original formulation, with roasted ginger replacing fresh ginger, as is often done when there is diarrhea as a symptom. There are added ingredients for treating diarrhea (peony, saussurea, mume), pain (corydalis), and bleeding (catechu). These ingredients replace four items in the original prescription: bupleurum and cimicifuga for raising qi, citrus for drying dampness, and tang-kuei for nourishing blood. The dosages of the Jianpilingingredients were indicated in a 1991 report (7), with equal amounts of each ingredient, except 2/3 as much saussurea and 1/3 as much licorice as the other ingredients. After the first report of the use of this formula, two additional ingredients, rubus (Rubus parvifolius) and coptis (Coptis chinensis), that were included the first time, were no longer mentioned.

The designer and principle researcher of this formulation is Chen Zhishui, at the Department of Traditional Chinese Medicine, No. 211 Hospital of the Chinese People's Liberation Army (PLA). He reported in 1987 (1, 2, 3) that 60 patients were treated by this formula in tablet form for 40-60 days. He claimed that by endoscopic examination 2/3 of the cases were cured, and nearly all others showed some degree of clinical improvement (only 2 cases failing to show positive response).

The dosage given was 8 tablets three times daily (total 24 tablets per day), for a total dosage of 12 grams of herb materials per day, derived from 18 grams of crude materials. A control group of 26 patients was treated with salicylazosulfapyridine at 1 gram, four times per day, and some patients received other drugs (e.g., diphenoxylate and other spasmolytics). In the control group, 8 patients were reported cured (about one-third the group), while the others showed some degree of improvement (except 3 cases failing to show positive response). Additional testing, including erythrocyte count, hemoglobin, serum albumin, D-xylose excretion rate, and cellular immunity (E-rosette formation rate, lymphocyte transformation rate, etc.), were said to reveal that the Chinese herb group benefited significantly but the control group did not. Further, the one year recurrence rate for those treated by Jianpiling was 10% while for the drug group it was 57%. There was a third group of 31 cases treated by herbal decoctions prescribed according to traditional means, and their results were intermediate between the drug and Jianpiling groups.

In a laboratory study of the effects of the formula on rabbit small intestine, the formula, applied in the form of a decoction, apparently inhibited peristalsis, antagonized stimulation by acetylcholine and barium chloride (preventing tonic seizure), directly inhibited smooth muscle contraction, and had transient antagonism to epinephrine (4).
In a follow-up study reported in 1989 (5, 6), 268 patients (176 with chronic colitis, 92 with atypical ulcerative colitis) were treated with the same protocol. It was reported that 170 were cured (63%) and that almost all others showed some degree of improvement (only 4 cases not responding favorably). D-xylose testing suggested that there was enhanced small intestine functioning in patients who had diarrhea.

Another report by Chen in 1991 (7) describes treatment of 596 cases, all diagnosed by colonoscopy. The mean duration of disease was 8.7 years. Of these, 370 cases (62%) were said to be cured (with no relapse during a six month follow-up), and nearly all patients showed some improvement (6 patients failed to respond favorably) by taking Jianpiling. Colonoscopy revealed that congestion, edema, and granule alteration were eliminated in more than 70% of the cases, and erosion, mucus accumulations, and bleeding spots were eliminated in over 90% of the cases.

In 1994, Chen (8) reported on a double blind trial of Jianpiling, with 153 cases of intractable ulcerative colitis. A retention enema was added to the protocol, comprised of sophora root and flower (S. flavascentis). One control group received salicylazosulfapyridine (which had previously been shown by Chen to be less effective) and a second control group received a placebo. After three months treatment time, the results were 53% of the Jianpiling group was deemed cured, but only 28% of the sulfapyridine group and only 19% of the placebo group. Although the cure rate was lower than with a more generalized group of colitis sufferers (as had been tested previously), this level for "intractable" colitis is impressive, and the 2:1 efficacy ratio of Jianpiling to sulfapyridine that was found before was replicated. In addition, it was shown that IgG, IgM, and C3 (third complement protein) were elevated in patients at the beginning of the trial and lowered by treatment with Jianpiling.

Thus, according to the claims of Chen Zhishui, administration of a modest dosage of herbs for about two months can lead to a cure of colitis (symptoms and signs disappear, colonoscopy reveals normal mucosal membrane) in nearly 2/3 of cases, with a very low rate of recurrence, and in three months it can cure about half of intractable cases. He has stated that there is greater safety, less toxicity, and fewer adverse side-effects when using Jianpiling Tablets than when using drug therapies. These findings should be further evaluated by additional clinical testing, though the research center where Chen Zhishui works reported in 1997 that altogether about 10,000 patients have been treated with this formula (9).

Other Formulations and Differential Approach

A similar approach was mentioned in a report from the Shanghai College of Traditional Chinese Medicine, published in the Journal of Traditional Chinese Medicine (1985). A decoction made with codonopsis, atractylodes, hoelen, ginger, saussurea, citrus, fraxinus, and sanguisorba (fraxinus relieves inflammation of the intestines and sanguisorba inhibits intestinal bleeding) was given. For severe cases of the disease, another mixture, made with a decoction of gall (wubeizi) and portulacca (machixian), into which the powder of indigo (qingdai) and sanqi were suspended, was additionally administered as a retention enema. This combination treatment was reported to be effective in 2/3 of the severe cases treated.

The use of herb enemas for treatment of intestinal diseases is a common practice in China: in one study, reported in the Beijing Journal of Traditional Chinese Medicine (1991), 93% of 184 patients with ulcerative colitis were reported cured as the result of 40 days treatment with herbs given by rectal infusion alone.

In the Journal of Traditional Chinese Medicine (1986), a treatment protocol for chronic colitis began with the division of patients into four categories, all of them involving stomach/spleen deficiency, for which four different formulas were administered accordingly:

1. Stomach/Spleen Deficiency Type: astragalus, codonopsis, atractylodes, saussurea, peony, licorice, citrus, bupleurum, cimicifuga, lotus seed, oldenlandia, and pulsatilla. The first six ingredients are in common with Jianpiling, and the citrus, bupleurum, and cimicifuga are ingredients of the original Ginseng and Astragalus Combination. Lotus seed is an astringent for diarrhea, and oldenlandia plus pulsatilla treat infection.

2. Deficiency Complicated by Cold: the same formula as above, but add the warming herbs aconite and ginger, delete the cooling herb bupleurum.

3. Deficiency Complicated by Damp Heat: astragalus, lotus seed, bupleurum, chih-shih, peony, coptis, pulsatilla, artemisia, sanguisorba. In this case, the base formula is Bupleurum and Chih-shih Formula (Si Ni San), with artemisia and sanguisorba to control bleeding.

4. Qi and Yin Deficiency: astragalus, lotus seed, atractylodes, tang-kuei, rehmannia, ophiopogon, melia, cimicifuga, pulsatilla, artemisia, sanguisorba, and rubia. In this case, tang-kuei, rehmannia, and ophiopogon nourish the yin and blood, while artemisia, sanguisorba, and rubia control bleeding.

The formulas were modified for certain symptoms: with incontinence of feces, add schizandra, kaolin, and pomegranate; for mucus in the feces, add pinellia, atractylodes (cangzhu), and bakeri; for sharp pain, add peony and corydalis; for bleeding, use the patent formula Yunnan Pai Yao. For severe cases, a retention enema with hemostatic herbs was used additionally. It was claimed that 84% of patients had notable improvements after using this treatment for three months.

In another study relying on modified Ginseng and Astragalus Combination, reported in the Hubei Journal of Traditional Chinese Medicine (1991), 12 patients, some with Crohn's disease and some with other chronic colitis disorders, were treated with a decoction of astragalus, codonopsis, atractylodes, citrus, cimicifuga, bupleurum, licorice, dolichos, and chih-ko for 24 to 120 days. Five patients were cured and there was no recurrence within a follow-up period of six months.

In the Jiangxi Journal of Traditional Chinese Medicine (1985) a variation of Pinellia Combination (Banxia Xiexin Tang) was mentioned as a treatment for chronic colitis. The ingredients were pinellia, coptis, scute, ginger, ginseng, licorice, jujube, pueraria, smilax, oldenlandia, and dandelion. Pueraria is often used in cases where diarrhea is accompanied by intestinal irritation: it is a source of soothing starch and anti-inflammatory flavonoids. Smilax, oldenlandia, and dandelion inhibit infection and inflammation. Twelve of fifteen patients were reported cured by this method, using a one to four month treatment time.

In the Compendium of Secret Chinese Traditional Formulas, several studies relying on spleen-tonifying methods are mentioned under the heading ulcerative colitis. Among the main formulas are:

Bupi Tongyong Fang: astragalus, codonopsis, atractylodes, licorice, saussurea, dioscorea, hoelen, crataegus, and cardamon.
Manxing Jie Changyan Fang: codonopsis, atractylodes, lotus seed, hoelen, plantago seed, purslane, malt, and oryza.

Bao Yuan Zhong Ji: astragalus, codonopsis, atractylodes (cangzhu), licorice, bletilla, agastache, zanthoxylum, cinnamon bark, sanqi, and terminallia.

Jianpi Lizhong Fang: astragalus, codonopsis, atractylodes, ginger, peony, tang-kuei, corydalis, chih-shih, catechu (ercha), cinnamon bark, mume, rubus, and cimicifuga.

These prescriptions were given to nearly 300 patients, and 77% were rated as cured. Treatment time was typically three months, though some patients were able to discontinue treatment before then due to good therapeutic results and some patients required four months of therapy. Sanqi vitalizes blood circulation and stops bleeding and it also has qi and blood nourishing actions. It is one of the main ingredients of Yunnan Pai Yao, and it has been used successfully in treating ulcerative colitis in combination with pearl powder, as reported in the Chinese Journal of Integrated Traditional and Western Medicine (1990). The effects of such Chinese formulas given for a few months is usually lasting. In a study reported in Henan Traditional Chinese Medicine (1987), 21 cases of chronic ulcerative colitis were treated with a decoction taken orally (including codonopsis, atractylodes, raw rehmannia, tang-kuei, cnidium, red peony, and licorice) and a retention enema made with borneol, borax, sanqi, and other herbs. 21 of the 31 patients so treated were cured, and follow-up of the cured cases 30 months later showed no relapse.

Chinese medical texts rarely differentiate Crohn's disease, ulcerative colitis, or other chronic inflammatory intestinal disorders. In the book Clinic of Traditional Chinese Medicine, in the section on non-specific chronic colitis, several approaches to treatment are mentioned. Under the heading of treating spleen/stomach deficiency, the symptom picture presented is quite similar to that for Crohn's disease, and the formula recommended is a modification of the Ginseng and Atractylodes Combination. In the book Formulas and Strategies, three formulas, Zhen Ren Yang Zang Tang, Tao Hua Tang, and Jian Pi Wan are each recommended for ulcerative colitis, Crohn's disease, and chronic dysentery. These formulas all warm the stomach and spleen; the first two intensely astringe the intestines and the latter stops diarrhea by removing food stagnation and accumulated fluids in the intestinal tract.

References

1. Chen Zhishui, Treatment of 60 cases of chronic ulcerative colitis with Jianpiling Tablet, Shanghai Journal of Traditional Chinese Medicine 1987; (5): 21-22.
2. Chen Zhishui, et al., Treatment of 60 cases of chronic ulcerative colitis with Jianpiling Tablet, Journal of Traditional Chinese Medicine 1987; 28 (10):748-750.
3. Chen Zhishui, A clinical study on Jianpiling Tablet in treatment of chronic ulcerative colitis, International Conference on Traditional Chinese Medicine and Pharmacology Proceedings, 1987 China Academic Publishers, Shanghai.
4. Chen Zhishui, Jia Danbing, and Zhang Zhiqing, Inhibitory effect of Jianpiling Decoction on isolated rabbit small intestine, Liaoning Journal of Traditional Chinese Medicine 1988; 12 (11): 36-37.
5. Chen Zhishui and Jia Danbing, Treatment of diarrhea due to spleen deficiency with Jianpiling, Chinese Journal of Integrated Traditional and Western Medicine 1989; 9(6):345-347.
6. Chen Zhishui, Gao Ping, and Wei Jianjun, Clinical and pharmacological effects of Jianpiling Tablet, Chinese Traditional and Herbal Drugs 1989; 20(1): 29-30, 24.
7. Chen Zhishui, et al., 596 cases of chronic colitis treated with Jianpiling Tablet, Shenxi Journal of Traditional Chinese Medicine 1991; 12(9): 406.
8. Chen Zhishui, Nie ZW, and Sun QL, Clinical study in treating intractable ulcerative colitis with traditional Chinese medicine, Journal of Integrated Chinese and Western Medicine 1994; 14(7):400-402.
9. Fu Kezhi, Personal Communication, 1997 ITM China Office, Harbin, China.
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