Chinese Herbal Medicine for Irritable Bowel Syndrome

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Chinese Herbal Medicine

 

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Vol. 282 No. 11,September 15, 1999

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Letters

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Letter 1

Letter 2

Letter 3

In Reply

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Letter 1

Letter 2

Letter 3

In Reply

Letters Information

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Letter 1

Letter 2

Letter 3

In Reply

Letters Information

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Letter 1

Letter 2

Letter 3

In Reply

Letters Information

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Letter 1

Letter 2

Letter 3

In Reply

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Letter 1

Letter 2

Letter 3

In Reply

Letters Information

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chinese Herbal Medicine for Irritable Bowel Syndrome

 

 

 

To the Editor: The study by Mr Bensoussan et

al1 demonstrated the effectiveness of Chinese

herbal medicine (CHM) in treating irritable bowel syndrome (IBS); however,

it did not explain the possible pharmacological actions of the herbs involved.A multitarget theory proposed by Zhou2

explains the actions of Chinese herbal formulas. Each formula, composed of

multiple herbs, inherently contains multiple chemical components. Each active

component, if used alone, usually enters the body at a level below that seen

in therapeutic dosing. Combined, these components selectively and repeatedly

interact with multiple sites and targets of a disease to achieve synergistic

therapeutic responses. The multitarget theory may explain the effectiveness

of treating heterogeneous disorders like IBS with CHM. Since IBS has been

linked to factors such as psychological stress, abnormal colonic motor activity,

dysfunction of the autonomic nervous system, and biliary dyspepsia, using

an herbal combination to treat various aspects of the disease seems logical.Pharmacological studies3-5

from China have shown that the clinical effectiveness of the herbs may be

related to: (1) antagonistic effects on acetylcholine and histamine on intestinal

smooth muscle; (2) sedative and regulatory effects on the central nervous

system and the autonomic nervous system; and (3) regulatory effects on the

hepatic and biliary systems.The herbal composition in the study consists of several classic Chinese

formulas that have been used for centuries in the treatment of gastrointestinal

tract distress. For instance, studies3 have

found that tong xie yao fang has a significant inhibitory

effect on peristaltic excitation of isolated intestinal smooth muscle induced

by acetylcholine and histamine, which is mediated by blocking muscarinic receptors. Dang shen (Codonopsis pilosulae,

radix), the major herb of si jun zi tang, another

classic formula, has a similar inhibitory effect on ileum contraction.4 Wu wei zi (Schisandrae, fructus) has broad sedative effects on autonomic activity

linked to the monoamine and dopamine systems. Yin chen

(Artemesiae capillaris, herba) improves the secretion

and excretion of bile and relaxes the sphincter of Oddi.5This study has not only provided a new therapeutic option for IBS but

has revealed a potential treatment model in managing heterogeneous and chronic

disorders by combining multiple natural or even synthetic components to affect

the multiple targets of these disorders.

 

 

 

 

Weidong Lu, MD

New England School of Acupuncture

Watertown, Mass

 

 

 

 

1.

Bensoussan A, Talley NJ, Hing M, Menzies R, Guo A, Ngu M.

Treatment of irritable bowel syndrome with Chinese herbal medicine:

a randomized controlled trial.

JAMA.

1998;280:1585-1589.

MEDLINE

 

 

2.

Zhou J.

Composite recipe of Chinese medicine, the natural combination of chemicals

and mechanism of multi-target action.

Chin J Integrated Tradit West Med.

1998;18:67.

 

 

 

3.

Liu S, Zhang S, Li C.

Tong xie yao fang.

In: Xie M, ed. Modern Study of the Medical Formulae

in Traditional . Beijing, China: Xue Yuan Press; 1997:244-247.

 

 

 

4.

Zao H.

Si jun zi tang.

In: Xie M, ed. Modern Study of the Medical Formulae

in Traditional . Beijing, China: Xue Yuan Press; 1997:471-487.

 

 

 

5.

Yin J, ed, Guo L, ed.

Modern Research and Clinical Applications of Chinese

Materia Medica.

Beijing, China: Xue Yuan Press; 1993:148-157, 484-489.

 

 

 

 

 

 

To the Editor: The clinical trial by Mr Bensoussan

and colleagues1 on CHM for IBS is an innovative

effort that respects the integrity of an alternative paradigm yet simultaneously

manages to adopt the methodological safeguards demanded by scientific research.

However, the answers to 3 questions are important in interpreting the results.

First, how was the standardized herbal formula selected or devised? My examination

of Chinese and English sources has not uncovered any similar prescription.2, 3 Second, what were the exact herbs

constituting the placebo? One needs to be vigilant about the possibility of

a noninert placebo causing independent harmful or beneficial effects that

could bias the outcome of a trial.4 Because

there are no regulations for the composition of placebos, this can present

a challenge in any clinical trial,5 but

it may be especially problematic with herbal placebos. Finally, why do the

ingredients of the standard herbal formula not add up to 100%?

 

 

 

 

Ted J. Kaptchuk, OMD

Harvard Medical School

Boston, Mass

 

 

 

 

1.

Bensoussan A, Talley NJ, Hing M, Menzies R, Guo A, Ngu M.

Treatment of irritable bowel syndrome with Chinese herbal medicine:

a randomized controlled trial.

JAMA.

1998;280:1585-1589.

MEDLINE

 

 

2.

Research Academy of Traditional .

Encyclopedia of Traditional : Herbal

Prescriptions.

Beijing, China: People's Press; 1983.

 

 

 

3.

Bensky D, Barolet R.

Chinese Herbal Medicine: Formulas & Strategies.

Seattle, Wash: Eastland Press; 1990.

 

 

 

4.

De Craen AJ, Tijssen JG, Kleijnen J.

Is there a need to control the placebo in placebo controlled trials?

Heart.

1997;77:95-96.

MEDLINE

 

 

5.

Golomb BA.

Paradox of placebo effect.

Nature.

1995;375:530.

MEDLINE

 

 

 

 

 

To the Editor: Mr Bensoussan and colleagues1 summarized the 20 herbal ingredients in the standard

formula capsule in a table but did not identify the 81 Chinese herbs used

in the individualized treatment group. No specific dosage was listed except

for percentage in the standard formula and the number of capsules used.The failure of accurate and full documentation of ingredients and dosage

in Chinese proprietary and herbal medicines is not uncommon.2

Misidentification of an herb3 was unlikely

in the study, although there was preparation of herbal powders from the plants,

introducing the possibility of inaccurate processing of ingredients.Fraxini cortex, used in the study, is among

the list of unapproved herbs in the German Commission E Monographs.4 The monographs recommend that the daily dose of Plantaginis (ovate) semen be 12 to 40 g, taken with sufficient

fluids (eg, 150 mL of water to 5 g of drug) a half hour to 1 hour after taking

other medication. It is not stated if any of the unidentified herbal plants

in the study appears in the monographs' unapproved list or may contain substances

causing adverse reactions including poisoning5

and allergy. In addition, many Chinese herbal plants are not listed in the

monographs.In the study, patients from the 2 treatment groups were disproportionately

lost to follow-up, including 8 (21%) of 38 in the individualized group. The

reasons for loss to follow-up were not given. If patients dropped out because

of adverse drug reactions or intensification of IBS, the scores in the 2 treatment

groups would be markedly different.Finally, several discrepancies should be clarified. Table 3 showed

that fewer patients in the 3 groups received gastroenterologist total Bowel

Symptom Scale scores at end of treatment than those with patient total Bowel

Symptom Scale scores. In addition, while 32 patients in the placebo group

completed the 16-week treatment, 33 patients were listed under patient rating

of response and 30 in the gastroenterologist rating of response in Table 4.

While 29 patients in the individualized group completed the study, Table 4

showed 28 in the patient rating and 30 in the gastroenterologist rating groups.

In the standard group, 38 patients are listed as having completed the study,

while only 37 are reported for the gastroenterologist rating. These discrepancies

were not explained in the article.

 

 

 

 

H. C. George Wong, MD, FRCPC

University of British Columbia

Vancouver

 

Jonathan K. T. Wong

Trinity Western University

Langley, British Columbia

 

Natasha Y. Y. Wong

University of Toronto at Mississauga

Mississauga, Ontario

 

 

 

 

1.

Bensoussan A, Talley NJ, Hing M, Menzies R, Guo A, Ngu M.

Treatment of irritable bowel syndrome with Chinese herbal medicine:

a randomized controlled trial.

JAMA.

1998;280:1585-1589.

MEDLINE

 

 

2.

Wong HCG, Wong NYY, Wong JKT, Wong AMY.

Chinese proprietary and herbal medicines used in three allergic diseases.

J Allergy Clin Immunol.

1999;103:A771.

 

 

 

3.

Vanhaelen M, Vanhaelen-Fastre R, But P, Vanherweghem JL.

Identification of aristolochic acid in Chinese herbs [letter].

Lancet.

1994;343:174.

MEDLINE

 

 

4.

Blumenthal M, ed.

The Complete German Commission E Monographs: Therapeutic

Guide to Herbal Medicines.

Austin, Tex: American Botanical Council; 1998.

 

 

 

5.

Chan TYK, Chan JCN, Tomlinson B, Critchley JAJH.

Chinese herbal medicines revisited: a Hong Kong perspective [review].

Lancet.

1993;342:1532-1534.

MEDLINE

 

 

 

 

 

In Reply: Dr Lu provides an interesting perspective

on the potential pharmacological basis of action of CHM. It could also be

postulated that there is a direct pharmacological action affecting visceral

hypersensitivity1 of the central mechanisms that appears to be dysregulated

in IBS. While it is likely that there is a synergism between certain herbs,

it is also possible that not all the herbs are efficacious.The standard formula was devised through the study and collaboration

of 2 principal Chinese herbalists. While contained within it are parts of

classic formulations, it does not strictly follow previous prescriptions.

The placebo was prepared by a pharmaceutical contractor with previous experience

in this area. It contained 78.2% calcium hydrogen phosphate, 19.6% soy fiber,

0.3% cosmetic brown, 0.5% cosmetic yellow, 0.01% edicol blue, 0.09% identical

licorice dry flavor, and 0.3% bitter flavor. We are reasonably confident that

the placebo was completely inert. Patients who received the placebo responded

in a predictable fashion overall. The gram proportions of herbal ingredients

in the standard formula were converted to the nearest 0.5%.Article length limitations prevented the listing of all 81 herbs made

available to the herbalists. The purpose of this third treatment arm was to

give herbalists reasonable autonomy to use the herbs they considered appropriate

for each individual patient. All the Chinese herbs used in the trial were

readily available over-the-counter in Australia. Because the herbs remained

in a raw state, volumes consumed were high5 capsules 3 times per day

amounted to 9 g/d of raw herbs.The German Commission E Monographs report no known risks for Fraxini cortex. It remains unapproved because of inadequate documentation

of clinical effectiveness. In contrast, this herb is approved for public use

by the Australian Therapeutic Goods Administration. Plantaginis ovate is a different species than che qian zi

(plantain seed, Plantaginis asiatica or P depressa)this is why the pinyin name has also been provided.

In dealing with Chinese herbs, the Chinese pharmacopoeia is generally more

helpful than the German monographs.Assessment of symptom change was made based on responses to a number

of questionnaire items completed by patients and gastroenterologists. Not

all items were completed by all patients or all gastroenterologists on all

occasionsthis is why there is a difference in the number of responses

(compared with patients who completed the study). Table 4 refers to patients'

responses on categorical items. Data for categorical items are also treated

according to an intention-to-treat protocol, in which patients who withdrew

from the trial were recorded as having worsened (if appropriate)hence,

the greater number of responses. Patients lost to follow-up were classified

as having received "ineffective intervention" if this was apparent. Adverse

reactions were also reported for 2 cases.

 

 

 

 

Alan Bensoussan, MSc

Research Unit for Complementary Medicine

University of Western Sydney

Sydney, Australia

 

Nick J. Talley, MD

Nepean Hospital

Sydney

 

Ross Menzies, PhD

University of Sydney School of Behavioural

and Community Health Sciences

Sydney, Australia

 

 

 

 

 

 

Letters Information

 

 

Guidelines for Letters

 

 

Edited by Margaret A. Winker, MD, Deputy

Editor, and Phil B. Fontanarosa, MD, Interim Coeditor.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

© 1999 American Medical Association. All rights reserved.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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