Agreements among traditional Chinese medicine practitioners in the diagnosis and treatment of irritable bowel syndrome

Aliment Pharmacol Ther 2004; 20: 1205 1210. doi: 10.1111/j.1365-2036.2004.02242.x Agreements among traditional Chinese medicine practitioners in the diagnosis and treatment of irritable bowel syndrome J. J. Y. SUNG*, W. K. LEUNG*, J. Y. L. CHING*, L. LAO, G. ZHANG, J.C.Y.WU*,S.M.LIANGà, H. XIEà, Y.P.HOà, L.S.CHANà, B.BERMAN & F. K. L. CHAN* *Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong; Center for Complementary and Alternative Medicine, University of Maryland at Baltimore, MD, USA; àthe School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Accepted for publication 14 August 2004 SUMMARY Background: Traditional Chinese Medicine was frequently used by patients with irritable bowel syndrome. Aim: To evaluate the agreement on diagnoses and prescription of irritable bowel syndrome among Traditional Chinese Medicine practitioners. Methods: Consecutive irritable bowel syndrome patients were interviewed independently by four Traditional Chinese Medicine practitioners. The study was divided into three phases: (i) blinded individual assessment, (ii) discussion to achieve consensus on diagnosis and treatment, (iii) individual assessment based on consensual diagnostic criteria. Patients with other causes of diarrhoea were recruited as controls in phase (iii). Percentage agreement and kappa-value in diagnosis, treatment principle and regime were determined. Results: Thirty-nine irritable bowel syndrome patients were assessed in phase (i) whereas 65 irritable bowel syndrome patients and 17 non-irritable bowel syndrome controls were studied in phase (iii). The mean agreement rates in diagnosis, treatment principle and regimen were: 57, 58 and 52% for phase (i) and 80, 81 and 80% for phase (iii) (P ¼ 0.002). Accordingly, there was significant improvement in the mean kappa-values in diagnosis (0.11 0.34, P ¼ 0.015) and treatment principle (0.16 0.37, P ¼ 0.002) but not in treatment regime. Conclusions: Variations in diagnosis and treatment principles do exist among Traditional Chinese Medicine practitioners. Concordant diagnosis can be reached by mutual understanding and converging opinion among Traditional Chinese Medicine practitioners. INTRODUCTION Traditional Chinese Medicine (TCM) and conventional western medicine represent two different paradigms. While conventional western medicine emphasizes specific disease entities and focus on anatomical and pathophysiological mechanisms, TCM takes a holistic approach and believes that disease is a result of Correspondence to: Dr J. J. Y. Sung, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong. E-mail: joesung@cuhk.edu.hk disharmony within the body and between body and environment. Diagnosis and treatment in TCM is based on five main theories, namely the Yin and Yang Theory, the Five Paths (Elemental Energies) Theory, the Vital Organs Theory, the Theory of Fundamental Substances and the Theory of the Meridians. 1 Although minor similarities exist, the vital organs of the body in TCM are different from the anatomical organs of western medicine. They are classified according to their functions or functional entities. The five yin organs the liver, heart, spleen, lungs and kidneys are situated deep inside the body. The six yang organs the small Ó 2004 Blackwell Publishing Ltd 1205

1206 J. J. Y. SUNG et al. intestine, large intestine, stomach, gall-bladder, urinary bladder and triple burner have direct contacts with the outside world. The liver and gall-bladder, according to TCM, react according to the functional state of the central and autonomic nervous systems as well as the visual function. The spleen is responsible for digestion, absorption, metabolism and the balance of body fluids. Diagnosis is hence based on the cause of the disease and the combination of the five main theories. The actual process is carried out through the classic Four Diagnostic Methods, which includes Observation, Inquiry, Smelling/listening and Palpation. One disease entity in western medicine may be divided into different syndrome patterns in TCM, whereas one syndrome pattern in TCM may be translated into different Western disease entities. 2 Hence, it is instrumental to ensure a mutual understanding of diagnostic criteria between TCM and western medicine before one can scientifically evaluate the effects of TCM on a particular medical condition. Irritable bowel syndrome (IBS) is a condition in which patients experience a variable combination of abdominal pain or discomfort and altered bowel function for which there is no organic cause to explain the symptoms. Epidemiological studies revealed that IBS affects 10 25% of women and 5 20% of men in the general population. 3, 4 Although this is not a lifethreatening disease, the chronic waxing and waning nature of the condition is debilitating. It also imposes tremendous impact on quality of life and productivity of patients. 5 Therapies for IBS from western medicine have so far been enjoying little success. Very few medications have proven benefit in relieving the symptoms of IBS 6, 7 and alternative medicine including TCM is very much used by patients. 8 Recently, a prospective randomized placebo-controlled study from Australia suggested that Chinese herbal medicine may be effective in treating IBS. 9 In particular, individualized treatment may be superior to standardized herbal treatment. In the absence of a structural or a biochemical marker of the disease, the diagnosis of IBS in western medicine is entirely based on symptomatology. The current definition of IBS, as agreed by an expert panel, is formalized in the Rome II criteria, 10 which are modification of the previous Manning criteria. 11 Since there is considerable difference in the diagnostic process between TCM and western medicine, the corresponding TCM diagnosis of patients with IBS remains unknown. Furthermore, it is recognized that different TCM practitioners may have variability in diagnosis and prescription patterns. 12 This potential variability may undermine the true benefits of TCM. The purpose of the study was to determine the variability in TCM diagnosis and prescription patterns among different TCM practitioners. We believe this is an important first step in the scientific research of efficacy of TCM on IBS patients. METHOD Patients The IBS patients recruited in this study were from the Gastroenterology Clinic of the Prince of Wales Hospital between January 2002 and August 2002. IBS was diagnosed by gastroenterologist according to Rome II criteria. 10 Specifically, symptoms included abdominal pain or discomfort along with two of following three features: (i) relieved with defecation; and/or (ii) onset associated with a change in frequency of stool; and/or (iii) onset associated with a change in form (appearance) of stool, for at least 12 weeks during the preceding 12 months in the absence of a structural or biochemical explanation. To further ensure consistency in diagnosis, we chose to study patients with diarrhoeapredominant type of IBS characterized by more than three stools per day, usually loose (or mushy) or watery and with the sense of urgency. Patients with predominant constipation or alternating bowel habits were excluded. All patients gave informed consent for participation in this study and the study protocol was approved by the Clinical Research Ethics Committee of the hospital. TCM practitioners Four TCM practitioners, who graduated from different traditional Chinese medical schools in China, participated in this study. They were all licensed TCM practitioners in Hong Kong with more than 5 years of experience. Phase (i): Initial blinded assessment Patients were first assessed by a gastroenterologist to verify the clinical symptoms. All patients were then seen by the four TCM practitioners individually with history taking and examination of the pulse and tongue. Each TCM practitioner was then asked to provide a TCM diagnosis, principle of treatment and herbal prescription

TRADITIONAL CHINESE MEDICINE AND IBS DIAGNOSIS 1207 for each patient according to the classic Four Diagnostic Methods, which includes Observation, Inquiry, Smelling/listening and Palpation. These assessments were given individually without discussion with other TCM practitioners. Specifically, they have to choose from the four common TCM diagnoses of chronic diarrhoea, their corresponding treatment principles and regimes. The four diagnoses were: 1 Stagnation of liver-energy and asthenia of spleen A morbid condition of hypofunction of the spleen and stomach caused by the stagnation of liver-energy; manifested as hypochondriac pain, anorexia, flatulence and lassitude. 2 Deficiency of spleen-energy A disorder of digestion and absorption because of hypofunction of the spleen; manifested as poor appetite, abdominal flatulence after meal, dizziness, fatigue and sallow complexion. 3 Accumulation of wetness-heat in the spleen and stomach A morbid condition manifested as icteric sclera, flatulence, poor appetite, nausea, fatigue, oliguria with dark colour urine, yellowish and greasy fur tongue, soft and rapid pulse. 4 Asthenia of spleen and kidney A morbid condition because of deficiency of kidneyyang, which fails to nourish spleen-yang, or vice versa; manifested as chilly sensation of the whole body, pale complexion and pain of the loins, knees or lower abdomen, morning diarrhoea, general dropsy, dysuria or polyuria, pale and tender tongue with whitish and moist fur, sunken and weak pulse. A fifth option of other alternative diagnosis was also available in case the TCM practitioners found that the patients clinical features did not fit into the above four diagnoses. Based on these four possible TCM diagnoses, four corresponding treatment principles were listed: 1 Checking hyperfunction of the liver and strengthening the spleen. 2 Promoting energy and strengthening the spleen. 3 Clearing away pathogenic heat and dampness. 4 Warming the kidney and reinforcing the spleen. The corresponding herbal formula for each condition listed above was: A B C D Tong Xie Yao Fang. Shen Ling Bai Shu San. Ge Gen Jin Lian Tang. Si Shen Wan He Fu Zi Li Zhong Tang. Phase (ii): Discussion and consensus In the second phase of the study, the four TCM practitioners were asked to see IBS patients together with a gastroenterologist. The gastroenterologist would first brief the TCM practitioners about the clinical symptoms of the patients and how the diagnosis of IBS was made. The four TCM practitioners would then interview and examine the patients together. It was followed by discussion among the TCM practitioners in order to arrive at a consensual TCM diagnosis, common treatment principle and regime for each individual patient as listed in previous section. The gastroenterologist was not involved in the discussion process. A total of 15 IBS patients were interviewed in this phase. Phase (iii): Blinded assessment This part followed the phase (ii) consensus. The design was similar to that of phase (i) except that patients with other organic causes of diarrhoea-like infectious diarrhoea and inflammatory bowel diseases were included as control, since the corresponding TCM diagnoses and treatments were different from that of IBS. After consultation with gastroenterologist, patients with diarrhoea were interviewed and examined by TCM practitioners individually. The TCM practitioners were asked to make independent assessment on diagnosis, principle of treatment and treatment regimen as in phase (i). The corresponding diagnosis made by gastroenterologists was not disclosed to TCM practitioners and discussion among the four TCM practitioners was not allowed. Statistics Agreement rates in diagnosis, principles of management and treatment regimen were presented in two ways: simple percentage agreements and kappa-values between any two TCM practitioners. The mean percentage agreement (with range) and kappa-value (with range) of individual item were presented. They were derived by the average of the sum of simple percentage

1208 J. J. Y. SUNG et al. agreements or simple kappa-values. All statistical analysis was made by spss software (version 11.0; SPSS Inc., Chicago, IL, USA). Statistical difference between phase (i) and phase (iii) was determined by Mann Whitney U-test. A two-sided P-value of <0.05 was considered to be statistically significant. RESULTS Phase (i) Thirty-nine patients with diarrhoea-predominant IBS were assessed in phase (i) (male 38%, mean age 46, s.d. ¼ 13 years). The most common diagnosis made by the TCM practitioners was stagnation of liver-energy and asthenia of spleen (68.3%). Accordingly, the most frequently adopted treatment principle was checking hyperfunction of the liver and strengthening the spleen (65.6%) and the treatment regime most often prescribed was formula A (49.2%). The mean percentage agreement in diagnosis, treatment principle and treatment regimen among the four TCM practitioners was: 57% (range: 46 71), 58% (range: 47 67) and 52% (range: 44 63) respectively. The corresponding mean kappavalue was poor in all three parameters: diagnosis ¼ 0.11; treatment principle ¼ 0.16; treatment regime ¼ 0.29 (Table 1). Phase (iii) After the consultation and discussion in phase (ii), 65 IBS patients (male 43%, mean age 46 years, s.d. ¼ 14 years) and 17 controls with other causes of diarrhoea (male 24%, mean age 42 years, s.d. ¼ 13 years) were recruited. Again, the most common diagnosis for diarrhoeapredominant IBS patients was stagnation of liverenergy and asthenia of spleen, which was made in 85% cases. Hence, checking hyperfunction of the liver and strengthening the spleen was the most frequently adopted treatment principle (85%) and formula A was the most frequently prescribed regime (85%). In contrast, none of the non-ibs controls was diagnosed to have the four possible TCM diagnoses for IBS. The respective mean percentage agreement in the diagnosis, treatment principle and treatment regime for IBS patients and controls was 80 (range: 78 84, Table 2), 81 (range: 79 84) and 80% (range: 78 84). When compared with phase (i), there was significant improvements in agreement rate of the four TCM practitioners in diagnosis (P ¼ 0.002), treatment principle (P ¼ 0.002) and treatment regime (P ¼ 0.002). The mean kappa-value of the four TCM practitioners in diagnosis was 0.34 [P ¼ 0.015 vs. phase (i)], in treatment principle was 0.37 [P ¼ 0.002 vs. phase (i)], and in treatment regime was 0.34 [P ¼ 0.4 vs. phase (i)]. DISCUSSION Although TCM, particularly individualized TCM treatment, has been shown to be efficacious in treating IBS patients, 9 the corresponding TCM diagnoses and prescription patterns remain elusive. More importantly, the potential variability in diagnosis for this disorder among different TCM practitioners has not been examined. This study addressed the consistency in diagnosis and treatment of IBS by different TCM practitioners and the way to minimize this variability. By using stringent criteria for diagnosis of IBS (Rome II) and the inclusion of patients with diarrhoeapredominant symptoms only, the most common diagnosis made by TCM practitioners during individual blinded assessment was stagnation of liver-energy and TCM practitioners A vs. B A vs. C A vs. D B vs. C B vs. D C vs. D Diagnosis Percentage agreement 58.8 55.9 70.6 46.2 51.3 61.5 Kappa-value 0.14 0.07 0.32 0.03 0.08 0.03 Treatment principle Percentage agreement 61.1 66.7 64.3 47.1 62.1 46.7 Kappa-value 0.16 0.2 0.23 0.12 0.15 0.10 Treatment regime Percentage agreement 48.0 62.5 60.0 44.7 44.1 51.5 Kappa 0.23 0.43 0.43 0.16 0.14 0.32 Table 1. Results of phase (i): percentage agreement and kappa-values on diagnosis, treatment principle and regime for diarrhoea-predominant irritable bowel syndrome (IBS) patients according to different pairings of Traditional Chinese Medicine (TCM) practitioners

TRADITIONAL CHINESE MEDICINE AND IBS DIAGNOSIS 1209 Table 2. Results of phase (iii): percentage agreement and kappa-values on diagnosis, treatment principle and regime for diarrhoea-predominant irritable bowel syndrome (IBS) patients by different pairings of Traditional Chinese Medicine (TCM) practitioners TCM practitioners A vs. B A vs. C A vs. D B vs. C B vs. D C vs. D Diagnosis Percentage agreement 80.5 78.9 84.4 79.0 79.3 77.8 Kappa-value 0.33 0.35 0.51 0.27 0.30 0.30 Treatment principle Percentage agreement 80.5 80.5 84.2 80.5 79.0 79.0 Kappa-value 0.33 0.41 0.51 0.33 0.29 0.35 Treatment regime Percentage agreement 80.5 79.2 84.2 79.3 79.0 77.8 Kappa 0.33 0.35 0.51 0.27 0.29 0.30 asthenia of spleen which was made in 68% of cases. Notably, there was considerable discrepancy in the diagnosis and treatment regime given by the four TCM practitioners in the phase (i) study. The overall agreement in diagnosis, treatment principle and regimes was between 52 and 58% and the corresponding kappa-values were considered poor in all three dimensions. Similar variability was also noticed in a previous study when different TCM practitioners were asked to see patients with rheumatoid arthritis. 12 The agreement on TCM diagnosis for rheumatoid arthritis was even lower (28%) than our current findings (57%). On the contrary, inconsistency in diagnostic assessments among different doctors was not uncommon in conventional western medicine when subjective judgements are involved. 13 15 This variability may be particularly relevant in functional bowel disorders where explicit signs and positive investigations are lacking. One of the reasons for the variability in TCM diagnoses and prescriptions may be related to the different backgrounds of the TCM practitioners including educations, trainings and experiences. To minimize this potential heterogeneity, the four TCM practitioners involved were all graduated from TCM schools in China and practiced in Hong Kong for at least 5 years. Interestingly, we noted that the discrepancy and variability in diagnosis and prescription could be minimized through discussion and opinion convergence. There was substantial improvement on the agreement rates on TCM diagnosis, principle of treatment and treatment regime of the four TCM practitioners after the discussion sessions in phase (ii). The gastroenterologist had no influence on the decision-making process and it was not clear whether the sources of disagreement were from the bias of information taking or the diagnostic criterion. Further study may help to clarify this issue. Nevertheless, our study demonstrated that it is important to have consensus on TCM diagnosis, a finding supported by other studies (G. Zhang, personal communication). To verify the specificity of TCM diagnosis for IBS, we included other non-ibs patients in this part of the study since the corresponding TCM diagnoses and treatments will be very different from that of IBS patients. None of the non-ibs patients was given the four TCM diagnoses for IBS. Since TCM diagnosis is based on symptoms and signs that may change in hours or days, multiple consultations may be necessary to formulate the most appropriate diagnosis, treatment principle and regime. Repeated consultations and modification of treatment regimes is a very common practice in TCM. The single consultation in this study may underestimate the agreement rates among different TCM practitioners. In this study, we had only included patients with diarrhoea-predominant symptoms. The reason for choosing this subtype is because this is the most frequently encountered subtype in Chinese population. 16 Intuitively, patients with constipation-predominant symptom or those with alternating symptoms may have different TCM diagnostic and prescription patterns by TCM practitioners. Further study may be necessary to clarify this uncertainty. Whilst treatment for IBS by conventional western medicine is generally unsatisfactory, many patients seek help from TCM for symptom control. Although this study is not designed to test the efficacy of TCM on IBS patients, results from this study explicitly illustrate that variability in TCM diagnosis and treatment exists. We have laid the foundation work for subsequent TCM studies to scientifically evaluate the efficacy of TCM on IBS. Consensual TCM diagnosis and treatment is of paramount importance on the conduction of proper clinical trials to evaluate the true benefits of TCM on treating IBS patients.

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