Traditional Chinese Medicine-Guided Dietary Intervention for Male Youth Undergoing Drug Detoxification: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate the effectiveness of traditional Chinese medicine- (TCM-) guided dietary interventions in improving yang-qi deficiency and yin-blood deficiency TCM syndromes according to the principles of TCM syndrome differentiation theory in male youths undergoing drug detoxification during the rehabilitation period who stayed in a compulsory isolation detoxification center. METHODS: Male youths undergoing drug detoxification who met the criteria to be included in the study were randomly divided into the intervention group (n = 62) and the control group (n = 61) according to a random number table in a 1 : 1 ratio. The intervention group received a TCM-guided diet, and the control group received routine food support. Over an intervention period of 3 months, we observed changes in the TCM syndrome element scores in the two groups before and after intervention. RESULTS: After 3 months, the qi deficiency, yin deficiency, blood deficiency, and yin-blood deficiency syndrome in the intervention group improved significantly (P values 0.009, 0.000, 0.005, and 0.001, respectively). In the control group, yang deficiency, qi deficiency, and yang-qi deficiency syndromes worsened significantly (P values 0.003, 0.032, and 0.009, respectively). The differences (post-pre) in yang deficiency, qi deficiency, yang-qi deficiency, yin deficiency, blood deficiency, and yin-blood deficiency syndromes between the two groups were statistically significant (P values 0.003, 0.003, 0.003, 0.001, 0.005, and 0.002, respectively). CONCLUSION: A TCM-guided diet can delay the worsening of yang-qi deficiency syndrome symptoms and improve yin-blood deficiency syndrome and the prognosis of male youth undergoing drug detoxification during the rehabilitation period.

Practitioners' perspectives on evaluating treatment outcomes in traditional Chinese medicine.

BACKGROUND: There are no generally accepted standards for evaluation of treatment outcomes in traditional Chinese medicine (TCM). Pattern differentiation and individual treatments are recognized as the most distinguishing features of TCM. Therefore, how practitioners determine curative effects is an issue worthy of research, though little has been done in this area up to this point. This study examines perceptions of the effectiveness of TCM treatments and the means of evaluating clinical outcomes from the practitioners' perspective. METHODS: Qualitative analysis of semi-structured interviews. RESULTS: A total of nine TCM practitioners from three university-affiliated hospitals and two scientific institutions participated in the interviews in August 2013. Participants reported evaluation of periodical treatment as an important part of the process of individual treatment based on pattern differentiation. Themes included (1) ways of evaluating treatment outcomes; (2) relationships between treatment outcomes and pathological transformation; and (3) distinguishing manifestations of the healing process from true adverse reactions. These considerations helped determine the optional treatment principles for further follow-up. An additional theme emerged related to the characteristics of diagnosis and treatment in TCM. CONCLUSIONS: Health professionals considered all of the following as important ways of evaluating TCM treatment outcomes: patients' input and subjective experience, physicians' intake and examination, laboratory tests and medical device measurements. Pathological conditions were determined based on all the above factors, and no single factor determined the effectiveness from the practitioners' perspectives. If the patients felt no significant beneficial effects, then it was necessary to judge the effectiveness from adverse effect. The follow-up measures were usually based on the previous treatment, and physicians' satisfaction with each phase of TCM treatment was a significant factor in the process of making further decisions.

Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID.

OBJECTIVE: The reporting of patient-reported outcomes (PRO) instrument development is vital for both researchers and clinicians to determine its validity, thus, we propose the Preferred Reporting Items for PRO Instrument Development (PRIPROID) to improve the quality of reports. METHODS: Abiding by the guidance published by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, we had performed 6 steps for items development: identified the need for a guideline, performed a literature review, obtained funding for the guideline initiative, identified participants, conducted a Delphi exercise and generated a list of PRIPROID items for consideration at the face-to-face meeting. RESULTS: Twenty three items subheadings under 7 topics were included: title and structured abstract, rationale, objectives, intention, eligibility criteria, conceptual framework, items generation, response options, scoring, times, administrative modes, burden assessment, properties assessment, statistical methods, participants, main results, and additional analysis, summary of evidence, limitations, clinical attentions, and conclusions, item pools or final form, and funding. CONCLUSIONS: The PRIPROID contains many elements of the PRO research, and this assists researchers to report their results more accurately and to a certain degree use this instrument to evaluate the quality of the research methods.

Parallel subgroup design of a randomized controlled clinical trial-comparing the approaches of Chinese medicine and Western medicine.

A new method for the comparison of the treatment efficacy for specific diseases or conditions between Chinese medicine and Western medicine, which serve the same medical aim but are based on substantially different theoretical systems, was identified. Abiding by the principle of parallel subgroup design of a randomized controlled trial (PSD-RCT), participants were recruited following identical inclusion and exclusion criteria and were randomly allocated into two groups to receive treatment using the respective approaches of Chinese medicine and Western medicine. The Chinese medicine group was divided into subgroups according to the theory of Chinese medicine and the Western medicine group was also divided into subgroups according to the theory of Western medicine. The treatment for each subgroup was well defined in the protocol, including major formulae and principles for individualized modifications. The primary outcome measure was ascertained to be directly related to the patients' status but independent from both theories of Chinese medicine and Western medicine, while the secondary outcomes were represented by the patient-reported outcomes and some laboratory tests commonly accepted by Chinese medicine and Western medicine. Then, taking functional dyspepsia as an example, the authors explain the framework of the PSD-RCT for efficacy comparisons between Chinese medicine and Western medicine, and recommend that the PSD-RCT can be used to compare treatment efficacy for a specific disease or condition between Chinese medicine and Western medicine, and the comparison among subgroups can provide valuable clues for further studies.

Development and validation of the Chinese Quality of Life Instrument.

BACKGROUND: This paper describes the development of the Chinese Quality of Life Instrument (ChQOL) which is a self-report health status instrument. Chinese Medicine relies very much on asking subjective feelings of patients in the process of diagnosis and monitoring of treatment. For thousands of years, Chinese Medicine practitioners have accumulated a good wealth of experiences in asking questions about health of their patients based on the concept of health in Chinese Medicine. These experiences were then transformed into questions for the ChQOL. It is believed that ChQOL can contribute to the existing Patient Report Outcome measures. This paper outlines the concept of health and disease in Traditional Chinese Medicine, the building of the conceptual framework of the ChQOL, the steps of drafting, selecting and validating the items, and the psychometric properties of the ChQOL. METHODS: The development of the ChQOL was based on the concept of health in Traditional Chinese Medicine with a theory driven approach. Based on the results of literature review, the research team developed an initial model of health which encompassed the concept of health in TCM. An expert panel was then invited to comment and give suggestions for improvement of the initial model. According to their suggestions, the model was refined and a set of initial items for the ChQOL was drafted. The refined model, together with the key domains, facets and initial items of the ChQOL were then mailed to a sample of about 100 Chinese medicine practitioners throughout Mainland China for their comments and advice. A revised set of items were developed for linguistic testing by a convenience sample consisting of both healthy people and people who attended Chinese Medicine treatment. After that, an item pool was developed for field-testing. Field test was conducted on a convenience sample of healthy and patient subjects to determine the construct validity and psychometric properties of the ChQOL. RESULTS: Construct validity was established by various methods, i.e. the internal consistency in all facets and domains were good; the correlation between facets to domain, and domains to overall ChQOL correlation were high; confirmatory factor analysis showed that the structure fitness of all facets, domain and overall structure were good with CFI > 0.9. Test-retest reliability was also good, especially in the domain scores with ICC value ranging from 0.83 to 0.90. No ceiling or floor effect was noted which indicated that ChQOL can be applied to subjects with a wide range of health status. Most facet scores, domain scores and the overall CHQOL scores were able to discriminate groups of subjects with known differences in health status. The ChQOL had mild positive convergence with the other generic health related QOL measures, i.e. the WHOQOL-100 and the SF-36, with moderate correlations. CONCLUSION: In conclusion, the study indicated that the ChQOL is conceptually valid with satisfactory psychometric properties. It can provide additional information on health and QOL on top of the existing generic health related QOL measures. Furthermore, it forms basis for further testing and applications in clinical trials.