Traditional chinese medicine (phytotherapy): health technology assessment report - selected aspects

Objective: A summary of main aspects from a Health Technology Assessment report on Traditional Chinese Medicine (TCM) in Switzerland concerning effectiveness and safety is given. Materials and Methods: Literature search was performed through 13 databases, by scanning reference lists of articles and by contacting experts. Assessed were quality of documentation, internal and external validity. Results: Effectiveness: 43 articles concerning 'gastrointestinal tract and liver' were assessed. The studies covering 7,436 patients were undertaken in China (35), Japan (3), USA (2) and Australia (3); 33/43 being controlled studies. 34/40 show significantly better results in the TCM-treated group. A comparison of studies on results of treatment based on a diagnosis according to TCM criteria and studies on results of treatment according to Western diagnosis shows that treatment based on TCM diagnosis improves the result. The comparison of treatment by individual medication and standard medication showed a trend in favor of individual medication. Safety: TCM training and practice for physicians in Switzerland are officially regulated. Side effects occur, but no severe effects have been registered up to now in Switzerland. TCM medicinals are imported; admission regulations are being installed. Problems due to production abroad, Internet trade, self-medication or admixtures are possible. Conclusion: The evaluation of the literature search provides evidence for a basic clinical effectiveness of TCM therapy. Severe side effects were not observed in Switzerland. Regulations for trading and use of medicinals prevent treatment risks. Further clinical studies in a Western context are required.

How Comprehensible, Interesting and Relevant is Current Research in Traditional Chinese Medicine for Practitioners?

Purpose: In traditional Chinese medicine (TCM) as in other fields of complementary medicine, research does not necessarily follow the sequence from in vitro studies via phase I to phase IV clinical trials, but all steps are being investigated simultaneously. Here, we aimed to investigate which kinds of studies were interesting and relevant for practitioners. Methods: Thirty abstracts from articles on TCM published between April and June 2012 were randomly chosen, including 5 abstracts each of in vitro studies, animal studies, case reports or series, studies with healthy volunteers, trials with patients, or reviews and meta-analyses. Six TCM practitioners (2 female, 5 non-medical, average age 46 years, average practical TCM experience 9 years) rated 10 abstracts each on a 5 point Likert scale (1=very poor to 5=very good) regarding comprehensibility, interest, relevance to practice, information for patients, and promoting reputation of TCM. Average ratings for each group of abstracts were calculated. Results: Comprehensibility of the abstracts was generally rated as good. Case reports/series, studies in healthy volunteers and trials with patients were rated interesting by the practitioners (average rating = 3.7, 3.8 and 3.7, respectively). Relevance to practice was mediocre for all types (2.5 to 3.5). In vitro studies and reviews/meta-analyses were not rated useful as information for patients (2.0). Reviews/Meta-analyses were considered negative for the reputation of TCM (2.2). Conclusions: Practitioners of TCM find abstracts of study results generally comprehensible and interesting. Case reports/series were rated in a similar way as trials with patients. Although TCM is commonly taught by means of case reports, practitioners seemed to value clinical trials. Abstracts of reviews/meta-analyses were rated rather uninformative, which was possibly due to several inconclusive results and the lack of detailed information in these abstracts.

[CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials (Chinese version)]

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

Effects of acupuncture and Chinese herbal medicine (Zhi Mu 14) on hot flushes and quality of life in postmenopausal women: results of a four-arm randomized controlled pilot trial

OBJECTIVE: The aim of this study was to evaluate the feasibility of a clinical trial investigating the effects of acupuncture (AP) and Chinese herbal medicine (CHM) on hot flushes and quality of life in postmenopausal women. METHODS: Forty postmenopausal women reporting at least 20 hot flushes per week were enrolled in a randomized controlled trial. They were randomly allocated to receive traditional Chinese medicine (TCM) AP, sham AP, verum CHM, or placebo CHM for 12 weeks. Follow-up assessment was conducted 12 weeks after intervention. Primary outcome measures included hot flush frequency and severity. As a secondary outcome measure, the severity of menopausal symptoms was assessed using the Menopause Rating Scale (MRS) II. RESULTS: TCM AP induced a significant decline in all outcome measures from pretreatment to posttreatment compared with sham AP (hot flush frequency, P = 0.016; hot flush severity, P = 0.013; MRS, P < 0.001). In the TCM AP group, a larger decrease in MRS scores persisted from pretreatment to follow-up (P = 0.048). No significant differences were noted between the verum CHM group and the placebo CHM group. Compared with the verum CHM group, there was a significant decrease in MRS scores (P = 0.002) and a trend toward a stronger decrease in hot flush severity (P = 0.06) in the TCM AP group from pretreatment to posttreatment. CONCLUSIONS: TCM AP is superior to sham AP and verum CHM in reducing menopausal symptoms, whereas verum CHM shows no significant improvements when compared with placebo CHM.

The Gender of Chinese Christianity: Evaluating a New Research Perspective

This paper will discuss how the gender perspective can be applied to the study of the Early Modern Jesuit China mission. I will show that the category of gender provides a promising research perspective on Sino-Western cultural exchange, for it brings to the forefront important aspects of social life in the “contact zone” of Chinese Christian communities. I will argue that through the intercultural contact initiated by the Jesuit China mission, gender roles started to shift slightly on both sides. On the one hand, the Jesuits adopted the Confucian ideal of the separation of the sexes (nannü zhi bie), building for example separate Churches for women, something unknown in Europe. On the other hand, Chinese Christians were urged to reconsider aspects of their traditional gender norms, when for instance some men left their concubines in order to become Christian. The paper will be divided in three parts. First, it will focus on the history of concepts and discuss what gender relations meant in the context of the Early Modern China mission. Then it will turn to the representation of female religiosity in Jesuit Annual Letters and show how the gender perspective can lead to a re-evaluation this source genre. Finally, it will reflect on how the gender perspective can give us fresh insights into well-known paradigms on Sino-Western relations, taking the accommodation paradigm as an example.

Prescriptions of Chinese medicinal herbs in Switzerland: the example of suan zao ren (Ziziphi Spinosae Semen)

Introduction According to the Swiss Health Survey 2007, 1.7% of the adult population use traditional Chinese medicine (including Chinese herbal medicine, but excluding acupuncture). In contrast to conventional drugs, that contain single chemically defined substances, prescriptions of Chinese herbs are mixtures of up to 40 ingredients (parts of plants, fungi, animal substances and minerals). Originally they were taken in the form of decoctions, but nowadays granules are more popular. Medium daily dosages of granules range between 8 to 12g. In a recent work we identified the most commonly used Chinese herbs (all ingredients are referred to as herbs for reasons of simplicity) and classical formulas (mixtures). Here we present a short overview and the example of suan zao ren (Ziziphi Spinosae Semen), which is used in the treatment of insomnia and anxiety and contains saponins that have been shown to increase sleep in animal studies. Material and Methods A random sample of 1,053 prescriptions was drawn from the database of Lian Chinaherb AG, Switzerland, and analysed according to the most frequently used individual herbs and classical formulas. Cluster analysis (Jaccard similarity coefficient, complete linkage method) was applied to identify common combinations of herbs. Results The most frequently used herbs were dang gui (Angelicae Sinensis Radix), fu ling (Poria), bai shao (Paeoniae Radix Alba), and gan cao (Glycyrrhizae Radix et Rhizoma); the most frequently used classical formulas were gui pi tang (Restore the Spleen Decoction) and xiao yao san (Rambling Powder). The average number of herbs per prescription was 12.0, and the average daily dosage of granules was 8.7g. 74.3% of the prescriptions were for female, 24.8% for male patients. Suan zao ren was present in 14.2% of all prescriptions. These prescriptions contained on average 13.7 herbs, and the daily dosage of granules was 8.9g. Suan zao ren was more frequently prescribed by practitioners of non-Asian than of Asian origin but equally often for female and male patients. Cluster analysis grouped suan zao ren with yuan zhi (Polygalae Radix), bai zi ren (Platycladi Semen), sheng di huang (Rehmanniae Radix) and dan shen (Salviae Miltiorrhizae Radix et Rhizoma). Discussion Prescriptions including suan zao ren contained on average slightly more herbs than other prescriptions. This might be due to the fact that two of the three most popular classical formulas with suan zao ren are composed of 13 and 12 herbs with the possibility of adding more ingredients when necessary. Cluster analysis resulted in the clustering of suan zao ren with other herbs of the classical formula tian wang bu xin dan (Emperor of Heaven’s Special Pill to Tonify the Heart), indicating the use of suan zao ren for the treatment of insomnia and irritability. Unfortunately, the diagnoses of the patients were unavailable and thus correlations between use of suan zao ren and diseases could not be analysed.