Combining rigour with relevance: A novel methodology for testing Chinese herbal medicine
ABSTRACT There is a need to develop an evidence base for Chinese herbal medicine (CHM) that is both rigorous and reflective of good practice. This paper proposes a novel methodology to test individualised herbal decoctions using a randomised, double blinded, placebo controlled clinical trial.
A feasibility study was conducted to explore the role of CHM in the treatment of endometriosis. Herbal formulae were pre-cooked and dispensed as individual doses in sealed plastic sachets. This permitted the development and testing of a plausible placebo decoction. Participants were randomised at a distant pharmacy to receive either an individualised herbal prescription or a placebo.
The trial met the predetermined criteria for good practice. Neither the participants nor the practitioner-researcher could reliably identify group allocation. Of the 28 women who completed the trial, in the placebo group (n=15) 3 women (20%) correctly guessed they were on placebo, 8 (53%) thought they were on herbs and 4 (27%) did not know which group they had been allocated to. In the active group (n=13) 2 (15%) though they were on placebo, 8 (62%) thought they were on herbs and 3 (23%) did not know. Randomisation, double blinding and allocation concealment were successful and the study model appeared to be feasible and effective.
It is now possible to subject CHM to rigorous scientific scrutiny without compromising model validity. Improvement in the design of the placebo using food colourings and flavourings instead of dried food will help guarantee the therapeutic inertia of the placebo decoction.
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ABSTRACT: Background Recurrent urinary tract infections (RUTIs) are common in women and are associated with considerable morbidity and health care costs. Antibiotic prophylaxis is currently successful but infections commonly reoccur and bacterial resistance is an increasing problem. Preliminary data suggests that Chinese herbal medicine (CHM) may have a role to play in managing RUTIs. CHM is a complex intervention that requires a thoughtful process of evaluation and testing. A prospective case series can be used to report ‘real world’ treatment using CHM and to investigate the feasibility of more rigorous research.Methods Fifteen women with RUTIs seen in routine clinical care by an experienced practitioner over a 6-month period were enrolled in a prospective case series. Treatment involved concentrated CHM powders for 12 weeks. Data was collected on common patterns of presentation, and participant response to CHM including compliance, overall changes in urinary tract symptoms, the frequency and severity of recurrent infection; change in use of antibiotics; and wellbeing.ResultsThirteen out of 14 participants who completed the course of treatment reported improvement in their symptoms and overall wellbeing. Antibiotic use declined. It was possible to detect common diagnostic patterns.ConclusionA case series can explore the routine delivery of an intervention and provide information on feasibility for future research. It provided a useful opportunity to introduce case record forms, to assess various outcome measures, to gain an idea of common diagnostic presentations, to assess the safety of CHM, and to explore different treatment strategies. It facilitated the identification of commonly used herbs in the treatment of RUTIs (Fig. 2) and allowed preliminary assessment of a standardised herbal formula for treatment of an acute UTI. However a case series lacks experimental rigour and is subject to considerable bias. The findings from this approach should be interpreted cautiously and seen as preliminary data that can help to inform subsequent more rigorous research.European Journal of Integrative Medicine 12/2012; 4(4):e421–e428. DOI:10.1016/j.eujim.2012.05.004 · 0.65 Impact Factor
04/2012; 2(1):23–25. DOI:10.1016/j.hermed.2012.01.001
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ABSTRACT: In order to investigate the relationship between the trace elements and the characteristics of the oysters, we analyzed the trace elements present in the germplasm of oysters from different producing areas in the Jiaozhou Bay. The element fingerprints were established to reflect the elemental characteristics of the oysters. Concentration patterns of the elements were deciphered by principle component analysis (PCA) and hierarchical cluster analysis (HCA). The six regions were discriminated with accuracy using HCA and PCA based on the concentration of 16 trace elements. The elements were viewed as characteristic elements of the oysters and the fingerprints of these elements could be used to distinguish the quality of the oysters.Journal of Ocean University of China 09/2012; 11(3). DOI:10.1007/s11802-012-1917-7 · 0.38 Impact Factor