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Objectives: When higher level of evidence is absent, findings of case series studies can be used to generate hypotheses for further research. However, to date, there has been no established instrument for determining their quality. This study was to develop and validate an instrument to assess the quality of case series studies on herbal medicines., Design: A draft instrument was developed based on items generated by judges. Raters (including judges), consisting of herbal medicine researchers, herbal medicine practitioners, and other professionals, used the draft instrument to assess the quality of sample case series reports. The number of quality assessment items was then reduced as much as possible in the instrument while maintaining its reliability and validity. Content and construct validity, and inter-rater agreement of the instrument were used as the main outcome measures., Results: Seven (7) judges from different backgrounds independently generated 68 nonredundant items for inclusion in the initial draft instrument. The content validity of these items was assessed by all judges for consensus using a seven-point scale, and a 24-item second-draft instrument was derived. The wording and sequence of these items were further revised and then used by 20 raters (including seven judges) to assess the quality of 35 case series reports. A 13-item instrument was finally developed. All raters, including the judges, demonstrated a high level of consistency on quality of the reports by using this instrument, despite their different backgrounds., Conclusions: High-level consistency can be achieved by using this instrument to assess the quality of case series studies. This instrument may facilitate the improvement of reporting quality of case series studies.

Objectives: When higher level of evidence is absent, findings of case series studies can be used to generate hypotheses for further research. However, to date, there has been no established instrument for determining their quality. This study was to develop and validate an instrument to assess the quality of case series studies on herbal medicines. Design: A draft instrument was developed based on items generated by judges. Raters (including judges), consisting of herbal medicine researchers, herbal medicine practitioners, and other professionals, used the draft instrument to assess the quality of sample case series reports. The number of quality assessment items was then reduced as much as possible in the instrument while maintaining its reliability and validity. Content and construct validity, and inter-rater agreement of the instrument were used as the main outcome measures. Results: Seven (7) judges from different backgrounds independently generated 68 nonredundant items for inclusion in the initial draft instrument. The content validity of these items was assessed by all judges for consensus using a seven-point scale, and a 24-item second-draft instrument was derived. The wording and sequence of these items were further revised and then used by 20 raters (including seven judges) to assess the quality of 35 case series reports. A 13-item instrument was finally developed. All raters, including the judges, demonstrated a high level of consistency on quality of the reports by using this instrument, despite their different backgrounds. Conclusions: High-level consistency can be achieved by using this instrument to assess the quality of case series studies. This instrument may facilitate the improvement of reporting quality of case series studies. [ABSTRACT FROM AUTHOR]

Background: The State of Victoria in Australia introduced Chinese medicine practitioner registration in 2000 and issued its education guidelines in late 2002 for introduction in 2005. This study obtained practitioners' views on desired capabilities for competent Chinese medicine practice and to identify professional development needs. Methods: A questionnaire, consisting of 28 predefined capabilities in four categories with a rating scale of importance from one to five, was developed and sent to all registered Chinese medicine practitioners in the State of Victoria, Australia in October, 2005. Results: Two hundreds and twenty eight completed questionnaires were returned which represented a response rate of 32.5%. Of the four categories of capabilities, technical capabilities were considered to be the most important for clinical practice. Specifically, the ability to perform acupuncture treatment and/or dispense an herbal prescription was ranked the highest. In contrast, research and information management capabilities were considered the least important. The educational background of practitioners appeared to be an important factor influencing their rating of capabilities. Significantly, nearly double the number of practitioners with Australian qualifications than practitioners trained overseas valued communication as an important capability. For continuing professional education, clinical skills courses were considered as a priority while research degree studies were not. Conclusion: Registered Chinese medicine practitioners viewed skills training as important but did not support the need for research and information management training. This represents a significant hurdle to developing Chinese medicine as a form of evidence-based healthcare. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the feasibility of implementing a clinical trial protocol of the herbal seeds Ziziphus spinosa (ZS) for people with insomnia.Design and Setting: A randomized, double-blind, placebo controlled, cross-over feasibility trial in Melbourne, Australia.Interventions: After two-week run-in participants were randomized to either ZS (encapsulated granules; 2 g daily) or placebo for four weeks. After four-weeks wash-out, participants swapped to the other treatment for four weeks.Main Outcome Measures: Sleep quality assessed by the Insomnia Severity Index and Pittsburgh Sleep Quality Index (PSQI). Quality of life, mood, functional impairment and sleep parameters were also assessed.Results: Twelve participants were randomized and completed both periods of cross-over (six in each sequence). Feasibility endpoints were acceptable. Improvements for sleep quality measured on the PSQI were statistically significant during the ZS treatment periods compared to placebo (t = -2.276, df = 10, 95 % CI -3.3 to -0.04, p = 0.046). There was no evidence of any significant carryover effects. However, there were period effects. Other outcomes showed no statistically significant difference between the treatments. Subjective sleep parameters measured on sleep diaries showed improvements after ZS in terms of total sleep time, sleep efficiency and sleep onset latency, but not after placebo. ZS was well tolerated with only minor adverse events.Conclusions: ZS is an acceptable and well-tolerated herbal candidate for the treatment of insomnia. The feasibility objectives of this study were achieved and ZS improved both subjective sleep quality and quantity compared to placebo. ZS should be explored in future clinical trials. [ABSTRACT FROM AUTHOR]

Context · Chinese herbal medicine (CHM) is widely used to treat seasonal allergic rhinitis (SAR), however, evidence of efficacy is lacking. Objective · To evaluate the efficacy of a Chinese herbal formulation for the treatment of SAR. Design · Randomized, double blind, placebo controlled trial. Setting · RMIT Chinese Medicine Clinic. Patients · 55 patients with seasonal allergic rhinitis (active 28, placebo 27). Interventions · CHM extract capsule (containing 18 herbs) or placebo, given daily for 8 weeks. Main Outcome Measures · The primary measure of efficacy were changes in severity of nasal and non-nasal symptoms using a Five Point Scale (FPS) measured by both patients and the practitioner. The secondary measure was the change in score for the domains measured in the Rhinoconjunctivitis and Rhinitis Quality of Life Questionnaire (RQLQ) assessed by patients. Results · Forty-nine patients completed the study (active 24; placebo 25). After eight weeks, the severity of nasal symptoms and non-nasal symptoms were significantly less in the active treatment group than in the control group, both for measurements made by patients and those by the practitioner. Comparison of active and placebo treatment groups RQLQ scores also indicated significant beneficial effects of treatment (end point Section 1: P<0.05; Section 2: P<0.01). Intention-to-treat analyses of categorical items showed moderate to marked improvement rates were 60.7% and 29.6% for active and placebo respectively. Eleven patients reported mild adverse events including I withdrawn from the trial. Conclusions · This CHM formulation appears to offer symptomatic relief and improvement of quality of life for some patients with seasonal allergic rhinitis. [ABSTRACT FROM AUTHOR]