There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed'by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and indicative for evidence evaluation for harm.
Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

Objective: This study explored the effects of individualized acupuncture when used alongside routine care for patients diagnosed with schizophrenia in order to assess the possibility and nature of potential benefits for this patient group. This study used an exploratory case study approach that included both quantitative and qualitative research tools, in order to generate a hypothesis questioning the possible benefits of acupuncture and develop future study designs. Methods: Eleven patients diagnosed with schizophrenia were given multiple validated quantitative and qualitative assessments before, during and after a 10-week acupuncture intervention. A range of qualitative and quantitative assessments were employed including review of acupuncture, general practitioner and mental health clinical case notes. Qualitative data were interrogated to explore the reliability of participants' reports to researchers, their clinicians and their carers while acting as informants in the study. Results: Eight out of eleven participants completed a course of acupuncture treatment and all eleven reported positive benefits as a result of acupuncture, including improvements in the symptoms of schizophrenia, side effects of medication, energy, motivation, sleep, addictions and other associated physical problems. However, participants' reports to the researcher and the acupuncturists varied at times and were often inconsistent between treatments, with participants revealing more information to the team towards the end of the study. Conclusion: The study indicates that patients diagnosed with schizophrenia would benefit from acupuncture treatment alongside conventional treatment. Triangulation of the data highlights some inconsistencies in reporting from participants, but also that this can be overcome through the use of mixed research methods. Comparison of data also shows that future studies would benefit from using a Positive and Negative Syndrome Scale, the Standards for Reporting Interventions in Controlled Trials of Acupuncture and an enhanced questionnaire regarding side effects of medication, exercise, sleep and daily routine. It is also worth noting that future studies of this nature must maintain consideration for the vulnerability of participants as they recover and make support easily accessible.

To compare the use of complementary and alternative medicine (CAM), including dietary supplements, by individuals with and without features of metabolic syndrome (FeMS).

In 2004 an estimated 17.1 million people died from cardiovascular diseases (CVDs) worldwide, representing 29% of all global deaths. According to the American Heart Association, heart disease and stroke are the main cause of death and disability among people with type 2 diabetes. Additional safe and effective approaches are needed for the prevention and management of CVDs which may include nutritional supplements.

The paper explores the concept of integrative medicine (IM) in relation to complementary and alternative medicine (CAM). It contrasts IM available in China to its availability in the West. The second part of the paper highlights tools which could facilitate opportunities for IM. The paper concludes with a plea to ensure and maintain the integrity of traditional Chinese medical practice, and to continue to increase developing the evidence base through a funded European Coordination Action between EU member states and China.
China ; European Union ; Humans ; Integrative Medicine ; Medicine, Chinese Traditional

Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, postmarketing surveillance (PMS) has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions (ADRs). Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines.
Evidence-Based Medicine ; methods ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; methods

The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in mainland China recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for effificacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this fifield both in China and abroad are urgently needed.
Clinical Trials as Topic ; Drug Evaluation, Preclinical ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; therapeutic use ; Hospital Information Systems ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; Registries ; Research ; Research Report

OBJECTIVETo compare the use of complementary and alternative medicine (CAM), including dietary supplements, by individuals with and without features of metabolic syndrome (FeMS).

METHODSUsing a cross sectional study design, information was obtained by self-administered questionnaires from 300 university individuals. FeMS was defined as any individuals self-reporting at least one of the clinical diagnoses of diabetes, hypertension, hyperlipidemia, or obesity. Finally, two categories were created for cross tabulation, and individuals with and without FeMS were compared.

RESULTSOf the 192 individuals completing the study, 39% (n=76) were currently using or had used CAM therapies in the past 12 months. Individuals with FeMS (n=54, 28%) were more likely (P<0.05) to use different types of CAM therapies, in particular dietary and herbal supplements, aromatherapy and massage therapy compared to individuals without FeMS (n=138, 72%).

CONCLUSIONIndividuals with FeMS were more likely to use CAM, particularly supplements. Doctors need to properly inquire about and understand their patients' supplement use, especially if CAM therapies are used in conjunction with conventional medications.

Adult ; Complementary Therapies ; Cross-Sectional Studies ; Female ; Humans ; Male ; Metabolic Syndrome ; therapy ; Middle Aged

OBJECTIVETo assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes.

METHODSThis randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks.

RESULTSThe change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study.

CONCLUSIONThis RCT failed to show a beneficial effect in reducing fibrinogen or influencing other selected CVD risk factors but suggests other avenues for subsequent research on bromelain.

Blood Glucose ; Bromelains ; pharmacology ; therapeutic use ; C-Reactive Protein ; metabolism ; Cardiovascular Diseases ; blood ; complications ; drug therapy ; Demography ; Diabetes Mellitus, Type 2 ; blood ; complications ; drug therapy ; Double-Blind Method ; Female ; Fibrinogen ; metabolism ; Humans ; Lipids ; blood ; Male ; Middle Aged ; Placebos ; Risk Factors ; Treatment Outcome

BACKGROUNDMusculoskeletal disorders (MSD) comprise a wide range of conditions, associated with an enormous pain and impaired mobility, and are affecting people's lives and work. Management of musculoskeletal disorders typically involves a multidisciplinary team approach. Positive findings have been found in previous studies evaluating the effectiveness of complementary therapies, though little attention has been paid to evaluating of the effectiveness of integrated packages of care combining conventional and complementary approaches for musculoskeletal conditions in a National Health Service (NHS) setting.

OBJECTIVETo determine the feasibility of all aspects of a pragmatic observational study designed: (1) to evaluate the effectiveness and cost effectiveness of integrated treatments for MSDs in an integrated NHS hospital in the UK; (2) to determine the acceptability of the study design and research process to patients; (3) to explore patients' expectation and experience of receiving integrated treatments.

METHODSThis is an observational feasibility study, with 1-year recruitment and 1-year follow-up, conducted in Royal London Hospital for Integrated Medicine, University College London Hospital Trust, UK. All eligible patients with MSDs newly referred to the hospital were included in the study. Interventions are integrated packages of care (conventional and complementary) as currently provided in the hospital. SF-36™ Health Survey, short form Brief Pain Inventory, Visual Analogue Scale, and modified Client Service Receipt Inventory will be assessed at 4/5 time points. Semi-structured interview/focus group will be carried out before treatment, and 1 year after commence of treatment.

DISCUSSIONWe intend to conduct a pragmatic observational study of integrated medical treatment of MSDs at a public sector hospital. It will inform the design of a future trial including recruitment, retention, suitability of the outcome measures and patients experiences.

Data Collection ; Feasibility Studies ; Humans ; Musculoskeletal Diseases ; therapy ; Outcome Assessment (Health Care) ; Statistics as Topic