- Email: [email protected]
A double-blind placebo phase 3 randomised controlled trial of Chinese herbal medicine in anterior uveitis
Abstracts / European Journal of Integrative Medicine 5 (2013) 571–582
Discussion: This systematic review revealed a disappointingly small number of qualitative studies of MT. However it suggests that MT is a promising intervention that would benefit from further investigation. It is essential to embed qualitative research of patients’ experience within any future trials of MT, and to extend this qualitative approach to health professionals, especially those in conventional care. Lessons from this review could also be incorporated into the design of outcome measures that fully reflect patients’ experiences. http://dx.doi.org/10.1016/j.eujim.2013.08.014 A double-blind placebo phase 3 randomised controlled trial of Chinese herbal medicine in anterior uveitis Wenqing Li 1,∗ , Oliver Backhouse 1 , Tiansheng Xie 2 , Richard Gale 3 , Bernie Chang 1 , Chunxiao Bong 1 1 Ophthalmology
Department St James Leeds University Teaching Hospital NHS, United Kingdom 2 Downing College, Cambridge University, United Kingdom 3 Ophthalmology Department The York University Teaching Hospital NHS, United Kingdom E-mail address: [email protected] (W. Li). Introduction: Uveitis is the most common inflammatory eye disease with a reported annual incidence of between 17 and 52.4 per 100,000 person-year and prevalence of between 38 and 370 per 100,000 of the population. It is estimated that 1 in 4500 people are affected by uveitis in any given year with 11,622 uveitis suffers and with 10,659 anterior uveitis (AU) cases in the UK as AU represents up to 90% of total cases of uveitis. The main age of onset is between 20 and 50 years old. In addition, 10% of patients are registered legally blind (under the age of 65) due to uveitis and its complications. At present, steroids are the first line treatment for AU and may cause negative effects leading to diseases such as cataract and glaucoma and can make the condition worse. The symptoms of AU frequently return after treatment and the inflammation possibly affects the whole eye. AU generates anxiety in both patients and their medical attendants adding to the physical and financial burden on the NHS, therefore, it is a problem which requires a solution. Considerable positive evidence from over 50 clinical trials including two reviews on the treatment of AU using Chinese herbal medicine (CHM) or integrated medicine has been described in detail. However, until now there has been no rigorous research into the clinical effectiveness of CHM for AU in the UK, hence the proposed research on treating AU using CHM which may yield an effective result with possible long-term lower costs and low risk.
577
Aim: To find out whether CHM in addition to usual secondary treatment can effectively treat AU and assess whether this is cost effective. Methods: This study is a double-blinded, placebo phase 3 RCT. The sample size is based on power 85%, significance level 5% for a single centre. The target population in this trial will be from the UK. The eligible AU participants who meet the inclusion and exclusion criteria will be randomly located to an intervention group (CHM + Prednisolone 1%) and a control group (placebo + Prednisolone 1%) after consenting. Total treatment duration is 8 weeks. The CHM treatment will be based on prescriptions from the Pharmacopoeia of People’s Republic of China and the principles of Chinese Medicine. Outcome measures: Primary outcome: Anterior chambercells and flare cells. Secondary outcome: (a). Pain scale, (b). Episodes of AU, duration of the treatment (recovery) and dosage of 1% Prednisolone, (c). SF-36 questionnaire, (d). AU related routine examination: visual acuity, intraocular pressure and blood tests, (e) Follow up questionnaires, (e). Cost and EQ-5D. Setting, ethics approval and informed consent: Ethics approval will be obtained from the NHS local Research Ethic Committee. Participants will be recruited and treated at the ophthalmology department of Leeds St James’s university teaching hospital in the UK. Results: Data will be analysed using SPSS 21. Analysis will be by intention-to-treat. To assess the effectiveness of the treatment and the cost of using CHM. http://dx.doi.org/10.1016/j.eujim.2013.08.015 A multi-sited ethnography of the professional practice of Western herbal medicine by medical herbalists in the UK Guy Waddell 1,∗ , Anthony Towell 2 , Volker Scheid 3 , Julie Whitehouse 1 1 Department
of Complementary Medicine, School of Life Sciences, University of Westminster, London, United Kingdom 2 Department of Psychology, School of Social Sciences, Humanities and Languages, University of Westminster, London, United Kingdom 3 EASTmedicine Research Centre, School of Life Sciences, University of Westminster, London, United Kingdom E-mail address: [email protected] (G. Waddell). Introduction: The political focus on the regulation of herbal practitioners as a group and the biomedical focus on herbal medicines themselves may be contrasted with the lack of investigation into the practices of medical herbalists. Aim: The aim of this study was initially broad: to investigate the construction of Western herbal medicine practice in the UK by medical herbalists and other influences found during the ethnography.
Discussion: This systematic review revealed a disappointingly small number of qualitative studies of MT. However it suggests that MT is a promising intervention that would benefit from further investigation. It is essential to embed qualitative research of patients’ experience within any future trials of MT, and to extend this qualitative approach to health professionals, especially those in conventional care. Lessons from this review could also be incorporated into the design of outcome measures that fully reflect patients’ experiences. http://dx.doi.org/10.1016/j.eujim.2013.08.014 A double-blind placebo phase 3 randomised controlled trial of Chinese herbal medicine in anterior uveitis Wenqing Li 1,∗ , Oliver Backhouse 1 , Tiansheng Xie 2 , Richard Gale 3 , Bernie Chang 1 , Chunxiao Bong 1 1 Ophthalmology
Department St James Leeds University Teaching Hospital NHS, United Kingdom 2 Downing College, Cambridge University, United Kingdom 3 Ophthalmology Department The York University Teaching Hospital NHS, United Kingdom E-mail address: [email protected] (W. Li). Introduction: Uveitis is the most common inflammatory eye disease with a reported annual incidence of between 17 and 52.4 per 100,000 person-year and prevalence of between 38 and 370 per 100,000 of the population. It is estimated that 1 in 4500 people are affected by uveitis in any given year with 11,622 uveitis suffers and with 10,659 anterior uveitis (AU) cases in the UK as AU represents up to 90% of total cases of uveitis. The main age of onset is between 20 and 50 years old. In addition, 10% of patients are registered legally blind (under the age of 65) due to uveitis and its complications. At present, steroids are the first line treatment for AU and may cause negative effects leading to diseases such as cataract and glaucoma and can make the condition worse. The symptoms of AU frequently return after treatment and the inflammation possibly affects the whole eye. AU generates anxiety in both patients and their medical attendants adding to the physical and financial burden on the NHS, therefore, it is a problem which requires a solution. Considerable positive evidence from over 50 clinical trials including two reviews on the treatment of AU using Chinese herbal medicine (CHM) or integrated medicine has been described in detail. However, until now there has been no rigorous research into the clinical effectiveness of CHM for AU in the UK, hence the proposed research on treating AU using CHM which may yield an effective result with possible long-term lower costs and low risk.
577
Aim: To find out whether CHM in addition to usual secondary treatment can effectively treat AU and assess whether this is cost effective. Methods: This study is a double-blinded, placebo phase 3 RCT. The sample size is based on power 85%, significance level 5% for a single centre. The target population in this trial will be from the UK. The eligible AU participants who meet the inclusion and exclusion criteria will be randomly located to an intervention group (CHM + Prednisolone 1%) and a control group (placebo + Prednisolone 1%) after consenting. Total treatment duration is 8 weeks. The CHM treatment will be based on prescriptions from the Pharmacopoeia of People’s Republic of China and the principles of Chinese Medicine. Outcome measures: Primary outcome: Anterior chambercells and flare cells. Secondary outcome: (a). Pain scale, (b). Episodes of AU, duration of the treatment (recovery) and dosage of 1% Prednisolone, (c). SF-36 questionnaire, (d). AU related routine examination: visual acuity, intraocular pressure and blood tests, (e) Follow up questionnaires, (e). Cost and EQ-5D. Setting, ethics approval and informed consent: Ethics approval will be obtained from the NHS local Research Ethic Committee. Participants will be recruited and treated at the ophthalmology department of Leeds St James’s university teaching hospital in the UK. Results: Data will be analysed using SPSS 21. Analysis will be by intention-to-treat. To assess the effectiveness of the treatment and the cost of using CHM. http://dx.doi.org/10.1016/j.eujim.2013.08.015 A multi-sited ethnography of the professional practice of Western herbal medicine by medical herbalists in the UK Guy Waddell 1,∗ , Anthony Towell 2 , Volker Scheid 3 , Julie Whitehouse 1 1 Department
of Complementary Medicine, School of Life Sciences, University of Westminster, London, United Kingdom 2 Department of Psychology, School of Social Sciences, Humanities and Languages, University of Westminster, London, United Kingdom 3 EASTmedicine Research Centre, School of Life Sciences, University of Westminster, London, United Kingdom E-mail address: [email protected] (G. Waddell). Introduction: The political focus on the regulation of herbal practitioners as a group and the biomedical focus on herbal medicines themselves may be contrasted with the lack of investigation into the practices of medical herbalists. Aim: The aim of this study was initially broad: to investigate the construction of Western herbal medicine practice in the UK by medical herbalists and other influences found during the ethnography.