Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults::a feasibility double-blind, placebo-controlled randomised trial

BACKGROUND: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries.STUDY DESIGN: Feasibility double-blind randomised placebo-controlled clinical trial.METHODS: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2-4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial.RESULTS: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18-21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex.CONCLUSIONS: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition.TRIAL REGISTRATION: HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884 .</p

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors

Background: Many cancer survivors following primary treatment have prolonged poor quality of life.Aim: To determine the effectiveness of a bespoke digital intervention to support cancer survivors.Design: Pragmatic parallel open randomised trial.Setting: UK general practices.Methods: People having finished primary treatment (&lt;= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score &lt;85, were randomised by online software to: 1) detailed ‘generic’ digital NHS support (‘LiveWell’;n=906), 2) a bespoke complex digital intervention (‘Renewed’;n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) ‘Renewed-with-support’ (n=903): ‘Renewed’ with additional brief email and telephone support. Results: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n’s respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified.Conclusion: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global healthenablement and symptom management, with substantially lower NHS costs.<br/

A randomised controlled trial of a digital intervention (renewed) to support symptom management, wellbeing and quality of life in cancer survivors

Background: Many cancer survivors following primary treatment have prolonged poor quality of life. Aim: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. Design: Pragmatic parallel open randomised trial. Setting: UK general practices. Methods: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed ‘generic’ digital NHS support (‘LiveWell’;n=906), 2) a bespoke complex digital intervention (‘Renewed’;n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) ‘Renewed-with-support’ (n=903): ‘Renewed’ with additional brief email and telephone support. Results: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n’s respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. Conclusion: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs

The OMII Software - Flexible for being a Grid and a Cloud

Cloud Computing aims to provide scalable and inexpensive on-demand computing infrastructures with good quality of service (QoS) levels. More specifically, this involves a set of network-enabled services that can be accessed in a simple and pervasive way [1]. Currently Amazon EC2/S3, Windows Azure, Google Docs and Google Apps are leading commercial service providers. Open source cloud projects such as Nimbus, Eucalyptus, CloudSim and Aneka are offering incentives for pioneering cloud projects. There are attempts for re-prototyping Grid software as bespoke Cloud software, which include Globus and Nimbus. There is a particular project, OMII-UK software, which is started as a Grid but also in the process to be part of, or fulfil capabilities as a Cloud. To achieve this, we propose an OMII-UK Cloud Framework 1.0 to describe how OMII platform can be used as a Grid and a Cloud, particularly targeting for Platform as a Service (Paas) and Software as a Service (SaaS)

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation

Objective: an economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain.Design: cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial. Participants: 579 patients with chronic or recurrent low back pain recruited from primary care. Interventions: normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse.Main outcome measures: costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves. Results: Intervention costs ranged from £30 for exercise prescription to £596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from £50 for 24 lessons in Alexander technique to £124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value (£61 per point on disability score, pound9 per additional pain-free day, £2,847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional £64 per point on disability score, £43 per additional pain-free day, £5,332 per QALY gain). Conclusions: an exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above £20,000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option

A randomised multi-arm, open label trial of nasal sprays and a behavioural intervention for acute respiratory illness in primary care

Background. Limited evidence suggests that nasal sprays, or physical activity and stress-management, could limit respiratory infections. This study aimed to assess the impact on respiratory illnesses from nasal sprays or promoting physical activity and stress-management. Methods. 13799 participants aged &gt;=18, from 332 GP practices, with co-morbidities and/or &gt;=3 self-reported recurrent illnesses , were randomised by online software to: i) usual care (n=3451) ii) gel-based spray (n=3448) (2 sprays per nostril, up to 6 times/day) iii) saline spray (n=3450) (same dosing), or iv) a brief behavioural website promoting physical activity and stress-management (n=3450). The sprays were relabelled. Primary outcome: respiratory illness days over 6 months. Harms: side effects, antibiotic use.Findings. The usual care group (n=2983 analysed) had a mean of 8 self-reported illness days which was reduced in both spray groups (gel-based (n=2935) 6.5 days adjusted incidence rate ratio (IRR) 0.82, 99% CIs 0.76, 0.90, p&lt;0.0001), Saline (n=2967) 6.4 days (IRR 0.81; 0.74,0.88, p&lt;0.0001), behavioural website (n=2727) 7.4 days (0.97; 0.91, 1.04), p=0.46); for those reporting an illness it was 15,12,11.8 and 14 days respectively. Headache was more common with the gel-based spray (7.8%(199/2556) vs 4.8% (123/2547) usual care; risk ratio 1.61, 95% CIs 1.30 to 1.99, p&lt;0.0001), but antibiotic use was lower for all interventions (IRRs (95% CIs) respectively 0.65 (0.50 to 0.84;p=0.001), 0.69 (0.45,0.88;p=0.003), 0.74 (0.57 to 0.94;p=0.02)).Interpretation. Advice to use either nasal spray at the first sign of an RTI reduced illness duration and both sprays and the behavioural website reduced antibiotic use.<br/