A Retrospective Observational Study Evaluating the Synergistic Effect of a Novel Combination of Alfapin + Native Type 2 Collagen + Mobilee (Hyaluronic Acid) + CurQlife (Curcumin) Nutraceuticals in the Symptomatic Improvement of Knee Osteoarthritis.

Background Treatment of pain and inflammation form the mainstay of osteoarthritis (OA) management. Non-steroidal anti-inflammatory drugs (NSAIDs), due to their inflammation-blocking mechanism, are a highly effective class of drugs for chronic pain and inflammation in OA. However, this comes at a cost of increased risk for multiple adverse effects, including gastrointestinal bleeding, cardiovascular side effects, and NSAID-induced nephrotoxicity. To minimize the potential risk of an adverse event, numerous regulatory bodies and medical societies recommend using the lowest effective NSAID dose for the shortest time necessary. One potential strategy to achieve this is the use of disease-modifying osteoarthritis drugs (DMOADs) containing anti-inflammatory and analgesic properties instead of NSAIDs for the management of OA. This study focuses on the efficacy of Clagen™ [Aflapin (Boswellia serrata extract) + native type 2 collagen + Mobilee (hyaluronic acid (60-70%), polysaccharides (>10%), and collagen (>5%)) + CurQlife (Curcumin)] for the symptomatic improvement in OA patients as well as if this combination is effective in the long-term management of OA instead of NSAIDs. Methodology In this retrospective observational study, a total of 300 patients were screened, of whom 100 OA patients who fulfilled the criteria and agreed to be part of the study were enrolled. The data were analyzed to evaluate the efficacy of the nutraceutical formulation Clagen™ in patients with OA of the knee. From the baseline to two months, primary outcomes of improvement in the Visual Analog Scale (VAS) score, range of motion, and Knee Injury and Osteoarthritis Outcome Score (KOOS) were measured at monthly follow-up. Statistical analyses were performed according to the results obtained from the parameters. The tests were performed at a 5% significance level (p <0.05). The qualitative characteristics were described using absolute and relative frequencies, and the quantitative measures were described as summary measures (mean, standard deviation). Results Of the 100 patients enrolled in the study, 99 (64 males and 35 females) completed the study. The mean age of the patients was 50.6 ± 13.9 years, and the mean body mass index was 24.5 ± 3.5 kg/m2. The statistical analysis of the outcomes from the baseline to the two-month follow-up was analyzed using paired t-test. The difference in the mean of VAS pain score at baseline and two months was 3.3 ± 1.8 [t (97) = 18.2; p < 0.05], which showed a significant reduction in pain at two months. Moreover, the difference in the mean of the goniometer value of 7.3 ± 7.3 [t (98) = -10.0, p < 0.05] indicated statistically significant improvements in the range of motion. It was also observed that Clagen™ significantly improved the composite KOOS score by 10.8% at the end of two months. Similarly, KOOS scores for Symptoms, Function, and Quality of Life showed improvements of 9.6%, 9.8%, and 7.8%, respectively, and were statistically significant (p < 0.05). Conclusions Clagen™ exerted positive adjuvant effects in the management of OA. The combination not only improved the symptoms and quality of life but, in the light of future perspective, NSAIDs can be withdrawn in OA patients, considering their long-term negative effects. To validate these findings further long-term studies with a comparison arm of NSAIDs are needed.

Evaluation of My Medication Passport: a patient-completed aide-memoire designed by patients, for patients, to help towards medicines optimisation.

OBJECTIVES: A passport-sized booklet, designed by patients for patients to record details about their medicines, has been developed as part of a wider project focusing on improving prescribing in the elderly ('ImPE'). We undertook an evaluation of 'My Medication Passport' to gain an understanding of its value to patients and how it may be used in communications about medicines. SETTING: The Passport was launched in secondary care with the initial users being older people discharged home after an admission to one of the four North West London participating Trusts. The uptake subsequently spread to other (community) locations and other age groups. PARTICIPANTS: We recruited more than 200 patients from a cohort who had been given a passport as part of the improvement projects at one of four sites. Of them, 63% (133) completed the structured telephone questionnaire including 27% for whom English was not their first language. Approximately half of the respondents were male and 40% were over 70 years of age. RESULTS: More than half of the respondents had found their medication passport useful or helpful in some way; 42% through sharing details from it with others (most frequently family, carer or doctor) or using it as a platform for conversations with healthcare professionals. One-third of those questioned carried the passport with them at all times. CONCLUSIONS: My Medication Passport has been positively evaluated; we have a better understanding of how it is used by patients, what they are recording and how it can be an aid to dialogue about medicines with family, carers and healthcare professionals. Further development and spread is underway including an App for smartphones that will be subject to wider evaluation to include feedback from clinicians.

A quality improvement programme to increase compliance with an anti-infective prescribing policy.

OBJECTIVES: The UK Department of Health has made recommendations on safe and appropriate prescribing of anti-infectives. In response, we reviewed our anti-infective policies to ensure they were in line with best practice. As a result, a new adult anti-infective policy was launched. To help facilitate its implementation, a quality improvement programme was established, with the aim of achieving >90% compliance with the new policy. METHODS: Patients under the care of the medical admissions teams who had been prescribed one or more systemic anti-infectives between January and November 2008 were included in the study. Study pharmacists collected data daily on all patients, including the anti-infective(s) prescribed and indication(s) documented on either the patient's drug prescription chart or health records. A definition of compliance was developed, which required documented indication(s) and associated anti-infectives to match the anti-infective policy. A baseline compliance level was established; we then implemented a series of interventions using the plan-do-study-act ('PDSA') approach to monitor and improve compliance. Three overlapping intervention phases were retrospectively identified: raising awareness; education; and weekly feedback of results in the form of run charts distributed to medical teams. RESULTS: Over the 11 month study period, compliance with the policy increased from 30% to 71%. Since 2008, we have seen the average compliance increase year-on-year to over 90% in 2010 using a sustainable once weekly data collection model. CONCLUSIONS: This study shows that it is possible to use quality improvement methodology to support antimicrobial stewardship within existing resources and suggests that an improvement in policy compliance can be both achieved and sustained.