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Evaluating the Effectiveness of Nutritional Therapy in the McClelland Teaching Clinic at the University of Worcester
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2021
Abstract
This pilot study by Harris and Benbow (University of Worcester) published in April 2021, highlights the effectiveness of Nutritional Therapy (NT) as an evidence-based complementary therapy for health and lifestyle improvements. The study used a symptom-specific outcome measure, Measure Yourself Medical Outcome Profile (MYMOP2) to evaluate client symptoms, activity and wellbeing, and the Working Alliance Inventory-Short Revised (WAI-SR) to evaluate therapist and client working relationship. Fifty-five clients and twenty-two students participated and preliminary results suggest that NT practice is effective in reducing symptoms and improving health and lifestyle, especially when facilitated by a strong therapist and client working relationship. Although further larger-scaled research is needed, these results are proof of the satisfactory outcomes that can be achieved through personalised nutritional therapy and lifestyle medicine.
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Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer.
Demark-Wahnefried, W, Nix, JW, Hunter, GR, Rais-Bahrami, S, Desmond, RA, Chacko, B, Morrow, CD, Azrad, M, Frugé, AD, Tsuruta, Y, et al
BMC cancer. 2016;16:61
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There is a strong body of evidence associating obesity and increased risk for more aggressive and progressive cancer. This paper aims to assess the feasibility of a presurgical diet and exercise weight loss intervention in men with newly-diagnosed prostate cancer who elected for prostatectomy. It also aims to explore the intervention’s effects on tumour proliferation rates and other biomarkers. The 3-weeks randomised controlled study included 40 overweight or obese men newly-diagnosed with prostate cancer. Participants in experimental arm were assigned to a healthy energy-restricted diet versus wait-list control arm. All feasibility endpoints were achieved with accrual completed within 2 years, retention of 85%, adherence of 95% and no adverse events. Biologic outcomes were not included in this paper, as biological testing was still ongoing. Authors concluded that this study’s methods and data on feasibility could provide useful framework for the design of future trials. They also highlighted the importance of presurgical trials as a feasible and safe means to assess the impacts of diet and exercise on tumour tissue.
Abstract
BACKGROUND Obesity is associated with tumor aggressiveness and disease-specific mortality for more than 15 defined malignancies, including prostate cancer. Preclinical studies suggest that weight loss from caloric restriction and increased physical activity may suppress hormonal, energy-sensing, and inflammatory factors that drive neoplastic progression; however, exact mechanisms are yet to be determined, and experiments in humans are limited. METHODS We conducted a randomized controlled trial among 40 overweight or obese, newly-diagnosed prostate cancer patients who elected prostatectomy to explore feasibility of a presurgical weight loss intervention that promoted a weight loss of roughly one kg. week(-1) via caloric restriction and physical activity, as well as to assess effects on tumor biology and circulating biomarkers. Measures of feasibility (accrual, retention, adherence, and safety) were primary endpoints. Exploratory aims were directed at the intervention's effect on tumor proliferation (Ki-67) and other tumor markers (activated caspase-3, insulin and androgen receptors, VEGF, TNFβ, NFκB, and 4E-BP1), circulating biomarkers (PSA, insulin, glucose, VEGF, TNFβ, leptin, SHBG, and testosterone), lymphocytic gene expression of corresponding factors and cellular bioenergetics in neutrophils, and effects on the gut microbiome. Consenting patients were randomized in a 1:1 ratio to either: 1) weight loss via a healthful, guidelines-based diet and exercise regimen; or 2) a wait-list control. While biological testing is currently ongoing, this paper details our methods and feasibility outcomes. RESULTS The accrual target was met after screening 101 cases (enrollment rate: 39.6%). Other outcomes included a retention rate of 85%, excellent adherence (95%), and no serious reported adverse events. No significant differences by age, race, or weight status were noted between enrollees vs. non-enrollees. The most common reasons for non-participation were "too busy" (30%), medical exclusions (21%), and "distance" (16%). CONCLUSIONS Presurgical trials offer a means to study the impact of diet and exercise interventions directly on tumor tissue, and other host factors that are feasible and safe, though modifications are needed to conduct trials within an abbreviated period of time and via distance medicine-based approaches. Pre-surgical trials are critical to elucidate the impact of lifestyle interventions on specific mechanisms that mediate carcinogenesis and which can be used subsequently as therapeutic targets. TRIAL REGISTRATION NCT01886677.
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Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial.
Szczurko, O, Cooley, K, Mills, EJ, Zhou, Q, Perri, D, Seely, D
Arthritis and rheumatism. 2009;61(8):1037-45
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Conventional treatment for rotator cuff tendonitis exhibit limited or inconsistent long-term success and the effectiveness of many alternative therapies have not yet been explored. The aim of this prospective randomised trial was to determine the impact of naturopathic care (NC) on rotator cuff tendonitis among 77 Canadian postal workers. Participants were randomised to either receive NC or standardised physical exercises (PE) for 12 weeks. NC consisted of dietary advice, acupuncture and hydrolytic enzymes and PE consisted of standard physical therapy exercises. Participants attended weekly sessions and completed the validated self-reported Shoulder Pain and Disability Index (SPADI) questionnaire. While both groups experienced significant improvements, greater improvement was seen in shoulder function and quality of life in the NC group compared to the PE group. Based on these results, the authors conclude naturopathic treatment to be a safe and effective approach for rotator cuff tendonitis.
Abstract
OBJECTIVE To explore the effectiveness of naturopathic care (NC) on rotator cuff tendinitis using a prospective randomized clinical trial design. METHODS Canadian postal workers with rotator cuff tendinitis for a duration of >6 weeks were randomized to receive NC (n = 43) or standardized physical exercises (PEs; n = 42) over 12 weeks. Participants in the NC group received dietary counseling, acupuncture, and Phlogenzym (2 tablets 3 times/day). The PE intervention group received passive, active-assisted, and active range of motion exercises and matched placebo. The primary outcome measure was the Shoulder Pain and Disability Index (SPADI), and secondary outcomes were the pain visual analog scale (VAS), Short Form 36 (SF-36), Measure Yourself Medical Outcomes Profile (MYMOP), and shoulder maximal range of motion. Participants and assessors were blinded to group and placebo allocation. RESULTS Seventy-seven participants (87%) completed >or=8 weeks of the trial. Final total SPADI scores decreased by 54.5% (P < 0.0001) in the NC group and by 18% (P = 0.0241) in the PE group. Between-group differences in changes to SPADI scores showed statistically significant decreases in shoulder pain and disability in the NC group compared with the PE group (P < 0.0001). Significant differences between groups were also observed in the pain VAS, MYMOP, SF-36, and shoulder extension, flexion, and abduction, with the NC group showing superiority in each outcome. No serious adverse reactions were observed. CONCLUSION NC and PE provided significant improvements, with greater improvement in shoulder function in the NC group compared with the PE group. Statistically significant improvements in quality of life measures were observed in the NC group as compared with the PE group.
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The impact of NHS based primary care complementary therapy services on health outcomes and NHS costs: a review of service audits and evaluations.
Wye, L, Sharp, D, Shaw, A
BMC complementary and alternative medicine. 2009;9:5
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Approximately 1500 trial based papers into the therapeutic effectiveness of complementary therapy treatments are published annually, however, there is less information on the impact of complementary therapy services on health outcomes or NHS costs. The aim of this study was to identify the potential impact of primary care complementary therapy services on health outcomes and NHS costs. The most common outcome tools used when evaluating complementary therapy services were SF36 or MYMOP questionnaires, and studies using these questionnaires were therefore selected for this review. Published and unpublished evaluations from November 2003 to April 2008 where the service was located within England or Wales, was delivered by NHS clinicians or professional therapists and was situated in an NHS primary care setting were selected. 14 services were identified that met the selection criteria. The authors found that whilst the complementary therapy services had a significant positive effect on the scores for the health status of service users, quality and quantity of data on NHS costs was less robust or available than data for health status. A methodological problem was that NHS cost data are less easily standardised than health status data and that the different evaluations used different ways to calculate costs. The authors conclude that NHS complementary therapy services may have an impact on health outcomes but that better quality evaluations are needed to assess the impact on NHS cost.
Abstract
BACKGROUND The aim of this study was to review evaluations and audits of primary care complementary therapy services to determine the impact of these services on improving health outcomes and reducing NHS costs. Our intention is to help service users, service providers, clinicians and NHS commissioners make informed decisions about the potential of NHS based complementary therapy services. METHODS We searched for published and unpublished studies of NHS based primary care complementary therapy services located in England and Wales from November 2003 to April 2008. We identified the type of information included in each document and extracted comparable data on health outcomes and NHS costs (e.g. prescriptions and GP consultations). RESULTS Twenty-one documents for 14 services met our inclusion criteria. Overall, the quality of the studies was poor, so few conclusions can be made. One controlled and eleven uncontrolled studies using SF36 or MYMOP indicated that primary care complementary therapy services had moderate to strong impact on health status scores. Data on the impact of primary care complementary therapy services on NHS costs were scarcer and inconclusive. One controlled study of a medical osteopathy service found that service users did not decrease their use of NHS resources. CONCLUSION To improve the quality of evaluations, we urge those evaluating complementary therapy services to use standardised health outcome tools, calculate confidence intervals and collect NHS cost data from GP medical records. Further discussion is needed on ways to standardise the collection and reporting of NHS cost data in primary care complementary therapy services evaluations.