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A poly-herbal blend (Herbagut®) on adults presenting with gastrointestinal complaints: a randomised, double-blind, placebo-controlled study.
Lopresti, AL, Gupta, H, Smith, SJ
BMC complementary and alternative medicine. 2018;18(1):98
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Functional gastrointestinal disorders are a group of conditions with no identifiable or diagnosable abnormality that commonly present as a range of symptoms including motility disturbance, pain and altered gut microbiota. Natural plant compounds show potential for restoring gastrointestinal health and reducing symptoms. Herbagut is a blend of 14 herbal extracts and according to unpublished studies, has exhibited antibacterial activity in the gut as well as improvements in constipation. The aim of this randomised controlled trial was to evaluate the efficacy and tolerability of Herbagut for the treatment of gastrointestinal symptoms in 50 adults with unsatisfactory bowel habits. Participants were randomly allocated to take Herbagut or a matching placebo for 28 days, and gastrointestinal changes and quality of life were measured through questionnaires. This study found Herbagut ingestion over a 28-day period resulted in improvements in several gastrointestinal symptoms, primarily constipation, as well as quality of life. Based on these results, the authors conclude that this poly-herbal blend be used for investigating larger samples and more diverse populations.
Abstract
BACKGROUND To evaluate the efficacy and tolerability of a poly-herbal formulation, Herbagut, for the treatment of gastrointestinal symptoms and its effect on quality of life parameters in patients presenting with self-reported, unsatisfactory bowel habits. METHODS This was a randomised, double-blind, placebo-controlled trial. Fifty adults with self-reported unsatisfactory bowel habits, primarily characterised by chronic constipation were randomly allocated to take Herbagut or a matching placebo for 28 days. Efficacy of gastrointestinal changes was measured by the completion of a patient daily diary evaluating changes in stool type (Bristol Stool Form Scale), ease of bowel movements, and feeling of complete evacuation; and the Gastrointestinal Symptom Rating Scale (GSRS). Changes in quality of life were also examined using the World Health Organization Quality of Life - abbreviated version (WHOQOL-BREF), and the Patient Assessment of Constipation-Quality of Life (PAC-QOL). RESULTS All participants completed the 28-day trial with no adverse events reported. Compared to the placebo, weekly bowel movements increased over time (p < .001), as did self-reported, normal bowel motions (76% vs 4%; p < .001). Self-reported incomplete evacuation was also lower in the Herbagut group compared to placebo (24% vs 76%; p = <.001). GSRS domain ratings for abdominal pain, constipation, diarrhoea, indigestion, and reflux also decreased significantly in people taking Herbagut compared to placebo (p < .001, for all domains). Moreover, quality of life significantly improved in the Herbagut group compared to placebo as indicated by significantly greater improvement in WHOQOL-BREF domain ratings for overall quality of life, social relations, environmental health, psychological health, and physical health (p < .001, for all domains); and PAC-QOL domain ratings for physical discomfort, psychosocial discomfort, worries and concerns, and life satisfaction (p < .001, for all domains). The changes were considered clinically meaningful as evidenced by their large effect sizes. CONCLUSION Herbagut ingestion over a 28-day period resulted in improvements in several gastrointestinal symptoms and overall quality of life. Further investigation utilising larger sample sizes and diverse clinical and cultural populations are needed. TRIAL REGISTRATION Clinical Trials Registry- India /2016/11/007479 . Registered 24 April 2015 (retrospectively registered).
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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.