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Mineral rich algae with pine bark improved pain, physical function and analgesic use in mild-knee joint osteoarthritis, compared to Glucosamine: A randomized controlled pilot trial.
Heffernan, SM, McCarthy, C, Eustace, S, FitzPatrick, RE, Delahunt, E, De Vito, G
Complementary therapies in medicine. 2020;:102349
Abstract
INTRODUCTION Osteoarthritis (OA) is characterised by synovial joint pain, functional disability and affects ∼13 % of people worldwide, of which ∼16-27 % report Knee-OA (KOA). Glucosamine (Glu) is the most widely used nutraceutical treatment for OA despite a lack of scientific consensus, therefore alternative nutraceutical treatments are required. The aim of this study was to investigate the effect of Lithothamnion species, seawater-derived magnesium and pine bark (Aq+) on pain, symptoms and improve physical function in symptomatic (sKOA), compared to Glu. METHODS 358 participants were screened. In a double-blinded crossover pilot-trial, sKOA participant (n = 30) were randomly assigned to either the Glu group (2000 mg day-1) or Aq+ (3056 mg day-1) for 12 weeks (clinicaltrials.gov:NCT03106584). The Knee Injury and Osteoarthritis Outcome Score was used to assess subjective pain and symptoms. Timed-up-and-Go (TuG) and Six minute walking distance were used to assess functional change and analgesic use was recorded. RESULTS Aq+ improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06). Only Aq+ improved pain (P < 0.05) for males (d' = 0.91, 95 %CI 0.162-1.667) and females (d' = 0.55, 95 %CI 0.210-1.299). In females, Aq+ improved TuG by -7.02 % (d' = 0.92, 95 %CI 1.699-0.141) while Glu worsened performance by 4.18 % (P = 0.04). Aq+ reduced analgesia by 71.6 %, compared to Glu (P = 0.02; d' = 0.82, 95 %CI 1.524-0.123). Aq+ was superior to Glu at improving pain, KOOS subscales, physical function and analgesia use in mild-sKOA. Given these data, Aq+ should be considered as a supplementary treatment for early-stage-KOA and may have the potential to reduce use of pain medication, although larger replication studies are required.
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Efficacy of a topical herbal and mineral formulation (Dynamiclear) for the treatment of herpes simplex labialis in the community setting: study protocol for a randomised, double-blind placebo-controlled trial.
Armour, M, Semprini, A, Ee, C, MacCullagh, L, Shortt, N
BMJ open. 2020;(1):e031876
Abstract
INTRODUCTION Herpes simplex labialis (HSL) is a common infection that can cause painful lesions on the oral mucosa, commonly referred to as cold sores. Current biomedical treatments include topical aciclovir, which reduces the episode duration by an average of 0.5 days. This study will examine the efficacy and tolerability of an over-the-counter topical treatment, Dynamiclear in reducing duration and severity of HSL episodes. METHODS AND ANALYSIS This prospective, randomised, double-blind, placebo-controlled, multi-centre trial will recruit a minimum of 292 adult participants across Australia and New Zealand who present with a cold sore within 48 hours of onset. They will be randomly allocated in a 2:1 ratio to receive either topical Dynamiclear (active) or placebo. Dynamiclear's active ingredients are Hypericum perforatum, Calendula Officinalis and copper sulfate. A single topical treatment of active or placebo will be applied by a pharmacy-based investigator, and participants will be provided with a viral swab kit to confirm presence of herpes virus 1 or 2 from ulcerated lesions. Participants will receive reminders by email and/or SMS to complete an online daily diary assessing their cold sore lesion using a visual guide, and recording other symptoms on numeric scales until healed. The primary outcome variable is median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin. Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration. ETHICS AND DISSEMINATION Australian ethics approval from Western Sydney University Human Research Ethics Committee, ref: H12776. New Zealand Ethics approval from The Health and Disability Ethics Committees (HDEC) ref: 18/CEN/151. Results will be published in a peer-reviewed academic journal, presented at academic meetings and reported to participants TRIAL REGISTRATION NUMBERS Australia and New Zealand Clinical Trials Registry (ACTRN12618000890235); Universal Trial Number (UTN) (U1111-1233-2426).
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TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial.
Chen, YI, Wyse, J, Lu, Y, Martel, M, Barkun, AN
Gastrointestinal endoscopy. 2020;(2):321-328.e1
Abstract
BACKGROUND AND AIMS TC-325 (Hemospray; Cook Medical, Winston-Salem, NC, USA), an endoscopic hemostatic powder, exhibits possible benefits in patients with malignant GI bleeding. Our aim is to assess feasibility and determine estimates of efficacy of TC-325 compared with standard of care (SOC) in terms of initial hemostasis and recurrent bleeding rates in comparable groups of patients with malignant GI bleeding. METHODS Adult patients presenting with acute malignant upper or lower GI bleeding were randomized to TC-325 or SOC. Measured outcomes included feasibility of recruitment and randomization in the urgent care setting, immediate hemostasis, recurrent bleeding, need for additional treatment modalities, and mortality. RESULTS A preplanned 20 patients (upper GI source in 85%) were randomized 1:1 to TC-325 or SOC (25% women, age 67.2 ± 15.9 years, oozing in 95%) over 20 months. Immediate hemostasis was achieved in 90% of patients treated initially with TC-325 versus 40% in the SOC group (P = .057). Overall, 83.3% crossed over to TC-325, with hemostasis then achieved at index endoscopy in 80%. Overall, hemostasis at index endoscopy (before or after crossover) was obtained in 87.7% of patients treated with TC-325. Recurrent bleeding over the next 180 days was 20% in the TC-325 group compared with 60% in the SOC group (P = .170). CONCLUSIONS This pilot trial demonstrates the feasibility of TC-325 in malignant GI bleeding and provides results to help inform a larger randomized trial. Although not powered for such, results suggest that use of TC-325 is a very promising modality in malignant GI bleeding in achieving immediate hemostasis and may even result in decreased subsequent recurrent bleeding. (Clinical trial registration number: NCT02135627.).
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Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study.
Humalda, JK, Yeung, SMH, Geleijnse, JM, Gijsbers, L, Riphagen, IJ, Hoorn, EJ, Rotmans, JI, Vogt, L, Navis, G, Bakker, SJL, et al
The Journal of clinical endocrinology and metabolism. 2020;(9):e3246-56
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Abstract
CONTEXT Although dietary potassium and sodium intake may influence calcium-phosphate metabolism and bone health, the effects on bone mineral parameters, including fibroblast growth factor 23 (FGF23), are unclear. OBJECTIVE Here, we investigated the effects of potassium or sodium supplementation on bone mineral parameters. DESIGN, SETTING, PARTICIPANTS We performed a post hoc analysis of a dietary controlled randomized, blinded, placebo-controlled crossover trial. Prehypertensive individuals not using antihypertensive medication (n = 36) received capsules containing potassium chloride (3 g/d), sodium chloride (3 g/d), or placebo. Linear mixed-effect models were used to estimate treatment effects. RESULTS Potassium supplementation increased plasma phosphate (from 1.10 ± 0.19 to 1.15 ± 0.19 mmol/L, P = 0.004), in line with an increase in tubular maximum of phosphate reabsorption (from 0.93 ± 0.21 to 1.01 ± 0.20 mmol/L, P < 0.001). FGF23 decreased (114.3 [96.8-135.0] to 108.5 [93.5-125.9] RU/mL, P = 0.01), without change in parathyroid hormone and 25-hydroxy vitamin D3. Fractional calcium excretion decreased (from 1.25 ± 0.50 to 1.11 ± 0.46 %, P = 0.03) without change in plasma calcium. Sodium supplementation decreased both plasma phosphate (from 1.10 ± 0.19 to 1.06 ± 0.21 mmol/L, P = 0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P = 0.02). Urinary and fractional calcium excretion increased (from 4.28 ± 1.91 to 5.45 ± 2.51 mmol/24 hours, P < 0.001, and from 1.25 ± 0.50 to 1.44 ± 0.54 %, P = 0.004, respectively). CONCLUSIONS Potassium supplementation led to a decrease in FGF23, which was accompanied by increase in plasma phosphate and decreased calcium excretion. Sodium supplementation reduced FGF23, but this was accompanied by decrease in phosphate and increase in fractional calcium excretion. Our results indicate distinct effects of potassium and sodium intake on bone mineral parameters, including FGF23. CLINICAL TRIAL REGISTRATION NUMBER NCT01575041.
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The effects of Shilajit supplementation on fatigue-induced decreases in muscular strength and serum hydroxyproline levels.
Keller, JL, Housh, TJ, Hill, EC, Smith, CM, Schmidt, RJ, Johnson, GO
Journal of the International Society of Sports Nutrition. 2019;(1):3
Abstract
BACKGROUND Shilajit is a safe, fluvic mineral complex exudate that is common to Ayurvedic medicine and is composed of fulvic acids, dibenzo-α-pyrones, proteins, and minerals. The purpose of this study was to examine the effects of 8 weeks of Shilajit supplementation at 250 mg·d- 1 (low dose) and 500 mg·d- 1 (high dose) versus placebo on maximal voluntary isometric contraction (MVIC) strength, concentric peak torque, fatigue-induced percent decline in strength, and serum hydroxyproline (HYP). METHODS Sixty-three recreationally-active men ([Formula: see text] ± SD: 21.2 ± 2.4 yr.; 179.8 ± 6.3 cm; 83.1 ± 12.7 kg) volunteered to participate in this study. The subjects were randomly assigned to the high dose, low dose, or placebo group (each group: n = 21). During pre-supplementation testing, the subjects performed 2 pretest MVICs, 2 sets of 50 maximal, bilateral, concentric isokinetic leg extensions at 180°·s- 1 separated by 2-min of rest, and 2 posttest MVICs. Following 8 weeks of supplementation, the subjects repeated the pre-supplementation testing procedures. In addition, the groups were dichotomized at the 50th percentile based on pre-supplementation MVIC and baseline HYP. Mixed model ANOVAs and ANCOVAs were used to statistically analyze the dependent variables for the total groups (n = 21 per group) as well as dichotomized groups. RESULTS For the upper 50th percentile group, the post-supplementation adjusted mean percent decline in MVIC was significantly less for the high dose group (8.9 ± 2.3%) than the low dose (17.0 ± 2.4%; p = 0.022) and placebo (16.0 ± 2.4%; p = 0.044) groups. There was no significant (p = 0.774) difference, however, between the low dose and placebo groups. In addition, for the upper 50th percentile group, the adjusted mean post-supplementation baseline HYP for the high dose group (1.5 ± 0.3 μg·mL- 1) was significantly less than both the low dose (2.4 ± 0.3 μg·mL- 1; p = 0.034) and placebo (2.4 ± 0.3 μg·mL- 1, p = 0.024) groups. CONCLUSIONS The results of the present study demonstrated that 8 weeks of PrimaVie® Shilajit supplementation at 500 mg·d- 1 promoted the retention of maximal muscular strength following the fatiguing protocol and decreased baseline HYP. Thus, PrimaVie® Shilajit supplementation at 500 mg·d- 1 elicited favorable muscle and connective tissue adaptations.
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Improvements in Glycemic, Micronutrient, and Mineral Indices in Arab Adults with Pre-Diabetes Post-Lifestyle Modification Program.
Alfawaz, H, Naeef, AF, Wani, K, Khattak, MNK, Sabico, S, Alnaami, AM, Al-Daghri, NM
Nutrients. 2019;(11)
Abstract
The present study aimed to investigate the changes in dietary patterns of adult Saudis with prediabetes who underwent a six-month lifestyle modification program. A total of 160 Saudis with prediabetes (baseline fasting glucose 5.6-6.9 mmol/L), aged 20-60 years, were enrolled in one of the two arms: A one-time general advice about lifestyle modification (GA group) at orientation or a well-structured and monitored nutrition and lifestyle counseling for six months (guidance group). Fasting blood samples and a dietary recall for daily intakes of macro/micronutrients using a validated computerized food database "ESHA-the Food Processor Nutrition Analysis program" were collected pre- and post-intervention. Compliance to reference daily intake (RDI) was also calculated at both time points. At baseline, overall, severe deficiencies in the majority of micronutrient intakes were observed. Post intervention, clinically significant improvements in the glycemic indices (fasting glucose and insulin resistance) were seen over time in the guidance group. Also, significant improvements in dietary habits and physical activity levels were more apparent in the guidance group than the GA group, particularly in the daily intakes of total carbohydrate (46.9% compliance post vs. 20.3% at baseline); dietary fiber (21.9% vs. 3.1%); and some micronutrients like vitamin B6 (21.3% vs. 6.7%), vitamin B12 (45.3% vs. 28%), vitamin C (21.9% vs. 7.8%), riboflavin (40% vs. 10.7%), niacin (41.3% vs. 14.7%), magnesium (18.8% vs. 4.7%), iron (54.7% vs. 34.4%), and copper (37.3% vs. 13.3%). The study highlights the effects of a six-month lifestyle modification program in improving dietary micronutrient intakes of Saudis with prediabetes. Since micronutrient intake was observed to be low, fortification of these micronutrients in the Saudi diet is recommended.
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Prospective and Randomized Evaluation of ChronOS and Bio-Oss in Human Maxillary Sinuses: Histomorphometric and Immunohistochemical Assignment for Runx 2, Vascular Endothelial Growth Factor, and Osteocalcin.
Bonardi, JP, Pereira, RDS, Boos Lima, FBDJ, Faverani, LP, Griza, GL, Okamoto, R, Hochuli-Vieira, E
Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons. 2018;(2):325-335
Abstract
PURPOSE The aim of this study was to compare ChronOS (β-tricalcium phosphate), Bio-Oss, and their addition to an autogenous bone graft in a 1:1 ratio in human maxillary sinus bone augmentation. MATERIALS AND METHODS Thirty maxillary sinuses were divided in 5 groups: group 1 included 6 maxillary sinuses grafted with autogenous bone graft alone; group 2 included 6 maxillary sinuses grafted with ChronOS; group 3 included 6 maxillary sinuses grafted with ChronOS and autogenous bone graft in a 1:1 ratio; group 4 included 6 maxillary sinuses grafted with Bio-Oss; and group 5 included 6 maxillary sinuses grafted with Bio-Oss and autogenous bone graft in a 1:1 ratio. The number of samples for each group was determined by the statistical power test. RESULTS The median areas of new bone formation in groups 1, 2, 3, 4, and 5 were 121,917.0, 83,787.0, 99,295.0, 65,717.0, and 56,230.0 μm2, respectively. Statistically significant differences were found between groups 3 and 5, groups 1 and 4, and groups 1 and 5 (P < .05). The median areas of remaining biomaterial were 2,900.5, 5,291.0, 2,662.0, 56,258.5, and 64,753.5 μm2 in groups 1, 2, 3, 4 and 5, respectively. Statistically significant differences occurred between groups 1 and 5, groups 3 and 5, and groups 2 and 5 (P < .05). Areas of connective tissue were 67,829.0 ± 22,984.6 μm2 in group 1, 97,445.9 ± 18,983.3 μm2 in group 2, 88,256.0 ± 21,820.5 μm2 in group 3, 65,501.8 ± 6,297.6 in group 4, and 70,203.2 ± 13,421.3 μm2 in group 5. CONCLUSIONS ChronOS combined with autogenous bone graft presented a behavior similar to that of autogenous bone graft alone. However, the groups treated with Bio-Oss showed immuno-labeling results indicating maturation of grafted bone.
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Microcomputed Tomography Evaluation of Dentine Mineral Concentration in Primary Molars Managed by Three Treatment Protocols.
Mijan, MC, Frencken, JE, Schwass, DR, Chaves, SB, Leal, SC
Caries research. 2018;(4):303-311
Abstract
The objectives of the study were to quantify the dentine mineral concentration (DMC) in teeth restored conventionally, according to the atraumatic restorative treatment (ART) and ultraconservative (UCT) protocols (open cavities and small ART restorations), and the DMC underneath the open cavities of teeth managed by UCT versus nontreated, open cavities. We studied 50 teeth with restorations/open cavities, 39 restored teeth (9 by conventional restorative treatment [CRT], 17 by ART, and 13 by UCT) and 16 teeth with open cavities. Each restoration/open cavity was scanned using microcomputed tomography, with 3 hydroxyapatite disks with respective densities of 1.24, 1.33, and 1.57 g/cm3 as a reference. Images were reconstructed and the greyscale images were converted into DMC values. For each restoration/open cavity, 15 measurements of dentine immediately underneath and from the corresponding area in sound dentine were taken. DMC was expressed as a percentage of the DMC of sound dentine. ANOVA and the Student t test were used for statistical analysis. The mean DMC underneath restorations of the ART protocol group (98.93%) was statistically significantly higher than that of the UCT protocol group (91.98%), but not of the CRT protocol group (91.33%). On multiple surfaces, mean DMC in the axial area (94.32%) was statistically significantly higher than in the gingival area (92.80%). The mean DMC of open cavities managed by UCT protocol (89.05%) was statistically significantly higher than in nontreated open cavities (83.90%). In conclusion, a dentine-hypermineralized area underneath ART restorations was observed. Managing open cavities with a toothbrush and fluoride toothpaste (the UCT protocol) resulted in higher mineralized dentine underneath the cavity than in nontreated open cavities.
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Comparative Effects of Cholecalciferol and Calcitriol on Circulating Markers of CKD Mineral Bone Disorder: A Randomized Clinical Trial.
Zelnick, LR, de Boer, IH, Kestenbaum, BR, Chonchol, M, Kendrick, J
Clinical journal of the American Society of Nephrology : CJASN. 2018;(6):927-928
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Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).
Issa, OM, Roberts, R, Mark, DB, Boineau, R, Goertz, C, Rosenberg, Y, Lewis, EF, Guarneri, E, Drisko, J, Magaziner, A, et al
American heart journal. 2018;:70-77
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IMPORTANCE In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials. OBJECTIVE To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. DESIGN TACT was a factorial trial testing chelation treatments and a 28-component high-dose oral multivitamins and multiminerals regimen versus placebo in post-myocardial infarction (MI) patients 50 years or older. PARTICIPANTS There were 460 (27%) of 1,708 TACT participants not taking statins at baseline, 224 (49%) were in the active vitamin group and 236 (51%) were in the placebo group. SETTING Patients were enrolled at 134 sites around the United States and Canada. INTERVENTION Daily high-dose oral multivitamins and multiminerals (6 tablets, active or placebo). MAIN OUTCOME The primary end point of TACT was time to the first occurrence of any component of the composite end point: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina. RESULTS The primary end point occurred in 137 nonstatin participants (30%), of which 51 (23%) of 224 were in the active group and 86 (36%) of 236 were taking placebo (hazard ratio, 0.62; 95% confidence interval, 0.44-0.87; P=.006). Results in the key TACT secondary end point, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (hazard ratio, 0.46; 95% confidence interval, 0.28-0.75; P=.002). Multiple end point analyses were consistent with these results. CONCLUSION AND RELEVANCE High-dose oral multivitamin and multimineral supplementation seem to decrease combined cardiac events in a stable, post-MI population not taking statin therapy at baseline. These unexpected findings are being retested in the ongoing TACT2.