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BACKGROUND: Soluble fibers, including those from psyllium husk, have been shown to augment the cholesterol-lowering effects of a low-fat diet in persons with hypercholesterolemia. As evidence of this, the US Food and Drug Administration recently authorized the use of health claims on food products containing soluble fiber from psyllium that state that they are associated with a decreased risk of coronary heart disease. OBJECTIVE: This meta-analysis was conducted to more precisely define the hypolipidemic effects and safety of psyllium when used adjunctive to a low-fat diet in men and women with hypercholesterolemia. DESIGN: The 8 studies in the meta-analysis included a total of 384 and 272 subjects receiving psyllium or cellulose placebo, respectively. All studies evaluated the hypocholesterolemic effects of 10.2 g psyllium/d adjunctive to a low-fat diet for >/=8 wk in individuals with mild-to-moderate hypercholesterolemia after a low-fat diet lead-in phase lasting >/=8 wk. The safety and adverse events associated with psyllium consumption were summarized from pooled data of 19 clinical studies ranging from 6 wk to 6 mo in duration. RESULTS: Consumption of 10.2 g psyllium/d lowered serum total cholesterol by 4% (P < 0.0001), LDL cholesterol by 7% (P < 0.0001), and the ratio of apolipoprotein (apo) B to apo A-I by 6% (P < 0.05) relative to placebo in subjects already consuming a low-fat diet, with no effect on serum HDL or triacylglycerol concentrations. CONCLUSIONS: Psyllium supplementation significantly lowered serum total and LDL-cholesterol concentrations in subjects consuming a low-fat diet. Psyllium is well tolerated and safe when used adjunctive to a low-fat diet in individuals with mild-to-moderate hypercholesterolemia. Copyright © 2000 American Society for Clinical Nutrition [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of continuous low-level heat wrap therapy for the treatment of various sources of wrist pain including strain and sprain (SS), tendinosis (T), osteoarthritis (OA), and carpal tunnel syndrome (CTS)., Design: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial., Setting: Two community-based research facilities., Participants: Ninety-three patients (age range, 18-65 y) with wrist pain., Intervention: Subjects with moderate or greater wrist pain were randomized and stratified to 1 of the following treatments: efficacy evaluation (heat wrap, n=39; oral placebo, n=42) or blinding (oral acetaminophen, n=6; unheated wrap, n=6). Data were recorded over 3 days of treatment and 2 days of follow-up., Main Outcome Measures: The primary comparison was between the heat wrap and the oral placebo group among SS/T/OA subjects for pain relief. Outcome measures included pain relief (0-5 scale), joint stiffness (101-point numeric rating scale), grip strength measured by dynamometry, and perceived pain and disability (Patient Rated Wrist Evaluation [PRWE]); subjects with CTS also completed the Symptom Severity Scale and Functional Status Scale., Results: Heat wrap therapy showed significant benefits in day 1 to 3 mean pain relief (P=.045) and increased day 3 grip strength (P=.02) versus oral placebo for the SS/T/OA group. However, joint stiffness and PRWE results were comparable between the 2 treatments. For the CTS group, heat wraps provided greater day 1 to 3/hour 0 to 8 mean pain relief (P=.001), day 1 to 3 mean joint stiffness reduction (P=.004), increased day 3 grip strength (P=.003), reduced PRWE scores (P=.0015), reduced symptom severity (P=.001), and improved functional status (P=.04). In addition, the heat wrap showed significant extended benefits through follow-up (day 5) in the CTS group., Conclusions: Continuous low-level heat wrap therapy was efficacious for the treatment of common conditions causing wrist pain and impairment.

Objective: To evaluate of the efficacy and safety of 8 hours of continuous, low-level heatwrap therapy administered during sleep., Design: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial., Setting: Two community-based research facilities., Participants: Seventy-six patients, aged 18 to 55 years, with acute, nonspecific low back pain., Interventions: Subjects were stratified by baseline pain intensity and gender and randomized to one of the following treatments: evaluation of efficacy (heatwrap, n=33; oral placebo, n=34) or blinding (unheated wrap, n=5; oral ibuprofen, n=4). All treatments were administered for 3 consecutive nights with 2 days of follow-up., Main Outcome Measures: Primary: morning pain relief (hour 0) on days 2 through 4 (0-5-point verbal response scale). Secondary: mean daytime pain relief score (days 2-4, hours 0-8), mean extended pain relief score (day 4, hour 0; day 5, hour 0), muscle stiffness, lateral trunk flexibility, and disability (Roland-Morris Disability Questionnaire)., Results: Heatwrap therapy was significantly better than placebo at hour 0 on days 2 through 4 for mean pain relief (P=.00005); at hours 0 through 8 on days 2 through 4 for pain relief (P<.001); at hour 0 on day 4 and at hour 0 on day 5 for mean pain relief (P<.001); on day 4 in reduction of morning muscle stiffness (P<.001); for increased lateral trunk flexibility on day 4 (P<.002); and for decreased low back disability on day 4 (P=.005). Adverse events were mild and infrequent., Conclusions: Overnight use of heatwrap therapy provided effective pain relief throughout the next day, reduced muscle stiffness and disability, and improved trunk flexibility. Positive effects were sustained more than 48 hours after treatments were completed., (Copyright 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation)

Objective: To evaluate the efficacy of 8 hours of continuous low-level heatwrap therapy for the treatment of acute nonspecific low back pain (LBP)., Design: Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial., Setting: Five community-based research facilities., Participants: Two-hundred nineteen subjects, aged 18 to 55 years, with acute nonspecific LBP., Intervention: Subjects were stratified by baseline pain intensity and gender and randomized to one of the following groups: evaluation of efficacy (heatwrap, n=95; oral placebo, n=96) and blinding (oral ibuprofen, n=12; unheated back, wrap n=16). All treatments were administered for 3 consecutive days with 2 days of follow-up., Main Outcome Measures: Primary: day 1 mean pain relief (0- to 5-point verbal response scale). Secondary: muscle stiffness (101-point numeric rating scale), lateral trunk flexibility (fingertip-floor distance), and Roland-Morris Disability Questionnaire over 3 days of treatment and 2 days of follow-up., Results: Heatwrap therapy was shown to provide significant therapeutic benefits when compared with placebo during both the treatment and follow-up period. On day 1, the heatwrap group had greater pain relief (1.76+/-.10 vs 1.05+/-.11, P <.001), less muscle stiffness (43.1+/-1.21 vs 47.6+/-1.21, P=.008), and increased flexibility (18.6+/-.44 cm vs 16.5+/-.45 cm, P=.001) compared with placebo. Disability was also reduced in the heatwrap group (5.3 vs 7.4, P=.0002). Adverse events were mild and infrequent., Conclusion: Continuous low-level heatwrap therapy was shown to be effective for the treatment of acute, nonspecific LBP., (Copyright 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation)