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1.
Obstet Gynecol ; 97(3): 343-9, 2001 Mar.
Article in English | MEDLINE | ID: mdl-11239634

ABSTRACT

OBJECTIVE: To compare the efficacy of topically applied heat for menstrual pain with oral ibuprofen and placebo treatment. METHODS: We conducted a randomized placebo and active controlled (double dummy), parallel study using an abdominal patch (heated or unheated) for approximately 12 consecutive hours per day and oral medication (placebo or ibuprofen 400 mg) three times daily, approximately 6 hours apart for 2 consecutive days. Pain relief and pain intensity were recorded at 17 time points. There was at least 85% power to detect a true one-unit difference in the 2-day pain relief treatment means for comparisons with the unheated patch plus oral placebo group using a one-tailed test at the.05 level of significance, based on an observed within-group standard deviation of 1.147. RESULTS: Eighty-four patients were enrolled and 81 completed the study protocol. Over the 2 days of treatment, the heated patch plus placebo tablet group (mean 3.27, P <.001), the unheated patch plus ibuprofen group (mean 3.07, P =.001), and the combination heated patch plus ibuprofen group (mean 3.55, P <.001) had significantly greater pain relief than the unheated patch plus placebo group (mean 1.95). Greater pain relief was not observed for the combination heated patch plus ibuprofen group compared with the unheated patch plus ibuprofen group (P =.096); however, the time to noticeable pain relief was statistically significantly shorter for the heated patch plus ibuprofen group (median 1.5 hours) compared with the unheated patch plus ibuprofen group (median 2.79 hours, P =.01). CONCLUSION: Continuous low-level topical heat therapy was as effective as ibuprofen for the treatment of dysmenorrhea.


Subject(s)
Analgesics, Non-Narcotic/therapeutic use , Dysmenorrhea/therapy , Hot Temperature/therapeutic use , Ibuprofen/therapeutic use , Adult , Double-Blind Method , Dysmenorrhea/drug therapy , Female , Humans , Middle Aged , Pain Measurement
2.
Am J Clin Nutr ; 71(2): 472-9, 2000 Feb.
Article in English | MEDLINE | ID: mdl-10648260

ABSTRACT

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.


Subject(s)
Hypercholesterolemia/diet therapy , Hypolipidemic Agents/therapeutic use , Lipids/blood , Psyllium/therapeutic use , Adult , Age Factors , Aged , Aged, 80 and over , Cholesterol, HDL/blood , Cholesterol, LDL/blood , Combined Modality Therapy , Controlled Clinical Trials as Topic , Female , Humans , Hypercholesterolemia/blood , Hypercholesterolemia/drug therapy , Male , Middle Aged , Psyllium/administration & dosage , Sex Factors , Triglycerides/blood
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