Adverse reactions to aspartame: double-blind challenge in patients from a vulnerable population.
Adult; Aspartame/*adverse effects/*therapeutic use; Cross-Sectional Studies; Depressive Disorder/diagnosis/*drug therapy/psychology; Double-Blind Method; Eye Diseases/etiology/physiopathology; Female; Headache/etiology; Humans; Male; Middle Aged; Placebos; Psychiatric Status Rating Scales; Vision Disorders/etiology/physiopathology
This study was designed to ascertain whether individuals with mood disorders are particularly vulnerable to adverse effects of aspartame. Although the protocol required the recruitment of 40 patients with unipolar depression and a similar number of individuals without a psychiatric history, the project was halted by the Institutional Review Board after a total of 13 individuals had completed the study because of the severity of reactions within the group of patients with a history of depression. In a crossover design, subjects received aspartame 30 mg/kg/day or placebo for 7 days. Despite the small n, there was a significant difference between aspartame and placebo in number and severity of symptoms for patients with a history of depression, whereas for individuals without such a history there was not. We conclude that individuals with mood disorders are particularly sensitive to this artificial sweetener and its use in this population should be discouraged.
Walton R G; Hudak R; Green-Waite R J
Biological psychiatry
1993
1993-07
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1016/0006-3223(93)90251-8" target="_blank" rel="noreferrer noopener">10.1016/0006-3223(93)90251-8</a>
Effect of resveratrol on herpes simplex virus vaginal infection in the mouse.
Animals; Antiviral Agents/administration & dosage/pharmacology/*therapeutic use; Drug Evaluation; Female; Herpes Genitalis/*drug therapy/pathology/virology; Herpesvirus 1; Herpesvirus 2; Human/*drug effects/physiology; Human/drug effects/isolation & purification/physiology; Mice; Placebos; Preclinical; Resveratrol; Stilbenes/administration & dosage/pharmacology/*therapeutic use; Survival Analysis; Vaginal Diseases/*drug therapy/virology; Viral Plaque Assay; Virus Replication/drug effects
Resveratrol (3,5,4'-trihydroxystilbene) is a natural component of certain foods, such as grapes, that, when topically applied, has been shown to limit HSV-1 lesion formation in the skin of mice [Antiviral Res. 61:19-26, 2004]. To determine if it is active on genital HSV infection, the vagina of mice were infected with HSV-2 or HSV-1 and treated with a cream formulation of resveratrol. Mice were evaluated daily for extravaginal disease and vaginal swabs were taken regularly and assayed for infectious virus. Initial studies demonstrated that 19% resveratrol cream administered intravaginally five times a day for 5 days beginning 1h after infection significantly reduced HSV-2 replication beginning on day 1 of infection and prevented extravaginal disease when compared to animals treated with placebo. When resveratrol was tested at a concentration of 6.25% and 12.5% administered five times a day, 6.25% limited virus replication only on day 1 and delayed development of extravaginal disease by 1 day. However, 12.5% resveratrol inhibited HSV-2 replication beginning on day 1 and abolished extravaginal disease. If the number of applications per day was reduced to three for 5 days, 12.5% resveratrol inhibited HSV-2 replication only on day 1, while 19% resveratrol inhibited it throughout the 9-day assay period. When the animals with three treatments per day were examined for extravaginal disease, it was found that 12.5% resveratrol was ineffective when compared to placebo, while animals treated with 19% resveratrol did not exhibit extravaginal disease. When treatment was delayed 6h, 12.5% resveratrol did not inhibit HSV-2 replication or extravaginal lesion formation, but 19% resveratrol did. When resveratrol was used to treat vaginal HSV-1 infection, it was found that 12.5% resveratrol did not limit replication or prevent extravaginal lesion formation. In contrast, 19% resveratrol did significantly limit vaginal HSV-1 replication and reduced extravaginal lesion formation, but the latter was not significant. Mortality rates in placebo-treated animals was 37%, 6.25% resveratrol-treated animals was 40%, 12.5% resveratrol-treated animals was 24%, and 19% resveratrol-treated animals was 3%. Collectively, these results demonstrate that resveratrol cream inhibits or reduces HSV replication in the vagina of mice and limits extravaginal disease.
Docherty John J; Fu Ming Ming; Hah Jennifer M; Sweet Thomas J; Faith Seth A; Booth Tristan
Antiviral research
2005
2005-09
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1016/j.antiviral.2005.06.008" target="_blank" rel="noreferrer noopener">10.1016/j.antiviral.2005.06.008</a>
Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children.
Adolescent; Catheterization; Central Venous/*adverse effects; Child; Emergency Medical Services; Ethyl Chloride/administration & dosage/*therapeutic use; Female; Humans; Male; Pain/*prevention & control; Placebos; Treatment Failure; Vinyl Chloride
The purpose of the study was to determine the effect of ethyl vinyl chloride vapocoolant spray on pain reported by children undergoing intravenous cannulation. A randomized, double-blinded, placebo-controlled trial was conducted on eligible children between the ages of 9 and 18 years seen in a pediatric emergency department and requiring intravenous cannulation. Informed consent was obtained, and children were randomized to receive ethyl vinyl chloride spray, isopropyl alcohol spray, or no spray (control group). Patient demographics and information pertaining to each intravenous cannulation were recorded. Children indicated the degree of pain associated with intravenous cannulation on a 100-mm visual analog scale (VAS) compared to a baseline pain score of "zero." Statistical analysis was performed by using Stata version 7. One hundred twenty-seven subjects were enrolled: 37 received ethyl vinyl chloride vapocoolant spray, 48 received isopropyl alcohol spray (placebo), and 42 received no pretreatment. Mean VAS scores for pain experienced during cannulation were 34, 33, and 31 mL for each group, respectively. Ethyl vinyl chloride vapocoolant spray failed to measurably reduce pain associated with intravenous cannulation when compared to those pretreated with isopropyl alcohol spray or receiving no intervention.
Costello Mary; Ramundo Maria; Christopher Norman C; Powell Keith R
Clinical pediatrics
2006
2006-09
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1177/0009922806291013" target="_blank" rel="noreferrer noopener">10.1177/0009922806291013</a>
Clonidine in the treatment of premenstrual syndrome: a subgroup study.
Adult; Female; Humans; Double-Blind Method; Clinical Trials as Topic; Psychiatric Status Rating Scales; Placebos; beta-Endorphin/blood; Clonidine/*therapeutic use; Premenstrual Syndrome/blood/*drug therapy/psychology
The authors studied the effects of clonidine on a subgroup of women who had symptoms associated with premenstrual syndrome; the subgroup comprised 24 women aged 19 to 41 years who had "moderate" to "severe" cyclic decreases in beta-endorphin levels. All of the women received clonidine and placebo in a double-blind cross-over design that spanned four menstrual cycles. Clonidine was significantly (p less than .05) more effective than placebo in reducing symptoms.
Giannini A J; Sullivan B; Sarachene J; Loiselle R H
The Journal of clinical psychiatry
1988
1988-02
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
Efficacy of intravenous lidocaine to reduce pain and distress associated with propofol infusion in pediatric patients during procedural sedation.
Female; Male; Child; Infant; Prospective Studies; Pain Measurement; Analysis of Variance; Placebos; Injections; Human; Chi Square Test; Preschool; Intravenous; Anesthetics; Treatment Outcomes; Double-Blind Studies; Hypnotics and Sedatives – Administration and Dosage; Lidocaine – Administration and Dosage; Local – Administration and Dosage; Propofol – Administration and Dosage
BACKGROUND: Research suggests that young children experience an increased incidence and severity of discomfort during propofol infusion. Evaluations of varied interventions to reduce or eliminate this discomfort with adult subjects suggest that premedication with intravenously administered lidocaine (0.5 mg/kg) offers the best overall effectiveness. OBJECTIVE: Because this regimen's efficacy in a pediatric population is undocumented, we conducted a randomized, double-blind, placebo-controlled study to determine the effectiveness of intravenous lidocaine pretreatment to alleviate pain in pediatric subjects before propofol infusion. METHODS: Subjects (aged 2-7 years) scheduled for painless diagnostic procedures received either a saline placebo or 1 of 2 lidocaine doses before administering propofol. To capture the patient's baseline behavioral state, a trained observer administered the validated Face, Legs, Activity, Cry, Consolability Pain Assessment Scale before propofol infusion. During deep sedation induction, the sedating physician, a trained research assistant, and the patient's parent documented maximum distress using a 100-mm visual analog scale (VAS). RESULTS: Ninety-one subjects participated. We found no difference in VAS pain scores between groups pretreated with lidocaine 0.25 mg/kg, lidocaine 0.5 mg/kg, and placebo. Statistical analysis also found no interrater differences between parents, physician, or observer VAS scores. CONCLUSIONS: Our data do not support using lidocaine pretreatment to alleviate pain/discomfort in pediatric patients during propofol infusion.
Depue K; Christopher NC; Raed M; Forbes ML; Besunder J; Reed MD
Pediatric emergency care
2013
2013-01
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
<a href="http://doi.org/10.1097/PEC.0b013e31827b227e" target="_blank" rel="noreferrer noopener">10.1097/PEC.0b013e31827b227e</a>