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At least 325 records · Page 18Linked to original sources
PubMed2005

Autologous haematopoietic-stem-cell transplantation for multiple sclerosis.

Intense immunosuppression followed by autologous haematopoietic-stem-cell transplantation (HSCT) is being assessed as a potential treatment for patients with severe multiple sclerosis (MS). The treatment was developed from research that showed autologous HSCT was as effective as allogeneic HSCT in the treatment of experimental autoimmune encephalomyelitis. The treatment is thought to eradicate the defective immune system, and the infused haematopoietic stem cells reconstitute an immune system that is more tolerant to the nervous system. About 250 patients with MS have been treated with autologous HSCT as part of phase I and phase II open trials. Autologous HSCT seems feasible in MS and assessment with clinical and MRI measures suggests it induces a profound and long-lasting suppression of inflammation. The course of MS seems to be stabilised after autologous HSCT, especially in ambulatory patients with evidence of active disease. Autologous HSCT deserves further study in randomised controlled trials.

Clinical Trials, Phase I as Topic↗
PubMed2004

Luteal phase administration of agents for the treatment of premenstrual dysphoric disorder.

This review focuses on current information about luteal phase administration (i.e. typically for the last 2 weeks of the menstrual cycle) of pharmacological agents for the treatment of premenstrual dysphoric disorder (PMDD). Compared with continuous administration, a luteal phase administration regimen reduces the exposure to medication and lowers the costs of treatment. Based on evidence from randomised clinical trials, SSRIs are the first-line treatment for PMDD at this time. Of these agents, sertraline, fluoxetine and paroxetine (as an extended-release formulation) are approved by the US FDA for luteal phase, as well as continuous, administration. Clinical trials of these agents and citalopram have demonstrated that symptom reduction is similar with both administration regimens. When used to treat PMDD, SSRI doses are consistent with those used for major depressive disorder. The medications are well tolerated; discontinuation symptoms with this intermittent administration regimen have not been reported. Other medications that have been examined in clinical trials for PMDD or severe premenstrual syndrome (PMS) using luteal phase administration include buspirone, alprazolam, tryptophan and progesterone. Buspirone and alprazolam show only modest efficacy in PMS (in some but not all studies), but there may be a lower incidence of sexual adverse effects with these medications than with SSRIs. Symptom reduction with tryptophan was significantly greater than with placebo, but the availability of this medication is strictly limited because of safety concerns. Progesterone has consistently failed to show efficacy for severe PMS/PMDD in large, randomised, placebo-controlled trials.

Animals↗
PubMed2003

Profiling penciclovir susceptibility and prevalence of resistance of herpes simplex virus isolates across eleven clinical trials.

Asusceptibility testing program was established to determine the prevalence of resistance to penciclovir among herpes simplex virus isolates collected from patients participating in 11 world-wide clinical trials involving penciclovir (topical or intravenous formulations) or famciclovir, the oral prodrug of penciclovir. These trials represented nine randomised double blind, placebo or aciclovir-controlled studies and two open-label studies. Groups surveyed included immunocompetent or immunocompromised patients receiving 2 to 12 months chronic suppressive therapy for genital herpes, immunocompetent patients with recurrent herpes labialis treated for four days, and immunocompromised patients with mucocutaneous herpes simplex virus (HSV). Another subset of patients had been identified as non-responders to aciclovir or to valaciclovir. This program assessed the susceptibility profile for a total of 2145 herpes simplex virus isolates from 913 immunocompetent and 288 immunocompromised patients treated with penciclovir, famciclovir, aciclovir or placebo (depending on trial design). HSV isolates were tested for susceptibility to penciclovir using the plaque reduction assay (PRA) in MRC-5 cells. Resistance was defined as an IC(50)>or=2.0 microg/ml or an IC(50)> 10-fold above the wild type control virus IC(50) within that particular assay. Penciclovir-resistant HSV was isolated from 0.22% immunocompetent patients, and 2.1% of immunocompromised patients overall and therefore the frequency of penciclovir-resistant herpes simplex virus in the immunocompetent population approximates that of aciclovir-resistant herpesvirus reported previously. Penciclovir-resistant HSV isolates were more common in isolates from immunocompromised patients, consistent with aciclovir clinical experience. Treatment with penciclovir (intravenous formulation) was associated with the development of resistant HSV in only one severely immunocompromised patient (day 7 isolate IC(50) = 2.01 microg/ml), although treatment was effective and resulted in the complete clearance of the lesion by day 8. No patients receiving topical penciclovir developed treatment-associated penciclovir-resistant HSV, and a single immunocompromised patient developed resistant HSV upon treatment with oral famiciclovir.

Acyclovir↗
PubMed2006

Imiquimod: new indication. Basal cell carcinoma: inferior to other treatments.

(1) Basal cell carcinoma is a common malignancy that is rarely life-threatening. The aim of treatment is to remove the tumour and prevent local recurrences. Surgical excision is the standard treatment, with a mean relapse rate of about 5% at 5 years. The main alternative is radiotherapy. (2) The Indications section of the Summary of Product Characteristics (SPC) for imiquimod cream in Europe now includes "topical treatment of small superficial basal cell carcinomas in adults". (3) Imiquimod cream was primarily evaluated in 2 double-blind randomised controlled trials versus excipient, in a total of 724 patients. In these trials, small basal cell tumours (maximum 2 cm in diameter) disappeared in three-quarters of patients after imiquimod application 5 or 7 days a week for six weeks. (4) A non comparative trial involving 143 patients showed a relapse rate of 21% at 2 years. Indirect comparisons show that this is a much higher relapse rate than after other well-assessed treatments for basal cell cancer. (5) During clinical trials, nearly one-third of patients who used imiquimod 5 times a week complained of pruritus, a burning sensation, or local pain. Nearly one-half of patients experienced these problems with daily use. (6) Imiquimod cream is relatively inconvenient to use: it has to be applied in the evening; residual cream must be removed the following morning; and baths, showers and direct sunlight must be avoided during treatment.

Adjuvants, Immunologic↗
PubMed2001

Interventions for herpes simplex virus epithelial keratitis.

BACKGROUND: Many clinical trials have been performed on the acute treatment of dendritic epithelial keratitis. Surveys of antiviral pharmacology and of herpes simplex virus eye disease have evaluated different commercially available agents, but a systematic review of all comparative clinical studies has not previously been undertaken. OBJECTIVES: The objective of this review is to compare the effects of various treatments for dendritic or geographic herpes simplex virus epithelial keratitis. SEARCH STRATEGY: Sources searched for relevant studies were the Cochrane Eyes and Vision Group specialized register, The Cochrane Controlled Trials Register - CENTRAL, MEDLINE, EMBASE, Index Medicus, Excerpta Medica Ophthalmology, reference lists of primary reports, review articles, and corneal textbooks and conference proceedings pertaining to ocular virology. SELECTION CRITERIA: This review includes comparative clinical trials that assessed oral or topical ophthalmic antiviral agents, or physical or chemical debridement in people with active epithelial keratitis. DATA COLLECTION AND ANALYSIS: The reviewer extracted data and assessed trial quality. Interventions were compared by the proportions of participants healed at seven days and at fourteen days after trial enrollment. MAIN RESULTS: This review includes data from 96 trials which randomised a total of 4991 participants. Compared to idoxuridine, the topical application of vidarabine, trifluridine, or acyclovir generally resulted in a significantly greater proportion of participants healing within one week of treatment. Among these three antiviral agents, no treatment emerged as significantly better for the therapy of dendritic epithelial keratitis. Insufficient placebo-controlled studies were available to assess debridement and other physical and physicochemical methods of treatment. Interferon monotherapy had a slight beneficial effect on dendritic epithelial keratitis, but not better than other antiviral agents, and was useful with debridement. REVIEWER'S CONCLUSIONS: Currently available and investigational antiviral agents are effective and nearly equivalent, but the combination of an antiviral nucleoside and interferon seems to speed healing. Future trials of the acute treatment of herpes simplex virus epithelial keratitis must aim to achieve adequate statistical power for assessing the primary outcome and should consider the effect of lesion size and other characteristics on treatment response.

Administration, Oral↗
PubMed2006

Effectiveness and acceptability of lidocaine spray in reducing perineal pain during spontaneous vaginal delivery: randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness and acceptability of a lidocaine spray in reducing perineal pain during spontaneous vaginal delivery. DESIGN: Randomised controlled trial. SETTING: Consultant led obstetric unit. PARTICIPANTS: 185 women who had a spontaneous vaginal delivery without epidural analgesia. INTERVENTIONS: Topically applied local anaesthetic spray (93 women) and placebo spray (92 women). MAIN OUTCOME MEASURE: Primary outcome measure was pain during delivery (0-100 scale). The 16 secondary outcome measures included second degree perineal trauma during delivery, trauma of the genital tract, and dyspareunia by two months. RESULTS: Lidocaine spray did not reduce pain during spontaneous vaginal delivery: mean 77 and 72 on a scale of 0-100 in the lidocaine and placebo groups, respectively (difference between means 4.8, 95% confidence interval -1.7 to 11.2). Lidocaine spray may reduce genital tract trauma during delivery, in particular second degree perineal trauma. The intervention was highly acceptable to the women and midwives. CONCLUSIONS: Although lidocaine spray applied to the perineum during spontaneous vaginal delivery did not reduce perineal pain, it was acceptable to both the women and the midwives. TRIAL REGISTRATION: Current controlled trials ISRCTN99732966 [controlled-trials.com].

Administration, Topical↗