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Secondary Efficacy Measures (secondary + efficacy_measure)

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Medical Sciences	100%

Selected Abstracts

Low-Dose Topiramate Versus Lamotrigine in Migraine Prophylaxis (The Lotolamp Study)

HEADACHE, Issue 3 2007
Praveen Gupta MD
Objective.,To assess the efficacy and safety of topiramate and lamotrigine for prophylaxis in patients with frequent migraine as compared to each other and to placebo. Methods.,Sixty patients with frequent migraine (more than 4 attacks per month) from the headache clinic at a tertiary referral centre in India were randomized to receive 50 mg topiramate/lamotrigine or matching placebo for 1 month each in 2 divided doses in 4 phases in a crossover manner with a washout period of 7 days in between. Primary efficacy measure was responder rate (50% decrease in mean migraine frequency/intensity). Secondary efficacy measures included reduction in mean monthly frequency, intensity, duration, rescue medication use, migraine associated symptoms, and adverse events. Statistical analysis.,Analysis was on intention to treat basis. Data were analyzed as correlated data. Generalized estimation equation was used to compute overall mean standard deviation and 95% confidence intervals for each of the outcome variables. Bonferroni's correction done for multiple comparisons. P value of <.017 was taken as significant. Results.,Fifty-seven patients comprised the intent-to-treat population. Four patients withdrew from the study at various phases, none because of the side effects. Responder rate for frequency was significantly higher for topiramate versus placebo (63% vs 30%, P < .001), and versus lamotrigine (63% vs 46 %, P= .02). For intensity of headache also a responder rate of topiramate versus placebo (50% vs 10%, P < .001), and versus lamotrigine (50% vs 41%, P= .01) was observed. Topiramate showed statistically significant benefits (P < .017) in most of the secondary efficacy measures while lamotrigine was beneficial for reduction in headache frequency, and migraine associated symptoms. Adverse events were similar. Conclusion.,Low-dose topiramate is efficacious in migraine prophylaxis as compared to both placebo and lamotrigine. Lamotrigine in low doses might be beneficial for headache frequency; however, longer trials are required to establish its efficacy on the intensity and frequency of migraine. [source]

MULTIDISCIPLINARY PAIN ABSTRACTS: 12

PAIN PRACTICE, Issue 1 2004
Article first published online: 15 MAR 200
The purpose of this study was to investigate whether selective nerve fiber dysfunction, as assessed by quantitative sensory testing (QST), correlates with the effectiveness of epidural steroid injections (ESI) in patients with lumbar radiculopathy. Twenty patients with unilateral painful sciatica caused by disc herniation participated in this open study. Before ESI, quantitative thermal and mechanical sensory testing was conducted at the most painful dermatome and the contralateral dermatome. The primary outcome measure used was the self-recording of pain intensity twice daily with a 0,10 numerical pain scale (NPS). Secondary efficacy measures included the Short Form of the McGill Pain Questionnaire, the straight leg raising test, and the lumbar range of motion. A significant difference in all types of sensory thresholds between the affected and the contralateral dermatomes was detected at baseline. All outcome measures improved subsequent to the ESI. A significant positive correlation was found between the increase in cold sensation thresholds of the affected dermatome (Adelta-fiber dysfunction) and the improvement in NPS. The increase in touch and vibration thresholds (Abeta-fiber dysfunction) was found to be inversely correlated with the improvement in NPS. No correlation was found between heat sensation thresholds and any of the outcome measures. These results suggest that QST has the potential to be an important tool in the selection of the appropriate treatment for patients with sciatica and may assist in identifying the mechanisms of pain generation in these patients. [source]

A double-blind, placebo-controlled pilot study of quetiapine for depressed adolescents with bipolar disorder

BIPOLAR DISORDERS, Issue 5 2009
Melissa P DelBello
Objective:, To conduct a pilot study comparing the effects of quetiapine and placebo for the treatment of depressive episodes in adolescents with bipolar I disorder. Method:, Thirty-two adolescents (ages 12,18 years) with a depressive episode associated with bipolar I disorder were randomized to eight weeks of double-blind treatment with quetiapine, 300,600 mg/day, or placebo. This two-site study was conducted from March 2006 through August 2007. The primary efficacy measure was change in Children's Depression Rating Scale,Revised Version (CDRS-R) scores from baseline to endpoint. Secondary efficacy measures included change in CDRS-R scores over the eight-week study period (PROC MIXED), changes from baseline to endpoint in Hamilton Anxiety Rating Scale (HAM-A), Young Mania Rating Scale (YMRS), and Clinical Global Impression,Bipolar Version Severity (CGI-BP-S) scores, as well as response and remission rates. Safety and tolerability were assessed weekly. Results:, There was no statistically significant treatment group difference in change in CDRS-R scores from baseline to endpoint (p = 0.89, effect size =,0.05, 95% confidence interval: ,0.77,0.68), nor in the average rate of change over the eight weeks of the study (p = 0.95). Additionally, there were no statistically significant differences in response (placebo =67% versus quetiapine = 71%) or remission (placebo = 40% versus quetiapine = 35%) rates, or change in HAM-A, YMRS, or CGI-BP-S scores (all p > 0.7) between treatment groups. Dizziness was more commonly reported in the quetiapine (41%) than in the placebo (7%) group (Fisher's exact test, p = 0.04). Conclusions:, The results suggest that quetiapine monotherapy is no more effective than placebo for the treatment of depression in adolescents with bipolar disorder. However, limitations of the study, including the high placebo response rate, may have contributed to our findings and should be considered in the design of future investigations of pharmacological interventions for this population. [source]

A randomized, controlled study of the safety and efficacy of topical corticosteroid treatments of sunburn in healthy volunteers

CLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 4 2002
L. Duteil
Summary Topical glucocorticosteroids are frequently used for the treatment of sunburn despite the scarcity of randomized, double-blind controlled trials to support this indication. This randomized, intra-individually controlled trial compared the efficacy and safety of two topical glucocorticosteroids, 0.1% methylprednisolone aceponate milk (MPA) and 0.1% hydrocortisone 17-butyrate emulsion (HCB), for treatment of sunburn in 24 healthy volunteers of skin type III. After irradiation of the skin by simulated sunlight, treatments were blinded and randomly allocated to 36 cm2 test areas on both sides of the spine. Volunteers were treated twice daily for 7 days and assessed daily with 1-day follow-up. The untreated area was not blinded. Primary efficacy measures were sum score and sunburn reaction based on erythema, oedema, burning and itching. Secondary efficacy measures were physician's global assessment, individual signs/symptoms, colorimetry, dermatological improvement, and time to healing. Intra-individual comparisons were made. Differences in sum score were apparent on days 3,4 and significant on days 4,5 for corticosteroids compared with nontreatment. Treated areas had significantly lower sunburn reaction than untreated areas (P = 0.1% and P = 0.5% for MPA and HCB, respectively). Differences between treatments were not significant. Secondary efficacy measures were in line with these findings. None of the three adverse events reported were considered to be related to treatment. We conclude that MPA and HCB are safe and effective in the treatment of sunburn. [source]