院外纳曲酮治疗酒精依赖的疗效观察

目的 :评估纳曲酮院外治疗酒依赖的临床疗效。方法 :采用随机对照的方法 ,分别对纳曲酮组和安慰剂组各 2 3例和 2 2例 ,作总疗程 12周的临床观察。结果 :纳曲酮显著降低病人对酒精的渴求程度 ,其疗后 4、 8、 12周的保持率分别为 91 3 %、 77 9%、 73 3 % ,明显高于安慰剂。纳曲酮的副作用与安慰剂相当 ,其主要副作用为轻度的恶心、厌食、头晕。结论 :纳曲酮是一种安全有效的治疗酒依赖的药物     

Clinical trials: specific problems associated with the use of a placebo-control group

In order to test hypotheses prospectively with hard data and against placebo, the scientific method of clinical trials has been developed. The present paper focuses on specific problems associated with the use of a placebo control group. (a) The placebo highlights the ethical dilemma that a controlled clinical trial can place us in. (b) Also, in a trial an atmosphere is created of enhanced risks of placebo effects. (c) Significantly different from placebo does not necessarily mean clinically relevant. (d) A biased placebo period due to carry-over effect is a common problem of controlled trials with a cross-over or self-controlled design. (e) Likewise an asymmetric placebo group is also a common problem in parallel-group designs. (f) The response to a placebo is generally small in comparison with the response to active treatment and is therefore sometimes more susceptible to bias. It is emphasized that routinely accounting for such problems may further improve the powerful method of controlled clinical trials.     

Response to placebo among bipolar I disorder patients experiencing their first manic episode

Background: The first episode of an illness may respond differently to any treatment compared to multiple episodes of the same illness. This study details the treatment response of six first-episode manic patients who participated in a previously reported study of 139 subjects comparing olanzapine to placebo in bipolar I mania (Tohen M, Sanger TM, McElroy SL, Tollefson GD, Chengappa KNR, Daniel DG. Olanzapine versus placebo in the treatment of acute mania. Am J Psychiatry 1999; 156: 702–709).

Methods: Six first-episode subjects participated in a 3-week double-blind, random assignment, parallel group, placebo-controlled study of olanzapine for bipolar mania. The Young Mania Rating Scale (Y-MRS), Clinical Global Impression, and Hamilton Depression ratings were administered weekly. Lorazepam as rescue medication was permitted for the first 10 days.

Results: Five subjects were randomized to placebo and one to olanzapine. Two subjects (40%) with psychotic mania (who also had their first-illness episode) were assigned to placebo and responded with greater than 50% reduction in the Y-MRS score and also remitted in 3 weeks. Another placebo-assigned subject had a 46% reduction in the Y-MRS scores, and two placebo-assigned subjects worsened. The olanzapine-assigned subject had a 44% reduction in the Y-MRS score. In contrast, 34 of 69 (48.6%) multiple-episode olanzapine subjects responded and 14 of 61 (23.0%) of placebo-treated subjects did.

Conclusions: This preliminary data set suggest there may be differences in treatment response between first-illness episode versus multi-episode bipolar manic subjects. Larger numbers of subjects with these illness characteristics are needed to either confirm or refute this suggestion.     

Mesalazine in treating diverticular disease of the colon

Evaluation of: Kruis W, Meier E, Schumacher M, Mickisch O, Greinwald R, Mueller R; German SAG-20 Study Group. Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon – a placebo-controlled study. Aliment. Pharmacol. Ther. 37(7), 680–690 (2013).

Although diverticular disease (DD) is one of the commonest diseases in the western world, robust evidences about its treatment are lack so far. A recent, placebo-controlled study found mesalazine effective in obtaining pain relief in patients suffering from DD. A brief comment is provided herein in order to assess the rationale of this drug in treating DD.     

Nausea Control by Needling at Acupuncture Point Neiguan (PC6) During an Intraoral Impression-Taking Procedure

The objective of this study was to evaluate the effectiveness of acupuncture point PC6 (Neiguan) in controlling nausea during intraoral impression taking. This study was conducted in Piracicaba, São Paulo, Brazil. The sample consisted of 33 adult volunteers with nausea, who were randomly divided into control and study groups, and treated with nonpenetrating sham acupuncture and real acupuncture, respectively, at acupoint PC6. The two groups had two maxillary impressions taken, one prior to acupuncture and the other after acupuncture. The nausea assessment was made using the visual analog scale, Gagging Severity Index (GSI), and Gagging Prevention Index. Volunteers' expectation that nausea would be reduced through acupuncture was also assessed. For statistical analysis, we used the t test and the Spearman correlation (p < 0.05). When assessed by Gagging Severity Index/Gagging Prevention Index, nausea was reduced in the real acupuncture group (p < 0.01). In the visual analog scale assessment, similar reductions of nausea were noted in both groups (p > 0.05). No correlation existed between the expected and the actual reductions in nausea. Our results indicate that acupoint PC6 was effective for controlling nausea during the maxillary impression-taking procedure. Patients' expectation did not influence the results.     

Placebo controlled evaluation of Xilei San,a herbal preparation in patients with intractable ulcerative proctitis

Background and Aim: Topical mesalamine or corticosteroid has shown efficacy in patients with ulcerative proctitis, but patients often become refractory to these interventions. Xilei San is a herbal preparation with evidence of anti‐inflammatory effects. We evaluated the efficacy of topical Xilei San in ulcerative proctitis patients. Methods: In a double blind setting, 30 patients with intractable ulcerative proctitis despite ≥ 4 weeks of topical mesalamine or corticosteroid were randomly assigned to True (n = 15) and placebo (n = 15). Patients in True received suppository Xilei San (0.1 g/dose per day of Xilei San), the other 15 received placebo suppository. The initial efficacy was evaluated on day 14. Primary endpoint of the trial was avoiding relapse during 180 days, relapse meant recurrence of active disease. Riley's index was applied for endoscopic and histological evaluations, while patients' quality of life was evaluated by an inflammatory bowel disease questionnaire. Results: On day 14, the number of patients who achieved remission, clinical activity index ≤ 4 in True was significantly higher versus placebo (P < 0.04). Likewise, at day 180, an 81.8% of patients in True were without relapse versus 16.7% in placebo (P < 0.001). Further, significant endoscopic (P < 0.01), histological (P < 0.02) and inflammatory bowel disease questionnaire (P < 0.04) improvements were observed in True, but not in placebo. Conclusions: This is the first controlled investigation showing significant clinical and endoscopic efficacy for Xilei San in patients with intractable ulcerative proctitis. Topical Xilei San was well tolerated, and was without safety concerns.     

Minoxidil 2% lotion for eyebrow enhancement: A randomized,double‐blind,placebo‐controlled,spilt‐face comparative study

Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side‐effects were also evaluated. Thirty‐nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side‐effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis.     

Dynamic features of placebo effects addressing persistent insomnia disorder: A meta‐analysis of placebo‐controlled randomized clinical trials

It has been accepted knowledge that placebo effects have been significant in insomnia clinical trials. However, the dynamic features of placebo effects have not been clarified. Our aim was therefore to conduct a meta‐analysis of placebo‐controlled randomized clinical trials to characterize the dynamic features of placebo effects addressing persistent insomnia disorder. We performed a comprehensive literature search for randomized, placebo‐controlled, double‐blind clinical trials evaluating the efficacy of therapeutic regimens addressing persistent insomnia disorder. We pooled separate effect size estimates (Hedge's g) of placebo and regimen conditions across trials for outcome measures, and multilevel mixed‐effects models were used to explore potential sources of heterogeneity. The placebo effects were significant and robust to improve the symptoms of insomnia, and subjective measures were significantly smaller than objective measures (p < .001), but placebo response rates were nearly identical between subjective and objective measures. The overall placebo effects were influenced by publication year (p = .015), treatment duration (p = .010), sample size (p < .001) and therapeutic regimen (p < .001). Placebo effects showed a diphasic feature within treatment duration: initially a decrease and subsequently being stable; a sustained decline trend after withdrawals; and a steady‐to‐upward trend for a mixed therapeutic regimens in a large‐scale period over decades. The dynamic features of placebo effects addressing persistent insomnia disorder may lead to the development and validation of dosing strategies that require less medication exposure to maintain clinical effects.