帕利哌酮治疗伴有精神病性症状的抑郁发作患者的疗效分析及对神经功能及血清BDNF的影响

摘要 目的：探讨帕利哌酮治疗伴有精神病性症状的抑郁发作患者的疗效分析及对神经功能及血清脑源性神经营养因子（BDNF）的影响。方法：选取本院2021年1月到2021年10月收治的100例伴有精神病性症状的抑郁发作患者作为研究对象,随机将其分为观察组（n=50）和对照组（n=50）。对照组采用常规药物为伴有精神病性症状的抑郁发作患者进行治疗,观察组在对照组的基础上采用帕利哌酮为伴有精神病性症状的抑郁发作患者进行治疗,对比两组患者治疗前、治疗后2周、治疗后6周的汉密尔顿焦虑量表（HAMD）评分、汉密尔顿抑郁量表（HAMA）评分、精神经功能缺损程度、血清BDNE、神经病评定量表（BPRS）评分、社会功能缺陷筛选量表（SDSS）评分、日常生活能力量表（ADL）评分以及不良反应发生率。结果：治疗前两组患者的HAMA评分和HAMD评分对比无明显差异（P>0.05）,治疗后2周、6周评分均降低,且观察组较对照组低（P＜0.05）;治疗前两组患者的NIHSS评分和血清BDNE水平对比无明显差异（P>0.05）,治疗后2周、6周两组患者的NIHSS评分均低,且相较于观察组,对照组较高（P＜0.05）,但血清BDNE水平均升高,且观察组较对照组高（P＜0.05）;治疗前两组患者的BPRS、SDSS、ADL评分对比明显差异（P＞0.05）。治疗后2周、6周两组患者的BPRS、SDSS皆降低,并且观察组低于对照组（P＜0.05）,但两组患者的ADL评分均升高并且观察组高于对照组（P＜0.05）;观察组患者的不良反应总发生率与对照组比较无差异（P>0.05）。结论：将帕利哌酮应用于伴有精神病性症状的抑郁发作患者当中,可改善患者的焦虑、抑郁以及神经功能缺损情况,提高血清BDNE水平,并降低神经病性和社会功能缺陷情况,提高患者日常生活能力,值得临床借鉴。     

氟哌啶醇与奥氮平治疗精神分裂症的疗效对比探究

目的：对比分析氟哌啶醇与奥氮平治疗精神分裂症的临床疗效。方法：回顾性分析我院2008年4月-2011年12月收治的精神分裂症患者62例,通过随机数法将其分为两组,其中31例为氟哌啶醇组,剩余31例为奥氮平组,比较两组服药后的临床疗效以及药物不良反应情况。结果：6周后氟哌啶醇组和奥氮平组的PANSS总分均明显低于治疗前PANSS总分,组间比较,治疗3周、6周后奥氮平组PANSS总分均低于氟哌啶醇组,并且同时段奥氮平组的减分率明显高于氟哌啶醇组,差异均具有统计学意义（P〈0.05）。氟哌啶醇组的心电图异常例数和静坐不能例数明显高于奥氮平组,差异均具有统计学意义。而氟哌啶醇组不良反应发生率为48.39%,奥氮平组不良反应发生率为51.61%,差异无统计学意义。奥氮平组治疗6周后TG含量明显高于治疗前,并且两组的BMI也明显高于治疗前,差异均具有统计学意义（P〈0.05）。结论：氟哌啶醇与奥氮平在治疗精神分裂症上均有较好疗效,不良反应发生率也相似,而奥氮平改善症状较好,同时对心脏影响小,但是比氟哌啶醇易引起TG和BMI的增高,临床上需要根据患者身体条件选择药物,提高其安全性。     

奥氮平合并丙戊酸钠治疗难治性精神分裂症的对照分析

目的:探讨奥氮平联合丙戊酸钠治疗难治性精神分裂症的疗效.方法:将80例精神分裂症患者按随机数字法分为联合用药组(奥氮平+丙戊酸钠组)40例和单用药组(奥氮平组)40例.联合用药组服用奥氮平起始量为10 mg/d,1周末加至20 mg/d,同时使用丙戊酸钠起始量为600 mg/d,最大剂量1200 mg/d.单药组服用奥氮平,用法同联合用药组.2组均为8周1疗程.对2组采用阳性与阴性症状量表(PANSS)评定疗效,采用不良反应量表(TESS)评定治疗中不良反应.于治疗2周末、4周末、8周末测定奥氮平血药浓度.结果:第8周末,两组PANSS评分较治疗前均下降(P均＜0.05),联合用药组较单用药组联合用药组PANSS(P＜0.001)、阳性症状(P＜0.001)、阴性症状(P＜0.05)均明显改善,两组不良反应差异无统计学意义(P＞0.05).结论:奥氮平联合丙戊酸钠治疗难治性精神分裂症可提高疗效且安全性高.     

奥氮平与氯氮平治疗急性期精神病的对照研究

目的:探讨奥氮平与氯氮平在治疗急性期精神病的疗效比较。方法:根据治疗方法不同,将符合条件的100例急性期精神病患者随机分为实验组与对照组,两组各50例,其中实验组采用奥氮平治疗,对照组采用氯氮平治疗,采用BPRS评分对治疗2周后的精神症状进行评价,同时对两组的总显效率进行比较。结果:治疗后实验组患者的BPRS评分较对照组明显降低,差异显著(P0.05),另外实验组的2周总显效率明显高于对照组,差异显著(P0.05)。结论:奥氮平与氯氮平均可以改善急性期精神病症状,但奥氮平具有见效快、疗效好等特点,是治疗急性期精神病值得临床推广的药物之一。     

注射用帕潘立酮与利培酮治疗精神分裂症的对照研究

目的:比较帕潘立酮棕榈酸盐与注射用利培酮微球治疗精神分裂症的疗效和不良反应。方法:96例精神分裂症患者被随机分为两组,分别给予帕潘立酮棕榈酸盐与注射用利培酮微球治疗,其中帕潘立酮组43例,利培酮组53例,疗程12周。分别采用阳性、阴性症状量表(PANSS)、人际和社会能力量表(PSP)评定疗效,采用不良反应量表(TESS)、锥体外系症状量表(BARS)、异常不自主运动量表(AIMS)以及临床实验室检查、生命体征、心电图以及体格检查对药物安全性进行全面评估。结果:在疗效方面,对PANSS、PSP量表评分进行两组总体疗效轮廓分析或协方差分析,两组药物在总体疗效、社会功能改善方面均较治疗前明显改善(P0.05),但是两组药物之间比较无明显差异,疗效相当(P0.05);在安全性方面,两组药物对体重的影响均较小,无明显锥体外系不良反应。心电图指标、体格检查以及生命体征亦均无明显改变。结论:帕潘立酮棕榈酸盐与注射用利培酮微球相比,疗效及安全性相当。     

阿立哌唑与利培酮治疗难治性精神分裂症的临床疗效对比

目的:研究对比阿立哌唑与利培酮治疗难治性精神分裂症(简称难治性精分症)的临床疗效。方法:选择2012年6月至2015年5月在我院接受治疗的难治性精分症患者108例进行研究。根据数字法随机将患者分成观察组及对照组各54例,观察组给予阿立哌唑治疗,对照组给予利培酮治疗,8周后对比两组治疗后的总体疗效,不良反应情况,以及不同时期阴性与阳性症状量表(PANSS)评分值。结果:观察组治疗后的总有效率92.59%,显著高于照组的77.78%(P0.05)。两组治疗1周后~治疗8周后的阳性症状、阴性症状、一般病理及PANSS总分均分别显著低于治疗前的水平(P0.05),且观察组治疗1周后~治疗8周后的阴性症状及PANSS总分均分别显著低于对照组(P0.05)。观察组治疗后的不良反应总发生率为33.33%,显著低于对照组的64.81%(P0.05)。结论:阿立哌唑较利培酮治疗难治性精分症可获得更好的疗效及安全性,建议可在临床进一步研究和推广应用。     

利培酮联合氯氮平在长住院精神分裂症的随机对照研究

目的:探讨利培酮联合氯氮平治疗精神分裂症的疗效和安全性。方法:200例长住院符合国际疾病分类第10版(ICD-10)诊断标准的精神分裂症患者随机分为利培酮联合氯氮平组(简称联合组,N=90)和单用利培酮组(简称单用组,N=110),采用简明精神病量表(The brief psychiatric rating scale,BPRS)及阳性和阴性症状量表(the Positive and Negative Syndrome Scale,PANSS)评定疗效,采用治疗中需处理的不良反应症状量表(Treatment Emergent Symptoms Scale,TESS)评定安全性。结果:联合组的显效率高于单用组(84.44%vs.64.54%,P<0.05);两组治疗后BPRS、PANSS评分均低于治疗前[如,联合组BPRS评分(23.02±6.26)vs.(45.01±5.78),PANSS评分(54.42±10.11)vs.(84.71±10.31),P<0.05;单用组BPRS评分(25.86±6.59)vs.(44.78±5.47),PANSS评分(57.70±10.15)vs.(85.96±10.13),P<0.05];治疗后,联合组BPRS、PANSS评分低于单用组[如,BPRS评分联合组(23.02±6.26)vs.单用组(25.86±6.59),PANSS评分联合组(55.42±10.11)vs.单用组(57.70±10.15),P<0.05]。两组TESS评分在治疗后差异无统计学意义(P>0.05)。结论:利培酮联合氯氮平治疗精神分裂症可提高疗效,安全性较高,是一种值得借鉴的策略。     

奥氮平联合重复经颅磁刺激或改良电休克治疗精神分裂症的疗效分析

目的:比较抗精神病药物奥氮平联合复经颅磁刺激(rTMS)或改良电休克(MECT)治疗精神分裂症的疗效。方法:将84例精神分裂症患者随机分为rTMS组(42例)与MECT组(42例),两组分别在奥氮平的基础上联合MECT或rTMS进行治疗。在治疗2、4、8周末后,采用阳性症状和阴性症状量表PANSS、治疗时出现症状量表TESS评估临床治疗效果及不良反应,同时采用修订韦氏记忆量表(WMS-RC)和威斯康星卡片分类测验(WCST)评定认知功能。结果:治疗后,两组总有效率比较无统计学差异(P0.05)。两组治疗后PANSS总分、阳性症状、阴性症状和一般病理分值均显著低于治疗前(P0.05,P0.01),但组间比较无统计学差异(P0.05)。两组TESS评分及不良反应的发生情况比较无统计学差异(P0.05)。与治疗前相比,两组患者治疗后认知功能均显著改善(P0.05,P0.01),且rTMS联合组在改善患者记忆功能、执行能力方面效果优于MTCT组(P0.05)。结论:奥氮平联合MECT或rTMS对精神分裂症状的疗效相当,但联合rTMS可更显著改善患者的认知功能。     

奎硫平与阿立哌唑治疗老年期首发精神分裂症临床分析

目的:观察奎硫平与阿立哌唑治疗老年期首发精神分裂症的临床疗效和安全性.方法:将我院收治的老年期首发精神分裂症患者108例随机分为A组和B组,每组54例,A组患者口服奎硫平,起始剂量50 mg/d,最大剂量450 mg/d,平均(327.8±75.8)mg/d;B组患者口服阿立哌唑,起始剂量5 mg/d,最大剂量30 mg/d,平均(21.5± 3.6) mg/d;疗程12周.于治疗前及治疗后2、4、8、12周末应用阳性症状和阴性症状量表(PANNS)评价临床疗效,应用副反应量表(TESS)评价药物不良反应.结果:①治疗12周后,A组痊愈19例(35.2％),显效15例(27.8％),好转15例(27.8％),无效5例(9.3％),显效率为63.0％,有效率为90.7％;B组痊愈20例(37.0％),显效14例(25.9％),好转15例(27.8％),无效5例(9.3％),显效率为70.0％,有效率为90.7％,两组比较无统计学差异(P＞0.05).②治疗2周末开始两组PANNS量表各项得分及总分均有所降低,与治疗前比较有统计学意义(P＜0.05);两组组间比较PANNS量表各项得分及总分无统计学差异(P＞0.05).③A组头晕、口干、食欲减退多于B组,B组失眠、恶心、呕吐、心动过速多于A组(P＜0.05).结论:奎硫平与阿立哌唑治疗老年首发精神分裂症不良反应虽有异同,但两种药物临床疗效相当,适合老年首发精神分裂症的治疗.     

右美托咪定和丙泊酚用于电休克治疗联合奥氮平治疗精神分裂症疗效的影响

摘要 目的：探究精神分裂症患者联用奥氮平与电休克治疗的可行性,并分析电休克治疗前应用右美托咪定和丙泊酚对患者应激反应的影响。方法：选择2019年4月至2021年4月在我院接受治疗的120例精神分裂症患者为研究对象,将其按照随机数字表法区分为A组、B组和C组（每组各40例患者）,A组患者单纯接受奥氮平治疗,B组患者在A组基础上加用电休克治疗（术前使用丙泊酚麻醉）,C组在B组电休克治疗基础上加用右美托咪定麻醉,就A组和B组患者治疗前后的PANSS评分及治疗效果进行比较,就B组和C组患者血流动力学指标、电休克治疗指标以及不良反应发生率进行比较。结果：（1）治疗前两组患者PANSS量表中阳性症状、阴性症状、一般精神病理及总分组间无差异（P>0.05）,治疗6周后B组患者阳性症状、阴性症状、一般精神病理及总分均明显低于A组（P<0.05）;（2）麻醉前（T0）时两组患者的HR、MAP组间比较无差异（P>0.05）,而在麻醉给药10 min（T1）和电击后5 min（T2）时,C组患者的HR与MAP均低于B组（P<0.05）;（3）B组与C组患者电休克治疗的相关指标诸如苏醒时间、自主呼吸恢复时间以及能量抑制指数上组间无差异（P>0.05）;（4）B组患者呃逆、躁动、头痛等不良反应总发生率为32.50 %（13/40）高于C组患者上述不良反应总发生率5.00 %（2/40）（P<0.05）。结论：电休克治疗联合奥氮平对精神分裂症具有较好的治疗效果,术前若能够联用右美托咪定和丙泊酚进行麻醉,将显著改善患者应激症状,降低术后各类并发症发生率。     

Acute Effects of Aerosolized Iloprost in COPD Related Pulmonary Hypertension - A Randomized Controlled Crossover Trial

Background

Inhaled iloprost potentially improves hemodynamics and gas exchange in patients with chronic obstructive pulmonary disease (COPD) and secondary pulmonary hypertension (PH).

Objectives

To evaluate acute effects of aerosolized iloprost in patients with COPD-associated PH.

Methods

A randomized, double blind, crossover study was conducted in 16 COPD patients with invasively confirmed PH in a single tertiary care center. Each patient received a single dose of 10 µg iloprost (low dose), 20 µg iloprost (high dose) and placebo during distinct study-visits. The primary end-point of the study was exercise capacity as assessed by the six minute walking distance.

Results

Both iloprost doses failed to improve six-minute walking distance (p = 0.36). Low dose iloprost (estimated difference of the means −1.0%, p = 0.035) as well as high dose iloprost (−2.2%, p<0.001) significantly impaired oxygenation at rest. Peak oxygen consumption and carbon dioxide production differed significantly over the three study days (p = 0.002 and p = 0.003, accordingly). As compared to placebo, low dose iloprost was associated with reduced peak oxygen consumption (−76 ml/min, p = 0.002), elevated partial pressure of carbon dioxide (0.27 kPa, p = 0.040) and impaired ventilation during exercise (−3.0l/min, p<0.001).

Conclusions

Improvement of the exercise capacity after iloprost inhalation in patients with COPD-associated mild to moderate PH is very unlikely.

Trial Registration

Controlled-Trials.com ISRCTN61661881     

Antibiotic Prophylaxis in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Background

Recent meta-analyses concluded that antibiotic prophylaxis is not warranted in low-risk laparoscopic cholecystectomy. However, most trials in the meta-analyses had a relatively small sample size and were statistically underpowered. In addition, many of the trials mentioned potential cost savings owing to the elimination of prophylactic antibiotics. However, no trial has statistically estimated the cost effectiveness. To evaluate the results of meta-analyses, we conducted a randomized controlled trial on the role of prophylactic antibiotics in low-risk laparoscopic cholecystectomy with an adequate sample size.

Methods

From March 2007 to May 2013, at the Department of Surgery, Kansai Medical University, patients who were scheduled for elective laparoscopic cholecystectomy were randomly assigned to one of two arms: those who were and were not administered prophylactic antibiotics. The primary endpoint was the occurrence of postoperative infections and secondary endpoints were postoperative hospital stay and medical costs.

Findings

During the study period, 518 patients were assigned to the Antibiotics group and 519 to the No antibiotics group. Occurrences of surgical site infections, distant infections and overall infections were significantly lower in the Antibiotics group than in the No antibiotics group (0.8 vs. 3.7%, p = 0.001, OR: 0.205 (95%CI: 0.069 to 0.606); 0.4 vs. 3.1%, p = 0.0004, OR: 0.122 (95%CI: 0.028 to 0.533); 1.2 vs. 6.7%; p<0.0001, OR: 0.162 (95%CI: 0.068 to 0.389), respectively). The postoperative hospital stay was significantly shorter in the Antibiotics group (mean, SD: 3.69±1.56 vs. 4.07±3.00; p = 0.01) and the postoperative medical costs were significantly lower in the Antibiotics group (mean, SD: $766±341 vs. 832±670; p = 0.047). Multivariable analysis showed that independent risk factors for postoperative infectious complications were no prophylactic antibiotics (p<0.0001) and age 65 or older (p = 0.006).

Conclusions

Perioperative administration of prophylactic antibiotics should be recommended in laparoscopic cholecystectomy to prevent postoperative infectious complications and to reduce medical costs.

Trial Registration

UMIN Clinical Trials Registry UMIN000003749.     

A Randomized Controlled Trial of Storytelling as a Communication Tool

Introduction

Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup.

Methods

Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution.

Results

There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement “I would go for the same choice if I had to do it over again”. The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups.

Conclusions

Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes.

Trial Registration

Current Controlled Trials, ISRCTN39642997 (http://www.controlled-trials.com/ISRCTN39642997)     

A Randomized Controlled Trial of a Commercial Internet Weight Loss Program

Objective: To assess, in a 1‐year randomized controlled trial, the efficacy of eDiets.com (a commercial Internet weight loss program) in improving weight, cardiovascular health, and quality of life. Research Methods and Procedures: Participants were 47 women with a mean age of 43.7 ± 10.2 (SD) years and a mean BMI of 33.5 ± 3.1 kg/m². They were randomly assigned to either: 1) eDiets.com , a commercial Internet‐based program available to the public; or 2) a weight loss manual (i.e., LEARN Program for Weight Control 2000). At baseline, participants in both groups met briefly with a psychologist who instructed them to follow the components of their program as closely as possible. Additional brief visits were provided at weeks 8, 16, 26, and 52 to review their progress. Change in weight was the main outcome measure. Results: At week 16, participants in eDiets.com lost 0.9 ± 3.2% of initial weight compared with 3.6 ± 4.0% for women assigned to the weight loss manual. At week 52, losses increased to 1.1 ± 4.0% and 4.0 ± 5.1%, respectively. Results of a last‐observation‐carried‐forward analysis found that women in the manual group lost significantly (p < 0.05) more weight (at both times) than those treated by eDiets.com . (Results, however, of baseline‐carried‐forward and completers analyses did not reach statistical significance.) There were no significant differences between groups in changes in cardiovascular risk factors or quality of life. Discussion: This study provides consumers with important information about the probable benefits they can expect from participating in a popular Internet‐based weight loss program.     

Lactation Support and Breastfeeding Duration in Jaundiced Infants: A Randomized Controlled Trial

Objectives

Neonatal jaundice is the most common problem in full-term infants during the immediate post-natal period. We examined the effect of a lactation support intervention on breastfeeding duration in hospitalized jaundiced infants.

Study Design

We conducted a randomized controlled trial with a qualitative component involving mothers of hospitalized jaundiced breastfed infants <4 weeks of age. Mothers receiving the intervention met with an International Board-Certified Lactation Consultant in hospital and 1–3 times post discharge. Both groups received the standard care for jaundice. The primary outcome was exclusive breastfeeding at 3 months. To the exception of research assistants enrolling participants and completing qualitative interviews, all research staff, investigators and statisticians were blinded to group assignment. Qualitative interviews elicited feedback on breastfeeding experiences for both groups.

Results

99 participants were recruited, and 86 analyzed for primary outcome. There was no difference in exclusive breastfeeding at 3 months between groups (RR 0.84, 95% CI 0.56–1.24, p = 0.40) or in the secondary outcomes. 31 participants were included in the qualitative analysis. Participants in the intervention group described an increase in comfort and confidence levels with breastfeeding. Participants in the control group reported limited lactation support.

Conclusions

Our hospital-based lactation support program did not result in a higher proportion of mothers exclusively breastfeeding at 3 months compared to current hospital standard care. Qualitative feedback from the intervention group suggests that mothers’ confidence was increased, which is linked to breastfeeding duration. The decision to breastfeed is multifactorial and hospital-based lactation support may be only a small piece of the puzzle in hospitalized jaundiced infants. Further studies may be needed to fully elucidate the impact of an in-hospital lactation support program on successful breastfeeding for these infants.

Trial Registration

ClinicalTrials.gov NCT00966719 https://www.clinicaltrials.gov/ct2/show/NCT00966719?term=Lactation+Support+and+Breastfeeding+Duration+in+Jaundiced+Infants%3A+a+Randomized+Controlled+Trial&rank=1     

Just-in-Time Information Improved Decision-Making in Primary Care: A Randomized Controlled Trial

Background

The “Just-in-time Information” (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction.

Methods and Finding

A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued.

Conclusions

In this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action.

Trial Registration

Controlled-Trials.com ISRCTN96823810     

Well-Loved Music Robustly Relieves Pain: A Randomized,Controlled Trial

Music has pain-relieving effects, but its mechanisms remain unclear. We sought to verify previously studied analgesic components and further elucidate the underpinnings of music analgesia. Using a well-characterized conditioning-enhanced placebo model, we examined whether boosting expectations would enhance or interfere with analgesia from strongly preferred music. A two-session experiment was performed with 48 healthy, pain experiment-naïve participants. In a first cohort, 36 were randomized into 3 treatment groups, including music enhanced with positive expectancy, non-musical sound enhanced with positive expectancy, and no expectancy enhancement. A separate replication cohort of 12 participants received only expectancy-enhanced music following the main experiment to verify the results of expectancy-manipulation on music. Primary outcome measures included the change in subjective pain ratings to calibrated experimental noxious heat stimuli, as well as changes in treatment expectations. Without conditioning, expectations were strongly in favor of music compared to non-musical sound. While measured expectations were enhanced by conditioning, this failed to affect either music or sound analgesia significantly. Strongly preferred music on its own was as pain relieving as conditioning-enhanced strongly preferred music, and more analgesic than enhanced sound. Our results demonstrate the pain-relieving power of personal music even over enhanced expectations.

Trial Information

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01835275","term_id":"NCT01835275"}}NCT01835275.     

Naturopathic Care for Anxiety: A Randomized Controlled Trial ISRCTN78958974

Background

Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial.

Methods

Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC) (n = 41) or standardized psychotherapy intervention (PT) (n = 40) over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera) (300 mg b.i.d. standardized to 1.5% withanolides, prepared from root). The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI) and secondary outcome measures included the Short Form 36 (SF-36), Fatigue Symptom Inventory (FSI), and Measure Yourself Medical Outcomes Profile (MY-MOP) to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention.

Results

Seventy-five participants (93%) were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001) in the NC group and 30.5% (p<0.0001) in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003). Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions were observed in either group.

Relevance

Many patients seek alternatives and/or complementary care to conventional anxiety treatments. To date, no study has evaluated the potential of a naturopathic treatment protocol to effectively treat anxiety. Knowledge of the efficacy, safety or risk of natural health products, and naturopathic treatments is important for physicians and the public in order to make informed decisions.

Interpretation

Both NC and PT led to significant improvements in patients'' anxiety. Group comparison demonstrated a significant decrease in anxiety levels in the NC group over the PT group. Significant improvements in secondary quality of life measures were also observed in the NC group as compared to PT. The whole system of naturopathic care for anxiety needs to be investigated further including a closer examination of the individual components within the context of their additive effect.

Trial Registration

Controlled-Trials.com ISRCTN78958974