scholarly journals Efficacy and safety of pregabalin in elderly people with generalised anxiety disorder

2008 ◽  
Vol 193 (5) ◽  
pp. 389-394 ◽  
Author(s):  
Stuart Montgomery ◽  
Krai Chatamra ◽  
Lynne Pauer ◽  
Ed Whalen ◽  
Francesca Baldinetti
Keyword(s):  
Anxiety Disorder ◽  
Adverse Events ◽  
Repeated Measures ◽  
Rating Scale ◽  
The European Union ◽  
Generalised Anxiety Disorder ◽  
Double Blind ◽  
Mixed Effect ◽  
Almost All ◽  
Hamilton Rating Scale

BackgroundPregabalin is a novel compound that has been shown to have efficacy in the treatment of generalised anxiety disorder and is licensed for the treatment of the disorder in the European Union.AimsThe current study was designed to evaluate the safety and efficacy of pregabalin, an α2δ-ligand, in the treatment of generalised anxiety disorder in people 65 years and older.MethodThis was a double-blind, randomised (2:1), placebo-controlled, 8-week trial of pregabalin, in flexible doses of 150–600 mg/day, in the treatment of DSM–IV generalised anxiety disorder with a baseline Hamilton Rating Scale for Anxiety (HRSA) total score ⩾20. The primary outcome was end-point (week 8 or last visit, with last observation carried forward (LOCF)) change in HRSA total score.ResultsA total of 273 patients (women, 78%; mean age, 72 years (s.d.=6); mean baseline HRSA total score, 26 (s.d.=4.6)) were randomised and received study treatment. On the primary intent-to-treat LOCF analysis, pregabalin was associated with a 2-point greater reduction in HRSA total score than placebo (12.87 v. 10.7; P<0.05). In a post hoc repeated measures mixed-effect model analysis, pregabalin was associated with significantly greater improvement than placebo in the HRSA total score from week 2 (–9.8 (s.d.=0.6) v. −7.2 (s.d.=0.8); P=0.0052) through week 8 (–14.4 (s.d.=0.6) v. −11.6 (s.d.=0.8); P=0.0070). Significant improvement was observed in the pregabalin group on both the HRSA psychic and somatic anxiety factors. There was a significantly greater decrease from baseline in mean Hamilton Rating Scale for Depression (HRSD) score with pregabalin compared with placebo (–5.48 (s.d.=0.46) v. −4.02 (s.d.=0.59); P=0.041). Pregabalin was well-tolerated, with almost all adverse events in the mild-to-moderate range, and self-limiting (median duration of 4–16 days). Discontinuations due to adverse events were similar for pregabalin (10.7%) and placebo (9.4%).ConclusionsPregabalin, in doses of 150–600 mg/day, was a safe and effective treatment of generalised anxiety disorder in patients 65 years and older. The anxiolytic efficacy of pregabalin had an early onset (by 2 weeks) and significantly improved both psychic and somatic symptoms of anxiety.

scholarly journals A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy

2020 ◽  
Vol 86 (5) ◽  
pp. 607-618 ◽  
Author(s):  
Masahito Kotaka ◽  
Yoji Saito ◽  
Takeshi Kato ◽  
Hironaga Satake ◽  
Akitaka Makiyama ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Repeated Measures ◽  
Randomized Study ◽  
Sensory Neuropathy ◽  
Severe Bleeding ◽  
Double Blind ◽  
Good Tolerability ◽  
Mixed Effect ◽  
Soluble Thrombomodulin

Abstract Purpose The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN). Methods This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner: placebo (placebo: days 1–3); 1-day ART (ART-123: day 1, placebo: days 2–3); and 3-day ART (ART-123: days 1–3). ART-123 (380 U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators. Results Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo: 7.3 [95% CI 1.9 to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo: 3.4 [95% CI −.1 to 9.0, p = 0.222]). The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: −23.5 [95% CI −48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo: −18.5 [95% CI −44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred. Conclusion ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date: June 8, 2016

A method for controlling for a high placebo response rate in a comparison of venlafaxine XR and diazepam in the short-term treatment of patients with generalised anxiety disorder

2003 ◽  
Vol 18 (4) ◽  
pp. 182-187 ◽  
Author(s):  
David Hackett ◽  
Vincent Haudiquet ◽  
Eliseo Salinas
Keyword(s):  
Anxiety Disorder ◽  
Rating Scale ◽  
Depression Scale ◽  
Placebo Response ◽  
Anxiolytic Effect ◽  
Controlled Study ◽  
Primary Efficacy ◽  
Generalised Anxiety Disorder ◽  
Short Term Treatment ◽  
Double Blind

AbstractThis randomised, double-blind, placebo-controlled study compared the efficacy of venlafaxine XR (75 or 150 mg/d) with diazepam (15 mg/d) over an 8-week treatment period in 540 non-depressed outpatients with generalised anxiety disorder (GAD). At week 8, significant improvements from baseline were observed in the venlafaxine XR, diazepam and placebo groups. Although these improvements were higher in the first two groups than in the placebo group for each of the primary efficacy variables (Hamilton Rating Scale for Anxiety (HAM-A) total, HAM-A psychic anxiety factor, Hospital Anxiety and Depression Scale (HAD) anxiety sub-scale and Clinical Global Impression (CGI) improvement), there were no statistically significant differences between groups. These non-positive results were thought to be due to the very high placebo response observed in some centres. To understand the variability of the study, a secondary preplanned analysis was performed. This involved sub-dividing the study centres according to their ability to detect a two-point mean difference between diazepam and placebo at week 8 on the HAM-A total score. Centres able to show such a difference were termed verum-sensitive. Improvements from baseline to week 8 in venlafaxine XR-treated patients from verum-sensitive centres were significantly greater than in placebo on each of the primary efficacy measures (P ≤ 0.05). This suggests that those centres able to detect an anxiolytic effect of diazepam were also able to detect an anxiolytic effect of venlafaxine XR. Significant differences in baseline demographics, rates of adverse event reporting and rates of patient discontinuations were noted between patients enrolled at verum-sensitive and verum-insensitive sites. These results reflect the importance of study centre selection in accurately determining efficacy in placebo-controlled trials.

scholarly journals Double-blind clonazepam vs placebo in panic disorder treatment

2000 ◽  
Vol 58 (4) ◽  
pp. 1025-1029 ◽  
Author(s):  
ALEXANDRE MARTINS VALENÇA ◽  
ANTONIO EGIDIO NARDI ◽  
ISABELLA NASCIMENTO ◽  
MARCO A. MEZZASALMA ◽  
FABIANA L. LOPES ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Rating Scale ◽  
Panic Attacks ◽  
Fixed Dose ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Dsm Iv ◽  
Disorder Treatment ◽  
Hamilton Rating Scale

OBJECTIVE: To assess the effectiveness of clonazepam, in a fixed dose (2 mg/day), compared with placebo in the treatment of panic disorder patients. METHOD: 24 panic disorder patients with agoraphobia were randomly selected. The diagnosis was obtained using the structured clinical interview for DSM-IV . All twenty-four subjects were randomly assigned to either treatment with clonazepam (2 mg/day) or placebo, during 6 weeks. Efficacy assessments included: change from baseline in the number of panic attacks; CGI scores for panic disorder; Hamilton rating scale for anxiety; and panic associated symptoms scale. RESULTS: At the therapeutic endpoint, only one of 9 placebo patients (11.1%) were free of panic attacks, compared with 8 of 13 (61.5%) clonazepam patients (Fisher exact test; p=0,031). CONCLUSION: the results provide evidence for the efficacy of clonazepam in panic disorder patients.

Comparative Efficacy and Safety of Sertraline Versus Nortriptyline in Major Depression in Patients 70 and Older

1999 ◽  
Vol 11 (1) ◽  
pp. 85-99 ◽  
Author(s):  
Sanford I. Finkel ◽  
Ellen M. Richter ◽  
Cathryn M. Clary
Keyword(s):  
Major Depression ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Change Score ◽  
Attrition Rate ◽  
Double Blind ◽  
Almost All ◽  
Positive Effect ◽  
Population Segment

Background. Few randomized, double-blind studies that examine antidepressant treatment in patients 70 years and older are available. To provide additional data on the safety and efficacy of antidepressants in this rapidly growing population segment, a subgroup analysis of a larger sertraline vs. nortriptyline elderly depression treatment study was performed. Methods. Outpatients (N = 76) who met DSM-III-R criteria for major depression with a minimum Hamilton Depression Rating Scale (HAM-D) severity score of 18 were randomized to 12 weeks of flexible dose treatment with sertraline (50–150 mg) or nortriptyline (25–100 mg). Results. Both treatments significantly improved depression as measured by the HAM-D and Clinical Global Impression scales. At Weeks 10, 12, and endpoint, sertraline demonstrated a significantly greater reduction in depression severity compared to nortriptyline as measured by improvement on the 24-item HAM-D (mean adjusted change score of 14.8 vs. 7.6, respectively, at Week 12; p = .001). Sixty-five percent of sertraline-treated patients were responders by Week 12 (50% or greater reduction from baseline in 24-item HAM-D score) compared to 26% of nortriptyline-treated patients (p < .05). Sertraline treatment had a significantly more positive effect, when compared to nortriptyline, across almost all associated measures of cognitive function, energy, anxiety, and quality of life and was better tolerated than nortriptyline, with a lower attrition rate/side effect burden. Conclusion. The efficacy advantage of sertraline appeared to be even greater in this subgroup of older patients drawn from a larger treatment study of depression that included elderly individuals over the age of 60.

A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD

2018 ◽  
Vol 24 (2) ◽  
pp. 318-325 ◽  
Author(s):  
Judy P. M. van Stralen
Keyword(s):  
Executive Function ◽  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
P Value ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Stimulant Therapy

Objective: To evaluate the effectiveness of guanfacine extended-release (GXR) versus placebo as adjunct therapy to usual care stimulant therapy in improving executive function in children aged 6 to 12 years diagnosed with ADHD. Method: In this single center, double-blind placebo-controlled crossover trial, subjects continued to take their psychostimulant and were randomly assigned at baseline to receive active treatment or placebo first. Efficacy measures included Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events and vital signs. Results: Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003). There were no serious adverse events and no new safety signals. Conclusion: Use of GXR as adjunctive therapy to stimulant therapy significantly improves executive function in children with ADHD.

scholarly journals Efficacy and safety of repetitive transcranial magnetic stimulation for generalised anxiety disorder: A meta-analysis

2019 ◽  
Vol 32 (5) ◽  
pp. e100051
Author(s):  
Huiru Cui ◽  
Lijuan Jiang ◽  
Yanyan Wei ◽  
Wei Li ◽  
Hui Li ◽  
...  
Keyword(s):  
Transcranial Magnetic Stimulation ◽  
Anxiety Disorder ◽  
Adverse Events ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Efficacy And Safety ◽  
Generalised Anxiety Disorder ◽  
Grade Approach

BackgroundPharmacological and conventional non-pharmacological treatments are only moderately effective in treating generalised anxiety disorder (GAD). Recently, repetitive transcranial magnetic stimulation (rTMS) has attracted interest because of its potential therapeutic value.AimTo investigate the efficacy and safety of rTMS treatment for GAD.MethodsLiterature studies published in English or Chinese were screened in 10 electronic databases up to 5 December 2018. The included studies’ bias risk was assessed using Cochrane risk of bias assessment tool. Meta-analysis was performed to compute the standardised mean difference (SMD) and risk ratio (RR) along with its 95% CIs through using RevMan V.5.3. Heterogeneity was inspected by I2 and the χ2 test. We performed subgroup analysis and meta-regression to investigate heterogeneity. We used funnel plot to assess publication bias. We used the GRADE approach to assess the whole quality of evidence.ResultsTwenty-one studies, with a total sample size of 1481, were analysed. The risk of bias in most studies included is moderate, the majority of which are lacking of blinding methods of treatment allocation. The treatment had beneficial effects in the rTMS group compared with the control group in mean anxiety score (SMD=−0.68; 95% CI −0.89 to −0.46). None of the 21 studies included here reported severe adverse events. As for dropout rates, there are no statistically significant differences between the two groups (RR 1.14, 95% CI 0.72 to 1.82) or adverse events (RR 0.95, 95% CI 0.77 to 1.18). No particular influence on the heterogeneity of any variable was observed. The risk of publication bias was low. According to the GRADE approach, the evidence levels of primary outcome (treatment effects) and secondary outcomes (acceptability and safety) were rated as ‘medium’.ConclusionThe use of rTMS combined with medication treatment may have a significant positive anti-anxiety effect on patients with GAD. However, we should interpret the results cautiously due to the relatively high heterogeneity of the meta-analysis. Future high-quality clinical trials are needed to confirm our results.

Lamotrigine augmentation in treatment-resistant unipolar depression: A comprehensive meta-analysis of efficacy and safety

2019 ◽  
Vol 33 (6) ◽  
pp. 700-713 ◽  
Author(s):  
Kah Kheng Goh ◽  
Chun-Hsin Chen ◽  
Yi-Hang Chiu ◽  
Mong-Liang Lu
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Meta Analysis ◽  
Unipolar Depression ◽  
Severe Illness ◽  
Discontinuation Rate ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Chinese Studies ◽  
Hamilton Rating Scale

Objective: Augmentation strategies are commonly applied when an individual is unresponsive to antidepressant monotherapy. Lamotrigine is currently considered at best only as second line augmentation for treatment-resistant unipolar depression while its clinical efficacy and safety profiles remain inconclusive. We intended to assess the therapeutic effects and safety profiles of lamotrigine augmentation in patients with treatment-resistant unipolar depression by conducting a meta-analysis. Methods: MEDLINE, Embase, EBSCO, Cochrane, Web of Science, Scopus, Wanfang and Ariniti databases were searched. Coprimary outcomes, including changes in severity of depression and response rate, were measured in this study. Secondary outcomes were defined as the safety profile of the intervention, including reported discontinuation rate and adverse events. Results: Eight double-blinded randomized controlled trials with 677 patients overall were included. Significant improvements in Hamilton Rating Scale for Depression scores and response rates were shown in lamotrigine augmentation groups compared with control groups, of which the pooled result of six Chinese studies showed positive effects of Hamilton Rating Scale for Depression improvement while the pooled result of two non-Chinese studies was statistically non-significant. Patients with more severe illness and longer duration of illness were more effectively treated with lamotrigine augmentation. The magnitude of depression improvement after lamotrigine augmentation was higher in patients treated with selective serotonin reuptake inhibitors than those treated with serotonin-norepinephrine reuptake inhibitors. Lamotrigine augmentation is well-tolerated in terms of all-cause discontinuation rate and adverse events. Conclusions: Lamotrigine augmentation may serve as a possible choice for patients with treatment-resistant unipolar depression and further trials are warranted to clarify the optimal dosage of lamotrigine augmentation together with the treatment duration and safety over time.

scholarly journals P210 Efficacy and safety of filgotinib for patients with RA with inadequate response to methotrexate: FINCH1 primary outcome results

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
David Walker ◽  
Bernard G Combe ◽  
Alan J Kivitiz ◽  
Yoshiya Tanaka ◽  
Désirée van der Heijde ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Study Drug ◽  
Janus Kinase ◽  
Controlled Study ◽  
Stock Ownership ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Mixed Effect ◽  
Patient Reported

Abstract Background Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 inhibitor that has shown good efficacy and was well tolerated for treatment of rheumatoid arthritis (RA). The objective of this study was to evaluate efficacy and safety of FIL treatment in patients with RA who have had an inadequate response to methotrexate (MTX). Methods This Phase 3, double-blind, active- and placebo (PBO)-controlled study randomised patients with active RA (3:3:2:3) to FIL 200mg, FIL 100mg, adalimumab [ADA] 40mg every 2 weeks, or PBO daily for up to 52 weeks; results through week 24 are presented. Patients also received background MTX. Primary efficacy endpoint was proportion of patients achieving ACR20 at week 12; additional clinical assessments included ACR50 and ACR70 and DAS28-CRP score ≤3.2 and &lt;2.6, and patient-reported outcomes including HAQ-DI. Safety endpoints included adverse event types and rates. Logistic regression was used for superiority test of FIL vs PBO for ACR response and other binary endpoints, while mixed-effect model for repeated measures (MMRM) were used for continuous endpoints. Non-inferiority test of FIL to ADA (preserving &gt;50% of ADA response) was performed for DAS28-CRP ≤3.2 and &lt;2.6. Results Of 1,759 patients randomised, 1,755 received study drug: 475 FIL 200mg; 480 FIL 100mg; 325 ADA; and 475 PBO, of which 89.5%, 90.4%, 88.9%, and 81.3%, respectively, completed 24 weeks of study drug. 81.8% were female, mean (standard deviation [SD]) duration of RA was 7.8 (7.6) years, and mean (SD) DAS28-CRP was 5.7 (0.9). At week 12, significantly more patients in the FIL 200mg and 100mg arms achieved an ACR20 improvement vs PBO (Table 1). More patients receiving FIL achieved ACR50 and ACR70 improvements, DAS28-CRP scores ≤3.2 and &lt;2.6 and reported improvements in HAQ-DI scores versus PBO (Table 1). Non-inferiority of FIL 200mg to ADA was met based on DAS28-CRP ≤3.2. The FIL safety profile was consistent with prior studies through Week 24. Conclusion FIL 200mg and 100mg led to significant improvement in signs and symptoms of RA, prevented radiographic progression, improved physical function compared to PBO, and was well-tolerated. Efficacy of FIL 200mg was non-inferior to ADA based on DAS28-CRP ≤3.2. Disclosures D. Walker: Other; Received support from Lilly, Pfizer, Novartis and Roche. B.G. Combe: Honoraria; Received honoraria from AbbVie, BMS, Gilead, Janssen, Eli Lilly and Co., MSD, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB. A.J. Kivitiz: Consultancies; Consultant to AbbVie, Celgene, Horizon, Jansses, Merck, Novartis, Pfizer, UCB, Genzyme, Sanofi, Regeneron, SUN Pharma Advanced Research, Boehringer Ingelheim, Flexion and Novartis. Shareholder/stock ownership; Shareholder of Novartis. Y. Tanaka: Honoraria; Honoraria from Daiichi-Sankyo, Astellas, Chugai, Eli Lilly ans Co., Pfizer, AbbVie, YL Biologics, BMS, Takeda, Misubishi-Tanabe, Novartis, Eisai, Janssen, Teijin. Grants/research support; Grant support from Asahi-Kasei, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, BMS, UCB, Daiichi-Sankyo, Eisai, Ono, Astellas, Eli Lilly, Pfizer, Abbvi and YL. D. van der Heijde: Corporate appointments; Director of Imaging Rheumatology bv. Consultancies; Consultant for consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB. F. Matzkies: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. B. Bartok: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. L. Ye: Corporate appointments; Employee of Gilead Sciences, Inc.. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. C. Tasset: Corporate appointments; Employee of Galapagos NV. J.S. Sundy: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. N. Mozaffarian: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. R.B.M. Landewé: Consultancies; Consultant for AbbVie, AstraZeneca, BMS, Galapagos, Pfizer, Eli Lilly, Novartis, and UCB.. S. Bae: None. E.C. Keystone: Consultancies; Consultant for AbbVie, Amgen, AstraZeneca Pharma, Biotest, BMS Canada, Celltrion, Crescendo, Bioscience, F.Hoffman-La Roche Inc., Genentech, Janssen, Eli Lilly and Co., Merck, Pfizer,, PuraPharm, Sandoz, Sanofi-Aventis, Sanofi-Genzyme, Samsumg Bioepsis, and UCB. P. Nash: Consultancies; Consultant for AbbVie, BMS, Jansses, Pfizer, Roche, Lilly, Sanofi, MSD, Novartis, Celgene and Gilead.

Spa Therapy in Anxiety Disorder in a 8 Week Comparative and Randomized Multicentre Study on 237 Patients

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
O. Dubois
Keyword(s):  
Anxiety Disorder ◽  
Multicentre Study ◽  
Rating Scale ◽  
Therapy Group ◽  
Spa Therapy ◽  
Generalized Anxiety ◽  
Generalized Anxiety Disorders ◽  
Spa Treatment ◽  
Dsm Iv ◽  
Hamilton Rating Scale

We compared spa therapy-like balneotherapy treatment with Paroxetine by means of a multicentre, comparative, randomized 8-week study. At least 200 patients fitting the diagnosed criteria of generalized anxiety disorder (DSM IV) were to be recruited. They were carried out by an independent, fully-trained and specialized assessor.The total score on the HAM-A scale (Hamilton Rating Scale for Anxiety) was the main measure for efficiency.There were 237 patients altogether attending in ambulatory who were admitted into the 4 French centres and joined the protocol. 117 were divided up by drawing lots into the Spa Therapy group and 120 into the Paroxetine group.All 207 patients were able to be assessed at W8. The HAM-A scores at W8 showed significant improvement in the Spa Therapy group compared to the Paroxetine group (t = 3.04 p≤ 0.0001). Remission and the rate of improvement (superior or equal to 50%) were markedly higher in the Spa Therapy group.Other analyses stemming from this assessment enrich the results, with complemetary information on the importance of a spa treatment course prescribed in a psychiatric aim.In conclusion, the Spa Therapy-based Balneotherapy treatment is one that has shown specific efficiency in generalized anxiety disorders. Its profile of being well-tolerated and well-accepted by the patients may enable to introduce it regularly in GAD, particularly for people who are resistent to, dependent on or have difficulty in tolerating pharmacology or psychotherapy treatments.

A Controlled Comparison of Simulated and Real ECT

1978 ◽  
Vol 133 (6) ◽  
pp. 514-519 ◽  
Author(s):  
J. Lambourn ◽  
D. Gill
Keyword(s):  
Rating Scale ◽  
Muscle Relaxation ◽  
Control Treatment ◽  
Treatment Procedure ◽  
Double Blind ◽  
Convulsive Therapy ◽  
Pre Treatment ◽  
Controlled Evaluation ◽  
Electro Convulsive Therapy ◽  
Hamilton Rating Scale

SummaryTwo groups of 16 patients with depressive psychosis took part in a controlled evaluation of electro-convulsive therapy (ECT). One group received six brief pulse unilateral shocks under conventional anaesthesia and muscle relaxation; the second group underwent the same procedure without receiving shocks. Outcome was assessed by a separate investigator using the Hamilton Rating Scale for Depression under double-blind conditions. The results showed that this form of ECT was only superior to the control treatment for one item in the scale, a finding which could have occurred by chance. The results suggest that the ECT pre-treatment procedure has an important therapeutic effect. This casts some doubt on current views of the effectiveness of electro-convulsive therapy in general, and of brief pulse unilateral ECT in particular.

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