Normobaric oxygen treatment for mild-to-moderate depression: a randomized, double-blind, proof-of-concept trial

AbstractOxygen enriched air may increase oxygen pressure in brain tissue and have biochemical effects even in subjects without lung disease. Consistently, several studies demonstrated that normobaric oxygen treatment has clinical benefits in some neurological conditions. This study examined the efficacy of normobaric oxygen treatment in subjects with depression. In a randomized, double-blind trial, 55 participants aged 18–65 years with mild to moderate depression (had a Hamilton Rating Scale for Depression [HRSD] score of ≥ 8) were recruited to the study from the Southern district in Israel. Participants underwent a psychiatric inclusion assessment at baseline and then were randomly assigned to either normobaric oxygen treatment of 35% fraction of inspired oxygen or 21% fraction of inspired oxygen (room air) through a nasal tube, for 4 weeks, during the night. Evaluations were performed at baseline, 2 and 4 weeks after commencement of study interventions, using the following tools: HRSD; Clinical Global Impression (CGI) questionnaire; World Health Organization-5 questionnaire for the estimation of Quality of Life (WHO-5-QOL); Sense of Coherence (SOC) 13-item questionnaire; and, Sheehan Disability Scale (SDS). A multivariate regression analysis showed that the mean ± standard deviation [SD] changes in the HRSD scores from baseline to week four were − 4.2 ± 0.3 points in the oxygen-treated group and − 0.7 ± 0.6 in the control group, for a between-group difference of 3.5 points (95% confidence interval [CI] − 5.95 to − 1.0; P = 0.007). Similarly, at week four there was a between-group difference of 0.71 points in the CGI score (95% CI − 1.00 to − 0.29; P = 0.001). On the other hand, the analysis revealed that there were no significant differences in WHO-5-QOL, SOC-13 or SDS scores between the groups. This study showed a significant beneficial effect of oxygen treatment on some symptoms of depression.Trial registration: NCT02149563 (29/05/2014).

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Paranasal sinus air suction for immediate pain relief of acute migraine – a randomized, double blind pilot study

BMC Neurology ◽

10.1186/s12883-019-1486-0 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

S. M. R. Bandara ◽

S. Samita ◽

A. M. Kiridana ◽

D. M. P. U. K. Ralapanawa ◽

H. M. M. T. B. Herath

Keyword(s):

Pain Relief ◽

Paranasal Sinus ◽

Rating Scale ◽

International Headache Society ◽

Treated Group ◽

Control Group ◽

Double Blind Study ◽

Airflow Rate ◽

Acute Migraine ◽

Double Blind

Abstract Background Migraine is a primary headache disorder, which cause significant disability in adolescence. This double blind, randomized clinical trial assessed the immediate effects of suction of paranasal sinus air during an acute migraine episode. Methods A randomized, double blind study was conducted with 56 selected Sri Lankan school children of 16–19 years of age. Participants who met International Headache Society criteria for migraine (with or without aura) were included in the study. Subjects were randomly allocated into 2 groups where one group was subjected to three intermittent 10 sec paranasal air suctions with a ten sec suction free interval between two suctions for each nostril and the other group was subjected to placebo air suction (no paranasal air suction) in similar arrangement. Severity of headache and sub–orbital tenderness before and after suction were recorded using standard pain rating scale. Results After dropouts, treated and placebo groups consisted of 27 and 23 subjects respectively. The mean headache pain score drop in the treated group was significantly higher compared to that of the control group. Moreover, there was a difference in the treatment response between the types of headache (with or without aura). With respect to tenderness there was a statistically significant drop in the treated group compared to the control. In general, airflow rates in left and right nostrils were different in these subjects. However such difference was not seen in the tenderness on two sides. Nevertheless it was revealed that airflow rate has a slight negative correlation with the tenderness irrespective of the side. Conclusion Sixty–second paranasal air suction can provide an immediate pain relief for acute migraine in adolescents. We did not assess pain outcomes beyond 60 s, but the initial responses suggests the need to further study the efficacy of paranasal suction in migraine. A further study is suggested to evaluate the acute effects, efficacy and side effects of paranasal air suction using follow up over a prolong period. Trial registration Sri Lanka Clinical Trials Registry SLCTR/2017/018, 29 Jun 2017. Retrospectively registered.

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Embitterment in war veterans with posttraumatic stress disorder (PTSD)

European Psychiatry ◽

10.1016/j.eurpsy.2017.02.354 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S359-S360 ◽

Cited By ~ 1

Author(s):

D. Sabic ◽

A. Sabic

Keyword(s):

Posttraumatic Stress Disorder ◽

Posttraumatic Stress ◽

Health Center ◽

Rating Scale ◽

Stress Disorder ◽

World Health ◽

Control Group ◽

War Veterans ◽

Significant Difference ◽

And Control

The aim of this study was to analyse frequency of embitterment in war veterans with Posttraumatic stress disorder (PTSD) as well as the potential impact of embitterment on the development of chronic PTSD.Patients and methodsIt was analyzed 174 subjects (from Health Center Zivinice/mental health center) through a survey conducted in the period from March 2015 to June 2016, of which 87 war veterans with PTSD and control subjects 87 war veterans without PTSD. The primary outcome measure was the post-traumatic embitterment disorder self-rating scale (PTED Scale) who contains 19 items designed to assess features of embitterment reactions to negative life events. Secondary efficacy measures included the clinician-administered PTSD scale–V (CAPS), the PTSD checklist (PCL), the combat exposure scale (CES), the Hamilton depression rating scale (HAM-D), the Hamilton anxiety rating scale (HAM-A) and the World health organization quality of life scale (WHOQOL-Bref). All subjects were male. The average age of patients in the group war veterans with PTSD was 52.78 ± 5.99. In the control group, average age was 51.42 ± 5.98. Statistical data were analyzed in SPSS statistical program.ResultsComparing the results, t-tests revealed significant difference between group veterans with PTSD and control group (t = −21,21, P < 0.0001). War veterans group with PTSD (X = 51.41, SD = 8,91), control group (X = 14.39, SD = 13.61).ConclusionEmbitterment is frequent in war veterans with PTSD.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Double-Blind, Randomized Trial of a Calf Lung Surfactant Extract Administered at Birth to Very Premature Infants for Prevention of Respiratory Distress Syndrome

PEDIATRICS ◽

10.1542/peds.76.4.593 ◽

1985 ◽

Vol 76 (4) ◽

pp. 593-599 ◽

Cited By ~ 4

Author(s):

Donald L. Shapiro ◽

Robert H. Notter ◽

Frederick C. Morin ◽

Karl S. Deluga ◽

Leonard M. Golub ◽

...

Keyword(s):

Respiratory Distress Syndrome ◽

Respiratory Distress ◽

Premature Infants ◽

Neonatal Intensive Care ◽

Distress Syndrome ◽

Lung Surfactant ◽

Treated Group ◽

Control Group ◽

Double Blind ◽

Severe Respiratory Distress

Organic solvent extraction of surfactant obtained by lavage of calf lungs yields a highly surfaceactive material. A double blind, randomized clinical trial to determine the effect of this material on respiratory distress syndrome in premature infants was initiated in the Neonatal Intensive Care Unit at the University of Rochester in December 1983. Infants 25 to 29 weeks gestational age were eligible for entry into the trial. At the time of this interim analysis 32 patients had been randomly selected and entered into the trial, 16 surfactant-treated patients and 16 in a control group who received only saline. At birth, intrapulmonary instillation of the calf lung surfactant extract dispersed in saline or saline alone occurred in the delivery room immediately after intubation and prior to ventilation; infants were then ventilated and treated as usual. At 6, 12, 24, 48, and 72 hours after birth, the severity of respiratory distress was categorized as either minimal, intermediate, or severe based on oxygen and mean airway pressure requirements. Differences observed at six hours after birth were of marginal significance, but at 12 and 24 hours the surfactant-treated group had significantly (P < .01) less severe respiratory distress compared with the control group. Differences between treated and control infants were not statistically significant at 48 and 72 hours after birth. In four surfactant-treated infants the severity of respiratory distress worsened between 24 and 48 hours after birth, suggesting that one dose of surfactant at birth may not be sufficient for some infants.

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Aspirin-Persantin Prophylaxis in Elective total hip Replacement

10.1055/s-0039-1682771 ◽

1977 ◽

Author(s):

A.J. Silvergleid ◽

R. Bernstein ◽

D.S. Burton ◽

J.B. Tanner ◽

J.F. Silverman ◽

...

Keyword(s):

Total Hip Replacement ◽

Hip Replacement ◽

Treated Group ◽

Control Group ◽

Double Blind ◽

Total Hip ◽

Blind Area ◽

Effective Prophylaxis ◽

Clinically Significant ◽

To Receive

A prospective, double-blind clinical study was performed to evaluate the combination of dipyridamole(Persantin)225 mg/day and acetyl salicyclic acid (ASA) 1 g/day prophylaxis of post-operative venous thromboembolism in elective total hip replacement. Patients were stratified according to age, and randomly assigned to receive drug or placebo. All patients were followed with 125I-labelledfibrinogen scanning for one week post-operatively, or until fully mobile. Venography was performed in 67/129 patients; in 27 patients the venogram was obtained to confirm a positive fibrinogen scan, in 40 patients an elective venogram was obtained on the 7th post-operative day to evaluate the operated thigh (a blind area for scanning). Thrombosis (by scan or venogram) was found in 16/66(24%) in the control group, and in 21/63(33%) in the treated group. Overall incidence was 37/129 (29%). Correlation of scan with venography was 90%. There were no clinically significant pulmonary emboli in either group. We conclude that the combination of ASA and dipridamole as given in this study is not effective prophylaxis in elective total hip replacement.

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Effects of Intraoperative Nefopam on Catheter-Related Bladder Discomfort in Patients Undergoing Robotic Nephrectomy: A Randomized Double-Blind Study

Journal of Clinical Medicine ◽

10.3390/jcm8040519 ◽

2019 ◽

Vol 8 (4) ◽

pp. 519

Author(s):

Chi-Bum In ◽

Young-Tae Jeon ◽

Ah-Young Oh ◽

Se-Jong Jin ◽

Byeong-Seon Park ◽

...

Keyword(s):

Postoperative Period ◽

Rating Scale ◽

Numeric Rating Scale ◽

Control Group ◽

Double Blind Study ◽

Analgesic Agent ◽

Double Blind ◽

Robotic Nephrectomy ◽

Male Patients ◽

Numeric Rating

Catheter-related bladder discomfort (CRBD) is one of the most difficult symptoms during the postoperative period. Nefopam is a non-narcotic analgesic agent, which also has anticholinergic action. This study was performed to evaluate the effects of nefopam on CRBD in male patients undergoing robotic nephrectomy. A total of 109 male patients were randomly divided into two groups: the control group (n = 55) received 20 mL of normal saline, and the nefopam group (n = 54) received 20 mg of nefopam 1 h before the end of the operation. At postoperative times of 20 min, 1 h, 2 h, and 6 h, the severity of CRBD was measured using an 11-point numeric rating scale, respectively. The severity of CRBD in the nefopam group was significantly lower than that in the control group at 20 min (4.8 ± 1.3 vs. 2.3 ± 1.0, respectively, p = 0.012) and at 1, 2, and 6 h (3.5 ± 1.2, 2.7 ± 0.9, and 2.5 ± 1.0 vs. 4.1 ± 0.8, 1.6 ± 0.8, and 1.3 ± 0.6, respectively, p < 0001). Intraoperative nefopam administration reduced the severity of CRBD in patients undergoing robotic nephrectomy.

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Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n5p67 ◽

2016 ◽

Vol 9 (5) ◽

pp. 67

Author(s):

Mansoureh Mirzadeh ◽

Najmeh Shahini ◽

Masoud Kashani Lotf Abadi ◽

Maryam Tavakoli ◽

Arash Javanbakht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Function ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

P Value ◽

Double Blind ◽

Randomized Controlled ◽

Significant Difference ◽

Schizophrenic Patients

Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients. This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2nd, 7th, 14th, 28th. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28th compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor p value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05. Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.

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Repeated oral ketamine for out-patient treatment of resistant depression: randomised, double-blind, placebo-controlled, proof-of-concept study

The British Journal of Psychiatry ◽

10.1192/bjp.2018.196 ◽

2018 ◽

Vol 214 (1) ◽

pp. 20-26 ◽

Cited By ~ 25

Author(s):

Yoav Domany ◽

Maya Bleich-Cohen ◽

Ricardo Tarrasch ◽

Roi Meidan ◽

Olga Litvak-Lazar ◽

...

Keyword(s):

Depressive Symptoms ◽

Rating Scale ◽

Control Group ◽

Number Needed To Treat ◽

Proof Of Concept ◽

Double Blind ◽

Double Blind Placebo ◽

Oral Ketamine ◽

Group A ◽

Resistant Depression

BackgroundKetamine has been demonstrated to improve depressive symptoms.AimsEvaluation of efficacy, safety and feasibility of repeated oral ketamine for out-patients with treatment-resistant depression (TRD).MethodIn a randomised, double-blind, placebo-controlled, proof-of-concept trial, 41 participants received either 1 mg/kg oral ketamine or placebo thrice weekly for 21 days (ClinicalTrials.gov Identifier: NCT02037503). Evaluation was performed at baseline, 40 and 240 min post administration and on days 3, 7, 14 and 21. The main outcome measure was change in Montgomery–Åsberg Depression Rating Scale (MADRS).ResultsTwenty-two participants were randomised to the ketamine group, and 19 to the control, with 82.5% (n = 33) completing the study. In the ketamine group, a decrease in depressive symptoms was evident at all time points, whereas in the control group a decrease was evident only 40 min post administration. The reduction in MADRS score on day 21 was 12.75 in the ketamine group versus 2.49 points with placebo (P < 0.001). Six participants in the ketamine group (27.3%) achieved remission compared with none of the controls (P < 0.05). The number needed to treat for remission was 3.7. Side-effects were mild and transient.ConclusionsRepeated oral ketamine produced rapid and persistent amelioration of depressive symptoms in out-patients with TRD, and was well tolerated. These results suggest that add-on oral ketamine may hold significant promise in the care of patients suffering from TRD in the community.Declaration of interestNone.

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Intravenous methylcobalamin effectively ameliorated painful diabetic neuropathy: A randomized double-blind placebo controlled trial

Romanian Journal of Neurology ◽

10.37897/rjn.2021.3.12 ◽

2021 ◽

Vol 20 (3) ◽

pp. 335-341

Author(s):

Thomas Eko Purwata ◽

◽

I Putu Eka Widyadharma ◽

Made Rudy ◽

Andreas Soejitno ◽

...

Keyword(s):

Treatment Group ◽

Diabetic Neuropathy ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

Painful Diabetic Neuropathy ◽

Double Blind ◽

Entire Study ◽

Double Blind Placebo ◽

And Control

Objective. Painful diabetic neuropathy (PDN) is a prevalent debilitating consequence of diabetes mellitus with lack of satisfactory therapeutic options. Methylcobalamin (MeCbl) is one of vitamin B12 analogs with known neurotrophic effects. We aimed to determine if MeCbl can relieve PDN. Materials and methods. This was a randomized (1:1) double-blind placebo-controlled trial involving PDN patients. Treatment and control group received daily 12.5 mg oral amitriptyline bid with either 500 µg of intravenous MeCbl or saline injection given on alternating days, respectively, for a 9-consecutive day period. PDN was assessed with douleur neuropathique 4 (DN4) questionnaire. Numeric pain rating scale (NPRS) was used to monitor pain intensity and treatment response. All investigators and patients were kept blinded throughout the study period. Outcomes. 42 patients, 21 on each arm had completed the study. The NPRS reduction can already be observed as early as day 2 post-intervention. Both the treatment and control group demonstrated sustained reduction of NPRS by almost one point per each time point of evaluation in the first three days (p<0.001). NPRS reduction remained until the end of the study period. The treatment group had a significantly lower NPRS score by 1.29 than that of the control group during the entire study period (95% CI -1.84 – -0.75; p < 0.001). Treatment group experienced significantly higher NPRS reduction when compared with control (4.19±1.54 vs. 2.1± 0.83; 95% CI 1.32-2.87; p < 0.001), i.e. 62.6% from baseline. Conclusions. MeCbl significantly and safely relieved PDN in a relatively rapid onset.

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Nephroprotective effect of virgin coconut oil in Plasmodium berghei ANKA infected Balb/c mice

Qanun Medika - Medical Journal Faculty of Medicine Muhammadiyah Surabaya ◽

10.30651/jqm.v5i2.5791 ◽

2021 ◽

Vol 5 (2) ◽

Author(s):

Syafarinah Nur Hidayah Akil ◽

Heny Arwati ◽

Puspa Wardhani ◽

Priangga Adi Wiratama

Keyword(s):

Plasmodium Berghei ◽

Coconut Oil ◽

Negative Control Group ◽

Treated Group ◽

Negative Control ◽

World Health ◽

Control Group ◽

Plasmodium Berghei Anka ◽

Virgin Coconut Oil ◽

Nephroprotective Effect

AbstractMalaria is a parasitic infectious disease caused by Plasmodium, which remains a world health problem with an estimated 219 million cases worldwide. In severe malaria infection, several organs of the body can be affected, including the kidneys. One of the pathophysiology associated with the worsening of this disease is oxidative stress. The use of antioxidants is expected to prevent this, and one product that has a high antioxidant content is virgin coconut oil (VCO). This study aimed to analyze the effect of VCO on the kidney in Plasmodium berghei ANKA-infected mice. This study was an in vivo laboratory experimental study with a randomized post-test only control group design using 35 BALB/c mice infected with P. berghei ANKA, weighing 20-30 grams. VCO with the Javara® brand is used with doses of 1, 5, and 10 ml/kg body weight (kgBW)/ day. The parameter assessed were levels of BUN, creatinine, and renal histopathological changes. The administration of VCO on the treated group shows minimal tubular necrosis and glomerulonephritis compared to the negative control group. The BUN and creatinine levels in the treated group were also lower than the negative control group. The results showed that VCO has a nephroprotective effect against P. berghei ANKA infection in mice.Keywords: malaria, kidney, virgin coconut oil

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Incidence of Ventricular Fibrillation after Aortic Cross-Clamp Release using Lignocaine Cardioplegia

Anaesthesia and Intensive Care ◽

10.1177/0310057x9402200420 ◽

1994 ◽

Vol 22 (4) ◽

pp. 442-446 ◽

Cited By ~ 2

Author(s):

S. R. Wallace ◽

A. B. Baker

Keyword(s):

Cardiac Surgery ◽

Ventricular Fibrillation ◽

Treated Group ◽

Control Group ◽

Ventricular Pacing ◽

Coronary Artery Surgery ◽

Aortic Cross Clamp ◽

Double Blind ◽

First Time ◽

Spontaneous Defibrillation

The occurrence of ventricular fibrillation after aortic de-clamping during cardiac surgery is common, and if prolonged may contribute to myocardial ischaemia. The use of lignocaine cardioplegia to minimize reperfusion ventricular fibrillation was studied in 141 patients undergoing first time coronary artery surgery in a double blind prospective randomized trial: 71 patients received lignocaine 100 mg/l in their cardioplegia, whereas a control group of 70 patients received cardioplegia without lignocaine. Lignocaine cardioplegia reduced significantly the incidence of reperfusion ventricular fibrillation from 63% to 42%. Of those patients developing reperfusion ventricular fibrillation, a higher proportion receiving lignocaine cardioplegia underwent spontaneous defibrillation (30% vs 11%) though this was not statistically significant. The incidence of atrio-ventricular (A-V) block necessitating ventricular pacing to separate from cardiopulmonary bypass was significantly higher in the lignocaine treated group (44%) than in the control group (20%): this may have been due to the additive effect of procaine in the cardioplegia solution. In the majority of cases this A-V block was transient and had resolved prior to the completion of surgery.

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