Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

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The Effects of Propolis Extract Administration on HIV Patients Receiving ARV

The Indonesian Biomedical Journal ◽

10.18585/inabj.v13i1.1381 ◽

2021 ◽

Vol 13 (1) ◽

pp. 75-83

Author(s):

Erwin Astha Triyono ◽

Sarah Firdausa ◽

Heru Prasetyo ◽

Joni Susanto ◽

James Hutagalung ◽

...

Keyword(s):

Quality Of Life ◽

Placebo Group ◽

Clinical Symptoms ◽

Cd4 Count ◽

Controlled Clinical Trial ◽

Human Immune System ◽

Hiv Patients ◽

Double Blind ◽

Significant Difference

BACKGROUND: Human immunodeficiency virus (HIV) is an infectious disease that targets the human immune system by attacking cluster of differentiation (CD)4 cells. The use of propolis in HIV patients is expected to be safe and beneficial in terms of increasing endurance and immunity by its role in increasing CD4 level. This study aimed to analyze the influence of propolis supplementation in increasing the CD4 level in anti-retroviral (ARV)-treated HIV patients.METHODS: Double-blind randomized controlled clinical trial was conducted in 50 HIV patients who took regular ARV therapy. The subjects were divided into two groups, one group was treated with ARV and propolis, while another one was given ARV and placebo. The CD4 cell count was measured during pre-treatment, in the 3rd month, in the 6th month after treatment. The level of hemoglobin, leukocyte, and platelets were also measured. The SF-12 questionnaire was used to evaluate quality of life of the subject.RESULTS: Out of 50 subjects, 43 subjects completed the study, which were 19 subjects from the propolis group and 24 subjects from the placebo group. After 3-month of treatment, there was a statistically significant difference in the incrwase of CD 44 level in propolis group, while the increment was not significant in the placebo group. After 6-month treatment, the increase of CD4 level was occurred in both groups, propolis and placebo, however the increment was not statistically significant. The levels of hemoglobin, leukocyte, and platelets were not altered by the treatment and remained normal throughout the study. The quality of life was improved during the study; however, it was also not statistically significant. Mild adverse events occurred in 3 subjects which were relieved after the treatment stopped.CONCLUSION: Based on the result of this study, the administration of propolis on HIV patients receiving ARV bring significant difference in the increase of CD4 in propolis group from baseline to 3 month after the treatment. While in placebo group, this increment was not significant. At the end of study, CD4 count continued to rise up, however the increase was not statistically significant. There are no hemoglobin, leukocyte, platelets, and quality of life abnormalities. Therefore, it is necesary to do further research with a spesific CD4 count. However, it may be beneficial in relieving the clinical symptoms and quality of life of patient living with HIV.KEYWORDS: CD4, ARV, HIV, propolis

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OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

British Homeopathic Journal ◽

10.1054/homp.1999.0208 ◽

1998 ◽

Vol 87 (02) ◽

pp. 69-76 ◽

Cited By ~ 39

Author(s):

Rosemarie Papp ◽

Gert Schuback ◽

Elmar Beck ◽

Georg Burkard ◽

Jürgen Bengel ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Rectal Temperature ◽

Muscle Pain ◽

Rating Scale ◽

Controlled Clinical Trial ◽

Double Blind ◽

Duration Of Symptoms ◽

Number Of Patients ◽

Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

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The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder

Acta Neuropsychiatrica ◽

10.1111/j.1601-5215.2010.00472.x ◽

2010 ◽

Vol 22 (5) ◽

pp. 237-242 ◽

Cited By ~ 5

Author(s):

Michael Berk ◽

Seetal Dodd ◽

Olivia M Dean ◽

Kristy Kohlmann ◽

Lesley Berk ◽

...

Keyword(s):

Clinical Trial ◽

Bipolar Disorder ◽

Internal Structure ◽

Adjunctive Therapy ◽

Rating Scale ◽

Bipolar Depression ◽

Controlled Clinical Trial ◽

Double Blind ◽

Rating Scale Data ◽

Scale Data

Berk M, Dodd S, Dean OM, Kohlmann K, Berk L, Malhi GS. The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder.Background:The phenomenology of unipolar and bipolar disorders differ in a number of ways, such as the presence of mixed states and atypical features. Conventional depression rating instruments are designed to capture the characteristics of unipolar depression and have limitations in capturing the breadth of bipolar disorder.MethodThe Bipolar Depression Rating Scale (BDRS) was administered together with the Montgomery Asberg Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) in a double-blind randomised placebo-controlled clinical trial of N-acetyl cysteine for bipolar disorder (N = 75).Results:A factor analysis showed a two-factor solution: depression and mixed symptom clusters. The BDRS has strong internal consistency (Cronbach's alpha = 0.917), the depression cluster showed robust correlation with the MADRS (r = 0.865) and the mixed subscale correlated with the YMRS (r = 0.750).Conclusion:The BDRS has good internal validity and inter-rater reliability and is sensitive to change in the context of a clinical trial.

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Efficacy of Weikang Pian in Patients with Functional Dyspepsia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/4827046 ◽

2019 ◽

Vol 2019 ◽

pp. 1-11

Author(s):

Lijing Yan ◽

Lijin Yu ◽

Linlin Zhao ◽

Dongsheng Wang ◽

Dilan Qin ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Gastric Emptying ◽

Functional Dyspepsia ◽

Secondary Outcome ◽

Controlled Clinical Trial ◽

Clinical Trial Registry ◽

Double Blind ◽

Gastric Emptying Rate ◽

Significant Difference

Background. FD (functional dyspepsia) is a common functional gastrointestinal disorder, which lacks effective and safe treatment. Chinese herbal medicine (CHM) has been applied in FD treatment for thousands of years with satisfactory clinical outcomes. Zhishi is a classical traditional Chinese medicine used to treat FD. Weikang pian (WKP) is made of flavonoids extracted from zhishi which could effectively alleviate the symptoms of FD. This research aimed to assess the efficacy and safety of WKP in FD treatment. Methods. This was a randomized, double-blinded and placebo-controlled clinical trial. The patients were diagnosed as FD according to RomeIII criteria. Then, FD patients were selected and assigned randomly to either WKP or placebo group. The subjects randomly received WKP or placebo for 4 weeks with 4 tablets each time, 3 times daily. The single dyspepsia symptom (SDS) scale and the gastric emptying function were measured before and after the treatment. Moreover, the safety of the trial and patient compliance were evaluated. Results. A total of 60 FD patients were eventually enrolled in the trial, among them 45 patients in the WKP group and 15 patients in the placebo group. The primary outcome was the SDS scale, including assessments of postprandial distension, early satiety, epigastric burning, and pain. The secondary outcome was the gastric emptying function. Compared with the placebo group, the symptoms of FD in the WKP group were relieved after 4 weeks of treatment (P<0.05). Some minor changes appeared in the four groups, but there were no significant differences in gastric emptying parameters of GER (2-hour gastric emptying rate) and GET/2 (gastric semiempty time) (P>0.05). Severe adverse events were absent. The compliance to treatment was 94%–96%, and there was no significant difference between the groups. Conclusion. WKP can relieve FD symptoms to some extent. This trial is registered with Chinese Clinical Trial Registry (ChiCTR): CTR 20132482.

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Neurodynamic mobilization and foam rolling improved delayed-onset muscle soreness in a healthy adult population: a randomized controlled clinical trial

PeerJ ◽

10.7717/peerj.3908 ◽

2017 ◽

Vol 5 ◽

pp. e3908 ◽

Cited By ~ 12

Author(s):

Blanca Romero-Moraleda ◽

Roy La Touche ◽

Sergio Lerma-Lara ◽

Raúl Ferrer-Peña ◽

Víctor Paredes ◽

...

Keyword(s):

Clinical Trial ◽

Muscle Soreness ◽

Pain Perception ◽

Rating Scale ◽

Adult Population ◽

Rectus Femoris ◽

Controlled Clinical Trial ◽

Double Blind ◽

Maximum Voluntary Isometric Contraction ◽

Significant Difference

Objectives Compare the immediate effects of a Neurodynamic Mobilization (NM) treatment or foam roller (FR) treatment after DOMS. Design Double blind randomised clinical trial. Setting The participants performed 100 drop jumps (5 sets of 20 repetitions, separated by 2 min rests) from a 0.5-m high box in a University biomechanics laboratory to induce muscle soreness. The participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group. Participants Thirty-two healthy subjects (21 males and 11 females, mean age 22.6 ± 2.2 years) were randomly assigned into the NM group (n = 16) or the FR group (n = 16). Main Outcome Measures The numeric pain rating scale (NPRS; 0–10), isometric leg strength with dynamometry, surface electromyography at maximum voluntary isometric contraction (MVIC) and muscle peak activation (MPA) upon landing after a test jump were measured at baseline, 48 h after baseline before treatment, and immediately after treatment. Results Both groups showed significant reduction in NPRS scores after treatment (NM: 59%, p < .01; FR: 45%, p < .01), but no difference was found between them (p > .05). The percentage change improvement in the MVIC for the rectus femoris was the only significant difference between the groups (p < 0.05) at post-treatment. After treatment, only the FR group had a statistically significant improvement (p < 0.01) in strength compared to pre-treatment. Conclusion Our results illustrate that both treatments are effective in reducing pain perception after DOMS whereas only FR application showed differences for the MVIC in the rectus femoris and strength.

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Intravenous Tenoxicam for Analgesia following Laparoscopic Cholecystectomy

Anaesthesia and Intensive Care ◽

10.1177/0310057x9802600108 ◽

1998 ◽

Vol 26 (1) ◽

pp. 56-60 ◽

Cited By ~ 15

Author(s):

F. J. Munro ◽

S. J. Young ◽

I. J. Broome ◽

H. M. Robb ◽

G. J. Wardall

Keyword(s):

Clinical Trial ◽

Laparoscopic Cholecystectomy ◽

Placebo Group ◽

Adverse Effects ◽

Controlled Clinical Trial ◽

Patient Controlled Analgesia ◽

Double Blind ◽

Rescue Analgesia ◽

Double Blind Placebo ◽

Pain Scores

In a double-blind, placebo-controlled clinical trial (power of 80% to detect a 30% reduction in morphine consumption, P<0.05) we have determined that intraoperative intravenous administration of tenoxicam 40 mg during laparoscopic cholecystectomy, when compared with placebo, was associated with a significant reduction in consumption of morphine at 6 hours and 12 hours (P<0.05) but not at 24 hours, when assessed by patient-controlled analgesia. Furthermore there was a significantly greater requirement for “rescue” analgesia with intramuscular morphine in the placebo group during the period of the study. There was no difference between the groups in pain scores, either at rest or on movement, nor in the incidence of nausea and vomiting. No patient in either group suffered a respiratory rate less than 8/min or oversedation at any time, and there were no other adverse effects.

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A Randomized, Double-blind, Placebo-controlled Trial of DL-3-n-butylphthalide in Amyotrophic Lateral Sclerosis Patients

10.21203/rs.3.rs-1142455/v1 ◽

2021 ◽

Author(s):

Mingsheng Liu ◽

Xiaoli Yao ◽

Xusheng Huang ◽

Huifang Shang ◽

Dongsheng Fan ◽

...

Keyword(s):

Amyotrophic Lateral Sclerosis ◽

Placebo Group ◽

Clinical Global Impression ◽

Rating Scale ◽

Controlled Trial ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference ◽

Lateral Sclerosis

Abstract Background: To determine the efficacy and safety of DL-3-n-butylphthalide (NBP) for the treatment of amyotrophic lateral sclerosis (ALS).Methods: A randomized, double-blind, placebo-controlled trial was performed at 19 ALS clinical centers of the Chinese ALS Association. Patients with definite or probable ALS were randomly treated with NBP or placebo for 12 months. The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score was the primary endpoint and was evaluated every 3 months. Secondary endpoints included survival and tracheotomy incidence, total Medical Research Council (MRC) score, percentage of predicted forced vital capacity (FVC), and clinical global impression scale score assessed using the visual analog scale. Results: Between November 23, 2015 and November 22, 2017, 312 ALS patients were enrolled and randomly allocated to either the NBP group (156 patients) or placebo group (156 patients). Ninety-three patients in the NBP group and 92 patients in the placebo group were included in the primary end point analysis. There was no significant difference in the ALSFRS-R score, total MRC score, or clinical global impression between the two groups after treatment. The NBP group exhibited a mild trend of less decrease in the percentage of predicted FVC between baseline and the 12-month visit than the placebo group (least-squares mean change from baseline ± standard error: -7.34±4.28, 95％CI(-15.24,0.56), p=0.0335). Adverse events were reported in 56.5% of patients in the placebo group and 68.8% of patients in the NBP group (χ2=2.99, P=0.0838). No serious adverse event related to treatment occurred.Conclusion: we found no evidence that NBP improved the ALSFRS-R score in patients with ALS. The results suggest a mild trend in the percentage of predicted FVC decreased slowly in the NBP treatment group than in the placebo group.Trial registration: A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis, ChiCTR-IPR-15007365, Registered 1 November 2015, http://www.chictr.org.cn/showproj.aspx?proj=12354

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Adjunctive Therapy to Manage Neuropsychiatric Symptoms in Moderate and Severe Dementia: Randomized Clinical Trial Using an Outpatient Version of Tailored Activity Program

Journal of Alzheimer s Disease ◽

10.3233/jad-210142 ◽

2021 ◽

pp. 1-12

Author(s):

Alexandra Martini Oliveira ◽

Marcia Radanovic ◽

Patricia Cotting Homem de Mello ◽

Patricia Cardoso Buchain ◽

Adriana Dias Barbosa Vizzotto ◽

...

Keyword(s):

Clinical Trial ◽

Sleep Disturbances ◽

Rating Scale ◽

Neuropsychiatric Symptoms ◽

Caregiver Training ◽

Controlled Clinical Trial ◽

Post Intervention ◽

Double Blind ◽

Activity Program ◽

Experimental Group

Background: Neuropsychiatric symptoms (NPS) such as aggression, apathy, agitation, and wandering may occur in up to 90%of dementia cases. International guidelines have suggested that non-pharmacological interventions are as effective as pharmacological treatments, however without the side effects and risks of medications. An occupational therapy method, called Tailored Activity Program (TAP), was developed with the objective to treat NPS in the elderly with dementia and has been shown to be effective. Objective: Evaluate the efficacy of the TAP method (outpatient version) in the treatment of NPS in individuals with dementia and in the burden reduction of their caregivers. Methods: This is a randomized, double-blind, controlled clinical trial for the treatment of NPS in dementia. Outcome measures consisted of assessing the NPS of individuals with dementia, through the Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and assessing the burden on their caregivers, using the Zarit Scale. All the participants were evaluated pre-and post-intervention. Results: 54 individuals with dementia and caregivers were allocated to the experimental (n = 28) and control (n = 26) groups. There was improvement of the following NPS in the experimental group: delusions, agitation, aggressiveness, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, and aberrant vocalization. No improvement was observed in hallucinations, sleep disturbances, and appetite disorders. The TAP method for outpatient settings was also clinically effective in reducing burden between caregivers of the experimental group. Conclusion: The use of personalized prescribed activities, coupled with the caregiver training, may be a clinically effective approach to reduce NPS and caregiver burden of individuals with dementia.

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Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽

10.3390/nu13072238 ◽

2021 ◽

Vol 13 (7) ◽

pp. 2238

Author(s):

Xiaomei Zhang ◽

Shanbin Chen ◽

Ming Zhang ◽

Fazheng Ren ◽

Yimei Ren ◽

...

Keyword(s):

Mental Illness ◽

Placebo Group ◽

Rating Scale ◽

Controlled Trial ◽

Fermented Milk ◽

Daily Consumption ◽

Double Blind ◽

Tnf Α ◽

Significant Difference ◽

Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

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Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections

10.1101/2021.09.28.21264242 ◽

2021 ◽

Author(s):

Aldo A M Lima ◽

Erico A G Arruda ◽

Roberto J Pires-Neto ◽

Melissa S Medeiros ◽

J Quirino-Filho ◽

...

Keyword(s):

Clinical Trial ◽

Vitamin C ◽

Respiratory Infection ◽

Clinical Symptoms ◽

Clinical Signs ◽

Signs And Symptoms ◽

Clinical Suspicion ◽

Pharmacological Intervention ◽

Controlled Clinical Trial ◽

Double Blind

This study aimed to evaluate the efficacy and toxicity of tenofovir (TDF) and TDF combined with emtricitabine (TDF/FTC) in patients with mild to moderate COVID-19 infections. We conducted a randomized, double-blind, placebo-controlled clinical trial in patients with clinical suspicion of mild to moderate respiratory infection caused by SARS-CoV-2 who were treated at an outpatient clinic. Patients were randomly recruited to take 10 days of TDF (300 mg/day), TDF (300 mg/day) combined with FTC (200 mg/day) or placebo Vitamin C (500 mg/day). The primary parameter was the score of symptoms and predictive signs of COVID-19, assessed on the seventh day of patient follow-up. From a total of 309 patients with clinical suspicion of SARS-CoV-2, 227 met the inclusion criteria and were randomly distributed into the following groups: (a) 75 (one did not initiate treatment) in the TDF group; (b) 74 in the TDF combined with FTC group; and (c) 77 in the Vitamin C group (placebo). Of the 226 patients, 139 (62%) were positive for SARS-CoV-2. Fever (37.8oC), ageusia or dysgeusia, anosmia or dysosmia, and two or more clinical symptoms or signs were significantly associated with SARS-CoV-2 infection. There was no significant change in clinical score based on clinical symptoms and signs between treatment groups. Patients with mild to moderate infection by SARS-CoV-2 had higher concentrations of G-CSF, IL-1β, IL-6 and TNF-α compared to patients without infection. Patients with mild to moderate respiratory infection, with fever (37.8oC), loss of smell, loss of taste and two or more symptoms, have a better prediction for the diagnosis of COVID-19. Patients with SARS-CoV-2 showed higher and more persistent proinflammatory cytokines profile compared to patients not infected with SARS-CoV-2. Pharmacological intervention with TDF or TDF combined with FTC did not change the clinical signs and symptoms score in mild to moderate respiratory infection in patients with SARS-CoV-2 compared to the Vitamin C group (placebo).

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