Efficacy of Polygonatum sibiricum on Mild Insomnia: A Randomized Placebo-Controlled Trial

Polygonatum sibiricum (PS) rhizome, which contains glyceryl-1-monolinoleate as its primary active component, has been shown to improve insomnia in animal models. Based on these findings, we aimed to investigate the safety and efficacy of PS rhizome extract in improving sleep quality in individuals with mild insomnia. Eighty individuals with mild insomnia were enrolled in a four-week, randomized, double-blind, placebo-controlled trial of PS rhizome extract (500 mg/day, n = 40, PS group) or placebo (n = 40, placebo group). The primary outcome measure was change in total score on the Athens Insomnia Scale (AIS) to indicate sleep quality. The secondary outcome measures included change in actigraphy data and perfusion levels in the brain regions within the default mode network (DMN), which is known to play a key role in insomnia. The PS group showed greater improvement in the total AIS score with a significant increase in total sleep time, relative to the placebo group. In addition, significant group-by-visit interactions were observed in the perfusion level of the medial prefrontal cortex within the DMN. Findings of the current study provide first evidence that PS rhizome extract could be an effective natural ingredient for improving sleep in mild insomnia using a human model.

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Differential Effects of DHA- and EPA-Rich Oils on Sleep in Healthy Young Adults: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu13010248 ◽

2021 ◽

Vol 13 (1) ◽

pp. 248

Author(s):

Michael J. Patan ◽

David O. Kennedy ◽

Cathrine Husberg ◽

Svein Olaf Hustvedt ◽

Philip C. Calder ◽

...

Keyword(s):

Sleep Quality ◽

Controlled Trial ◽

Sleep Time ◽

Sleep Efficiency ◽

Omega 3 ◽

Double Blind ◽

Differential Effects ◽

Positive Effects ◽

Time In Bed ◽

Oily Fish

Emerging evidence suggests that adequate intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs), which include docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), might be associated with better sleep quality. N-3 PUFAs, which must be acquired from dietary sources, are typically consumed at suboptimal levels in Western diets. Therefore, the current placebo-controlled, double-blind, randomized trial, investigated the effects of an oil rich in either DHA or EPA on sleep quality in healthy adults who habitually consumed low amounts of oily fish. Eighty-four participants aged 25–49 years completed the 26-week intervention trial. Compared to placebo, improvements in actigraphy sleep efficiency (p = 0.030) and latency (p = 0.026) were observed following the DHA-rich oil. However, these participants also reported feeling less energetic compared to the placebo (p = 0.041), and less rested (p = 0.017), and there was a trend towards feeling less ready to perform (p = 0.075) than those given EPA-rich oil. A trend towards improved sleep efficiency was identified in the EPA-rich group compared to placebo (p = 0.087), along with a significant decrease in both total time in bed (p = 0.032) and total sleep time (p = 0.019) compared to the DHA-rich oil. No significant effects of either treatment were identified for urinary excretion of the major melatonin metabolite 6-sulfatoxymelatonin. This study was the first to demonstrate some positive effects of dietary supplementation with n-3 PUFAs in healthy adult normal sleepers, and provides novel evidence showing the differential effects of n-3 PUFA supplements rich in either DHA or EPA. Further investigation into the mechanisms underpinning these observations including the effects of n-3 PUFAs on sleep architecture are required.

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Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

International Journal of Rheumatology ◽

10.1155/2011/585497 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Angela Smith ◽

Caroline Doré ◽

Peter Charles ◽

Alena Vallance ◽

Tara Potier ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Placebo Group ◽

Active Treatment ◽

Active Rheumatoid Arthritis ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Good Evidence ◽

Double Blind ◽

Acr20 Response ◽

Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

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Online Left-Hemispheric In-Phase Frontoparietal Theta tACS for the Treatment of Negative Symptoms of Schizophrenia

Journal of Personalized Medicine ◽

10.3390/jpm11111114 ◽

2021 ◽

Vol 11 (11) ◽

pp. 1114

Author(s):

Chuan-Chia Chang ◽

Cathy Chia-Yu Huang ◽

Yong-An Chung ◽

Jooyeon Jamie Im ◽

Yen-Yue Lin ◽

...

Keyword(s):

Large Scale ◽

Negative Symptoms ◽

Controlled Trial ◽

Unmet Need ◽

Subscale Score ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Neurocognitive Performance ◽

Double Blind ◽

Replication Studies

Negative symptoms represent an unmet need for schizophrenia treatment. The effect of theta frequency transcranial alternating current stimulation (theta-tACS) applied during working memory (WM) tasks on negative symptoms has not been demonstrated as of yet. We conducted a randomized, double-blind, sham-controlled trial of 36 stabilized schizophrenia patients, randomized to receive either twice daily, 6 Hz 2 mA, 20 min sessions of in-phase frontoparietal tACS or sham for five consecutive weekdays. Participants were concurrently engaged in WM tasks during stimulation. The primary outcome measure was the change over time in the Positive and Negative Syndrome Scale (PANSS) negative subscale score measured from baseline through to the 1-month follow-up. Secondary outcome measures were other symptom clusters, neurocognitive performance, and relevant outcomes. The intention-to-treat analysis demonstrated greater reductions in PANSS negative subscale scores at the end of stimulation in the active (−13.84%) than the sham (−3.78%) condition, with a large effect size (Cohen’s d = 0.96, p = 0.006). The positive effect endured for at least one month. Theta-tACS also showed efficacies for cognitive symptoms, WM capacity, and psychosocial functions. Online theta-tACS offers a novel approach to modulate frontoparietal networks to treat negative symptoms of schizophrenia. The promising results require large-scale replication studies in patients with predominantly negative symptoms.

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Treatment of acute bronchitis in adults with extract of Pelargonium Sidoides: a randomised, double-blind, placebo controlled trial

Russian Pulmonology ◽

10.18093/0869-0189-2007-0-6-49-55 ◽

2007 ◽

pp. 49-55

Author(s):

A. G. Chuchalin ◽

B. Berman ◽

V. Lemakher

Keyword(s):

Placebo Group ◽

Adverse Events ◽

Controlled Trial ◽

Alternative Therapy ◽

Acute Bronchitis ◽

Complete Recovery ◽

Primary Outcome Measure ◽

Double Blind ◽

Double Blind Placebo ◽

Pelargonium Sidoides

Acute bronchitis is a wide-spread disease. Although it is generally caused by viruses, antibiotics are used for its treatment too much often. So it is very important to evaluate alternative therapy of acute bronchitis. The aim of the trial was to assess efficacy and safety of Pelargonium Sidoides (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co, Karlsruhe, Germany) compared to placebo in patients with acute bronchitis. Study design: randomised, double-blind, placebo controlled trial with planned interim analysis. The trial centres: 6 outpatient medical centres. Patients: 124 adult patients with acute bronchitis, onset of the disease ≤ 48 h, and severity of symptoms ≥ 5 according to BSS scale gave written informed concert. EPs 7630 or placebo were administered in the dose of 30 drops t.i.d. during 7 days. The primary outcome measure was BSS scoring at the 7th day of the treatment. BSS scoring decreased by 7.2 ± 3.1 in the EPs 7630 group (n = 64) vs 4.9 ± 2.7 in the placebo group (n = 60). 95 % confidence interval (CI, 1.21, 3.56) for difference of the effects between two groups demonstrated significant improvement in the EPs 7630 in 7 days of the treatment compared to the placebo group (p < 0.0001). The EPs 7630 patients had parameters of complete recovery for every of 5 individual symptoms reliably higher compared to placebo patients. During the first 4 days of the treatment therapeutic effect was noted in 68.8 % of the EPs 7630 group vs 33.3 % of the placebo group (p < 0.0001). Health-related quality of life improved better in the EPs 7630 patients compared to the placebo group. Adverse events were found in 25 of 124 patients: 15 / 64 in the EPs 7630 group and 10 / 60 in the placebo group. All the adverse events were considered as non-serious. The efficacy of EPs 7630 in treatment of adults with acute bronchitis was higher compared to placebo. It could be an efficient alternative drug in therapy of acute bronchitis at the absence of indications for antibiotics administration.

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Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.754921 ◽

2021 ◽

Vol 12 ◽

Author(s):

Jiaojiao Zhou ◽

Xu Chen ◽

Le Xiao ◽

Jingjing Zhou ◽

Lei Feng ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Depression Scale ◽

Cordyceps Militaris ◽

Secondary Outcome ◽

Controlled Study ◽

Depression Symptom ◽

Hamilton Depression Scale ◽

Efficacy And Safety ◽

Double Blind

Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the efficacy and safety of duloxetine with C. militaris in improving sleep symptoms in patients with depression.Methods: This study was a single-center, randomized, double-blind, placebo-controlled study that recruited outpatients admitted to Beijing Anding hospital from January 2018 to January 2019. Major depressive disorder (MDD) with insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and Mini-International Neuropsychiatric Interview (M.I.N.I.). Eligible subjects will be randomly assigned to two treatment groups in a 1:1 ratio, and receive treatment and follow-up of about 6 weeks of duloxetine plus Cordyceps militaris or placebo, respectively. The severity of depression and insomnia was evaluated at baseline and at 1, 2, 4, and 6 weeks using the 17-item Hamilton Depression Scale (HAMD-17) and Athens Insomnia Scale (AIS).Results: A total of 59 subjects were included in the study (31 in the placebo group and 28 in the C. militaris group). 11 (18.6%) participants withdrew during the study period, 5 (17.9%) in the C. militaris group, and 6 (19.3%) in the placebo group. Depressive and sleep symptoms in all patients reduced over time. We found that the total scores of AIS and its subscales decreased more in the placebo group compared to the C. militaris group (p < 0.05). Secondary outcome revealed that there were no significant differences between the two groups in total HAMD-17 and its sleep factor scores (p > 0.05) at 1, 2, 4, and 6 weeks after treatment initiation. The incidences of adverse events were not significantly different between the two groups (all p > 0.05).Conclusion:C. militaris at the current dose and duration did not improve sleep symptoms in patients with depression, but it is safe with rare side effects.

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Erythromycin in Acute Laryngitis in Adults

Annals of Otology Rhinology & Laryngology ◽

10.1177/000348949310200308 ◽

1993 ◽

Vol 102 (3) ◽

pp. 209-214 ◽

Cited By ~ 22

Author(s):

Lucyna Schalén ◽

Carl Kamme ◽

Ingvar Eliasson ◽

Claes Schalén

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Voice Quality ◽

Clinical Signs ◽

Group Differences ◽

Upper Respiratory Tract ◽

Bacterial Isolation ◽

Double Blind ◽

Significant Group ◽

Upper Respiratory

Moraxella catarrhalis and Hemophilus influenzae are isolated from the nasopharynx in 50% to 55% and 8% to 15%, respectively, of cases of acute laryngitis in adults. This finding indicates that these organisms, M catarrhalis in particular, are in some way involved in the pathogenesis of the disorder. In the present double-blind, placebo-controlled trial, the effect of erythromycin ethylsuccinate (0.5 g twice a day for 5 days) on the elimination of nasopharyngeal pathogens and reduction of clinical signs of upper respiratory tract infection, as well as on subjective complaints, was evaluated in 106 adults with acute laryngitis. The bacterial isolation rates at presentation were M catarrhalis 50%, H influenzae 18%, and Streptococcus pneumoniae 4%. In the 99 patients who completed the study, the elimination of M catarrhalis after 1 week was better in the erythromycin group (25 of 30 cases) than in the placebo group (6 of 19 cases; p ≤ .00038). The elimination of H influenzae was unaffected by erythromycin. Otolaryngologic examination did not reveal any significant group differences regarding laryngitis, pharyngitis, or rhinitis. Voice quality was improved after 1 week, irrespective of treatment. However, as compared to the placebo group, the erythromycin group reported fewer voice complaints after 1 week and fewer coughing complaints after 2 weeks. As acute laryngitis in adults is self-limiting, and subjective symptoms are spontaneously reduced after 1 week in most cases, antibiotic treatment does not seem warranted as a general policy. However, erythromycin may be justified in patients who are professionally dependent on voice function.

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A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease

International Psychogeriatrics ◽

10.1017/s1041610213000239 ◽

2013 ◽

Vol 25 (6) ◽

pp. 919-927 ◽

Cited By ~ 34

Author(s):

Nathan Herrmann ◽

Serge Gauthier ◽

Neli Boneva ◽

Ole Michael Lemming

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Outcome Measures ◽

Primary Outcome ◽

Controlled Trial ◽

Neuropsychiatric Symptoms ◽

Primary Outcome Measure ◽

Community Dwelling ◽

Secondary Outcome ◽

Double Blind

ABSTRACTBackground: Agitation and aggression in Alzheimer's disease (AD) are amongst the most serious of neuropsychiatric symptoms, and contribute to poor outcomes and worse quality of life. Previous studies have suggested a benefit for memantine on agitation and aggression, but none have examined its efficacy in community-dwelling patients with significant agitation and aggression at baseline, utilizing these behaviors as a primary outcome measure.Methods: Patients with moderate-to-severe AD with Neuropsychiatric Inventory (NPI) total score ≥13 and NPI agitation/aggression score ≥1 were randomized to placebo or 20-mg memantine in a double-blind, 24-week trial. Co-primary outcome measures were behavior, measured by total NPI score, and cognition, using the Severe Impairment Battery (SIB). Secondary outcome measures included global assessment, function and other measures of behavior. This trial was registered as Clinicaltrials.gov: NCT00857649.Results: A total of 369 patients (average age = 75, average MMSE = 12) were randomized to placebo or memantine. The study was prematurely terminated due to recruitment problems. There were no statistically significant differences between memantine and placebo in mean change from baseline in NPI, SIB, or any of the secondary outcome measures. Behavior improved in both groups (total NPI change scores −3.90 ± 1.24 for memantine and −5.13 ± 1.23 for placebo). Memantine was generally well tolerated and patient retention in both treatment arms was good.Conclusions: The study failed to show the superiority of memantine in this sample of patients with moderate-to-severe AD with significant baseline agitation and aggression. Methodological limitations could have contributed to these results.

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Assessing the effectiveness of perioperative s-ketamine on new-onset headache after resective epilepsy surgery (ESPAIN-trial): protocol for a randomised, double-blind, placebo-controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-030580 ◽

2019 ◽

Vol 9 (8) ◽

pp. e030580

Author(s):

Jiske Cornelia Theresa Sloekers ◽

Michael Bos ◽

Govert Hoogland ◽

Caroline Bastiaenen ◽

Sander van Kuijk ◽

...

Keyword(s):

Human Subjects ◽

Controlled Trial ◽

Scientific Journal ◽

Length Of Hospital Stay ◽

Primary Outcome Measure ◽

Temporal Lobectomy ◽

Secondary Outcome ◽

Drug Resistant ◽

Double Blind ◽

New Onset

IntroductionEffective treatment of new-onset headache after craniotomy, especially anterior temporal lobectomy (ATL) and amygdalohippocampectomy for drug-resistant temporal lobe epilepsy, is a challenge. The current practice, acetaminophen combined with opioids is often reported by patients as insufficient and sometimes accompanied by opioid-related adverse effects. Based on expert opinion, anaesthesiologists therefore frequently consider s-ketamine as add-on therapy. This randomised parallel group design trial compares s-ketamine with a placebo as add on medication to a multimodal pain approach.Methods and analysisIn total 62 adult participants, undergoing ATL for drug resistant epilepsy under general anaesthesia, will be randomised to either receive a 0.25 mg/kg bolus followed by a continuous infusion of 0.1 mg/kg/hour of s-ketamine or placebo (0.9% NaCl) starting before incision and continued for 48 hours as an addition to acetaminophen and opioids administered in a patient-controlled analgesia pump. The primary outcome measure is the cumulative postoperative opioid consumption. Patient recruitment started August 2018 and will end in 2021. Secondary outcome measures are postoperative pain intensity scores, psychological parameters, length of hospital stay and adverse events and will be reassessed at 3 and 6 months after surgery, with a baseline measurement preoperatively. All data are collected by researchers who are blinded to the treatment. The data will be analysed by multivariable linear mixed-effects regression.Ethics and disseminationEthical approval has been given by the local medical ethical committee (NL61666.068.17). This study will be conducted in accordance with the Dutch Medical Research Involving Human Subjects Act and the Declaration of Helsinki. The results of this trial will be publicly disclosed and submitted for publication in an international peer-reviewed scientific journal.Trial registration numberNTR6480.

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Efficacy of Manual Acupuncture Versus Placebo Acupuncture for Generalized Anxiety Disorder (Gad) in Perimenopause Women : Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-577572/v1 ◽

2021 ◽

Author(s):

Xin Liu ◽

Xiaoyan Xie ◽

Yingjia Li ◽

Meichen Li ◽

Yuting Wang ◽

...

Keyword(s):

Clinical Trial ◽

Anxiety Disorder ◽

Behavioral Therapy ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Manual Acupuncture ◽

Clinical Trial Registry ◽

Double Blind ◽

Placebo Acupuncture

Abstract BackgroundGeneralized anxiety disorder (GAD) is common among perimenopause women. Drug treatment and cognitive behavioral therapy have their pros and cons. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT) and adrenocorticotropic hormone (ACTH). The object of this study is to assess the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopause women with GAD. MethodsThis study is a single center, randomized, double blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for four weeks. The primary outcome measure will be the score of GAD-7. The secondary outcome measures will be the score of HAMA and PSQI, and the level of CORT and ACTH. The evaluation will execute at baseline, 2 weeks, the end of the treatment and a follow-up period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. DiscussionThis study intends to conduct to compare the efficacy between MA and PA in the treatment of perimenopause woman with GAD, and to further study the mechanisms of effect. Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2100046604. Registered on 22 May 2021. URL: http://www.chictr.org.cn.

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Comparison of Mulligan Sustained Natural Apophyseal Glides and Maitland Mobilizations for Treatment of Cervicogenic Dizziness: A Randomized Controlled Trial

Physical Therapy ◽

10.2522/ptj.20120483 ◽

2014 ◽

Vol 94 (4) ◽

pp. 466-476 ◽

Cited By ~ 34

Author(s):

Susan A. Reid ◽

Darren A. Rivett ◽

Michael G. Katekar ◽

Robin Callister

Keyword(s):

Randomized Controlled Trial ◽

Placebo Group ◽

Manual Therapy ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Mean Difference ◽

Double Blind ◽

Randomized Controlled ◽

Therapy Interventions ◽

Cervicogenic Dizziness

Background There is short-term evidence for treatment of cervicogenic dizziness with Mulligan sustained natural apophyseal glides (SNAGs) but no evidence for treatment with Maitland mobilizations. Objective The purpose of this study was to compare the effectiveness of SNAGs and Maitland mobilizations for cervicogenic dizziness. Design A double-blind, parallel-arm randomized controlled trial was conducted. Setting The study was conducted at a university in Newcastle, Australia. Participants Eighty-six people with cervicogenic dizziness were the study participants. Interventions Included participants were randomly allocated to receive 1 of 3 interventions: Mulligan SNAGs (including self-administered SNAGs), Maitland mobilizations plus range-of-motion exercises, or placebo. Measurements The primary outcome measure was intensity of dizziness. Other outcome measures were: frequency of dizziness, the Dizziness Handicap Inventory (DHI), intensity of pain, and global perceived effect (GPE). Results Both manual therapy groups had reduced dizziness intensity and frequency posttreatment and at 12 weeks compared with baseline. There was no change in the placebo group. Both manual therapy groups had less dizziness intensity posttreatment (SNAGs: mean difference=−20.7, 95% confidence interval [95% CI]=−33.6, −7.7; mobilizations: mean difference=−15.2, 95% CI=−27.9, −2.4) and at 12 weeks (SNAGs: mean difference=−18.4, 95% CI=−31.3, −5.4; mobilizations: mean difference=−14.4, 95% CI=−27.4, −1.5) compared with the placebo group. Compared with the placebo group, both the SNAG and Maitland mobilization groups had less frequency of dizziness at 12 weeks. There were no differences between the 2 manual therapy interventions for these dizziness measures. For DHI and pain, all 3 groups improved posttreatment and at 12 weeks. Both manual therapy groups reported a higher GPE compared with the placebo group. There were no treatment-related adverse effects lasting longer than 24 hours. Limitations The therapist performing the interventions was not blind to group allocation. Conclusions Both SNAGs and Maitland mobilizations provide comparable immediate and sustained (12 weeks) reductions in intensity and frequency of chronic cervicogenic dizziness.

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