Traditional Chinese Herbal Patch for Short-Term Management of Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial

Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽

10.1136/gutjnl-2018-316434 ◽

2018 ◽

Vol 67 (12) ◽

pp. 2107-2115 ◽

Cited By ~ 96

Author(s):

Sofie Ingdam Halkjær ◽

Alice Højer Christensen ◽

Bobby Zhao Sheng Lo ◽

Patrick Denis Browne ◽

Stig Günther ◽

...

Keyword(s):

Gut Microbiota ◽

Controlled Trial ◽

Symptom Relief ◽

Controlled Study ◽

Faecal Microbiota ◽

Double Blind ◽

Double Blind Placebo ◽

Faecal Microbiota Transplantation ◽

Faecal Samples ◽

Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

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Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study

10.2337/figshare.14473611.v1 ◽

2021 ◽

Author(s):

Nina L Petrova ◽

Nicholas K. Donaldson ◽

Maureen Bates ◽

Wegin Tang ◽

Timothy Jemmott ◽

...

Keyword(s):

Parathyroid Hormone ◽

Controlled Trial ◽

Linear Regression Analysis ◽

Controlled Study ◽

X Rays ◽

Human Parathyroid Hormone ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference ◽

Prolonged Immobilization

Objectives: Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures. Research Design and Methods: People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full length PTH (1-84) or placebo therapy - both in addition to below-knee casting and Calcium and Vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference below 2°C at two consecutive monthly visits. Results: Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. There was no significant difference in time to resolution between the groups (mixed effects logistic regression; p=0.64). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74), p=0.64 and the odds ratio of resolution by 12 months was 1.22 (0.90, 1.67), p=0.20 (intervention versus control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on magnetic resonance imaging <a>scans </a>(coef= 0.13; 95% CI -0.62, 0.88; p=0.73) and on foot and ankle X-rays (coef= 0.30; 95% CI -0.03, 0.63; p=0.07). Conclusions: This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN.

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Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study

Australian & New Zealand Journal of Psychiatry ◽

10.1177/0004867419891246 ◽

2019 ◽

Vol 54 (3) ◽

pp. 288-297 ◽

Cited By ~ 2

Author(s):

Jerome Sarris ◽

Gerard J Byrne ◽

Chad A Bousman ◽

Lachlan Cribb ◽

Karen M Savage ◽

...

Keyword(s):

Anxiety Disorder ◽

Anxiety Reduction ◽

Phase Iii ◽

Controlled Study ◽

Relative Reduction ◽

Generalised Anxiety Disorder ◽

Short Term ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

Objective: Previous randomised, double-blind, placebo-controlled studies have shown that Kava (a South Pacific medicinal plant) reduced anxiety during short-term administration. The objective of this randomised, double-blind, placebo-controlled study was to perform a larger, longer-term trial assessing the efficacy and safety of Kava in the treatment of generalised anxiety disorder and to determine whether gamma-aminobutyric acid transporter (SLC6A1) single-nucleotide polymorphisms were moderators of response. Methods: The trial was a phase III, multi-site, two-arm, 16-week, randomised, double-blind, placebo-controlled study investigating an aqueous extract of dried Kava root administered twice per day in tablet form (standardised to 120 mg of kavalactones twice/day) in 171 currently non-medicated anxious participants with diagnosed generalised anxiety disorder. The trial took place in Australia. Results: An analysis of 171 participants revealed a non-significant difference in anxiety reduction between the Kava and placebo groups (a relative reduction favouring placebo of 1.37 points; p = 0.25). At the conclusion of the controlled phase, 17.4% of the Kava group were classified as remitted (Hamilton Anxiety Rating Scale score < 7) compared to 23.8% of the placebo group ( p = 0.46). No SLC6A1 polymorphisms were associated with treatment response, while carriers of the rs2601126 T allele preferentially respond to placebo ( p = 0.006). Kava was well tolerated aside from poorer memory (Kava = 36 vs placebo = 23; p = 0.044) and tremor/shakiness (Kava = 36 vs placebo = 23; p = 0.024) occurring more frequently in the Kava group. Liver function test abnormalities were significantly more frequent in the Kava group, although no participant met criteria for herb-induced hepatic injury. Conclusion: While research has generally supported Kava in non-clinical populations (potentially for more ‘situational’ anxiety as a short-term anxiolytic), this particular extract was not effective for diagnosed generalised anxiety disorder.

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Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study

10.2337/figshare.14473611 ◽

2021 ◽

Author(s):

Nina L Petrova ◽

Nicholas K. Donaldson ◽

Maureen Bates ◽

Wegin Tang ◽

Timothy Jemmott ◽

...

Keyword(s):

Parathyroid Hormone ◽

Controlled Trial ◽

Linear Regression Analysis ◽

Controlled Study ◽

X Rays ◽

Human Parathyroid Hormone ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference ◽

Prolonged Immobilization

Objectives: Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures. Research Design and Methods: People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full length PTH (1-84) or placebo therapy - both in addition to below-knee casting and Calcium and Vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference below 2°C at two consecutive monthly visits. Results: Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. There was no significant difference in time to resolution between the groups (mixed effects logistic regression; p=0.64). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74), p=0.64 and the odds ratio of resolution by 12 months was 1.22 (0.90, 1.67), p=0.20 (intervention versus control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on magnetic resonance imaging <a>scans </a>(coef= 0.13; 95% CI -0.62, 0.88; p=0.73) and on foot and ankle X-rays (coef= 0.30; 95% CI -0.03, 0.63; p=0.07). Conclusions: This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN.

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The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial

Journal of Pediatric Oncology Nursing ◽

10.1177/1043454218782133 ◽

2018 ◽

Vol 35 (6) ◽

pp. 392-398 ◽

Cited By ~ 8

Author(s):

Anna Evans ◽

Jemily Malvar ◽

Cassie Garretson ◽

Eliza Pedroja Kolovos ◽

Mary Baron Nelson

Keyword(s):

Essential Oil ◽

Assessment Tool ◽

Controlled Trial ◽

Controlled Study ◽

Children With Cancer ◽

Double Blind ◽

Double Blind Placebo ◽

Statistical Significant Difference ◽

Significant Difference

Introduction: Chemotherapy-induced nausea can be distressing and difficult to manage in children with cancer. The purpose of this study was to investigate the utility of ginger aromatherapy in relieving chemotherapy-induced nausea in children with cancer. Method: This randomized, double-blind, placebo-controlled study of 49 children with cancer explored whether inhalation of the aroma of essential oil of ginger during chemotherapy decreased nausea compared with a placebo (water) or control (Johnson’s baby shampoo) measured by prechemotherapy and postchemotherapy assessment with the Pediatric Nausea Assessment Tool (PeNAT). Results: While well received, well tolerated, nontoxic, and noninvasive, ginger aromatherapy did not significantly decrease nausea in patients enrolled in this study. Among 21 patients who indicated feeling nausea prechemotherapy, 67% reported improvement, 5% worsening, and 28% no change in their postinfusion PeNAT score. We failed to detect a statistical significant difference in the change in PeNAT scores among the three groups.

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Efficacy of Chuanxiong Ding Tong Herbal Formula Granule in the Treatment and Prophylactic of Migraine Patients: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/967968 ◽

2012 ◽

Vol 2012 ◽

pp. 1-9 ◽

Cited By ~ 8

Author(s):

Caihong Fu ◽

Lihua Yu ◽

Yihuai Zou ◽

Kegang Cao ◽

Jianjun Zhao ◽

...

Keyword(s):

Controlled Trial ◽

Blood Stasis ◽

Controlled Study ◽

Herbal Formula ◽

Double Blind ◽

Chinese Herbal ◽

Significant Difference ◽

Vas Scores ◽

To Receive

Objective.To evaluate the efficacy of traditional Chinese herbal ChuanXiong Ding Tong herbal formula granule (CXDT-HFG) for migraine patients with “the Syndrome of Liver Wind and Blood Stasis.”Methods.150 migraine patients were recruited and assigned randomly in a double-blind, placebo-controlled study to receive CXDT-HFG (n=99) plus necessary analgesics, or placebo (n=51) plus necessary analgesics for 16 weeks (12 weeks’ intervention and 4 weeks’ follow up). Outcome measures included migraine days, frequency of migraine attacks, analgesics consumption for acute treatment, and the proportion of responders as well as the visual analogue scale (VAS) scores and intensity for pain.Results.Compared with the placebo group, the CXDT-HFG group showed significant reduction in migraine days and attacks frequency at week 12 and follow-up period (P<0.05) as well as in the reduction of VAS scores at follow-up period.There was significant difference in the proportion of responders between the two groups at follow-up period (P=0.014). However there were no significant differences between the two groups in analgesics consumption (P>0.05). Conclusion.CXDT-HFG was more effective than placebo in decreasing days of migraine attacks, frequency, VAS scores, and relieving pain intensity for migraine patients.

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A randomized double blind, placebo controlled trial of a Chinese herbal preparation (CH100) in chronic Hepatitis C

Gastroenterology ◽

10.1016/s0016-5085(01)81907-7 ◽

2001 ◽

Vol 120 (5) ◽

pp. A384-A384

Author(s):

L MOLLISON ◽

L TOTTEN ◽

C HOVELL ◽

K THAYNE ◽

C CONNELLY ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis C ◽

Chronic Hepatitis C ◽

Controlled Trial ◽

Herbal Preparation ◽

Double Blind ◽

Double Blind Placebo ◽

Chinese Herbal

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Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial

Trials ◽

10.1186/1745-6215-14-383 ◽

2013 ◽

Vol 14 (1) ◽

pp. 383 ◽

Cited By ~ 3

Author(s):

Jin-Tao Liu ◽

De-Zhi Tang ◽

Xiao-Feng Li ◽

Zhi-Gang Zhang ◽

Wan-Bo Ji ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Study Protocol ◽

Pain Therapy ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo

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Involvement of N-methyl-d-aspartate receptors in plasticity induced by paired corticospinal-motoneuronal stimulation in humans

Journal of Neurophysiology ◽

10.1152/jn.00457.2017 ◽

2018 ◽

Vol 119 (2) ◽

pp. 652-661 ◽

Cited By ~ 9

Author(s):

Siobhan C. Dongés ◽

Jessica M. D’Amico ◽

Jane E. Butler ◽

Janet L. Taylor

Keyword(s):

Biceps Brachii ◽

Motor Evoked Potentials ◽

Controlled Study ◽

Spinal Level ◽

Double Blind ◽

Double Blind Placebo ◽

Human Spinal Cord ◽

Significant Difference ◽

Antidromic Potentials ◽

Dependent Mechanism

Plasticity can be induced at human corticospinal-motoneuronal synapses by delivery of repeated, paired stimuli to corticospinal axons and motoneurons in a technique called paired corticospinal-motoneuronal stimulation (PCMS). To date, the mechanisms of the induced plasticity are unknown. To determine whether PCMS-induced plasticity is dependent on N-methyl-d-aspartate receptors (NMDARs), the effect of the noncompetitive NMDAR antagonist dextromethorphan on PCMS-induced facilitation was assessed in a 2-day, double-blind, placebo-controlled experiment. PCMS consisted of 100 pairs of stimuli, delivered at an interstimulus interval that produces facilitation at corticospinal-motoneuronal synapses that excite biceps brachii motoneurons. Transcranial magnetic stimulation elicited corticospinal volleys, which were timed to arrive at corticospinal-motoneuronal synapses just before antidromic potentials elicited in motoneurons with electrical brachial plexus stimulation. To measure changes in the corticospinal pathway at a spinal level, biceps responses to cervicomedullary stimulation (cervicomedullary motor evoked potentials, CMEPs) were measured before and for 30 min after PCMS. Individuals who displayed a ≥10% increase in CMEP size after PCMS on screening were eligible to take part in the 2-day experiment. After PCMS, there was a significant difference in CMEP area between placebo and dextromethorphan days ( P = 0.014). On the placebo day PCMS increased average CMEP areas to 127 ± 46% of baseline, whereas on the dextromethorphan day CMEP area was decreased to 86 ± 33% of baseline (mean ± SD; placebo: n = 11, dextromethorphan: n = 10). Therefore, dextromethorphan suppressed the facilitation of CMEPs after PCMS. This indicates that plasticity induced at synapses in the human spinal cord by PCMS may be dependent on NMDARs. NEW & NOTEWORTHY Paired corticospinal-motoneuronal stimulation can strengthen the synaptic connections between corticospinal axons and motoneurons at a spinal level in humans. The mechanism of the induced plasticity is unknown. In our 2-day, double-blind, placebo-controlled study we show that the N-methyl-d-aspartate receptor (NMDAR) antagonist dextromethorphan suppressed plasticity induced by paired corticospinal-motoneuronal stimulation, suggesting that an NMDAR-dependent mechanism is involved.

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Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽

10.1136/bmjopen-2018-024065 ◽

2019 ◽

Vol 9 (5) ◽

pp. e024065 ◽

Cited By ~ 1

Author(s):

Henrik Gudbergsen ◽

Marius Henriksen ◽

Eva Ejlersen Wæhrens ◽

Anders Overgaard ◽

Henning Bliddal ◽

...

Keyword(s):

Weight Loss ◽

Body Weight ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Single Centre ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

Parallel Group ◽

Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

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