Oxypertine in Tardive Dyskinesia: An 8-week Controlled Study

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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Oral Intake of Hydrangea serrata (Thunb.) Ser. Leaves Extract Improves Wrinkles, Hydration, Elasticity, Texture, and Roughness in Human Skin: A Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽

10.3390/nu12061588 ◽

2020 ◽

Vol 12 (6) ◽

pp. 1588

Author(s):

Da-Bin Myung ◽

Jeong-Hun Lee ◽

Hee-Soo Han ◽

Kwang-Young Lee ◽

Hye Shin Ahn ◽

...

Keyword(s):

Human Skin ◽

Elastic Recovery ◽

Controlled Trial ◽

Water Extract ◽

Hot Water ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Skin Wrinkles

Previously, we reported that the hot water extract of Hydrangea serrata leaves (WHS) and its active component, hydrangenol, possess in vitro and in vivo effects on skin wrinkles and moisturization. We conducted a randomized, double-blind, placebo-controlled trial to clinically evaluate the effect of WHS on human skin. Participants (n = 151) were randomly assigned to receive either WHS 300 mg, WHS 600 mg, or placebo, once daily for 12 weeks. Skin wrinkle, hydration, elasticity, texture, and roughness parameters were assessed at baseline and after 4, 8, and 12 weeks. Compared to the placebo, skin wrinkles were significantly reduced in both WHS groups after 8 and 12 weeks. In both WHS groups, five parameters (R1–R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks. Compared with the placebo, three parameters of skin elasticity, including overall elasticity (R2), net elasticity (R5), and ratio of elastic recovery to total deformation (R7), improved after 12 weeks of oral WHS (600 mg) administration. Changes in skin texture and roughness were significantly reduced in both WHS groups. No WHS-related adverse reactions were reported. Hence, WHS could be used as a health supplement for skin anti-aging.

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900023075 ◽

2005 ◽

Vol 10 (6) ◽

pp. 3-5

Author(s):

Richard H. Weisler

Keyword(s):

Extended Release ◽

Rating Scale ◽

Controlled Trial ◽

Controlled Study ◽

Mixed States ◽

Open Label ◽

Young Mania ◽

Double Blind ◽

Double Blind Placebo ◽

Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

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Is Diltiazem Effective in Treating the Symptoms of (Tardive) Dyskinesia in Chronic Psychiatric Inpatients? A Negative, Double-Blind, Placebo-Controlled Trial

Journal of Clinical Psychopharmacology ◽

10.1097/00004714-199202000-00007 ◽

1992 ◽

Vol 12 (1) ◽

pp. 39???42 ◽

Cited By ~ 17

Author(s):

ANTON J. M. LOONEN ◽

HETTY A. VERWEY ◽

PETER R. ROELS ◽

LAURENS P. van BAVEL ◽

CEES H. DOORSCHOT

Keyword(s):

Tardive Dyskinesia ◽

Controlled Trial ◽

Psychiatric Inpatients ◽

Double Blind ◽

Double Blind Placebo

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Poster #213 EFFICACY OF AN NMDA RECEPTOR ANTAGONISTIN THE TREATMENTOF TARDIVE DYSKINESIA: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Schizophrenia Research ◽

10.1016/s0920-9964(12)71045-9 ◽

2012 ◽

Vol 136 ◽

pp. S358 ◽

Cited By ~ 2

Author(s):

Sofia Pappa ◽

Sofia Tzouli ◽

Venös Mavreas ◽

Spyros Konitsiotis

Keyword(s):

Nmda Receptor ◽

Tardive Dyskinesia ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900024500 ◽

2005 ◽

Vol 10 (S1) ◽

pp. 3-5

Author(s):

Richard H. Weisler

Keyword(s):

Extended Release ◽

Rating Scale ◽

Controlled Trial ◽

Controlled Study ◽

Mixed States ◽

Open Label ◽

Young Mania ◽

Double Blind ◽

Double Blind Placebo ◽

Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

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