Efficacy of Individualized Homeopathic Medicines in the Treatment of Atopic Dermatitis in Adults: A Double-Blind, Randomized, Placebo-Controlled, Preliminary Trial

2021 ◽  
pp. 1-10
Author(s):  
Samit Dey ◽  
Abdur Rahaman Shaikh ◽  
Sangita Saha ◽  
Ekta Agrawal ◽  
Ashish Kumar Gautam ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Adverse Events ◽  
Quality Index ◽  
Life Quality ◽  
Short Term ◽  
Double Blind ◽  
Preliminary Trial ◽  
Intention To Treat ◽  
Hospital Patients ◽  
Secondary Outcomes

<b><i>Introduction:</i></b> Individualized homeopathy (IH) in atopic dermatitis (AD) remained under-researched. <b><i>Objective:</i></b> We aimed at evaluating efficacy of IH in AD. <b><i>Methods:</i></b> A double-blind, randomized, placebo-controlled, short-term, preliminary trial was conducted in an Indian homeopathy hospital. Patients were randomized to either IH (<i>n</i> = 30) or identical-looking placebo (<i>n</i> = 30) using computerized randomization and allocation. Outcomes were patient-oriented scoring of AD (PO-SCORAD; primary end point), Dermatological Life Quality Index (DLQI) score, and AD burden score for adults (ADBSA; secondary end points), measured monthly for 3 months. An intention-to-treat sample was analyzed after adjusting baseline differences. <b><i>Results:</i></b> On PO-SCORAD, improvement was higher in IH against placebo, but nonsignificant statistically (<i>p</i><sub>month 1</sub> = 0.433, <i>p</i><sub>month 2</sub> = 0.442, <i>p</i><sub>month 3</sub> = 0.229). Secondary outcomes were also nonsignificant – both DLQI and ADBSA (<i>p</i> &#x3e; 0.05). Four adverse events (diarrhea, injury, common cold) were recorded. <b><i>Conclusions:</i></b> There was a small, but nonsignificant direction of effect towards homeopathy, which renders the trial inconclusive. A properly powered robust trial is indicated.

Children’s dermatology life quality index and family dermatology life quality index as criteria for the efficiency of physiorehabilitation of children with atopic dermatitis

2020 ◽  
pp. 43-49
Author(s):  
T. V. Koroleva ◽  
I. I. Ivanova ◽  
E. V. Filatova
Keyword(s):  
Atopic Dermatitis ◽  
Dermatology Life Quality Index ◽  
Quality Index ◽  
Life Quality ◽  
Polarized Light ◽  
Social Maladjustment ◽  
Life Quality Index ◽  
Laser Blood Irradiation ◽  
Intensity Laser

Social maladjustment of children with atopic dermatitis, an increase in the number of cases of disability in pediatric practice, violation of intra-familial relations, rise in the level of anxiety of parents, in particular, of mothers, are closely associated with the formation of protracted recurrent forms. Educational programs for parents, traditional conservative treatment and hydrotherapy in combination with polychromatic polarized light and low-intensity laser blood irradiation significantly improve the quality of life of patients and their families, according to the corresponding indices.

scholarly journals 245 Validation and interpretation of short form 12 and comparison with dermatology life quality index in adult atopic dermatitis

2019 ◽  
Vol 139 (5) ◽  
pp. S42
Author(s):  
J. Silverberg ◽  
J.M. Gelfand ◽  
D.J. Margolis ◽  
M. Boguniewicz ◽  
L. Fonacier ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Dermatology Life Quality Index ◽  
Quality Index ◽  
Short Form ◽  
Life Quality ◽  
Life Quality Index

scholarly journals Randomized, Double-Blind, Placebo-Controlled Studies to Assess Safety and Prophylactic Efficacy of Naphthoquine-Azithromycin Combination for Malaria Prophylaxis in Southeast Asia

2018 ◽  
Vol 62 (9) ◽  
Author(s):  
Henglin Yang ◽  
Jingyan Wang ◽  
Hui Liu ◽  
Xingliang Li ◽  
Renhua Nie ◽  
...  
Keyword(s):  
Adverse Events ◽  
Southeast Asia ◽  
Clinical Laboratory ◽  
Protective Efficacy ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Prophylactic Efficacy ◽  
Content Type ◽  
Double Blind Placebo ◽  
Intention To Treat

ABSTRACTNew prophylactic drugs against malaria infections are urgently needed. We conducted randomized, double-blind, placebo-controlled, phase 2 trials of a new antimalarial drug combination, naphthoquine-azithromycin (NQAZ), to determine its safety and protective efficacy in a low-endemicity area of Southeast Asia. In the first trial, 127 healthy volunteers were randomized to receive two single doses of either 400 mg of NQAZ (200 mg of each drug), 800 mg of NQAZ (400 mg of each drug), or placebo on day 0 and day 30. Weekly follow-ups were performed for 2 months, and physical and clinical laboratory exams were done during the second and eighth week. Both drug regimens were well tolerated, without any serious adverse events. Four adverse events (transient and slight elevations of serum transaminase concentrations) were found only in the two drug-treated groups and thus might be drug-related. In the second trial, 353 volunteer villagers were randomized into the same three groups as in the first trial, and malaria infections were followed for a month. For the intention-to-treat analysis, both regimens offered greater than 90% prophylactic efficacies against all malaria infections. When the analysis was done according to parasite species, 400 mg and 800 mg NQAZ provided 81.63 and 90.59% prophylactic efficacies, respectively, againstPlasmodium falciparuminfections, whereas both offered 100% prophylactic efficacy againstPlasmodium vivaxandPlasmodium ovale. These trials showed that NQAZ had a good safety profile, and monthly single doses of 400 mg or 800 mg for adults offered excellent prophylaxis against malaria infections, especially the two relapsing species.

scholarly journals Can We Rely on the Dermatology Life Quality Index as a Measure of the Impact of Psoriasis or Atopic Dermatitis?

2012 ◽  
Vol 132 (1) ◽  
pp. 76-84 ◽  
Author(s):  
James Twiss ◽  
David M. Meads ◽  
Elizabeth P. Preston ◽  
Sigrid R. Crawford ◽  
Stephen P. McKenna
Keyword(s):  
Atopic Dermatitis ◽  
Dermatology Life Quality Index ◽  
Quality Index ◽  
Life Quality ◽  
Life Quality Index ◽  
The Impact

Modafinil for the Treatment of Fatigue in Lung Cancer: Results of a Placebo-Controlled, Double-Blind, Randomized Trial

2014 ◽  
Vol 32 (18) ◽  
pp. 1882-1888 ◽  
Author(s):  
Anna Spathis ◽  
Kate Fife ◽  
Fiona Blackhall ◽  
Susan Dutton ◽  
Ronja Bahadori ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Performance Status ◽  
Evidence Base ◽  
Double Blind ◽  
Fatigue Score ◽  
Intention To Treat ◽  
Cancer Related Fatigue ◽  
Patient Reported ◽  
Secondary Outcomes ◽  
And Performance

Purpose Fatigue is a distressing symptom occurring in more than 60% of patients with cancer. The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue, despite a limited evidence base. We aimed to evaluate the efficacy and tolerability of modafinil in the management of fatigue in patients with non–small-cell lung cancer (NSCLC). Patients and Methods Adults with advanced NSCLC and performance status of 0 to 2, who were not treated with chemotherapy or radiotherapy within the last 4 weeks, were randomly assigned to daily modafinil (100 mg on days 1 to 14; 200 mg on days 15 to 28) or matched placebo. The primary outcome was change in Functional Assessment of Chronic Illness Therapy (FACIT) –Fatigue score from baseline to 28 days, adjusted for baseline fatigue and performance status. Secondary outcomes included safety and patient-reported measures of depression, daytime sleepiness, and quality of life. Results A total of 208 patients were randomly assigned, and 160 patients (modafinil, n = 75; placebo, n = 85) completed questionnaires at both baseline and day 28 and were included in the modified intention-to-treat analysis. FACIT-Fatigue scores improved from baseline to day 28 (mean score change: modafinil, 5.29; 95% CI, 2.57 to 8.02; placebo, 5.09; 95% CI, 2.54 to 7.65), but there was no difference between treatments (0.20; 95% CI, −3.56 to 3.97). There was also no difference between treatments for the secondary outcomes; 47% of the modafinil group and 23% of the placebo group stated that the intervention was not helpful. Conclusion Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting. Its use was associated with a clinically significant placebo effect.

scholarly journals Controlled Trial of 3-Day Quinine-Clindamycin Treatment versus 7-Day Quinine Treatment for Adult Travelers with Uncomplicated Falciparum Malaria Imported from the Tropics

2001 ◽  
Vol 45 (3) ◽  
pp. 932-935 ◽  
Author(s):  
Phillippe Parola ◽  
Stephane Ranque ◽  
Sekene Badiaga ◽  
Mohamadou Niang ◽  
Olivier Blin ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Controlled Trial ◽  
Cure Rate ◽  
Short Term ◽  
Double Blind ◽  
Intention To Treat ◽  
The Tropics ◽  
Severe Adverse Reactions ◽  
Cessation Of Treatment ◽  
Treat Analysis

ABSTRACT We conducted a randomized, double-blind, placebo-controlled trial to compare a 3-day quinine-clindamycin regimen (group QC) with a 7-day quinine regimen (group Q) for the treatment of uncomplicatedPlasmodium falciparum malaria in travelers returning from the tropics. A total of 55 and 53 patients in groups Q and QC were analyzed, respectively. Adverse effects were similar in both groups, although two patients in group Q had severe adverse reactions, leading to the cessation of treatment. The 28-day cure rate for the evaluated patients (per-protocol analysis) was 100% for group QC, whereas it was 96.3% for group Q (P = 0.5). The 28-day cure rate in the intention-to-treat analysis was 96.2% for group QC, whereas it was 94.6% for group Q (P = 1). There were no significant differences between the two regimens with regard to parasite and fever clearance times. Our study shows that the 3-day quinine-clindamycin regimen is well tolerated and compares favorably with a 7-day quinine treatment. This short-term regimen had previously been evaluated only in areas of endemicity. According to our results, the 3-day quinine-clindamycin regimen may be an alternative for the treatment of imported uncomplicated P. falciparum malaria in travelers returning from the tropics.

Atopische Dermatitis: IL-13-Antikörper macht Hoffnung auf gut verträgliche und lang wirkende Therapieoption

2021 ◽  
pp. 1-2
Author(s):  
Sandra Philipp
Keyword(s):  
Atopic Dermatitis ◽  
Initial Period ◽  
Human Monoclonal Antibody ◽  
Life Quality ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Inadequate Response ◽  
Double Blind ◽  
Topical Corticosteroids ◽  
Phase Ii Studies

<b>Background:</b> Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin-13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms. <b>Objectives:</b> To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate-to-severe AD who had an inadequate response to topical treatments. <b>Methods:</b> In two 52-week, randomized, double-blind, placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Primary endpoints were Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. The trials were registered with ClinicalTrials.gov: NCT03131648 and NCT03160885. <b>Results:</b> At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 [difference 8·6%, 95% confidence interval (CI) 4·1–13·1; P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 (11·1%, 95% CI 5·8–16·4; P &#x3c; 0·001) and EASI 75: 25·0% vs. 12·7% (12·1%, 95% CI 6·5–17·7; P &#x3c; 0·001) and 33·2% vs. 11·4% (21·6%, 95% CI 15·8–27·3; P &#x3c; 0·001). Early improvements in pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient-Oriented Eczema Measure were observed from the first postbaseline measurements. The majority of week 16 tralokinumab responders maintained response at week 52 with continued tralokinumab treatment without any rescue medication (including topical corticosteroids). Adverse events were reported in 76·4% and 61·5% of patients receiving tralokinumab in ECZTRA 1 and ECZTRA 2, respectively, and in 77·0% and 66·0% of patients receiving placebo in ECZTRA 1 and ECZTRA 2, respectively, in the 16-week initial period. <b>Conclusions:</b> Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.

scholarly journals Low-dose naltrexone for the treatment of fibromyalgia: protocol for a double-blind, randomized, placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karin Due Bruun ◽  
Kirstine Amris ◽  
Henrik Bjarke Vaegter ◽  
Morten Rune Blichfeldt-Eckhardt ◽  
Anders Holsgaard-Larsen ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Low Dose ◽  
Controlled Trial ◽  
Muscle Performance ◽  
Double Blind ◽  
Intention To Treat ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Secondary Outcomes ◽  
Low Dose Naltrexone

Abstract Background Low-dose naltrexone (LDN) is used widely as an off-label treatment for pain despite limited evidence for its effectiveness. A few small trials with a high risk of bias have investigated the effect of LDN on pain associated with fibromyalgia in women, but larger and more methodologically robust studies are needed. The primary aim of this randomized controlled trial is to investigate if 12 weeks of LDN treatment is superior to placebo in reducing the average pain intensity during the last 7 days in women with fibromyalgia. Methods A single-center, permuted block randomized, double-blind, placebo-controlled, parallel-group trial will be performed in Denmark. Randomization comprises 100 women aged 18–64 years diagnosed with fibromyalgia who will be treated with either LDN or placebo for 12 weeks including a 4-week titration phase. The primary outcome is change in average pain intensity (during the last 7 days) from baseline to 12 weeks. Secondary outcomes are other fibromyalgia-related symptoms, i.e., tenderness, fatigue, sleep disturbance, stiffness, memory problems, depression, anxiety and measures of global assessment, physical function, impact of fibromyalgia, pain distribution, and health-related quality of life. Intention-to-treat analysis will be performed, and the number of responders with a more than 15%, 30%, and 50% improvement of pain after 12 weeks will be calculated for the LDN and placebo groups. Exploratory outcomes include measures of pain sensitivity, muscle performance, and biomarkers. Discussion This study will contribute with high-level evidence on the efficacy of low-dose naltrexone for the treatment of pain in women with fibromyalgia. Secondary outcomes include both disease-specific and generic components investigating whether LDN influences other symptoms than pain. Explorative outcomes are included to provide greater insight into the mechanism of action of LDN and possibly a better understanding of the underlying pathology in fibromyalgia. Trial registration EudraCT 2019-000702-30. Registered on 12 July 2019. ClinicalTrials.gov NCT04270877. Registered on 17 February 2020

scholarly journals Early use of nitazoxanide in mild Covid-19 disease: randomised, placebo-controlled trial

2020 ◽  
pp. 2003725
Author(s):  
Patricia R. M. Rocco ◽  
Pedro L. Silva ◽  
Fernanda F. Cruz ◽  
Marco Antonio C. M. Junior ◽  
Paulo F. G. M. M. Tierno ◽  
...  
Keyword(s):  
Viral Load ◽  
Adverse Events ◽  
Controlled Trial ◽  
Nasopharyngeal Swab ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Symptom Resolution ◽  
Days Of Therapy ◽  
Secondary Outcomes

Nitazoxanide is widely available and exerts broad-spectrum antiviral activity in vitro. However, there is no evidence of its impact on SARS-CoV-2 infection. In a multicenter, randomised, double-blind, placebo-controlled trial, adult patients presenting up to 3 days after onset of Covid-19 symptoms (dry cough, fever, and/or fatigue) were enrolled. After confirmation of SARS-CoV2 infection by RT-PCR on a nasopharyngeal swab, patients were randomised 1:1 to receive either nitazoxanide (500 mg) or placebo, TID, for 5 days. The primary outcome was complete resolution of symptoms. Secondary outcomes were viral load, laboratory tests, serum biomarkers of inflammation, and hospitalisation rate. Adverse events were also assessed. From June 8 to August 20, 2020, 1575 patients were screened. Of these, 392 (198 placebo, 194 nitazoxanide) were analysed. Median time from symptom onset to first dose of study drug was 5 (4–5) days. At the 5-day study visit, symptom resolution did not differ between the nitazoxanide and placebo arms. Swabs collected were negative for SARS-CoV-2 in 29.9% of patients in the nitazoxanide arm versus 18.2% in the placebo arm (p=0.009). Viral load was also reduced after nitazoxanide compared to placebo (p=0.006). The percent viral load reduction from onset to end of therapy was higher with nitazoxanide (55%) than placebo (45%) (p=0.013). Other secondary outcomes were not significantly different. No serious adverse events were observed. In patients with mild Covid-19, symptom resolution did not differ between nitazoxanide and placebo groups after 5 days of therapy. However, early nitazoxanide therapy was safe and reduced viral load significantly.

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