A Comparative Study of 50-Millesimal Potencies and Centesimal Potencies in the Treatment of Tinea Corporis: An Open, Randomised, Pilot Trial

2021 ◽  
Vol 34 (04) ◽  
pp. 267-277
Author(s):  
Pallavi Hazra ◽  
Shyamal Kumar Mukherjee ◽  
Subhasish Ganguly ◽  
Aniket Singha Roy ◽  
Souvik Dutta ◽  
...  
Keyword(s):  
Rating Scale ◽  
Pilot Trial ◽  
Intervention Group ◽  
Tinea Corporis ◽  
Repeated Measure ◽  
Feasibility Trial ◽  
Group Differences ◽  
Serious Adverse Events ◽  
Significant Group ◽  
Secondary Outcomes

Abstract Introduction Standard management of dermatophytosis involves the use of topical antifungals in limited disease and oral therapy for more extensive cases. Despite the evidences favouring homeopathy in tinea corporis (TC) is inadequate, patients are increasingly opting for it. This trial attempts to assess the feasibility of a trial evaluating individualised homeopathic (IH) medicines in centesimal and 50-millesimal potencies in treating TC. Methods An open, randomised, pilot feasibility trial was conducted at the dermatology outpatient of D. N. De Homoeopathic Medical College and Hospital, West Bengal, India. Patients were randomised to receive IH medicines in either centesimal potencies (n = 30) or in 50-millesimal potencies (n = 30). Primary outcome measure was intensity of pruritus on a 0 to 10 numeric rating scale; secondary outcomes were Skindex-29 and dermatology life quality index questionnaires—all measured at baseline, and after 6 and 12 weeks of intervention. Group differences were calculated on intention-to-treat (ITT) sample as well as following per protocol (PP) analysis. Results Recruitment and attrition rates were 69 and 16.7% respectively. Both ITT and PP analysis revealed that intra-group changes in both the primary and secondary outcomes to be statistically significant in both the groups (all p < 0.05, one-way repeated measure analysis of variance). There were no significant group differences over 6 and 12 weeks (all p > 0.05, unpaired t-tests); thus, indicating similar pattern of improvement in both the groups. Most frequently used medicines were Natrum sulphuricum (28.3%), Natrum muriaticum (25%), Sulphur (8.3%) and Bacillinum (6.7%). No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. Conclusion An adequately powered trial exploring effectiveness of both scales in TC appeared to be feasible in future. Though the sample size was too small to arrive at any definite conclusion, both centesimal and 50-millesimal potencies of IH medicines appeared to be equally useful in improving pruritus intensity and quality of life in patients suffering from TC.

scholarly journals Mindfulness-Based Cognitive Therapy as Migraine Intervention: a Randomized Waitlist Controlled Trial

2021 ◽  
Author(s):  
K. Simshäuser ◽  
R. Pohl ◽  
P. Behrens ◽  
C. Schultz ◽  
C. Lahmann ◽  
...  
Keyword(s):  
Cognitive Therapy ◽  
Psychological Functioning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Medium Effect ◽  
Headache Frequency ◽  
Post Intervention ◽  
Significant Group ◽  
Secondary Outcomes ◽  
And Coping

Abstract Background Based on promising effects seen in a pilot study evaluating a generic mindfulness-based program for migraine, we developed a migraine-specific adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The aim of this study was to evaluate this program for feasibility and effectiveness in a randomized controlled trial. Method Fifty-four patients suffering from migraine were randomly allocated to either waitlist or the adapted MBCT. Outcomes were migraine-related parameters as well as variables of psychological functioning and coping. Assessment took place at baseline and post-intervention, for the intervention group also at follow-up (7 months). The effects of the intervention were analyzed by the use of ANCOVAs and linear mixed models. Results With respect to migraine parameters we did not find a significant group difference in the primary outcome (headache-related impairment), but the intervention resulted in a significant reduction of headache frequency (p = .04). In the analysis of secondary outcomes, MBCT showed superiority in four out of eight psychological parameters (perceived stress, anxiety, rumination, catastrophizing) with small to medium effect sizes. The intervention proved to be feasible and participants reported high degrees of contentment and achievement of personal goals. Conclusions The migraine-specific MBCT program did not result in improvements with regard to headache-related impairment but showed a reduction in headache frequency as well as improved psychological functioning in secondary outcomes. Trial Registration This trial was registered in the German Trial Registry “Deutsches Register Klinischer Studien” (ID: DRKS00007477), which is a WHO-listed primary trial register.

scholarly journals Mothers with and without bipolar disorder and their infants: group differences in mother-infant interaction patterns at three months postpartum

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Teija M. S. Anke ◽  
Kari Slinning ◽  
Vibeke Moe ◽  
Cathrine Brunborg ◽  
Torill S. Siqveland ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Depressive Symptomatology ◽  
Group Differences ◽  
Maternal Behaviour ◽  
Interaction Patterns ◽  
Young Mania ◽  
Significant Group ◽  
Interaction Quality ◽  
Affective Symptoms

Abstract Background Women with bipolar disorder (BD) have a high risk of illness relapse postpartum. The risk coincides with the period when mother-infant interactions are evolving. We compared mother-infant interactions in dyads where the mothers have BD with dyads where the mothers have no mental disorder. The association between concurrent affective symptoms of BD mothers and interaction quality was investigated. Methods Twenty-six women with BD and 30 comparison women with infants were included. The Parent-Child Early Relational Assessment (PCERA) was used to assess maternal behaviour, infant behaviour and dyadic coordination in interactions at 3 months postpartum. The Inventory of Depressive Symptomatology and Young Mania Rating Scale were used to assess affective symptoms of BD mothers at the time of interaction. Results There were significant group differences with medium to large effect sizes (0.73–1.32) on five of six subscales within the three interactional domains. Most interactional concerns were identified in dyadic coordination. No significant associations were found between maternal symptom load and interaction quality within the BD sample. Forty-six percent of the BD mothers experienced a mood episode within 0–3 months postpartum. Conclusions The present study identified challenges for mothers with BD and their infants in “finding” each other in interaction at 3 months postpartum. If sustained, this interaction pattern may have a long-term impact on children’s development. We suggest interventions specifically focusing on sensitising and supporting mothers to read infants’ cues on a micro-level. This may help them to respond contingently and improve dyadic coordination and synchronicity.

scholarly journals Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial

Rheumatology ◽  
2019 ◽  
Vol 58 (8) ◽  
pp. 1344-1352 ◽  
Author(s):  
Carly A Janssen ◽  
Martijn A H Oude Voshaar ◽  
Harald E Vonkeman ◽  
Tim L Th. A Jansen ◽  
Matthijs Janssen ◽  
...  
Keyword(s):  
Rating Scale ◽  
Analysis Of Covariance ◽  
Acute Gout ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment As Usual ◽  
Double Blind Placebo ◽  
Active Comparator ◽  
Secondary Outcomes ◽  
Gout Flares

AbstractObjectivesTo evaluate the efficacy and safety of anakinra in treating acute gout flares in a randomized, double-blind, placebo-controlled, active comparator, non-inferiority (NI) trial.MethodsPatients with a crystal-proven acute gout flare were randomized (1: 1) to treatment with anakinra or treatment as usual (free choice: either colchicine, naproxen or prednisone). The primary end point was the change in pain between baseline and the averaged pain score on days 2–4 measured on a five-point rating scale. NI of anakinra would be established if the upper bound of the 95% CI of the numeric difference in changed pain scores between treatment groups did not exceed the NI limit of 0.4 in favour of treatment as usual, in the per-protocol (PP) and intention-to-treat (ITT) populations, assessed in an analysis of covariance model. Secondary outcomes included safety assessments, improvement in pain, swelling, tenderness and treatment response after 5 days, assessed using linear mixed models and binary logistic regression models.ResultsForty-three patients received anakinra and 45 treatment as usual. Anakinra was non-inferior (mean difference; 95% CI) to treatment as usual in both the PP (–0.13; –0.44, 0.18) and ITT (–0.18; –0.44, 0.08) populations. No unexpected or uncommon (serious) adverse events were observed in either treatment arm. Analyses of secondary outcomes showed that patients in both groups reported similar significant reductions in their gout symptoms.ConclusionEfficacy of anakinra was shown to be non-inferior to treatment as usual for the treatment of acute gout flares, suggesting that anakinra is an effective treatment alternative for acute gout flares.Trial registrationHet Nederlands Trial Register, www.trialregister.nl, NTR5234

scholarly journals Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

2016 ◽  
Vol 41 (9) ◽  
pp. 948-956 ◽  
Author(s):  
C. Jerosch-Herold ◽  
J. Houghton ◽  
L. Miller ◽  
L. Shepstone
Keyword(s):  
Carpal Tunnel ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Hand Function ◽  
Group Differences ◽  
Level Of Evidence ◽  
Significant Treatment ◽  
Significant Group ◽  
Group A ◽  
Secondary Outcomes

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning ( n = 52) or control ( n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II

OS10.4.A The effects of SmartCare on neuro-oncology family caregivers’ distress: a randomized controlled trial

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii13-ii13
Author(s):  
F W Boele ◽  
J M Weimer ◽  
J Proudfoot ◽  
A L Marsland ◽  
T S Armstrong ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Physical Consequences

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. MATERIAL AND METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

Effects of Interactive Book Reading for Increasing Children’s Knowledge of Instructional Verbs

2018 ◽  
Vol 39 (4) ◽  
pp. 477-489 ◽  
Author(s):  
Joneen Lowman ◽  
Laura T. Stone ◽  
Jing Guo
Keyword(s):  
Intervention Group ◽  
Teacher Talk ◽  
Book Reading ◽  
Group Differences ◽  
Control Group ◽  
Reading Group ◽  
Significant Group ◽  
Academic Content ◽  
Interactive Book

Interactive book reading (IBR) has proven effective for increasing children’s lexicons with most of the results based on students’ learning of nouns. Little is known about the application of IBR to instructional verbs (i.e., words used during the instruction of academic content). To address this gap, 122 prekindergarten children were recruited from seven elementary schools. Each school was randomly assigned to the intervention group or the control group. Children in the intervention group were taught 12 instructional verbs across a 3-week period using interactive book-reading strategies. Children assigned to the control group only received implicit exposure to instructional verbs during teacher talk. Children in the book-reading group knew significantly more words on a receptive picture identification task than children in the control group both at posttesting and at follow-up testing in the fall. No significant group differences were noted at spring testing.

QOLP-29. THE EFFECTS OF AN ONLINE, NURSE-LED NEEDS-BASED SUPPORT PROGRAM ON NEURO-ONCOLOGY FAMILY CAREGIVERS' DISTRESS: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi189-vi189
Author(s):  
Florien Boele ◽  
Paula Sherwood ◽  
Jason Weimer ◽  
Judith Proudfoot ◽  
Anna Marsland ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Support Program ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

Individualized Homeopathic Medicines in the Treatment of Generalized Anxiety Disorder: A Double-Blind, Randomized, Placebo-Controlled, Pilot Trial

2021 ◽  
pp. 1-11
Author(s):  
Maneet Parewa ◽  
Avijit Shee Burman ◽  
Arabinda Brahma ◽  
Lex Rutten ◽  
Satarupa Sadhukhan ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Pilot Trial ◽  
Retention Rates ◽  
Group Differences ◽  
Generalized Anxiety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Positive Direction ◽  
Definitive Trial

Introduction: Evidence favoring homeopathy in generalized anxiety disorder (GAD) remains scarce. The objective of this pilot trial was to test feasibility of a definitive trial in future. We also experimented whether individualized homeopathic medicines (IH) plus psychological counseling (PC) can produce significantly different effects beyond placebo plus PC in the treatment of GAD. Methods: A double-blind, randomized, placebo-controlled, parallel arm, pilot trial was conducted on 62 GAD patients at the National Institute of Homoeopathy, India. GAD-7 questionnaire and Hamilton Anxiety Scale (HAM-A) were used as the primary and secondary outcomes, respectively, measured at baseline and 3 months. Patients received either IH plus PC (n = 31) or identical-looking placebo plus PC (n = 31). Intention-to-treat sample was analyzed to detect group differences using unpaired t tests. Results: Recruitment and retention rates were 56 and 90%, respectively. Mean age was 31.5 years; 56.5% were male. GAD-7 reductions were non-significantly higher in IH than placebo (p = 0.122). Group differences on HAM-A favored IH significantly (p = 0.018). Effect sizes were small to medium. Calcarea carbonica was the most frequently indicated medicine. No serious adverse events happened. Conclusions: A small but positive direction of anxiolytic effect was observed favoring homeopathy over placebo. A definitive trial appeared feasible in future.

scholarly journals Pre-exposure prophylaxis recent adherence with real-time adherence feedback and partner HIV self-testing: A pilot trial among postpartum women

2021 ◽  
Author(s):  
Dvora Leah Joseph Davey ◽  
Kathryn Dovel ◽  
Rufaro Mvududu ◽  
Dorothy Nyemba ◽  
Nyiko Mashele ◽  
...  
Keyword(s):  
Real Time ◽  
Pilot Trial ◽  
Intervention Group ◽  
Standard Of Care ◽  
Postpartum Women ◽  
Urine Test ◽  
The Past ◽  
Self Testing ◽  
Secondary Outcomes ◽  
Exposure Prophylaxis

Abstract Background Pre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. HIV self-testing (HIVST) for male partners combined with biofeedback counselling through real-time adherence measures may improve PrEP use among postpartum women. Methods Between August-2020-April-2021 we randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counselling following urine tenofovir test) or to standard of care (SOC: facility-based HIV tests and routine counselling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72 hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomisation. Secondary outcomes included proportion of partners who tested for HIV and discrepancy between self-reported PrEP adherence and urine tenofovir result. Results We enrolled 106 women (median age=26yrs). At enrolment 72% of women reported missing &lt;2 doses in the past 7-days; 36% of women had tenofovir present in her urine. One month after enrolment, 62% (n=33) of women in the intervention arm had tenofovir present in their urine compared to 34% (n=18) in SOC (RR=1.83; 95% CI=1.19-2.82; p=0.001). Two-thirds of women in the intervention arm reported that her partner tested for HIV (66%; n=35); compared to 17% (n=9) in SOC (RR=3.89; 95% CI=2.08-7.27; p&lt;0.001). Self-reported PrEP adherence (took PrEP &gt;5 of last week) with no tenofovir in urine test was lower in the intervention group (17% vs 46%; RR=0.33; 95% CI=0.17-0.67; p=0.03). No social or clinical adverse events were reported in the intervention arm. Conclusions HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population.

scholarly journals Timing of selective basal ganglia white matter loss in Huntington’s disease

2021 ◽  
Author(s):  
Paul Zeun ◽  
Peter McColgan ◽  
Thijs Dhollander ◽  
Sarah Gregory ◽  
Eileanoir B Johnson ◽  
...  
Keyword(s):  
White Matter ◽  
Basal Ganglia ◽  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Rating Scale ◽  
Point Group ◽  
Disease Onset ◽  
Group Differences ◽  
Significant Group ◽  
Gene Carriers

AbstractObjectivesTo investigate the timeframe prior to symptom onset when cortico-basal ganglia white matter (WM) loss begins in premanifest Huntington’s disease (preHD), and which striatal and thalamic sub-region WM tracts are most vulnerable.MethodsWe performed fixel-based analysis, which allows resolution of crossing WM fibres at the voxel level, on diffusion tractography derived WM tracts of striatal and thalamic sub-regions in two independent cohorts; TrackON-HD, which included 72 preHD (approx. 11 years before disease onset) and 85 controls imaged at three time points over two years; and the HD young adult study (HD-YAS), which included 54 preHD (approx. 25 years before disease onset) and 53 controls, imaged at one time point. Group differences in fibre density and cross section (FDC) were investigated.ResultsWe found no significant group differences in cortico-basal ganglia sub-region FDC in preHD gene carriers 25 years before onset. In gene carriers 11 years before onset, there were reductions in striatal (limbic and caudal motor) and thalamic (premotor, motor and sensory) FDC at baseline, with no significant change over 2 years. Caudal motor-striatal, pre-motor-thalamic, and primary motor-thalamic FDC at baseline, showed significant correlations with the Unified Huntington’s disease rating scale (UHDRS) total motor score (TMS). Limbic cortico-striatal FDC and apathy were also significantly correlated.ConclusionsOur findings suggest that the initiation of disease modifying therapies 25 years before onset could protect these important brain networks from undergoing neurodegeneration and highlight selectively vulnerable sub-regions of the striatum and thalamus that may be important targets for future therapies.

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