scholarly journals Salvage therapy with Sodium chlorosum (formerly DAC N-055) for cases of refractory lupoid cutaneous leishmaniasis: results from a compassionate use study with 0.09% Sodium chlorosum in amphiphilic basic cream

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Sara Molkara ◽  
Elaheh Poursoltani ◽  
Kurt-Wilhelm Stahl ◽  
Masoud Maleki ◽  
Ali Khamesipour ◽  
...  

Abstract Background Lupoid cutaneous leishmaniasis (LCL) is known as a rare but serious complication of anthroponotic cutaneous leishmaniasis (ACL) resistant to conventional treatments. Sodium chlorosum, a pro-oxidative preparation of pharmaceutical sodium chlorite (NaClO2), has been successfully used for the treatment of Old World cutaneous leishmaniasis lesions (OWCL) and of some LCL cases in Afghanistan. This clinical trial study aimed to evaluate the effect of a last resort therapy with topical 0.09% sodium chlorosum on LCL in Iran. Methods Twenty Iranian patients (12 women and 8 men) with LCL refractory to treatment were included in this salvage study. A magistral preparation of sodium chlorosum (10 mM NaClO2 in amphiphilic basic cream) was applied twice daily to the lesions for 6 weeks and continued up to 12 weeks in patients who showed a clinical response within the first 6 weeks. Responders were followed up for a maximum of 1 year. Lesions were photographed during weekly visits. Disappearance of erythema and indurated lesions were rated as complete clinical response. Results Patients with a mean age of 28.6 (±24.3) and with an ACL proven lesion history of 3.8 (±1.4) years were treated for an average of 7.9 (±1.8) weeks. At the end of the treatment period (12th week), a complete response was observed in 9 of 20 patients (45%). During the one-year follow-up period, LCL lesions recurred in 4 of these 9 patients (with one patient showing only a tiny lesion) and one case lost to follow up whereas the other four remained completely lesion-free. Mild temporary side-effects such as erythema and itching were seen in 4 of 20 patients (20%). Conclusions Topical sodium chlorosum showed promising therapeutic results and can be considered as safe, painless, and relatively effective treatment for LCL, an ethical prerequisite for a two-armed controlled trial. Trial registration This study was registered in Iranian registry of clinical trials on 2019-02-02 with registration number IRCT20190114042356N1.

2015 ◽  
Vol 2015 ◽  
pp. 1-14 ◽  
Author(s):  
Yanyi Wang ◽  
Charlie Changli Xue ◽  
Robert Helme ◽  
Cliff Da Costa ◽  
Zhen Zheng

Objectives. This study aimed to evaluate the efficacy and safety of manual acupuncture as a prophylaxis for frequent migraine.Methods. Fifty frequent migraineurs were randomly allocated to receive 16 sessions of either real acupuncture (RA = 26) or sham acupuncture (SA = 24) during 20 weeks. The primary outcomes were days with migraine over four weeks, duration, and intensity of migraine and the number of responders with more than 50% reduction of migraine days. The secondary outcomes were the relief medication, quality of migraine, quality of life, and pressure pain thresholds.Results. The two groups were comparable at baseline. At the end of the treatment, when compared with the SA group, the RA group reported significant less migraine days (RA: 5.2 ± 5.0; SA: 10.1 ± 7.1;P=0.008), less severe migraine (RA: 2.18 ± 1.05; SA: 2.93 ± 0.61;P=0.004), more responders (RA: 19 versus SA: 7), and increased pressure pain thresholds. No other group difference was found. Group differences were maintained at the end of the three-month follow-up, but not at the one-year follow-up. No severe adverse event was reported. Blinding was successful.Discussion. Manual acupuncture was an effective and safe treatment for short-term relief of frequent migraine in adults. Larger trials are warranted.


1994 ◽  
Vol 5 (3) ◽  
pp. 182-185 ◽  
Author(s):  
L Olmos ◽  
J Vilata ◽  
A Rodríguez Pichardo ◽  
A Lloret ◽  
A Ojeda ◽  
...  

A randomized, double-blind, placebo-controlled trial was conducted to assess interferon-beta efficacy and safety in the treatment of anogenital condylomatous lesions. One hundred patients received a daily intramuscular injection of either interferon-beta (IFN-β) (2 MIU/day) or placebo for 10 days. Of 94 evaluable patients, the complete response rate observed 8 weeks after treatment was significantly higher in the group receiving IFN-β, as compared to the placebo-treated group (51% vs 28.9%, P<0.05). After one year, 24 patients (100%) out of 24 complete responders to IFN-β who attended for follow-up remained free of lesions. Twelve of 13 patients with complete response to placebo (92.3%) remained free of lesions after one year. Side effects were mild and no significant analytical changes were observed. In conclusion, interferon-beta is an effective and safe treatment for long-term eradication of anogenital condylomatous lesions.


2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Thierry Hanh ◽  
Patrick Serog ◽  
Jérôme Fauconnier ◽  
Pierre Batailler ◽  
Florence Mercier ◽  
...  

Objective. To assess the one-year effectiveness on weight loss of a 3-week balneotherapy program (BT).Method. A Zelen double consent randomised controlled trial to compare one-year BMI loss between a 3-week BT program versus usual care (UC) for overweight or obese patients (BMI: 27–35 kg/m2), associated or not with a dietary motivational interview (DMI) during the follow-up, using a 2 × 2 factorial design. Main analysis was a per protocol analysis comparing patients attending BT to patients managed by UC, matched on sex, overweight or obese status, DMI randomisation and a propensity score to attend BT or to be managed by UC.Results. From the 257 patients who completed the follow-up, 70 patients of each group could be matched. Mean BMI loss was 1.91 kg/m2[95%CI: 1.46; 2.35] for the BT patients and 0.20 kg/m2[−0.24; 0.64] for the UC patients (P<0.001), corresponding to a significant BT benefit of 1.71 kg/m2[1.08; 2.33]. There was no significant effect of DMI and no interaction with BT or UC. No adverse reaction was observed for patients attending BT.Conclusion. A 3-week BT program provided a significant one-year benefit over the usual GP dietary advice for overweight and obese patients.


Author(s):  
Piia Karjalainen ◽  
Päivi Santalahti ◽  
Eeva T. Aronen ◽  
Olli Kiviruusu

Abstract Background This randomized controlled trial (RCT) evaluated the long-term effectiveness of the Incredible Years® (IY) Parenting Program in modifying children’s externalizing problems among families in Child Protection Services (CPS) and using other special support services. We also examined whether parent-reported effects of the IY® generalize to the daycare/school setting as reported by teachers. Methods Participants in the study were 3–7-year-old children with behavioural problems (N = 102 at baseline, N = 89 at one-year follow-up). Participants were randomized to intervention (N = 50) and control groups (N = 52) after the baseline assessment. The intervention group received 19-week IY® Parenting Program. The effectiveness of the intervention was analyzed using linear mixed model. Results Our previously reported pre-post intervention effects on CBCL (Child Behavior Checklist) and ECBI (Eyberg Child Behavior Inventory) were not sustained to the one-year follow-up. Child conduct problems decreased from baseline to follow-up in both intervention and control groups. The positive changes were not observed at daycare/school from baseline to post-intervention or to the one-year follow-up, and there were no significant differences in changes between the groups. Conclusions Evidence-based parenting program IY® seems to be an effective intervention for child conduct problems in the short term in families in the CPS context, but sustaining the positive effects and generalizing them to the daycare/school context are challenging. Trial registration: The trial is registered in the ClinicalTrials.gov registry (NCT03239990), Registered August 4th, 2017; https://clinicaltrials.gov/ct2/results?cond=&term=NCT03239990&cntry=&state=&city=&dist=


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15525-e15525
Author(s):  
Maria Fernanda Noriega-Iriondo ◽  
Laura Elia Martinez Garza ◽  
Juan Francisco Gonzalez Guerrero ◽  
Oralia Barboza Quintana ◽  
Daneli Ruiz Sanchez ◽  
...  

e15525 Background: Human papillomavirus (HPV) is associated with carcinoma of the cervix (CC). There is evidence that clearance of the virus occurs after chemoradiotherapy which is the standard treatment for this disease. Methods: Eligible patients with bulky IB to IVA CC were treated with once weekly cisplatin (40 mg/m2) chemotherapy and standard pelvic teletherapy and brachyterapy. HPV detection and typing was performed with DNA microarrays from liquid based cytologies before and 4 to 6 weeks after treatment completion. Clinical response was assesed by physical exam and liquid based cytology. Results: 23 patients (pt) with CC , were tested for HPV. Their age ranged from 33 to 80 years (mean 65), clinical stage I 8.6%, StageII 39%, stageIII 25.9% and stageIV 26.5%.VPH was found in 20 patients (87%). 34% of the patients had more than one type of HPV. 13 types of VPH were found,the most prevalent type was 16 in 47.8%, followed by type 72 in 13%.7 patients were lost to follow up during therapy. 16 patients were tested after completion of therapy ,there was HPV persistence in 5 patients (38.5%),whereas 61.5% cleared the virus. Of the persisting HPV the most prevalent type was 16 in two pt. and 61 in two pt. three pt had more than one HPV type after completion of therapy (types 11,81,35,39,56,84,66were found in different combinations in the pts). Response rate was as follows, 84.6% complete response,and two pt. had partial response. Viral clearance did not correlate with complete response in this study. Conclusions: HPV types 16 and 72 were the most prevalent in this population from northern Mexico. Infection with multiple viral types was common. Viral clearance occured in 61.5% and this did not correlate with complete clinical response. Persistence of multiple HPV types after completion of therapy may have unknown clinical and prognostic implications.


2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
M.-B. Drugli ◽  
B. Larsson

Although most parent training programs produce positive effects, about one third of the children still show conduct problems at clinical levels after treatment.In the present study, predictors and mediators of treatment non-response among children aged 4-8 years were investigated one-year after treatment with the Incredible Years parent training program (PT), or combined parent training and child treatment (PT+CT) in a randomized controlled trial. the study was conducted in two university cities in Norway.KIDDIE-SADS, Eyberg Child Behavior Inventory (ECBI), Child Behavior Checklist (CBCL), Parent Practices Interview (PPI), Parent Stress Index (PSI), Preschool Behavior Questionnaire (PBQ), Teacher Report Form (TRF), were used.Before treatment all children fulfilled the criteria for an ODD diagnosis or a sub-threshold diagnosis. at the one-year follow-up 33 % of the treated children still showed such a diagnosis, and they were defined as treatment non-responders.Both family and child variables predicted treatment non-response at the one-year follow-up, although being involved with the child protection services was found to be the strongest predictor in multivariate analysis. Pretreatment child characteristics predicting treatment non-response at the one-year follow-up were high levels of child internalizing and aggression problems as reported by mothers. Further, mothers of children still showing a ODD diagnosis at the one-year follow-up, reported less change in negative parenting practices as compared to mothers of treatment responders.


VASA ◽  
2012 ◽  
Vol 41 (2) ◽  
pp. 120-124 ◽  
Author(s):  
Asciutto ◽  
Lindblad

Background: The aim of this study is to report the short-term results of catheter-directed foam sclerotherapy (CDFS) in the treatment of axial saphenous vein incompetence. Patients and methods: Data of all patients undergoing CDFS for symptomatic primary incompetence of the great or small saphenous vein were prospectively collected. Treatment results in terms of occlusion rate and patients’ grade of satisfaction were analysed. All successfully treated patients underwent clinical and duplex follow-up examinations one year postoperatively. Results: Between September 2006 and September 2010, 357 limbs (337 patients) were treated with CDFS at our institution. Based on the CEAP classification, 64 were allocated to clinical class C3 , 128 to class C4, 102 to class C5 and 63 to class C6. Of the 188 patients who completed the one year follow up examination, 67 % had a complete and 14 % a near complete obliteration of the treated vessel. An ulcer-healing rate of 54 % was detected. 92 % of the patients were satisfied with the results of treatment. We registered six cases of thrombophlebitis and two cases of venous thromboembolism, all requiring treatment. Conclusions: The short-term results of CDFS in patients with axial vein incompetence are acceptable in terms of occlusion and complications rates.


2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Afona Chernet ◽  
Nicole Probst-Hensch ◽  
Véronique Sydow ◽  
Daniel H. Paris ◽  
Niklaus D. Labhardt

Abstract Objective Eritrea is the most frequent country of origin among asylum seekers in Switzerland. On their journey through the desert and across the Mediterranean Sea, Eritrea refugees are often exposed to traumatizing experiences. The aim of this study is to assess the mental health status and resilience of Eritrean migrants in Switzerland upon arrival and one-year post-arrival, using standardized mental health screening and resilience assessment tools. Results At baseline, 107 refugees (11.2% female, median age 25) were interviewed: 52 (48.6%) screened positive for Post-Traumatic Stress Disorder (score ≥ 30), 10.3% for anxiety (≥ 10) and 15.0% for depression (≥ 10); 17.8% scored as risk/hazardous drinkers (≥ 8). The majority (94.4%) had a high resilience score (≥ 65). For one-year follow-up, 48 asylum seekers could be reached. In interviews 18 (38%) of these reported imprisonment in a transit country and 28 (58%) that they had witnessed the death of a close person along the migration route. At the one year assessment, rates of risky/hazardous alcohol use remained unchanged, rates of positive PTSD screening tended to be lower (50.0% (24/48) at baseline vs 25.0% (12/48) at follow-up), as were rates of positive screening for anxiety (8.3% vs 4.2%) and depression (14.6 vs 6.3%).


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