Therapeutic Response to Thermotherapy in Cutaneous Leishmaniasis Treatment Failures for Sodium Stibogluconate: A Randomized Controlled Proof of Principle Clinical Trial

Treatment failure to intralesional sodium stibogluconate (IL-SSG) is a health challenge for cutaneous leishmaniasis (CL) in Sri Lanka. A randomized controlled proof of principle clinical trial, with two arms (viz., radio frequency–induced heat therapy [RFHT] by a ThermoMed™ device and thermotherapy by a handheld exothermic crystallization thermotherapy for CL [HECT-CL] device) was conducted on 40 CL treatment failures to IL-SSG, from three hospitals in Tangalle, Hambantota, and Anuradhapura, from January 2017 to January 2018, followed up for 180 days post-thermotherapy with a final follow-up in February 2020. Intention-to-treat cure rates were calculated at day 90 (initial cure rate) and at day 180 (final cure rate) posttreatment. Radio frequency–induced heat therapy group: the initial cure rate was 100% (20/20) and the final cure rate was 95% (19/20), with one patient relapsing. The HECT-CL group: both the initial and final cure rates were 80% (16/20), with no relapses and one excluded from the trial. In February 2020 (1.6–3 years posttreatment), 27 traceable patients (RFHT = 16, HECT-CL = 11) remained healed. Second-degree burns were observed with RFHT in 65% (13/20), with HECT-CL in 15% (3/20), which completely resolved subsequently. The cure rates between the two treatment groups were comparable (P = 0.15). Radio frequency–induced heat therapy consumed less time and required only a single hospital visit. Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG. This study is the first proof that thermotherapy is an efficacious and safe treatment for CL patients in Sri Lanka, complicated by treatment failure to IL-SSG.

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A Randomized Controlled Trial of Local Heat Therapy Versus Intravenous Sodium Stibogluconate for the Treatment of Cutaneous Leishmania major Infection

PLoS Neglected Tropical Diseases ◽

10.1371/journal.pntd.0000628 ◽

2010 ◽

Vol 4 (3) ◽

pp. e628 ◽

Cited By ~ 56

Author(s):

Naomi E. Aronson ◽

Glenn W. Wortmann ◽

William R. Byrne ◽

Robin S. Howard ◽

Wendy B. Bernstein ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Leishmania Major ◽

Controlled Trial ◽

Local Heat ◽

Sodium Stibogluconate ◽

Major Infection ◽

Randomized Controlled ◽

Heat Therapy ◽

Intravenous Sodium

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Increasing the Radioiodine Dose Does Not Improve Cure Rates in Severe Graves' Hyperthyroidism: A Clinical Trial with Historical Control

Journal of Thyroid Research ◽

10.1155/2013/958276 ◽

2013 ◽

Vol 2013 ◽

pp. 1-5 ◽

Cited By ~ 5

Author(s):

Jose Miguel Dora ◽

Walter Escouto Machado ◽

Vânia A. Andrade ◽

Rafael Selbach Scheffel ◽

Ana Luiza Maia

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Thyroid Tissue ◽

Thyroid Volume ◽

Historical Control ◽

Control Group ◽

Cure Rate ◽

Group 2 ◽

Cure Rates ◽

Group 1

Objective. It is generally accepted that higher doses of radioiodine (131I) improve cure rates in Graves’ disease (GD). In this trial we sought to evaluate whether very high131I doses increase the efficacy of treatment in severe GD.Design. Clinical trial with historical control. Patients with GD and a goiter ≥48 mL were eligible for the study. The patients in the contemporaneous intervention cohort were treated with 250 μCi of131I/mL thyroid tissue, corrected by 24-RAIU values (Group 1;n=15). A subgroup of patients with GD and a goiter ≥48 mL who were treated with 200 μCi of131I/mL/24-RAIU in a previously published randomized controlled trial served as a historical control group (Group 2;n=15). The primary outcome evaluated was the one-year cure rate.Results. There were no significant baseline differences regarding age, gender, body mass index, smoking status, pretreatment with methimazole, thyroid volume, or thyroid hormone levels of the two treatment groups. The cumulative 12-month cure rate for the patients in Group 1 was 66.6%, a figure similar to the 12-month cure rate observed in Group 2 (60.0%;P=0.99).Conclusions. Our results suggest that increasing the131I dose does not improve cure rates in severe GD. This trial is registered with ClinicalTrials.govNCT01039818.

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Efficacy and safety of the combination nifuratel-nystatin and clindamycin-clotrimazole, in the treatment of bacterial vaginosis. Randomized controlled clinical trial

10.36811/ijrmsh.2021.110010 ◽

2021 ◽

pp. 1-10

Author(s):

Franklin José Espitia De La Hoz

Keyword(s):

Clinical Trial ◽

Bacterial Vaginosis ◽

Reproductive Age ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Randomized Controlled Clinical Trial ◽

Cure Rate ◽

Clinical Criteria ◽

Randomized Controlled ◽

Group B

Introduction: Bacterial vaginosis (BV) is the most frequent gynecological infection in women of reproductive age, thus driving the search for effective and safe treatments. Objective: To compare the efficacy and safety of the combination nifuratel-nystatin and clindamycinclotrimazole, in the treatment of bacterial vaginosis. Materials and Methods: Randomized controlled clinical trial in 147 single women (18 to 39 years old), non-pregnant and sexually active, with a diagnosis of BV according to the Amsel clinical criteria and the Nugent score; between 2016 and 2018. In a highly complex private clinic in Armenia, Colombia. Women were randomized into two groups: "A" (73 participants: nifuratel (500 mg) - nystatin (100,000 IU) and "B" (74 participants: clindamycin (100 mg) - clotrimazole (200 mg)); both groups were treated with vaginal ovules, "A" for six days and "B" for three days. All participants were followed-up for clinical and microbiological healing at 7 and 30 days, respectively, after completion of treatment, the STATA® 14.0 program was used. Results: The mean age of women was 28.35±5.79 years. The clinical cure rate with the nifuratelnystatin combination was 93.15%, and that of clindamycin-clotrimazole 97.29%, (p=0.123). The microbiological cure rate with the nifuratel-nystatin combination was 87.67%, and that of clindamycin-clotrimazole 93.24%, (p=0.102). Regarding safety, there were also no significant differences between the two groups (p=0.144); Mild adverse reactions were observed. Recurrence in group "A" was 12.32% compared to 6.75% in group "B" (p>0.05). Conclusions: In this study, the combinations nifuratel (500 mg) -nystatin (100,000 IU) and clindamycin (100 mg)-clotrimazole (200 mg), reported that both are equally effective and safe options in the treatment of BV. It is necessary to evaluate the effect and safety of other combinations in order to implement timely interventions. Keywords: Vaginosis; Bacterial; Efficacy; Safety; Nifuratel; Nystatin; Clindamycin; Clotrimazole.

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Kala-azar in Children: A Retrospective Study

TAJ Journal of Teachers Association ◽

10.3329/taj.v17i2.3455 ◽

1970 ◽

Vol 17 (2) ◽

pp. 99-103

Author(s):

MI Bari ◽

MQK Talukdar ◽

FH Nazir ◽

AB Siddiqui ◽

MH Haidary

Keyword(s):

Body Weight ◽

Sodium Stibogluconate ◽

Cure Rate ◽

College Hospital ◽

Medical College ◽

Kala Azar ◽

Group A ◽

Group B ◽

Discharge From Hospital ◽

Cure Rates

Fifty children with Kala-azar {27 male (54%) and 23 female (46%)} aged between 2-12 yrs, were studied retrospectively in the pediatric unit of Rajshahi Medical College Hospital to find out the optimal treatment of Kala-azar in children. Sodium stibogluconate was given intravenously at a dose of 10 mg/kbw/day for 20 days in one group (Group-A), 15 mg/kbw/day for 20 days in another group (Group-B), 10 mg/kbw/day B.D. for 20 days in another group (Group-C), and 20 mg/kg of body wt/day for 40 days is last group (Group-D). The apparent cure rates of all regimens were 100%. Side effects of sodium stibogluconate were mild, however, myocarditis developed on 37th day of treatment in one patient which reversed to normal after discontinuation of the drug. 27 patients (54%) could be followed up to six months after discharge from hospital. Two patients in group-A relapsed and none relapsed from group B, C or D. Follow-up of patients in group B, C and D showed improvement in general condition, increase in body weight, Hb% and regression of the size of the liver and spleen and ultimate rate of cure in B, C, D regimens were 100%. But ultimate cure rate in-group A was 71.4% and the significance of difference between A and other regimens (P<0.10) were statistically significant. Sodium stibogluconate 15mg/kg body weight once daily for 20 days (Group-B) had the best of cure rate with low toxicity and may be recommended for routine treatment of childhood Kala-azar in this country. doi: 10.3329/taj.v17i2.3455 TAJ 2004; 17(2): 99-103

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One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial

Journal Of Clinical Periodontology ◽

10.1111/j.1600-051x.2009.01432.x ◽

2009 ◽

Vol 36 (8) ◽

pp. 661-666 ◽

Cited By ~ 85

Author(s):

Martina Lulic ◽

Isabelle Leiggener Görög ◽

Giovanni E. Salvi ◽

Christoph A. Ramseier ◽

Nikolaos Mattheos ◽

...

Keyword(s):

Clinical Trial ◽

Photodynamic Therapy ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

One Year ◽

Periodontal Maintenance ◽

Proof Of Principle

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Effectiveness and safety of ciclopirox olamine in patients with dermatophytosis: a retrospective cohort analysis

International Journal of Research in Dermatology ◽

10.18203/issn.2455-4529.intjresdermatol20205592 ◽

2020 ◽

Vol 7 (1) ◽

pp. 38

Author(s):

Vinay Saraf ◽

Satyaprakash Mahajan ◽

Gaurav Deshmukh ◽

Dhiraj Dhoot ◽

Hanmant Barkate

Keyword(s):

Treatment Failure ◽

Clinical Cure ◽

Retrospective Cohort ◽

Antifungal Agents ◽

Topical Therapy ◽

Cohort Analysis ◽

Cure Rate ◽

Ciclopirox Olamine ◽

Treatment Naïve ◽

Cure Rates

Background: The current scenario of dermatophytosis is alarming, despite the availability of multiple antifungal agents the management of dermatophytosis is still challenging. Hence there is a need for a different antifungal with a novel mechanism of action for the management of dermatophytosis.Methods: It was retrospective cohort study where in record of patients with dermatophytosis who were candidates for topical therapy only were analysed. All the patients were treated with Ciclopirox olamine 1% twice daily for 6 weeks. The efficacy end points were complete cure rate, mycological cure rate and clinical cure rate.Results: 613 patients were included in the final analysis. At the end of study period the complete, mycological and clinical cure rates were 73.89%, 75.37% and 77.65% respectively. Out of 613 patients included 528 patients showed treatment failure to previous topical antifungal agents while 84 patients were treatment naïve. In treatment failure patients the complete, mycological and clinical cure rates were 72.15%, 73.48, and 75.56% respectively. In treatment naïve patients the complete, mycological and clinical cure rates were 84.70%, 87.05% and 90.58% respectively. 5.70% reported adverse events. The most common adverse event was pruritus followed erythema, dryness and rash.Conclusions: Results of this study proves that ciclopirox is efficacious and safe in the management of dermatophytosis. This study also proves that ciclopirox is useful in those patients who failed to respond to other topical antifungal agents.

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