Pub Date : 2019-01-01DOI: 10.4172/2167-0870.1000359
S. Maouni, El Anzi Ouiam, S. Asmae, Zenati Kaoutar, Meziane Mariam, Senouci Karima, Hassam Badredine
Lichen planus pemphigoides (LPP) is an uncommon skin condition that is characterized by signs of lichen planus associated to subepidermal detachment with deposits of autoantibodies along dermal-epidermal junction basement membrane. LPP is infrequent in adults, but extremely rare in pediatric population; indeed just 17 cases were reported. We report a rare case history of a 6-year-old boy with clinical and histological findings of an erythrodermic LPP.
{"title":"A Pediatric Case of Erythrodermic Lichen Planus Pemphigoides","authors":"S. Maouni, El Anzi Ouiam, S. Asmae, Zenati Kaoutar, Meziane Mariam, Senouci Karima, Hassam Badredine","doi":"10.4172/2167-0870.1000359","DOIUrl":"https://doi.org/10.4172/2167-0870.1000359","url":null,"abstract":"Lichen planus pemphigoides (LPP) is an uncommon skin condition that is characterized by signs of lichen planus associated to subepidermal detachment with deposits of autoantibodies along dermal-epidermal junction basement membrane. LPP is infrequent in adults, but extremely rare in pediatric population; indeed just 17 cases were reported. We report a rare case history of a 6-year-old boy with clinical and histological findings of an erythrodermic LPP.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"71 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86409726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.4172/2167-0870.1000361
C. M. Aalst, M. Vonder, J. Gratama, H. Adriaansen, D. Kuijpers, Sabine J A M Denissen, P. Harst, R. Braam, P. Dijkman, R. V. Bruggen, F. Beltman, M. Oudkerk, H. J. Koning
Objectives: This article aims to describe the rationale, study design, and the recruitment process of the Dutch Risk or Benefit in Screening for Cardiovascular Disease (ROBINSCA) trial, worldwide the first population-based randomized-controlled Computed-Tomography (CT) screening trial for cardiovascular disease, powered to detect a benefit of 15% reduced Coronary Heart Disease (CHD) morbidity and mortality. Methods: Addresses of men (aged 45-74 years) and women (aged 55-74 years) were obtained (n=394,058) from the national population registry. All received a mailing with an information brochure, a questionnaire and waist measurement tape and an informed consent form. Asymptomatic people with an expected high-risk for developing CHD were included in this study: 1) a waist circumference of ≥ 102 cm (men) or ≥ 88 cm (women), 2) Body Mass Index of ≥ 30 kg/m2, 3) current smoker and/or 4) a family history of CHD. Eligible respondents were Randomized (1:1:1) to one of the study arms: intervention arm A (screening traditional risk factors), intervention arm B (screening by Coronary Artery Calcium scoring only) or the control arm (usual care). Screened participants with a high risk for developing CHD were referred to the general practitioner for cardiovascular risk management. Linkages with national registries will be performed to measure (CHD-related) morbidity and mortality. Results: A total of 87,866 (22.3%) people responded to the questionnaire, of which 43,447 (49.4%) were Randomized to intervention arm A (n=14,478 (33.3%)), intervention arm B (n=14,450 (33.3%)), or the control arm (n=14,519 (33.4%)). Of those who were considered to be ineligible, one had prior diagnosis of CHD (n=14,156), a medication for hypercholesterolemia and hypertension (n=13,670), no completed informed consent (n=4,490), previous cardiovascular surgery (n=4,146), and/or a CAC score within the last 12 months (n=393). Conclusion: Evidence for net-effectiveness of population-based screening for cardiovascular risk in an asymptomatic population will possibly enable large-scale implementation with large health gains.
{"title":"Risk or Benefit in Screening for Cardiovascular Disease (ROBINSCA): The Rationale and Study Design of a Population-Based Randomized-Controlled Screening Trial for Cardiovascular Disease","authors":"C. M. Aalst, M. Vonder, J. Gratama, H. Adriaansen, D. Kuijpers, Sabine J A M Denissen, P. Harst, R. Braam, P. Dijkman, R. V. Bruggen, F. Beltman, M. Oudkerk, H. J. Koning","doi":"10.4172/2167-0870.1000361","DOIUrl":"https://doi.org/10.4172/2167-0870.1000361","url":null,"abstract":"Objectives: This article aims to describe the rationale, study design, and the recruitment process of the Dutch Risk or Benefit in Screening for Cardiovascular Disease (ROBINSCA) trial, worldwide the first population-based randomized-controlled Computed-Tomography (CT) screening trial for cardiovascular disease, powered to detect a benefit of 15% reduced Coronary Heart Disease (CHD) morbidity and mortality. Methods: Addresses of men (aged 45-74 years) and women (aged 55-74 years) were obtained (n=394,058) from the national population registry. All received a mailing with an information brochure, a questionnaire and waist measurement tape and an informed consent form. Asymptomatic people with an expected high-risk for developing CHD were included in this study: 1) a waist circumference of ≥ 102 cm (men) or ≥ 88 cm (women), 2) Body Mass Index of ≥ 30 kg/m2, 3) current smoker and/or 4) a family history of CHD. Eligible respondents were Randomized (1:1:1) to one of the study arms: intervention arm A (screening traditional risk factors), intervention arm B (screening by Coronary Artery Calcium scoring only) or the control arm (usual care). Screened participants with a high risk for developing CHD were referred to the general practitioner for cardiovascular risk management. Linkages with national registries will be performed to measure (CHD-related) morbidity and mortality. Results: A total of 87,866 (22.3%) people responded to the questionnaire, of which 43,447 (49.4%) were Randomized to intervention arm A (n=14,478 (33.3%)), intervention arm B (n=14,450 (33.3%)), or the control arm (n=14,519 (33.4%)). Of those who were considered to be ineligible, one had prior diagnosis of CHD (n=14,156), a medication for hypercholesterolemia and hypertension (n=13,670), no completed informed consent (n=4,490), previous cardiovascular surgery (n=4,146), and/or a CAC score within the last 12 months (n=393). Conclusion: Evidence for net-effectiveness of population-based screening for cardiovascular risk in an asymptomatic population will possibly enable large-scale implementation with large health gains.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"28 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78674899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.4172/2167-0870.1000388
S. Cimpean, Arianna Grilli Mattia Bez, Marechal Marie Therese, B. Cadière, Luca Pau, G. Cadière
Anastomotic leak is a frequent complication in general surgery which is related to significant morbidity and mortality. Nowadays, several approaches are utilized, frequently invasive for the patient. Nevertheless, a common strategy for anastomotic leak management has not been identified. We report here an alternative surgical procedure, associated to reduced interventional time and less invasively for the patient.
{"title":"Fistula after a Left Colectomy- a Simple Suture and Drainage Can Be an Option?","authors":"S. Cimpean, Arianna Grilli Mattia Bez, Marechal Marie Therese, B. Cadière, Luca Pau, G. Cadière","doi":"10.4172/2167-0870.1000388","DOIUrl":"https://doi.org/10.4172/2167-0870.1000388","url":null,"abstract":"Anastomotic leak is a frequent complication in general surgery which is related to significant morbidity and mortality. Nowadays, several approaches are utilized, frequently invasive for the patient. Nevertheless, a common strategy for anastomotic leak management has not been identified. We report here an alternative surgical procedure, associated to reduced interventional time and less invasively for the patient.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"19 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80482352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.4172/2167-0870.1000392
Selim Unsal, T. Karlıdağ, Į. Kaygusuz, E. Keleş, Ş. Yalçın
Abstract Aim: This study is realized with the aim to investigate whether or not there is congenital and progressive hearing loss in the children aged between 1 and 4 whose mothers experienced mild or severe preeclampsia in their pregnancy. Material and Methods: Total 60 children participated in the study whose mothers had mild preeclampsia [20 children] and severe preeclampsia [20 children] and whose mothers were healthy [20 children] for the control group. After the Ear-Nose-Throat [ENT] examination, immitansmetric examination, otoacoustic emission test, Automatic Auditory Brainstem Response [A-ABR] measurement and Free Field [FF] audiometry were applied to the children. Result: As a result of audiological evaluation, Type C tympanogram was observed in the right ear of one child in the group with mild preeclampsia, and in the left ears of total four children in the group with severe preeclampsia [2 children] and in the healthy group [2 children]. No ipsilateral reflex was obtained in the right ears of total two children in the groups with mild [1 child] and severe [1 child] preeclampsia, and in the left ear of one child in the group with severe preeclampsia. One child in the group with mild preeclampsia did not pass from the OAE test. Normal immitansmetric findings and passed result from OAE test were obtained in the second audiological evaluation. All children passed the Automatic Auditory Brainstem Response [A-ABR] test. Hearing thresholds between 125-4000 Hz were obtained in the FF and at 30 dB. Conclusion: When comparison is made between the hearings of children whose mothers were healthy and have experienced preeclampsia; normal hearing findings were obtained for groups, and it is considered that preeclampsia did not cause any congenital and/or progressive hearing loss by it.
{"title":"Evaluation of the Hearing in Children of Mild and Severe Pre-Eclamptic Mothers","authors":"Selim Unsal, T. Karlıdağ, Į. Kaygusuz, E. Keleş, Ş. Yalçın","doi":"10.4172/2167-0870.1000392","DOIUrl":"https://doi.org/10.4172/2167-0870.1000392","url":null,"abstract":"Abstract Aim: This study is realized with the aim to investigate whether or not there is congenital and progressive hearing loss in the children aged between 1 and 4 whose mothers experienced mild or severe preeclampsia in their pregnancy. Material and Methods: Total 60 children participated in the study whose mothers had mild preeclampsia [20 children] and severe preeclampsia [20 children] and whose mothers were healthy [20 children] for the control group. After the Ear-Nose-Throat [ENT] examination, immitansmetric examination, otoacoustic emission test, Automatic Auditory Brainstem Response [A-ABR] measurement and Free Field [FF] audiometry were applied to the children. Result: As a result of audiological evaluation, Type C tympanogram was observed in the right ear of one child in the group with mild preeclampsia, and in the left ears of total four children in the group with severe preeclampsia [2 children] and in the healthy group [2 children]. No ipsilateral reflex was obtained in the right ears of total two children in the groups with mild [1 child] and severe [1 child] preeclampsia, and in the left ear of one child in the group with severe preeclampsia. One child in the group with mild preeclampsia did not pass from the OAE test. Normal immitansmetric findings and passed result from OAE test were obtained in the second audiological evaluation. All children passed the Automatic Auditory Brainstem Response [A-ABR] test. Hearing thresholds between 125-4000 Hz were obtained in the FF and at 30 dB. Conclusion: When comparison is made between the hearings of children whose mothers were healthy and have experienced preeclampsia; normal hearing findings were obtained for groups, and it is considered that preeclampsia did not cause any congenital and/or progressive hearing loss by it.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"43 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84991279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-11-05DOI: 10.4172/2167-0870-C3-029
pChalachew Alemayehup
{"title":"Assessing the acceptability of N-of-1 trials/tests and their implementation: Getting ready for piloting N-of-1 trials in Ethiopia","authors":"pChalachew Alemayehup","doi":"10.4172/2167-0870-C3-029","DOIUrl":"https://doi.org/10.4172/2167-0870-C3-029","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77455322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-08-09DOI: 10.4172/2167-0870-c2-025
Sepideh Khazeni, P. Varamini
{"title":"Development of in vitro methodologies to study the behaviour of LHRH-receptor targeted drug delivery systems","authors":"Sepideh Khazeni, P. Varamini","doi":"10.4172/2167-0870-c2-025","DOIUrl":"https://doi.org/10.4172/2167-0870-c2-025","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85782790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-07-12DOI: 10.4172/2167-0870.1000346
K. Matsui, Tetsu Takahashi, T. Kawai, S. Kamakura
Secondary bone grafting of alveolar cleft using autologous particulate cancellous bone from the ilium is an essential treatment for cleft lip/palate patients. However, secondary surgical invasion represents a disadvantage. To avoid this disadvantage, octacalcium phosphate collagen composites (OCP/Col) were developed as a new bone substitute material. Through preclinical studies and clinical application for cyst holes and extraction sockets, OCP/Col demonstrated satisfactory bone repair. In this case report, OCP/Col alone was implanted into a 13-year-old patient with incomplete unilateral cleft lip and alveolus. Postoperative changes of the OCP/Col treated site were evaluated by computed tomography for two years after operation. It was revealed that sufficient bone bridge was formed in the treated alveolar cleft after implantation of OCP/Col without autologous bone grafting. At the bottom of the nasal cavity, preoperative asymmetry was improved. In addition, usual orthodontic treatment was completed 1 year and 10 months postoperatively, and good occlusion was achieved. These results suggest that OCP/Col is clinically applicable as bone regenerative material, representing an alternative to autologous bone grafting.
{"title":"First Clinical Application of New Bone Substitute Material to the Alveolar Cleft","authors":"K. Matsui, Tetsu Takahashi, T. Kawai, S. Kamakura","doi":"10.4172/2167-0870.1000346","DOIUrl":"https://doi.org/10.4172/2167-0870.1000346","url":null,"abstract":"Secondary bone grafting of alveolar cleft using autologous particulate cancellous bone from the ilium is an essential treatment for cleft lip/palate patients. However, secondary surgical invasion represents a disadvantage. To avoid this disadvantage, octacalcium phosphate collagen composites (OCP/Col) were developed as a new bone substitute material. Through preclinical studies and clinical application for cyst holes and extraction sockets, OCP/Col demonstrated satisfactory bone repair. In this case report, OCP/Col alone was implanted into a 13-year-old patient with incomplete unilateral cleft lip and alveolus. Postoperative changes of the OCP/Col treated site were evaluated by computed tomography for two years after operation. It was revealed that sufficient bone bridge was formed in the treated alveolar cleft after implantation of OCP/Col without autologous bone grafting. At the bottom of the nasal cavity, preoperative asymmetry was improved. In addition, usual orthodontic treatment was completed 1 year and 10 months postoperatively, and good occlusion was achieved. These results suggest that OCP/Col is clinically applicable as bone regenerative material, representing an alternative to autologous bone grafting.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"91 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85842830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-06-09DOI: 10.4172/2167-0870-C1-022
G. Sethi
{"title":"Multifaceted role of gamma-Tocotrienol in cancer therapy","authors":"G. Sethi","doi":"10.4172/2167-0870-C1-022","DOIUrl":"https://doi.org/10.4172/2167-0870-C1-022","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87340134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-05-29DOI: 10.15226/2374-6882/5/2/00151
A. Abbas, Royan Richard, E. Mildred, A. Duncan
Implantable Cardioverter Defibrillator (ICD) was initially used for secondary prevention of sudden cardiac death due to VF/ VT [1]. The first use of ICD to prevent sudden cardiac death was in 1980 [1]. Currently, ICD is indicated for secondary prevention of SCD due to sustained VT or VF (in whom there is no identifiable cause) and primary prevention of SCD in patients who are at risks of SCD due to VT/VF2. This includes patients with ischemic cardiomyopathy with EF ≤ 30% or non-ischemic cardiomyopathy with NYHA class II/III and EF ≤ 35%. ICD is not recommended if the patient survival is less than a year or if there are reversible causes [2]. More often, patients who are candidates for ICD are also candidate for Cardiac Resynchronization Therapy RCT (or biventricular pacing) if QRS duration ≥ 120 milliseconds [3]. Compared to medical therapy, CRT improves survival according to CARE-HF trial [4]. Combination of both biventricular pacing and ICD is recommended to reduce mortality and morbidity in patients with heart failure and prolonged QRS complex [3]. According to COMPANION trial, the benefit of this combination is greatest in presence of LBBB and QRS ≥ 150 milliseconds [5].
{"title":"ICD Lead Migration: A Lesson to Learn","authors":"A. Abbas, Royan Richard, E. Mildred, A. Duncan","doi":"10.15226/2374-6882/5/2/00151","DOIUrl":"https://doi.org/10.15226/2374-6882/5/2/00151","url":null,"abstract":"Implantable Cardioverter Defibrillator (ICD) was initially used for secondary prevention of sudden cardiac death due to VF/ VT [1]. The first use of ICD to prevent sudden cardiac death was in 1980 [1]. Currently, ICD is indicated for secondary prevention of SCD due to sustained VT or VF (in whom there is no identifiable cause) and primary prevention of SCD in patients who are at risks of SCD due to VT/VF2. This includes patients with ischemic cardiomyopathy with EF ≤ 30% or non-ischemic cardiomyopathy with NYHA class II/III and EF ≤ 35%. ICD is not recommended if the patient survival is less than a year or if there are reversible causes [2]. More often, patients who are candidates for ICD are also candidate for Cardiac Resynchronization Therapy RCT (or biventricular pacing) if QRS duration ≥ 120 milliseconds [3]. Compared to medical therapy, CRT improves survival according to CARE-HF trial [4]. Combination of both biventricular pacing and ICD is recommended to reduce mortality and morbidity in patients with heart failure and prolonged QRS complex [3]. According to COMPANION trial, the benefit of this combination is greatest in presence of LBBB and QRS ≥ 150 milliseconds [5].","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77842177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-04-16DOI: 10.4172/2167-0870.1000343
M. Hakim, Nani Kurniani, R. Pinzon, D. Tugasworo, Mudjiani Basuki, Hasnawi Haddani, Pagan Pambudi, A. Fithrie, A. D. Wuysang
Objective: The 12-week prospective, non-interventional study conducted in Indonesia aimed to evaluate the effectiveness and safety of a fixed combination of high-dose vitamin B1, B6 and B12 in subjects with peripheral neuropathy (PN) of various etiology. As PN is known to significantly impair patients’ quality of life (QoL), special attention has been paid to this aspect and QoL data were collected as secondary outcome parameters over time. Methods: The study enrolled subjects aged 18–65 years with mild or moderate PN of various etiologies. PN symptoms were measured by Total Symptom Score (TSS) and Visual Analogue Scale (VAS) at visit 1 (baseline), visit 2 (day 14), visit 3 (day 30), visit 4 (day 60), and visit 5 (day 90). At visits 1, 3, 4, and 5, the subjects also reported QoL data as assessed by the Short Form 8 (SF-8) Health Survey Questionnaire. Changes from baseline to other follow-up visits were calculated by exploratory analysis for TSS, VAS, and QoL scores. Results: Data of 411 subjects with PN (104 diabetic, 44 carpal tunnel syndrome, 112 idiopathic, 25 other, and 126 with combinations of different causes) were available at baseline. Mean total TSS had improved by 62.9% at visit 5. Mean VAS reductions at visit 5 ranged from 57.8–89.6% for the evaluated symptoms numbness, burning, tingling, pain, and paresthesia. Symptom relief was associated with a significant improvement in QoL. This was evident in the total population by a significant increase of the physical component summary score (PCS) and the mental component summary score (MCS) at visit 5 compared to baseline (both p<0.0001). In addition, all etiologic subgroups showed a significant progressive QoL improvement over time. Study results related to effectiveness have been published previously; the focus of this publication is on QoL improvement, assessed by one of the secondary parameters. Conclusion: The study results suggest that the fixed dose combination of high-dose vitamin B1, B6 and B12 is effective to treat mild to moderate PN of various etiologies and is well tolerated. The improvements in PN positively affected the patients’ QoL as reflected by the SF-8 scores.
{"title":"Improvement of Quality of Life in Patients with Peripheral Neuropathy Treated with a Fixed Dose Combination of High-Dose Vitamin B1, B6 and B12: Results from a 12-week Prospective Non-interventional Study in Indonesia","authors":"M. Hakim, Nani Kurniani, R. Pinzon, D. Tugasworo, Mudjiani Basuki, Hasnawi Haddani, Pagan Pambudi, A. Fithrie, A. D. Wuysang","doi":"10.4172/2167-0870.1000343","DOIUrl":"https://doi.org/10.4172/2167-0870.1000343","url":null,"abstract":"Objective: The 12-week prospective, non-interventional study conducted in Indonesia aimed to evaluate the effectiveness and safety of a fixed combination of high-dose vitamin B1, B6 and B12 in subjects with peripheral neuropathy (PN) of various etiology. As PN is known to significantly impair patients’ quality of life (QoL), special attention has been paid to this aspect and QoL data were collected as secondary outcome parameters over time. Methods: The study enrolled subjects aged 18–65 years with mild or moderate PN of various etiologies. PN symptoms were measured by Total Symptom Score (TSS) and Visual Analogue Scale (VAS) at visit 1 (baseline), visit 2 (day 14), visit 3 (day 30), visit 4 (day 60), and visit 5 (day 90). At visits 1, 3, 4, and 5, the subjects also reported QoL data as assessed by the Short Form 8 (SF-8) Health Survey Questionnaire. Changes from baseline to other follow-up visits were calculated by exploratory analysis for TSS, VAS, and QoL scores. Results: Data of 411 subjects with PN (104 diabetic, 44 carpal tunnel syndrome, 112 idiopathic, 25 other, and 126 with combinations of different causes) were available at baseline. Mean total TSS had improved by 62.9% at visit 5. Mean VAS reductions at visit 5 ranged from 57.8–89.6% for the evaluated symptoms numbness, burning, tingling, pain, and paresthesia. Symptom relief was associated with a significant improvement in QoL. This was evident in the total population by a significant increase of the physical component summary score (PCS) and the mental component summary score (MCS) at visit 5 compared to baseline (both p<0.0001). In addition, all etiologic subgroups showed a significant progressive QoL improvement over time. Study results related to effectiveness have been published previously; the focus of this publication is on QoL improvement, assessed by one of the secondary parameters. Conclusion: The study results suggest that the fixed dose combination of high-dose vitamin B1, B6 and B12 is effective to treat mild to moderate PN of various etiologies and is well tolerated. The improvements in PN positively affected the patients’ QoL as reflected by the SF-8 scores.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"132 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2018-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74887873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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