scholarly journals ANALISIS KORELASI SKOR GEJALA TOTAL, NYERI, DAN KUALITAS HIDUP SETELAH PENGOBATAN VITAMIN B1, B6, DAN B12 DOSIS TINGGI PADA NEUROPATI PERIFER

2018 ◽  
Vol 35 (2) ◽  
Author(s):  
Manfaluthy Hakim ◽  
Nani Kurniani ◽  
Rizaldy Pinzon ◽  
Dodik Tugasworo ◽  
Mudjiani Basuki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Correlation Analysis ◽  
Symptom Score ◽  
Vitamin B1 ◽  
Total Symptom Score ◽  
High Dose ◽  
Open Label ◽  
Combination Tablet

CORRELATION ANALYSIS OF TOTAL SYMPTOM SCORE, PAIN, AND QUALITY OF LIFE POST HIGH DOSE VITAMIN B1, B6, DAN B12 TREATMENT IN PERIPHERAL NEUROPATHYABSTRACTIntroduction: Peripheral neuropathy (PN) is a clinical condition in which nerves of the peripheral nervous system are damaged and is associated with various symptoms affecting the patients’ quality of life (QoL).Aims: To understand the  effect of Vitamin B1, B6, and B12 combination in mild to moderate PN.Methods: This is a prospective, open label, multicenter, single arm observational study involved 399 subjects with PN of different etiology. Subjects received the vitamin B1, B6, and B12 combination tablet orally once daily and were observed for 3 months. Total symptom score (TSS), visual analog score (VAS) and QoL were assessed, and the correlation between these parameters was analyzed.Results: Clinically significant reductions were observed from baseline to subsequent visits for TSS and VAS. Positive correlation  was observed between TSS and components of VAS. The study treatment was associated with a significant improvement in QoL parameters. Inverse correlation was observed between QoL and TSS as well as QoL and components of VAS. The study treatment was found to be well tolerated.Discussion: The correlation  analysis between different outcome measures demonstrated the beneficial effect of combination of vitamin B1, B6, and B12 in relief from symptoms and improvement in QoL of PN.Keyword: Correlation analysis, peripheral neuropathy, SF-8, TSS, VAS, vitamin B1, B6, and B12ABSTRAKPendahuluan: Neuropati perifer (NP) merupakan kondisi klinis akibat kerusakan pada sistem saraf tepi yang memengaruhi kualitas hidup (quality of life/QoL) pasien.Tujuan: Mengetahui efek pemberian kombinasi vitamin B1, B6, and B12 pada NP ringan hingga sedang.Metode: Penelitian observasional dan prospektif secara open label, multisenter, dan single arm, yang melibatkan 399 subjek penderita neuropati perifer dengan etiologi yang berbeda-beda. Subjek mengonsumsi tablet kombinasi vitamin B1, B6, and B12 secara oral satu kali sehari dan diamati selama 3 bulan. Dilakukan penilaian skor gejala total (total symptom score/TSS), visual analog scale (VAS), dan QoL, serta korelasi antara parameter-parameter tersebut.Hasil: Terdapat penurunan TSS dan VAS yang bermakna secara klinis antara baseline (awal) dengan kunjungan berikutnya. Terdapat korelasi yang positif antara TSS dengan komponen-komponen VAS. Pemberian perlakuan dalam penelitian berkorelasi secara bermakna dengan perbaikan parameter dalam QoL. Teramati juga adanya hubungan terbalik antara QoL dengan TSS serta QoL dan komponen VAS. Pengobatan pada penelitian ini juga terbukti dapat ditoleransi dengan baik.Diskusi: Analisis korelasi antara berbagai macam metode pengukuran yang berbeda menunjukkan manfaat dari pemberian kombinasi vitamin B1, B6, and B12 dalam mengurangi gejala dan perbaikan QoL pada pasien PN.Kata kunci: Analisis korelasi, neuropati perifer, kualitas hidup, SF-8, TSS, VAS, vitamin B1, B6, and B12

scholarly journals Management of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1, B6 and B12: A 12-week prospective non-interventional study in Indonesia

2018 ◽  
Vol 9 (1) ◽  
pp. 32-40 ◽  
Author(s):  
Manfaluthy Hakim ◽  
Nani Kurniani ◽  
Rizaldy Taslim Pinzon ◽  
Dodik Tugasworo ◽  
Mudjiani Basuki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Vitamin B1 ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
High Dose ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Dose Combination

Background: Peripheral neuropathy is a common condition which can have a significant impact on quality of life. It occurs as a component of several common and rare diseases or can be idiopathic and can present with various symptoms.Aims and Objectives: This study is aimed at evaluating the effectiveness and safety of the fixed dose combination of vitamin B1, B6 and B12in mild to moderate peripheral neuropathy of various etiologies in the Indonesian population.Materials and Methods: This was a prospective, open label, multi-center, single arm observational study (Indonesian Clinical Trial Registry No: INA-KPA0DYA). A total of 411 subjects with mild to moderate peripheral neuropathy of various etiologies, who met the eligibility criteria, were included in the study. A subject was considered to have “completed” the study if the study procedures, up to Visit 3 (one month of treatment) were accomplished. Procedural results and 12-week clinical outcomes are reported.Results: Treatment with combination of vitamin B1, B6 and B12 in subjects with symptoms of PN showed significant improvement in overall Total Symptom Score (TSS), within 14 days. The treatment also successfully reduced individual components of TSS from baseline to Visit 5. A significant percentage reduction was also observed for all the Visual Analogue Scale (VAS) parameters at the end of 12 weeks, while the Quality of Life (QoL) scores increased from baseline to the end of treatment.Conclusions: The fixed dose combination of vitamin B1, B6 and B12 was effective and welltolerated in subjects with mild to moderate peripheral neuropathy, of various etiologies.Asian Journal of Medical Sciences Vol.9(1) 2018 32-40

SO051PROSPECTIVE OPEN-LABEL EXPLORATIVE RANDOMISED SINGLE CENTRE COMPARATIVE STUDY TO DETERMINE THE EFFECTS OF VARIOUS INTRAVENOUS IRON PREPARATIONS ON HAEMOGLOBIN, HAEMETENICS, MARKERS OF KIDNEY FUNCTION, QUALITY OF LIFE AND SAFETY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xenophon Kassianides ◽  
Ahmed Zeidan ◽  
Sunil Bhandari
Keyword(s):  
Quality Of Life ◽  
Kidney Function ◽  
Intravenous Iron ◽  
P Value ◽  
High Dose ◽  
Short Term ◽  
Open Label ◽  
Post Dose ◽  
Iv Iron

Abstract Background and Aims Iron deficiency in Chronic Kidney Disease (CKD) is common. It frequently necessitates the use of intravenous (IV) iron for correction. A number of second and third generation preparations are now in clinical use with potentially increased efficacy and improved safety profiles. Concerns remain regarding the potential impact of intravenous iron on oxidative stress, kidney function, inflammation and endothelial function, which in turn may represent non-traditional cardiovascular risk factors. The aim of this study is to verify whether three different IV iron preparations have similar safety, efficacy and effects on oxidative stress, inflammation, endothelial and renal function in a non-dialysis CKD population in the short term. Method This was a prospective open-label exploratory randomized, single-centre study comparing the efficacy and safety of three parenteral iron formulations (Iron Dextran (ID), Iron Sucrose (IS) and Iron Isomaltoside (IIM)). Patients with established CKD stages 3-5 and ferritin (SF) < 200microg/L and/or transferrin saturation (TS) <20% were recruited. They were randomized in a 1:1:1:1 ratio receiving a single infusion of ID 200mg IS 200mg, or IIM either at a low (200mg) or high dose (1000mg). Follow-up took place at 2 hours, 1 day, 1 week, 1 month and 3 months post-infusion. Response to iron was assessed using haemoglobin, TS and SF. Kidney function (Creatinine (Cr), eGFR) and proteinuria as a marker of injury (protein:creatinine, albumin:creatinine) were monitored. C-reactive protein (CRP) was used as an inflammatory indicator. Arterial response was monitored using Pulse wave velocity (PWVI). Quality of Life was assessed via the SF-36 questionnaire. Adverse events (AEs) were captured throughout the study, recorded for safety analysis and evaluation of relationship to treatment. Data is presented as means and standard error of the mean (SEM). Statistical analysis was carried out using ANOVA. A p value of <0.05 was statistically significant. Results: Forty patients were recruited and randomized ten to each group; 58% of the patients were male. The mean age was 58.8 years (±2.2). TS and SF rose in response to iron. Greater and more lasting ferritin repletion was seen in the group receiving 1000mg of IIM (pre-dose: 69.1 microg/L (±18.4); 3 months: 271.0 microg/L (±83.3)). All IV iron preparations led to a significant but transient rise in TS within the first 2 hours especially IIM 1000 group (17.8% to 98.7%; p-value <0.001) and IS (21.1% to 91.4%; p-value<0.01) to values >90%. These returned to baseline within 1 week. There was no statistical difference in haemoglobin concentration throughout both cumulatively and comparatively. CRP increased within one day but returned to normal values within one week – this was most pronounced with IS (pre-dose CRP: 8.1 (±3.3) 1-day CRP: 36.1 (±27.0); p=0.29). There was no short-term impact on renal function; mean Cr pre-dose: 234.6 umol/L (±16.6), to 216.6umol/L (±16.2) and mean eGFR pre-dose: 28.2 ml/min (±2.2) to 28.5 ml/min (±2.5). Proteinuria following infusion with IV iron was unchanged (pre-dose: 154.2 mg/mmol (±48.4); 2-hours post-dose: 127.5 mg/mmol (±45.2). Arterial stiffness (PWVI) did not increase following IV iron infusion irrespective of preparation or dosage. Quality of Life improved, which was more evident one month following infusion (pre-dose: 47.7 (±3.8); post-dose 54.4 (±4.3). There was one serious AE in the IIM high dose group with a death more than 2 weeks following infusion likely unrelated to infusion. Conclusion Both high and low dose intravenous irons are effective in replenishing the iron stores with significant increase in iron biomarkers. In the short-term there was no impact on kidney function, inflammation or vascular function. Intravenous iron, irrespective of impact on haemoglobin, translates to improvement in quality of life. Larger and more long-term studies are required to further assess safety.

scholarly journals Myeloproliferative Neoplasm (MPN) Symptom Assessment Form Total Symptom Score: Prospective International Assessment of an Abbreviated Symptom Burden Scoring System Among Patients With MPNs

2012 ◽  
Vol 30 (33) ◽  
pp. 4098-4103 ◽  
Author(s):  
Robyn M. Emanuel ◽  
Amylou C. Dueck ◽  
Holly L. Geyer ◽  
Jean-Jacques Kiladjian ◽  
Stefanie Slot ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Symptom Score ◽  
Myeloproliferative Neoplasm ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Response To Therapy ◽  
Total Symptom Score ◽  
Life Questionnaire ◽  
Scoring Method

Purpose Myeloproliferative neoplasm (MPN) symptoms are troublesome to patients, and alleviation of this burden represents a paramount treatment objective in the development of MPN-directed therapies. We aimed to assess the utility of an abbreviated symptom score for the most pertinent and representative MPN symptoms for subsequent serial use in assessing response to therapy. Patients and Methods The Myeloproliferative Neoplasm Symptom Assessment Form total symptom score (MPN-SAF TSS) was calculated as the mean score for 10 items from two previously validated scoring systems. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. Results MPN-SAF TSS was calculable for 1,408 of 1,433 patients with MPNs who had a mean score of 21.2 (standard deviation [SD], 16.3). MPN-SAF TSS results significantly differed among MPN disease subtypes (P < .001), with a mean of 18.7 (SD, 15.3), 21.8 (SD, 16.3), and 25.3 (SD, 17.2) for patients with essential thrombocythemia, polycythemia vera, and myelofibrosis, respectively. The MPN-SAF TSS strongly correlated with overall quality of life (QOL; r = 0.59; P < .001) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) functional scales (all P < .001 and absolute r ≥ 0.50 except social functioning r = 0.48). No significant trends were present when comparing therapy subgroups. The MPN-SAF TSS had excellent internal consistency (Cronbach's α = .83). Factor analysis identified a single underlying construct, indicating that the MPN-SAF TSS is an appropriate, unified scoring method. Conclusion The MPN-SAF TSS is a concise, valid, and accurate assessment of MPN symptom burden with demonstrated clinical utility in the largest prospective MPN symptom study to date. This new prospective scoring method may be used to assess MPN symptom burden in both clinical practice and trial settings.

scholarly journals Assessment of quality of life measured by rhinoconjuctivits quality of life questionnaire in patients of allergic rhinitis treated with commonly used oral antihistaminics

2019 ◽  
Vol 8 (8) ◽  
pp. 1830
Author(s):  
Ganesh S. Pentewar ◽  
Ranjit J. Wagh
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Symptom Score ◽  
Life Questionnaire ◽  
Open Label ◽  
Treatment Groups ◽  
Quality Of Life Questionnaire ◽  
Nasal Symptoms ◽  
The Impact

Background: Nasal and non-nasal symptoms in allergic rhinitis (AR) can be assessed by measuring health related quality of life (HRQOL). Present study was to assess the impact of use of antihistaminic in AR which will affect the work productivity, sleep, frequent visits to health care professional and expenditure on medicines. For this evaluation, Rhinoconjuctivits Quality Of Life Questionnaire (RQLQ) has been used.Methods: In this study 52 patients with AR were randomized in an open-label, 4-arm, parallel group, single center study. Questionnaire information was obtained about allergy-related RQLQ. Subjects received either Tablet Cetirizine 5 mg, Levocetirizine 5 mg, Loratidine 5 mg or Fexofenadine 120 mg. Changes from baseline until the end of study visit (1 week following) were evaluated by RQLQ.Results: When compared between treatment groups using one-way ANOVA it was observed that there is no variation in RQLQ overall Score in all the four treatment groups and there is no difference from treatment to treatment. Overall RQLQ score was reduced maximum in Levocetirizine group. Individual symptoms of RQLQ that is sleep score, non-hay fever, practical problem, nasal symptom score, Eye symptom Score, activities Score, and emotion score were also improved in the Levocetirizine group.Conclusions: Patients of all four study groups showed an improved perception of their HRQL according to the RQLQ. Significant improvements are reported in nasal symptoms, daily activities, sleep and psychological impact. Our results provide support for an AR and its impact on quality of life. Our recommendation stipulating that levocetirizine is superior to rest drug group for the treatment of AR with safety and tolerability.

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