Global Assessment Of Tolerability Research Articles

The Safety and Effectiveness of Decapeptide in Patients With Vitiligo: A Real-World Study.

Background Vitiligo, a chronic autoimmune depigmenting skin disease, affects a significant portion of the global population. One of the topical treatment options for vitiligo is basic fibroblast growth factor (bFGF)-related decapeptide (bFGFrP) 0.1% solution. This study aimed to assess the real-world effectiveness and safety of decapeptide in treating vitiligo. Methods This retrospective analysis utilized data collected from routine clinical practice in the management of vitiligo, focusing on patients treated with topical decapeptide lotion (Melgain™, manufactured by Zydus Healthcare Ltd., Ahmedabad, India). The primary outcome measures included the extent of re-pigmentation (EOR) and the grade of re-pigmentation (GOR) assessed at each follow-up visit. Results The analysis included data from 65 patients (24 males and 41 females) with an average age of 30.83 years. Segmental vitiligo was present in 52.31% of cases, with the face being the most commonly affected site. Among the patients, 33 received decapeptide as monotherapy, while 32 received decapeptide alongside adjuvant drug/phototherapy. The mean duration of treatment was five months. The first, second, and final follow-ups were observed to be at a mean of 45 days, two months, and five months, respectively. During the second and final follow-up, a significant response (>75% re-pigmentation) was observed in 12% (eight) and 71% (46) of the patients. A mild response (<50% re-pigmentation) was noted in 45% (29) of the patients during the first follow-up visit, 15% (10) during the second follow-up visit, and 6% (four) during the final follow-up visit. Grade 6 and 7 re-pigmentation occurred in a higher number of patients at the final visit, indicating treatment effectiveness. Overall, nearly all patients (96.92%) reported excellent tolerability of the decapeptide lotion based on the global assessment of tolerability. Conclusion This real-world study demonstrates that decapeptide promotes re-pigmentation and improves patient outcomes in vitiligo. Both decapeptide regimens, as monotherapy or in combination with other therapies, were effective and well tolerated by most patients. Thus, decapeptide represents a safe and effective therapeutic option for vitiligo treatment.

Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study.

Background:The aim of the study is to assess the anxiolytic effects of yogic relaxation technique (YRT) in patients requiring root canal treatment (RCT).Materials and Methods:In this prospective, randomized, placebo-controlled study, 30 patients undergoing RCT with baseline visual analog scale for anxiety (VAS-A) of score >4 were divided into Group 1: YRTs; Group 2: alprazolam (0.25 mg/0.5 mg), and Group 3: placebo. After 30 min of completion of YRT, endodontic treatment was performed. Reduction in anxiety was analyzed using state anxiety score (domain) of the state-trait anxiety inventory scale.Results:There was no significant difference in anxiety score 1 h before RCT between groups (P = 0.401). Ten minutes before (P < 0.0001) and after RCT (P < 0.0001), there was significant difference between groups (yogic relaxation vs. alprazolam [P < 0.0001]; yogic relaxation vs. placebo [P < 0.0001]). Ten minutes before RCT, yoga relaxation showed significant difference in anxiety score for pain versus alprazolam and placebo (P < 0.0001 for both). Ten minutes after RCT, the change from baseline in mean anxiety score for pain was significantly different with yogic relaxation (versus alprazolam [P = 0.043]; versus placebo [P = 0.002]). As per the global assessment of efficacy, the response was excellent in 9 (90%), 2 (20%), and 1 (10%) patients in yoga relaxation group, alprazolam group, and placebo group, respectively. Difference in response between three groups was significant (P < 0.0001). There was no significant difference in the global assessment of tolerability between three groups (P = 0.535). No adverse events were reported.Conclusion:Before RCT, YRT is an effective alternative to anxiolytic agents, alprazolam.

Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001) in the treatment of irritable bowel syndrome: a multicentre, randomised, double-blind, placebo-controlled clinical trial

Bifidobacterium bifidum MIMBb75 is one of a few probiotic strains that have been shown to be effective in the treatment of irritable bowel syndrome (IBS) and its symptoms. Non-viable strains might have advantages over viable bacteria for product stability and standardisation, as well as for tolerability because safety concerns have been raised for specific patient groups who are susceptible to infection. We aimed to assess the efficacy of non-viable, heat-inactivated (HI) B bifidum MIMBb75 (SYN-HI-001) in the treatment of IBS and its symptoms. We did a double-blind, placebo-controlled trial in which patients with IBS were recruited from 20 study sites in Germany and randomly assigned to receive either two placebo capsules or two capsules with a combined total of 1 × 109 non-viable B bifidum HI-MIMBb75 cells to be taken orally once a day for 8 weeks. Eligible patients were diagnosed with IBS according to Rome III criteria and had abdominal pain (≥4 on an 11-point numerical rating scale) on at least 2 days during a 2-week run-in phase. Patients with chronic inflammatory bowel diseases, systemic diseases, cancer, autoimmune diseases, with an intake of antipsychotic medications 3 months before study start, or with an intake of systemic corticosteroids within 1 month before study start were excluded. Randomisation was in a 1:1 ratio according to a computer-generated blocked list. Patients, investigators, clinical monitors, project managers, and statisticians were masked to the randomisation. The primary composite endpoint was the combination of at least 30% improvement of abdominal pain and adequate relief of overall IBS symptoms being fulfilled in at least 4 of 8 weeks during treatment. Analysis of the primary endpoint included all randomly assigned patients receiving at least one dose of study medication and who had no severe protocol violation. Safety analysis included all patients who had taken at least one dose of the study medication and was based on frequency and severity of adverse events, laboratory evaluation, and global assessment of tolerability. This trial is registered with the ISRCTN registry, ISRCTN14066467, and is completed: the results shown here represent the final analysis. Patients were screened between April 15, 2016, and Feb 3, 2017, and 443 patients were allocated to the placebo group (n=222) or the B bifidum HI-MIMBb75 group (n=221). The composite primary endpoint was reached by 74 (34%) of 221 patients in the B bifidum HI-MIMBb75 group compared with 43 (19%) of 222 in the placebo group (risk ratio 1·7, 95% CI 1·3-2·4; p=0·0007). No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group. No deaths were reported in this study. The most common reported adverse event with a suspected relationship to the study product was abdominal pain, which was reported in two (<1%) patients in the B bifidum HI-MIMBb75 group and one (<1%) in the placebo group. Tolerability was rated as very good or good by 200 (91%) patients in the B bifidum HI-MIMBb75 group compared with 191 (86%) in the placebo group. This study shows that B bifidum HI-MIMBb75 substantially alleviates IBS and its symptoms in a real-life setting. These results indicate that specific beneficial bacterial effects are mediated independently of cell viability. Synformulas.

Efficacy and Tolerability of Fixed-Dose Combination of Dexketoprofen and Dicyclomine Injection in Acute Renal Colic

Objective. To evaluate the efficacy and tolerability of a fixed-dose combination of dexketoprofen and dicyclomine (DXD) injection in patients with acute renal colic. Patients and Methods. Two hundred and seventeen patients were randomized to receive either DXD (n = 109) or fixed-dose combination of diclofenac and dicyclomine injection (DLD; n = 108), intramuscularly. Pain intensity (PI) was self-evaluated by patients on visual analogue scale (VAS) at baseline and at 1, 2, 4, 6, and 8 hours. Efficacy parameters were proportion of responders, difference in PI (PID) at 8 hours, and sum of analogue of pain intensity differences (SAPID). Tolerability was assessed by patients and physicians. Results. DXD showed superior efficacy in terms of proportion of responders (98.17% versus 81.48; P < 0.0001), PID at 8 hours (P = 0.002), and SAPID0–8 hours (P = 0.004). The clinical global impression for change in pain was significantly better for DXD than DLD. The incidence of adverse events was comparable in both groups. However, global assessment of tolerability was rated significantly better for DXD. Conclusion. DXD showed superior efficacy and tolerability than DLD in patients clinically diagnosed to be suffering from acute renal colic.

Efficacy of a Comfrey root extract ointment in comparison to a Diclo-fenac gel in the treatment of ankle distortions: Results of an observer-blind, randomized, multicenter study

In the treatment of minor blunt injuries several topical drugs are known to have anti-inflammatory and analgesic properties. They represent, however, two fundamentally different major pharmacological therapy approaches: the "chemical-synthetical" and the "phytotherapeutical" approach. The main objective of this trial (CODEC_2004) was to compare the efficacy and tolerability of an ointment of Comfrey extract (Extr. Rad. Symphyti) with that of a Diclofenac gel in the treatment of acute unilateral ankle sprain (distortion). In a single-blind, controlled, randomized, parallel-group, multicenter and confirmatory clinical trial outpatients with acute unilateral ankle sprains (n=164, mean age 29.0 years, 47.6% female) received either a 6 cm long ointment layer of Kytta-Salbe f (Comfrey extract) (n=82) or of Diclofenac gel containing 1.16 g of diclofenac diethylamine salt (n=82) for 7 +/- 1 days, four times a day. Primary variable was the area-under-the-curve (AUC) of the pain reaction to pressure on the injured area measured by a calibrated caliper (tonometer). Secondary variables were the circumference of the joint (swelling; figure-of-eight method), the individual spontaneous pain sensation at rest and at movement according to a Visual Analogue Scale (VAS), the judgment of impaired movements of the injured joint by the method of "neutral-zero", consumption of rescue medication (paracetamol), as well as the global efficacy evaluation and the global assessment of tolerability (both by physician and patient, 4 ranks). In this study the primary variable was also to be validated prospectively. It was confirmatorily shown that Comfrey extract is non-inferior to diclofenac. The 95% confidence interval for the AUC (Comfrey extract minus Diclofenac gel) was 19.01-103.09h*N/cm2 and was completely above the margin of non-inferiority. Moreover, the results of the primary and secondary variables indicate that Comfrey extract may be superior to Diclofenac gel.

Efeitos da titulação de doses no perfil de tolerabilidade de Tramadol de liberação prolongada&lt;a href="#back1"&gt;*&lt;/a&gt; em pacientes com dor crônica não-oncológica

Este estudo multicêntrico teve por objetivo comparar os efeitos de dois esquemas posológicos no perfil de tolerabilidade do tramadol de liberação prolongada em pacientes com dor crônica não-oncológica. A casuística envolveu 189 pacientes com idade entre 14 e 75 anos, divididos em 2 grupos aleatoriamente: grupo A com 96 e o grupo B com 93 pacientes que receberam a medicação do estudo por 15 dias. O grupo A utilizou uma dose inicial de tramadol de liberação prolongada de 50mg a cada 12 horas por 3 a 7 dias, passando para uma dose de manutenção de 100mg a cada 12 horas até o 15º dia. O grupo B fez uso de uma dose padronizada de 100mg a cada 12 horas de tramadol de liberação prolongada durante os 15 dias do estudo. Os aspectos analisados foram o tipo de dor crônica não-oncológica, a intensidade da dor através da escala visual analógica, a aderência ao tratamento prescrito, a necessidade do uso da medicação de resgate, os efeitos adversos, a avaliação global da eficácia pelo médico e pelo paciente, bem como a tolerabilidade global na opinião do médico e do paciente. A dor de origem músculo-esquelética, definida como dor muscular com suas inserções no osso, foi a mais freqüente com 45,8% dos casos no grupo A, enquanto a dor osteoarticular foi a mais observada no grupo B (47,3%). Verificou-se uma melhora altamente significante tanto intra grupos como entre grupos, quanto à intensidade da dor, com redução de 67% em ambos os grupos. No grupo A, 77,1% dos pacientes cumpriram adequadamente o tratamento prescrito e no grupo B, a proporção foi de 75,3%, não havendo diferença estatisticamente significativa entre os grupos. Os grupos foram semelhantes entre si quanto à utilização da medicação de resgate, onde apenas 9,7% dos pacientes do grupo A e 15,1% do grupo B necessitaram-na durante o período do estudo. Não houve diferença significante na freqüência de eventos adversos nos dois grupos ( 30,2% e 36,6% respectivamente). Nos pacientes cuja dose final foi de 200mg/dia, a avaliação global da eficácia foi considerada boa e excelente pelos investigadores no grupo A em 86,7% dos pacientes e no grupo B o resultado foi de 78,8%. Os pacientes do grupo A consideraram a avaliação global da eficácia como boa e excelente em 88,9% e no grupo B 78,8%. A tolerabilidade da droga foi considerada entre boa e excelente pelos investigadores no grupo A em 86% e no grupo B o resultado foi de 77,2%. Os pacientes consideraram a tolerabilidade da droga como boa e excelente no grupo A em 77,4% e no grupo B o resultado foi de 71,5%. Em conclusão, os dois grupos de tratamento foram estatisticamente semelhantes em relação a todos os parâmetros estudados, com exceção da intensidade da dor, a qual foi inicialmente maior no grupo B, sendo equivalente em ambos os grupos ao final do estudo. Houve uma tendência favorável, porém não significante, ao esquema terapêutico de titulação de doses.