scholarly journals The Effect of Intravenous Lidocaine on Trigeminal Neuralgia: A Randomized Double Blind Placebo Controlled Trial

ISRN Pain ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Evmorfia Stavropoulou ◽  
Erifili Argyra ◽  
Panagiotis Zis ◽  
Athina Vadalouca ◽  
Ioanna Siafaka
Keyword(s):  
Trigeminal Neuralgia ◽  
Controlled Trial ◽  
Line Treatment ◽  
Intravenous Lidocaine ◽  
Inclusion Criteria ◽  
First Line ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Therapeutic Results ◽  
First Line Treatment

Trigeminal neuralgia is the most common neuralgia. Its therapeutic approach is challenging as the first line treatment often does not help, or even causes intolerable side effects. The aim of our randomized double blind, placebo controlled, crossover study was to investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia. Twenty patients met our inclusion criteria and completed the study. Each patient underwent four weekly sessions, two of which were with lidocaine (5 mgs/kg) and two with placebo infusions administered over 60 minutes. Intravenous lidocaine was superior regarding the reduction of the intensity of pain, the allodynia, and the hyperalgesia compared to placebo. Moreover, contrary to placebo, lidocaine managed to maintain its therapeutic results for the first 24 hours after intravenous infusion. Although, intravenous lidocaine is not a first line treatment, when first line medications fail to help, pain specialists may try it as an add-on treatment. This trial is registered with NCT01955967.

Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study

2007 ◽  
Vol 25 (30) ◽  
pp. 4779-4786 ◽  
Author(s):  
Charles S. Fuchs ◽  
John Marshall ◽  
Edith Mitchell ◽  
Rafal Wierzbicki ◽  
Vinod Ganju ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Primary Study ◽  
Line Treatment ◽  
First Line ◽  
Double Blind ◽  
First Line Treatment

PurposeThis phase III study compared the safety and efficacy of the following three different irinotecan-containing regimens in the first-line treatment of metastatic colorectal cancer: irinotecan plus infusional fluorouracil (FU)/leucovorin (LV) (FOLFIRI), irinotecan plus bolus FU/LV (mIFL), and irinotecan plus oral capecitabine (CapeIRI).Patients and MethodsA total of 430 previously untreated metastatic colorectal cancer patients were randomly assigned to receive FOLFIRI (n = 144), mIFL (n = 141), or CapeIRI (n = 145). Patients were concurrently randomly assigned to a double-blind treatment with celecoxib or placebo. After a protocol amendment, an additional 117 patients were randomly assigned to either FOLFIRI plus bevacizumab (FOLFIRI+Bev; n = 57) or mILF plus bevacizumab (mIFL+Bev; n = 60), whereas the CapeIRI arm was discontinued. The primary study end point was progression-free survival (PFS), with secondary end points of overall survival (OS), response rate, and toxicity.ResultsMedian PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (P = .004 for the comparison with FOLFIRI), and 5.8 months for CapeIRI (P = .015). Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (P = .09), and 18.9 months for CapeIRI (P = .27). CapeIRI was associated with higher rates of severe vomiting, diarrhea, and dehydration. After the amendment to add bevacizumab, the median survival time has not yet been reached for FOLFIRI+Bev and was 19.2 months for mIFL+Bev (P = .007). FOLFIRI+Bev was associated with a higher rate of ≥ grade 3 hypertension than mIFL+Bev.ConclusionFOLFIRI and FOLFIRI+Bev offered superior activity to their comparators and were comparably safe. An infusional schedule of FU should be the preferred irinotecan-based regimen in first-line metastatic colorectal cancer.

scholarly journals Chinese Herbal Medicine (Yiqi-Yangyin-Jiedu Decoction) Combined With Osimertinib As First-Line Treatment For Advanced Non-Small-Cell Lung Cancer With EGFR Sensitizing Mutation (CATLA-2): A Study Protocol For A Double-Blind Randomized Controlled Trial

2021 ◽  
Author(s):  
Yan Lu ◽  
Jialin Yao ◽  
Lijing Jiao ◽  
Ling Bi ◽  
Wenxiao Yang ◽  
...  
Keyword(s):  
First Generation ◽  
Controlled Trial ◽  
Acquired Resistance ◽  
Line Treatment ◽  
First Line ◽  
Double Blind ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
Egfr Tkis ◽  
First Line Treatment

Abstract Background: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (EGFR-TKIs) significantly improve the prognosis of non-small cell lung cancer (NSCLC) with EGFR sensitizing mutation. Although third-generation EGFR-TKI osimertinib is demonstrated with superior efficacy compared with first-generation EGFR-TKIs, acquired resistance to EGFR-TKIs remains the bottleneck. The Chinese herbal medicine (CHM) Yiqi-Yangyin-Jiedu decoction (YYJD) has been proved to delay acquired resistance to first-generation EGFR-TKIs in CATLA study, but there is no high-level evidence for its effect when combined with osimertinib. This trial aims to examine the efficacy and safety of YYJD combined with osimertinib as first-line treatment for advanced NSCLC harboring EGFR sensitizing mutation.Methods: This is a double-blind, multi-center, randomized controlled trial conducted in 8 hospitals in China. A total of 314 participants will be randomly assigned to the osimertinib plus YYJD group (O+YYJD) or the osimertinib plus placebo group (O+placebo). Treatment will last until disease progression or death. Patients diagnosed with stage IV NSCLC harboring EGFR exon 19 del or exon 21 L858R will be enrolled if they are in accordance with deficiency of Qi and Yin pattern, ready to take osimertinib as first-line treatment, aged 18 to 74 years old, and provide signed informed consent. The primary outcome is progression-free survival (PFS). The secondary outcomes include a comparison of overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL). The analysis will be on intention-to-treat and per-protocol subject analysis principles.Discussion: The goal of this trial is to evaluate the efficacy and safety of YYJD when added to 3 osimertinib as first-line treatment for advanced NSCLC with EGFR sensitizing mutation.Trial registration: Chictr.org.cn ChiCTR1900026748. Registered on 20th October 2019.

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