scholarly journals Effects of Dexamethasone on Post-dural Puncture Headache in Patients Undergoing Orthopedic Surgery

2020 ◽  
Vol 13 (1) ◽  
pp. 42-46
Author(s):  
Hadis Barkhori ◽  
Farhad Arefi ◽  
Kiavash Hushmandi ◽  
Salman Daneshi ◽  
Jafar Salehi ◽  
...  
Keyword(s):  
Orthopedic Surgery ◽  
Dural Puncture ◽  
Controlled Trial ◽  
Study Groups ◽  
Control Group ◽  
Double Blind ◽  
Post Dural Puncture Headache ◽  
Double Blind Placebo ◽  
Dexamethasone Group ◽  
Post Operative Period

Background: The effect of Dexamethasone on Post-Dural Puncture Headache (PDPH) after spinal anesthesia has not been well elucidated. The aim of the current study was to evaluate the effect of prophylactic intravenous dexamethasone on the incidence and severity of PDPH in patients undergoing orthopedic surgery. Methods: This randomized, double-blind, placebo-controlled trial was carried out in patients undergoing orthopedic surgery. The subjects were randomly divided into a placebo (n=140) and a dexamethasone (n=140) group. During the surgery, the control group participants were injected 2cc of distilled water, and the dexamethasone group participants were injected 2cc (8mg) of dexamethasone as an infusion in the veins. The incidences of PDPH on the first, third and seventh postoperative days were studied. Data were analyzed using SPSS version 22. Results: A total of 280 patients with a mean age of 32.7 ± 11.0 years were studied. The incidence of PDPH on the first day of post-operative period was lower in the dexamethasone group than the control group (21 vs. 34, P<0.05). This difference was disappeared on days 3 and 7. Nausea or vomiting occurred less in the dexamethasone group (9 vs. 26, P<0.05). However, no statistically significant association was found between study groups and the incidence of back pain (P>0.05). Conclusion: Although the frequency of PDPH was less in patients receiving dexamethasone, the incidence increased days after the operation and reached the level of the placebo group. We do not recommend prophylactic intravenous dexamethasone for the prevention of PDPH.

scholarly journals Suboccipital Muscles Injection for Management of Post-Dural Puncture Headache After Cesarean Delivery: A Randomized-Controlled Trial

2019 ◽  
Vol 7 (4) ◽  
pp. 549-552 ◽  
Author(s):  
Mhamed Abdelraouf ◽  
Maged Salah ◽  
Mohsen Waheb ◽  
Ahmed Elshall
Keyword(s):  
Cesarean Section ◽  
Dural Puncture ◽  
Controlled Trial ◽  
Demographic Data ◽  
Visual Analogue Score ◽  
Control Group ◽  
Neck Muscle ◽  
Rescue Analgesia ◽  
Post Dural Puncture Headache ◽  
Control Group Group

INTRODUCTION: Post-dural puncture headache (PDPH) is a common complication following neuraxial anaesthesia that increases the duration of hospital stay. AIM: This study aims to evaluate the effectiveness of injection of the dexamethasone-lidocaine mixture in suboccipital muscles treatment of PDPH after cesarean section. PATIENT AND METHODS: A group of 90 females with PDPH following cesarean section under spinal anaesthesia were randomly allocated into two equal groups: study group (Group S) and control group (group C). All patients received bilateral intramuscular (in the suboccipital muscle) (Group S) (n = 45) patients received lidocaine 40 mg (2 mL of 2% solution) and dexamethasone 8mg in a total volume of 4 mL; whilst, patients in the control group (group C) (n = 45) received 4 mL normal saline. The primary outcome is the Visual Analogue Score for a headache at 24 hours after injection. RESULTS: Demographic data and the baseline, headache score, neck muscle spasm, and nausea were comparable in both groups. Group S showed lower headache score compared to group C at all the post-injection time points. All patients in group S showed resolution of nausea after the intervention; while none of the control group showed any improvement. All patients of group C needed rescue analgesia; while only 6 (13.3%) patients in group S asked for an analgesic. Time to the first analgesic request was longer in group S compared to group C (10.17 ± 7.96 hours versus 1.00 ± 0.00 hours, P < 0.001). CONCLUSION: Ultrasound-guided injection of the dexamethasone-lidocaine mixture in suboccipital muscles is effective management of PDPH after CS.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

scholarly journals Efficacy and Safety of Chuanxiong Qingnao Granule in Patients with Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Yi-Fan Li ◽  
Hui-Min Hu ◽  
Bo-Ning Wang ◽  
Yi Zhang ◽  
Xing Liu ◽  
...  
Keyword(s):  
Treatment Group ◽  
Migraine Attack ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Attack Frequency ◽  
Double Blind ◽  
Double Blind Placebo

Objective. To evaluate the efficacy and safety of Chuanxiong Qingnao Granule (CQG) to treat migraine. Method. This study was a randomized, double-blind, placebo-controlled trial. All migraineurs were recruited and randomly assigned into a treatment group treated with CQG and a control group treated with a placebo. The whole research process included a 4-week baseline, 12-week intervention, and 12-week follow-up. The primary outcome was responder rate, defined as the percentage of migraineurs with 50% or more reduction in the frequency of migraine attack during treatment and posttreatment period compared with the baseline. The secondary outcomes were the number of migraine days, migraine attack frequency, visual analogue scale (VAS), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HAMD), and Migraine Disability Assessment (MIDAS). Results. A total of 346 migraineurs completed the research and were included in the intention-treatment analyses. The response rates differed significantly between the treatment group and the control group (71.5% vs. 12.1% at week 12 and 83.1% vs. 3.4% at week 24). Attack frequency, days of headache attack, VAS, FSS, HAMD, and MIDAS decreased at week 12 in both groups with more reduction in the treatment group ( P < 0.001 ). No severe adverse events were observed in this trial. Conclusion. Chuanxiong Qingnao Granule can significantly improve headache symptoms in patients with migraine while improving disability, fatigue, and depression with a good safety profile.

scholarly journals Intravenous methylcobalamin effectively ameliorated painful diabetic neuropathy: A randomized double-blind placebo controlled trial

2021 ◽  
Vol 20 (3) ◽  
pp. 335-341
Author(s):  
Thomas Eko Purwata ◽  
◽  
I Putu Eka Widyadharma ◽  
Made Rudy ◽  
Andreas Soejitno ◽  
...  
Keyword(s):  
Treatment Group ◽  
Diabetic Neuropathy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Painful Diabetic Neuropathy ◽  
Double Blind ◽  
Entire Study ◽  
Double Blind Placebo ◽  
And Control

Objective. Painful diabetic neuropathy (PDN) is a prevalent debilitating consequence of diabetes mellitus with lack of satisfactory therapeutic options. Methylcobalamin (MeCbl) is one of vitamin B12 analogs with known neurotrophic effects. We aimed to determine if MeCbl can relieve PDN. Materials and methods. This was a randomized (1:1) double-blind placebo-controlled trial involving PDN patients. Treatment and control group received daily 12.5 mg oral amitriptyline bid with either 500 µg of intravenous MeCbl or saline injection given on alternating days, respectively, for a 9-consecutive day period. PDN was assessed with douleur neuropathique 4 (DN4) questionnaire. Numeric pain rating scale (NPRS) was used to monitor pain intensity and treatment response. All investigators and patients were kept blinded throughout the study period. Outcomes. 42 patients, 21 on each arm had completed the study. The NPRS reduction can already be observed as early as day 2 post-intervention. Both the treatment and control group demonstrated sustained reduction of NPRS by almost one point per each time point of evaluation in the first three days (p<0.001). NPRS reduction remained until the end of the study period. The treatment group had a significantly lower NPRS score by 1.29 than that of the control group during the entire study period (95% CI -1.84 – -0.75; p < 0.001). Treatment group experienced significantly higher NPRS reduction when compared with control (4.19±1.54 vs. 2.1± 0.83; 95% CI 1.32-2.87; p < 0.001), i.e. 62.6% from baseline. Conclusions. MeCbl significantly and safely relieved PDN in a relatively rapid onset.

scholarly journals Clinical Study on the Prevention of Oxaliplatin-Induced Neurotoxicity with Guilongtongluofang: Results of a Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Yunfang Liu ◽  
Guangying Zhu ◽  
Li Han ◽  
Jie Liu ◽  
Ting Ma ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Rating Scale ◽  
Tumor Response ◽  
Controlled Trial ◽  
Control Group ◽  
Trial Group ◽  
Peripheral Neurotoxicity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Objective. Oxaliplatin-induced peripheral neurotoxicity continues to be a kind of frequent dose-limiting toxicity for many cancer patients. This study evaluated the preventive effects of Guilongtongluofang on peripheral neurotoxicity induced by oxaliplatin in patients with colorectal tumor.Patients and Methods. From May 2007 to May 2011, we conducted a randomized, double-blind, placebo-controlled trial. 120 patients of colorectal cancer treated with adjuvant oxaliplatin-based chemotherapy were randomly enrolled into the trial group and the control group. The trial group received Guilongtongluofang (at a dose of 200 mL once a day) from 3 days prior to chemotherapy. The control group received a placebo from 3 days prior to chemotherapy. Every 2-week cycle, neurotoxicity was evaluated using numeric rating scale for pain intensity and experienced relief. The primary endpoint was efficacy measurement which included oxaliplatin-induced neurotoxicity and tumor response. The differences of side effects between the two groups were also analyzed.Results. The percentage of grades 1-2 neurotoxicity was significantly lower in the trial group than that in the control group (13.3% versus 20.0%;P<0.05) after two cycles of treatment. The difference of the percentage of neurotoxicity between the two groups was significant after six cycles (51.7% versus 70.0%;P<0.05). Significant difference for the mean time to the development of grade 1+ neurotoxicity was found between the two groups (9.4 w in the trial group versus 6.5 w in the control group,P<0.05). The cumulative incidence of grade 1 or more sensory neurotoxicity was significantly lower in the trial group than that in the control group (P<0.05). No significant differences of tumor response rate were found between the two groups the trial group and the control group. No significant difference was found between the trial group and the control group (allP>0.05).Conclusion. This study provides evidence that Guilongtongluofang is a promising drug for the prevention of oxaliplatin-induced neurotoxicity in patients with colorectal cancer, and it does not reduce the efficacy of oxaliplatin.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Xiaochen Yang ◽  
Lanping Liu ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome

Abstract Introduction Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) could suppress ventricular hypertrophy and inflammatory responses, lower blood pressure, and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension. Methods and analysis This trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experimental group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is the change in 24-h average systolic and diastolic blood pressure. The secondary outcomes include heart rate variability, pharmacogenomic evaluation, improvement in TCM syndrome, and serum pro-inflammatory/anti-inflammatory cytokines between the two groups. The safety of medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0. Ethics and dissemination This study has been approved by the Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial, and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. Discussion We hypothesize that patients with low-to-medium-risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trial Registry ChiMCTR1900002876. Registered in November 2019

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