scholarly journals Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo—Controlled Trial

Toxins ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 168
Author(s):  
Young Joo Shim ◽  
Hee Jin Lee ◽  
Keun Jeong Park ◽  
Hyung Tack Kim ◽  
Il Hee Hong ◽  
...  
Keyword(s):  
Placebo Group ◽  
Botulinum Toxin ◽  
Treatment Group ◽  
Masseter Muscle ◽  
Controlled Trial ◽  
Group Interaction ◽  
Sleep Bruxism ◽  
Peak Amplitude ◽  
Significant Time ◽  
Botulinum Toxin Therapy

The purpose of this study is to evaluate the effects of botulinum toxin type A (BoNT-A) for managing sleep bruxism (SB) in a randomized, placebo-controlled trial. Thirty SB subjects were randomly assigned into two groups evenly. The placebo group received saline injections into each masseter muscle, and the treatment group received BoNT-A injections into each masseter muscle. Audio–video–polysomnographic recordings in the sleep laboratory were made before, at four weeks after, and at 12 weeks after injection. Sleep and SB parameters were scored according to the diagnostic and coding manual of American Academy of Sleep Medicine. The change of sleep and SB parameters were investigated using repeated measures analysis of variance (RM-ANOVA). Twenty-three subjects completed the study (placebo group 10, treatment group 13). None of the SB episode variables showed a significant time and group interaction (p > 0.05) except for electromyography (EMG) variables. The peak amplitude of EMG bursts during SB showed a significant time and group interaction (p = 0.001). The injection decreased the peak amplitude of EMG bursts during SB only in the treatment group for 12 weeks (p < 0.0001). A single BoNT-A injection cannot reduce the genesis of SB. However, it can be an effective management option for SB by reducing the intensity of the masseter muscle.

A randomized controlled trial of botulinum toxin for treating sleep bruxism: a polysomnographic evaluation

2019 ◽  
Vol 64 ◽  
pp. S193
Author(s):  
K.J. Park ◽  
Y.J. Shim ◽  
H.J. Lee ◽  
B.E. Kim ◽  
J.E. Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Botulinum Toxin ◽  
Controlled Trial ◽  
Sleep Bruxism ◽  
Randomized Controlled

scholarly journals Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trial

2021 ◽  
Vol 49 (5) ◽  
pp. 030006052110135
Author(s):  
Reaz Mahmud ◽  
Md. Mujibur Rahman ◽  
Iftikher Alam ◽  
Kazi Gias Uddin Ahmed ◽  
A.K.M. Humayon Kabir ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Confidence Interval ◽  
Recovery Time ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Data Repository ◽  
Rt Pcr ◽  
Clinical Recovery ◽  
Number Of Patients

Objective We evaluated whether ivermectin combined with doxycycline reduced the clinical recovery time in adults with COVID-19 infection. Methods This was a randomized, blinded, placebo-controlled trial in patients with mild-to-moderate COVID-19 symptoms randomly assigned to treatment (n = 200) and placebo (n = 200) groups. The primary outcome was duration from treatment to clinical recovery. Secondary outcomes were disease progression and persistent COVID-19 positivity by RT-PCR. Results Among 556 screened patients, 400 were enrolled and 363 completed follow-up. The mean patient age was 40 years, and 59% were men. The median recovery time was 7 (4–10, treatment group) and 9 (5–12, placebo group) days (hazard ratio, 0.73; 95% confidence interval, 0.60–0.90). The number of patients with a ≤7-day recovery was 61% (treatment group) and 44% (placebo groups) (hazard ratio, 0.06; 95% confidence interval, 0.04–0.09). The proportion of patients who remained RT-PCR positive on day 14 and whose disease did not progress was significantly lower in the treatment group than in the placebo group. Conclusions Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative by RT-PCR on day 14. Trial Registration ClinicalTrials.gov Identifier: NCT04523831. Data Repository ID Dryad. doi:10.5061/dryad.qjq2bvqf6

scholarly journals Outcomes of Ultrasound-Guided Gastrocnemius Injection With Botulinum Toxin for Chronic Plantar Fasciitis

2019 ◽  
Vol 41 (1) ◽  
pp. 63-68 ◽  
Author(s):  
Mohammadreza Abbasian ◽  
Salar Baghbani ◽  
Samira Barangi ◽  
Paul Gilbert Fairhurst ◽  
Adel Ebrahimpour ◽  
...  
Keyword(s):  
Placebo Group ◽  
Botulinum Toxin ◽  
Plantar Fasciitis ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Level Of Evidence ◽  
The Mean ◽  
Level I ◽  
American Orthopaedic

Background: The objective of this study was to determine whether the injection of botulinum toxin A (BTA) in the medial head of the gastrocnemius muscle could yield improvements in function and disability in patients with chronic plantar fasciitis with follow-up 12 months after treatment. Methods: Thirty-two patients with chronic plantar fasciitis were included in the study and randomly allocated to the BTA and placebo groups. The visual analog scale (VAS) and American Orthopaedic Foot & Ankle Society (AOFAS) scores were used to evaluate pain levels pre- and postinjection as well as function of the foot, respectively. Patients were also asked to rate their treatment satisfaction 1 year after injection. The range of dorsiflexion was measured before and 12 months after the injection. Results: At the 12-month follow-up, the mean VAS decreased from 7.8 to 4 in the placebo group and from 8 to 0.33 in the BTA group. Furthermore, the mean AOFAS scores increased from 48.4 to 65.3 in the placebo group and from 45.5 to 90.6 in the BTA group. The postinjection scores in the BTA group were significantly higher than those in the placebo group ( P < .001). Patient satisfaction in the BTA group was higher than that in the placebo group at the 12-month follow-up. Conclusion: In patients with chronic plantar fasciitis, the use of BTA had a positive effect on improvement in pain and foot function 1 year after treatment. Level of Evidence: Level I, prospective randomized controlled trial.

Botulinum Toxin A in the Prophylactic Treatment of Migraine – A Randomized, Double-Blind, Placebo-Controlled Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 838-843 ◽  
Author(s):  
S Evers ◽  
J Vollmer-Haase ◽  
S Schwaag ◽  
A Rahmann ◽  
I-W Husstedt ◽  
...  
Keyword(s):  
Placebo Group ◽  
Botulinum Toxin ◽  
Treatment Group ◽  
Prophylactic Treatment ◽  
Botulinum Toxin A ◽  
Neck Muscles ◽  
Toxin A ◽  
Double Blind ◽  
Accompanying Symptoms ◽  
To Receive

Botulinum toxin A has been suggested to be effective in the prophylactic treatment of migraine. However, only very few randomized, double-blind, placebo-controlled studies are available. We designed such a study with a specific focus on different injection sites. Sixty patients with a migraine according to the criteria of the International Headache Society were randomly assigned to receive either placebo in the frontal and neck muscles, or to receive 16 U botulinum toxin A in the frontal muscles and placebo in the neck muscles, or to receive in total 100 U botulinum toxin A in the frontal and neck muscles. The observation period was 3 months. In both treatment groups, 30% of patients showed a reduction of migraine frequency in month 3 by at least 50% compared with baseline, in the placebo group 25% of the patients showed such a reduction ( P = 0.921). There were no significant differences between the three study groups with respect to reduction of migraine frequency, number of days with migraine, and the number of total single doses to treat a migraine attack. In the post hoc analysis, the reduction of all accompanying symptoms was significantly higher in the 16 U treatment group compared with the placebo group. In the 100 U treatment group significantly more adverse events occurred compared with the placebo group. All adverse events were mild and transient. Our study did not show any efficacy of botulinum toxin A in the prophylactic treatment of migraine. Only accompanying symptoms were significantly reduced in the 16 U but not in the 100 U treatment group. Future studies should focus on the efficacy of botulinum toxin A in specific subgroups of patients, on the efficacy of repetitive injections, and on other injection sites.

scholarly journals The Effect of Vitamin D Supplementation on Hepcidin, Iron Status, and Inflammation in Pregnant Women in the United Kingdom

Nutrients ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. 190 ◽  
Author(s):  
Vickie Braithwaite ◽  
Sarah Crozier ◽  
Stefania D’Angelo ◽  
Ann Prentice ◽  
Cyrus Cooper ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Treatment Group ◽  
Vitamin D3 ◽  
Iron Status ◽  
Controlled Trial ◽  
Late Pregnancy ◽  
Inflammatory Status ◽  
25Ohd Concentration ◽  
Vitamin D3 Supplementation

Iron and vitamin D deficiencies are common during pregnancy. Our aim was to identify whether antenatal vitamin D3 supplementation affects iron status (via hepcidin suppression) and/or inflammation. Using a subset of the UK multicenter Maternal Vitamin D Osteoporosis Study (MAVIDOS)—a double-blinded, randomized, placebo-controlled trial (ISRCTN82927713; EudraCT2007-001716-23)—we performed a secondary laboratory analysis. Women with blood samples from early and late pregnancy (vitamin D3 (1000 IU/day from ~14 weeks gestation n = 93; placebo n = 102) who gave birth in the springtime (March–May) were selected as we anticipated seeing the greatest treatment group difference in change in 25-hydroxyvitamin D (25OHD) concentration. Outcomes were hepcidin, ferritin, C-reactive protein, and α1-acid glycoprotein concentration in late pregnancy (25OHD concentration was measured previously). By late pregnancy, 25OHD concentration increased by 17 nmol/L in the vitamin D3 group and decreased by 11 nmol/L in the placebo group; hepcidin, ferritin, and inflammatory markers decreased but no treatment group differences were seen. In late pregnancy, positive relationships between 25OHD and hepcidin and 25OHD and ferritin in the placebo group were observed but not in the treatment group (group × 25OHD interaction, p < 0.02). Vitamin D3 supplementation had no effect on hepcidin, ferritin, or inflammatory status suggesting no adjunctive value of vitamin D3 in reducing rates of antenatal iron deficiency.

scholarly journals Pengaruh Suplementasi Ekstrak Ikan Gabus (Channa Striata ) Terhadap Kadar Albumin, Kolesterol, Waktu Remisi Dan Kejadian Relaps Pada Anak Sindrom Nefrotik

2019 ◽  
Vol 6 (1) ◽  
pp. 7-12
Author(s):  
Muhammad Heru Muryawan ◽  
Ag Soemantri ◽  
Hertanto Wahyu Subagio ◽  
Nanan Sekarwana
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Treatment Group ◽  
Controlled Trial ◽  
Test Design ◽  
Chi Square ◽  
Randomized Controlled ◽  
Post Test ◽  
Relapse Time ◽  
Channa Striata

Background : Nephrotic syndrome (NS) is common in children with massive proteinuria causing severe hypoalbuminemia and hypercholesterolemia. Various attempts are required to increase albunin serum, accelerate remission time, and prevent relapse in order to reduce kidney damage. The Channa striata extract is known for its benefits in increasing albumin levels. Objective : To prove channa striata extract supplementation effect in increasing albumin serum, reducing cholesterol serum, remission and relapse time in children with NS. Methods :This is a double blind randomized controlled trial pre and post test design, 60 children with NS aged 1-15 years were included. A total of 500 mg / day channa striata extract capsule supplementation were administrated 2x1 to the treatment group for 21 days, meanwhile control group received placebo. Children with other chronic disease and with steroid resistance NS were excluded. The outcomes were serum albumin, cholesterol levels, remission and relapse time. Analysis data of albumin and cholesterol was performed by using unpaired t test and Mann-Whitney test. Remission and relapse times were analyzed by chi-square test. Results: There are 60 children met the inclusion criteria (32 children received Channa extract and 28 children were given placebo). Increased albumin level after supplementation was 3,6+0.8 g/dL(p<0.05) higher compared to placebo group 3,2+0.8 g/dL( p<0.05). Decreased levels of total cholesterol between the two groups were not significant (p>0.05). The treatment group remission time was 8.4+2.9 days, 11.0+3.7 day faster compared to placebo group (p <0.05). Relapse in the treatment group (21.4%) were similar to the placebo group (21.9%) (p> 0.05). Conclusions: Channa striata extract supplementation 3x500 mg/day for 21 days is effective to increase albumin levels and accelerate remission time significantly. Decreased cholesterol serum and relapse were not significant. Keywords: nephrotic syndrome, channa striata extract, albumin, cholesterol, remission time, relapse   Latar Belakang: Sindrom nefrotik (SN) banyak dijumpai pada anak dengan proteinuria masif yang menyebabkan hipoalbuminemia berat dan hiperkolesterolemia. Diperlukan upaya meningkatkan kadar albumin, mempercepat waktu remisi dan mencegah relaps guna mengurangi kerusakan ginjal. Ekstrak ikan gabus (EIG)/Channa striata) diketahui dapat meningkatkan kadar albumin. Tujuan: Membuktikan pengaruh suplementasi EIG terhadap peningkatan kadar albumin, penurunan kolesterol,waktu remisi dan kejadian relaps pada anak SN. Metode: Penelitian randomized controlled trial pre and post test design, tersamar ganda, dilakukan mulai Maret-November 2017 terhadap 70 anak SN usia 1-15 tahun, terbagi menjadi 35 anak kelompok suplementasi EIG 2x500 mg/hari selama 21 hari; 35 anak kelompok kontrol. Anak dengan penyakit kronis lain, anak dengan resisten steroid di eksklusi. Luaran yang diteliti adalah kadar albumin, kolesterol, waktu remisi dan kejadian relaps. Analisis data kadar albumin dan kolesterol dengan uji t tidak berpasangan dan uji Mann-Whitney, waktu remisi dan kejadian relaps dengan uji Chi-Square. Hasil: Enam puluh subyek masuk kriteria penelitian (32 di kelompok EIG dan 28 di kelompok plasebo). Peningkatan kadar albumin setelah pemberian EIG 3,6+0,8 g/dL lebih tinggi dibanding kontrol 3,2+0,8 g/dL (p<0,05). Penurunan kadar kolesterol total diantara dua kelompok didapatkan nilai p>0,05. Waktu remisi kelompok EIG 8,4+2,9 hari, lebih cepat dibanding kontrol 11,0+3,7 hari (p<0,05). Kejadian relaps kelompok EIG (21,4%) sama dengan kontrol (21,9%) (p>0,05). Kesimpulan: Suplementasi EIG 2x500 mg/hari selama 21 hari, efektif meningkatkan kadar albumin dan mempercepat waktu remisi secara bermakna. Penurunan kadar kolesterol dan kejadian relaps tidak bermakna. Kata kunci: sindrom nefrotik, ekstrak ikan gabus, albumin, kolesterol, waktu remisi, relaps

Attenuation of the Preoperative Stress Response with Midazolam

2000 ◽  
Vol 93 (1) ◽  
pp. 141-147 ◽  
Author(s):  
Zeev N. Kain ◽  
Ferne Sevarino ◽  
Sharon Pincus ◽  
Gerianne M. Alexander ◽  
Shu Ming Wang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Global Health ◽  
Outpatient Surgery ◽  
Controlled Trial ◽  
Self Report ◽  
Anesthetic Technique ◽  
Double Blind ◽  
Clinical Recovery ◽  
Sf 36

Background Previously, effects of preoperative sedatives were assessed mainly with respect to preoperative outcomes such as anxiety and compliance. The purpose of this investigation was to evaluate the effects of preoperative sedatives on postoperative psychological and clinical recovery. Methods Patients undergoing general anesthesia and outpatient surgery were enrolled in a double-blind, randomized, placebo-controlled trial. Subjects (n = 55) were randomly assigned to receive either 5 mg intramuscular midazolam (n = 26) or a placebo injection (n = 29) at least 30 min before surgery. The anesthetic technique was controlled. Postoperative anxiety, pain, analgesic consumption, clinical recovery parameters, and global health (SF-36) were evaluated up to 1 month after surgery. Results Surgery length did not differ significantly between the treatment and placebo groups (118 +/- 45 min vs 129 +/- 53 min; P = NS). Throughout the first postoperative week, subjects in the treatment group reported a greater reduction in postoperative pain compared with subjects in the placebo group (F1,50= 3.5; P = 0.035). Moreover, at 1 week, ibuprofen use was reported by less subjects in the treatment group than in the placebo group (0% vs 17.2%; P = 0.026). Subjects in the treatment group also reported a greater reduction in postoperative anxiety throughout the follow-up period (F1,53 = 9.2; P = 0.04). However, global health indexes (SF-36) did not detect any significant differences between the two experimental groups (multivariate F1,45 = 0.44; P = 0.51). Conclusion Subjects treated with midazolam preoperatively self-report improved postoperative psychological and pain recovery. However, the clinical significance of these findings is unclear at the present time.

scholarly journals Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial

2020 ◽  
pp. 026921552096385
Author(s):  
Cameron Lindsay ◽  
Sissi Ispoglou ◽  
Brinton Helliwell ◽  
Dawn Hicklin ◽  
Steve Sturman ◽  
...  
Keyword(s):  
Botulinum Toxin ◽  
Treatment Group ◽  
Controlled Trial ◽  
Post Injection ◽  
Onabotulinumtoxin A ◽  
Arm Function ◽  
Contracture Formation ◽  
Randomised Controlled ◽  
To Receive ◽  
Mean Time

Objective: Does early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function. Design: Randomised placebo-controlled-trial Setting: Specialised stroke-unit. Participants & Intervention: Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment). Outcome-Measures: Spasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection. Results: Ninety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between –8.5(95% CI –17 to 0) to –9.4(95% CI –14 to –5) µV. Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI –0.7 to –12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively. Arm-function was not significantly different between the groups MD2.4 (95% CI –5.3 to 10.1) and 2.9 (95% CI –5.8 to 11.6) at week-12 and month-6 respectively. Conclusion: BoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function. Trial Registration: EudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.

The ‘Dry-Needle Technique’: Intramuscular Stimulation in Tension-Type Headache

Cephalalgia ◽  
2001 ◽  
Vol 21 (8) ◽  
pp. 813-817 ◽  
Author(s):  
B Karakurum ◽  
O Karaalin ◽  
ö Coskun ◽  
B Dora ◽  
S üçler ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Controlled Trial ◽  
Trigger Points ◽  
Tension Type Headache ◽  
Needle Technique ◽  
Muscle Tenderness ◽  
Before And After ◽  
The Difference ◽  
Type Headache

The ‘dry-needle technique’, an intramuscular stimulation technique carried out by using a fine solid, 1-inch long, 30-gauge needle, was investigated in the treatment of tension-type headache (TTH) in a randomized, placebo-controlled trial. Fifteen patients with TTH received intramuscular needle insertions into six designated trigger points, while 15 controls received subcutaneous insertions. Headache indices, muscle tenderness and neck ROMs were evaluated before and after treatment. Mean headache indices improved significantly after treatment, both in the treatment group and in the placebo group, but the difference between the two groups was insignificant. In the treatment group the tenderness score and the neck ROM limitation score were significantly improved after treatment, while there was no significant improvement in the placebo group. We conclude that more and larger controlled, comparative trials are needed to show whether the dry-needle technique is an effective non-pharmacological alternative for the treatment of TTH.

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