Efficacy of Chewing Gum to Reduce Orthodontic Pain Compared to Placebo: A Blinded, Parallel-Group, Preliminary Clinical Trial

2019 ◽  
Vol 33 (3) ◽  
pp. 301-307
Author(s):  
Athbi Alqareer ◽  
Asma Alyahya ◽  
Saud Al-Anezi ◽  
Ahmad AlAwadhi ◽  
Salem Al Qabandi ◽  
...  

2021 ◽  
Vol 36 (1) ◽  
pp. 38-44
Author(s):  
Mohadeseh Delavarian ◽  
Mohammad Moslem Imani ◽  
Fatemeh Delavarian ◽  
Shahin Bayani


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020



BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044934
Author(s):  
Melanie Louise Plinsinga ◽  
Rebecca Mellor ◽  
Jenny Setchell ◽  
Kelsie Ford ◽  
Leonard Lynch ◽  
...  

ObjectiveTo explore participants’ perspectives on, and experiences of, being assigned to a wait-and-see arm of a gluteal tendinopathy trial.DesignDescriptive qualitative.SettingGeneral community in Brisbane and Melbourne, Australia.ParticipantsFifteen participants who had been randomly allocated to the wait-and-see group in a recent parallel group superiority clinical trial. That trial compared the wait-and-see approach to a physiotherapist-led education plus exercise approach, and an ultrasound-guided corticosteroid injection. The wait-and-see approach involved one physiotherapy session in which participants received reassurance, general advice and encouragement to stay active for the management of gluteal tendinopathy.Data collection and analysisSemistructured interviews were conducted by four interviewers in person or over the internet, audio recorded and transcribed verbatim. Transcripts were coded and data analysed using an inductive thematic approach.ResultsFive themes were extracted from the interview transcripts: (1) Feeling disenfranchised by being assigned to a wait-and-see approach; (2) the importance of having a clinical and imaging diagnosis during screening for inclusion into the clinical trial; (3) feelings regarding the effectiveness of the approach; (4) the convenient and easy to follow nature of the wait-and-see approach and (5) the connotation of wait-and-see not always being perceived as an intervention.ConclusionsParticipants found the wait-and-see approach convenient and easy to follow, yet almost always felt disenfranchised that nothing was being done. Participants highlighted the importance of a definite clinical and imaging diagnosis.Trial registration numberACTRN12612001126808; Post-results.



Science ◽  
1986 ◽  
Vol 231 (4745) ◽  
pp. 1504-1505
Author(s):  
J. Marx




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