Meta-analysis of Placebo Response in Randomized Clinical Trials of Antipsychotic Drugs Using PANSS Focusing on Different Approaches to the Handling of Missing Data

2018 ◽  
Vol 38 (8) ◽  
pp. 751-761 ◽  
Author(s):  
Akiko Matsusaki ◽  
Masayuki Kaneko ◽  
Mamoru Narukawa
SLEEP ◽  
2019 ◽  
Vol 43 (3) ◽  
Author(s):  
Dongmei He ◽  
Binghu Jiang ◽  
Zhiwei Guo ◽  
Qiwen Mu ◽  
Morgan A Mcclure

Abstract Objectives The placebo response to orexin receptor antagonists in primary insomnia is little-known. Our aim was, therefore, to conduct a systematic review of placebo-controlled randomized clinical trials to characterize placebo response. Methods We performed a comprehensive literature search for randomized, placebo-controlled, double-blind clinical trials evaluating the efficacy of orexin receptor antagonists addressing primary insomnia. To pool effect size estimates (Cohen’s d) of placebo and orexin receptor antagonists across trials for outcome measures, a meta-analysis was done according to the Cochrane guideline. Results The placebo response was significant and robust to improve the symptoms of insomnia in terms of objective and subjective measures, and the effects (0.70 ± 0.51) in subjective measures were smaller than that (1.10 ± 1.14) in objective measures (p = 0.027). The biphasic feature of placebo response showed an initial short-term increase of placebo effect and subsequent changeless long-term effect. Conclusion The biphasic feature of placebo response is clinically useful, and neuroimaging is essential to clarify the long-term mechanism in the future.


2021 ◽  
Author(s):  
Osmar Clayton Person ◽  
Fernando Veiga Angelico Junior ◽  
Rodrigo Lima de Godoy Santos ◽  
William Marasini de Rezende ◽  
Maria Fernanda Giusti ◽  
...  

Introduction: The effectiveness of tinnitus treatment represents a huge gap in the medical science. Acamprosate is a glutamatergic antagonist drug and GABA-agonist that could be used to control tinnitus due to its action on peripheral and central neurotransmission. Purpose: To assess the effectiveness of acamprosate in the treatment of tinnitus. Material and Methods: This is a systematic review and we searched for randomized clinical trials linking acamprosate to tinnitus in six databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), IBECS (1982-2021), QINSIGHT (2021) and SCOPUS (2021). Two researchers independently extracted the data and assessed the quality of the studies. Results: Two trials involving 121 patients were included. The methodological quality of these studies was low. Both studies evaluated as primary outcome the efficacy of acamprosate in improving tinnitus. The meta-analysis by random model resulted in no significant difference between the groups treated with acamprosate and placebo (RR = 3,69, 95% CI 0,87-15,62; p=0,08), considering tinnitus improvement. Conclusions: There is no evidence that acamprosate is effective for tinnitus treatment. We recommend new trials using rigorous methodology. Randomization and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies.


2019 ◽  
Vol 15 (4) ◽  
pp. 232-237
Author(s):  
Mir Hadi Musavi ◽  
Behzad Jodeiri ◽  
Keyvan Mirnia ◽  
Morteza Ghojazadeh ◽  
Zeinab Nikniaz

Background: Although, some clinical trials investigated the maternal and neonatal effect of fentanyl as a premedication before induction of general anesthesia in cesarean section, to the best of our knowledge, there is no systematic review to summarize these results. Objectives: The present systematic review and meta-analysis evaluated the maternal and neonatal effect of intravenous fentanyl as a premedication before induction of general anesthesia in cesarean section. Methods: The databases of Pubmed, Embase, Scopus and Cochrane library were searched till July 2017 to identify randomized clinical trials which evaluated the effects of intravenous fentanyl as a premedication before induction of general anesthesia compared with placebo on neonate first and fifth minute Apgar score and maternal heart rate and mean arterial pressure (MAP) in cesarean section. Standard Mean difference (SMD) was calculated and I-square statistic test was used for heterogeneity analysis. Results: The present systematic review and meta-analysis consisted of three clinical trials including 180 women in labor. Considering the results of meta-analysis, there is no significant differences between fentanyl and placebo in the case of Apgar score at 1 minute; however, the Apgar score of 5 minutes was significantly lower in fentanyl group compared with placebo (SMD -0.68, 95%CI: - 0.98, -0.38, p<0.001). In the term of maternal hemodynamics, the heart rate (SMD -0.43, 95%CI: - 0.72, -0.13, p=0.004) and MAP (SMD -0.78, 95% CI: -1.09, -0.48, p<0.001) in fentanyl group were significantly lower compared with placebo group. Conclusion: The present meta-analysis showed that using intravenous fentanyl as a premedication before induction of general anesthesia had adverse effects on neonate Apgar score. However, it had positive effects on preventing adverse consequences of intubation on maternal hemodynamics.


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