scholarly journals Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
M. Y. Di ◽  
J. L. Tang
Keyword(s):  
Observational Studies ◽  
Randomized Trials ◽  
Clinical Evidence ◽  
Evaluation Process ◽  
Laboratory Research ◽  
Safety And Efficacy ◽  
Chinese Medicines ◽  
Investigational Drugs ◽  
Staged Testing ◽  
And Control

Four phases of trial are widely used in testing drugs, surgery, and diagnosis in Western medicine (WM). The staged testing process helps protect patients from unnecessary harms and control costs while assessing safety and efficacy. In this paper we adapt the four phase trials for traditional Chinese medicine (TCM). As TCM has been used in humans for thousands of years and there has been good preliminary clinical evidence on safety and efficacy for many of its therapies, in most cases its evaluation can start directly in humans, and preclinical laboratory research can be conducted in phase 4 trials after the efficacy is firmly demonstrated. Furthermore, unlike investigational drugs, TCM therapies are various in the certainty of their safety and efficacy and thus should not enter the evaluation process at the same stage. Unlike in WM, clarifying and refining PICO (patients, intervention, comparator, and outcome) are an important part of evaluation of newly designed TCM therapies. The incommensurability between WM and TCM causes additional difficulties in TCM trials regarding defining and choosing PICO, for which some suggestions are made. Observational studies seem to have a greater role in evaluation for TCM although the efficacy must be confirmed with randomized trials.

scholarly journals PRO: Carbapenems should be used for ALL infections caused by ceftriaxone-resistant Enterobacterales

2021 ◽  
Vol 3 (1) ◽  
Author(s):  
David L Paterson ◽  
Burcu Isler ◽  
Patrick N A Harris
Keyword(s):  
Antibiotic Resistance ◽  
Observational Studies ◽  
Randomized Trials ◽  
Antibiotic Resistance Genes ◽  
Definitive Treatment ◽  
In Vitro Activity ◽  
Genes Encoding ◽  
Amoxicillin Clavulanate ◽  
Trial Outcomes

Abstract Ceftriaxone resistance in the Enterobacterales is typically the result of production of ESBLs or AmpC β-lactamases. The genes encoding these enzymes are often co-located with other antibiotic resistance genes leading to resistance to aminoglycosides, quinolones and trimethoprim/sulfamethoxazole. Carbapenems are stable to ESBLs and AmpC giving them reliable in vitro activity against producers of these β-lactamases. In contrast, piperacillin/tazobactam and amoxicillin/clavulanate are compromised by co-production of OXA-1, which is not inhibited by tazobactam or clavulanate. These in vitro findings provide an explanation for the MERINO trial outcomes, where 3.7% (7/191) randomized to meropenem died compared with 12.3% (23/187) randomized to piperacillin/tazobactam as definitive treatment of bloodstream infection due to ceftriaxone-resistant organisms. No randomized trials have yet put cefepime and carbapenems head to head, but some observational studies have shown worse outcomes with cefepime. We argue that carbapenems are the antibiotics of choice for ceftriaxone-resistant Enterobacterales.

A randomized controlled clinical trial to evaluate safety and efficacy of a Unani formulation in the management of Kalaf (Melasma)

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ifra Abdul Qaiyyum ◽  
Mohammad Nawab ◽  
Munawwar Husain Kazmi
Keyword(s):  
Quality Of Life ◽  
Test Group ◽  
Control Group ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
End Point ◽  
Intergroup Comparison ◽  
And Control ◽  
Change In Mean

Abstract Objectives Kalaf (Melasma) is an acquired facial hypermelanism. It has direct impact on patient’s quality of life and leads to development of various personality disorders. Lack of effective treatment and recurrences have drawn the attention of researcher to find alternative treatment. This study aimed to evaluate safety and efficacy of a topical Unani formulation in the management of melasma. Methods We conducted a prospective randomized controlled clinical study on the participants diagnosed with melasma. The participants (n=72) randomized into test (n=36) and control (n=36) groups. Sixty participants (n=30 in each group) completed the duration of therapy. The participants of the test group were treated with a classical Unani formulation and control group with hydroquinone 4%. The primary end point was change in mean MASI score and secondary end point was improvement in quality of life after eight weeks of treatment. Results The Unani formulation reduced 40.5% mean MASI score (17.31 ± 9.58 to 10.28 ± 5.92) in comparison to 32% reduction in mean MASI score (20.58 ± 9.49 to 13.92 ± 7.38) in the control group after eight weeks of treatment. When comparing with baseline the difference in MASI score was found statistically significant in both groups (p<0.05). On intergroup comparison, the change in MASI score between both groups was not statistically significant (p>0.05). In addition, MQOL and DQLI also improved significantly in both groups. Conclusions This study concluded that the Unani formulation and the control drug were equally effective and safer in the management of melasma.

scholarly journals New insights and long-term safety of tocilizumab in rheumatoid arthritis

2018 ◽  
Vol 10 (10) ◽  
pp. 195-199 ◽  
Author(s):  
Graeme Jones ◽  
Elena Panova
Keyword(s):  
Rheumatoid Arthritis ◽  
Observational Studies ◽  
Randomized Trials ◽  
Treatment Options ◽  
Safety Data ◽  
Signs And Symptoms ◽  
Western Society ◽  
Interleukin 6 Receptor ◽  
Term Data

Rheumatoid arthritis is a leading musculoskeletal cause of disability in Western society. Therapeutic options have expanded rapidly with the advent of biological agents as treatment options. One of these, tocilizumab, targets the interleukin-6 receptor and has been approved since the late 2000s in many jurisdictions. This approval was based on 6–12 month trials. It is now appropriate to look at longer-term studies and what new insights they have provided into this agent. Data are based largely on observational studies with their well-known limitations as well as some further randomized trials and provide a number of important observations regarding both efficacy and safety. In conclusion, the longer-term data suggest tocilizumab efficacy increases over time for both signs and symptoms and radiographic change. It is also corticosteroid sparing. The safety data are consistent with the shorter-term trials and are largely reassuring but some questions still remain over cardiovascular safety and cancer risk.

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