1.Guidelines for planning and conducting high-quality research and testing on animals
Laboratory Animal Research 2020;36(3):146-151
There are important scientific, legal and ethical reasons for optimising the quality of animal research and testing. Concerns about the reproducibility and translatability of animal studies are now being voiced not only by those opposed to animal use, but also by scientists themselves.Many of the attempts to improve reproducibility have, until recently, focused on ways in which the reporting of animal studies can be improved. Many reporting guidelines have been written. Better reporting cannot, however, improve the quality of work that has already been carried out - for this purpose better planning is required.Planning animal studies should involve close collaboration with the animal facility where the work is to be performed, from as early a stage as possible. In this way, weaknesses in the protocol will be detected and changes can be made before it is too late. Improved planning must focus on more than the “mathematical” elements of experimental design such as randomisation, blinding and statistical methods. This should include focus on practical details such as the standard of the facility, any need for education and training, and all the factors which can improve animal welfare.The PREPARE (Planning Research and Experimental Procedures on Animals: Recommendations for Excellence) checklist was developed to help scientists be more aware of all the issues which may affect their experiments. The checklist is supported by comprehensive webpages containing more information, with links to the latest resources that have been developed for each topic on the list.
2.The Effects of a Saffron Extract (affron ® ) on Menopausal Symptoms in Women during Perimenopause: A Randomised, Double-Blind, Placebo-Controlled Study
Adrian L. LOPRESTI ; Stephen J. SMITH
Journal of Menopausal Medicine 2021;27(2):66-78
Objectives:
There is preliminary evidence suggesting saffron may effectively treat menopausal symptoms. The aim of this study was to examine the tolerability and efficacy of a standardised saffron extract (affron® ) on menopausal complaints in perimenopausal women.
Methods:
In this 12-week, parallel-group, double-blind, randomised controlled trial, 86 perimenopausal women experiencing menopausal complaints received either a placebo or 14 mg of a saffron extract (affron® ), twice daily. Outcome measures included the Greene Climacteric Scale (GCS), Positive and Negative Affect Schedule (PANAS), and Short Form-36 Health Survey (SF-36).
Results:
Based on data collected from 82 participants, saffron was associated with greater improvements in mood and psychological symptoms compared to the placebo. Results from the GCS revealed a significantly greater reduction in the GCS psychological score (P = 0.032), characterised by a 33% reduction in anxiety and a 32% reduction in depression scores from baseline to week 12. There was also a significantly greater reduction in the PANAS negative affect score (P = 0.043) compared to the placebo. However, compared to the placebo, saffron was not associated with greater improvements in vasomotor symptoms, somatic symptoms, or other quality of life measures. Saffron intake was well tolerated with no reported major adverse events.
Conclusions
The saffron extract, affron® , administered for 12 weeks at a dose of 14 mg twice daily was associated with greater improvements in psychological symptoms. Further studies in perimenopausal women presenting with varying severity of menopausal symptoms, using different doses of saffron will be useful to examine in future clinical trials.
3.The Effects of a Saffron Extract (affron ® ) on Menopausal Symptoms in Women during Perimenopause: A Randomised, Double-Blind, Placebo-Controlled Study
Adrian L. LOPRESTI ; Stephen J. SMITH
Journal of Menopausal Medicine 2021;27(2):66-78
Objectives:
There is preliminary evidence suggesting saffron may effectively treat menopausal symptoms. The aim of this study was to examine the tolerability and efficacy of a standardised saffron extract (affron® ) on menopausal complaints in perimenopausal women.
Methods:
In this 12-week, parallel-group, double-blind, randomised controlled trial, 86 perimenopausal women experiencing menopausal complaints received either a placebo or 14 mg of a saffron extract (affron® ), twice daily. Outcome measures included the Greene Climacteric Scale (GCS), Positive and Negative Affect Schedule (PANAS), and Short Form-36 Health Survey (SF-36).
Results:
Based on data collected from 82 participants, saffron was associated with greater improvements in mood and psychological symptoms compared to the placebo. Results from the GCS revealed a significantly greater reduction in the GCS psychological score (P = 0.032), characterised by a 33% reduction in anxiety and a 32% reduction in depression scores from baseline to week 12. There was also a significantly greater reduction in the PANAS negative affect score (P = 0.043) compared to the placebo. However, compared to the placebo, saffron was not associated with greater improvements in vasomotor symptoms, somatic symptoms, or other quality of life measures. Saffron intake was well tolerated with no reported major adverse events.
Conclusions
The saffron extract, affron® , administered for 12 weeks at a dose of 14 mg twice daily was associated with greater improvements in psychological symptoms. Further studies in perimenopausal women presenting with varying severity of menopausal symptoms, using different doses of saffron will be useful to examine in future clinical trials.