Author Interviews, Pain Research / 16.07.2018

MedicalResearch.com Interview with: Dawn Hershman, MD, MS, FASCO Professor of Medicine and Epidemiology Leader, Breast Cancer Program Herbert Irving Comprehensive Cancer Center Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Aromatase inhibitors are effective in reducing the risk of recurrence in hormone sensitive breast cancer, however they commonly cause joint pain and stiffness that can lead to early discontinuation of treatment. We know that women who stop early do not get the same benefits as those who continue for the full duration. Acupuncture has been shown to improve a variety of pain syndromes. We conducted a large multicenter trial among women with joint pain on aromatase inhibitors and randomized patients to true acupuncture, sham acupuncture and a waitlist control arm. We found that acupuncture resulted in more pain reduction than the other 2 control groups. Measuring pain can be challenging in clinical trials. We now know that a meaningful reduction for a patient is 2 points on a 10 point scale. We found that nearly 60 percent of women in the true acupuncture group experienced at least a 2-point reduction in pain, versus 33 percent of the sham acupuncture group and 31 percent of the controls. These results where highly statistically significant.  (more…)
Author Interviews, Pain Research, Pharmaceutical Companies / 04.06.2018

MedicalResearch.com Interview with: Zosano Pharma Dr. Peter Schmidt, MD, MSc Senior Director, medical Affairs and Clinical Development Zosano Pharma   MedicalResearch.com: What is the background for this study? What are the main findings? Response: This was a post-hoc analysis of Zosano’s pivotal efficacy trial using its adhesive dermally-applied microarray (ADAM) zolmitriptan formulation, M207. The trial found that M207 was effective versus placebo for the co-primary endpoints of pain freedom and most bothersome symptom (MBS) freedom, both at two hours. The MBS endpoint was just ratified as a new endpoint in the FDA’s February 2018 guidance for acute migraine trials. The stated aim of this new endpoint is “…to better align the study outcome with the symptom(s) of primary importance to patients…” This is logical, as a given migraine patient may not experience all four previous symptom endpoints (pain, photophobia, phonophobia, nausea). (more…)