"All the patients said that they were pleased with the acupuncture that they received, and about 75% said that they would refer other people going through BCG to acupuncture," says Sarah P. Psutka, MD, MS.
In this video, Sarah P. Psutka, MD, MS, highlights key findings from the study, “Phase I/II randomized clinical trial of in-clinic acupuncture prior to BCG in patients with high-risk non-muscle invasive bladder cancer,” which was presented at the 2023 ASCO Annual Meeting in Chicago, Illinois. Psutka is an associate professor of urology at the University of Washington Medical Center in Seattle.
First of all, the trial successfully recruited. The target sample we wanted to recruit was 45 patients. Of course, this happened in the middle of COVID, but we actually were remarkably successful. We did recruit 45 patients. Ultimately, we randomized 45 patients, and in total, 43 patients made it through the trial. Several patients dropped out at certain specific time points, not due to problems with the intervention, but due to progression of disease in a few cases and in 1 case, the patient was randomized to our control arm and did not wish to participate, which of course is for the patient's preference.
Importantly, there were no safety [adverse] effects. There were 2 grade 1 adverse events, but no grade 3 or greater adverse events related to the acupuncture itself. When we looked at whether or not the acupuncture interfered with the patient's ability to receive BCG, the acupuncture did not, in any case interfere with the patient's ability to receive BCG, or was associated with any delays to receipt of care. The way we set up the trial was, in a normal practice, the workflow is such that the patients come in and have a urine sample obtained to make sure there's no blood or infection. That means that it's safe to go ahead with BCG for that day. Then they wait about an hour while that sample is processed for their appointment. During that hour was when we brought the patients back into a study room. Patients who were randomized to the acupuncture arm would undergo a 35- to 45-minute acupuncture intervention that was directed to specifically toward managing the symptoms related to the bladder, but also managing anxiety and general pain. If the patients were randomized to the control waitlist arm, they underwent the other similar preparations, wrapped up in warm blankets, and were allowed to rest in a quiet space before going in and having their BCG treatment. So, there was no increased time in the clinic, there were no additional visits, which was important in terms of optimizing the efficiency of care for the patients.
We demonstrated that we could recruit and we could retain patients in the trial; it was safe. Then importantly, patients loved the therapy. About 95% of patients said that they were either very satisfied or extremely satisfied with the intervention. All the patients said that they were pleased with the acupuncture that they received, and about 75% said that they would refer other people going through BCG to acupuncture. Then finally, when we did look at the patient reported outcomes, really interestingly – it's a small study, so we have to take this with a grain of salt because obviously, this study was not powered to detect differences in quality of life – however, there was a trend towards reductions in pain scores, and not stable pain scores or differences in pain scores between the arms, but the patients in the acupuncture arm actually their pain scores across the 6 weeks declined. More importantly, across those 6 weeks, their urinary symptoms declined. Patients in the acupuncture arm actually ended the trial with fewer urinary symptoms than they started the trial with, which is virtually unheard of when it comes to folks going through BCG. So, that's a really exciting signal. It's something that we definitely are excited to pursue in future studies. It gives us enough of a reason to move forward that we'd like to take this concept forward and to see if we can design a phase 3 study to really get at that efficacy question in a much more detailed way.
This transcription has been edited for clarity.