Stimulated by Psutka et al 2024.[1]
BCG – Bacillus Calmette-Guérin
TB – tuberculosis
IF – impact factor
NMIBC – non-muscle-invasive bladder cancer
EA – electroacupuncture
UTI – urinary tract infection
PROMs – patient-reported outcome measures– key to acronyms
The title of this paper captured my attention because a colleague had undergone BCG instillation into the bladder to treat bladder cancer a few years ago. Up to that point I don’t think I was aware of it as a treatment for this indication.
BCG was developed in the early 20th century (1921) as a vaccine against TB. At the time it was also investigated as a possible cancer treatment, but it was not until the 1970’s that it gained approval as an immunotherapy in bladder cancer.[2]
The trial I am highlighting is a small feasibility trial, but it is the first report of the use of acupuncture to mitigate adverse effects of this particular cancer treatment. The paper is published in the journal European Urology Oncology (IF 8.2).
90% of patients experience adverse effects with BCG treatment, with 75% getting a local acute inflammatory response, and 20% stopping treatment because of adverse effects. It seems reasonable to try using acupuncture to reduce the impact of adverse effects and retain patients in treatment.
43 patients with NMIBC were randomised 2:1 to acupuncture plus standard care versus standard care with an attention control. Acupuncture including EA was administered directly before BCG instillation, which was usually weekly for 6 weeks.
Patients received acupuncture side-lying on their favourite side and the protocol involved unilateral points in the limbs, bilateral points over the sacrum (BL31, BL32, BL33), midline points (Yintang, GV20), and one ear point on the upper side (Shenmen).
Points in the upper limb (LI11, LU7) were treated on the upper side, and points on the lower limb (KI3, KI7, SP6, KI10) were treated on the lower side. KI3 and KI7 were connected with EA at 20Hz for 30 minutes at 1–10mA.
The needles used were Seirin 30mm to 40mm length and 0.16mm to 0.25mm gauge (ie red and pink ones, I guess red 30mm and pink 40mm). I use the word pink rather than purple because the key count is less when typing in patients’ notes. I had to download the protocol to find the needle details and EA parameters.[3]
As this was a feasibility trial the main outcomes concerned the practicalities of running a trial, such as recruitment and retention of patients, and delivery of the intervention. Of 50 patients screened for eligibility, 45 were randomised, and 6 dropped out fairly early in the trial due to disease progression (n=4), refractory haematuria (n=1), and patient preference (n=1). Four dropped out before treatment started, and the other 2 dropped out after the first and third sessions.
No patients dropped out of the BCG treatment due to adverse effects in either group, but tumour staging changed in 2 patient (1 in each group, as mentioned above), and this led to a change of approach. All the other patients completed the course of BCG treatment and the acupuncture pre-treatment. One patient ended up with an extra acupuncture session due to a UTI delaying the BCG instillation by a week.
The trial was not specifically powered to assess the effectiveness of acupuncture in reducing symptoms of the BCG treatment; however, there was a significant benefit in the PROMs rating of urinary symptoms, and a trend in favour of acupuncture for pain.
The take-home message is that this feasibility trial is likely to lead to a larger trial to test efficacy or effectiveness of this acupuncture protocol, and the early signs are that it could be a useful intervention. I imagine that if this was done in China the acupuncture would be performed 2 or 3 times a week, and probably be more effective, but that is just a guess.
References
1 Psutka SP, Veleber S, Siman J, et al. Phase 1/2 Randomized Clinical Trial of In-clinic acupuncture Prior to Bacillus Calmette-Guérin in Patients with High-risk Non-muscle-invasive Bladder Cancer. Eur Urol Oncol. 2024;S2588-9311(24)00091-9.
2 Guallar-Garrido S, Julián E. Bacillus Calmette-Guérin (BCG) Therapy for Bladder Cancer: An Update. ImmunoTargets Ther. 2020;9:1–11.
3 Psutka SP, Veleber S, Siman J, et al. Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer receiving induction intravesical BCG therapy: Study protocol for a randomized, controlled pilot and feasibility study. Contemp Clin Trials Commun. 2022;30:101044.
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