Patients with moderate to severe interstitial cystitis/bladder pain syndrome (IC/BPS) experience significant improvement after receiving only advice and support, according to the findings of a proof-of-concept study.
Consequently, physicians should review standard advice with all IC/BPS patients before starting medical treatment, stated investigator Philip C. Bosch, MD, of Palomar Medical Center in Escondido, Calif.
Dr. Bosch conducted a double-blind, placebo-controlled study enrolling 43 patients with moderate to severe IC/BPS. Patients were randomly assigned to receive subcutaneous adalimumab (21 patients) or subcutaneous placebo (22 patients). At the onset of the study all patients received standard advice and support.
Overall, patients in the placebo arm had a statistically significant improvement in the Interstitial Cystitis Symptom Index (ICSI) at week 12 compared with baseline, as reported by Dr. Bosch in Urology. The ICSI outcome data showed that 11 placebo recipients (50%) had a statistically significant improvement.
“Patients who received placebo and statistically improved were surprised that they had not received the study drug adalimumab,” he observed.
Most of the improved placebo patients reported that this was due to following physician behavior modification advice and less stress while in the study, rather than a placebo effect, Dr. Bosch added. “The greatest improvement was seen in patients who were stricter about their diet and used stress reduction techniques while in the study,” Dr. Bosch said. Stress was the most significant flare factor for IC/BPS patients.
In a previous study comparing adalimumab and placebo for IC/BPS, Dr. Bosch found that 50% of the placebo recipients had a 50% or greater overall improvement in global response assessment (GRA), according to his report in The Journal of Urology (2014;191:77-82). These results were comparable to those found in a study by Harris E. Foster, Jr., MD, and colleagues, which was published in the same journal (2010;183:1853-1858).
That study compared amitriptyline and placebo in a randomized double-blind trial which included 271 IC/BPS patients, all of whom had received a standardized education and behavior modification program at the beginning of the study. The rate of response of participants reporting either moderately or markedly improved from baseline was 55% and 45% in the amitriptyline and placebo groups respectively, a difference that was not statistically significant.
“This significant improvement with only advice and support is higher than many commonly used medications for the treatment of IC/BPS,” Dr. Bosch emphasized.
Based on American Urological Association guidelines and his own experience, Dr. Bosch developed a practical IC/BPS standard advice checklist to guide patient management. According to the checklist, clinicians should validate to the patient that they have IC/BPS, explain that IC/BPS is a chronic disease requiring a long-term healthcare plan, encourage water hydration, recommend a bowel program, explain dietary restrictions, discuss sexual therapy, explain stress reduction, and discuss support resources.
“Validation of the disease is important to patients, as many have lived with IC/BPS symptoms for years,” Dr. Bosch stated. “Patients are reassured to know that they are not alone with these symptoms, and they are part of a well-described syndrome, which is not life-threatening.”