Study: Elavil not effective for IC

[kevin]

Effect of Amitriptyline on Symptoms in Treatment Naïve Patients With Interstitial Cystitis/Painful Bladder Syndrome.
Foster HE Jr, Hanno PM, Nickel JC, Payne CK, Mayer RD, Burks DA, Yang CC, Chai TC, Kreder KJ, Peters KM, Lukacz ES, Fitzgerald MP, Cen L, Landis JR, Propert KJ, Yang W, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network.

PURPOSE: Amitriptyline is frequently used to treat patients with interstitial cystitis/painful bladder syndrome. The evidence to support this practice is derived mainly from a small, single site clinical trial and case reports. MATERIALS AND METHODS: We conducted a multicenter, randomized, double-blind, placebo controlled clinical trial of amitriptyline in subjects with interstitial cystitis/painful bladder syndrome who were naïve to therapy. Study participants in both treatment arms received a standardized education and behavioral modification program. The drug dose was increased during a 6-week period from 10 up to 75 mg once daily. The primary outcome was a patient reported global response assessment of symptom improvement evaluated after 12 weeks of treatment. RESULTS: A total of 271 subjects were randomized and 231 (85%) provided a global response assessment at 12 weeks of followup. Study participants were primarily women (83%) and white (74%), with a median age of 38 years. In an intent to treat analysis (271) the rate of response of subjects reporting moderate or marked improvement from baseline in the amitriptyline and placebo groups was 55% and 45%, respectively (p = 0.12). Of the subgroup of subjects (207) who achieved a drug dose of at least 50 mg, a significantly higher response rate was observed in the amitriptyline group (66%) compared to placebo (47%) (p = 0.01). CONCLUSIONS: When all randomized subjects were considered, amitriptyline plus an education and behavioral modification program did not significantly improve symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. However, amitriptyline may be beneficial in persons who can achieve a daily dose of 50 mg or greater, although this subgroup comparison was not specified in advance.

This is pretty significant. Elavil is being increasingly recommended for IC, but this study throws that practice into doubt. The study suggests that daily doses of 50mg or greater is effective; the next step is to see if this finding can be replicated.

[gmccormack]

kevin, good find..

Yea I think it's one of those things where it works for a small minority of patients in a large trial although this one isn't that big the number of people that do benefit is insignificant and shows poor results.

Can someone tell me how or why JC Nickel is part of 90% of CPPS/IC studies, I know he is the go to uro for NIH and most pharma's, but I think it may become biased. Every uro and likely everyone on this board has his or her own theories and it's hard to pry them to shift. The argument on the other side is the numbers don't lie regardless of what the researchers in the study may think. However, I think in reality study results can be "willed" a certain way as long as its within reason.

[webslave]

Nickel has slowly built up a reputation as being "Mr Prostatitis". I saw a presentation he gave that made the field seem like a confusing mishmash of unresolved theories and ideas, which it is to some extent, but not as much as he gave the audience to understand, I suspect. I also noted some errors in his presentation, and some notable omissions, specifically the Wise-Anderson theories, although he's probably including that in his current offerings. I gave him access to this forum, the only serious one on the internet dealing with this issue, but he only ever visited once, despite his supposedly deep interest in this field. I found that surprising.

[Jay]

I suppose this goes back to urology being a surgical specialty, and as such, prostatitis isn't always addressed logically. Then again, one could also note that there isn't much profit in sending patients off to be healed by PT. No surgery in that, no money for the pharma companies. Take from that what you will.

[carld]

As one of my Uros said..."Cancer is sexy, prostatitis isn't" that told me everything I needed to know and what I was up against...

[carld]

Also it's important to understand this aspect...At a low dose Elavil can ease anxiety according to my doctor...Which makes sense why it has helped in my case. Ease anxiety you ease chronic tensing of muscles and so forth...Now it's to the point where I take 10mg a week! Not to treat the syndrome but to manage my anxiety which in turns help manage my UCPPS...