Zeureka wrote:
Dr Sclafani, I am wondering how such studies could be/will be or have already been started to be performed? Catheter vengography applied to all and for the placebo-group then just not apply the dilatation/ballooning? Without them knowing that it has been done or not? For how long would the improvements be compared in such a study (and by which criteria), and for how long would the placebo group not know it was placebo? Is this a realistic and necessary direction the neurologists are pushing us to go for? Placebo treatments without applying venoplasty?
This is the closest I've come to finding a similar sham surgery:
Quote:
N Engl J Med. 2002 Jul 11;347(2):81-8.
A controlled trial of arthroscopic surgery for osteoarthritis of the knee.
Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP.
Houston Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX 77030, USA.
Comment in:
N Engl J Med. 2002 Jul 11;347(2):137-9.
N Engl J Med. 2002 Jul 11;347(2):132-3.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
J Bone Joint Surg Am. 2003 Feb;85-A(2):387.
ACP J Club. 2003 Mar-Apr;138(2):49.
Curr Womens Health Rep. 2003 Feb;3(1):63-4.
Summary for patients in:
J Fam Pract. 2002 Oct;51(10):813.
BACKGROUND: Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee.
METHODS: A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery. Patients in the placebo group received skin incisions and underwent a simulated débridement without insertion of the arthroscope. Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 24-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. A total of 165 patients completed the trial.
RESULTS: At no point did either of the intervention groups report less pain or better function than the placebo group. For example, mean (+/-SD) scores on the Knee-Specific Pain Scale (range, 0 to 100, with higher scores indicating more severe pain) were similar in the placebo, lavage, and débridement groups: 48.9+/-21.9, 54.8+/-19.8, and 51.7+/-22.4, respectively, at one year (P=0.14 for the comparison between placebo and lavage; P=0.51 for the comparison between placebo and débridement) and 51.6+/-23.7, 53.7+/-23.7, and 51.4+/-23.2, respectively, at two years (P=0.64 and P=0.96, respectively). Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference.
CONCLUSIONS: In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.
PMID: 12110735 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/12110735
Thankl-you Eric593. I am very interested in how one can ethically do "sham" surgery. Whether informed consent is sufficient for the risks of the incision and insertion of the catheter is interesting to me. In angioplasty, though, the level of sedation is very low, and although not painful, I think you can feel the catheter moving in the body, so merely numbing the insertion site and sheilding the patient's eyes would not be sufficient. Plus the follow-up requires a warfarin regime, and a patient would know ilf they were receiving a placebo and not the anti-clotting drug. The anti-clotting drug is a risky thing. Those following the CCSVI history know that the one death that happened was due to the anti-clotting drugs that were part of the post-stenting procedure.
I have heard, but do not know first hand that Stanford is planning to insert the catheter into all subjects but in the placebo arm, not inflate the balloon. I have no idea what they would plan to do about the warfarin regiment.