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Another point to keep in mind is that the increase "on" time with COMTAN and Sinemet is only true when COMTAN is added to immediate release Sinemet. To my knowledge, a similar study to establish the benefit of COMTAN when added to Sinemet CR or Generic Levodopa/Carbidopa Extended Release has NOT been done. This is not to say that it is not of benefit: only that the study has not been done to show whether there is any benefit. Jorge Romero, MD ----- Original Message ----- From: Phil Tompkins <[log in to unmask]> To: <[log in to unmask]> Sent: Tuesday, July 11, 2000 6:14 AM Subject: Re: Comtan > I believe we need to think critically about reports about Comtan and > the importance of its effects, and to consider alternatives. > > I took a look at the label information approved by the FDA for > Comtan. It is at > > http://www.fda.gov/cder/foi/label/1999/20796LBL.PDF > > Three studies are cited. In so far as I am able to understand the > results, they indicate that patients on Sinemet who have about 10 > hours of "on" time per day without Comtan can on the average > expect to have a total "on" time increase per day of slightly more > than one hour by taking Comtan. > > Two news items regarding Comtan posted at the NPF web site > report on two of these studies. They are at > > http://www.parkinson.org/texthtms/tcom.htm and > http://www.parkinson.org/texthtms/tcom2.htm. > > According to the news items, the studies of Comtan demonstrate a > "significant increase in daily 'on' time". The quantity of the > increase is not given. > > The word "significant" can be misleading. When used in a > statistical context, it denotes a difference that is greater than could > be accounted for by mere chance. Statistical significance has a > precise mathematical definition. > > Outside the statistical context, "significant" means "important", a > meaning which is much less precise and quite different. > > It is easy to slip from one meaning to the other, and the NPF news > items facililtate this. They summarize the study results in > apparently popular language while retaining the statistical > terminology. This will change "significant" to "important" in the > mind of the reader. I would guess that this was not intentional. > > By the way, if the increase is "significant," wouldn't it be worth > saying what it is? > > One more hour per day may be statistically significant but is it all > that important? Can't the same results can be achieved by a slight > increase in the frequency of Sinemet doses and/or by tighter > control of dose vs. meal schedules and limiting of dietary fat and > protein? > > These are questions that I think ought to be raised with one's > doctor. > > Phil Tompkins > Amherst, Mass > age 62/dx 1990 >