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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
>
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February 1996, Week 3 February 1996, Week 2 February 1996, Week 1 January 1996, Week 5 January 1996, Week 4 January 1996, Week 3 January 1996, Week 2 January 1996, Week 1 December 1995, Week 5 December 1995, Week 4 December 1995, Week 3 December 1995, Week 2 December 1995, Week 1 November 1995, Week 5 November 1995, Week 4 November 1995, Week 3 November 1995, Week 2 November 1995, Week 1 October 1995, Week 5 October 1995, Week 4 October 1995, Week 3 October 1995, Week 2 October 1995, Week 1 September 1995, Week 5 September 1995, Week 4 September 1995, Week 3 September 1995, Week 2 September 1995, Week 1 August 1995, Week 5 August 1995, Week 4 August 1995, Week 3 August 1995, Week 2 August 1995, Week 1 July 1995, Week 5 July 1995, Week 4 July 1995, Week 3 July 1995, Week 2 July 1995, Week 1 June 1995, Week 5 June 1995, Week 4 June 1995, Week 3 June 1995, Week 2 June 1995, Week 1 May 1995, Week 5 May 1995, Week 4 May 1995, Week 3 May 1995, Week 2 May 1995, Week 1 April 1995, Week 5 April 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Week 5 June 1994, Week 4 June 1994, Week 3 June 1994, Week 2 June 1994, Week 1 May 1994, Week 5 May 1994, Week 4 May 1994, Week 3 May 1994, Week 2 May 1994, Week 1 April 1994, Week 5 April 1994, Week 4 April 1994, Week 3 April 1994, Week 2 April 1994, Week 1 March 1994, Week 5 March 1994, Week 4 March 1994, Week 3 March 1994, Week 2 March 1994, Week 1 February 1994, Week 4 February 1994, Week 3 February 1994, Week 2 February 1994, Week 1 February 1994 January 1994 December 1993 November 1993
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