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The Marshall Protocol Study Site > PROF. MARSHALL'S PERSPECTIVE > Prof. Marshall's Perspective > Data needed for FDA (DEXA, calcium use, BP improvements)


Data needed for FDA (DEXA, calcium use, BP improvements)
 Moderated by: Prof Trevor Marshall Page:    1  2  3  4  5  6  ...  Next Page Last Page  
 

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Prof Trevor Marshall
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 Posted: Tue Mar 27th, 2007 12:03

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I need some help in quickly getting together some data the FDA has requested. We have just made a significant step forward, and I need to get data together to capitalize on this opportunity...

Firstly, any of you who had DEXA bone scans, or other measurements of bone density, and which were performed both before starting the protocol and also during the protocol, can you please post the data so that we can collate it. We may need to get you to ask Doc for the actual lab printouts, but at this time I just need a raw count of who has had their bone densities measured more than once, and whether it went up, down, or stayed about the same...

Second, anybody who has a copy of, or who can get a copy of, any letter from Sankyo talking about the safety (or lack of safety) of Benicar at any dosage level, I need to know what words the letter uses, and I may need you to mail me a copy. But right now all I need is to know that you/your pharmacist/your doctor received information (preferably written), from Sankyo, that the dosage of Benicar used in the MP might in some way harm you...

Third, any of you who have experienced particularly low blood pressures (under 90/55), and whose pressures have returned more towards the normal (120/60), can you please let us know. We don't think we will need to assemble written data on this,

There may be other things we need as we prepare the documents requested by the FDA, and if so, I will post further requests as an addendum to this message :)

Feel free to post here with information, or, if it is private, you can PM me.


Thanks for your help
Trevor

added: 3/28:-
Those of you posting DEXA scan data, can you please indicate whether you were taking any calcium supplement, and what form of calcium that was (citrate, etc)? The brand name would be helpful.

Also, if you were taking other supplements, eg magnesium or phosphorus, please make sure you let us know (by PM, if necessary).

Also let us know what your other major calcium sources are and either the amount of the food (eg. a cup of yogurt a day) or, even better, if you can, an estimate of the average amount of calcium from them based on the label or other information (eg., see amounts of calcium in food at: http://www.marshallprotocol.com/forum32/1083.html )

Once again, this detail is only necessary from members who have the DEXA data.

Grace
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 Posted: Tue Mar 27th, 2007 12:51

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Dec 2002 {CFS 3yrs}

Hip BMD =1.199, Hip T-score=1.86, Spine BMD=1.306, Spine T-score=1.39

June 2006 {MP 18 mths}

Hip BMD =1.198, Hip T-score=2.11, Spine BMD=1.332, Spine T-score=1.75.

Can get BP score from doctor's rooms.He has confirm I no longer have POTS :D



____________________
CFS, oct04 Ds=26/48, 4/07=7/24 MP PHI 2/05, PhII 6/05, PhIII 6/06, beni Q6H, Noirs rarely inside no nature light low watt, outside 40%10%, Hat, all covered, no gloves, paracetamol
Hityty
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 Posted: Tue Mar 27th, 2007 13:10

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MP 8/06 / (Mod phase 2 on 3-24-07) Mino 25mg q3D & Benicar 40mg q6H

My BP was high before starting MP: (highest BP was 162/107 & 171/100)

After starting MP, BP lowered to & maintained at "normal" levels. (avg: 110/60)

My BP dropped 2-3 months ago, tested at doctors Feb-07 at: (80/62)

Cut Beni dose to 40mg q8h for 2 weeks, BP steadily rose & I returned to Beni dose 40mg q6h.

BP has remained at normal levels last 30 days averaging at: (105/66)



____________________
DX: FMS, Candida, Hypothy, Merc/Lead tox; Ambien(10mg), Zoloft(100mg)
(((Old Signature: Started Beni 8/13/06 (40mg q6h); Mino (25mg q72h) Mod Phase 2; (Feb07 25D=7.0); (8/061,25D=34 25D=6.7)))
shegeek
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 Posted: Tue Mar 27th, 2007 13:19

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I had a DEXA done a couple of weeks before starting the protocol (I was avoiding light and D), and I am still waiting on the results of one I had done about three weeks ago. I just emailed my doctor about it, and I will post the results as soon as I can.



____________________
FMS,IBS,osteoarthritis,osteopenia, hypertension/ 1,25D/25D=45/44 (10/04), 44/13 (1/05), 36/8 (7/05)
25D<4 (6/06) 25-D=5 (4-08). Avoid light & D w/NoIRs 11/04 Benicar 40mg/q4h(since 1/27/05) Phase 3
scooker48
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 Posted: Tue Mar 27th, 2007 13:46

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I will get the BP readings from my MP doctor's chart as soon as I can see her--maybe Thursday 3/29.  I trust this is soon enough...

Sherry



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D25, Total: 12 measured 11/3/15 Started MP=01/04/05 Diagnosis: Sarc 12/04; "cat scratch disease" or necrotizing graunulomas 10/88; Raynaud's (diagnosed 1980?)
prugg21
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 Posted: Tue Mar 27th, 2007 16:08

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When I started the MP a year ago, my BP was typically in the 70/40 range.

It is now normally anywhere from 85/55 to 100/70.

Pam



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MCS/CFS/FM,22+yrs,Gerd,migraines,insomnia,avoiding light & D,NoIRS,benicar 3/30/06 40mg Q4-6H,mino,4/18/06,mod/ph2-
10/17/06,probx,estriol, 3/06-25D=27,9/06-25D=26,11/06-25D=21,4/07-25D=22,7/07-25D=19
wwspic36
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 Posted: Tue Mar 27th, 2007 16:17

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Last year at this time my blood pressure was 78/40.  I didn't tell my doctor because I was afraid that he'd talk me out of taking the Benicar.  This year it is 110/60 and sometimes even higher.  I have taken the Benicar t.i.d. for the last 2 1/2 years without any interruption.  It's not the Benicar that makes the blood pressure so low; it's fighting the illness.  I've found that as I heal my blood pressure returns to normal.  I also think that I have better thyroid and para-thyroid function.  I never thought that was my problem although.  What a nice benefit!  



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Fatique, headaches, hives, flush skin, sore muscles & joints 125D44 MP1Jul04 Ph2Aug04 Ph3Jul06 NoIRs lite exp r/t to commute covered 25D13Jul07
Bbnomas
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 Posted: Tue Mar 27th, 2007 16:48

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Am I missing something? Has someone heard that Benicar at MP doses is bad for us? Why the sudden concern and what specifically is it regarding? Just BP or something else? Please advise.

My BP was once 68 over 39 something crazy but I never had any sense of impending doom enough to go to the ER and I was having severe BP symtoms - close to passing out alot but that was at the beginning and now its mostly 100/50. Once a month after my period I have pretty dehabilitating hypotensive  symtoms - it fits in with my history of having sever lyme flares at that time each month. but the hypotensive symptom sgo away within that week and then I'll have some low BP symptoms here and there in between periods but nothing horrible or scary. Salt water helps with that as well. I have no major worries at this point re: BP and benicar. My sense is that it will mostly go away after I improve more on the MP.

:o) Meredith



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Lyme, Babs, bart, Ehrlichia, EBV, FM, CFS, Myco pneum| 25D-22.2 1,25D-49.4 CD8-CD57: 64(60-360) +-20| Mod Ph 2 May 15, 40beniQ8
Prof Trevor Marshall
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 Posted: Tue Mar 27th, 2007 16:58

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Merideth - Cool it -:):)
I am looking for data to buttress our observation that there is no problem. Don't read any further into it than that. A scientist has to do this all the time...

Alayne
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 Posted: Tue Mar 27th, 2007 17:01

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For years pre-MP I tended to have what was labeled low pressure. 85-95/65-75.

After starting MP, the lowest BP reading was 73/42 - last year. However, I didn't feel any difference.

Latest check-up a couple of weeks ago, it was 100/80.

I've felt no different with the BP variances.

Perhaps I should note here that I've increased my salt intake since starting the MP. I've felt a natural urge to do so. Pre-MP I ate very little salt.

-Alayne

Last edited on Tue Mar 27th, 2007 17:04 by Alayne



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CFS/FM/Lyme - Health challenged 35+yrs. NoIRs/Zinc oxide. 6/05:25D-34, 1,25D-69; 11/07:25D-8 1,25-37. 11/17/05-Ph1, 5/06-MPh2, 12/06-MPh2#2, 6/07-MPh2#3,1/08-Ph2, 4/08-Ph3. 4/09-10/09 weaned off abx. 2/12: 25D<14, 3:15-25D<7 1,25D-36
wytnez
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 Posted: Tue Mar 27th, 2007 17:08

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Hi MP team,

My BP was about 112/74 pre MP and the last reading was 130/76.  The time prior to that was 112/80 some where around there.  It never gets below 98/60 on my home BP monitor.

Hope this helps.

Saj



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sarc lymph nodes. ph1 1/05,125D 33,25D 10,ph2 5/05,ph3 12/05,125D 21, 25D less than 7
JudyBeauty
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 Posted: Tue Mar 27th, 2007 17:53

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My blood pressure pre Mp was in the 135/85 range whenever I went to the doctors office and now it's been in the 112/70 range at the doctors office.

I don't take it at home.

Judy



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CFS viral onset 1986 1-25D-53,25D-12 1/5 Noir's/D avoid July04/ Beni 3/22/05 40mg q6h Stop Benicar 4/23/05 Restart Beni 8/13/05,Valium
Bbnomas
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 Posted: Tue Mar 27th, 2007 18:02

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TM:

No need for me to cool it - Im pretty chill with Benicar if you read my entire post, but I feel its a vaild question. If you dont wish to answer thats up to you. I dont know that you as a scientist have to do this all the time and still I'm wondering what is  prompting this. It something I'd ask my dr. or anyone if they said as much. :) Im sure you can understand that

Meredith



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Lyme, Babs, bart, Ehrlichia, EBV, FM, CFS, Myco pneum| 25D-22.2 1,25D-49.4 CD8-CD57: 64(60-360) +-20| Mod Ph 2 May 15, 40beniQ8
Prof Trevor Marshall
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 Posted: Tue Mar 27th, 2007 18:45

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Meredith,
Please let me be the scientist, and trust what I say on its face, without trying to impune any ulterior motivation:)

PaulT
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 Posted: Tue Mar 27th, 2007 18:56

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Blood pressure pre MP taking Micardis 80+ and Zanidip 10mg daily around 140/95

Since starting MP around 120/80

Paul



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Sarcoid diag 1/05 - Cough, fatigue, Feb 07 125D=59.6, Oct 07 25D=12, May 08 25D=7.5, Feb 09 25D = 13 avoid light/D, Noirs, covering up, Zinc Oxide on exposed skin.
sunflower
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 Posted: Tue Mar 27th, 2007 22:07

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hi dr. marshall,

my first bone density analysis was done 2-2-2004 before beginning the MP.  the results were:  spine bmd=1.157  t-score=-0.4     femure bmd=o.784  t-score=-1.8

after 8 months on the MP i had another one done.  the results were:  spine bmd=1.106  t-score=-0.6     femure bmd=0.717  t-score=-2.3

from the time i had the 1st bone density analysis done, i was counselled to take 800 iu of vitamin d per day (which i did until starting the MP in november of 2005).

regarding the blood pressure, since beginning the MP i have taken benicar 40 mg q6h--a total of about 17 months now.  my BP has regularly been in the 80's-90's/50's-60's since the start, but i do notice when i am feeling better and not having as much immunopathology, my bp always tests higher (low 100's/high 60's) even though the dose and schedule of benicar remains the same.

          good luck with whatever opportunity is at hand.....sun



____________________
lyme,fibro,candida,allergies,gerd,osteopenia/ pain,fatigue,dizzy,memoryloss20+yrs/ celexa,vicodin,cal-mag/beni 40mg q6h 11-05/phase 3,8-06/1,25d=34 25d=36,18,17,10,13,5,7
DMiller
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 Posted: Wed Mar 28th, 2007 03:10

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Pre MP my bp was typically 115-125/70-80. After starting the Benicar it dropped to 95-110/58-68 for a couple of months, but then returned to 115-120/70-80.

Is the FDA close to granting orphan status to Benicar? Thank you for all of your hard work on our behalf. It is greatly appreciated.



____________________
Don: Sarc-Lungs dx Jul 05; DVTs, Factor 5 Leiden dx Aug 2000; Sep05: 1,25D=56 25D=19. Started MP 11/4/05; Started mino 11/11/05; Phase 2: 1/9/06; Apr06: 25D=6; Phase 3: 6/22/06; Non-MP meds: coumadin; 10% NoIRs outdoors
Freddie Ash
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 Posted: Wed Mar 28th, 2007 04:03

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HI ALL

This is Fred in WV.  I have had a lot of low B/P over my life.  I was getting about 84/45 reading after the by pass surgerys.  Since I have been on the MP I get 110/58 readings now.  I have even had reading as low as 48/26 before the MP.

I have not had a DEXA bone scans.

I sent you a faxed copy of a letter my doctor received about the benicar once.  I will have to look for it if you need another copy of that.  Let me know.

Also, you all know about my problems with my family doc last year at this time and the benicar being safe.  Well last week I ask him again why he stopped the Rx for the benicar for me and he said that the company told him if something happened to me he would be sued.

There is my story about the benicar. I hope this helps.

Remember, we are all in this together and I am pulling for us.

Your friend in sarcoidosis

Freddie



____________________
Freddie: dx-sarc 2/82 lymph; skin, eyes, joints, esophagus, intestines, spleen, heart,lungs-25D-7; 125-D43
IngeD
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 Posted: Wed Mar 28th, 2007 05:48

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I have not had bone scans or had any letters re benicar but can report something on blood pressure.

Prior to commencing MP I was suffering from hypertension and with 2 meds (coversyl 5mg and teventan 6mg) my blood pressure was still elevated anything from 120/80 to 140/90 approx. It was also very erratic. Forked out for 2 expensive monitors because I couldn't figure out the wild variations!

When I first started on the MP with Benicar 40 mg Q6h and discontinued all other bp meds, my bp started to drop over the first weeks until the lowest reading of 80 / 60 1 month into treatment. Since then it has steadily climbed back up and last 2 readings were 100 /60 and today 112/68.

I will check if my doctor has received any letters and also check with the pharmacy. Inge.



____________________
MP start Jan'07 | Rickettsiosis, gastric ulcers, peripheral neuropathy, chronic bronchitis, adhesions/IBS/Crohn's, pre-diabetes, hypertension | initial 125D=51, 25D=26 | last 25D= 8.4 ng/mL Mar '11 |9.2 ng/ml Feb 12
Claudia
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 Posted: Wed Mar 28th, 2007 06:38

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My Blood Pressure story:

Pre MP = always normal/low around 112/78

Benicar 40mg q8hr begins Feb 2006. After 1 week, BP stable at 86/50

Phase II = cruising along, BP generally around 80/40

Phase III = November 2006 - Kidneys affected with strong IP symptoms, BP drops to 74/40   Benicar increased to 40mg q6h - 1 week later, Kidney symptoms are relieved, and BP has gone up to 94/57 and stable since then.

:D Claudia Gaber

(If you can't use "Foreigners" in your study, list me as a resident of Crystal River, Florida, where I still am technically a resident.)



____________________
MP Phase1 23Mar_06; Phase2 July 10_06; Phase3 Nov 4_06. Dx Thyroiditis (Thyroxine); arthritis; glaucoma; CFS (1988-92);Kidney & bladder probs., Osteoporosis Dx 2015, Burning Mouth Syndrome! 2016. Feb06 1,25D=43.3; Aug07 1,25D=27.5; Feb06 25D=44; Mar08

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