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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)
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Prof Trevor Marshall
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Joined: Fri Jul 9th, 2004
Location: Thousand Oaks, California USA
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 Posted: Thu Apr 19th, 2007 13:32

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Everything helps us Morris, thanks for the BP data.

debbie y
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 Posted: Thu Apr 19th, 2007 16:11

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I am in ph3.  Have just had bone dexa done.  Several dexa scans done in past. 

From 7/19/05 pre MP:  My report states "This lady has had 2 previous  bone density scans.  Since the initial scan of 12/20/99, there has been a 9.2% decrease in bone density of the spine.  T-value of L femoral neck bone is -2.0.  Since bone density of 12/20/99, there has been a 7.4% decrease in bone density of L femoral neck."

I had been on Fosamax but it was d/c'd when I was put on steroids for sarcoid in Mar. 2004.  I was on steroids for 18 months.  During that time and after steroids, I was on nothing for bones.  No supplements OTC or otherwise.  I started the MP in Feb. 2006.  This is the first DEXA since then.

Report from 4/12/97 post MP 1 yr, 2 months:  Lumbar spine, average T-score -1.8, bone mineralization the least at L1, L2 and L4, T-score -1.9.  This is increase of 1% since July 2005 and an overall decrease of 8.2% from baseline study of 12/19/1999.  Within hips, average T-score -1.6, bone mineralization the least at Ward's triangle L hip, T-score -3.2.  Right femoral neck is -2.6.  Since 2005, bone mineral density within the L hip has improved 3.5%.  Osteopenia of both lumbar spine and L femoral neck.  Both the lumbar spine and L femoral neck have decreased since the previous DEXA.

I do not take anything for calcium or vit d.  I eat foods with calcium but not any above average amount.  I drink milk with NO vit D., about 2x a week. My calcium levels have remained normal.

BP has always been normal.  90/50 or 60.  My BP has not changed in ANY way since being on Benicar, even when I started it.  I take Benicar 40mg q8hrs.  Last OV BP was 100/60.

I hope this information will be useful.

debbie y:)



____________________
Sarcoidosis/lungs '04' DM type 1 celiac sprue Insulin via pump synthroid,lunesta Ph1Feb06 Ph2Jun06 Ph3Dec06, 1,25 22.9 on 2/23/09,25D <7 8/09, 25D 16.3 6/10
MrsKeeper
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 Posted: Tue Apr 24th, 2007 12:40

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I finally got in for my appointment today and I have the bone density test results and BP history. I will PM the density scan to Dr. Marshall.

In a nutshell:

At the L2-L1 level score is 1.6
Left femoral neck is 1.8
Right femoral neck is 1.9
Within normal range indicating negligible fracture risk.

I had supplemented with calcium, magnesium, and vitamin D and taken flax and fish oil products in the attempt to gain health for at least a year or more prior to this test. :?

My blood pressure history:

BP before MP;
8/04=115/80 (average/normal)

Began Benicar in 10/04;
6/05=110/75
9/05=120/70
2/06=100/60
1/07=110/70
4/07=100/60

benk
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 Posted: Wed Apr 25th, 2007 04:42

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I have had no bone tests. Hope my BP data helps.

Well before starting the MP I was taking mainly verelan and propranolol for high BP. During November 8-11, 2006, I measured my BP (4-6 times each day from early morning to late evening, at least 2 hours between measurements, grand total of 20 measurements). Mean systolic = 140.2 (min 125, max 151 mmHg) and mean diastolic = 83.3 (min 80, max 104). Then I quit taking the drugs and my systolic went to near 150 and sometimes higher. (I did not care because the side effects of the drugs were so bad.)

I started taking Benicar on December 26, 2006. I expected a herx. Instead, by the second day, I experienced an intense feeling of physical well-being and contentment! (It still lasts, but not with such intensity)

After a month on 4x40 mg/day of Benicar (and Mino) I noticed a small decrease in BP. 

From March 22 through April 18, 2007 (end of phase 2) I took 3-5 BP measurements each day (a total of more than  75 measurements). The results are:

Mean systolic =127 (min 103, max 142)

Mean diastolic = 81 (min 68, max 92)

[Mean pulse = 71 (min 61, max 93 beats per minute)]

PS. I am very happy with my Microlife automatic BP monitor (about $70 at Costco). It downloads data to a PC, and facilitates data analysis.

Moderator's note: It is not necessary to monitor your blood pressure unless your doctor has advised you to do so.



____________________
Lyme 125D77 Ph1Dec06 Avodart Cr picolinate vit B12 NoIRs low lux home fully covered if outdoors Ph3Feb07 25D8Mar08
jcwat101
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 Posted: Mon Apr 30th, 2007 09:56

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I have only had one DEXA scan, about a year into the MP and my bone density did not show any osteoporosis.  I have not had any other scans, so have nothing to compare it with.  If anyone wants me to give more details of my one report, you can let me know.  I have been taking at least 1000 mg chelated calcium (and also the supplements listed here: Should I be concerned about osteoporosis


Blood Pressure:
Some readings prior to MP: 
The few days prior to beginning the MP:  6 readings ranged between 98/60 and 107/67 
 
First 10 days on 160 mg Benicar (late October, 2004):
Bp between 95/60 and 98/61, with a few higher and lower values, from 93/60 and 107/68.  Overall, very little change compared to pre MP.
 
More recently, on different levels of Benicar:
 
12/31/07 when on 100 mg Benicar:  99/62
2/11/07 when on 200 mg Benicar:  93/60, 91/62
2/14/07 when on no Benicar:  97/62
 
I have not noticed any symptoms that correlate with my blood pressure levels.
 
Joyce Waterhouse 
PS  Let me know if you would rather have the individual values instead of the ranges.

Last edited on Mon Apr 30th, 2007 09:58 by jcwat101



____________________
20 yrs with CFS/FM/Lyme/IBS, food sensitivities; 1,25D/25D 8/04:64/11 http://SynergyHN.wordpress.com
laura1814
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 Posted: Thu Jun 7th, 2007 11:29

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Is there any followup? Were you successful in collecting the data you needed for the FDA? Any expectation of how long before the FDA makes a decision?



____________________
CFS, EBV, PCOS, POF, TMJ, hypoglycemia, hyperlipidemia, MP 1/08; OTC acid reducer PRN; NoIRs, low lux home, limited outings, covered up; 25D=<4ng/mL (since 2008), (pre-MP 1,25D=37pg/mL, 5mg Cortef 3x in week before blood draw). Benicar q4h.
Prof Trevor Marshall
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 Posted: Thu Jun 7th, 2007 12:54

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Yes, thank you, We had a very good meeting with the FDA in April.
There will be announcements coming from time to time. Please keep an eye out for them.
 

laura1814
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 Posted: Thu Jun 7th, 2007 17:54

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Thanks for your quick response! I'm glad to hear the meeting went well.

Perhaps this would be a good time to request a general news update? There hasn't been anything posted in the Announcements forum since mid-April, and no new topics at all since November. I gleaned from reading in other forums that there have been at least two conferences so far this year.

(I submitted a 2" binder of MP info to my doctor yesterday, and have a consultation with him July 2nd. Hope to be starting the MP shortly after that!)



____________________
CFS, EBV, PCOS, POF, TMJ, hypoglycemia, hyperlipidemia, MP 1/08; OTC acid reducer PRN; NoIRs, low lux home, limited outings, covered up; 25D=<4ng/mL (since 2008), (pre-MP 1,25D=37pg/mL, 5mg Cortef 3x in week before blood draw). Benicar q4h.
Prof Trevor Marshall
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 Posted: Thu Jun 7th, 2007 18:15

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Laura,
The medical world does not understand the transparency that we have practiced at this site. So we need to tread a delicate line between keeping folk informed, and embarrasing our research partners. Please honor our judgement of what you need to know, and when you need to know it:)
 

laura1814
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 Posted: Thu Jun 7th, 2007 19:43

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I was not impugning your judgment. Posting summaries of events takes time, and I know you're busy. I was just asking. I'm sorry if I offended you.

Last edited on Thu Jun 7th, 2007 19:44 by laura1814



____________________
CFS, EBV, PCOS, POF, TMJ, hypoglycemia, hyperlipidemia, MP 1/08; OTC acid reducer PRN; NoIRs, low lux home, limited outings, covered up; 25D=<4ng/mL (since 2008), (pre-MP 1,25D=37pg/mL, 5mg Cortef 3x in week before blood draw). Benicar q4h.
Frans
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 Posted: Fri Jun 8th, 2007 07:35

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Trevor, I think we all respect your judgement after you have led us all this far.

On the other hand I for one am hungering for more and more info. Especially to fight my own private little battle against all the non-believers, but also, more important than that, to get people aboard the MP, to get the message out.

Every piece info you have provided, be it the info-laden presentations or just remarks in some threads, has aided me in understanding things better and better, making it easier for me to explain it to others in return.

I think we are all very much interested in getting the message out and I think every one of your accomplishments helps to drive another nail into the coffin of these diseases.

However, I understand that there are politics at work we cannot even begin to fathom and I for one trust you to have the best overview and insight in what needs to be done and how it has to be done.

I also understand that this study site is absoletely unique in the world of medicine and paradigm changes just don't happen overnight.

Your insights have already brought health and hope back to people who had already given up, so we owe it to you to give you the credit that your decisions about what to tell us and when are well founded.

I know that you know very well what you are doing, but would like to know the same :D:D:D

Sincerely,

An eager, but patient Frans :)



____________________
Burn-out/nervous breakdown Jan01 125D 48 25D8.48 Ph1Nov06 ModPh2Jan07 Ph2Apr08 Cipramil Seroquel NoIRs lite exp r/t work cover up 25D3.9(Oct07)
Perezt
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 Posted: Mon Jun 11th, 2007 08:52

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Dual Energy X-ray Absorptiometry (DXA)s Bone Mineral Density (BMD) performed on HOLOGIC DISCOVEY:

Jan 16, 2007 -       Density               T-score        Z-score

L1-L4                   1.122 gm/cm2       0.3 SD         0.7 SD

Femoral Neck         0.854                  -0.9 SD       -0.1 SD

Forearm 1/3           0.830                   0.1 SD        0.6 SD

1.122 gm/cm2      

April 5, 2005          Density                T-score       Z-score

L1-L4                   1.112 gm/cm2        0.2 SD         0.6 SD

Femoral Neck         0.841                  -1.0 SD       -0.3 SD

Forearm 1/3          0.793                   -0.6 SD       -0.1 SD

History:  On Prednisone Jan - Nov. 2005

            On Fosamax and likely Vit. D with Ca during part of 2005

Began MP on 12/23/05



____________________
Dx Sarcoid 1989 / Oct05 1,25-D=126 & 25-D=30; Began: MP Dec2405 / P2 Mar2206 / P3 May2106 / P4 Feb0108
jasmine
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 Posted: Mon Jun 11th, 2007 15:54

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Hi Dr. Marshall,

I just started your protocol and hope this helps with your mission.

Bone Density:

Pre-MP, June 2003, age 49

Hip:  BMD= .781  T= -1.3         Spine:  BMD= .845   T= -1.8

Prescribed Fosamax and 1000 mg (daily) Citracal

June 2005

Hip:  BMD= .778  T= -1.3         Spine:  BMD= .898  T= -1.4

Taken off Fosamax June 2005 due to acid reflux
Prescribed 1000 mg Vit. D2  Aug. 2006-Dec 2007, changed to 800 mg. Vit. D3 Jan.2007-April 2007

Limit Vit. D beginning 5/2007, limit sunlight beginning 6/2007

Just had my follow-up bone density scan today, and will report results a.s.a.p.

BP:

Pre-MP  80-90/50-60
Started Benicar 6/8/07
6/9/07: 91/53, 6/10/07: 93/61, 9/11/07: 87/49

Respectfully submitted,
Jasmine



____________________
Lyme,autoimmune thyroid disease,migraine,CFS,FM,neuro pain,arthritis,osteopenia,anemia,CKD,scoliosis,IBS,MCS,Lupus; 125D=45 6/07, 25D=12 8/09, 25D=5 10/15; PH1-6/07, ModPH2-7/07, PH2-1/08, PH3-12/08, BeniOnly 6/2010
jasmine
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 Posted: Fri Jun 22nd, 2007 10:04

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Hi Dr. Marshall,

I received my bone density results taken 6/11/07:

Hip      BMD: .862      Total: -.7
Spine   BMD: .908      Total: -1.3

It looks like I have improved in both areas, but still have osteopenia in my spine.

Respectfully submitted,
Jasmine



____________________
Lyme,autoimmune thyroid disease,migraine,CFS,FM,neuro pain,arthritis,osteopenia,anemia,CKD,scoliosis,IBS,MCS,Lupus; 125D=45 6/07, 25D=12 8/09, 25D=5 10/15; PH1-6/07, ModPH2-7/07, PH2-1/08, PH3-12/08, BeniOnly 6/2010
margaretdm
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 Posted: Sun Jun 24th, 2007 07:40

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My doctor and I had always suspected that my hypertensive crisis reactions were due to inflammatory disease. Prior to MP it ranged from a high of 212/135.  I'm ranging from 100/60 to 86/58 with no side effects at low pressure on Benicar 40 mg Q6-8hrs.

Last edited on Sun Jun 24th, 2007 12:25 by



____________________
Sarc 5/30/07 + Multiple other,(hartnup, physical allergy) Photosens| 6/4/07 1,25D=36.7 25D=12.2 9/7/07 1,25 D=30.4 25D=14.0| NoIR outside|blackout shades inside. avoid D| Beni 40mg 6/20/07 Q6hrs| Mino 6/30/07|50mg Q48 7/16/07|75mg Q48 8/5/07|back to 50mg
Ames
Research Team


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 Posted: Sun Jun 24th, 2007 15:18

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I wish I had insurance because I had pretty bad bone loss pre-MP. In another three months I will be able to get insurance again and look forward to re-testing my bone mass.

I do have two dexa scan results, a year apart, once my CFS had really kicked in badly. Interestingly, I spent most of that year on the beach in Acapulco. Worst decision of my life. For all that vitamin D I was getting from the sunlight, my bones got substantially worse in a very short period of time. If you'd like those results I can put them up.

My BP was super low pre-MP. I saw a CFS specialist (Dr. Lapp) who told me I had the lowest BP he had ever registered. He made me see a cardiologist that same day. I think maybe I was 30/50 or something along those line. I don't know if I have the records.

When I went to a a doc appointment a year into the MP my BP was 81/110. I nearly fainted..because it was so high and normal. I couldn't believe it. I can tell it still drops when the IP gets bad. When the BP symptoms are extra bad I always take EXTRA Benicar. My BP will go UP, and become more stable. If you'd like i can try taking some BP readings before and after a Benicar dose.

Amy



____________________
CFS/FMS/osteopenia/severe insomnia Non -MP meds: Gabitril (16 mg),Trazodone (150 mg),Tramadol (20 mg) for pain. Light: Noirs (outside and bright lights), thick layers, sunscreen
jcwat101
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 Posted: Mon Jun 25th, 2007 12:15

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I don't know if this will be useful, because I did not have a bone density test done before or since, but this was done a year after being on the MP and it shows my BMD was fine.  I had been having some D supplementation before beginning the MP in September of 2004 (like around 800-1000 IU per day).  I had been and have continued to get about 1000-1300 mg per day of calcium from supplements (along with around 800 mg magnesium).

So, they came out pretty good, despite the fact that I had some risk factors (years of a lot of bed rest and some several years of amenorrhea).  But being premenopausal, of course, reduces the tendency to have osteoporosis.

Vertebral levels
L2-L4        Lumbar 1.583    T score  3.2 
Normal is above  -1
Total Hip  0.997   T score  0.0
Normal is above 0

Anyway, my 25D was only 11 ng/ml even before I began the MP, so it shows a low 25D wasn't a problem for me (my 1,25D was 64 pre MP).

Joyce Waterhouse



____________________
20 yrs with CFS/FM/Lyme/IBS, food sensitivities; 1,25D/25D 8/04:64/11 http://SynergyHN.wordpress.com
tgritton
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 Posted: Wed Jun 27th, 2007 17:33

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I don't have any BMD results but do have urine N-telopeptide level, which is a marker for bone resorption.

3m preMP -> 41 nmole BCE/mmo Creatinine (range:11-103,no age range spec)
19m MP(5/17/07) -> 16 nmole BCE/mmo Creatinine (range:9-60,30-59years)

both Quest Labs



____________________
Prostate & assoc. neuropathies (was Lyme arrhythmias) | MP start Oct05 125D76 25D39 Olm&Antibiotics Nov05 Antibiotics stop Jun09 | Now Olm 40q4h 0Meds 0Supps Diet&Lite strictly controlled 25D <4 mostly(7y) 125D 15-80
Aussie Barb
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 Posted: Sat Sep 1st, 2007 23:22

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Sydney Chris wrote:

Saw the Dr this morning.. confirmed my bone density reading was 5% above the population norm for my age after 2.5 years on a low Vit D diet !!

He was a bit surprised and delighted that the regime of small, regular doses of calcium rich foods each day has avoided any issues in this area.

That said he has had no bone density issues with his other long term MP'er to this point.

Best to all.

Chris
___________________
Chris: MP Mar 05. IgG deficiency, post viral syndrome. VitD ratio 2.8:1 (177/63), Votum Q6h, NoIR's, sunlight, diet. Ph 2 Nov05. Mod PhII Jan 06. Feb 06: 25OH 6.8ng/ml, 1.25D 18.8pg/ml. Ph 3 July 06. Sept 06: 25OH - <7.2ng/ml, Jan 07, 25OH - 11.2



____________________
♥Barb♥: Dx Inflammation - Endocrine Imbalance 2003| Depression| 24+ years not Dx| MP Aug04-Aug2010| barbliv @ hotmail.com | ABC of MP| Barb's Story|
Aussie Barb
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 Posted: Mon Sep 10th, 2007 19:29

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Kas wrote:

Anyhow, here is probably the best news I have received in a long time.

Today, I went for my bone density test, which was last done two years back and which showed stable osteopenia I had already been avoiding D foods and pretty much eliminating sunlight for over a year at that time. Usually the radiographers to not give out the results here, but I had a very amiable fellow and he could not believe that I was not taking any supplemental D, let alone avoiding food sources, when he blurted out in amazement that my spine is in the totally NORMAL range and my hip,although a little down ( normal for my age), is smack in the middle of the NORMAL range. No osteopenia whatsoever!!

To say I felt I was soaring, was an understatement!! Of course, my doctor will get the report in about a week and I will be able to give actual figures here.
___________________
Kas: Sarc Dx by splenectomy 03 Lung, lymph node, liver| Jul/06 Beni s-r 40mgQ6H| Mino July06| Avoid LightD 04| mino alone 6 mths| NoIRs| Mod Ph2 Oct06



____________________
♥Barb♥: Dx Inflammation - Endocrine Imbalance 2003| Depression| 24+ years not Dx| MP Aug04-Aug2010| barbliv @ hotmail.com | ABC of MP| Barb's Story|

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