Protocols

Treatment protocols for Chlamydia Pneumoniae, usually using combination antibiotics.

Editorial: Be Considered in Using Survey Results

Submitted by Jim K on Sat, 2006-04-15 09:25

When I first started www.cpnhelp.org one of my dreams was to be able to gather some real data about users experiences and results on cpn protocols. I know from my training as a psychologist that having such a ready data pool is a priceless opportunity. It would allow us to go beyond mere anecdote to some real, statistically relevant results. I was joined in this by Marie Rhodes whose training and intelligent understanding of medical research gave her an interest in gathering some "hard" data, i.e. medically sanctioned measures such as EDSS scores, blood results and the like.

But when I started the site 33 weeks ago and put up the first survey, we had only 4 people who had met the three month criteria and could fill out the survey. It took us 8 months to make for reasonable numbers that I felt were worth reporting on. The results of that survey can be found at Survey #1 Results.

Since that report, I've seen others referring to it, like me grateful to have some kind of data they can point to.  We aren't just going on our personal impressions any more.

Having been worried about the lack of data, now I'm getting worried about how data is being used and misused. In case you haven't gathered by now, I'm a worrier by nature. This could be a genetic defect on my part. You've heard the joke about the Jewish mother who gives her son two ties for his birthday? The next morning he comes down proudly wearing one of them, and she says "What's the matter, you didn't like the other one?"

My worries- that these very preliminary results will be referred to as firm findings. The data group is so small (23) that anything in this survey is merely suggestive. And barely that.

This is even more true with any results derived from breaking down findings into subgroups, like the MS/CFS-FM groups. In that case we have even tinier groups, and less validity to draw on. Such fndings are even less generalizable because each group is now so small that any large differences by any one member within the group will skew the results of that group.

I almost regret having broken the results down this way, especially with those damned charts of which I was so proud, because the charts make everything look so official. Slick presentation impresses us beyond the actual validity of the data itself.

However, our numbers are growing every day. I put up a poll up recently to get a clearer idea of how many people are actually doing the protocol: 35, plus 3 people additional actually done with the thing! Thirty-eight is not bad. When we hit 50+, we might even have some data worth doing statistical analysis on. Getting closer to that every day.

The results of this first survey have inspired Marie and I to take the next step, and build a survey which is much more detailed and will include some hard measures of functioning in it as well. It will take time to develop, but it's coming.

In the mean time, I want to ask everyone to please be cautious about how you refer to any findings of the current survey. If you refer to these findings, please, please use qualifiers like "It looks like..." and "preliminary survey results have suggested..." and the like.

It's good to be enthusiastic about the CAP's and your own personal experience, but be tentative about how firmly you make claims based on this data. Make sure newbies know that, while the survey found one thing, their own results may differ, and that there is a big range of response within the survey reports.

Thanks to everyone who contributed to Survey #1. I'll be relying on you all to provide even more data next time!


First Report: Results of CAP's Treatment Survey #1

Submitted by Jim K on Tue, 2006-04-04 10:09

Finally we have the results of our first survey of CAP's treatment!

The detail hounds might find a few numbers that don't add up. If so, let me know and I'll double check the data. It's as accurate as I could get it given mostly hand tabulation. I'm relying on you to keep me honest, as I'm only one day post Tini and not seeing everything clearly this morning!

Please remember that these are small numbers reporting in, and a rather rough set of questions. It's a survey, not a statistical study. The charts are impressive, but should be taken with caution as visual aids can look better than the data set they come from!

Find it at:

First Report: Results of CAP's Treatment Survey #1 

Stratton/Mitchell & Siram Case Reports

Submitted by Jim K on Sat, 2006-01-21 20:33

Does it work?

It has been noted that most users of the combination antibiotic protocols commenting here have not been on the treatment long enough to give a big enough pool of reports to feel assured of the efficacy of this approach. I had asked Drs. Stratton, Wheldon, and Powell to perhaps tally up at least some basic numbers from their case experience to help us out with this problem, but this would involve problems of confidentiality and use of private data, etc.  

Then, I suddenly realized that we already have a good list of anecdotal reports of response to treatment reported data available to us... right in the Stratton/Mitchell patent materials! (Sheepish, embarrassed grin). So I took it as a project to summarize this data by disease treated. Occasionally I have used the exact wording from the patent materials as they were brief and descriptive. We have the full text referenced in our treatment and links if you want to see more detail.

All reported had with positive serology for Cpn using the highly sensitive tests developed by Stratton/Mitchell. I left out a few whose diagnosis was not clear to me, you can see them in the patent materials #6,884,784
All on some form of the combination antibiotic therapy protocol.

Much ado about a small poll

Submitted by Jim K on Mon, 2006-01-16 21:09

Summary of our Cpn Treatment Poll:

The poll was out for two weeks, and represents a snapshot of protocol users at this point in time. We had slightly different numbers participating in each section of the poll, perhaps some questions did not have exclusive answers for those voters. Obviously, 25-28 people is not enough to draw scientifically valid results from, but I intend to speculate on some suggestive patterns in the data.

Gender:
Female: 61% (17 votes)
Male: 39% (11 votes)
Total votes: 28
This ratio is commonly reported in CFS/FM, MS and other "autoimmune" diseases, so is not surprising. We would expect that if more people with Cardiac diseases were searching out Cpn treatment, with a higher male to female ratio, this might change.

Age:
20-29 years = 7% (2 votes)
30-39 years = 14% (4 votes)
40-49 = 32% (9 votes)
50-59 years = 39% (11 votes)
60-69 years = 7% (2 votes)
Total votes: 28
Our largest group is between ages 40 to 59. I suspect that this age does not reflect the period when people are morel likely to be infected, but rather a range where long term persistent infections are have accumulated enough damage to force us to seek out "desperate measures" such as the multi-antibiotic protocol recorded here.

Primary diagnosis:
Over half the total in the poll have a diagnosis of MS. The second largest group are those with a diagnosis of CFS/FMS. This likely influences the treatment response reported later which suggest that improvements are noticed most after 5 or more pulses.
CFS/FM = 28% (8 votes)
MS = 55% (16 votes)
Asthma = 3% (1 vote)
Cardiac disease = 3% (1 vote)
OTHER = 10% (3 votes)
Total votes: 29

Serology
Positive blood test for Cpn
48% (12 votes)
Negative blood test for Cpn
16% (4 votes)
Not been tested for Cpn
36% (9 votes)
Total votes: 25
Well over half either have negative or no serology for Cpn, suggesting that they are engaging in a completely empirical (based on symptoms or theoretical connection between disease and Cpn) protocol.

Antibiotics
I take AT LEAST TWO of: doxycycline/azithromycin/roxithromycin/rifamcin/minocycline/INH-: 73% (19 votes)
Single antibiotic only: 20% (5 votes)
I take only INH: 8% (2 votes)
Total votes: 26
This poll speaks for itself. 73% are already on the dual antibiotics, a small number appear to be early in treatment, confirmed by findings below that 40% have not yet done a pulse of bacteriacidal,  and have only added one agent. As INH is used as a single agent with the flagyl pulses in some versions of the Cpn protocol and, together with NAC for the EB phase I have reported it separately.

Bacteriacidal Agent Used-
I take metronidazole (Flagyl) for bacteriacidal pulses
81% (13 votes)
I take tinidazole (Tinactin) for bacteriacidal pulses
19% (3 votes)
Total votes: 16

Pulses of bacteriacidal
I've done NO pulses yet of metronidazole/tinidazole
40% (10 votes)
I've done some partial pulses of metronidazole/tinidazole
4% (1 vote)
I have had LESS than 5 full pulses (at least 5 days each) of metronidazole/tinidazole
24% (6 votes)
I have had MORE than 5 full pulses (at least 5 days each) of metronidazole/tinidazole
32% (8 votes)
Total votes: 25
Over half in this small pole have done at least a full pulse of bacteriacidal agent, with only 8 people reporting 5 full pulses or more. This shows that we are still, as a group, in earlier phases of treatment. As the results below suggest, more significant improvement starts to accrue beyond 5 pulses of the bacteriacidal.

Response to treatment-

1. On 1 0r 2 antibiotics ONLY My primary condition is the SAME or WORSE
13% (3 votes)
2. On 1 0r 2 antibiotics ONLY My primary condition is SOMEWHAT improved
13% (3 votes)
3. On 1 0r 2 antibiotics ONLY My primary condition is SIGNIFICANTLY improved
13% (3 votes)
4. Less than 5 full pulses: My primary condition is the SAME or WORSE
13% (3 votes)
5. Less than 5 full pulses: My primary condition SOMEWHAT improved
9% (2 votes)
6. Less than 5 full pulses: My primary condition SIGNIFICANTLY improved
4% (1 vote)
7. MORE than 5 full pulses: My primary condition is the SAME or WORSE
0% (0 votes)
8. MORE than 5 full pulses: My primary condition SOMEWHAT improved
13% (3 votes)
9. MORE than 5 full pulses: My primary condition SIGNIFICANTLY improved
22% (5 votes)
Total votes: 23

These results are more obvious when grouped.
If we collect together everyone in early phase of treatment (#1-6) and we see that 26% are the SAME or WORSE
28% are SOMEWHAT IMPROVED
17% are SIGNIFICANTLY IMPROVED
Actually, to have 35% already reporting any improvement in their condition this early in the protocol is striking to me. I expected less noticeable improvement at this stage, especially given the numbers being treated for otherwise "intractable" diagnoses such as MS and CFS/FM.

But it is when users of the protocol get to 5 pulses (#7-9) or more, in this small sample, that the number in SIGNIFICANTLY IMPROVED seems to begin to creep upwards. Perhaps when we get a better sample of longer term users we will be able to sort out the "magic number" of pulses where more significant improvements take place. From reports in blogs and forums on this site, somewhere around 7-9 pulses seems to be a period where people are feeling much better and more significant changes in their primary diagnosis are occurring.

Take the Two Week Cpn Treatment Poll

Submitted by Jim K on Thu, 2005-12-29 21:59

I'm trying an experiment with a series of polls that will gather a quick snapshot of cpnhelp.org users experience in treatment. It will only be available 12/30/05 and 1/13/06. Let's see what we get from everyone on a combination antibiotic protocol!

To take the series click on each link below in turn, vote on the appropriate choice, then return here and take the next one in the series.

  1. Primary Diagnosis
  2. Serology
  3. Antibiotics
  4. Antibacteriacidal
  5. Pulses

Dr. Michael Powell: A Rheumatologist Treating Cpn in CFIDS, FM, Lupus and other "auto immune" disorders

Submitted by Jim K on Sun, 2005-11-06 16:33

I spoke with a rheumatologist in California, Dr. Michael Powell, who is cautiously using a combination of antibiotics in conjunction with standard therapeutics for the treatment of nanobacterium (including Cpn) in patients suffering from FM, CFS and autoimmune disorders. His results with this treatment program have been encouraging. He faxed me some examples of patient feedback forms, excerpts from which you can see below. Recovery is not instantaneous, but tends to occur over a 6 to 12 month period. The graphs of subjective improvement are drawn from visual analogue scores compiled during each visit. When summarized in this manner these data give a time-lapsed impression of the response to treatment.

One of the interesting things he mentioned was in relation to negative patient serology for Cpn when other clinical signs lead him to suspect some involvement. Serologic assays for IgG, IgM and IgA are sent to confirm infection prior to treatment. He would like to see a positive serology in patients before engaging them in a combination antibiotic protocol, but recognizes that patients may not have antibody reactions. This may be due to the ability of intracellular organisms like Cpn to evade a humoral response (antibody production), immunoglobulin depletion, or other factors. In these cases, when there is a high index of suspicion for the infection without a humoral response, he tests the spouse of the partner for Cpn. He sees the "non-symptomatic" partner as a good indicator of Cpn in the patient, given the infectious nature of Cpn. Thus far, most spouses are positive when an ill family member is non-reactive.

In our discussion Dr. Powell pointed out the many similarities between TB and Cpn.  Both organisms  can evade our immune system.  Both organisms can be carried from the lungs, the original site of infection, and infect other tissues. Both require prolonged treatment with multiple drugs to eradicate the infection.  Both are sensitive to stress levels. Optimal therapy is being evaluated at various research centers and new medications for Cpn are on the horizon (see activbiotics.com).

INH and supplements for endotoxins-
Dr. Powell finds most patients improve on a standard combination antibiotic protocol for Cpn. Rheumatologist have apparently been using doxycycline for many years with success for inflammatory arthritis but there is evidence that using doyxcycline in combination with rifampin is even more effective. Some patients plateau after about 8 months of treatment he has found variations in the treatment protocol have made a difference. One protocol he uses involves the use of NAC 600 mg twice daily, INH 300 mg once daily before breakfast, and metronidazole 500 mg twice daily pulsed with 5 days on and two weeks off.  It is essential to start each agent separately and gradually increase the dose over weeks or months as tolerated.  The use of Vitamin C 500 - 1000 mg four times daily (the half life of vitamin C is 30 minutes and little remains after 3 hours) to offset the release of toxins during therapy.  B6 is important to control INH related peripheral neuropathy.  Monthly laboratory evaluation of AST, ALT, Cr, and CBC are recommended for all who engage in this protocol.  It is not uncommon for liver enzymes to show a mild elevation during the initial stages of treatment.  Antibiotic therapy should be temporarily discontinued during periods of toxicity, should it arise. He emphasized the importance of insuring that yeast and fungal infections do not overgrow during protracted antibiotic use. He recommends the use of acidophillus, nystatin, diflucan, oregano oil, and/or grapefruit seed extract as needed to prevent secondary opportunistic infection during treatment.

Covering for the possibility of yeast and fungal overgrowth during antibiotic therapy is essential.  If diarrhea develops, stool must be evaluated for antibiotic associated diarrhea (C. difficile).  This is not a simple protocol and it is best if it is guided by an experienced clinician who is familiar with the medications and methods of minimizing toxicity related to killing the nanobacterium.

A link to Dr. Powells clinic may be found on our links page. Dr. Powell does do telephone consultations by arrangement and may be a resource for those who have had difficulty finding a Cpn knowledgeable doctor in their area. He requires an initial visit with a physical examination before initiating therapy (lab work can be performed prior to the initial visit to facilitate diagnosis and treatment), and monthly laboratory testing with monthly phone consults are then the norm. Treatment of related hormone imbalances in the thyroid system and nutritional support, temporary antidepressant support as needed, and sleeping medications are useful adjuncts to the antibiotic protocol. It is necessary for patients to have a primary care physician to monitor health matters that are unrelated to FM, CFS and autoimmune disease.

Cpn Treatment Information

Submitted by Jim K on Wed, 2005-10-05 17:52

The links below will take you to pages with specific information involved in the treatment of Cpn.

Diagnostic Testing For Cpn
Information on serological testing and the problems of this in Cpn.
Combination Antibiotic Treatment Protocols for Cpn
Links to pages on the current versions of Vanderbilt/Stratton and Wheldon Protocols for treating Cpn infections in various diseases.
Experts Comments

Commentary and interviews  with various experts in treating Cpn which help guide and inform about various facets of treatment.
Treatment Reactions
Information on some of the kinds and sources of treatment reactions one can expect on combination antibiotic protocols in treating Cpn, including cytokine reactions, endotoxin reactions, secondary porphyria and other reactions. These are often lumped under the term "herx," an inaccurate term and not as useful as really understanding what's going on.

 

Comments by David Wheldon in response to questions about choice of antibiotics in his protocal versus the Vanderbilt protocal:

Submitted by Jim K on Tue, 2005-08-23 22:21

I believe that Stratton and co-workers used a beta-lactam (penicillin, amoxycillin or similar) to attack the infectious stage
(elementary body) of the organism. They did some in vitro work to support this, which they should publish, because it's
fundamental. I reasoned that, as culture was so rare in persistent human infections, the numbers of elementary bodies would
be small. Also, any elementary body entering a phagosome in a cell containing bacterial protein-synthesis inhibitors would be
doomed, as the organism needs to fabricate proteins immediately to survive. Coupled with this was a native gut-reaction that
people would buy into the idea more readily if there were fewer antibiotics. And, further, that one is taught at med school
never to combine cidal and static agents. In the higher levels of microbiology that's not always true, but basically you just
want people to believe you and treat, as early as possible, and the more complications you put in their way the more difficult
that is.