Southern Arizona Fibromyalgia Friends

Jess | December 23, 2014

Famvir + Celebrex Phase II Clinical Trials

There’s an important clinical trial that has just wrapped up phase II that should be of interest to anyone who has Fibromyalgia. Dr. William Pridgen and Associate Professor Carol Duffy at the University of Alabama have been experimenting with the use of Famvir, an anti-viral drug that is commonly used for the treatment of Herpes Simplex, combined with Celebrex, a COX-2 inhibitor, as a method of treating Fibromyalgia.

After watching many of his patients struggle with gastrointestinal

Professor Duffy had previously isolated the herpes simplex I virus in the digestive tract of Fibromyalgia patients.

issues for decades, Dr. Pridgen gave several patients Famvir on a hunch. He figured that if the GI symptoms intensified during periods of increased stress, a virus could possibly be to blame. Professor Duffy had previously isolated the herpes simplex- I virus in the GI tracts of Fibromyalgia patients. Dr. Pridgen used Duffy’s work to guide his treatment of these FM patients. Although the patients’ symptoms improved, Dr. Pridgen felt that there must be a second drug that would provide a better result if added to the Famvir. He added Celebrex, and found that many patients responded more favorably to this combination.

Here is Dr. Pridgen’s description of the method he is using to test this hypothesis- that the combination of Famvir (famciclovir) and Celebrex (celecoxib) will result in a significant decrease in Fibromyalgia symptoms:

A total of 143 patients selected using the ACR 2010 FM criteria were enrolled at 12 sites in a 16-week, double-blind, placebo-controlled trial. Patients were randomized (1:1) to receive a proprietary combination of celecoxib + famciclovir or placebo. Outcome measures included a 24-hour recall pain numeric rating scale (NRS), Fibromyalgia Impact Questionnaire (FIQ-R), Patient Global Impression of Change (PGIC), and the PROMIS fatigue short form at baseline, and after 6, 12 and 16 weeks of study participation.

Here are Dr Pridgen’s results:

The primary efficacy endpoint was change in pain from baseline. Pain reduction was evaluated using the pain NRS and the 7-day recall pain item from the FIQ-R. Change from baseline was determined using an MMRM approach with LOCF/ BOCF imputation for missing data. A significant decrease in pain was observed for patients on treatment vs. placebo at 16 weeks by both measures. The absolute change on the NRS was -1.9 units vs -1.1, comparing active to placebo (p=0.031). On the FIQ-R item, the change was -2.2 vs -0.92 (p=0.001). Key secondary endpoints included analysis of the PGIC, where a value of “1” or “2” was considered a clinical responder. Significantly improved PGIC response rates were noted at endpoint: 33.3% for active vs 19.2% in placebo patients (p=0.031). Total FIQR score change at the endpoint visit was -17.54 vs -7.87 (p=0.002), while changes in the 3 domains were 14.29 vs -5.44 (p=0.004) for Function, -4.29 vs -1.89 (p=0.003) for Overall Impact, and -16.77 vs -7.90 (p=0.004) for Symptoms. In addition, improvements in fatigue were seen at endpoint on the PROMIS fatigue (-7.62 units vs -4.15; p=0.020).

The safety profile was especially encouraging. Despite the celecoxib component, gastrointestinal and nervous system treatment emergent adverse events were reported significantly more often in the placebo treatment group (GI: 29.0% vs 42.5%; nervous system: 17.4% vs 23.3%; active to placebo), and study completion rates favored active treatment over placebo (82.6% vs. 60.8%) (largely driven by higher placebo discontinuation rates due to adverse events and lack of efficacy).

In short, Dr. Pridgen used two different methods to track patients pain. He used a Numeric Rating Scale (NRS), which is the 0-10 scale that so many of us are so familiar with. He also used The Revised FM Impact Questionnaire (FIQR) to assist patients in reporting their pain levels. This questionnaire requires patients to respond to a variety of statements such as, “[How difficult is it to] Change sheets on bed,” on a scale that ranges from No Difficulty to Very Difficult. Both systems showed a significant decrease in symptoms following treatment with both Famvir and Celebrex.

In an article written by the University of Alabama, Dr Pridgen stated,

The patients who took both drugs, however, came back and said everything was better. Their fibromyalgia was gone. Their chronic fatigue was gone. Their headaches were gone. All of these things had cleared up. When the first few patients approached him, he thought it was a fluke, but as more and more and more patients said the same thing, he knew it couldn’t be a coincidence.

Here are Dr. Pridgen’s conclusions from his Phase-IIa trials:

A proprietary combination of famciclovir, which we postulate is inhibiting herpesvirus replication, and celecoxib, known to inhibit both herpesvirus replication and reactivation, was efficacious in treating multiple symptoms of FM. Given the simultaneous improvement in many domains and the surprising tolerability of this combination of drugs, we believe this combination warrants further study as a potential new therapy for fibromyalgia patients.

Coping With Emotional Pain

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“Be kind to people and don’t judge, for you do not know what demons they carry and what battles they are fighting.”
― Vashti Quiroz-Vega

I’ve had some pretty high pain levels over the last week. I do not share this because I am seeking pity, sympathy, or empathy. It is what it is. I am fortunate to have a supportive, loving spouse and supportive, loving friends, many of whom fight the same daily battles that I fight. I am fortunate to have developed coping skills over the last 11 years to help get me through rough days and weeks. Weeks like last week, when getting the kitchen clean was a major accomplishment. Weeks like last week, when it felt that no matter what I did, I could not escape the pain. Weeks like last week, when I knew my ‘to do’ list was exceptionally long, and yet, it felt as if I just could not make a significant dent in it, no matter how hard I tried. This morning, I awoke to a filthy dirty kitchen, and had to wonder to myself, ‘How did THAT happen? This kitchen was spotless two days ago!” Pain, my friends, is what happened. Pain is very tiring.

But the worst of it for me, by far, are the emotional consequences of living in pain. Physical pain is hard, but emotional pain is harder. There is no pill you can take to escape emotional pain. For example: having to tell a friend, “I’m sorry, but I just can’t make it to dinner,” when I was the one who scheduled dinner in the first place. Cancelling on my trainer because I don’t feel well enough to drive

Thanks for the suggestion, but I really don’t think Rice-a-Roni is the answer I’m looking for!

into town by myself to exercise, even though I know the exercise will help me (oh, the irony!), simply because I feel that my mind is not sharp enough to concentrate on driving safely. Wondering how my body will cope when my husband and I have kids. Wondering if I will ever gain enough control over this pain to teach full-time again without calling out sick once a week. Dealing with thoughtless and careless comments, like “If you just did _____, you’d feel SO much better!” And, “Oh, if you’re still eating Rice a Roni, you’ll never get any better!” (Yes, someone actually said that to me last week.) Or, my personal favorite, the condescending looks that I feel I am receiving when my gait is unsteady because of a muscle spasm in my knee or hip while walking, and a disparaging comment from someone else that follows the spasm.

At times, I feel like saying, “Oh, really? Is THAT the magical cure that I’ve been missing for all these years? And to think, none of my doctors have ever thought to mention that to me! I’ll have to pass that along to my medical team, so tell me, which study and publication gave you that information? I’d love to look up the original research on PubMed.” I know that this semi-sarcastic response is really not going to help anyone, but I can’t help but think how great it would feel in that moment. Pop-culture does not equal medicine.

These comments hurt because I did not choose this life. Because I never prayed to God for a life filled with internal conflict with myself, external conflict with the world, physical pain, emotional isolation, and feeling as if others are looking down on me for ‘not working hard enough.’ If you truly believe this is a path that any person would choose, you must have some serious emotional baggage of your own. I cannot come to any other conclusions than that. Nobody chooses this life. It simply happens. And it can happen to ANYONE.

I was 18 years old, and the healthiest I’d ever been when I got sick. In a matter of three weeks, I went from doing 160lb leg presses regularly (I weighed 130lbs at the time), and running a 5K every week to having to sit and rest during a 1/4 mile walk on a gentle incline from my dorm room to the dining hall. Why did I have to sit and rest? Because I was so winded that I felt as if I was going to pass out, right there on the sidewalk. That kind of deterioration does not just happen to healthy people. Later, we discovered, my blood pressure was plummeting (sometimes to as low as 80/40, while my heart rate was at a high 130), sometimes after only mild exertion. Medications that “should help,” (my doctor’s words) granted me the gift of 50+ extra pounds to carry around, which only made the pain worse. This completely off-set any benefits I had been receiving from those medications. I’ve managed to lose some of that weight, but some of it just does not seem to want to go anywhere, no matter what I try. I have not given up on trying to drop this extra weight, but I have accepted it for what it is. My story, sadly, is not unique.

I know that when I am in pain, thoughtless comments affect me more. It feels as though the coping mechanisms I have worked so hard to build up over these last 11 years are suddenly not available when I am in pain, while I am still expected to meet functional and social obligations during these periods. The reason for this might be explained by a study performed at Harvard in 2012 using fMRI scans showed that Fibromyalgia patients express fewer neural connections within the brain to the amygdala, hippocampus, and the brain stems during pain episodes as compared to healthy controls.

Patients with FM displayed less connectivity within the brain’s pain inhibitory network during calibrated pressure pain, compared to healthy controls. The present study provides brain-imaging evidence on how brain regions involved in homeostatic control of pain are less connected in FM patients. It is possible that the dysfunction of the descending pain modulatory network plays an important role in maintenance of FM pain and our results may translate into clinical implications by using the functional connectivity of the pain modulatory network as an objective measure of pain dysregulation.

In other words, pain signals can actually block normal homeostasis in Fibromyalgia patients. It’s little wonder that pain also makes us forget all of the coping skills we’ve worked hard to master, even if it is only temporary. It’s little wonder that we try to “make up” for less productive days when we feel better, which sometimes sends us into a rebound flare. And, it’s little wonder that some of us have more digestive problems when our pain levels are higher, whether that is the result of taking more pain medications (which tend to cause constipation), or just a result of the pain pathways affecting homeostasis (digestion). This may also explain why Fibromyalgia patients are more irritable during high pain episodes, and why we have a harder time coping with stress in general; both are processed in part by the amygdala.

Most Fibromyalgia patients are experts in hiding their pain. It is a social taboo to talk about it extensively. Many pain patients are concerned about losing their jobs, housing, and sometimes even insurance or doctors if they talk about their pain or how it affects their lives too much. Or if they ask for “too many” work accommodations (for some people, this means even asking for ONE accommodation), even if the accommodations are truly necessary. Eventually, we all hit a point when we cannot hide it anymore. That may only last a day, a week, or a month- or it may be a permanent change. I think this homeostatic dysfunction plays a role in this phenomenon. When you are struggling to regulate your digestive tract, or to not think about how you’d really love to amputate your right arm because it hurts so G-damn fucking much at that moment, filtering your thoughts during a conversation sometimes just does not feel as important as it once did.

Many patients do not talk about their pain because of the kinds of insensitive comments I experienced this week. It is difficult to talk about pain. The problem is that when we do not talk about our pain, it’s easier for society to pretend that it’s not there. It’s easier for us to pretend it’s not there. We become even more isolated. When we don’t talk about these tough issues, we don’t see legislative changes like the Americans with Disabilities Act and Affordable Care Act, which help prevent disability-related discrimination. We don’t see the development of new research (like the study above), that may eventually help to develop more effective treatments.

While it helps to know what’s going on in my body during these high pain weeks, careless comments still sting. I think that they probably always will. This is where the benefits of a support group can help; we have all heard these careless comments, and we have all heard them when we’re in a lot of pain. Sharing the insensitive comment with a support group can be cathartic. Just hearing from other pain patients that the comment truly was insensitive and offensive, helps. Knowing that you’re not the only person fighting these internal and external battles, helps. None of us are truly alone.

Original image from: http://scn.youngeasy.com/list/hiding%20pain/1.html

If you are having trouble coping with a pain disorder, find a support group. Reach out. Talk to other patients. Find someone in your life who will simply listen to you vent- and maybe even give you a hug when you’re done. Talk to your doctor about the way you are feeling; it’s possible that a few weeks or months of talk therapy might help you develop more coping skills and it might even help you to come to terms with your illness. When your burden becomes too heavy, let someone else help you carry it for a while. You are not alone, and you are NOT your illness.

Category: Living Well, pain management, Social Support |

Jess | March 15, 2014

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Traveling with Fibromyalgia

Travel can be difficult, if not outright impossible, for anyone with fibromyalgia. I personally prefer to drive, because that way I don’t have to deal with TSA. Below are the special routines I’ve developed for myself to make that process a littler smoother and less chaotic for me. I also have specific routines that help make a road trip more feasible without putting my body through too much strain.

Driving:

Stopping every 1.5-2 hours on a road trip to stretch and massage my legs and shoulders helps to keep adhesions (knots) at bay. I also tweak my “normal” med dosages (amount AND timing) to accommodate higher pain levels during travel.

HG17779_QA_man-sleepless-triggers-fibromyalgia_FS

“Cheap motel? What was I thinking?!”

Avoiding certain foods (very spicy, or anything that has a remote chance of causing gas, for obvious reasons) and including more fruits and vegetables a few days before travel helps make travel easier on my body. I also try to clear as much of my schedule as possible a few days before so I’m a little more well-rested for the trip.

If I know we’ll be staying at a hotel that might not have a great bed/pillow arrangement, I bring a pillow, and sometimes a spare blanket, too!

During a trip, I sometimes have to schedule in some down time so I can actually enjoy the trip. My fiance and I have started to get really good at building in a balance of activity + restful activities during our trips, which also helps to reduce MY stress with it all!

Flying:

-My Rx meds and daily supplements go in one gallon-size ziploc bag. If I have a med planner to take with me, I seal that in another ziploc, roll it up, and stick it in the bottom/side of the first gallon ziploc bag so it doesn’t fly open (this way, even if the med planner DOES open up, the pills aren’t going very far). Nothing worse than playing “medication roulette” in an airport bathroom!

– Any OTC products, like Biofreeze, ibuprofen, knee brace, etc., go in a second gallon ziploc. Both of these bags will need to come out for x-ray/hand inspection (you just have to ask TSA for a hand-inspection of your stuff if you don’t want it going through x-ray). Keeping the OTC stuff used “as needed” separate makes it easier to find if I’m in the middle of an airport and start having muscle spasms in my ribcage or something. Medical items are NOT limited to the 3.5 oz rule that toiletries are limited to. So, take that 6oz bottle of Biofreeze with confidence! Just make sure it’s clear somehow that it’s a medical item. In my case, I bag the non-prescription stuff up in the same way I bag the Rx stuff. So far, I’ve not had any problems with that.

– Pack any toiletries I probably won’t need during the flight (like a razor) in my checked bag, if I’m checking anything. Keep toothbrush, toothpaste, contact solution (this one actually goes in one of my gallon-sized ziploc bags since TSA classifies this as MEDICAL), and anything I might need for the first 24 hours after I arrive, should my luggage get lost. These toiletries (and lip gloss, lotion, etc from my purse) go in a quart-sized bag. These also have to come out for security. (In other words, when I get to security, I have three ziploc bags to pull out of my carry-on.)

-I bring an empty Nalgene bottle with me. That way I can fill it up on the other side of security without worrying about if I’m going to drop that flimsy paper cup from Sbarro’s OR what I’m going to do for liquid if I need to take a pill in between beverage service on the plane, particularly if it’s during a period of “rough air.”

Three Coloured Nalgene Tritan Wide Mouth Water Bottles

Take that, $5 bottle of airport water!

-When I pack my carry-on, I make sure these items (plus wallet/ID/boarding pass) are towards the top of my bag, so that when I get to security, I just have to unzip my carry-on, pull them out from the top, and put them in a plastic bin for x-ray.

-Once I get through security, I re-arrange my carry-on so that whatever I’m reading/listening to on the plane is easier to find, which sometimes means sticking my earbuds in my pocket or wrapping them around my phone.

-I usually have a lightweight change of clothes in the bottom of my bag, and that stays in the bottom since I’m less likely to need that. That usually also lets me layer more or less if I need to. I try to stick a light sweater in there, too.

- I also keep some kind of healthy-ish snack with me- things that I know my stomach handles well. Trail mix, dried fruit, a cookie, etc. My dietary wants/needs seem to change a bit when I fly. For example, if I’ve got a layover and need to eat, I do better with really soft stuff that *doesn’t* have probiotics in it, like ice cream. For whatever reason, probiotics make my IBS flare up when I fly, either shortly before, during, or shortly after. So, no yogurt for me.

– Purse: some trips I have kept my purse separate from the rest of my carry-on stuff, but I find it’s easier to manuever through an airport if I can pack the contents of my purse in my carry-on, especially if it’s a long flight. Sometimes this means packing the purse itself in my checked bag, but keeping the contents in my carry-on.

Key things to know about flying with a chronic illness:

If you don’t want to go through those body scanners, you can request a pat-down instead. They will still use the magnetic wand on you unless you have a specific reason why they can’t (like a pacemaker). If this is the case for you, make sure you have some kind of documentation showing that you have a pacemaker. Your cardiologist should know what you need. It’s just not worth the risk! It is up to you to decide whether you want the pat down or the x-ray. Neither is really a good option for someone with Fibromyalgia, but those seem to be the options that TSA has given us.

TSA allows you to take anything through of ANY quantity, as long as it is MEDICAL.

So, if you have a dysautonomia issue (POTS, etc) and you need to keep a specific formulation of a rehydration solution with you, you can bring it through security. It does need to be in the original bottle/packaging. And to be safe with something like that, I’d have a doctor’s note, pharmacy info (from the pharmacy, if it’s an Rx) with it. As noted above, TSA considers contact solution to be a medical necessity, so you’re actually not limited to just a 3.5 oz bottle. I’ve actually taken huge containers of powdered medical food through without a problem (think 60 oz). Just a few weird looks from other passengers. Meh.

All medications HAVE to be in the original bottles. I’ve never had a problem with pills in a med planner (technically, I don’t think they’re supposed to let those through, but I could be wrong on that), but I also make a point to put the Rx bottles in the same clear plastic bag as the med planner. If you get super-huge bottles for 3-months worth of meds at a time, you can ask your doc to write a script for however many pills you’ll need during the trip + a few extra in case of emergencies. Obviously, there might be some insurance authorizations required here for extra fills. I’ve had doctors prescribe the same drug at half dose for me before specifically for a trip- that usually gets around the insurance pre-authorization/extra fills issue. It also gives me more flexibility with dosing if the normal 20mg dose of Flexeril is not enough for the added stress of travel. Just be sure that you have a conversation about that kind of thing with your doctor before your trip!

If you think you’ll be fine without a wheelchair, but then get to security and feel sick, let somebody know. TSA CAN wheel you through security if you really need it. You can always ask for a wheelchair at any point during your travel, whether you’ve requested it ahead of time or not. If you know you’ll need a chair, note that on your reservation (there’s usually a box to check), and call the night before/morning of to confirm that someone will be able to meet you with a chair when you arrive at the airport. That person will also escort you through security, at no charge. It is, however, appropriate to tip your wheelchair wrangler.

Do you have other travel tips? Let us know! Join us on Facebook at: https://www.facebook.com/groups/120979651274630/ *

*Please note that we do NOT allow spam of any kind in this group. We’re happy to hear about your experiences with different therapies, but any posts that even remotely look like spam will be treated as such. We also do not tolerate trolling or verbal/emotional abusive posts.

Category: Living Well, pain management |

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