| Clinical Investigation Of Enteric Delivered Cetyl Myristoleate In Various Disease Models
David Eckes, M.D., et al. 1. P.A. is a 52 year old white female with fibromyalgia, IgA deficiency, osteoarthritis of the thumb from computer mouse work, allergic rhinitis with chronic sinusitis, tension headaches and sinus headaches trigger migraine headaches. She has a history of gastric ulcers and is on Prilosec for same. Also on antidepressants to help control fibromyalgia and depressive mood swings created by chronic pain. She started AlphaFlex 12/00 and continues on 3 daily. It helps her hand joints so she can continue to use the computer. It keeps her headaches in better control. It does not bother her GI tract so she has less distress than when she used Vioxx and ibuprofen. She has been able to stop those anti-inflammatories, cut down on Ultram, Tyl #3, Percocet. After 3 weeks on the AlphaFlex®, she writes on 12/22/00 "Dr. Dave, My right hand isn't throbbing today and other joints are moderately sore! I am so excited. Wed. & Thurs. I finished my Christmas shopping which included carrying a lot of packages through stores, wrapping everything, and not getting much rest. I truly hope this is a turnaround point for me, a real miracle at Christmas. Thank you for selecting me for your project. I'm sure there were many others suffering as much or more than me." After 8 weeks on AlphaFlex®, she writes on 2/7/01 "Hi Dr. Dave, I wish you could see my thumb - you wouldn't believe how much improvement there has been. Even my knees are better now. I'm still having problems with my jaws but it doesn't seem as bad as before. The headaches I've had lately have mostly been sinus and not migraine. I hadn't thought of the connection between the AlphaFlex® land migraines before, but it makes perfect sense. I have not taken any anti-inflammatory meds because I need to know that any relief I'm getting is from the AlphaFlex®." After 12 weeks on AlphaFlex®, she writes on 3/7/01 "Hi Dr. Dave, I just want to let you know that AlphaFlex® has done wonders for my joints. My hands and knees were usually extremely sore the day after I scrubbed floors. I still experience the fibro pain but the knees and hands are much better. I continue on 3/day. I would like to get everyone I know that has arthritis to give AlphaFlex® a chance! Glucosamine sulfate did not reduce the swelling. This does. The joints are so much more mobile." After 14 weeks on AlphaFlex®, she writes on 3/21/01 "Dr. Dave, The only thing I am taking for fibro pain is Ultram. I don't have any narcotics and have stayed away from NSAIDS because of the AlphaFlex®." After 16 weeks on AlphaFlex®, she writes on 4/7/01 "Hi Dr. Dave, "I've had no arthritis problems. Yesterday I went to Home Depot for a birthday gift for my oldest son, and halfway thru the store I realized I was moving so much better than the last time I was there. Then I went to Target. By the time I was done at Target I needed to come home because of fatigue, not joint pain." After 21 weeks on AlphaFlex®, she writes on 5/14/01 "Hi Dr. Dave, "I started with another bad headache Sat. night and I still have it. I tried the Maxalt and it didn't do a thing so I'm assuming it is sinus-related. I have had a couple of migraines the past month but they only lasted a day rather than the 2-3 day pattern, so maybe the AlphaFlex® is helping with that." After 26 days on AlphaFlex®, she writes on 6/12/01 "Hi Dr. Dave, I realized it has been a month since I've contacted you. I have told several more people about AlphaFlex® in that time, and all of them were very interested. I had 5 days of feeling so great that I was sure I was getting my old life back. Yesterday morning I crashed but I'm thankful for the 5 days. I did so much in that time - I really needed it mentally as well as physically! I think the barometer changes yesterday had a lot to do with everything. My knees are even hurting and that's the first time since I started taking AlphaFlex®. I used the AlphaFlex® cream on all my joints today. I'm trying to remember to use it everyday after I shower but sometimes I forget. Brain fog." I hope this is the type of stuff you want. Let me know. I have much shorter stories to tell, but this was a good one. 2. M.N. is an 80 year old retired physicians wife. She has osteoarthritis of her hand joints, shoulder, feet, hip, and ankles all of which bother doing housework and golfing. She had been taking 6-8 aspirin a day for a decade because it helped her pain, and she was told "it is as good as anything" else on the market. She also was noticing a slower gait; sometimes she would not get up from the couch to get to the ringing phone in time to talk to the caller. She stayed on her aspirin and started a slow dose buildup schedule for AlphaFlex®. In 2 weeks she came to me with a big smile. "Dr. Dave, do you see this ring on my finger?" She was spinning around her mother's ring with the seven stones in place which represented her children. "I haven't been able to put that on my ring finger for 2 years because of that swollen knuckle!!!" She also found that her phone answering improved. It now only takes her two rings to get up off the couch and get the phone answered. She has continued 3 AlphaFlex® per day, and stopped the big dose of aspirin. She does not need supplements for pain, and the hand joint swelling stays in control. I personally played golf with her several times. Before AlphaFlex® was started, she would shoot 60-64 for nine holes and be satisfied. With her increased flexibility and improved hand control of the club, she hits the ball farther so in scoring in the 54-60 range now. She is a happy golfer, but still lets the cleaning lady do her housework!!!! 3. B.N. is a 50 Year old male athletic director at a middle school. He is in good health, except he is a "battered athlete". He has degenerated joints from the wear and tear of his sporting career playing college football; osteoarthritis is starting in most of his joints. His main complaint is bilateral knee pain and left hip pain. "I am very stiff in the mornings. It takes about an hour to warm up. On bad days, I am stiff all day. Especially when a weather front is moving in. I have not been able to run or play any sports. I use a cart when I play golf. My handicap has gone up the last two years as my pain has worsened in my right knee. My left knee needs a replacement. It has had three major operations and three scopes. The right knee has had two scopes, meniscus tears, and partially torn Cruciate ligament. The hip joint inflammation comes from being out of balance right to left. I have also dislocated the right big toe six times and it gets swollen and painful when on my feet. I used Feldene and Naprosyn for many years, but quit taking them 5 years ago. Aspirin does nothing to dull the pain. Ibuprofen works a little bit in large doses. This last year I have taken Vioxx, which works, but is an anti-inflammatory I am trying to avoid. I tend to take products intermittently when I can no longer stand the pain. I stated taking AlphaFlex® the first of March. Six weeks later I played some floor hockey at school because I felt good enough to run!!! Played six times in two weeks, then stepped on a stick blade and had a set back. Will be able to tell more when golf starts on my rotation and swing. I am currently taking AlphaFlex® 3 times a day. The Naprosyn and Feldene did not work all that well and were tough on my stomach and kidneys." I have played golf with him. He is much happier on AlphaFlex® than the other NSAIDS and Vioxx. He has no acid symptoms from the AlphaFlex®. Walks the golf course in more comfort, and his handicap is dropping again. As an athletic director, he can now get out and play with his students, and be more involved in their athletic development. He told me his father-in-law has to be on a lifetime of dialysis for chronic renal failure triggered, in part, by chronic use of NSAIDS. That is why he is so skeptical of those drugs that he had to use to stay comfortable, and why he is also leery of the COX-II inhibitors like Vioxx. I have recommended he boost his dose of AlphaFlex® to 4 per day when bad weather fronts move in, or after he overuses and/or abuses his joints in some fashion. I also recommended he take most, or all of his AlphaFlex® at bedtime in an attempt to maximize its anti-inflammatory and analgesic effect in the morning when he finds the osteoarthritis the most disabling. 4. B.S. is a 49 year old male golf professional. He is a "battered professional athlete". He had complaints of chronic shoulder pain triggered by an auto accident. He also developed a painful lumbar disc bulge related to the MVA. Prior to the auto accident, he had tendon surgery on a hand due to another injury while in his 20's. His daily pain was not controlled despite Vioxx, and his performance on the golf course was "fading". He had to undergo rotator cuff repair on the left shoulder to try to correct his chronic pain and limited range of motion. Surgery helped only modestly. With chronic pain, slow physical therapy progress, looking at the possibility of more shoulder surgery, and chronic problems with performance on the golf course, he decided to try AlphaFlex®. Initially he experienced some diarrhea on the AlphaFlex®, but with a slower dosing schedule, diarrhea abated and he has been on AlphaFlex® at 3/day now for 6 months. He has no side effects now and feels AlphaFlex® has helped both his shoulders and lumbar disc pain. He has narrow shoulder arches, shown on a recent MRI scan, which may require decompressive scope surgery, but as long as AlphaFlex® is helpful, he can delay those surgery procedures. His lumbar disc pain has responded to AlphaFlex®, he feels that he can do lumbar exercises to keep in shape and thus reduce the stress on the discs. His chronic hand swelling, from gripping golf clubs and from scar left behind by previous hand surgery, has not been painful. He has been able to reduce his Vioxx use to supplement the AlphaFlex® "as needed" when pain in the shoulders escalates with too much golfing or when bad weather systems move in. He doesn't use OTC ibuprofen or Tylenol for painful days anymore. He is happy with the help AlphaFlex® has given him with several chronic pain problems. It has helped restore his golf game on the course and practice tee to expected levels and thus served as a "performance-enhancer" for him. 5. C.S. is a 50 year old housewife who also lives and works on the farm. She has 15 years of chronic back strain from farm work with the animals and barn work. A MVA aggravated her chronic pain, but she could not get relief from chiropractic care or Glucosamine used at 3/day for several months. She decided to try AlphaFlex®, in place of the Glucosamine, to reduce chronic back strain and neck strain pain. She otherwise was a healthy pre-menopausal female on Femhart for hot flashes. Within 3 days of starting AlphaFlex®, she developed daily headaches. She had never experienced headaches like these before. I told her to stop the AlphaFlex® and blamed the headaches on a allergy to soybean oil, which is part of the formulation medium used in the enteric coated AlphaFlex® product. Her headaches relented. I don't feel comfortable giving her another trial of AlphaFlex® until a formulation change occurs. We did talk about formulations using olive oil. Perhaps that type of formulation would be less "allergic" for some individuals. She has resumed glucosamine and chiropractic care for her chronic spine pain. 6. S.D. is a 47 year old former smoker with migraine headaches since age 20, hysterectomy age 37, menopausal symptoms being treated with Estraderm patch, hypothyroidism treated with replacement hormone, Raynaud's disease treated with Verapamil, restless leg syndrome treated with Clonazepam, chronic low back pain secondary to lumbar disc disease, osteoarthritis evolving in spine and hips. She takes Bayer coated aspirin 8-10/day and adds Advil 6-8/day in winter when she can't get pain control or feels a migraine evolving. Because of her vascular problems, she is not a candidate for Imitrex or its derivatives for migraine control. She has prolonged migraines with vomiting, and usually makes at least 2 trips per year to the emergency room for Compazine and narcotic injections to control the nausea and pain of the migraine. She has ragweed induced allergic rhinitis, winter eczema treated with IM Kenalog and hydrocortisone cream respectively. Her past history is significant for aspirin-induced stomach ulcers requiring UGI endoscopy for treatment and diagnosis in 1996, followed by Zantac therapy. Dr. Dave started her on AlphaFlex® 8/21/01 with the hope of reducing her need for aspirin and Advil, the hope of reducing the frequency and intensity of her migraines, and the hope of reducing her need for Zantac. The patient recently reported that she has had significant improvement in her pain problems to the point she has eliminated the NSAIDS and aspirin, so her stomach is also less acidic. She has had only one migraine in 5 months, but this was easily controlled with some oral narcotic and not as debilitating as her usual migraine headache. She feels much more lively and less depressed as her chronic pain has been reduced. She feels it has helped her chronic disc pain, her restless legs at night (really a neuritis related to legs with vascular insufficiency), her osteoarthritis in her hips, and indirectly reduced her acid problems and subsequent risk of recurrent stomach ulcers. She is very happy to continue AlphaFlex®. 7. J.G. is a 46 year old professional with per-menopausal migraines as well as degenerative arthritis evolving in her knees. She tries to stay away from NSAIDS because of their side effects. She has been unable to find a suitable program to prophylacticly control her unpredictable migraines. She has avoided estrogens to control her menopause symptoms because they aggravated her migraines. A bad migraine will make her miss days of work, which is particularly troublesome for a professional who works on a tight schedule. Lost work time is not only lost income, but other professionals depend on her being at work as part of the team. After starting AlphaFlex®, she noticed that her knee aching, grinding and cracking was better within 3 weeks. With time, she noticed no more migraines. She thought that she was through the menopausal migraine phase in her life, so tapered off of the AlphaFlex®. Her headaches and knee pain returned. She then resumed AlphaFlex® at therapeutic doses and got the control of her knee pain and migraines as she had experienced previously. Editorial comment: A dollar each day Is small price to pay Keep migraines away The AlphaFlex® way!!!! 8. B.K. is an avid 45 year old golfer who works daily at a resort golf course. His joints began deteriorating 15 years earlier from avascular necrosis requiring a first hip replacement at age 40. His daily joint pain was being treated with Celebrex 200mg 2x/day, both glucosamine and MSN supplements on a daily basis, with many Tylenol on bad weather days or after excessive golf activity. His avascular necrosis is progressing to his other hip and both shoulders, but his goal is to stay with golf course administration as a career as he continues to pursue education to become a PGA certified professional. Six weeks after starting AlphaFlex®, he was able to stop the MSN and glucosamine, not being convinced either did much to control his pain. On 5/20/01, about 12 weeks after starting AlphaFlex®, he writes "I just wanted to let you know that I have been feeling pretty good lately. My shoulders are better and my hip has been quite a bit better; doesn't bother me nearly as much as what I think it did at times before. I'm going to be ordering more AlphaFlex®. Thanks!" On 8/4/01 he writes "I'm still taking AlphaFlex® and I think getting good results. The hip, I think, hurts less and my shoulders, which an MRI showed was arthritis, are better." On 12/3/01 he writes "Still using AlphaFlex®, usually 2 a day. Still taking 100mg Celebrex daily though. AlphaFlex® helps me infinitely more than any non-prescription supplement ever did. No side effects at all. I plan to continue taking AlphaFlex® and was going to order more in the near future. The joints overall are quite good and I think a lot is because of AlphaFlex®." This patient has an unusual circulatory problem leading to premature degeneration of the cartilage in his major joints. Hip and shoulder replacements are costly at any age, but replaced joints in young people usually means they will need further replacements, with newer technology, down the road. Any product that can potentially slow the progression of the inflammatory joint disease is worth a try, especially if that product does not create toxicity, and works as a prophylactic agent on the joint, improving flexibility and decreasing pain on a day to day basis. In this case, AlphaFlex® has allowed B.K. to stop all other supplements and decrease the dose of the toxic COX-II inhibitor Celebrex. It has allowed him to pursue a career in golf despite the stress that sport puts on his shoulders, hips and other joints. It acts as a "performance-enhancer". Editorial comments: An art-ti-fi-cial hip Can slow a walker's clip, Take AlphaFlex® each day To keep surgeons away!!! 9. .J. is a retired 64-year-old hospital administrator. In June 1999, he fell off his roof while doing home repairs, injuring his right foot and ankle. This home accident shattered his calcaneus and fractured the ankle. It also compressed the ankle joint cartilage so he lost ? inch of height in that joint. The foot and ankle fractures healed, but the pain and joint disability from the compressed joint cartilage has never improved. The pain persists in the joint; the swelling in the retinaculum, tendonitis, and subtendonous bursitis contribute to daily pain. Years of glucosamine/condroitin, NSAID's of all varieties, and physical therapy sessions ad infinitum were used in an attempt to control pain and improve range of motion. "On September 6 of 2002 you introduced me to AlphaFlex®, both the pill and the cream. I quit taking all pain medication and such for three days prior to starting AlphaFlex®. At first I thought it was psychological, but I noticed a lot of relief in the first treatments. Subsequently I was pain free in all areas except the inferior peroneal retinaculum and peroneus brevis tendon. I have found that the more generous I use the products, the more relief I get. I am a true believer in this product. I have learned that I have to make two applications of the cream per day and cannot miss one or else I can tell the difference." Editorial comment: clearly, AlphaFlex® products can be combined to help alleviate chronic pain from severe bone and joint injury. J.J. continues on 6 AlphaFlex® enteric-coated capsules daily and AlphaFlex® cream applications twice daily. Omega 5 products have reduced his chronic pain and improved his ankle function whereas three years of trying other medications and physical therapy failed. 10. B.A. is a 60-year-old sign painter/housewife. In an attempt to lose weight, she started working out on a treadmill at home three times a week. Part of the workout involved raising the bed of the treadmill so she was actually walking uphill. Then her heel started hurting and her walking routine had to stop. She had developed plantar fascistic. She tried orthotics, NSAID's and rest all without relief. After several frustrating months, she started AlphaFlex® Cream and capsules. She now recounts; "Dr. Dave, I think my heel problem is gone. I started taking AlphaFlex® 5 months ago and still take 3 capsules a day. I haven't noticed any heel pain for a long time now. You told me to use the cream and massage my heel in the morning and bedtime. I did that for a week or two and I can't even remember when it stopped hurting. I have been walking every day this week and it doesn't bother it at all. I can even wear my dress shoes again. My knees, legs and ankles don't seem as stiff anymore either. I think AlphaFlex® has helped me a lot and I plan to keep taking it." Editorial comment: plantar fasciitis can be a frustrating problem. I usually try athletic rest, silicone heel cushions, and anti-inflammatory medications before I resort to injections of cortisone into the inflamed tendon area on the underside of the heel. This is a very painful shot; doctors nor patients like giving or receiving it. Omega 5 cream and capsules will save many fasciitis victims from "the shot" and then prophylactic AlphaFlex®, orthotics and common sense will keep the problem in control. 11. M.S. is a 45 year old desk clerk. She started to work out to lose weight and get in better shape. Then her heel started hurting. Her gait and balance changed as she tried to adjust for the pain, but then her knee became swollen, stiff, and painful. She went to physical therapy, tried Naprosyn, temporary then permanent orthotics was added, but all these modalities gave her no relief. With two joints bothering her, and the source being workouts to get in better shape, she asked Dr. Dave for advice. She states; "In August you gave me AlphaFlex® pills and topical cream. I took 3 pills daily, and rubbed the topical cream on twice a day, sometimes 3 times daily. My knee problems disappeared by the middle of September, about 6 weeks. It was so nice to be able to bend my knee again. It only took approx 6 weeks for my knee to get better, keeping in mind that for three months I was in therapy with small progress. AlphaFlex® really helped my knee. My heel was another story. Originally we thought I had a bone spur. However, after x-rays, it was determined that there was no bone spur, but the podiatrist diagnosed an inflamed nerve in my heel.It ended up that I needed shots in my heel directly into this nerve to slowly kill it. I had a total of 5 shots (of sodium morrhulate); these were very painful. Not only getting the shot, but the next day, trying to walk on the foot was terrible. That is where I believe AlphaFlex® cream and pills really helped in the healing of my left heel. It seemed to calm the area (outside with the cream and inside with the pills) that was so aggravated by the shot. Plus, it kept me walking around, which controlled my weight during this time.Now I am walking 3 miles a day, and trying to learn to jog on my treadmill. With this activity, my foot is just fine. And, since I am back to walking normal again, my knee is no longer an issue. In the event I do too much in one day, I still rub on the AlphaFlex® morning and night which sooths the area.Thank you for giving this product to me. I believe this really helped me during this time." Editorial comment: here is a case of "neuritis" acting like a case of fasciitis. Omega 5 can reduce nerve inflammation/pain as well as joint inflammation/pain. In this case it was a heel nerve and a knee joint that were both helped by the combination of capsules and cream. 12. A.S. is a 25-year-old computer worker with osteogenesis imperfecta; an inborn genetic error that affects the way bone is manufactured and laid down. He is prone to fracture from simple activity and casual falls; between the ages of 11 and 14 he had broke arm bones 6 times. When he was 15, he partially tore his supraspinatus rotator cuff tendon. At the age of 20, he had surgery to mend the tear, to remove a bone spur from the acromion process and clean up some damage to the labrum cartilage in the shoulder. Five years later he was rear ended in a car accident. He jammed the shoulder, compressed the tendons and started experiencing pain related to the posttraumatic tendonitis. During this painful time, he was given two cortisone shots, two cycles of oral Predispose, a course of Ibuprofen, then Celebrex, then a course of Vioxx. He also had to take daily Vicodin, or Percocet, or Darvocet to help control his pain. He related that aspirin did the best at controlling his pain, but was not to take it with the other NSAID programs because of expected GI or renal side effects. The shoulder tendonitis slowed, but there was always a click in the shoulder. Throwing action would cause inflammation to escalate, as would heavy manual labor. In the weight room, there were good days and bad painful days. "On good days, shoulder abduction was possible up to 12 pounds (20 reps x1 set) but clicking and popping was felt in the joint. Should press was possible up to 65 pounds before pain set in, and I was able to bring the weight just behind my head, near to the level of my ears." "On bad days, I was unable to do any shoulder abduction exercises with weight greater than 3 pounds without pain. I was unable to shoulder press more than 35 pounds without pain, and I was unable to bring the weight behind my head, near to the level of my ears." "Every day in the weight room I went through a series of exercises that were not affected by pain due to the injury: external shoulder rotation, internal rotation, low row, forward extension, straight arm pull downs and reverse fly exercises." After discussing my rehab pain and post injury problems with Dr. Dave, I started taking AlphaFlex® capsules 3 per day on 12/22/02, "and saw great improvement starting at the end of the first week." Now I have the following summary. "Bad days on AlphaFlex®: shoulder abduction with 8 pounds results in no clicking, no pain, 12 pounds produces clicking (25 reps). Shoulder press up to 65 pounds with full range of motion results in no pain." "Good days on AlphaFlex®: Shoulder abduction up to 20 pounds without pain or clicking, (strength is the limiter here, rather than pain.) x8 reps. Shoulder press up to 105 pounds x8 reps, no pain or clicking (strength again the limiter)." "I have also noticed an increase in strength of my other rehabilitation exercises. I have noticed a reduction in my recovery time. I feel ready to go in 75% of the time I needed before. I still take 100% of the time I used to take, but the result is that every time I hit the weight room, I feel like I have rested a week, only without the associated decrease in strength. I am seeing an increase in the amount of weight that I lift that I have never seen myself capable of doing. The associated strength is resulting in more joint stability, and in turn building on itself, allowing me to get even stronger. Also, any time I happen to get a slight pull or light injury, I haven't had to worry about it affecting my performance, because by the next time I exercised that muscle group again, the injury had healed. Thank you very much." Editorial comment: I cannot say it any better than this patient has. Excellent results, in difficult circumstances, are very gratifying. The Federal Trade Commission (FTC) monitors advertising. Sierra Life Sciences Inc. wishes to comply with their regulations. We need to inform all in attendance that the issuance of U.S. patents does not prove that AlphaFlex® products are effective in treating or alleviating any symptoms of disease. Mouse research studies do not, in the eyes of the FTC, prove efficacy of the product either. Testimonials from consumers may not reflect the typical experience of members of the public who use the AlphaFlex® products. On the other hand, the patents, the mouse research, and the testimonials may just be entirely truthful. Before there was an FTC, people believed in testimonials, used common sense, and new product testing didn't require $100 million to bring a drug to market with brand name recognition. We hope this information is informative. We believe it truthful. |
