Tuesday, August 21, 2012

Benign Fasciculation Syndrome-BFS (Part IV)

CONCLUSIONS and DISCUSSION:

Why Publish a Survey Data Paper

Most medical professionals are against publishing a paper based solely on survey data when there is no control group, clinical trial, or observation of patients. Here are the reasons our survey is acceptable for publication:

First, this paper is not statistically flawed like most medical research papers or clinical trials. One research paper estimates that 2 in 5 medical research papers are flawed due solely to an inadequate sample size. [9] This paper meets survey guidelines to meet a 95% confidence level for its data results because it has a sample size of 384. To dismiss our survey is the same as saying a population of 25 million people are all lying about their symptoms. Our survey questionnaire asks control questions to eliminate any participants that have not been officially diagnosed with BFS and a statistical analysis is performed on each test to eliminate any responses in the questionnaire that are outside of +/- 3 standard deviations of the normal distribution. Besides, most medical studies using “acceptable methods” are statistically flawed, and what’s worse most doctors that read these medical research papers do know they are flawed: “The increasing volume of research by the medical community often leads to increasing numbers of contradictory findings and conclusions. Although the differences observed may represent true differences, the results also may differ because of sampling variability as all studies are performed on a limited number of specimens or patients. When planning a study reporting differences among groups of patients or describing some variable in a single group, sample size should be considered because it allows the researcher to control for the risk of reporting a false-negative finding (Type II error) or to estimate the precision his or her experiment will yield. Equally important, readers of medical journals should understand sample size because such understanding is essential to interpret the relevance of a finding with regard to their own patients. At the time of planning, the investigator must establish (1) a justifiable level of statistical significance, (2) the chances of detecting a difference of given magnitude between the groups compared, i.e., the power, (3) this targeted difference (i.e., effect size), and (4) the variability of the data (for quantitative data). We believe correct planning of experiments is an ethical issue of concern to the entire community.” [9] Our survey analysis follows these guidelines.

Secondly, we know very little about BFS so all the information in this writing is not only statistically and practically significant, but it is also novel regardless of no, weak, moderate, or strong correlation between parameters.

Thirdly, we must combat the fallacies about survey usefulness and accuracy and highlight inadequacies of controlled studies, clinical trials, and patient observation. Surveys are cost effective while controlled studies and clinical trials are in most cases cost prohibitive. Doesn’t it make sense to conduct a survey to find statistical and practical significance and correlation before moving on to an expensive controlled experiment or clinical trial? One would hope so. Proximity is not an issue with surveys, they are global meanwhile controlled studies and clinical trials can limit the sample size to a more localized region. Our study learned that stress BFS is more statistically significant in North America than other global areas. In fact, nearly one third of the survey participants are located outside of North America. Hence, proximity sample size restrictions can hide relevant results. Observation and examination can be overrated. In an anonymous survey the reviewer can only rely on the data and the statistical analysis – there is no human bias. However, in clinical research trials, bias and opinion are routinely injected in these studies by medical personal. One study on 21 clinical trials found “On average, non-blinded assessors of subjective binary outcomes generated substantially biased effect estimates in randomized clinical trials, exaggerating odds ratios by 36%.” [10] There is also evidence that money used to fund clinical trials by industry and the government can bias outcomes. "Thus, although there is little direct evidence that industry sponsorship has led to deliberate skewing of the results or reporting, there are multiple cases in which industry and government sponsors have withheld important study results and in which the conclusions presented in the reports appear to overstate the study findings. The risk of undue influence in research exists." [11] Besides, doctors must rely more on patient input and history than patient observation simply because they do not have the time to monitor dozens of patients 24/7. For BFS sufferers many of the symptoms cannot be observed, hence patient input is the only true indicator to identify how extreme their symptoms may be – hence a survey about BFS makes sense. Patient observation can also be influenced by stress. My BFS symptoms and even my blood pressure are much higher every time I see my doctor due to anxiety.

Fourth, some may argue my lack of a medical degree disqualifies me from publishing a medical paper in a medical journal. However, there is nothing medical about this paper. This paper is merely a thorough statistical analysis about a medical issue that we know very little about - BFS. My 22 years of engineering experience dealt extensively with data statistical analysis and modeling – this is what qualifies me to write this paper. I was a Distinguished member of the Technical Staff at Texas Instruments (1% of technical force have this honor). In fact, I have a patent on testing high speed analog to digital converters which are the main integrated circuits used in medical imaging products: Sonogram, MRI, and CAT Scan machinery. I was also the chief technologist over the development of these types of integrated circuits used in medical imaging products.

Does the Data Make Sense?

Every person analyzing data for their study must ask themselves the question: Does the data make sense? This is a difficult question to answer especially regarding neurological disorders because no one really knows what the expected outcome will be. However, there are some control questions within our survey where the expected outcome of the question is more predictable. So it comes as no surprise there is statistical significance between women are more likely to try yoga as a remedy; exercise is more likely to help alleviate stress induced BFS; stress exasperates stress induced BFS symptoms; exercise is more likely to exasperate exercise induced BFS; an illness is more likely to exasperate illness induced BFS; and headaches are likely to affect the head to name a few. These trends are what one would suspect, so we can conclude that people are answering the survey correctly.

Misconceptions of BFS

This paper also refutes a few myths about BFS. The first myth is that BFS is “No big deal”. For most individuals it is true, BFS is no big deal, but there are many chronic sufferers from this disorder that are ignored. Consider this, the average BFS sufferer in this survey suffers from muscle twitching (75% of the time), pins and needles (38%), cramps (34%), numbness (27%), muscle fatigue and weakness (42%), headaches (25%), itching (20%), muscle soreness and pain (45%), muscle buzzing and vibration (46%), and sensitivity to temperatures (30%). They feel these symptoms in their feet (56% of the time), lower leg (74%), upper leg (54%), back (33%), buttock (39%), abdomen (31%), chest (27%), head (36%), hands (46%), and arms (51%). From this data we can conclude that the people in this survey suffer from chronic BFS because they live with symptoms 24/7 over their entire body. What’s worse, the best remedies for relieving symptoms inebriate suffers – sleeping pills (3.03 out of 10) and benzodiazepine drugs (3.3 out of 10). None of this should be surprising since these people belong to a BFS social networking site. People would only go to these forums if they have a chronic condition for which they cannot find any relief. Besides, nearly 50% of the participants in the survey have had both an MRI and EMG and nearly 80% have had either an EMG or MRI. This is significant because only people with chronic fasciculation issues would be subject to such expensive testing.

This paper also refutes the claim that BFS is always “benign”. In medicine, benign is defined as “of no danger to health; not recurrent or progressive; not malignant.” However, the survey results show that only stress induced BFS sufferers (this is the most common form of BFS) can control their symptoms over time. All other forms of BFS identified in this paper have their symptoms get progressively worse over time. Since symptoms are progressive, by definition BFS is not “benign” in these cases. A better name would be Progressive Fasciculation Disorder (PFD) for chronic sufferers of BFS that is not stress induced.

Multiple Forms of BFS

The nine forms of BFS hypothesized in this paper are unique because there is very little overlap between the statistical significance of symptoms and remedies for these different BFS classifications. In fact, most parameters within the 9 classifications of BFS, as expected, show little statistical significance with other parameters – they are random and vastly different. In some cases, people believe they have had more than one potential trigger – meaning they may have a combination of BFS types. For instance, with the author’s own experience with BFS, he believes there may have been a multitude of triggers for his symptoms including exercise (high altitude climbing and mountaineering), history (grandmother with Parkinson’s disease), sickness (had a gamma globulin deficiency that caused infectious boils), prescription drugs (regular use of antibiotics for folliculitis, and allergy medications), and most like others surveyed, had experienced a great deal of stress.

It is possible that once afflicted with BFS that other triggers can make symptoms worse and introduce new symptoms. This should be explored further. Our findings show that each form of BFS is unique. Considering this uniqueness in this umbrella diagnosis, it is no surprise that it is difficult to cure or find solutions to alleviate symptoms. While BFS is benign, it is still an illness for which its sufferers would benefit from an effective treatment or cure. We hope by identifying these categories that further research can take place on exploring them further, and help doctors understand this mysterious ailment better.

How to Solve Neurological Mysteries?

Doctors and researchers strive to be one to find the cure to ALS and Parkinson’s disease. If they do, what they uncover will surely help find a cure for BFS. The reverse is also true, if researchers find a cure for BFS it will undoubtedly go a long way in helping to find a cure for ALS and Parkinson’s disease. As an engineer I witnessed too many times how we tried to make a product that included too many features. The project would result in a costly failure and years later we would developed three or four products to do the job of the one we tried to achieve all at once. Over time, the products eventually could be integrated into one product. I see the same mistake in medicine. Researchers are working endlessly and racking up billions in costs to try to find that magical cure that will end the suffering of millions of people with neurological disorders. Instead, it would make more sense to try to take small steps and gains in order to achieve that ultimate goal. This approach would be much more cost and time effective. I think finding a cure for BFS is that first baby step.

Statistical Significance, Practical Significance, and Correlation

No survey discussion is complete without talking about statistics. Statistics can be vastly confusing and open to many interpretations. Statistical significance between parameters does not imply practical significance. Sometimes commonsense has to be used to determine practical significance from statistical significance. However, in a complicated survey on a complicated subject (in which we know little about) such as BFS this is hard to decipher. In fact, because we know little about BFS, one could conclude any statistical significance is also practical significance.

High correlation does not imply statistical significance especially if the sample size is small. Conversely, statistical significance may not imply strong correlation, it may only occur because the sample size is large. Hence, it important to report statistical significance, sample size, and correlation, together as one item, to determine practical significance. [12] In this survey, since the sample size is becoming large, it is probable that the data may indicate strong statistical significance between various parameters, but only weak to moderate correlation – yet this data can be of practical significance. Weak correlation, strong statistical significance, and large sample size is usually better than weak statistical significance, small sample size, and strong correlation. [12] My original assumption that if moderate to high statistical significance only yielded weak Spearman correlation, this would be practical significance because BFS is a syndrome we know nothing about. Hence, any correlation weak or strong would be new and helpful information. For this reason, I did not run the Spearman correlation models. After all, if weak correlation was practically significant than why bother with the models. My assumption might be true, but based on [12] the results of Spearman correlation still need to be calculated and added to this writing.

A Day in the Life with BFS

I take medication to help me sleep because the twitching and paraesthsia symptoms are too bothersome. I wake up every half hour or so to rescue my arms that have gone dead from the elbow to the finger tips. Mix in a few foot and calf cramps and I finish another restless night of sleep. I take about 10 minutes before getting up to get the feeling and strength back in my arms and legs. Once out of bed I take another 15 to 20 minutes to get the stiffness out. I teach myself how to touch my toes again and to put on my workout clothes. After breakfast I hike, bike, or climb for several hours fighting cramps throughout the body. I exercise daily to prove to myself I have nothing worse than chronic BFS. The exercise exasperates my symptoms, but a long hot bath seems to help some. Most of my work is computer related and it is usually interrupted by finger oscillations, stiffness, muscle pain, or the fact my hands have lost their feeling. I have to wear big booties on my feet because they get cold even when the room is over 80 degrees. Sometimes I even wear gloves when it is 80 degrees. The evening hours of my day is usually confined to laying down on the couch thinking about another restless night of sleep all the while feeling the barrage of BFS symptoms ravaging my body. My muscles are too fatigued and sore by this time to do much of anything.

11 comments:

  1. It sounds like a terrible thing to live with, Patrick. The human body, as miraculous as it is, can be a terrible source of frustration sometimes when it comes to understanding its mysteries.

    You did a very good job on your paper and it looks like you did a lot of work. I hope you will ultimately get to share it in a forum where other people with the same condition will have the opportunity to read it.

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  2. Yes, BFS can be very difficult, but it is certainly better than other neurological disorders - so for many reasons I am happy with what I got because it could be worse.

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  3. I applaud your positive attitude, Patrick!

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  4. Hi Patrick

    Thank you for your articles. My husband recently noticed twitching in both his calve muscles. We started reading articles on the internet about ALS and were extremely worried. We went to a neurologist last week and he did a full examination and said that he was 99.999% sure it was BFS. In BFS are the twitches always felt as my husband cannot feel the twitches.

    Thanks

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    1. Hi Sue,

      That is correct, you cannot always feel the twitches. Many are small muscle fiber twitches. That is good, because the bigger twitches that are felt can keep you up at night.

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  5. Hi there. I am 45 and have been vexed with "benign" fasciculations for 4 months now. I am very interested in your research as there is so little of it out there. I am particularly interested in the "spinal injury" classification of BFS, as neither my neurologist nor my neurosurgeon believes that a neck injury should lead to "lower motor neuron" symptoms in the rest of my body. (I have found some old case reports that contradict their assertions). What % of your "patients" were triggered by a spine injury? Did those patients also experience fasciculations everywhere from the face on down? Cramps? I look forward to hearing from you.

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  6. Ryan, about 11% claim to have BFS issues from a spinal injury. Since people can claim more than one cause, only a few people have said a spinal injury is the lone cause (2%). There is not direct correlation with a spinal injury to any one symptom. This tells me that symptoms vary from spinal injury to spinal injury. This is not surprising. I have BFS to be very unique from person to person. No two people have the same issues regardless of the cause. To make matters worse, remedies are also unique. What works for one person will not necessarily work for another. I wish I had better answers for you, but this may help explain why we know so little about nerve disorders.

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  7. 11%! Wow, that seems significant given that I could only find 7 case reports in the medical literature, and none since the 70s. Does this group also have cramps? Did any indicate that they had received corticosteroids as a treatment for the spine? Did any of this group have fascics above the level of their injury, i.e. the face?

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  8. As far as I know the people claiming spinal injury can have their symptoms coming from another cause? As for your second question that was never asked in my survey, I have no data. As for the final question, there is no correlation between the face and spinal injuries as I kind of eluded to earlier, there is really no correlation to make any kind of assessments. I doubt you will find a similar case to yours, BFS is highly unique and individualized.

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  9. Very interesting. Non-correlated meaning some had it, but not a significantly higher (or lower) % than people with other causes. It doesn't make sense to me how it could, but none of these symptoms have made sense to me these last few months, and I'm an MD! The surgeon was ready to operate on me before the fascics hit in earnest. He called it off until neuro workup done (all negative except high CPK). It's basically done, but ironically, my original complaint, the paresthesias following the injury, have basically subsided. So I, like you for a while, an in limbo.
    Your blog has gone to other topics now; did you get better?

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  10. No, I am getting progressively worse (but only slightly) over time. I am trying less to dwell about BFS so less writing.

    High CPK seems to be common for BFS. I have high CPK (600 - 700) but I exercise intensely since I still compete in cycling. If muscles do not relax, it seems CPK can be elevated.

    Not finding any significant correlation was a bummer, but a statistical analysis of the disorder was probably needed.

    No need to feel bad about being a MD and not knowing about BFS. Anyone who claims to understand BFS is only pretending. I have had conversations with dozens of confused doctors. I saw 5 neurologists before finding one that had a basic understanding of the disorder. I do not expect doctors to understand everything medical, but I do not like it when they give you false information. It sounds like you have been given some false information. I was told I probably would not be able to exercise intensely anymore. It has been 8 years and I have been getting better even with more intense symptoms. But it is fair to say that many things I cannot do anymore like be a wrestling coach or rock climb. The paresthesia in the hands and feet make this really hard.

    Do not get surgery unless you absolutely need it and have no other options. I am sure you know this.

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