Weak Evidence Antidepressants Treat Pain in Older Adults

By Crystal Lindell

New research shows that there’s not much evidence that antidepressants actually work at treating pain in people over 65 years old. 

The study, which comes out of the University of Sydney in Australia, is concerning because older adults with chronic pain are often prescribed antidepressants instead of pain medication. 

However, in a frustrating conclusion, the authors still do not recommend the one medication that is proven to treat pain in older adults: Opioids. 

Instead, they suggest that doctors use a “multidimensional approach using non-pharmacological strategies, such as physical exercise and cognitive behavior therapy.” 

In other words, they essentially conclude that pain patients should get no medication.

However, I am glad that more research is coming out to expose how ineffective antidepressants usually are at treating pain. That class of medication has long been held up as an opioid alternative, despite the fact that many patients don’t get much relief from them. 

The researchers found that international guidelines that recommend antidepressants for chronic pain are heavily based on studies that either exclude older adults or include only a small number of them.  

The researchers found that in the last 40 years there have been just 15 clinical trials globally that focused on the use of antidepressants for pain in older people. And many of them were industry-funded trials with fewer than 100 participants.

The authors say their research fills a much-needed information gap, by bringing together the data from these trials to look at the efficacy and adverse effects of antidepressants for acute and chronic pain in older adults..

They found a lack of evidence to support the use of antidepressants for most pain conditions – despite the fact that they are often recommended in clinical guidelines. And none of the research they analyzed looked at the effectiveness of antidepressants for acute pain, such as shingles or muscular pain.

“These medicines are being prescribed to remedy patients' pain, despite the lack of evidence to adequately inform their use,” said co-author Dr. Christina Abdel Shaheed, an Associate Professor at the University of Sydney’s Institute for Musculoskeletal Health.

The findings mirror those of a recent study in the United Kingdom, which found that there is “no reliable evidence for the long‐term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point." 

Withdrawal and Other Side Effects

Shaheed says the potential harms of antidepressants in older people are well documented, and should be factored into any decisions about prescribing the medications. The study found that people taking antidepressants experienced more side effects effects, such as falling, dizziness, and a higher risk of being injured. The potential withdrawal if patients abruptly stop taking antidepressants can also be severe.

The study found that duloxetine, which is sold under that brand names Cymbalta and Yentreve, was able to relieve osteoarthritis knee pain in older adults during the intermediate term, but not short-term or long-term.

As a patient who often shares my health issues publicly, I often get messages and questions from readers who are also dealing with chronic pain. Anytime they mention Cymbalta, I pause. 

I had a horrible experience trying to come off Cymbalta, and I don’t think it even helped much with my pain when I was on it. Plus, my columns about the withdrawal experience apparently resonated, because they are among the most-read, liked and commented on articles I’ve ever written. In other words, it’s not just me. 

If Cymbalta or another antidepressant does help someone, I think they should take it. But I don’t think doctors are fully transparent about how bad the withdrawal can be or how little evidence there is that they even help with pain in the first place. 

“For clinicians and patients who might be using or considering duloxetine for knee osteoarthritis, the message is clear: benefits may be seen with a little persistence, but the effects may be small and need to be weighed up against the risk,” said lead author Dr. Sujita Narayan, an Academic Fellow at the Institute for Musculoskeletal Health.

Again, I’m glad the authors are drawing attention to the problems with prescribing antidepressants for pain management. I just find it alarming that they don’t even bother to mention any alternative medications, and instead suggest non-pharmacological treatments. 

Looking back, I guess I took for granted in the early days of opioid-phobia that most people in the medical field at least recognized that giving zero medication for pain was inhumane. That often meant doctors went from prescribing opioids to prescribing antidepressants. It came with a lot of downsides for patients, but at least it was something. 

If the next stage of opioid-phobia really is just “all medications are bad at treating pain,” then things are worse than I thought. And a lot of people are going to be suffering unnecessarily. 

We already have effective treatments, we just need to use them.

Little Evidence That Antidepressants Work for Chronic Pain

By Drs. Hollie Birkinshaw and Tamar Pincus

About one in five people globally live with chronic pain, and it is a common reason for seeing a doctor, accounting for one in five GP appointments in the UK.

With growing caution around prescribing opioids – given their potential for addiction – many doctors are looking to prescribe other drugs, “off-label”, to treat long-term pain. A popular option is antidepressants.

In the UK, doctors can prescribe the following antidepressants for “chronic primary pain” (pain without a known underlying cause): amitriptyline, citalopram, duloxetine, fluoxetine, paroxetine and sertraline. Amitriptyline and duloxetine are also recommended for nerve pain, such as sciatica.

However, our review of studies investigating the effectiveness of antidepressants at treating chronic pain found that there is only evidence for one of these drugs: duloxetine.

We found 178 relevant studies with a total of 28,664 participants. It is the largest-ever review of antidepressants for chronic pain and the first to include all antidepressants for all types of chronic pain.

Forty-three of the studies (11,608 people) investigated duloxetine (Cymbalta). We found that it moderately reduces pain and improves mobility. It is the only antidepressant that we are certain has an effect. We also found that a 60mg dose of duloxetine was equally effective in providing pain relief as a 120mg dose.

In comparison, while 43 studies also investigated amitriptyline (Elavil), the total number of participants was only 3,372, indicating that most of these studies are very small and susceptible to biased results.

The number of studies and participants for the other antidepressants are:

• Citalopram (Celexa): five studies with 209 participants

• Fluoxetine (Prozac): 11 studies with 622 participants

• Paroxetine (Paxil): nine studies with 960 participants

• Sertraline (Zoloft): three studies with 210 participants.

The evidence for amitriptyline, citalopram, fluoxetine, paroxetine and sertraline was very poor, and no conclusions could be drawn about their ability to relieve pain.

This is particularly important as UK prescribing data shows 15,784,225 prescriptions of amitriptyline in the last year. It is reasonable to assume that a large proportion of these may be for pain relief because amitriptyline is no longer recommended for treating depression.

This suggests that millions of people may be taking an antidepressant to treat pain even though there is no evidence for its usefulness. In comparison, 3,973,129 duloxetine prescriptions were issued during the same period, for a mixture of depression and pain.

In light of our findings, which were published in May 2023, the UK’s National Institute for Health and Care Excellence (Nice) recently updated its advice to doctors on how to treat chronic pain.

The updated Nice guidance now suggests 60mg of duloxetine to treat [chronic primary pain] and the same drug and dose to treat nerve pain.

Limited Treatments Options

GPs often report frustration at the limited options available to them to treat patients experiencing chronic pain. Amitriptyline is cheap to prescribe – only 66p per pack (US 82.5 cents) – which may explain the high number of prescriptions for this drug.

This is an example of how the gap between evidence and clinical practice could harm patients. Although our review was unable to establish the long-term safety of antidepressant use, previous research has highlighted the high rates of side-effects for amitriptyline, including dizziness, nausea, headaches and constipation.

It’s important to bear in mind, though, that pain is a very individual experience, and the evidence in our review is based on groups of people. We acknowledge that certain drugs may work for people even when the research evidence is inconclusive or unavailable. If you have any concerns about your pain medication, you should discuss this with your doctor.

Hollie Birkinshaw, PhD, is a Research Fellow at University of Southampton. She specializes in research involving chronic musculoskeletal pain, and the integration of psychology in pain and health services. Birkinshaw receives funding from the UK’s National Institute for Health and Care Research (NIHR).

Tamar Pincus, PhD, is a Professor of Health Psychology at University of Southampton. Her research focuses on the psychological aspects of chronic pain. Pincus receives funding from NIHR, Medical Research Council and Versus Arthritis.  

This article originally appeared in The Conversation and is republished with permission.

‘No Reliable Evidence’ That Antidepressants Work for Chronic Pain

By Pat Anson, PNN Editor

Medical guidelines in the United States and United Kingdom may recommend antidepressants for treating chronic pain, but there is “no reliable evidence” that the medications actually work for that purpose, according to a new Cochrane review.

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence, while dismissing poor quality research.

A team of UK researchers, led by scientists at the University of Southampton, spent two years examining 176 clinical trials involving nearly 30,000 patients who were prescribed antidepressants for pain. Among the drugs studied were fluoxetine (Prozac), sertraline (Zoloft), amitriptyline (Elavil), milnacipran (Savella), citalopram (Celexa), paroxetine (Paxil) and duloxetine (Cymbalta).

“Our review found no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for their safety for chronic pain at any point. Though we did find that duloxetine provided short-term pain relief for patients we studied, we remain concerned about its possible long-term harm due to the gaps in current evidence,” said lead author Tamar Pincus, PhD, a Psychology Professor at the University of Southampton.

“This is a global public health concern. Chronic pain is a problem for millions who are prescribed antidepressants without sufficient scientific proof they help, nor an understanding of the long-term impact on health.”

In the United States, duloxetine is FDA-approved for fibromyalgia, diabetic neuropathy and musculoskeletal pain. The recently updated CDC guideline recommends that duloxetine and other SNRI antidepressants be used for fibromyalgia and neuropathy, because they provide “small to moderate improvements in chronic pain and function.”

The UK’s National Institute for Health and Care Excellence (NICE) guideline goes even further, stating that antidepressants are better than opioids and other analgesics in treating fibromyalgia, chronic headache, Complex Regional Pain Syndrome (CRPS), musculoskeletal pain and other types of “primary chronic pain” for which there is no known cause.   

The authors of the Cochrane review say regulators in the US and UK should reconsider their recommendations.

“We are calling on governing health bodies NICE and the FDA to update their guidelines to reflect the new scientific evidence, and on funders to stop supporting small and flawed trials. Evidence synthesis is often complex and nuanced but the evidence underpinning the use of these treatments is not equivalent, so current treatment modalities are hard to justify,” said co-author Gavin Stewart, PhD, a statistician at Newcastle University.

Amitriptyline is one of the most commonly prescribed antidepressants for chronic pain in the world. In the last year, around 10 million prescriptions for amitriptyline were given to patients in England for pain, about twice the number prescribed for depression. Many other antidepressants are also prescribed “off-label” for pain, despite limited evidence to support their use.

“Though previous investigations show that some antidepressants might relieve pain, there has never been a comprehensive study examining all medications across all chronic conditions – until now,” said co-author Hollie Birkinshaw, PhD, a Research Associate at the University of Southampton.

“The only reliable evidence is for duloxetine. Adopting a person-centered approach is critical to treatment and, when patients and clinicians decide together to try antidepressants, they should start from the drug for which there is good evidence.”

The reviewers say duloxetine was the highest-rated antidepressant for treating fibromyalgia, musculoskeletal and neuropathic pain. Standard doses of duloxetine were just as effective as higher ones. Milnacipran was also effective at reducing pain, although the evidence was weaker.

“We simply cannot tell about other antidepressants because sufficiently good studies are not available – but it does not mean that people should stop taking prescribed medication without consulting their GP,” said Pincus.

A common complaint of patients who take duloxetine is that it makes them dizzy and nauseous. Many quickly become dependent on the drug and then have severe withdrawal symptoms when they stop taking it.

Several previous studies have also raised questions about using antidepressants for pain. A recent review of over two dozen clinical trials by Australian researchers found little evidence to support the use of antidepressants in pain management. Nearly half of the trials had ties or funding from the pharmaceutical industry.

Most Antidepressants Ineffective for Chronic Pain

By Pat Anson, PNN Editor

Most of the antidepressant drugs that are prescribed for chronic pain are either ineffective or the evidence supporting their use as pain relievers is weak, according to a new analysis published in The British Medical Journal (BMJ).

The use of antidepressants such as duloxetine (Cymbalta) and fluoxetine (Prozac) has doubled in recent years, with much of the increase due to their off-label prescribing to treat conditions such as fibromyalgia, neuropathy and back pain.

But in a review of 26 studies on the analgesic effects of antidepressants, Australian researchers found little evidence to support their use in pain management. The data on side effects was also weak, meaning the safety of antidepressants was also uncertain. Nearly half of the studies had ties or funding from the pharmaceutical industry.

“Recommending a list of antidepressants without careful consideration of the evidence for each of those antidepressants for different pain conditions may mislead clinicians and patients into thinking that all antidepressants have the same effectiveness for pain conditions. We showed that is not the case,” said lead author Giovanni Ferreira, PhD, from The Institute for Musculoskeletal Health at the University of Sydney.

“Some antidepressants were efficacious for some pain conditions; however, efficacy appears to depend on the condition and class of antidepressant. The findings suggest that a more nuanced approach is needed when prescribing antidepressants for pain.”

Ferreira and his colleagues say no study provided high quality evidence on the effectiveness of antidepressants for any pain condition. 

But they did find moderate quality evidence supporting the use of serotonin-norepinephrine reuptake inhibitors (SNRIs) for back pain, postoperative pain, fibromyalgia and neuropathic pain. Low-quality evidence suggested that SNRIs could be used for pain linked to breast cancer treatment, depression, knee osteoarthritis, and pain related to other underlying conditions.

The researchers say only low-quality evidence supports the use of selective serotonin reuptake inhibitors (SSRIs) for depression and pain related to other conditions; and tricyclic antidepressants (TCAs) as a treatment for irritable bowel syndrome, neuropathic pain, and chronic tension-type headaches. 

Antidepressants ‘Disappointing’ for Most Pain Patients

An accompanying editorial, also published in The BMJ, said the study adds to growing evidence that many medications prescribed for pain – not just antidepressants – are only modestly effective.

“Their findings suggest that for most adults living with chronic pain, antidepressant treatment will be disappointing. This is important given emerging concerns about increases in the prescribing of antidepressants and the challenges patients describe when trying to withdraw from treatment,” wrote Cathy Stannard, MD, UK National Health Service, and Colin Wilkinson, a pain patient and consultant at Centre for Pain Research, University of Bath.

“Clinicians continue to prescribe medicines for which the evidence is poor because they observe that some people respond to them, albeit modestly. But all medicines carry risk of harm and there are other, less potentially harmful options more likely to help people to live well with pain.”

Stannard and Wilkinson said exercise and physical activity might be better options than medication for some patients.

Ironically, a little over a year ago, the UK’s National Institute for Health and Care Excellence (NICE) released new guidelines that recommend antidepressants for adults with chronic primary pain, even when they are not depressed. NICE said antidepressants may help with quality of life, pain, sleep and psychological distress.

The NICE guideline is at odds with other studies that found antidepressants are minimally effective for back pain and osteoarthritis and often have adverse side effects. A common complaint of patients who take Cymbalta, for example, is how quickly they became dependent on the drug and have severe withdrawal symptoms when they stop taking it.

Antidepressants Ineffective for Back Pain and Osteoarthritis

By Pat Anson, PNN Editor

Antidepressants like duloxetine (Cymbalta) are increasingly being prescribed to treat various types of pain, but a new study shows the medications are largely ineffective for people suffering from chronic back pain or osteoarthritis and may even cause harm.

Many clinical guidelines recommend using antidepressants as pain relievers – even when depression is not involved -- yet evidence supporting that use is uncertain. To address that knowledge gap, researchers at the University of Sydney reviewed data from 33 controlled trials involving more than 5,000 adults who took antidepressants for low back or neck pain, sciatica, or hip or knee osteoarthritis.

Their findings, published in The BMJ, show that for people with back pain the effects of antidepressants were too small to be worthwhile, but for those with osteoarthritis there may be a small beneficial effect.

“The use of antidepressants to treat people with chronic back pain and osteoarthritis is increasing worldwide, but prior to our work, it was not clear whether antidepressants relieved pain or were safe,” said lead author Dr. Giovanni Ferreira, PhD, a postdoctoral research fellow at the Institute for Musculoskeletal Health at the University of Sydney. 

“We conducted a review of all randomised clinical trials evaluating the efficacy of antidepressants for people with back pain or knee osteoarthritis and found that for back pain the antidepressants were either ineffective or provided a very small effect, which was unlikely to be perceived as worthwhile by most patients. For people with osteoarthritis, effects were still small, but could be potentially perceived as worthwhile by some patients” 

Ferreira and his colleagues reviewed six classes of antidepressants: serotonin-noradrenaline reuptake inhibitors (SNRIs); selective serotonin reuptake inhibitors (SSRIs); noradrenaline-dopamine reuptake inhibitors (NDRIs); tricyclic antidepressants; and tetracyclic antidepressants. 

Results showed that SNRIs such as duloxetine reduced back pain after three months, but the benefits were so small they were unlikely to be considered clinically important to most patients. SNRIs had a slightly stronger effect on sciatica and osteoarthritis pain. 

Tricyclic antidepressants were ineffective for back pain, but might reduce pain in people with sciatica, although the evidence for that was weak.  

Industry Funded Studies 

Importantly, about two-thirds of people taking SNRI antidepressants experienced an adverse event such as nausea, fatigue, mood swings and weight gain.

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm,” said Ferreira, adding that doctors need to be upfront with patients about possible side effects.

Researchers say the long-term effects of antidepressants prescribed for chronic pain are not well known and many of the studies that do exist were sponsored by industry, raising the risk of bias. 

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm.”

— Dr. Giovanni Ferreira

“Large, definitive trials free of industry ties are urgently needed to evaluate the efficacy of antidepressants,” Ferreira said. “There needs to be more transparency about how evidence coming from those trials is appraised by guideline panels. A good starting point would be to consider all industry-funded trials to be at high risk of bias, and downgrade the strength of recommendations where industry-sponsored trials represent an important part of the available evidence.”

The Food and Drug Administration recently approved duloxetine as a treatment for fibromyalgia in pediatric patients, largely on the basis of a small trial conducted by Eli Lilly, Cymbalta’s manufacturer. Children enrolled in the study did show a modest improvement in pain, but several of them had serious adverse events, including two attempted suicides, suicidal thoughts, an intentional drug overdose, depression and hallucinations.

In their published findings in the journal Pediatric Rheumatology, Eli Lilly researchers downplayed the adverse events associated with duloxetine, saying they were not drug related or “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

A common complaint of patients who take duloxetine is how quickly they become dependent and what happens when they stop taking the drug. Many complain of severe withdrawal symptoms, including electric-like sensations called “brain zaps.”

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded nearly 35,000 cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 4,000 of those adverse events resulted in death.

Should Children Be Prescribed Cymbalta?

By Pat Anson, PNN Editor

The Food and Drug Administration has quietly expanded the use of an antidepressant to treat fibromyalgia in pediatric patients between 13 to 17 years of age – despite the known risk of suicidal behavior by children on antidepressant drugs.  

Cymbalta (also known by its generic name, duloxetine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) made by Eli Lilly that was first approved by the FDA as a treatment for depression in 2004.

In the years that followed, Cymbalta’s use greatly expanded as it was also approved as a treatment for anxiety, diabetic neuropathy, chronic musculoskeletal pain and fibromyalgia in adults.

The approvals came with a major caveat: a black box warning label that specifically cautioned patients and providers that “Cymbalta is not approved for use in pediatric patients” because it could increase the risk of suicidal thinking and behavior in children.

2007 Cymbalta warning label

So why is the FDA now approving the use of Cymbalta by children?  

The federal agency issued no press release when it sent a letter to Eli Lilly on April 20 notifying the company that it was approving its longstanding request to allow Cymbalta to be prescribed for juvenile fibromyalgia. Lilly itself has made no public announcement about the approval.

Health and Human Services Secretary Alex Azar, who oversees the FDA, was President of the U.S. division of Eli Lilly from 2012 to 2017, a period when the cost of Cymbalta doubled.

‘No New Safety Concerns’

The FDA’s approval of Cymbalta for pediatric cases appears to be based on a single placebo-controlled study -- sponsored by Eli Lilly -- in which 184 children with juvenile fibromyalgia were given duloxetine, placebo or a combination of the two over the course of 39 weeks.

Eli Lilly not only funded the study, but its employees designed it, collected data, conducted the analysis, and wrote the article that reported on its findings, which was published last year in the journal of Pediatric Rheumatology.

While the study did not show that duloxetine was significantly better than placebo, patients taking the drug did show a modest improvement in pain severity. Notably, Eli Lilly researchers also said they found “no new safety concerns” about duloxetine.

Which doesn’t mean there were no safety concerns, it just means they didn’t find any new ones. Duloxetine is well known to have side effects in adults, such as fatigue, nausea, mood swings and weight gain.

“The safety profile of duloxetine observed in this study was similar to that observed in previous pediatric duloxetine trials of other indications, as well as in duloxetine trials in adults with FM (fibromyalgia). Nausea, headache, vomiting, and decreased appetite were the most frequently reported AEs (adverse events) in the present study, which are similar to those reported previously in adult population with FM,” wrote lead author Himanshu Upadhyaya, Global Lead Physician in Psychiatry at Eli Lilly.

But a closer look at the study findings – which anyone can see for themselves at clinicaltrials.gov – shows that 6 children taking duloxetine exhibited alarming signs of self-harm. There were two attempted suicides and one intentional drug overdose. One child intentionally injured himself and two had suicidal thoughts. Three other children on duloxetine experienced depression, hallucinations and a seizure.

Granted, nine children in total isn’t that many – but in a small study with 184 participants, it’s concerning – especially when no one in the placebo group had the same behavior or symptoms, according to study results posted on the government-run website.

However, in their published findings in Pediatric Rheumatology, Eli Lilly researchers downplayed the suicidal thinking and other side effects associated with duloxetine, saying they were “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

“In the present study, the suicidal ideation events reported with duloxetine were not significantly different from placebo-treated patients. Similar results were reported previously, including the exposure-adjusted analysis of suicidal ideation events, which have not shown any significant difference between duloxetine and placebo,” researchers said.

“None of the SAEs (serious adverse events) reported were considered to be study drug-related and none have led to study discontinuation. There were no deaths reported during the study. There were no significant differences between groups in suicide-related behaviors or ideation.”

Eli Lilly went to great lengths to conduct the study. Its researchers said it took almost 7 years and significant recruitment efforts to find enough children to participate with parental approval. Most of the participants were in the United States, but some were recruited as far away as India and Argentina.

Suicide has long been associated with duloxetine, going back to its earliest clinical trials. A 19-year college student participating in one study killed herself in 2004, four days after being taken off the drug. Four other patients who took duloxetine during clinical trials also committed suicide, although Eli Lilly said at the time there was no evidence directly linking those deaths to the drug.

Withdrawal ‘Brain Zaps’

A common complaint of patients who take duloxetine is how quickly they become addicted and what happens when they stop taking the drug. Many complain of severe withdrawal symptoms such as mood swings, nausea, fatigue and electric-like sensations called “brain zaps.”

PNN columnist Crystal Lindell went through withdrawal when she started weaning herself off Cymbalta in 2015. Her column on that experience (see “How I took Myself Off Cymbalta”) has become a reference point for hundreds of patients trying to get off the drug.

Crystal thinks expanding the use of Cymbalta to include pediatric patients is not a good idea.

“I would urge extraordinary caution when it comes to giving Cymbalta to teenagers,” Crystal says. “When I was first given Cymbalta about seven years ago, I was 29. At that time, the doctor told me I may be too young to take it because it was known to cause suicidal thoughts in young people. He advised me to be in touch with him if that starts to happen. And I was much older than the age group they just approved to take this drug.  

“I hope doctors will be more cautious about giving Cymbalta to teenagers than they have been about giving it to adults. I always advise readers to listen to their doctor first and foremost, but don't be shy about pressing them on which medications they prescribe you. Ask them about side effects and withdrawal so that you can feel comfortable about what you’re taking.”

The FDA’s new warning label for Cymbalta still cautions about suicidal thinking and behavior in children, but no longer warns that the drug is not approved for use by pediatric patients.

NEW CYMBALTA WARNING LABEL

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded over 33,500 serious cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 3,900 of those adverse events resulted in death.

Although Eli Lilly’s patent on duloxetine expired years ago, Cymbalta remains a top money-maker for the company. Cymbalta sales during the first quarter of 2020 were up 28% from a year ago to more than $210 million.

In addition to treating juvenile fibromyalgia, Cymbalta could be repurposed in other ways to boost sales for Eli Lilly. Over 300 clinical studies are underway to explore the use of duloxetine to treat a smorgasbord of other conditions, including shingles pain, cancer pain, surgical pain, post-traumatic stress disorder, attention deficit disorder, and cocaine addiction.

In short, a drug with risky side effects that was originally developed to treat depression is being used for health conditions it was never intended to treat. And more could be added to the list.

Readers Sound Off on Fibromyalgia Drugs

By Lana Barhum, Columnist

In my previous column, “Lyrica, Cymbalta and Savella: Do They Work?” I shared research studies and my own experience with the three medications approved for use in treating fibromyalgia.

Clinical studies on all three drugs don’t seem to offer enough creditable evidence that they are effective in managing fibromyalgia symptoms.  Moreover, they carry very harsh side effects, including weight gain, edema, nausea, headaches, vertigo, sleep issues, and changes in blood pressure.

My experience was similar. Lyrica, Cymbalta and Savella were ineffective for me, and had some tough and life-altering side effects.

It makes me wonder why doctors are still prescribing these medications and why the Food and Drug Administration continues to allow them to stay on the market. 

In 2012, German researchers aimed to assess the benefits and harms of Cymbalta and Savella in treating fibromyalgia.  Ten studies with over 6,000 fibromyalgia patients were reviewed. 

The results were that 22 percent of patients reported substantial relief and 21 percent had to quit treatment due to unpleasant side effects.

In reader comments on our website and Facebook page, many of you had comparable experiences:

“Tried all 3…nothing but weight gain and dizziness. No pain relief. Still haven't found anything that works.”

“I've had multiple spinal surgeries and fusions, and have severe nerve damage. And severe chronic pain. So, I've taken all three of these meds. Without success.”

I will not discount the fact that Lyrica, Cymbalta and Savella work for some people, but they appear to help only about 20 to 30 percent of patients who try them:

“I take one 60mg (of) Cymbalta a day, and it doesn't take away all the pain, but it does make it a bit more bearable.”

“I am using all three. There is relief but in moderation.”

“I have been on Lyrica since 2007 and do have relief of my Fibro pain. I am also on Cymbalta, a muscle relaxant and pain med that really (does) make a difference with my Fibro, arthritis and osteo pain.”

“Tried Savella, no good. Lyrica did not decrease pain enough to continue. I've used Cymbalta and had good results. Best results have been from using Gabapentin (Neurontin) since 1996, up to 3600 mg daily.”

“I'm back on Lyrica and Cymbalta. I know of the side effects with this medicine but it is the only option that remotely helps.”

The effectiveness of Lyrica and Cymbalta, in particular, has been hyped up with aggressive advertising by their manufacturers. And while research and patient experience show improvement on any of the medications is spotty at best, doctors continue to prescribe them.  This is yet another example where the medical field, in general, has not done a good job in treating, understanding or advocating for fibromyalgia patients.          

Side effects reported by readers to the three drugs include dizziness, mood changes, cognitive issues, swelling, sleep issues, weight gain, increased blood pressure, blackouts and more.  Many of these side effects have a detrimental effect on the daily lives of fibromyalgia sufferers – as if our lives were not difficult enough.

“Lyrica was the worst! I became a sleep-walking zombie. I was so out of it at night that I rarely made it to bed laying down. I would find myself in weird places asleep, such as with my head resting on the faucet in the bathroom sink. Or, I would sleepwalk and fall, like down the stairs. Certainly not good for helping my pain!”

“Lyrica did nothing for me. Cymbalta changed my personality completely. I became mean and hateful. When I asked the (doctor) about it, he's like, yeah that can happen.”

“I have taken Neurontin, Lyrica, Savella, and currently take Cymbalta. Neurontin gave me bad nausea, and the feeling of bugs crawling all over my body. Lyrica made me gain a lot of weight, and didn't help my pain at all. The Savella was the worst for me, it gave me very bad suicidal thoughts, so bad I had to stop taking it, it also never helped with pain.”

If only there was an ideal treatment for fibromyalgia -- one that would offer real relief from the worst symptoms and with few side effects.  But such a treatment could only come with a real understanding about the causes and symptoms of fibromyalgia, and I don’t feel medical research has gotten there yet.

The worst part of my experience with fibromyalgia is trying countless treatments to no avail. And there is nothing worse than being told, as I was, by a medical provider that if you expect real relief, you should also expect side effects and learn to cope with them. That statement shows what little understanding and empathy the medical community has about fibromyalgia, its process, and its difficulties.

I wish I had some good treatment advice to offer, but the fact is, like so many of you, I am exhausted. Years of trying medication after medication has left me weary of the medical community and the companies that manufacture fibromyalgia drugs. 

I have accepted defeat and refuse to try anything new.  Neurontin, Cymbalta, and muscle relaxers offer me some relief from nerve pain, depression, and muscle spasms, so I continue to take them.   Even so, I still live with widespread muscle and tissue pain, and a whole host of other symptoms fibromyalgia brings in its wake.

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

McCain Calls for New Study of Veteran Suicides

By Pat Anson, Editor

Arizona Senator John McCain has reintroduced legislation that calls for a comprehensive review of veteran suicides by the Department of Veterans Affairs (VA), including the role of opioids and other prescription drugs in their deaths.

Veterans suffer from high rates of chronic pain, depression and post-traumatic stress disorder (PTSD). According to a recent VA study, an average of 20 veterans die each day from suicide, a rate that is 21 percent higher than the civilian population.

“The tragedy of 20 veterans a day dying from suicide is a national scandal,” said McCain. “Combatting this epidemic will require the best research and understanding about the key causes of veteran suicide, including whether overmedication of drugs, such as opioid painkillers, is a contributing factor in suicide-related deaths.”

If passed, the Veterans Overmedication Prevention Act would authorize an independent study by the National Academies of Sciences of veterans who died of suicide, violent death or accidental death over the last five years – including what drugs they were taking at the time of their death.

The bill specifically calls for a listing of “any medications that carried a black box warning, were prescribed for off-label use, were psychotropic, or carried warnings that include suicidal ideation.”

SEN. JOHN MCCAIN

Dozens of medications prescribed to treat chronic pain, depression or PTSD are psychotropic – meaning they affect a patient’s mental state. They include tranquilizers, sedatives, antidepressants and anticonvulsants such as Lyrica (pregabalin), Cymbalta (duloxetine), Neurontin (gabapentin), Xanax (alprazolam), and Valium (diazepam). Many of the drugs also have warning labels that they “may cause suicidal thoughts or actions.”

McCain’s bill may bring new attention to something that is rarely discussed in the national debate over opioids and the overdose epidemic: many of the drugs prescribed "off label” as alternatives to opioids raise the risk of suicide and have other side effects.

“I almost committed suicide myself after being prescribed Lyrica and Cymbalta. I went from 190 pounds to 300 pounds, and had suicidal thoughts almost from the outset,” Alessio Ventura wrote in a recent guest column for PNN. “After the Lyrica and Cymbalta were stopped, I stayed on OxyContin and had bi-weekly testosterone shots. I lost all of the weight and the suicidal thoughts went away. It was a miracle.”

Vietnam veteran Ron Pence was pressured by VA doctors to take Cymbalta for his chronic arthritis.

“The VA is really pushing these drugs that I would not give to a dog. They are a lobotomy in a pill. I WILL DIE BEFORE TAKING THEM. They take away your ability to think, speak and make decisions; and come with side effects such as permanent blindness, kidney stones and suicide, even in non-depressed people with no mental problems,” Pence wrote in a guest column.

“Even trying to get off this drug under a doctor's care can end in death for some people. Besides that, it’s nothing more than a sugar pill for the pain.”

As PNN has reported, the VA recently adopted new clinical guidelines that strongly recommend against the prescribing of opioids for chronic pain. The guidelines recommend exercise and psychological therapies such as cognitive behavioral therapy, along with non-opioid drugs such as Neurontin. No mention is made that Neurontin and other non-opioid drugs raise the risk of suicide, only that they “carry risk of harm.”

McCain’s bill would require the National Academies of Science to study the medications or illegal substances in the system of each veteran who died; whether multiple medications were prescribed by VA physicians or non-VA physicians; and the percentage of veterans who are receiving psychological therapy and its effectiveness versus other treatments.

Few Drugs Effective in Treating Neuropathy Pain

By Pat Anson, Editor

Cymbalta and some other anti-depressants are moderately effective at relieving diabetic nerve pain, according to a new report by the Agency for Healthcare Research and Quality (AHRQ).

But researchers found little or no evidence that opioids, Lyrica, Neurontin and other widely prescribed medications are helpful in treating neuropathy pain.

Nearly 26 million Americans have diabetes and about half have some form of neuropathy, according to the American Diabetes Association. 

Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients can feel stinging or burning pain, as well as loss of feeling, in their toes, feet, legs, hands and arms.

"Providing pain relief for neuropathy is crucial to managing this complicated disease," said lead author Julie Waldfogel, PharmD, of The Johns Hopkins Hospital in Baltimore.

"Unfortunately, more research is still needed, as the current treatments have substantial risk of side effects, and few studies have been done on the long-term effects of these drugs."

In a systematic review of over 100 clinical studies published in the journal Neurology, AHRQ researchers found moderate evidence that the SNRI antidepressants duloxetine (Cymbalta) and venlaxine (Effexor) were effective in reducing neuropathic pain. Nausea, dizziness and somnolence were common side effects of the drugs.

The evidence was weaker for anti-seizure medication such as pregabalin (Lyrica) and oxcarbazepine (Trileptal). Common side effects from those drugs are weight gain, dizziness, headache and nausea.

While pregabalin works in the same way as gabapentin (Neurontin) -- both are often used to treat nerve pain -- the reviewers found gabapentin was not more effective than placebo. The seizure drug valproate and capsaicin cream were also found to be ineffective.

Oxycodone was not effective in treating neuropathy pain, and the evidence was weak for two other opioids, tramadol and tapentadol.

The U.S. Food and Drug Administration has approved only three medications -- duloxetine, pregabalin and tapentadol -- for diabetic nerve pain. However, many others drugs are prescribed “off label” for the disease.

"We hope our findings are helpful to doctors and people with diabetes who are searching for the most effective way to control pain from neuropathy," said Waldfogel. "Unfortunately, there was not enough evidence available to determine if these treatments had an impact on quality of life.”

Researchers noted that all of the studies were short-term, many for less than three months, and even the most effective drugs had relatively high rates of side effects. They say longer-term studies are needed so that adverse effects and the continued effectiveness of the drugs can be assessed.

Lyrica, Cymbalta and Savella: Do They Work?

By Lana Barhum, Columnist

If you have fibromyalgia, chances are your doctor has prescribed one or more of the three drugs approved for fibromyalgia by the U.S. Food and Drug Administration (FDA).   It is also likely you have been disappointed when they didn’t work and by the side effects they caused.

I have tried Lyrica (pregabalin), Cymbalta (duloxetine) and Savella (milnacipran). My experience is they don’t work well and clinical research doesn’t offer up enough credible evidence that they do.

Patient feedback on these medications is actually more telling than recent studies.  Just check any fibromyalgia online forum and you will find your unpleasant experiences with these medications aren’t unique and shared by many.

Lyrica

Lyrica was developed by Pfizer as a treatment for epilepsy, but it is now widely prescribed for many different types of pain. Lyrica was approved by the FDA in 2007 as the first drug specifically for the treatment of fibromyalgia. Pfizer notes on its website that Lyrica “significantly relieves fibromyalgia pain and improves physical function” in fibromyalgia patients.  But does it really?

An initial study from 2005, with results published in Arthritis & Rheumatology, found Lyrica to be effective at relieving pain in only 29% of the 529 fibromyalgia patients in the study group. 

A major shortcoming of the study was that weight gain affected 10% of the study participants.

What was also interesting about the Arthritis & Rheumatology study is that a large number of participants dropped out due to Lyrica's side effects, which included edema, dry mouth, weight gain, infection, increased appetite and constipation.

A 2014 study of out of the University of Calgary, with results published in the journal Therapeutic Advances in Drug Safety,  also found that Lyrica causes edema and weight gain in some patients. 

Those side effects, especially the weight gain, aren’t worth it for a drug that doesn’t seem to work well for most people. You would get more benefit from dietary changes for fibromyalgia than with Lyrica - at least that was my experience. 

All I got from taking Lyrica was a 40 pound weight gain that took me two years to take off. I made the mistake of staying on it for too long, believing that it would one day work for me.

Cymbalta

Cymbalta was originally developed and marketed by Eli Lilly as a treatment for depression. You may even remember some of the commercials for it. In 2008, Cymbalta become the second drug approved by the FDA to treat fibromyalgia.

While Cymbalta doesn’t have stellar ratings amongst fibromyalgia patients, it does outperform Lyrica in my opinion. Initial trials, with results published in The Primary Care Companion to The Journal of Clinical Psychiatry, show that over a third (36%) of study participants reported at least a 50% reduction in pain, based on a dosage of 60 mg once or twice per day.

A report published in the journal Expert Review of Clinical Immunology found that many participants dropped out of Phase I, II, and III trials of Cymbalta due to side effects, including nausea, headache, and sleep issues. 

Cymbalta has given me some pain relief over the years, but I have also made changes to my diet and lifestyle which may have helped as well.  If Cymbalta has helped me with anything, it is managing the depressed feelings fibromyalgia often leaves in its wake.

Savella

My Savella experience was far worse than my experiences with Lyrica and Cymbalta.  I could only stay on it for two weeks because the side effects were more than I could handle. Dizziness, vertigo, nausea, fatigue, and severe headache were a few of the side effects that stood out.  And I didn’t get any fibromyalgia pain or symptom relief.

Savella was developed by Forest Laboratories specifically for fibromyalgia and was approved by the FDA in 2009.

Like Lyrica and Cymbalta, studies confirm Savella’s poor performance. One double-blind study, reported in the journal Pharmacy & Therapeutics, found that only about one in four fibromyalgia patients (26%) were getting pain relief. 

The rate of discontinuation due to Savella’s side effects and treatment failure was also high -- nearly 43 percent.

In 2010, the consumer advocacy group Public Citizen petitioned the FDA to remove Savella from the market because it increased blood pressure in patients who didn’t have high blood pressure to start with. The group also argued Savella posed an increased risk for suicidal thoughts.

The FDA responded last year and denied Public Citizen’s petition, but said it would continue to monitor the safety of Savella.

My Thoughts

The only medication that I have seen that offers real improvement is Pfizer’s Neurontin (gabapentin), which is prescribed “off label” because it is not specifically approved to treat fibromyalgia by the FDA. Neurontin has helped my nerve pain and I also take muscle relaxers as needed, as I am frequent sufferer of muscle cramps and spasms. 

Studies have confirmed Neurontin’s effectiveness in treating fibromyalgia pain and improving sleep and fatigue. One double-blind study, with results published in Arthritis & Rheumatism, found that over half (51%) of fibromyalgia patients were finding relief with Neurontin.   

That’s not bad for a medication that was originally developed to manage seizures and whose formula has been the same since 1993. While it has helped me, I certainly understand Neurontin hasn’t helped everyone. There are even reports of Neurontin being abused by addicts. 

I am not sure why the makers of Lyrica, Cymbalta and Savella continue to market medications that don’t offer most people real results.  Yet, these medications remain available and doctors are still prescribing them to treat fibromyalgia. 

Let's just hope there are new fibromyalgia drugs on the horizon that actually work and give us real and reliable symptom and pain relief.

What has been your experience with Lyrica, Cymbalta and Savella?

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

It's Time for Chronic Pain Patients to Act

By Alessio Ventura, Guest Columnist

I am a chronic pain sufferer who recently had multiple emergency surgeries due to sepsis infection after a shoulder replacement.

I have had 17 surgeries since 2008, including major back surgery, rotator cuff repair, biceps tendonitis, knee surgery and hernia surgery. Bottom line: my body is now wracked with arthritis and post-surgical pain.

I have tried several pain treatment modalities over the years, including Lyrica, Cymbalta, chiropractic, injections, NSAIDs, and acupuncture. The only effective treatment in my case has been the legitimate, professional application of opioid medicine by pain management physicians.

I have severe allergic reactions to NSAIDs, which kill 15,000 per year and send 100,000 to the hospital.  A friend of mine died from a stroke because of NSAIDs.

After my recent surgeries related to the shoulder replacement and subsequent infection, my wife had to travel to 25 different pharmacies before she finally found someone willing to fill my scripts for Oxycontin and Percocet.

This is not unusual though. Each month is a long trek to find pain medicine. What has happened due to government restrictions on opioids is a reduction in the supply of opioid medicine. The drug companies see the writing on the wall and are slowly trying to get out of the business.

ALESSIO VENTURA

At the same time, the government sets limits on how much a pharmacy can stock. That is according to pharmacists I have spoken to, but is denied by the DEA and FDA in response to letters I have written.

It truly is a nightmare. Each month, you have to go to pharmacy after pharmacy before you find a pharmacist willing to dispense the medicine, which pharmacists are under no legal obligation to provide. Many pain patients go into withdrawal each month as they search, while at the same time enduring intractable pain.

Most of us have tried every single alternative to opioids, but the anti-opioid hysteria paints a picture that there are better and safer therapies. That simply is not true. The only thing that works for many of us is an opioid-based medicine.

The madness is spreading. New Jersey governor Chris Christie has signed into law a bill that limits the first script for opioids to 5 days. After the four surgeries I’ve had since August, I was bedridden and could not visit a doctor after 5 days. They could not identify the infectious agent as they were unable to grow it in cultures. Eventually I was treated with 3 broad spectrum antibiotics, which in addition to killing the infection, also killed the "good" bacteria in my system, which caused severe fatigue and gastrointestinal side effects.

Many acute traumas, like when someone is shot or in a horrible car accident, will not provide for easy travel to visit a doctor to refill an opioid after 5 days, and it is currently illegal for a doctor to call in a script for controlled substances. This caused a run on opioid medicine in New Jersey as hospitals and surgery centers accumulated as much as they could, and with the cutback by drug companies, many people could not get their scripts filled.

My 85 year old mother in New Jersey had back surgery recently. My sister drove to 30 pharmacies -- starting in Bridgewater and working her way along Route 22 toward Newark -- and she was unable to get our mother’s scripts filled. My mother was in horrible pain and my sister had to rush her back to the ER. It was horrible. My sister broke down in tears at the ER as she explained her plight and the suffering of my mother.

There is a reason why army medics carry morphine to the battlefield. It is the only thing that has a chance to address severe acute pain.

In addition to supply limits, there is the prescription drug monitoring system. The government now tracks every single opioid that you legally acquire. If for whatever reason you find yourself away from home and cannot see your physician and you attempt to refill or get new pain medicine because of an injury, surgery or chronic pain, you will not be able to do it legally without first getting in touch with your doctor so they can coordinate care. Often this is not possible.

If you do get pain medicine while away without coordinating, you will be investigated and may be subject to arrest. Your doctor may also drop you from their practice. Your rights as a patient, especially your privacy rights and your right to seek pain relief, are now severely trampled.

Politicians are playing with fire as the opioid hysteria grows. More people will commit suicide rather than live with intractable pain, because politicians think they know more than doctors treating patients.

Who is going to listen to us? Politicians and some in the medical community conveniently conflate overdose data from the illegal use of opioids with legitimate use for intractable pain. They are also dismissive and try to tell us that we should try alternatives. For example, Lyrica is now being pushed by many, but it was developed only for a specific class of nerve pain, and possible side effects include suicide, weight gain, and a host of other things.

I almost committed suicide myself after being prescribed Lyrica and Cymbalta. I went from 190 pounds to 300 pounds, and had suicidal thoughts almost from the outset. When I told my doctors, they said, "Give it more time, the side effects will subside".

After the Lyrica and Cymbalta were stopped, I stayed on OxyContin and had bi-weekly testosterone shots. I lost all of the weight and the suicidal thoughts went away. It was a miracle.

There is a literal civil war occurring now between physicians who understand pain, and others who refuse to admit the truth about the efficacy of legitimate pain management via the use of opioids. Unless we all collectively speak up and scream loudly, meaning writing formal, respectful, but firm and forceful letters to our representatives, they will continue to step on us and cause our lives to be living hell.

It is time. Find out who your state and federal representatives are. Find out who your local, state, and federal health organization leaders are. Write formal letters, not emails or phone calls, to your representatives. After you write your letters, request meetings with your representatives and go to that meeting. Do whatever you can in a professional, respectful, but aggressive way in order to bring attention to our plight.

The time is now. Failure to act most assuredly means an end to our rights, a lifetime of pain, more illegal use of drugs, and in many cases, death.

Alessio Ventura was born in Italy, came to the U.S. at 17, and finished high school in Newark, New Jersey. He worked for Bell Laboratories for 35 years as a network and software engineer. Alessio has been married for 35 years and has 4 adult children, including triplets.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Lyrica and Cymbalta Advised for Diabetic Neuropathy

By Pat Anson, Editor

New guidelines by the American Diabetes Association for the treatment of diabetic neuropathy strongly discourage the use of opioids to treat nerve pain, while recommending pregabalin (Lyrica) and duloxetine (Cymbalta).

Nearly 26 million people in the United States have diabetes and over half have some form of neuropathy, which often causes a painful stinging or burning sensation in the hands or feet.  Nerve pain is often the first symptom that prompts people to seek medical care before getting a diabetes diagnosis.

Researchers at the University of Michigan led a group of internationally recognized endocrinologists and neurologists, and teamed up with the American Diabetes Association (ADA) to craft a new position statement on the prevention, treatment and management of neuropathy. The ADA last released a statement on diabetic neuropathy in 2005.

"Our goal was to update the document so that it not only had the most up-to-date evidence, but also was easy to understand and relevant for primary care physicians," said lead author Rodica Pop-Busui, MD, a professor of internal medicine at Michigan Medicine Division of Metabolism, Endocrinology and Diabetes.

"Treatment of neuropathy pain is specifically relevant because, unfortunately, there has been much overprescribing of narcotics for neuropathic pain."

Although opioids like oxycodone and tramadol are effective in relieving nerve pain, they are not recommended by the ADA as a first, second or even a third-line treatment.

“Despite the demonstrated effectiveness of opioids in the treatment of neuropathic pain, there is a high risk of addiction, abuse, sedation, and other complications and psychosocial issues even with short-term opioid use. For these reasons, opioids are not recommended in the treatment of painful DSPN (distal symmetric polyneuropathy) before failure of other agents that do not have these associated concerns,” the guideline states.

Instead of opioids, the ADA recommends either pregabalin (Lyrica) or duloxetine (Cymbalta) as an initial treatment for neuropathic pain. Gabapentin (Neurontin) can also be considered.

PNN readers often complain of side effects from all three drugs – such as depression, fatigue, nausea, headache and weight gain -- yet the ADA statement only vaguely warns that their “adverse effects may be more severe in older patients.”

"Lyrica did help with my nerve pain but the side effects were intolerable and the withdrawal was absolute hell," said Laura.  "I gained 20 pounds in a month and was even more of a zombie than when I was on gabapentin. I had no personality, no interest in anything, and had completely lost motivation to do anything."

"I have been on Cymbalta a couple of years. It has helped overall with depression, anxiety and pain. I also can't miss a dose or try to quit cold turkey," wrote Rebecca Williams. "I become very dizzy, nauseated, night sweats, crazy dreams, electrical zaps in my head. I don't know how I would ever get off of it because the withdrawal symptoms are unbearable."

The ADA guidelines recommend that physicians try different therapies to prevent or slow the progression of diabetic neuropathy, most of which focus on controlling high blood sugar (glucose), which can cause irreversible damage to small nerve fibers. Insulin, regular exercise and a low-calorie, low-fat diet can help regulate glucose levels.

To see the ADA’s recommendations, click here.

The VA’s Opioid Policy Hurts Veterans Like Me

(Editor’s note: In 2015, Congress passed and President Obama signed into law legislation that requires the Veterans Administration to adopt the CDC’s “voluntary” opioid guidelines, which discourage the prescribing of opioids for chronic pain. Over the past year, the VA has implemented the guidelines throughout its healthcare system, which provides medical services to 6 million veterans -- over half of whom suffer from chronic pain. One of them is Ron Pence.)

By Ron Pence, Guest Columnist

I am a Vietnam veteran who turned to the VA health system in 2001, when I started having pain from polymyositis and chronic arthritis, the worst kind of arthritis caused by autoimmune disease. My own body was attacking my joints and muscles. They said CPK enzyme levels in my blood were very high and in danger of shutting down my kidneys.

Back then the VA cared about vets. I was started on pain meds and they moved me up the ladder as the pain increased.

The head of rheumatology started me on morphine because he said it was the only drug he had to offer. He was right. After 3 pain management visits, 3 more doctors agreed I was on the correct needed dose. X rays of the arthritis in my back ruled out chiropractic care.

I was on the same dose of morphine for 9 years. It worked well enough for me to function and to live alone. The VA promised to continue my opiate therapy as long as I did not break their rules.

After 5 years or so they came out with a new contract and forced us to sign it. I was told either sign it or you don’t gets your meds. I was never accused of breaking their rules and never have. I pointed out the new contract was totally in favor of the VA doing as they please and was signed under duress.

RON PENCE

Now out of the clear blue they cut my dose in half over two months and they may cut it completely because I refuse to take terrible and dangerous psychiatric drugs with the worst side effects. Just search the Internet for “Cymbalta side effects” and you’ll see what I mean.

The VA is really pushing these drugs that I would not give to a dog. They are a lobotomy in a pill. I WILL DIE BEFORE TAKING THEM. They take away your ability to think, speak and make decisions; and come with side effects such as permanent blindness, kidney stones and suicide, even in non-depressed people with no mental problems. Even trying to get off this drug under a doctor's care can end in death for some people. Besides that, it’s nothing more than a sugar pill for the pain.

Why start something like that when what I was taking had no side effects for me and was working fine? I am sure the pills they are pushing will end in a lot more deaths and terrible disabilities and suffering.

My companion almost died after taking Enbril. The VA doctors write prescriptions for Enbril, Humira, etc. as if they were candy. Four shots a month cost $2,000. Far more dangerous than opiates, but someone lines their pockets and the drug companies make over $10 billion a year on them. There is more here than meets the eye.

The CDC in Atlanta says their opioid prescribing guidelines are just that, guidelines. Doctors at the VA must not be smart enough to know what a guideline is. They’re pushing very dangerous, expensive and destructive drugs to replace opioids. Pray and try to find a substitute that works. Doctors sit and lie about what the guidelines say. The stress of not knowing if you are going to be cut off completely is as bad as the pain.

Since the big cutback in my pain medication, I am far less functional. Just standing up 30 seconds to snatch my clothes out of the washer puts me in hollering pain and I fall back into my wheelchair. Cutting the meds even makes it hard to get on the toilet. I am 70 and live alone. My family brings me food to keep me from starving most of the time. I have lost over 90 pounds.

This is going to mean the nursing home for a lot of people like me and I cannot stand the thought of living or existing in a nursing home. Karma is going to get a lot of people making these bad decisions.

I don’t take complaints to Washington because I am old and an 8 mile trip to Walmart wipes me out for a couple of days. This is a fight for the younger guys.

We are in one of the most advanced countries in the world medically, yet the doctors and politicians will not use that knowledge to ease pain and suffering. We have to find a solution.

Ron Pence lives in Florida. Ron enlisted in the Air Force in 1963 – at the age of 17 -- and served his country for 6 years.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Two Drug Combo More Effective for Fibromylagia

By Pat Anson, Editor

Two drugs commonly prescribed for fibromyalgia – Lyrica and Cymbalta – are more effective in treating the disorder when used together, according to a new study by Canadian researchers.

Lyrica (pregabalin) is an anti-seizure nerve drug, while Cymbalta (duloxetine) works primarily as an anti-depressant. Both have been used for years to treat fibromyalgia -- a poorly understood disorder characterized by deep tissue pain, fatigue, insomnia, and mood swings. Until now no one has studied how effective the two drugs could be when used in combination.

"We are very excited to present the first evidence demonstrating superiority of a duloxetine-pregabalin combination over either drug alone," said lead author Ian Gilron, MD, Director of Clinical Pain Research at Queen’s University in Kingston, Ontario.

“The results of this trial suggest that combining pregabalin with duloxetine can safely improve outcomes in fibromyalgia including pain relief, physical function and overall quality of life.”

This was a small study – only 41 fibromyalgia patients participated – and the researchers admit that larger trials are needed to see if the results can be replicated. The new research was published in the journal Pain.

The study is the latest in a series of clinical trials -- funded by the Canadian Institutes of Health Research -- which Gilron and his colleagues have conducted on combination therapies for chronic pain conditions. By studying promising drug combinations, they hope to show physicians how to make the best use of current treatments.

"The value of such combination approaches is they typically involve drugs that have been extensively studied and are well known to health-care providers," says Gilron.

Patients in the study were divided into three groups that either took pregabalin alone, duloxetine alone or a combination of the two for six weeks. Doses were gradually increased in the study to the maximum tolerated dose. When used in combination, patients could only tolerate relatively low doses of pregabalin and duloxetine, suggesting the drugs have an overlap effect when used together.

“The pharmacological diversity of a pregabalin-duloxetine combination is a mechanistically appealing feature that increases the likelihood of additive analgesic actions although there could similarly be some additive adverse effects with this combination. Even at significantly lower doses during combination therapy, superior global pain relief during combination therapy would suggest a greater additive effect for pain reduction than for side effects,” said Gilron.

The biggest side effect of the pregabalin-duloxetine combination was drowsiness, and the researchers admit that reduced physical activity caused by drowsiness could have contributed to pain reduction. 

Patients have long complained of other side effects from pregabalin and duloxetine when used separately, such as weight gain, nervousness, and brain fogginess. Many have also reported severe withdrawal symptoms and “brain zaps” when trying to get off the drugs. The study apparently didn’t address those issues. 

Lyrica (pregabalin) is one of Pfizer’s top selling drugs and generates over $5 billion in revenue annually. In addition to fibromyalgia, Lyrica is approved by the Food and Drug Administration to treat chronic pain associated with epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.

Cymbalta (duloxetine) generated sales of $5 billion for Eli Lilly until its patent expired in 2013 and cheaper generic versions of duloxetine became available. Cymbalta is approved for fibromyalgia, neuropathy, osteoarthritis, depression and anxiety.

Only one other medication – Savella – is approved by the FDA for fibromyalgia, but it is not as widely used as the other drugs.

Fibromyalgia was initially thought to be a musculoskeletal disorder, but research now suggests it's a disorder of the central nervous system - the brain and spinal cord. Researchers believe that fibromyalgia amplifies painful sensations by affecting the level and activity of brain chemicals responsible for processing pain signals. It affects twice as many women as men.

Let’s Talk About Sex, Baby — and Chronic Pain

By Crystal Lindell, Columnist

The thing that nobody tells you about Cymbalta is that it takes a machine gun to your sex drive. Seriously. When I was on it, I was so repulsed by sex that I started to think maybe I was legitimately asexual. 

I mean, when the doctor hands you the prescription, it would be nice if they threw in something like, “BTW, you’re never going to want to make passionate love while you’re on this medicine.”

But of course, doctors never tell you stuff like that. And God forbid they give you a handout of some sort that maybe mentions it. No, they just leave you to Google “asexual” at 1 a.m. on a Tuesday night when you realize you’re identifying a little too much with Sheldon on the Big Bang Theory.

Don’t get me wrong, I have definitely been in such tragic levels of pain, that if someone had asked me if I wanted to give up sex so I could feel better, I wouldn’t have even thought twice about cutting off my own vagina and handing it over. 

But the thing is nobody asked me. They didn’t tell me I might have to make that sacrifice when they put me on Cymbalta. So I didn’t even know it was happening. And that’s when you get to some pretty dark places. 

Thankfully, I’ve since gone off Cymbalta, and my sex drive came back like a freight train. 

But that doesn’t mean there aren’t other issues related to sex and chronic pain.

Like when you have stabbing rib pain on your right side, so you can only tolerate sports bras, and then he goes to unhook the back, and it kills the mood because there is no hook in the back of a sports bra. And he’s mad that you’re dressed like someone planning to run a 5K, and then you’re mad that he’s mad that you’re dressed like someone planning to run a 5K, and so you just leave.

Or when he wants to cuddle, and you have to explain that, “Sorry, I can’t lay on my right side because when I do it feels like someone is jack hammering into my bones through the mattress. Hope that’s not a deal breaker!”

Not to mention the fact that when you’re in physical pain, the last thing you feel is sexy. And you most certainly don’t feel like having anyone touch you ever. 

First, there’s just the literal pain that can come from someone passionately throwing you against the wall, or even a pillow top mattress for that matter. When you feel like you always have a broken rib, even passionate love making can make you wince. 

Then, there’s the fact that the pain probably keeps you from showering as often as most Americans believe is normal, which means you probably smell, which means you’re probably not feeling very romantic. 

And of course, there’s the side effects from the medications, which make you gain weight, sleep all day, and zone out in front of YouTube videos about makeup while you simultaneously lose the ability to actually wear makeup. 

Not to mention the fact that it’s just really hard to make love to someone, while you yell things like, “OH GOD! OH GOD! OH GOD!  IF YOU TOUCH MY RIGHT SIDE AGAIN I’M GOING TO STAB YOU TO DEATH!’ or “YES! YES! YES! I NEED YOU TO AVOID MY CHEST AREA AT ALL COSTS!”

That’s the kind of stuff that can turn an evening of “Netflix and Chill” into an evening where you actually watch Netflix and chill. 

But even with so many things working against the sex lives of those with chronic pain, that doesn’t mean people should give up. 

For one, that old saying about how, “You can have great sex without having a great relationship, but you can’t have a great relationship without great sex,” is actually pretty true in my experience. Having sex is an important part of being a healthy couple. Of course, that doesn’t mean partners shouldn’t be understanding of the situation, and our pain levels. What it does mean is that avoiding sex, regardless of how legitimate the reasons for doing so are, will likely put a strain on your love life. 

Also, sex is just a good thing to have in general. It helps your mood, it can be a great pain reliever and stress reducer. And, you know, it’s fun.

So I don’t think patients should just resign themselves to the idea that having chronic pain means giving up good sex for the rest of their lives.

Unfortunately, I don’t have magical solutions to offer people with chronic pain struggling to work sex back into their daily life. But there are a couple things you can at least try.

Frist, there’s always the obvious “talk to your doctor” advice. Yes, I know that conversation can be awkward — both for the patient and the physician. If you’re up for the conversation though, I definitely recommend it. Your doctor might be able to recommend other medications that don’t kill your sex drive, some less painful positions or other techniques to help you out.

In the end though, I honestly think the best thing you can do is be open about the issues without whomever you’re making love to. Just like with anything, talking about what’s going on usually does the most good.

And if you both decide that maybe you can try to get a wire-free bra with a hook in that back because that’s what he’s into, as long as he promises to never touch your right boob, then great! Or, if you decide that having sex just isn’t worth the pain, then that’s great too.

After all, there’s always Better-than-Sex cake in a pinch.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.