The FDA’s approval of Savella for the treatment of fibromyalgia, comes 19 months after the approval of Lyrica, the first drug approved for fibromyalgia and roughly nine months after the approval of Cymbalta.
Savella is similar to Cymbalta, both are antidepressants known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs). These drugs are supposed to help a person re-uptake and use the serotonin (calming brain hormone) and norepinephrine (stimulating brain hormone) more effectively.
The approval of Savella was based on two clinical trials involving 2,084 fibromyalgia patients (1,460 on Savella and 624 on placebo).
About 25 percent of people taking Savella had a positive response. This was considerably better than the 13 percent who had a positive response to placebo.
However, while the maker’s of Savella will be sure to promote it as being twice as effective as a placebo, what they won’t say is what you now know- the drug failed to help 1,095 of the 1,460 participants in the study who were taking Savella.
There are no studies directly comparing Savella to Cymbalta, although it’s likely that because of their similar mechanisms of action they would be similar in effectiveness.
If you’ve read my book, “Treating and Beating Fibromyalgia and Chronic Fatigue Syndrome” or past articles on fibromyalgia, you know that those with fibromyalgia have low serotonin and norepinephrine levels due to bankrupting their stress coping savings account.
Serotonin is a brain chemical that helps regulate deep restorative sleep, reduces pain, boosts mood and mental clarity, and controls digestion and elimination (IBS).
The brain chemical norepinehrine helps boost moods, mental and physical energy, and block pain.
Restoring serotonin and norepinehrine to optimal levels often yields dramatic improvement in the chronic pain, poor sleep, low moods, and brain fog associated with fibromyalgia.
But using SNRI drugs like Savella is analogous to using a gasoline additive to help your car get more mileage out of the gasoline in their gas tank.
Unfortunately, for the majority of the individuals who suffer with fibromyalgia and or depression, they don’t have any serotonin or norepinephrine in their brains to re-uptake.
A gasoline additive poured into an empty gasoline tank doesn’t help much, if at all. A SRNI drug given to someone with little to no serotonin or norepinephrine to re-uptake doesn’t do much- results are usually short-lived and disappointing.
Studies show that the use of antidepressants causes the brain to release less and less serotonin and norepinephrine over time. SNRI drugs work by blocking the removal of serotonin and norepinephrine from its synapse.
Over time, the brain tries to compensate by shutting down the nerves that produce these two neurotransmitters.
This is known as down-regulation. Eventually, the brain begins to reduce the number of serotonin and norepinephrine receptors–up to 40-60 percent in some parts of the brain–until they literally disappear from the brain.
Now the patient is really in trouble as depression, anxiety, chronic pain, irritable bowel, brain fog, and poor sleep become even worse.
This may explain why patients often switch from one antidepressant drug to another in hopes of feeling better.
Common side effects of prescription antidepressants may include anxiety, depression, headache, muscle pain, chest pain, nervousness, sleeplessness, drowsiness, weakness, changes in sex drive, tremors, dry mouth, irritated stomach, loss of appetite, dizziness, nausea, rash, itching, weight gain, diarrhea, impotence, hair loss, dry skin, chest pain, bronchitis, abnormal heart beat, twitching, anemia, low blood sugar, and low thyroid.
Savella may be helpful, certainly safer than Lyrica, but no one suffers from a Savella or antidepressant deficiency.
Amino Acid Therapy/Nutritional Therapy
Neurotransmitters or brain chemicals like serotonin and norepinephrine are produced from the amino acids 5-hydroxytryptophan (5HTP) and S-Adenosyl-methionine (SAMe).
These 2 amino acids along with B vitamins and certain minerals (one of many reasons why I recommend my patients take the CFS/Fibromyalgia Formula and the Fibromyalgia Jump Start Package) produce the brain chemicals serotonin and norepinephrine.
Use the Brain Function Questionnaire to Know if You’re Low in Serotonin and or Norepinephrine-
The Brain Function Questionnaire
The “S” Group (S for Serotonin)
Please check the items, which apply to your present feelings:
- It’s hard for you to go to sleep.
- You can’t stay asleep.
- You often find yourself irritable.
- Your emotions often lack rationality.
- You occasionally experience unexplained tears.
- Noise bothers you more than it used to. It seems louder than normal.
- You “flare up” at others more easily than you used to.
- You experience unprovoked anger.
- You feel depressed much of the time.
- You find you are more susceptible to pain.
- You prefer to be left alone.
5HTP- Boosts Serotonin Levels
Supplementing with 5-hydroxytrryptophan (5HTP), a form of tryptophan helps raise serotonin levels. Studies show that 5HTP is as effective as antidepressant drug therapy including SSRI medications. One study showed that patients on 5HTP had a 50 percent improvement in their mood disorder symptoms.
Start with 50mg of 5HTP 30 minutes before bed on empty stomach with 4 ounces of grape juice. If you don’t fall asleep and sleep through he night keep increasing your dose by 50mg each night until fall asleep and sleep thgrough the night or reach 300mg. If you take 5HTP at bedtime on empty stomach and it wakes you up, take it during the day with food- start with 50mg a day and build up to 300mg a day with food (won’t make you tired or sleepy if take it with food).
The “N” Group (N for Norepinephrine)
Please check the items which apply to your present feelings:
- You suffer from a lack of energy.
- You often find it difficult to “get going.”
- You suffer from decreased drive.
- You often start projects and then don’t finish them.
- You frequently feel a need to sleep or “hibernate.”
- You feel depressed a good deal of the time.
- You occasionally feel paranoid.
- Your survival seems threatened.
- You are bored a great deal of the time.
The neurotransmitter Norepinephrine, when released in the brain, causes feelings of arousal, energy, and drive. On the other hand, a short supply of it will cause feelings of a lack of ambition, drive, and or energy.
S-Adenosyl-methionine (SAMe)- is involved in regulating the brain’s neurotransmitters. SAMe has been shown through several recent, well designed, studies to be one of the best natural antidepressants available.
SAMe helps boost serotonin and epinephrine levels. It also helps increase the production of endorphins.
SAMe Helps Boost the Effects of Antidepressants
Research has already shown that SAMe increases both serotonin and norepinephrine levels (brain chemicals) and is a potent antidepressant by itself. Now researchers have shown that combining SAMe with prescription antidepressants reduces the failure rate by 43%.
There are over 100 peer-reviewed studies showing that S-adenosyl-methionine (SAMe) is a safe and effective antidepressant.
It also helps increase the production of endorphins. Endorphins are the bodies natural pain blocking chemicals and are more powerful than morphine.
SAMe helps manufacture and repair cartilage components. A study of osteoarthritis patients compared SAMe with NSAID drugs in its ability to reduce pain.
One double-blind study showed SAMe was superior to ibuprofen in the treatment of osteoarthritis.
Several studies involving SAMe and fibromyalgia patients yielded substantial improvement in over all pain levels (as well as depression).
Start with 400mg taken on an empty stomach (30 minutes before breakfast) in the morning and if needed increase up to 1200mg.
The best way to boost your serotonin and norepinephrine levels, improve your sleep, moods, IBS, mental clarity, and reduce your pain is to take the CFS/Fibromyalgia Jump Start Package and add SAMe.
You can learn more about ways to safely and effectively reduce your pain, IBS, fatigue, depression, brain fog, and episodes of poor sleep by ordering my book “Treating and Beating Fibromyalgia and Chronic Fatigue Syndrome.”