Milnacipran For Fibromyalgia – Only Good On Paper?

Article in press using large number of cases, demonstrates statistical superiority of Milnacipran in Fibromyaglia. Although thoroughly disguised, absolute results don’t look that great.


J Rheumatol. 2010 Apr;37(4):851-859. Epub 2010 Feb 15.
A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia.
Branco JC, Zachrisson O, Perrot S, Mainguy Y

I do NOT liked combined scales like an Impact scale – a little bit better here, a little here, and adding it up looks like it’s a lot better when it is only really a little bit better overall.  Hence I stick to pain scores; the only absolute pain value I could find for before and after was Pain Experience Diary (PED) 24hr. pain recall. I scaled it so results started at 7/10 pain and looked for results as compared to all the others.


Compared to all the others scaled down to 7/10 to start:

Results:

* = may wear off at 8 weeks
What gives? – this is no better than any of the other treatments despite the 0.001 significance values they obtained by using big groups!!!

Side effects: PLACEBO MILNACIPRAN (%)
Nausea 11.2 | 26.0
Hyperhidrosis 2.9 | 23.7
Headache 12.3 | 16.9
Constipation 2.2 | 12.5
Dizziness 7.6 | 10.2
Palpitations 2.9 | 7.9
Insomnia 5.4 | 7.7
A Cold 7.4 | 7.7
Hot flash 1.1 | 7.0
Tachycardia 0.7 | 6.7
Vomiting 3.4 | 5.1

Look like, just as Cymbalta, nausea is going to be a consideration.
Comment – A bottom line is to consider that “responders” got better results. For example, on “Full set analysis”, 31.3% of cases were responders and got better results.

Nonetheless, I would start with 5-10 mg amitriptyline and work up to 25 mg. then afterwards consider Gabapentin, Lyrica, Cymbalta or Milnacipran until you find a good response. Beyond Amitriptyline which is very cheap, gabapentin is the only other one on our drug plan and will take over a month to achieve useful doses, if achievable at all. Cymbalta and Milnacipran have advantages that they are antidepressants.
Also a bottom line is that in order to achieve clinically sigificant results, you will have to combine may treatments as suggested in:

What Does It Take to Feel Substantially Better In Fibromyalgia?

Addendum:

Nat Rev Rheumatol. 2010 Aug;6(8):439-40.
Pain management: Fibromyalgia drugs are ‘as good as it gets’ in chronic pain.
Clauw DJ.    no abstracvt

Discusses fact that none of new drugs really work better than the other except “duloxetine for fatigue, milnacipran for sleep disturbance, and pregabalin for depressed mood.” – Huh, would have thought the antidepressants would have been better for mood…
Any comments?

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