Stoll redux, or for real?

I just read a potentially practice changing  article in Bipolar Disorders: Adjunctive probiotic microorganisms to prevent rehospitalization in patients with acute mania: A randomized controlled trial, by Dickerson et al.


Sixty-six patients hospitalized for mania were randomized to either receive 1 probiotic tablet or placebo for 24 weeks. The results were dramatic. The 33 patients on placebo had 24 hospitalizations (average length 8.3 days)  versus 8 hospitalizations for the 33 on probiotics (average length 2.8 days).


As the authors note, probiotics are safe, tolerable, and cheap. The compound they used “is commercially available in Europe but is not commercially available in the USA”. They used one tablet “containing Lactobacillus GG and Bifidobacterium lactis strain Bb12 (>108 colony forming units) in maltodextrin and microcrystalline cellulose…obtained from Chr. Hansen (Horsholm, Denmark).”


If this is replicated, it could be huge. As the authors put it, “The probiotic compound was well tolerated and had low levels of side effects. The adjunctive use of probiotics might represent a major addition to the therapeutic armamentarium for the management of mania and other mood disorders.”


It’s hard not to get excited about a result like this.


But, it hasn’t been replicated.


It reminds me of my enthusiasm 19 years ago for Andrew Stoll, MD et al.’s paper in the Archives of General Psychiatry in May, 1999, Omega 3 Fatty Acids in Bipolar Disorder: A Preliminary Double-blind, Placebo-Controlled Trial. This was “a 4-month, double-blind, (randomized)  placebo-controlled study, comparing ω3 fatty acids (9.6 g/d) vs placebo (olive oil), in addition to usual treatment, in 30 patients with bipolar disorder”, which found that “the ω3 fatty acid patient group had a significantly longer period of remission than the placebo group (P=.002; Mantel-Cox). In addition, for nearly every other outcome measure, the ω3 fatty acid group performed better than the placebo group.”


But, as you know, we don’t recommend omega 3 fatty acids to our patients with bipolar disorders because Stoll’s work wasn’t replicated.


For example, in Keck  et al’s Double-blind, randomized, placebo-controlled trials of ethyl-eicosapentanoate in the treatment of bipolar depression and rapid cycling bipolar disorder, “overall, there were no significant differences on any outcome measure between the EPA and placebo groups…this study did not find overall evidence of efficacy for adjunctive treatment with EPA 6 g/day in outpatients with bipolar depression or rapid cycling bipolar disorder.”


So it’s probably too early  to start hunting for a facsimile of Faith Dickerson’s probiotic. One might eat  4 ounces of Straus yogurt/day, with its living yogurt cultures, including  Lactobacillus bulgaricus and Bifidobacterium lactis. But, as Dickerson et al remind us, “care is required in determining equivalence in terms of the quantity and viability  of the microorganisms in different preparations.”

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