Probiotics for bipolar disorder mania

reference

Dickerson, F., Adamos, M., Katsafanas, E., et al. Adjunctive probiotic microorganisms to prevent new hospital instruction in patients with acute mania: a randomized controlled study. bipolar disorder . 2018; 20 (7): 614-621.

objective

to determine whether the additional probiotic administration reduces the renewed hospital admission of patients with bipolar disorder 1 after a hospital stay due to mania.

draft

randomized, double blind, placebo-controlled 24-week intervention with personal visit every 4 weeks. Statistics used intention-to-treat analyzes.

Intervention

Lactobacillus GG and Bifidobacterium lactis Stamm BB12 Combined probiotic (> 10 8 coloning units [CFUS]) or placebo once.

participant

Sixty patients between the ages of 18 and 65, who had been admitted to psychiatric inpatient or day clinics in Baltimore for mania, were admitted after their release. Fifty -two participants ended the study (26 in each group). All participants were recorded with a diagnosis of bipolar 1 (individual manic episode, last manic episode or last mixed episode) or schizo-savvy disorder, bipolar type (manic or mixed condition; DSM-IV-TR), which was confirmed by the structured clinical study interview to diagnose DSM-IV disorders of the axis I (SCID). The participants continued their regular medication and other psychiatric treatments as usual.

exclusion criteria included:

• substance -induced or medically induced mania
• HIV infection or other immune deficiency
• disease that affects the brain or cognitive function and/or diagnosis of a mental disability
• drug abuse or dependency within 3 months before the start of the course
• History of an intravenous drug consumption
• Participation in a drug study within 30 days before the start of the course
• pregnant or plan to get pregnant during the study period
• documented celiac disease

study parameters evaluated

• duration until rehospitalization after the discharge
• Total number of hospital admissions in each group
• Average number of hospital days in the study period
• Total days of hospitalization
• Psychiatric indicators every 4 weeks: Letter Psychiatric Rating Scale (BPRS), Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (Madrs)
• inflammatory score using blood that was taken at the start of the study and when the study/24 weeks were concluded. The inflammatory score used these variables: immunoglobulin (IG) G antibodies against the NR2 peptide fragment of the N-methyl-D-Aspartate (NMDA) receptor, Gliadin and the gag protein of the Mason Pfizer-Affizer virus; and IGM-class antibodies against toxoplasma gondii .

primary result measurements

The primarily measured endpoints were the effects of probiotics:

• inflammatory score
• Number and duration of the rehospitalization
• relative risk of rehospitalization
• Psychiatric evaluation scales

important knowledge

• overall fewer rehospitalization events in the probiotic vs. placebo group (8 vs. 24; hazard ratio [hr]: 0.28, p = 0.009)
• less risk of a first psychiatric rehospitalization in the probiotic vs. placebo group (Mr.: 0.37; 95 % confidence interval [CI]: 0.15-0.91, p = 0.029)
• During the 24-week study period, the probiotic group spent a total of 182 days less in the hospital, and the average stay was shorter (mean [SD] length of stay = 2.8 days [6.3] compared to 8.3 days [12.4], p = 0.017)
• The psychiatric scales (Madrs, YMRS, BPRS) did not differ between the groups at any time of the follow -up examination in the study.
• No discontinuation of study on complaints about study medication; The registered undesirable events were equally
in both groups

The following finding tends towards significance ( p = 0.0596): The higher the inflammation at the beginning of the study in all patients, the higher the risk of a new hospital inscription.

Interestingly, the study does not quantify neither the change in the inflammatory value in the group as a whole, nor compares the two groups. However, the authors found that the participants with higher inflammation values ​​(determined than above the 50th percentile of a separate control group without psychiatric symptoms from another study 1 ) were associated with the greatest decline in the dismantling risk risk. The authors comment: "For individuals [who experience mania] with relatively high rates of systemic inflammation, accompanying probiotic treatment was associated with a 90 percent reduction in the risk of another hospital instruction."

practice implications

This study is particularly interesting because you examine 2 questions at the same time: 1) Are probiotics helpful in reducing hospital admissions due to mania? and 2) If so, does the mechanism have anything to do with inflammation?

The answer to the first question was - in this study additional probiotic treatment for 24 weeks after hospitalization due to mania de reduction of the risk and the length of length of a rehospitalization for mania. It is an apparently uncomplicated result that could possibly change the treatment standard for bipolar disorders, schizo -affective disorders and other diseases. Even if the hospital protocol does not change, outpatient doctors can use the results of this study to start long -term probiotic treatment for patients with mania in history.

patients in the probiotic group were less in the hospital, but were they symptomatic better?

The answer to the second question - is the benefits achieved by reducing inflammation? - is less clear. No data on the final inflammatory values ​​or their changes were published, nor has there been a discussion about the significance between the two groups. Only 1 comment mentioned that people with higher levels of inflammation had a lower risk relationship in connection with another hospital admission - which may mean that the protective effect of probiotics in patients with stronger inflammation was stronger. Although encouraging and in accordance with the studies cited in the introduction of the paper, it would be helpful to concretize this hypothesis a little more. Clinicers do not normally rate inflammation with special tests, such as B. the IgG and IGM markers for various pathogens used in this study. They rely more on the C reactive protein (CRP) and the erythrocytensediment rate (ESR) in combination with physical symptoms to assess or appreciate the systemic level of inflammation.

Note that the probiotics used in the study are dosed quite low with 100 million KBE. Usually used probiotics in naturopathy are 10 to 25 billion KBE per dose, and some intensive probiotics contain over 150 billion KBE per dose.

Finally, there is little attention to the fact that the results differ at no point between the probiotic and the placebo group at a psychiatric level. Patients in the probiotic group were less in the hospital, but were they symptomatic better? We assume that the hospital stay was the primary result of the study because it speaks the language of the medical establishment: money. A hospital stay in psychiatry is very expensive, and the costs are often even higher than the hospitals, whereby a 5.5-day hospital stay to treat a bipolar disorder in the United States costs $ 4,356 for 9.4 days). If the treatment of 66 people saves the hospital stay in this study (275 minus 93 days), that saves almost . That is about $ 4,400 per patient in the 33-member probiotic group.

For those of us who treat patients outpatient, the financial figures are less important than knowing that something as simple as probiotics could save the patient the great living interruption caused by hospital stays. Doctors both within and outside of hospitals should consider probiotic treatment due to their low risk profile and their great benefit potential. Continued large studies will be helpful in assessing the symptomatic benefit.