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Imipramine versus placebo for multiple functional somatic syndromes

Discussion in 'Other Health News and Research' started by Murph, Apr 15, 2017.

  1. Murph

    Murph :)

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    Imipramine versus placebo for multiple functional somatic syndromes (STreSS-3): a double-blind, randomised study.

    https://www.ncbi.nlm.nih.gov/pubmed/28408193

    Abstract
    BACKGROUND:
    Functional somatic syndromes, including chronic fatigue syndrome or irritable bowel syndrome, often co-exist. Treatment guidelines supported by high quality evidence exist for most functional somatic syndromes, but are lacking for multiple comorbid functional somatic syndromes. We aimed to assess the effect of the tricyclic antidepressant, imipramine, in patients with multiple functional somatic syndromes defined by the criteria for multiorgan bodily distress syndrome, a unifying diagnosis that encompasses most functional somatic syndromes and somatoform disorders.

    METHODS:
    In this single-centre, double-blind, randomised trial done in a Danish university hospital setting, participants were patients consecutively referred (age 20-50 years) fulfilling criteria for multiorgan bodily distress syndrome with no concurrent comorbid depression or anxiety disorder. Participants were randomly assigned (1:1) to receive either 10 weeks of low-dose imipramine or placebo (oral daily doses of 25-75 mg). The hospital pharmacy handled randomisation (computer-generated) and masking, providing sequentially numbered packs of study drug that were given serially to the participants.

    All others involved were masked to allocation. Primary outcome was patient-rated overall health improvement on a 5-point clinical global improvement scale. Improvement was defined as patients responding "better" or "much better" as opposed to "unchanged" and "worse" or "much worse" when rating their overall health status after 10 weeks of minimum 25 mg study drug. Analyses included patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT01518634.

    FINDINGS:
    Between Jan 30, 2012, and Nov 24, 2014, 138 patients were randomly assigned; 70 to receive imipramine and 68 to receive placebo. The study was completed on May 1, 2015. 125 patients received at least one dose of study drug: 65 received imipramine and 60 received placebo. Treatment was terminated prematurely for eight (12%) patients receiving imipramine and seven (12%) patients receiving placebo. Data were missing for two (3%) patients receiving imipramine and three (5%) patients receiving placebo. Of the 120 patients (96%) who provided primary outcome data, 33 (53%) receiving imipramine reported their overall health status as "better" or "much better" compared with 14 patients (25%) receiving placebo.

    The improvement after imipramine was significantly greater than after placebo (odds ratio 3·3 [95% CI 1·6-6·8]; p=0·001). Number needed to treat was 3·6 (95% CI 2·3-8·9). Analysis of the worst-case scenario for patients with missing outcome did not change the interpretation of the results. 32 patients (49%) receiving imipramine and 10 patients (17%) receiving placebo had at least one adverse event of moderate intensity (p=0·0001); eight patients (12%) receiving imipramine and three patients (5%) receiving placebo had at least one adverse event of severe intensity (p=0·1496). One patient (1%) receiving placebo experienced a serious adverse event (a subdural haematoma sustained after an accident). Adverse events caused dropout in four patients (6%) receiving imipramine and three patients (5%) receiving placebo.

    INTERPRETATION:
    Imipramine treatment compared with placebo significantly improved overall health in patients with multiple functional somatic syndromes when both treatments were supported by regular contacts with clinicians. Adverse events were more common in the imipramine group, but only rarely led to discontinuation of treatment.

    nb. According to this Fink, CFS is included in "bodily distress syndrome."
     
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  2. halcyon

    halcyon Senior Member

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    So..doesn't that basically prove that people meeting the bodily distress syndrome criteria have an organic illness? If they were truly functional somatic syndromes, shouldn't the placebo group have improved as well?
     
  3. trishrhymes

    trishrhymes Save PR. Sack the President of the Board.

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    Since a low dose of tricyclics (eg amitriptiline) is a common, well established symptomatic treatment for pain and sleep problems in all sorts of conditions, surely all they were showing was that it helps symptomatic relief in some ME and IBS patients too.

    Given the fluctuating nature of ME and IBS, it's not surprising that 25% of the placebo group were 'improved' at the end of trial.

    Despite being properly double blinded etc, this trial seems pretty poor to me - small numbers of patients, including patients in the results who had taken 'at least one dose' of their allocated medication, and quite a high rate of adverse events, and no mention of numbers who got worse or used other treatments at the same time.

    I have only read the abstract, so don't have full information on how they measured improvement. Just using a global 'are you feeling better' kind of measure seems very crude and limited. Why not detailed assessment of actual IBS symptoms, and actometer etc. for ME symptoms? Ah, but I was forgetting - these are people classing us as having functional somatic sydromes, not real illnesses.
     
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  4. TiredSam

    TiredSam The wise nematode hibernates

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    This is beyond satire. A double-blind, randomised study is for studying things that actually exist. Trumpeting the method to lend credibility to a delusional belief system (multiple functional somatic syndromes) is laughable. How about "Garlic versus wooden stakes for monstrous blood-sucking syndrome: a double-blind, randomised vampirical study."
     
    Last edited: Apr 15, 2017
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  5. Effi

    Effi Senior Member

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  6. Dolphin

    Dolphin Senior Member

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    They mention the lack of objective measures in the limitations section:
    I think it is less of an issue in a double-blind trial like this.
     
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  7. Dolphin

    Dolphin Senior Member

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    They do give the percentage of who reported themselves worse in the full text:
     
  8. Dolphin

    Dolphin Senior Member

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    I thought it was interesting that 0% in the placebo group reported being "much better".

    23% in the placebo group did report being better, some of which could be due to biased reporting due to placebo and some might be due to random fluctuations of their illness.
     
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  9. Dolphin

    Dolphin Senior Member

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    It would have been interesting to have the magnitude of the improvements for the secondary outcomes. We are just given the odds ratios compared to the placebo group.
     
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  10. Dolphin

    Dolphin Senior Member

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  11. Dolphin

    Dolphin Senior Member

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  12. Dolphin

    Dolphin Senior Member

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    I thought the table with the specific adverse events was interesting as it showed that the drug did tend to cause more adverse events in a number of different domains/symptom areas.
     
    Last edited: Apr 24, 2017
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  13. Dolphin

    Dolphin Senior Member

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    Apart from the comments above, I don't have major criticisms of the trial.

    A related tricyclic drug, trimipramine (Surmontil, Rhotrimine, Stangyl) has helped me with sleep and pain though my overall functioning remains low.
     
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  14. Dolphin

    Dolphin Senior Member

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