Thursday, October 01, 2009

Can Patient Counseling Lower Adherence?

The abstract of a recently published article, "A systematic review of adverse events in placebo groups of anti-migraine clinical trials", stated:


"We found that the rate of adverse events in the placebo arms of trials with anti-migraine drugs was high. In addition, and most interestingly, the adverse events in the placebo arms corresponded to those of the anti-migraine medication against which the placebo was compared. For example, anorexia and memory difficulties, which are typical adverse events of anticonvulsants, were present only in the placebo arm of these trials. These results suggest that the adverse events in placebo arms of clinical trials of anti-migraine medications depend on the adverse events of the active medication against which the placebo is compared. These findings are in accordance with the expectation theory of placebo and nocebo effects."

Could counseling on all common side effects lower adherence by increasing the incidence of adverse events?  I could not find any research on this subject.  Therefore,  I likely would draw the line, as I actually did in the USP-DI side effects listing below, at reviewing the adverse events that require medical attention.  I am not sure whether I would want to exclude information from the printed counseling materials.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Most side effects of sumatriptan are milder and occur less often with thetablets than with the injection. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
    Stop using this medicineand check with your doctor immediately if any of the following side effectsoccur:
      Rare
        Chest pain (severe); changes in skincolor on face; convulsions (seizures); fast or irregular breathing; puffinessor swelling of eyelids, area around the eyes, face, or lips; shortness of breath, troubled breathing, or wheezing
    Check with your doctor right away if any of the following side effects continuefor more than 1 hour. Even if they go away in less than 1 hour, check with your doctor before using any more sumatriptan ifany of the following side effects occur:
      Less common
        Chest pain (mild); heaviness, tightness,or pressure in chest and/or neck
    Also check with your doctor as soon as possibleif any of the following side effects occur:
      Less common
        Difficulty in swallowing; pounding heartbeat; skin rash, hives, itching, or bumps on skin

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Other side effects may occur that usually do not need medical attention.Some of the following effects, such as nausea, vomiting, drowsiness, dizziness,and general feeling of illness or tiredness, often occur during or after amigraine, even when sumatriptan has not been used. Most of the side effectscaused by sumatriptan go away within a short time (less than 1 hour afteran injection or 2 hours after a tablet). However, check with your doctor ifany of the following side effects continue or are bothersome:
    More common
      Burning, discharge, pain, and/or soreness in the nose; burning, pain, or redness at place of injection; change in sense of taste; discomfortin jaw, mouth, tongue, throat, nose, or sinuses; dizziness; drowsiness; feeling of burning, warmth, heat, numbness, tightness, or tingling; feeling cold, ?strange,? or weak; flushing; lightheadedness; muscle aches, cramps, or stiffness; nausea or vomiting
    Less common or rare
      Anxiety; general feeling of illnessor tiredness; vision changes
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

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