Clinical Briefs-By Louis Kuritzky, MD
Clinical Briefs-By Louis Kuritzky, MD
Smoking Cessation in Patients with Chronic Obstructive Pulmonary Disease
Smoking cessation for patients with COPD is the most important single step for reducing risk of disease progression. Although there are numerous reports of smoking cessation that use a variety of tools and techniques, none has specifically addressed the efficacy of buproprion SR (BUP) for patients with existing COPD. This report provides specific focus on a population (n = 404) of mild-to-moderate COPD patients treated with traditional dosing BUP in a placebo-controlled trial for 12 weeks. In addition to BUP (or placebo), all participants received counseling about smoking cessation.
The most common adverse drug effects were insomnia, headache, anxiety, and dry mouth. The discontinuation rate for BUP was not different from placebo, and there were no serious adverse events.
At 7 weeks, 28% of subjects remained smoking abstinent (placebo = 16%). This number decreased to 16% (placebo = 9%) 14 weeks after cessation of pharmacotherapy.
Though these rates are a bit less than those demonstrated in some previous trials, the potential for success in even a small subgroup of COPD patients has important individual and public health implications. v
Tashkin D, et al. Lancet. 2001;357: 1571-1575.
Is the Placebo Powerless?
The word placebo in medical usage is derived from the Latin word which means "to please." The intent of current parlance is that a placebo is any concrete intervention that possesses no demonstrable inherent therapeutic effect. Hence, any effect occurring in placebo recipients, favorable or untoward, is attributed to other secondary effects, such as the personal belief system of the patient, positive thinking, etc. Your reviewer prefers to think of placebo as the channel of forces that can be marshaled (for positive or negative outcomes) in persons given appropriate stimuli. For instance, mothers confronted with their child trapped beneath a heavy vehicle call upon untapped strength to free their child, yet when strength-tested under less stimulating situations, are unable to repeat such acts.
Quantification of the effect of placebo has perhaps been overestimated, since most trials compare placebo with an active therapy. During such a trial, regression to the mean and natural history of the disease over time might be misinterpreted as favorable placebo effects. Hence, the best comparison trial for placebo effect would be placebo vs. no treatment. To this end, Hrobjartsson and Gotzsche performed a meta-analysis on 114 trials (n = 3795).
Hrobjartsson and Gotzsche comment that there were no significant placebo effects on objective outcomes. Subjective outcomes and pain demonstrated some small possible benefit, but since their review also shows that increasing sample size was associated with lesser magnitude of effect, the possibility of bias related to trial size is evident. Hrobjartsson and Gotzsche posit, based upon this review, that use of placebos is unjustified outside the setting of clinical trials.
Hrobjartsson A, Gotzsche PC. N Engl J Med. 2001;344:1594-1602.
Understanding the Experience of Pain in Terminally Ill Patients
At least 20% of terminal patients experience moderate to severe pain, and the proportion may be as high as 75%, specifically among seriously ill cancer patients. Because of concerns about the veracity of data referable to pain in terminally ill patients, Weiss and colleagues surveyed by personal interview almost 1000 terminally ill patients. The line of inquiry was specifically: 1) In the past 4 weeks, did you desire more pain medicine than you received from your PCP/pain specialist? 2) Why did you not want more?
Half of these patients reported moderate-to-severe pain in the previous 4 weeks, the majority of whom had seen their PCP during this period. Most PCP patients (62%) were satisfied with their level of analgesia, but almost one-third did desire increased analgesia, and 9% wanted a decrease or cessation of analgesia.
Patients who did not desire more analgesia mentioned fear of addiction, adverse drug effects, and desire to avoid medication as their rationale.
Since the demographics of this report include a diversity of US communities and ethnicities, it may well be representative of clinical practice in a variety of settings. It is encouraging that the background level of moderate-severe pain in this group is not as high as previously described in some studies, yet the 30% of individuals reporting a desire for increased analgesia highlights the need for continued vigilance to analgesic adequacy.
Weiss SC, et al. Lancet. 2001;357: 1311-1315.
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