In Defense of Butalbitalh

Lawrence Robbins, MD

Disclosures

Headache. 2012;52(8):1323-1324. 

Abstract and Introduction

Introduction

The article on butalbital-containing medicines (BCMs) by Tfelt-Hansen and Diener[1] accurately summarizes the literature. They appropriately call for a limit on BCM. However, the authors oversimplify an important and complex topic. There are significant advantages to BCM that should also be acknowledged.

Why use BCM? We use BCM partly because our alternatives often fall short. Triptans and dihydroergotamine do not work for many patients, may not be appropriate for others, or may be limited because of finances and insurance. Many patients take their triptan, and later, they also utilize an analgesic, such as a BCM. Ergots are rarely appropriate. Non-steroidal anti-inflammatory drugs and aspirin are only mildly effective and have significant side effects, particularly with advancing age. Over-the-counter combinations (usually containing caffeine) are only modestly effective. They may cause medication overuse headache (MOH) and may cause other adverse effects. Isometheptene-containing compounds have limited efficacy, may not be well tolerated, and often are unavailable. Opioids create the same problems as BCM, with overuse, addiction, and adverse effects being commonplace.

To minimize the use of BCM (and other abortives), preventives are utilized. However, the available preventives often fail over the long-term.[2] Previously, I evaluated preventives in 540 chronic headache patients over a 6-month time period. Only 46% of patients remained on any preventive for at least 6 months. Fifty-four percent of patients dropped off of the preventives because of declining efficacy and/or adverse reactions.[3]

The use of onabotulinumtoxinA (Botox) has improved our success with preventives. Many patients, however, cannot afford the injections or find that the Botox is ineffective. Even those who do find some success with preventives still require abortive medications, such as BCM.

The positive attributes of BCM include: (1) reasonable efficacy (primarily anecdotal); (2) low cost; (3) minimal cardiac and other side effects (except for sedation); (4) relatively few drug interactions, they may be used with most other abortives, such as triptans; (5) Reasonably well tolerated at older age ranges; (6) versatility, available with acetaminophen or aspirin, with or without caffeine, and with or without codeine; (7) BCM may alleviate both migraine and tension-type headaches; (8) anti-anxiety effects (though we would not specifically prescribe BCM to treat anxiety or moods); (9) BCM will produce a mild euphoria or act as a mood enhancer in some individuals; while this is not our intent on prescribing BCM, in certain patients, this is not an undesirable side effect, improving quality of life (QoL); (10) in some patients, BCM will alleviate certain other painful conditions, such as fibromyalgia, neck or back pain, or arthritis; while we would not specifically prescribe BCM for those conditions, the relief of other painful conditions may enhance QoL; and (11) refractory headache patients usually require analgesics, and BCMs are one of our available choices.[4]

The downsides of BCM include the milder side effects (such as fatigue), the tendency of these drugs to contribute to MOH, and most importantly, the risk of addiction. Medication overuse (MO) is common among those with chronic migraine, but MO does not always lead to MOH. BCM, along with opioids and high caffeine-containing analgesics, are more likely to cause MOH than most abortives, such as triptans. Dependence upon BCM is occasionally encountered, with the dose remaining stable for months or years. Dependence may be justified in some patients with chronic pain. True addiction also occurs with the use of BCM, where patients cross the line into a set of addictive behaviors. Addiction and MOH are the 2 serious consequences from the use of BCM.

A previous study described 10 trials of BCM, but none was a well-done, randomized, controlled trial (RCT).[5] A recent RCT was fairly negative for BCM.[6] The lack of RCTs for BCM reflects the era during which they were introduced. The paucity of trial evidence does not mean that BCM are not efficacious. We rely on anecdotal evidence for many of our older therapies. Although funding could be difficult, as these drugs are generic, it would be worthwhile to pursue at least one additional well-done RCT of BCM.

To minimize the risks of BCM, patient selection is crucial. I have found that the highest risk lies with those who have certain personality disorders, along with patients who previously overused addicting medications.[7] Patients with severe anxiety and/or depression may also be at risk for overuse. Reasonable limits on BCM might be: use restricted to 2 days per week and a limit of 20 tablets per month. There are outliers who do very well on 30–60 tablets of BCM per month, without MOH or addiction.

In an ideal world, BCM would not be necessary: preventive approaches would work well for a high percentage of patients, and our abortives would be headache-specific, non-addicting, and safe for all ages. We are a long way away from this ideal situation. If we eliminate BCM, many patients are left without effective options. We would not have BCM-mediated MOH, but many of these patients would subsequently overuse opioids, along with other analgesics. BCM have well-known downsides, but they also provide significant benefits.

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