Donald Moss, Ph.D., President, Association for Applied Psychophysiology and Biofeedback

Frank Andrasik, Ph.D., Senior Research Scientist, Institute for Human and Machine Cognition, University of West Florida, Pensacola

Angele McGrady, Ph.D., Professor, Dept of Psychiatry, and Director, Complementary Medicine Center, Medical College of Ohio

John D. Perry, Ph.D., M.Div., Psychologist (ret.), Webmaster, InContiNet.com

Steven M. Baskin, PhD, Director, New England Institute for Behavioral Medicine, Stamford, Connecticut

Reuters Health Network distributed a press release on May 8, 2001, based on research by William J. Mullally, stating that biofeedback is not an effective treatment for migraine and tension-type headaches in adults because it did not improve on results obtained by other standard treatments.

The Mullally Study. In some respects, Mullally’s report does not warrant a response. No research report was ever published, except as a presentation at the American Academy of Neurology meeting on May 8, 2001. A full methodological analysis of his study is not possible, because he has declined to provide a full description of his methodology and results to support his conference abstract.

According to Reuters Health, Mullally’s subjects had been referred to a 6-week day-treatment program, which emphasized training in pain management. Pain management methods included instruction in relaxation, meditation, self-hypnosis, cognitive therapy, and art and movement therapy with a pain clinician. Then 33 randomly selected graduates were given ten weekly 50-minute EMG and thermal biofeedback sessions. According to Reuters, all patients showed statistically significant improvement, and the biofeedback-treated patients did not show any better rate of improvement than the others.

Without actual outcome data, it is impossible to determine exactly what happened in the Mullally study. There are two possible explanations for the lack of group differences. It may be that all patients were cured or nearly cured of their symptoms by the six-week program, which already included most of the recognized effective treatments for headache, so that there would not be anything significant to add with biofeedback training. Alternatively, it may be that the ten weekly biofeedback sessions were not of sufficient quality to produce any improvement. We note, for instance, that there is no assertion that the biofeedback trainer was qualified or certified in Biofeedback – only that the trainer was "a psychologist." But under the ethics code of the American Psychological Association, additional special training is required in order to practice in a specialty. Without added details, we cannot draw any conclusions from the Mullally study.

Unwarranted Influence. Nevertheless Mullally continues to influence opinion in health care by interview reports in such publications as CNS News, an online journal (Bowser, 2001). In the CNS News article, Mullally is quoted as saying that biofeedback "is an extremely costly and time consuming treatment" that offers no benefits for migraine and tension headache. The statements about biofeedback clearly are unfounded based on the limited nature and specialized population of subjects in Mullally’s study, and the abundance of contrary evidence. The Mullally statements about biofeedback and headache were based on an interim report on one investigation that apparently included intractable chronic headache patients in an intensive treatment program. The Reuters press release gave the findings an undeserved credibility, and we continue to hear that various physicians groups and other audiences are still reporting the Mullally findings. Therefore the Biofeedback Newsmagazine is providing an opportunity for a rebuttal of Mullally’s conclusions.

The Human and Economic Costs of Headache. Headaches take a tremendous toll in human suffering, and cost employers millions of dollars each year in absenteeism, disability, and lost productivity. Headaches affect 91 % of males and 96 % of females in the course of their lifetimes. Chronic headaches are challenging to treat, accounting for about 18 million medical visits per year, and many patients continue to suffer in spite of extensive and expensive treatment (McGrady, Andrasik, Davies, et al, 1999).

The Efficacy of Biofeedback for Headache. We believe that Dr. Mullally is wrong, based on an abundance of research studies and clinical reports. Three decades of clinical practice and research have shown repeatedly that biofeedback can be helpful for patients with migraine, tension headache and mixed headache. Several authors have described effective treatment programs, typically including combinations of EMG biofeedback, thermal biofeedback, relaxation training, and cognitive behavioral interventions for tension type and migraine headache (McGrady, Andrasik, Davies, et al., 1999; Degood, Manning, Middaugh, & Davies, 1997; Schwartz, 1995a; Schwartz, 1995b). Patients routinely report reduced intensity or frequency of headache, and some report a complete remission, with a corresponding decrease in medication use.

Many other research investigations have shown clear benefits either from biofeedback alone, or from a combination of biofeedback with other treatments. Several meta-analyses (Blanchard, Andrasik, Ahles, Teders, & O’Keefe, 1980; Blanchard & Andrasik, 1987; Bogaards & ter Kuile, 1994; Haddock, Rowan, Andrasik, Wilson, Talcott, & Stein, 1997; Holroyd & Penzien, 1986, 1990; McCrory et al., 1996) and even more research reviews summarize the positive outcomes available for both tension and migraine headache. An NIH panel on the efficacy of behavioral and relaxation therapies for chronic pain found that EMG biofeedback was more effective than psychological placebo and equally effective to relaxation therapies for tension headache (NIH Technology Assessment Panel, 1996). McGrady, Andrasik, Davies et al (1999) refer to over 100 empirical studies judging the efficacy of biofeedback and behavioral therapies for headache. Their review finds approximately a 50 % reduction in head pain following biofeedback/relaxation therapy and stress management training.

The National Headache Foundation has published Standards of Care for Headache Diagnosis and Treatment, which state that "biofeedback has been shown to be an excellent treatment in the long term management of migraine and tension-type headache disorders (NHF, 1999, p. 17)." The Agency for Health Care Policy and Research commissioned a meta-analysis of the available reports on behavioral interventions for migraine. Thermal biofeedback, relaxation therapy, and cognitive-behavioral therapies were found to be at least moderately effective for migraine, by comparison to waiting-list controls (Goslin, Gray, McCrory, et al, 1999). Another meta-analysis showed moderate effectiveness for EMG biofeedback, relaxation therapy, and cognitive-behavioral therapy in alleviating tension-type headache (McCrory, Penzien, Rains, et al, 1996). The meta-analysis by Holroyd and Penzien (1990) showed biofeedback/relaxation to be identical in effectiveness to propranolol, to date the most researched prophylaxis for migraine. Both of these treatments in turn significantly surpassed placebo and no treatment.

Qualitative Advantages of Biofeedback Treatment. Biofeedback also has particular advantages over most medical treatments for headaches. Not only can it produce long-term remission of symptoms, but it does so without side effects. On the contrary, common side effects of medical treatments of headache include weight gain, sedation, and impaired concentration, and headache medications frequently lose their effectiveness over time. There is even preliminary evidence to suggest that successful treatment with biofeedback and relaxation can result in substantial cost savings (Blanchard, Jaccard, Andrasik, Guarnieri, & Jurish, 1985).

Conclusion: Biofeedback Can Help Headache Sufferers. Clinical experience and research show that headaches remain a challenge for the physician and the patient. Many patients continue to suffer daily severe pain, in spite of heroic treatment regimens. Health care cannot afford to dismiss any intervention that benefits large groups of patients with "modest" improvement, and occasional patients with dramatic improvements. It is irresponsible for Dr. Mullally to dismiss biofeedback overall, simply because one study of patients in an intensive headache program failed to show added benefit. It would be more responsible to limit one's conclusions to the conditions of this specific study. Mullally's study apparently showed that severe headache patients, who have already had a wide variety of interventions in an intensive six-week program, showed no benefit from the addition of biofeedback to their program.

Null results from Mullally's one small study do not negate the large quantity of other clinical and experimental research showing that biofeedback can effectively help many patients suffering from headache. For many patients, with mild to severe tension or migraine headache, biofeedback remains a valuable and risk-free approach to treatment.

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Blanchard, E.B., Jaccard, J., Andrasik, F., Guarnieri, P., & Jurish, S.E. (1985). Reduction in headache patients' medical expenses associated with biofeedback and relaxation treatments. Biofeedback and Self-Regulation, 10, 63-68.

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Bowser, A. (2001, August). Study shows biofeedback ineffective as headache treatment. CNS News, Online, 3 (8), 31-47.

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Haddock, C.K., Rowan, A.B., Andrasik, F., Wilson, P.G., Talcott, G.W., & Stein, R.J. (1997). Home-based behavioral treatments for chronic benign headache: A meta-analysis of controlled trials. Cephalalgia, 17, 113-118.

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