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Ajs17111 98.10

Pharmacological Approaches to StutteringTreatment: Reply to Meline and Harn (2008) Purpose: To address questions raised by T. Meline and W. E.
used in our review, however, Maguire et al.’s results met Harn (2008) in their critique of our previous article (A. K.
neither of our two outcomes criteria (stuttering, disfluency, Bothe, J. H. Davidow, R. E. Bramlett, D. M. Franic, & R. J.
or any such measure below 5%, or documented improvement in any nonspeech variable) at either of the two times we Method: Additional information is provided to address several assessed (immediately posttreatment and 6 months post- treatment). Maguire et al.’s results also did not meet our Results and Conclusions: Our previous systematic reviewomitted 1 relevant article about the use of olanzapine in secondary outcome criterion of a 50% reduction in stuttering stuttering, but the minimal effectiveness and the known (or any such variable), which we assessed in case the serious side effects of this drug limit the implications of this absolute 5% criterion could be viewed as too stringent.
omission. While we do not agree with many of Meline and Meline and Harn questioned whether Maguire et al.’s Harn’s critiques of our review, we do agree with them that results might nevertheless be interpreted as positive. They several larger points raise interesting questions about the mentioned the quality of life literature in this context, writing structure, analysis, and usefulness of literature reviews in that “a standardized effect size of 0.50 (half a standard de- stuttering and in other areas. Fundamentally, we reassert our viation) is equivalent to increasing the success rate from agreement with Meline and Harn that there is insufficient 25% to 75%” (p. 95). Equating standard deviations of evidence to support the use of existing pharmacological test scores and effect sizes is problematic, however; the agents in the treatment of stuttering.
intended meaning within the quality of life literature was Key Words: stuttering, olanzapine, systematic review that 0.5 SD represents a change of 8% of the quality of lifescale (Sloan, Symonds, Vargas-Chanes, & Fridley, 2003).
Overall, in addressing our choice of outcomes criteria,Meline and Harn suggested that some improvements canbe important even if they do not represent a completecure, and of course we agree. The point of our review, Meline and Harn (2008) raised several interesting however,wasnottoidentifyalltreatmentsthatmight issues about pharmacological treatments for stut- represent some improvement to someone, but to identify tering, about our recent review of the literature those treatments that met one set of reasonable, objective, in this area (Bothe, Davidow, Bramlett, Franic, & Ingham, and actually rather lenient outcomes criteria.
2006), and about reviews of the literature in general. We It is also important to note that Maguire et al. (2004, p. 66) are pleased to have this opportunity to respond to, and described olanzapine as “well-tolerated.” Meline and Harn, similarly, quoted both a well-known stuttering textbook(Guitar, 2006) and a new chapter from a book on stuttering Olanzapine in the Treatment of Stuttering (Ludlow, 2006) as suggesting that side effects are not prob-lematic for olanzapine, “indicating that further research Among the most straightforward of Meline and Harn’s would be warranted” (Ludlow, 2006, p. 248; Meline & Harn, points is their first: that our review did not include or refer 2008, p. 93). The known side effects of olanzapine are to Maguire et al.’s (2004) double-blind, placebo-controlled trial serious and numerous, however, even if they have not of the use of olanzapine for developmental stuttering. In the been reported in the relatively small studies of its use for terms used in our review, Maguire et al.’s study met three out stuttering. It is critical for readers to be aware, for example, of five methodological criteria (random assignment to groups, that a “Dear Doctor” letter about olanzapine (marketed pretreatment and posttreatment data, and reliability data, but by Eli Lilly as Zyprexa) was released on March 1, 2004.
no speech rate or speech naturalness data and no beyond- “Dear Doctor” letters are typically required by the U.S. Food clinic data). It should have been included in our review as and Drug Administration to be forwarded to physicians by a relatively well-designed study and discussed in more detail manufacturers if there have been problems with a product.
in our article. Our only response to Meline and Harn on this In this case, it was noted that “hyperglycemia, in some cases point is simply to agree that we missed it (and, indeed, to extreme and associated with ketoacidosis or hyperosmolar wonder with them how we could possibly have missed it).
coma or death” (U.S. Food and Drug Administration, 2004, More interesting than this study’s absence, however, para. 2) had been reported as associated with use of Zyprexa are its implications. Maguire et al. (2004) concluded that (olanzapine). More recently, a New York Times article (“Lilly olanzapine was “statistically superior to placebo” (p. 65) Settles,” 2007) reported that the company has now settled for three different dependent variables and described it as lawsuits involving 18,000 individuals who claimed they had “useful” (p. 66) in the treatment of stuttering. In the terms “developed diabetes or other disorders after taking Zyprexa” American Journal of Speech-Language Pathology • Vol. 17 • 98–101 • February 2008 • A American Speech-Language-Hearing Association ( p. C1). This means that, along with earlier settlements, at 1970 because we wanted to address stuttering treatments least 28,500 individuals have received compensation from developed since the introduction of prolonged speech; we the manufacturer for claims that they were injured by searched certain journals and used the key words we selected because they seemed a relevant and comprehensive subset Such issues are obviously serious and raise questions in (and we note that Meline and Harn suggested only the one our minds about describing this agent as “well tolerated.” article that we missed, an omission that was a human error, While there may yet be situations in which olanzapine could not a flaw in our selection of databases or a problem that be used, its known side effects must be considered in any would have been solved by more databases); and we chose, calls for “further research.” We might suggest that any given the structure of our project and after consultation with further research of its use in stuttering must, at a minimum, the editors during the review process, to make the larger include repeated fasting and postprandial blood glucose list of all the articles we had consulted available to interested testing; the blood testing reported by Maguire et al. was readers upon request rather than taking the journal space insufficient for an agent known to have hyperglycemic side to publish them. Meline and Harn are correct in noting that effects (Cavalot et al., 2006; Kendall, 2005; Liebl, 2003).
we did not describe in detail the process through which we In addition, because this agent is an antipsychotic drug, removed inappropriate articles (e.g., those that were about further information is needed regarding its cognitive impact pharmacological agents that caused stuttering-like speech) in nonschizophrenic patients before it could reasonably from the initial pool retrieved by our searches; that task, like be recommended as a treatment for stuttering.
the others in our project, was completed by multiple readers.
Meline and Harn also commented on the fact that our review included only published articles. They are correct in noting that some definitions of systematic reviews emphasizethe importance of including unpublished material, but there is by no means universal agreement about this point. One The bulk of Meline and Harn’s letter proceeded to critique important reason to seek unpublished literature is because of an the Bothe, Davidow, Bramlett, Franic, and Ingham (2006) accepted general tendency for positive results to be published article in several larger senses, or to review our review. Their and for negative results not to be. Drawing the conclusion efforts in this area raise several interesting issues.
from published literature that a treatment is effective may be Previous summaries. Meline and Harn noted, to begin problematic, therefore, if there is important information to the with, that the review’s conclusions were more negative than contrary in unpublished sources. This problem did not occur for the conclusions reached in some previous reviews of related the Bothe et al. review, given our conclusion of the relative literature. As they also noted, we did address this question ineffectiveness of the pharmacological agents.
in our original article, which also discussed part of the an- Several other lines of reasoning also suggest an emphasis swer: It has become relatively well established that more on published literature; it is available to all readers, for ex- stringently conducted clinical research often leads to more ample, and it has already passed the test of peer review. The negative results than those obtained in smaller or less con- decision to concentrate on published literature also draws trolled studies. Because our review incorporated trial quality an objective line that avoids the complex problems inherent assessment, and based its results on those articles that met in deciding which unpublished literature to include and which a trial quality criterion, its conclusions could be predicted to to exclude, because as reasonable as the inclusion of some be more negative than the conclusions reached in less selec- unpublished information might be, the decision to include all tive reviews. We also must point out that our conclusions unpublished information about a given topic will usually did not differ from all previous conclusions. Meline and be unreasonable. Biddle, Watson, Hooper, Lohr, and Sutton Harn quoted Ingham’s (1984, p. 413) suggestion, for ex- (2002), as one example, in a relevant recent review, initially ample, that some pharmacological agents “are undoubtedly concentrated on published peer-reviewed information only, reliable I for reducing state anxiety.” That particular quote but then made the decision to include published but not peer- was less relevant to the issues at hand, however, than the reviewed test manuals as another source of information for same chapter’s succinct and quite negative summary a few some specific reasons. While other lines can be defensible pages later: “For the present, it is safe to conclude there is and could certainly serve legitimate purposes, in summary, it little evidence that stuttering can be usefully treated by drug is not an error to draw a line between published peer-reviewed therapy” (Ingham, 1984, p. 424). In fact, if we have learned research and other types of information.
anything from the drug treatments of stuttering, especially Outcome criteria. Meline and Harn discussed the pos- investigations into the efficacy of anxiolytic drugs, it must sibility that our use of a 5% criterion “biased” the con- be that stuttering is neither inextricably nor functionally clusions drawn because it is an “imprecise measure of related to anxiety. There is simply no evidence that an- treatment success or failure” (p. 94). While we certainly xiolytics have helped to eliminate or reduce stuttering.
agree wholeheartedly with the latter, we do not believe Search strategies, inclusion criteria, and references.
that selecting a binary outcome criterion, or using speech Meline and Harn also raised some specific questions about outcomes as one of two types of outcome criteria in a review the databases and search strategies we had used, and they of stuttering treatment, creates “bias” in a review. Quite questioned the information we provided about the articles the opposite: Such a method provides an objective (i.e., selected for review. The answer to most of their questions is specifiable and repeatable) method through which a set of simply that one must draw a line somewhere: We selected articles can be divided into those that meet a relevant outcome criterion and those that do not. There are other sets of criteria (see Bothe, Davidow, Bramlett, & Ingham, ways to create reviews of the literature, but such methods as meta-analysis (combining results mathematically) or cal- Meline and Harn, in a parallel fashion, sought to deter- culation of effect sizes (as Meline and Harn discussed) mine whether our review had been done “well enough.” impose multiple restrictions on the articles that can be in- Their efforts to define “well enough” led them to Oxman and cluded (because of the need for individual data or variability Guyatt’s (1988, p. 698, Table I) “guidelines for assessing data) in a manner that we believed to be too restrictive for our research reviews” and to Oxman et al.’s (1991, p. 92, Table 1) purposes in reviewing stuttering treatment research.
and Oxman and Guyatt’s (1991, p. 1272, Table 1) related It is also important to note that Meline and Harn (2008, “criteria for assessing the scientific quality of research p. 94) summarized our review as having required “the overviews.” Their abstract stated that they had adopted frequency of ‘stuttering’ to be reduced to 5% or less.” “A. D. Oxman and G. H. Guyatt’s (1998) guidelines I and This summary is misleading. We used a 5% criterion for A. D. Oxman and G. H. Guyatt’s (1991) criteria” for their any measure of disfluency, nonfluency, stuttering, or any review of our article. The structure of their letter was not reported variable; we investigated the alternative possibility based on Oxman and Guyatt’s lists, however; instead, Meline that any such measure had been reduced by half if the and Harn seem to have structured their letter around a Web absolute 5% criterion were not met; we identified all studies site (Davies & Crombie, undated, cited by Meline & Harn where pretreatment values had been below 5% to assess at their p. 94) and around a previous Meline (2006) article.
them separately; and we also looked for any documented Their intent, as described in their abstract, to use a “7-point pretreatment to posttreatment change in any social, emotional, scale from extensive flaws on the high end to minimal flaws or cognitive variable. We certainly agree with Kazdin’s (2001, on the low end” (Meline & Harn, 2008, p. 93) also does p. 461) warning, quoted by Meline and Harn in this con- not seem to appear explicitly in their letter, nor does such a text, that “we cannot merely decide a criterion as a cutoff and scale appear anywhere in the Oxman and Guyatt (1988, assume those who have made the cutoff have improved.” 1991) or Oxman et al. (1991) articles.
Kazdin’s (2001) point is not that no criterion or cutoff should The structure of their letter thus leads to some interesting ever be used, however, only that one must also consider observations. First, it is clearly possible to review a set of the impact of treatment on quality of life or patient preferences studies, or to review a review, using more than one set of as well. In stuttering, one of the many possible variables criteria, and identifying or establishing those criteria is not that must be assessed in comparing treatment options is necessarily straightforward. It is also possible, even given whether they tend to result in improved speech; our review the same criteria, to reach different conclusions. As an did this. It is also reasonable to address other variables, example, we must respectfully disagree with Meline and and our review did that as well (as has some of our other Harn’s (2008, p. 94) conclusion that our review “lacked work; see Bramlett, Bothe, & Franic, 2006; Franic & Bothe, transparency” in a way that created “major flaws.” We specified the publication years, publication language, search Sample size, external validity, and confounding variables.
strategy, and topics covered by our project; we published Finally, Meline and Harn mentioned several problems with references to all the articles that met our methodological many clinical studies that they believed the Bothe et al. re- inclusion criteria, which were the articles our review dis- views should have emphasized. The problems discussed in cussed; we offered to make lists of all the articles we had this section of Meline and Harn’s letter are indeed problems initially reviewed available to interested readers (and we have with many studies. They were not addressed in detail in our in fact since done so); and we described in detail the methods original articles in part for reasons of space and in part because and the results from the multiple reviewers who assessed we sought to use a relatively short list of extremely basic each article using a written data-extraction instrument. That methodological criteria to assess all studies in an objective way.
it would have been possible to select different publicationyears, different publication languages, or different searchstrategies is not a problem of the transparency of our review; it is simply a statement that other authors or researchers couldhave made other equally defensible decisions.
Criteria for the Criteria for the Criteria One problem with assessing a review of a review, how- The most intriguing feature of Meline and Harn’s letter ever, is that these issues are in danger of becoming the old may be that it parallels so closely several of the complex joke represented visually by a person looking at a picture issues we also faced in developing and reporting our sys- of herself looking at a picture of herself looking at a picture tematic review articles. The essential goal of our project, of herself. The present authors enjoy these issues as aca- which was a systematic review with trial quality assessment, demic exercises, and we suspect Meline and Harn do as well.
was to identify those stuttering treatment research articles In the particular case of pharmacological treatments for that had been done “well enough” that we believed they stuttering, we agree with Meline and Harn’s basic conclusion could reasonably serve as a body of literature to be sum- that “the existing evidence for the use of pharmacological marized and potentially acted upon. Because there is no agents with persons who stutter is insufficient to recommend single definition of “well enough,” we turned to multiple them in practice” (p. 95). We cannot agree with some of previous sources and assembled five common methodolog- the other implications in their final paragraph, such as that ical requirements, and we also compared the results from being “acceptable” to clients can be equated with “no un- those criteria with the results obtained using two existing desirable side effects.” Undesirable side effects are common 100 American Journal of Speech-Language Pathology • Vol. 17 • 98–101 • February 2008 and do not contraindicate the use of a drug, as long as the Guitar, B. (2006). Stuttering: An integrated approach to its nature benefits are viewed as outweighing the risks.
and treatment (3rd ed.). Philadelphia: Lippincott, Williams & Such minor differences aside, we appreciate Meline and Harn’s careful reading of our articles. We also appreciate Ingham, R. J. (1984). Stuttering and behavior therapy: Cur- rent status and experimental foundations. San Diego, CA: their help in bringing the problems of olanzapine to light for speech-language pathologists, and we appreciate the Ingham, R. J., & Cordes, A. K. (1997). Self-measurement and opportunity to address the larger issues raised by their ques- evaluating stuttering treatment efficacy. In R. F. Curlee & G. S.
tions. We also suspect that Meline and Harn would agree Siegel (Eds.), Nature and treatment of stuttering: New direc- with us that all of us who have the luxury of expending tions (Rev. ed., pp. 413–437). Boston: Allyn & Bacon.
energy on such exercises as reviewing reviews of reviews Kazdin, A. E. (2001). Almost clinically significant ( p < .10): of reviews also have the responsibility to ensure that our Current measures may only approach clinical significance.
efforts lead, somehow, to improved assessment, treatment, Clinical Psychology: Science and Practice, 8, 455–462.
and management methods for the people living with the Kendall, D. M. (2005). Postprandial blood glucose in the man- disorders we study. We hope that this exchange of letters agement of Type 2 Diabetes: The emerging role of incretinmimetics. Medscape Diabetes & Endocrinology, 7(2), Retrieved might represent some small progress in that direction.
August 30, 2007, from
Liebl, A. (2003). Postprandial blood glucose as the driving force in pathogenesis of type 2 diabetes. Medizinische Klinik, Lilly settles with 18,000 over Zyprexa. (2007, January 7).
Ludlow, C. L. (2006). Neuropharmacology of stuttering: Concepts and current findings. In N. B. Ratner & J. Tetnowski (Eds.), Cur- rent issues in stuttering research and practice ( pp. 239–254).
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Maguire, G. A., Riley, G. D., Franklin, D. L., Maguire, M. E., Nguyen, C. T., & Brojeni, P. H. (2004). Olanzapine in the treatment of developmental stuttering: A double-blind, placebo-controlled trial. Annals of Clinical Psychiatry, 16, 63–67.
Meline, T. (2006). Selecting studies for systematic review: In- clusion and exclusion criteria. Contemporary Issues in Com-munication Science and Disorders, 33, 21–27.
Biddle, A., Watson, L., Hooper, C., Lohr, K. N., & Sutton, Meline, T., & Harn, W. E. (2008). Comments on Bothe, Davidow, S. F. (2002). Criteria for determining disability in speech- Bramlett, Franic, and Ingham (2006). American Journal of language disorders (Evidence Report/Technology Assessment Speech-Language Pathology, 17, 93–97.
No. 52; Prepared by the University of North Carolina Evidence- Oxman, A. D., & Guyatt, G. H. (1988). Guidelines for reading Based Practice Center under Contract No. 290-97-0011; literature reviews. Canadian Medical Association Journal, 138, AHRQ Publication No. 02-E010). Rockville, MD: Agency for Healthcare Research and Quality.
Oxman, A. D., & Guyatt, G. H. (1991). Validation of an index of Bothe, A. K., Davidow, J. H., Bramlett, R. E., Franic, D. M., the quality of review articles. Journal of Clinical Epidemiology, & Ingham, R. J. (2006). Stuttering treatment research 1970–2005: II. Systematic review incorporating trial quality Oxman, A. D., Guyatt, G. H., Singer, J., Goldsmith, C. H., assessment of pharmacological approaches. American Journal Hutchison, B. G., Milner, R. A., & Streiner, D. L. (1991).
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Agreement among reviewers of review articles. Journal of Bothe, A. K., Davidow, J. H., Bramlett, R. E., & Ingham, R. J. (2006). Stuttering treatment research 1970–2005: I. Sys- Sloan, J., Symonds, T., Vargas-Chanes, D., & Fridley, B.
tematic review incorporating trial quality assessment of behav- (2003). Practical guidelines for assessing the clinical signifi- ioral, cognitive, and related approaches. American Journal of cance of health-related quality of life changes in clinical Speech-Language Pathology, 15, 321–341.
trials. Drug Information Journal, 37, 23–31.
Bramlett, R. E., Bothe, A. K., & Franic, D. F. (2006). Using U.S. Food and Drug Administration. (2004, March 1). Safety preference based measures to assess quality of life in stuttering.
data on Zyprexa ® (olanzapine)—hyperglycemia and diabetes Journal of Speech, Language, and Hearing Research, 49, [Dear Doctor letter]. Retrieved January 8, 2007, from the U.S.
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Cavalot, F., Petrelli, A., Traversa, M., Bonomo, K., Fiora, E., gov/medwatch/SAFETY/2004/zyprexa.htm.
Conti, M., et al. (2006). Postprandial blood glucose is astronger predictor of cardiovascular events than fasting blood glucose in type 2 diabetes mellitus, particularly in women: Lessons from the San Luigi Gonzaga Diabetes Study. The Journal of Clinical Endocrinology and Metabolism, 91, 813–819.
Franic, D. M., & Bothe, A. K. (2008). Psychometric evaluation Contact author: Anne K. Bothe, Department of Communication of condition-specific instruments used to assess health-related Sciences and Special Education, 516 Aderhold Hall, quality of life, attitudes, and related constructs in stuttering.
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