THIS HOUSE BELIEVES

OUR NEW SERIES AIMS TO DEVELOP YOUR SKILLS FOR CRITICAL APPRAISAL MAKING DECISIONS EVIDENCE BASED PRACTICE

This House Belie

The Proposition case: Botox makes sense
Adductor spasmodic dysphonia is a focal laryngeal dystonia that adversely effects the normal contraction of muscles used to adduct (close) the vocal folds (Baylor et al., 2007; Hogikyan et al., 2001; Wingate et al., 2005). The abnormal contraction causes excessive spasms that lead to voice stoppages and / or a strained-strangled vocal quality (Hogikyan et al., 2001; Wingate et al., 2005). The cause of adductor spasmodic dysphonia remains unknown; although it is widely accepted to be neurological, some authors believe that there may be emotional factors involved (Anari et al., 2007). People with the condition have reported adverse effects on job performance and reduced social interactions (Baylor et al., 2007; Wingate et al., 2005). Use of botulinum toxin injection is generally regarded as the primary pharmacological treatment. Botulinum toxin, a neurotoxic protein, blocks the release of acetylcholine, which subsequently paralyses the muscles near the injection site (Anari et al., 2007). Although numerous studies have supported the efficacy of such treatment, concerns regarding the methodological quality of these studies and potential for harmful side effects are only recently being debated in the literature. Speech and language therapists are frequently involved in the care of people with adductor spasmodic dysphonia. Should clinicians advise and encourage these clients to receive botulinum toxin injections? Localised injection of botulinum toxin causes temporary chemical denervation of the injected laryngeal muscle (Wingate et al. 2005). Dysphonic symptoms such as hoarseness, strain and breathiness may be improved due to the reduction of laryngeal spasm (Baylor et al., 2007). Symptom relief can provide improvement in quality of life for people with adductor spasmodic dysphonia according to the World Health Organisation model. The World Health Organisation encourages evaluation from the perspective of the person with the disability in order to understand issues related to social participation and quality of life (Baylor et al., 2007). People with adductor spasmodic dysphonia report adverse effects on social interactions and job performance. Qualitative methods evaluating the use of Botox (Botox; Allergen, Inc., Irvine, CA) injections on clients psychosocial well-being allow for a patientauthentic view in the context of their daily lives (Baylor et al., 2007). Baylor and colleagues (2007) interviewed 6 adults receiving Botox injections on a long-term basis. All 6 reported improvement in voice quality after receiving injections, including some

Kendrea Focht and Paula Leslie debate the motion that speech and language therapy clinicians should advise clients with adductor spasmodic dysphonia to receive botulinum toxin injections.
This House Believes explained
In her teaching, Paula Leslie uses a debating idea from the British Medical Journal to get her students to critically review a controversial subject. By understanding the strengths and weaknesses of the arguments on both sides, the students are better prepared to develop their own views. Students are strictly limited in word count and number of references to foster concise and relevant writing. Their work is now being adapted for Speech & Language Therapy in Practice. The debating format means: the Proposition is required to prove its case, while the Opposition aims to show why the Proposition is wrong either side can interrupt with a point of information while the other side is speaking our authors reach a conclusion based on the evidence and readers can continue the floor debate at the forum: http://members.speechmag.com/ forum/.

Defining the topic

who reported that their voice had returned to normal during the time the treatment was maximally effective. Some also reported improved participation within social and community activities but details on exactly how many were not reported. POINT OF INFORMATION: Although the interviews were guided around three general questions regarding their experience with Botox injections, it is unclear how many interviewers were involved. The authors also did not disclose how the interviews were verified to determine if phenomenological guidelines for conducting qualitative research were followed.

Overwhelmingly positive

Symptom relief

Nonetheless, this is one of the few studies that attempted to understand the impact of Botox intervention on quality of life. The results were overwhelmingly positive. Hogikyan and colleagues (2001) also examined the effects on quality of life. Twentyseven clients completed the Voice-Related Quality of Life Measure (V-RQOL) (Hogikyan & Sethuraman, 1999) prior to their first Botox injection and were then reassessed 6-8 weeks later. This cycle was repeated prospectively for each subsequent injection during an 18month period (Hogikyan et al., 2001). V-RQOL is a validated and reliable self-reported measure that has been shown to be responsive to change in a variety of populations, although Hogikyan and colleagues never mentioned whether the V-RQOL had been validated on people with adductor spasmodic dysphonia. The researchers found that, prior to injection, V-RQOL scores were significantly lower then the published normative data (approximately 70 points) (Hogikyan et al., 2001). Participants scores significantly improved from pre-treatment to post-treatment for each subsequent injection, although the magnitude of the treatment effect was significantly less after the second injection.

Summing up the case for the proposition

Kendrea

Paula

Kendrea L. Focht is a clinical fellow in the medical speech-language pathology clinical doctoral program at the University of Pittsburgh, USA, e-mail klf59+@pitt.edu. Paula Leslie is Associate Professor, Communication Science and Disorders at the University of Pittsburgh, USA, e-mail pleslie@pitt. edu. Paula is also a specialist advisor in swallowing disorders for the Royal College of Speech & Language Therapists.

In conclusion, the studies reviewed have shown significant and dramatic improvements on participants quality of life after receiving Botox injections. As clinicians, we have an obligation to encourage botulinum toxin injections so that our clients can improve their social participation and overall quality of life.

20

SPEECH & LANGUAGE THERAPY IN PRACTICE spring 2009

THIS HOUSE BELIEVES

eves in Botox
Clinicians should not advise people with adductor spasmodic dysphonia to receive botulinum toxin injections. Botulinum toxin injections offer the possibility (not a guarantee) for temporary improvement. There have been some concerns with introducing a toxin into a clients body. Those who have received injections report post treatment symptoms such as swallowing difficulties, inability to speak, swelling / soreness at the injection site, breathy vocal quality, burning sensation, and irritation (Fisher et al., 1998; Galardi et al., 2001). Clinicians need to be aware of the harmful side effects of botulinum toxin, especially when the failure rate of treatment is one in three (Galardi et al., 2001).

The Opposition case: insufficient evidence

Placebo effect
As discussed, studies have demonstrated improvement in patients scores on the V-RQOL after receiving Botox injections. The question remains whether the improvement in scores indicates treatment success or a placebo effect. Anari et al. (2007) examined 38 people with adductor spasmodic dysphonia to compare Voice Handicap Index (Jacobson et al., 1997) scores across three points in time: immediately prior to injection (baseline), one day post-injection and two weeks post-injection. The investigators found that most of the changes in the scores occurred between the baseline and one day post-injection. Statistically significant changes included the total and emotional domains. Since the neurotoxic effect is expected to take 2-3 days to be noticeable, the investigators offered three explanations for their results: the toxin may take effect more quickly than previously reported, the toxin may have a strong placebo effect, and / or the effects of the toxin are not real. POINT OF INFORMATION: Limitations of the study include clients who already have had injections (and thus have some prior notion that it is successful) and inclusion of a small number with abductortype spasmodic dysphonia.

Judgement:

The motion is carried

Botulinum toxin injection is currently considered the gold standard for treatment of adductor spasmodic dysphonia. On the evidence presented, we recommend that clinicians continue to offer Botox injections to people with the condition. However, clinicians also have a responsibility to discuss both the benefits and risks associated with receiving Botox injections. This includes possible side-effects, variation in success with each injection and reported failure rates. Such discussion encourages the informed consent process for people undergoing the procedure. Unrealistic expectations on behalf of the client can also be addressed at this time.
Anari, S., Carding, P., Hawthorne, M., Deakin, J., & Drinnan, M. (2007) Nonpharmacological effects of botulinum toxin on the life quality of patients with spasmodic dysphonia, Laryngoscope, 117, pp.1888-1892. Baylor, C., Yorkston, K., Eadie, T., & Maronian, N. (2007) The psychosocial consequences of BOTOX injections for spasmodic dysphonia: a qualitative study of patients experiences, Journal of Voice, 21, pp.231-247. Fisher, K., Giddens, C., & Gray, S. (1998) Does botulinum toxin injections alter laryngeal secretions and mucociliary transport? Journal of Voice, 12, pp.389-410. Galardi, G., Guerriero, R., Amadio, S., Leocani, L., Teggi, R., Melloni, G., & Comi, G. (2001) Sporadic failure of botulinum toxin treatment in usually responsive patients with adductor spasmodic dysphonia, Neurological Sciences, 22, pp.303-306. Hogikyan, N., & Sethuraman, G. (1999) Validation of an instrument to measure voice-related quality of life (V-RQOL), Journal of Voice, 13, pp.557-569. Hogikyan, N., Wodchis, W., Spak, C., & Kileny, P. (2001)Longitudinal effects of botulinum toxin injections on voice-related quality of life (V-RQOL) for patients with adductory spasmodic dysphonia, Journal of Voice, 15, pp.576-586. Jacobson, B.H., Johnson, A., Grywalski., C., Silbergleit, A., Jacobson, G., Benninger, M.S. & Newman, C.W. (1997) The Voice Handicap Index (VHI): development and validation, American Journal of Speech-Language Pathology, 6, pp.66-70. Truong D., Rontal M., Rolnick M., Aronson A., & Mistura K. (1991) Double blind controlled study of botulinum toxin in adductor spasmodic dysphonia, The Laryngoscope Journal, 101, pp.630-634. Watts, C., Nye, C., & Whurr, R. (2006) Botulinum toxin for treating spasmodic dysphonia (laryngeal dystonia): a systematic Cochrane review, Clinical rehabilitation, 20, pp.112-122. Wingate, J., Ruddy, B., Lundy, D., Lehman, J., Casiano, R., Collins, S., Woodson, G. & Sapienza, C. (2005) Voice handicap index results for older patients with adductor spasmodic Dysphonia, Journal SLTP of Voice, 19, pp.124-131.

Side effects

Laryngeal tissues receive autonomic innervation which is thought to control muscle tone, laryngeal blood flow and regulation of secretions (Fisher et al., 1998). Botox injections may alter the secretions near the larynx and result in client discomfort. Fisher and colleagues (1998) retrospectively examined 26 people with adductor spasmodic dysphonia one or more weeks after injection. Prior to injection there were no reports of symptoms relating to autonomic failure to maintain balance of secretions. Within one hour of injection, and lasting over a week, 14 per cent of participants reported symptoms possibly due to altered balance of secretions such as irritation, thick mucus and swallowing difficulties. Botox may exacerbate the effects of xerostomia (dry mouth) due to side-effects from medication or disease. POINT OF INFORMATION: As the study was retrospective, the researchers were unable to determine whether or not there was a direct link between the symptoms and altered laryngeal secretions. Subsequent botulinum toxin injections do not always give the same results concerning the degree and extent of efficacy, time needed to achieve maximum results, and occurrence of side effects (Galardi et al., 2001). Galardi and colleagues (2001) examined the failure rates of 15 people with adductor spasmodic dysphonia given either Botox or Dysport (Ipsen, Milan, Italy) injections over the course of three years (total of 148 injections). Failure rates were 26 per cent and 30 per cent for Dysport and Botox respectively. This difference in failure rates between the two types of injection was not statistically significant (Galardi et al., 2001). Response failure was found to be unpredictable and a client with success after one injection may have a failure after the next one. POINT OF INFORMATION: The study was retrospective and the success against failure rate was judged by the participants during a telephone interview (Galardi et al., 2001).

Lack of evidence

The opposition point here is that there is a lack of evidence that Botox really works. Watts et al. (2006) attempted a systematic Cochrane review examining the efficacy of botulinum toxin injections for treatment of spasmodic dysphonia. Only one study (Truong et al., 1991) met the inclusion criteria, which included a treatment / no treatment comparison. POINT OF INFORMATION: Readers should note that Truong et al. (1991) was a double-blind, placebo-controlled study. It compared saline versus Botox and showed improvement in both acoustical measurements and patient self-assessment in people receiving the Botox injections. Effect sizes were calculated and demonstrated a significant improvement in fundamental frequency (pitch), pitch range and clinicians overall rating of severity.

References

Treatment failure

Summing up the opposition case

In summary there is a lack of supporting evidence from sound methodological studies and the possibility that reported improvement may be the result of a placebo effect. Clinicians cannot draw conclusions regarding the efficacy of botulinum toxin as a treatment for people with adductor spasmodic dysphonia.

SPEECH & LANGUAGE THERAPY IN PRACTICE spring 2009

21