tr2 tables sd - ancdsdevelopment of practice guidelines in dysarthria: ancds. (please do not quote...

Development of Practice Guidelines in Dysarthria: ANCDS. (Please do not quote or distribute without permission from author.)TR2 Tables SD

BT Injection

11/16/11 of 1BT Injection

Table 2. Evidence for BT Injection (note that 1 = reported and 0 = not reported).Table 2. Evidence for BT Injection (note that 1 = reported and 0 = not reported).Table 2. Evidence for BT Injection (note that 1 = reported and 0 = not reported).Type of StudyType of StudyType of StudyType of Study Subject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject CharacteristicsSubject Characteristics

# Reference Authors Date Sorting Code Case/Case SeriesSingle SubjectGroup Primary focus Number of Subjectsage gendertype of dysarthriaacoustic datameds tx historydiadochokinesisTPO medical dxseverity of dysarthriaphysiologic dataneuro exam dataSES or educationdisease severityspeech characteristicscognition/languagehearing/visionsensationother Total Candidacy Summary

1

Brin, MF, Fahn, S., Moskowitz, C., Friedman, A., Shale, HM, Greene, PE, Blitzer, A., List, T., Lange, D., Lovelace, RE, McMahon, D. (1987), Localized injections of botulinum toxin for the treatment of focal dystonia and hemifacial spasm. Movement Disorders, 2, 237-254. Brin et al 1987 Voice/SD 1

Effect of botox inj on a variety of focal/segmental dystonia on pts injected by authors between 1984-1986 3 0 0 1 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 3 ADSD

2

Jankovic, J., Orman, J. (1987). Botulinum A toxin for cranial-cervical dystonia: a double-blind, placebo-controlled study. Neurology, 37, 616-623. Jankovic & Orman 1987 Voice/SD 1

Effects of botox on blepharospasm & oromandibular dystonia were prime focus, but 3 pts with SD were also injected & studied 3 1 1 1 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 5 SD

3

Miller, RH, Woodson, GE, Jankovic, J. (1987). Botulinum toxin injection of the vocal fold for spasmodic dysphonia. Archives of Otolaryngology/Head and Neck Surgery, 113, 603-605. Miller et al 1987 Voice/SD 1

Outcome of unilateral laryngeal botox inj for SD 2 1 1 1 0 0 1 0 1 1 1 1 0 0 1 1 0 0 0 0 10

Incapacitating SD, not responsive to voice tx

4

Ludlow, CL, Naunton, RF, Sedory, SE, Schulz, GM, Hallett, M. (1988). Effects of botulinum toxin injections on speech in adductor spasmodic dysphonia. Neurology, 38, 1220-1225. Ludlow et al 1988 Voice/SD 1 1

Effects of botox for ADSD in pts who had previous RLN surgery with return of SD SXs 16 1 1 1 1 1 0 0 1 1 1 0 0 0 1 1 0 0 0 1 11

SD; no neuro or psych probs prior to SD onset; stable for 2 years; no surgery for SD; overadduction of cords on laryngoscopy; sx reduction after xylocaine

5

Brin, MF, Blitzer, A., Fahn, S., Gould, W., Lovelace, RE. (1989). Adductor Laryngeal Dystonia (Spastic Dystonia): Treatment with Local Injections of Botulinum Toxin (Botox). Movement Disorders, 4, 287-296. Brin et al 1989 Voice/SD 1

Outcome of percutaneous EMG guided laryngeal botox inj into the vocalis muscles for ADSD 42 1 1 1 0 1 1 0 1 1 1 0 0 0 1 0 0 0 0 0 9

Pts with clinical dx of ADSD, some who had previous pharmaco tx & 4 who had had or RLN resection. 26 had focal dystonia; remainder had segmental, multifocal or generalized dystonia

6

Ford, CN, Bless, DM, Lowery, JD. (1990). Indirect laryngoscopic approach for injection of botulinum toxin in spasmodic dysphonia. Otolaryngology-Head and Neck Surgery, 103, 752-758. Ford et al 1990 Voice/SD 1 1

The results of indirect laryngoscopic approach to inj botox for ADSD 16 1 1 1 1 1 0 0 1 1 0 1 0 0 0 1 0 0 0 1 10

DX of ADSD; complete ORL exam; neuro screening;, incl EMG of vocalis & CT.

7

Jankovic, J., Schwartz, K., & Donovan, DT (1990). Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonia and hemifacial spasm. J of Neurology, Neurosurgery, & Psychiatry, 53, 633-639. Jankovic et al 1990 Voice/SD 1 1 Outcome of botox inj for SD 24 1 1 1 0 1 0 0 1 1 0 0 0 0 0 0 0 0 0 0 6 DX of SD (SD type not specified)

8Ludlow, CL (1990). Treatment of speech and voice disorders with botulinum toxin. JAMA, 264 (20), 2671-2675. Ludlow 1990 Voice/SD 1

Case study of 1 S with SD who underwent laryngeal botox inj 1 1 1 1 1 1 1 0 1 1 1 1 1 0 1 1 0 0 0 1 14

Dx of ADSD & failed voice tx, medication, hypnosis, acupuncture, & counseling.


BT Injection


ReplicabilityReplicabilityReplicability Outcomes

Type of DysarthriaMedical

Diagnosis Rationale for Treatment ReplicableGeneral InformationIncomplete Impairment Activity LimitationParticipation Restriction Study Conclusions Psychometric Adequacy

Hyperkinetic (ADSD) SDchemical denervation to control dystonic spasm 1 1

Pt questionnaires re improvement and side effects. None

Yes (pt able to return to graduate school)

All 3 pts with dystonic SD and & all 3 with lingual dystonia had sx relief with botox Absent

Hyperkinetic (SD) dystonic SD

Standard botox rationale, but apparently 1/3 pts with SD had posterior pharyngeal muscle inj, not TA inj 1

Simple description of improvement

None, but 1 pt said able to talk on phone for 1sr time in 9 years None

Pts with SD improved and could speak freely with only mild hoarseness Absent

Hyperkinetic (SD) SDBotox is effective for dystonias; it should be for dystonic SD 1 intrathoracic pressure None

Pts said to be severely incapacitated

Both pts improved without significant complications. The injection can be repeated as outpatient procedure. This is a preliminary report of a promising technique. Absent

Hyperkinetic (SD) SD Standard botox rationale for SD 1

% of aperiodic phonation and voice breaks; pitch breaks; sentence duration; indirect laryngoscopy

Pt diaries of sxs (? Impairment, not functional) None

Botox led to sig sx reduction on acoustic measures when it resulted in unilateral vocal cord paralysis. Botox reduces glottal resistance by weakening an adductor muscle but it may not alter pathophysiology of the disorder. Present to some degree

Hyperkinetic (ADSD) ADSDBotox for SD because it had been successful in tx other focal dystonias 1 None

Pt & physician ratings of % of normal speech, ranging from no speech/"full disability" to normal. Pt diaries of weakness, breathiness, choking etc

see functional limitation

Bilateral low dose laryngeal botox is tx of choice for SD. They report abandoning RLN resection as primary tx because of high recurrence rates. Absent

Hyperkinetic (ADSD) SD

Precise delivery of botox to TA using indirect laryngoscopy to guide the needle should result in more accurate placement without need for EMG monitoring 1

EMG, aerodynamic, acoustic, & videolaryngoscopy

Pt ratings of voice & duration of benefit None

The technique is effective and can be performed in office without EMG guidance. Results comparable to other reports of efficacy of botox for ADSD No reliability data

Hyperkinetic (SD) SD Standard Botox rationale 1

Severity rated on 5-point scale by clinicians; pts rated latency of response & time of peak effect after inj; Peak effect rated by pts on 5-pt scale; global rating represented peak effect minus pts for complications; number of weeks of peak effect also rated by pts None None

All 24 pts with SD had very satisfactory result, with avg. of 15 weeks of peak effect. Authors conclude botox inj is safe & effective tx for pts with focal dystonia & hemifacial spasm & SD. Absent


Perceptual ratings, acoustic data, EMG, & fiberoptic measures.

Description of pt social & work limitations & changes after inj

Description of pt social & work limitations & changes after inj Botox can significantly improve SD & limitations imposed Absent


BT Injection


Classification of EvidenceClassification of Evidence

Evidence for Control Reported Risks & Complications AAN Levels Beukelman Levels Raters Comments

Pre vs post inj pt comparisons 3/3 Ss had 3 days of mild choking and aspiration IV O SCS

This study reports botox inj results for 93 pts with a variety of focal/segmental dystonias (blepharospasm, torticollis, oromandibular dystonia, limb dystonia, lingual dystonia, & ADSD).Injections were bilateral (2.5 units per cord). For lingual destonia, the genioglossus and hyoglossus were injected. This may be the first large N report of botox results for a variety of dystonias

Pre vs post comparison None noted IV O SCS

This study was primarily focused on botox for blepharospams & cranial-cervical/oromandibular dystonia. The reports for SD are treated almost incidentally. No reliability data for SD pts and no formal rating procedures are discussed. This is an early report.

Pre vs post comparison Neither pt developed dysphagia or aspiration. IV O SCS

This is an early report of botox use. There is little description of speech characteristics & no attempt to rate pre vs post results perceptually or acoustically. Intrathroacic pressure during speech was measured

Pts served as own controls from baseline through 3 postinj assessments

In adductor patients, mild temporary breathiness (in 35%), coughing on fluids (15%); <1% had local pain/sore throat, slight blood tinged sputum, itch, or rash. In abductor patients, mild stridor in ~4%; ~ 10% had dysphagia; side effects usually lasted < III E SS

Injections were all unilateral, ranging from 15 to 60 units over 3 injections to get desired result. Avg. duration of benefit was 6 weeks. All pts benefited. Multiple sites were injected and result said better than initial studies with injection at only 1 point on TA

Pre vs post-tx ratings.

Most frequent were: 45% had period of breathy hypophonia for avg. of 9 days; 22% had mild choking on fluids for avg. of 2 datys. Other side effects were <2% of 95 treatments reported. IV O SCS

Scored in nonblinded fashion. Most conservative ratings used to measure improvement. Degree of improvement was 61%. All pts responded to retreatment with longest follow-up to 3.5 years. Avg. duration of benefit was 84 days. Avg. dose was bilat (2.5-3.75 per cord).

Pre vs post inj using several measures of impairment and disabilityBreathiness was main side effect (in 9/16). Occasional choking, lasting ~ 1 week (5 pts) IV O SCS

All pts rated results favorably. Mean duration of response ~ 12.2 weeks (range = 5.5-22)) with onset of response from 1-31 days. Good summary of videostrobe results and EMG. Most common EMG abnormalities were tremor & abnormal patterns of motor unit recruitment. Effective dose was less than in other reports, perhaps because of exact placement permitted by technique.

Pre vs post inj comparisons Hypophonia or hoarseness in 7 pts & dysphagia in 3. IV O SCS

Subject description re SD characteristics not provided; we must take authors' word for the dx of SD and can't be sure if all had ADSD. Pt & clinician ratings presented as group data and are convincing in demonstration of change (although no control group or reliability data reported). This is an early study that demonstrated efficacy of botox for several dystonic conditions.

Pre vs post inj comparisons on several measures Not reported IV O CSSingle case study documenting improvements assoc with laryngeal botox, including major life style improvements (more social, resumed desired job).


BT Injection


9

Ludlow, CL, Naunton, RF, Fujita, M., Sedory, SE. (1990). Spasmodic dysphonia: botulinum toxin injection after recurrent nerve surgery. Otolaryngology-Head and Neck Surgery, 102, 122-131. Ludlow et al 1990 Voice/SD 1 1c

Effects of botox for ADSD in pts who had previous RLN surgery with return of SD SXs 5 1 1 1 1 1 1 0 1 1 1 1 1 0 1 1 0 0 0 1 14

ADSD with no psychiatric disorder prior to dx; previous RLN surgery with benefit followed by sx recurrence; no hx of phenothiazine use, no essential tremor or Meige syndrome

10

Blitzer, A., Brin, M. (1991). Laryngeal Dystonia: A Series With Botulinum Toxin Therapy. Annals Of Otology, Rhinology & Laryngology, 100, 85-89. Blitzer & Brin 1991 Voice/SD 1

Review of outcomes in a series of >200 Pts treated with botox for various forms of laryngeal dystonia 210 0 1 1 0 1 1 0 0 1 0 0 1 0 0 1 0 0 0 0 7

Pts treated with laryngeal botox who had ADSD or ABSD, some who had RLN resection failure

11

Ludlow, CL, Naunton, RF, Terada, S., Anderson, BJ. (1991). Successful treatment of selected cases of abductor spasmodic dysphonia using botulinum toxin injection. Otolaryngology-Head and Neck Surgery, 104, 849-855. Ludlow et al 1991 Voice/SD 1c

Effectiveness of botox inj to CT muscle to tx ABSD 10 1 1 1 1 1 0 0 0 1 0 1 0 0 0 1 0 0 0 0 8

Dx of ABSD on basis of fiberoptic laryngoscopic exam & EMG & perceptual judgments

12

Rontal, M., Rontal, E., Rolnic, M., Merson, R., Silverman, B., Truong, DD. (1991). A Method for the Treatment of Abductor Spasmodic Dysphonia With Botulinum Toxin Injections: A Preliminary Report. Laryngoscope, 101, 911-914. Rontal et al 1991 Voice/SD 1

To describe a technique for injecting the PCA in pts with ABSD 6 1 1 1 1 1 1 0 1 1 0 0 0 0 0 1 0 0 0 0 9

Dx of ABSD with no prior surgical tx of SD

13

Truong, DD, Rontal, M., Rolnick, M., Aronson, AE, Mistura, K. (1991). Double-Blind Controlled Study of Botulinum Toxin in Adductor Spasmodic Dysphonia. Laryngoscope, 101, 630-634. Truong et al 1991 Voice/SD 1c

Double-blind, randomized, placebo controlled study of effect of botox for ADSD 13 0 0 1 1 1 0 0 0 1 0 0 0 0 0 1 0 0 0 0 5

ADSD with agreement of dx by SLP, ORL, & neurologist

14

Blitzer, A., Brin, MF, Stewart, C., Aviv, JE, Fahn, S. (1992). Abductor Laryngeal Dystonia: A Series Treated With Botulinum Toxin. Laryngoscope, 102, 163-167. Blitzer et al 1992 Voice/SD 1

Outcome of percutaneous laryngeal botox inj into the PCA muscles for abductor SD 32 1 1 1 0 1 0 0 0 1 1 0 0 0 1 0 0 0 0 1 8

Pts with voice characteristic consistent with dx of ABSD. All underwent "comprehensive" neuro, ORL, & Speech Path exams

15

Green, DC, Ward, PH, Berke, GS, Gerratt, BR. (1992). Point-Touch Techniques of Botulinum Toxin Injection For The Treatment of Spasmodic Dysphonia. Annals of Otology, Rhinology, and Laryngology, 101, 883-887. Green et al 1992 Voice/SD 1

To describe an anatomic approach to laryngeal botox inj that requires only flexible nasopharyngeal endoscopy & careful eval of anatomic landmarks 13 1 1 1 1 1 1 0 1 1 0 1 0 0 0 1 0 0 0 0 10 Dx of ADSD

16

Lees, AJ, Turjanski, N., Rivest, J., Whurr, R., Lorch, M., & Brookes, G. (1992). Treatment of cervical dystonia hand spasms and laryngeal dystonia with botulinum toxin. Journal of Neurology, 239, 1-4. Lees et al 1992 Voice/SD 1

Outcome of laryngeal botox for SD pts treated with botox 25 1 1 1 0 1 0 0 1 1 0 0 0 0 0 0 0 0 0 0 6

DX of SD; 22 with ADSD; 2 with tremor; 1 with "compensatory adductor tremor."


BT Injection


Hyperkinetic (ADSD) SDBotox could relieve sx of ADSD that have recurred after RLN surgery 1

EMG, acoustic analysis, & fiberoptic laryngoscopy None None

Significant reductions in all sxs occurred after injection. EMG measures demo sig reductions in % activation levels of both injected & noninjected muscles. Botox was an effective tx of postsurgical sx recurrence in ADSD. No reliability data reported/

Hyperkinetic (SD) laryngeal dystonia

Outcomes for what the authors describe is now their tx of choice for laryngeal dystonia. 1

Postinj EMG "in a limited # of Ss, but results not reported

Nonblinded subjective ratings on a % scale ranging from "no speech or full disability" to normal speech. Ratings made by patients & physicians. Pts also recorded duration of breathy dysphonia, swallowing probs, & other "notable events." The most conservative ratings were used as the index of % of improvement. None

Pts derived benefit within 24-72 hours, with sustained improvement for 2-9 months, with avg. of 4 months. Pts improved to avg. of 90% of normal function. Authors say botox has become their tx of choice for dystonic conditions of the larynx. Absent

Hyperkinetic (SD) SD

To examine effectiveness of botox for ABSD in selected pts with increased CT muscle activity 1

laryngoscopy, EMG, & acoustic analysis

Clinical impression of voice improvement None

6/10 pts with CT abnormalities benefited substantially from CT inj on acoustic & clinical impression. Pts with constant breathiness & other (non CT) muscle abnormalities did not benefit. ABSD pts should be examined for CT abnormalities during speech; those with CT abnormalities & mod-severe pitch & voice breaks during speech are best candidates for CT injection Present

Hyperkinetic (ABSD) SD

Attempt to contribute to effective tx of ABSD by developing technique for inj PCA 1

Acoustic/spectrographic measures of harmonic breakdowns, frequency variation & perturbation Perceptual descriptions of voice None

Percutaneous with EMG guidance & fiberoptic laryngoscopic monitoring technique that places botox close to PCA muscle (unilaterally), to allow diffusion to PCA is effective in reducing/eliminating abductor spasms during phonation & improving functional speech communication. Absent

Hyperkinetic (ADSD) SDTo investigate effectiveness of botox (bilateral) for treating SD 1

Acoustic analysis (Fo, Fo range, phonation time, perturbation, & spectrographic analysis

Patient self ratings of improvement after injection None

Botox proved to be effective & safe tx of ADSD.Markedly reduced perturbation, decr Fo frequency range, & improved spectrographic features occurred with botox. Patient ratings of voice improvement sig better than the saline injection group.(saline txd patients noted no change after botox. Absent

Hyperkinetic (ABSD) SDBotox for ABSD because it had been successful in tx ADSD 1 1 None reported

Pt, physician & SLP ratings of % of normal function, overall severity, breathiness, aphonia, & voice tremor before & after inj None

ABSD can be safely & effectively treated with percutaneous unilat or bilat PCA botox inj. Avg. improvement was to 70% of normal function (from baseline of 31%), with degree of improvement averaging 39%, with range from 5-85%. Several pts also benefited from cricothyroid inj or type I thyroplasty to max benefit. Absent

Hyperkinetic (ADSD) SD 1

Acoustic measure of jitter, measure of glottal resistance, & stroboscopic imaging

Pt satisfaction & whether they returned for subsequent inj None

Objective pre & post tx data indicates success for all 13 pts using this inj technique Absent


Perceptual judgments of voice quality, acoustic analyses of Fo & phonation time, & apparent measures of TA muscle activity - but no quantified data presented None None Botox inj is a safe & effective method of tx for SD Absent


BT Injection


Acoustic measures were blinded to pt ID & testing condition. Pre vs postinj comparisons & comparison to control Ss were made. Not reported III E SS

TA injections were on side operated in all pts, with additional inj on side not operated in 2 pts. Inj were repeated at 2-week intervals until a speech benefit or loss of volume occurred. Outcome measures were acoustic measures of pitch breaks, phonatory breaks, & irregular aperiodic phonation. Pts who received bilat inj had greatest benefit. EMG results suggest sx return may be partly assoc with TA innervation on side operated; compensation on side not operated may also be a factor. A good study.

Pre vs post injection comparisons, nonblinded.

Mild breathy voice beginning on avg. at 3rd day postinj & lasting 4-14 days in 45%. 22% had mild choking on fluids for 1st several days, but no cases of aspiration. Several hyperventillated & became dizzy trying to speak when hypophonic & several had blood tinged sputum &/or sore throat. One pt had some itching but no rash. They also state that to date no pt had sustained any disability from the injection, or became refractory to injection. IV O SCS

The tx protocol was not standard for all pts. Authors report result of the tx as the protocol (e.g., dose level) evolved based on their experience. The report success in some pts who had failed RLN resection. They report success in 8/12 pts with ABSD, with avg. improvement to 57% normal. 10% of pts whose dystonia began in larynx had spread to another body part. 17% had positive family hx of dystonia. This appears to be an early large series report of outcomes with botox for SD.

Comparison of change made to normal Ss who did not receive injections Pts who did not benefit had some swallowing difficulties & further loss of loudness III E C6/19 of their clinic's ABSD pts had predominance of abnormal activation in CT muscles; remainder had probs primarily in PCA muscles.

Pre vs post inj changes in voiceAll pts had postinj breathiness, lasting 2 mo. in 2 pts. No pt had respiratory or swallowing probs. IV O SCS

5/6 pts had reduction in abductor spasms; substantial reduction in speech effort; absence of speech fatigue; disappearance of acoustic evidence of spasms. Benefits lasted 3-6 months. Method for rating speech change not described & acoustic methods not described - Results described in general terms, without quantitative data. Purpose of paper was more to describe the technique than to detail the results.

Random assignment to botox vs saline injection group. Blinded evaluation by judges and patients were unaware of tx they received.

Excessive breathiness noted in 2 patients, lasting for ~ 2 weeks. One pt had mild bleeding after botox. I E RCS

An early study that was well controlled re blinding and randomization of control (placebo) and botox treatments. N was small. Poor S description re age, severity, prior tx, etc. but 3 clinicians agreed on dx of SD. Although data not reported the report indicates that ratings of voice quality by a SLP agreed with patient ratings. Note that postinj ratings and acoustic analyses were done only 4 days postinj, so not likely measures were made at point of optimal benefit. Inj were bilateral with EMG & Laryngoscopic guidance.

Pts served as own control in a pre vs post tx comparison 2 pts had transient (1 week) exertional stridor & two had transient dysphagia IV O SCS

Study includes a description of evolution of the technique from direct laryngoscopy inj to percutaneous. Some pts had unilat inj, some bilat. Some had cricothyroid inj, & 3 also had type I thyroplasty. Study did not report results of neuro, ORL or SLP exams. Not clear if results are based on pt, SLP or physician ratings, or a combination of them. No reliability across raters provided.

Pre vs post tx comparison

5/13 pts had period of postinj breathiness ranging from 2-4 weeks. No airway complications or infections or aspiration. All had mild vocal fold edema that resolved. IV O SCS

The real purpose of this paper was to describe the injection technique. But all 13 had "increase in fluency" & were pleased; all returned for subsequent inj. Authors provide nice summary of advantages & disadvantages of the technique; one major advantage is that EMG monitoring is not necessary. Results in terms of duration of benefit and side effects seem comparable to those reported for EMG guided techniques.

Absent ( as far as can be determined)

Temporary pain at site of inj, reduced cough, dry mouth, breathiness & hypophonia & mild swallowing difficulty - generally tolerated well & lg majority of patients wished to continue injections IV O SCS

Inadequate subject description and no quantified data provided for any outcome measure. Authors report all 25 pts showed worthwhile benefit" and side effects were "generally tolerable." Intention of article seemed to be to provide a general description of botox outcomes for laryngeal dystonia, cervical dystonia, and hand spasms, rather than to provide convincing data for efficacy.


BT Injection


17

Zwirner, P., Murry, T., Swenson, M., Woodson, GE. (1992). Effects of Botulinum Toxin Therapy in Patients With Adductor Spasmodic Dysphonia: Acoustic, Aerodynamic, and Videoendoscopic Findings. Laryngoscope, 102, 400-406. Zwirner et al 1992 Voice/SD 1

To documents acoustic, airflow, & videoendoscopic findings, functional status, & their interelationships, before, 1 week & 1 month after unilateral botox inj for ADSD 11 1 1 1 1 1 1 0 1 1 1 1 0 0 1 1 0 0 0 0 12

ADSD; unilat botox inj; no previous botox; no other neuro, psychiatric, or speech disorder; no prior surgical mgmt of SD; pre inj, 1 week & 1 month postinj data

18

Adams, SG, Hunt, EJ, Charles, DA, & Lang, AE. (1993). Unilateral versus bilateral botulinum toxin injections in spasmodic dysphonia: acoustic and perceptual results. Journal of Otolaryngology, 22, 171-175. Adams et al 1993 Voice/SD 1c

Comparison of results of unilateral vs bilateral laryngeal botox inj for ADSD 26 0 0 1 1 1 0 0 0 1 1 0 0 0 1 1 0 0 0 0 7 Dx of ADSD

19

Aronson, AE, McCaffrey, TV, Litchy, WJ, Lipton, RJ. (1993). Botulinum Toxin Injection for Adductor Spastic Dysphonia: Patient Self-Ratings of Voice and Phonatory Effort After Three Successive Injections. Laryngoscope, 103, 683-692. Aronson et al 1993 Voice/SD 1 1

Patient ratings of voice & vocal effort following laryngeal botox for ADSD 10 1 1 1 0 1 1 0 0 1 1 0 1 0 1 1 0 0 0 0 10

ADSD of neurologic origin treated with laryngeal botox on 3 consecutive occasions

20

Kobayashi, T., Niimi, S., Kumada, M., Kosaki, H., Hirose, H. (1993). Botulinum Toxin Treatment for Spasmodic Dysphonia. Acta Otolaryngologica, 504, 155-157. Kobayashi et al 1993 Voice/SD 1

To report outcome of laryngeal botox inj for SD 17 1 1 1 0 1 1 0 1 1 0 0 0 0 0 1 0 0 0 0 8

Dx of SD (adductor or abductor) who received laryngeal botox

21

Whurr, R., Lorch, M., Fontana, H., Brookes, G., Lees, A., Marsden, CD. (1993). The use of botulinum Toxin in the treatment of adductor spasmodic dysphonia. Journal of Neurology, Neurosurgery, and Psychiatry, 56, 526-530. Whurr et al 1993 Voice/SD 1

Acoustic & patient rating data in response to percutaneous bilateral laryngeal botox 31 1 1 1 1 1 1 0 1 1 1 0 1 0 1 0 0 0 0 0 11

ADSD with or without assoc neuro signs, 71% of whom had previous nonbotox treatments without lasting effects

22

Zwirner, P, Murry, T., & Woodson, GE. (1993). Perceptual-acoustic relationships in spasmodic dysphonia. Journal of Voice, 7 (2), 165-171. Zwirner et al 1993 Voice/SD 1 1c

Perceptual parameters in SD prior to & after botox, & relationship between perceptual measures & acoustic parameters known to change after botox. 19 0 0 1 1 1 0 0 0 1 1 0 0 0 1 1 0 0 0 0 7 Dx of ADSD & tx with botox

23

Zwirner, P., Murry, T., Woodson, GE. (1993). A Comparison of Bilateral and Unilateral Botulinum Toxin Treatments for Spasmodic Dysphonia. European Archives of Oto-Rhino-Laryngology, 250, 271-276. Zwirner et al 1993 Voice/SD 1c

To assess efficacy of bilateral or unilateral botox tx for SD 24 1 1 1 1 1 1 0 1 1 0 1 1 0 0 1 0 0 0 0 11

Dx of ADSD; 1st botox inj; no prior Lo surgery; no hx of neuro, psych, or other speech disorder. 11 received unilat inj; 13 received bilat inj

24

Giladi, N., Meer, J., Kidan, C., Greenberg, E., Gross, B., Honigman, S. (1994). Interventional Neurology: Botulinum Toxin As A Potent Symptomatic Treatment In Neurology. Israel Journal of Medical Sciences, 30, 816-819. Giladi et al 1994 Voice/SD 1

Report of experience with botox for a variety of CNS disorders, including SD & palatal myoclonus 3 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 dx of spastic dysphonia


BT Injection


Hyperkinetic (ADSD) SD Standard unilat laryngeal botox inj for SD 1

Acoustic measures, airflow recordings, & videolaryngoscopy

Ratings of functional status re ability to communicate with most severe included career/employment changes or decreased social interaction

See functional limitation

Botox inj into TA is effective & safe tx for ADSD. Acoustic measures demo sig voice improvement; airflow rates increase 1 week postinj with almost normal values at 1 month; videolaryngoscopy demo reduced intrinsic laryngeal hyperfunction postinj. Relationships between videoendoscopic findings & acoustic &/or aerodynamic findings were not significant. Change in functional status offered support for the acoustic & physio measures Absent


To compare effectiveness and side effects of two accepted approaches (unilateral vs bilateral) to laryngeal botox tx for ADSD. 1

Acoustic measures of vowel duration, Fo, jitter, shimmer, & voice breaks per sec

Blinded ratings by 4 SLPs of severity of voice spasms & vocal breathiness using direct magnitude estimation None

Both types of inj were assoc with sig improvements in SD. Both were assoc with increased vocal breathiness at 2 weeks post-inj. Acoustic measures suggest unilat inj may provide both superior & longer lasting benefits than bilat inj.

Reliability of perceptual judgments reported

Hyperkinetic (ADSD)

ADSD, neurologic (tremor or dystonia)

To reduce sx of ADSD with laryngeal botox injection 1 None

Patient ratings of voice & vocal effort before & at 2 week intervals after transcutaneous botox inj.

Testimonial comment within a few case summaries

1. 80% of pts improved In voice & physical effort at 24-48 hours after inj. 2. Breathiness/aphonia occurred after 43% of inj, max at 2 weeks post inj. 3. Max improvement in voice was at 1.9 months & effort at 1.3 months post inj. 4. Avg. duration of max improvement in voice at 1.3 mo. 5. Avg. duration before decline was 3.9 mo. for voice & 4.0 mo. for effort.. 6. Avg. duration to request for reinjection was 4.8 mo. Considerable postinj fluctuation within and among pts. Absent

Hyperkinetic (SD) SDTo document effects of botox on SD, a tx effective for other forms of dystonia 1 1 Laryngoscopy Pts' subjective judgment of benefit None

Botox to the TA muscle cords is effective tx for ADSD, but was not effective for 2 pts with ABSD Absent

Hyperkinetic (ADSD) SDBotox for SD because it had been successful in tx other focal dystonias 1

Acoustic analysis of SD of Fo

Patient diaries re degree and duration of benefit None

Botox is effective method of tx for ADSD, enabling pts to use voice effortlessly & communicate easily. 96% reported improvement in voice, on avg. beginning by day 7 with peak effect lasting 5 weeks (benefits described by pts as reduced # of pitch & voice breaks, increased loudness, reduced effort to speak. SD of Fo was less postinjection than preinjection Absent


Perceptual measures of OA severity, strained voice, and breathiness; acoustic measures of voice breaks (VBF) & SD of Fo (SDFO). None None

SD voice is perceived as less severe, less strain-strangled, & more breathy 1 week after botox than preinj. Perceptual results were related to VBF & SDFO, parameters known to change after botox.

Intr & interjudge reliability data presented for perceptual judgments by 5 SLPs


To compare effectiveness and side effects of two accepted approaches (unilateral vs bilateral) to laryngeal botox tx for ADSD. 1

Acoustic measures & airflow recordings None None

Both inj modes resulted in sig improvement of vocal function using objective acoustic & aerodynamic measures. Absent

Hyperkinetic (SD) dystoniaTo report aus' experience with botox for a variety of neuro disorders 1 None Pt rating of % of improvement None

Pts with SD reported 92% improvement. Injection of 1 patient with palatal myoclonus said to be effective Absent


BT Injection


Videoendoscopic ratings were blinded Not addressed IV O SCS

Uncertain who made ratings of functional status (clinician vs patients). Botox dose depended on severity so varied among pts (this is reasonable re typical clinical practice). The study basically indicates that acoustic & physio & endoscopic measures detect abnormalities before botox and changes after botox in a direction consistent with functional findings.

Perceptual judgments were blinded to tx type and time of injection. No indication that Ss were randomly assigned to tx groups Breathiness at 2 weeks postinj was sig greater than preinj ratings for both groups III E C

Results demonstrate effectiveness of both treatment approaches & the side effect of breathiness in both. By 6 weeks breathiness was at preinj level so it demonstrates that the side effect is temporary. The acoustic measures identified differences between unilat vs bilat inj whereas the perceptual measures did not. The comparison of unilateral (15 units) vs bilateral (2.5 per side) is probably no longer relevant because patients today receiving unilateral injections rarely get a dose as large as 15 units, in my experience. The study did not address patient satisfaction or ratings of voice, side effects, etc., so we do not learn whether there are differences between the 2 txs in that regard.

Pre & postinjection ratings, with multiple postinj ratings after 3 different injections Breathy/aphonia period in 43% of total injections, max. at 2 weeks postinj. IV O Q

Variable inj. Protocol re dosage, with some receiving bilat & some unilat inj, & many receiving different dosages on subsequent inj., but this reflected appropriate dose adjustments based on prior results. All data based on pt ratings. Pts represented 1st 10 to be injected at this institution & au indicated consecutive dosages were "tailored" as experience increased, so variability and duration data may exceed that in practice today (e.g., dosages were higher than typically used today; 20 units unilaterally & 5 units per cord for bilateral inj.). Study points out variability in response across and, most important, within pts.

Pre vs postinj judgment of laryngoscopy & pts' pre vs postinj ratings of voice

2 cases were hoarse for 2 weeks. 1 pt was aphonic for 3 weeks. No systemic complications were observed on repeated inj in the series IV O SCS

All pts with ADSD showed laryngoscopic or subjective improvements lasting for avg. of 3 months. The 2 pts with ABSD did not improve but the TA was injected. This is a purely descriptive study with little detailing of pt characteristics or the ratings that were made by pts.

Pts served as own control in a pre vs post tx comparison25% had some transitory dysphagia for fluids without aspiration, weak cough, or pain at site of injection. IV O SCS

A pre-post comparison study. Authors indicate postinj acoustic analysis are probably conservative because they were often made after peak benefit. Au note that these pts continued with successful injections.

Judges blinded to pre vs postinj status & purpose of study. Results compared to a control (non-SD) group Post inj breathiness rated as increased in 12/19) III E C

Limited S description but reference given to article in which those characteristics were well summarized (Zwirner et al 1991).Post inj ratings done at 1 week postinj, so benefits may have been minimized & measures of breathiness inflated. The study clearly documents perceptual improvement in voice postinj, esp for the measure of OA severity of voice (14/19 pts had decreased severity rating postinj). Ratings of OA severity were still worse than controls post inj, however -- but again, this was at 1 week postinj, so benefits may not yet have reached maximum.

Pre inj vs 1 week postinj & 1 month post inj comparisonsNo aspiration or sig dysphagia, but "tickling" sensation common when swallowing liquids; 54% of bilat pts had swallowing probs vs27% in unilat group III E C

It is not clear if Ss were randomized to the 2 tx conditions. The bilat group was more severe prior to tx on several measures; the two groups were equivalent on others. At 1 week the unilat group showed gains on all measures except SNR. In bilat group, values for jitter & SNR were worse at 1 week. Four weeks after inj, bilat group was not sig different from unilat group on measures of VBF & only slightly higher on airflow. Bilat inj resulted in sig improvement at much lower doses than that used in unilat inj (i.e.5-30 vs 1.5-2 per cord). No perceptual measures from clinicians or pts. No pt satisfaction reported.

None except for pre vs post injection comparisons dysphagia noted in all 3 pts with SD and in 1 with palatal myoclonus IV O SCS

Poor study re control, S description, & outcome measures. The SD portion was embedded within a report of botox results for a wide variety of movement disorders, most with blepharospasm, neck dystonia & limb dystonia (total N = 65)


BT Injection


25

Maloney, AP & Morrison, MD (1994). A comparison of the efficacy of unilateral versus bilateral botulinum toxin injections in the treatment of adductor spasmodic dysphonia. Journal of Otolaryngology. 23, 160-164.

Maloney & Morrison 1994 Voice/SD 1

Comparison of efficacy of unilateral versus bilateral botox inj for ADSD re duration of effect vs side effects of breathiness & swallowing difficulty 24 1 1 1 0 1 1 0 1 1 0 0 0 0 0 1 0 0 0 1 9

Dx of ADSD with initial bilat inj of botox who then elected to have at least 1 unilat inj, followed in future by their choice of unilat or bilat injection. Pts with prior RLN resection were excluded.

26

Murry, T, Cannito, MP, & Woodson, GE. (1994). Spasmodic dysphonia: Emotional status and botulinum toxin treatment. Archives of Otolaryngology, Head and Neck Surgery, 120, 310-316. Murry et al 1994 Voice/SD 1c

To determine effects of botox inj on measures of depression, anxiety, & somatic complaints in pt with SD 32 1 1 1 0 1 0 0 1 1 0 0 0 0 0 1 0 0 0 0 7

Dx of SD; no previous botox tx; sx > 1 year; not under psychiatric care or med dx of mood disorder or depression; no other speech disorder; volunteered to participate; improved postinj by pt self-report & acoustic analysis

27

Rhew, K., Fiedler, D., Ludlow, CL. (1994). Technique for injection of botulinum toxin through the flexible nasolaryngoscope. Otolaryngology-Head and Neck Surgery, 111, 787-794. Rhew et al 1994 Voice/SD 1c

Results of unilateral & bilateral laryngeal botox for ADSD using flexible nasolaryngoscope inj technique 12 1 1 1 1 1 1 0 1 1 1 1 1 0 1 1 0 0 0 1 14

ADSD, without h/o speech or voice probs; without h/o prior botox tx or laryngeal surgery; non smokers

28

Adams, SG, Hunt, EJ, Irish, JC, Charles, DA, Language, AE, Durkin, LC, Wong, DLH. (1995). Comparison of Botulinum Toxin Injection Procedures in Adductor Spasmodic Dysphonia. Journal of Otolaryngology, 24, 345-351. Adams et al 1995 Voice/SD 1

Comparison of unilateral vs bilateral TA botox injection for ADSD 50 1 1 1 1 1 0 0 1 1 1 0 0 0 1 1 0 0 0 0 10

Dx of ADSD based on perceptual, acoustic, aerodynamic, & laryngoscopic signs of adductor vocal spasms

29

Murry, T., Woodson, GE. (1995). Combined-Modality Treatment of Adductor Spasmodic Dysphonia with Botulinum Toxin and Voice Therapy. Journal of Voice, 9, 460-465. Murry & Woodson 1995 Voice/SD 1c

Comparison of results for botox for ADSD to botox + subsequent voice tx for ADSD 17 1 1 1 1 1 0 0 1 1 0 1 0 0 0 0 0 0 0 0 8

Dx of ADSD; no prior botox tx; no prior RLN resection or other laryngeal surgery; sx > 1 year; no other speech disorder

30

Wong, DLH, Adams, SG, Irish, JC, Durkin, LC, Hunt, EJ, Charlton, MP. (1995) Effect of Neuromuscular Activity on the Response to Botulinum Toxin Injections in Spasmodic Dysphonia. Journal of Otolaryngology, 24, 209-216. Wong et al 1995 Voice/SD 1c

Effect on voice outcome of speaking vs silence following percutaneous laryngeal botox injection for SD 20 1 1 1 1 1 0 0 1 1 1 1 0 0 1 1 0 0 0 0 11

Pts with SD with no previous laryngeal surgery or hx of laryngeal trauma or CA, or sensitivity to botox or other illness that would preclude safe injection


BT Injection



To compare effectiveness of unilat vs bilat inj, both legitimate methods for ADSD. 1 None

Pt diary ratings of goodness of voice, duration of benefit, of breathiness, & swallowing probs. Phone interview response to query re preference for bilat vs unilat inj & assessment of max voice improvement in response to each. None

Botox is a useful tx for ADSD. Inj should be initiated using bilateral protocol; if pts experience severe side effects, a unilat inj may be offered with understanding that vocal benefit & duration of effect may be reduced. Bilat inj resulted in 14.7 weeks of benefit, 3.2 weeks of breathiness & 1.8 weeks of swallowing difficulty. Unilat resulted in 11.4 weeks of benefit, 2 weeks of breathiness, & 0.9 weeks of swallowing probs. 71% felt bilat inj was superior 29% preferred unilat. Pts consistently & sig rated voice improvement higher after bilat than unilat inj. Men had prolonged benefit with bilat inj; women did not. Absent

Hyperkinetic (SD) SD

Not a tx study per se. Rationale was to determine if botox tx for Sd would influence depression, anxiety, & somatic complaints. 1 None

Self-ratings of anxiety, depression, and somatic complaints None

SD Ss exhibit elevated levels of depression & anxiety preinj. They were sig reduced ~ 1 week postinj & maintained 2 months later. Results suggest that SD pts with elevated depression and anxiety show reduction in those after inj. Present

Hyperkinetic (ADSD) ADSD

To determine outcome of laryngeal botox using flexible nasolaryngoscope for inj instead of traditional transcutaneous technique 1

1. Spectrographic analysis of pitch breaks, phonatory breaks, sentence duration, aperiodicity, & Fo. 2. Videolaryngoscopy to examine changes in mucosal wave.

Pt diaries of magnitude & duration of side effects and change relative to preinj voice None

Flexible nasolaryngoscopic technique is a safe & effective technique for inj botox into laryngeal muscles for tx of SD. Results seem comparable to those reported for other approaches

Reliability apparently checked for speech measures but not for videolaryngoscopy


Typical rationale for botox. Compare outcomes of unilat vs bilat injection because results of prior studies were inconsistent. 1

max phonation time; SD of Fo; jitter, shimmer; S/N; Fo; voice breaks/sec; spasm severity; breathy voice None None

Standard unilat & bilat botox inj provide equivalent degrees of improvement in sx of ADSD. Bilat inj are assoc. with longer period of excessive phonatory airflow than unilat inj.

Reliability for perceptual scaling provided


To determine if adjunctive voice tx results in longer period between injections than botox without voice tx. 1 1

Airflow measures, acoustic analysis

Duration between injections was primary outcome measure None

ADSD is txd most effectively when txd with botox & extrinsic hyperfunctional vocal behaviors are txd with voice tx after injection. Duration between injections was greater for those with voice tx + botox than botox alone, including after a subsequent inj without subsequent voice tx in those initially receiving voice tx Absent


Hypothesized that vocalization immediately after inj would increase neuro/metabolic activity of target neurons, and possible enhance botox binding to targets 1

Aerodynamic measures of subglottic pressure, translaryngeal airflow, & laryngeal resistance. Acoustic analysis of Fo, SDFo, shimmer & jitter, SN ratio, & max phonation time

Perceptual ratings by SLPs of severity of spasm & degree of breathiness None

Vocal rest, rather than vocalization for 30 min following botox inj produces a superior & longer lasting response in SD Pts receiving botox. Both groups had breathiness & reduced spasm after inj but nonvocalizing pts had greater reduction in spasm severity at 2 & 10 weeks post inj. Both groups had reduced acoustic abnormalities but nonvocalizers had closer to normal values of max phonation time. Both groups had sig changes in laryngeal resistance, airflow, & variability of airflow but no diffs between groups on aerodynamic measure post inj.


BT Injection


Pts served as own control. Swallowing probs & breathiness did occur & are summarized (see Study conclusions) IV O SCS

Study based on retrospective chart review & prospective phone interviews. Dose level was empirically determined for each pt but avg. was 2.5 per cord for bilat & 4.5 for unilat (percutaneous inj was used). Analysis based on avg. of 3.3 bilat inj & 1.5. unilat inj per subject. Pts did not necessarily receive equal # of txs for the 2 methods compared, so results could reflect that bias (e.g., 1 bad result not necessarily due to unilat vs bilat effect may have biased subsequent choice of inj method & stated preference.

Measures compared to normal controls. Measures compared at 3 points in time (preinj, 1 week postinj, 2 months postinj). Not addressed III E C

Study found depression & anxiety to be elevated in SD pts (in ~ 50% of the group) as compared to controls, but not elevated on measure of somatic complaints. Depression & anxiety reduced after inj to levels well within normal limits, with no pt receiving a score that would suggest referral for psychiatric care. Authors point out that results don't necessarily support a psychogenic cause of SD; results suggest elevated depression & anxiety are result not cause of SD.

Acoustic measures were blinded re inj status. Pre vs post inj comparisons.

No airway problems, allergic reactions, or serious dysphagia with aspiration. 9 pts had mild swallowing difficulty for avg. of 14 days. 8 had breathiness for avg. of 23 days. 7 had abnormally high pitched voice for avg. of 69 days. III E C

Pts were not randomly assigned to unilat vs bilat inj. Optimal inj dose was established for unilat & bilat inj by inj some pts & examining results; unilat in received total of 6 units divided across 2 locations in the TA. Bilat inj were 2 units into one site in each TA. After initial inj some pts had dose adjusted. The inj technique is very well described. Both groups improved comparably in breaks & sentence length. Videolarng showed reduction in asymmetry of movement in both groups. All pts reported improvement & said procedure was tolerable; they were willing to have the technique again. Mean duration of reduced sx was 136 days (90-238), comparable to their reported results with EMG technique. Paper presents very nice summary of advantages and disadvantages of the technique, including relative to percutaneous-EMG technique..

Random assignment of pts to tx groups (unilat vs bilat). 15 control Ss also assessed for comparative purposes. Perceptual ratings were blinded. Breathiness and reduced max phonation time at 2 weeks in both groups at 2 weeks II E C

Bilat group had sig greater reduction of max phonation time than the unilat group at 6 weeks. Both groups differed from controls on SDFo, jitter, shimmer, S/N, voice breaks, & spasm severity pre injection. They differed from controls on all acoustic and perceptual measures postinj, except Fo (at all points postinj) and breathiness at 6 weeks. Measures were made preinj and at 2 & 6 weeks postinj.

Pts txd with voice tx were also seen after a period of no tx after a second botox injection Not addressed III E C

Group assignment was not random; pts who declined voice tx were put in the botox only group, so factors of motivation may be relevant. Although those receiving voice tx were also followed after botox without voice tx, this was not counterbalanced; it would have been better if all pts were followed for a no tx period and then the voice tx study begun This is a good study in the sense that it combines medical & behavioral tx. Results not entirely convincing but impressive enough to warrant work toward clinical trial.

Random assignment to treatment groups. Perceptual ratings were blinded to tx group assignment

Both groups had sig increase in breathiness at 2 weeks, more so in the nonvocalizing group II E RCS

Good study of the comparisons made (vocalizing vs nonvocalizing post inj) that provides general support for the effectiveness of botox in general. The vocalizing group had sig greater laryngeal resistance before injection so it is possible that severity index influenced outcome of comparisons, although there were apparently no sig differences preinj on any other measures. Reliability of perceptual judgments was reported but not reliability of acoustic & aerodynamic measures.


BT Injection


31

Wong, DLH, Irish, JC., Adams, SC., Durkin, LC., & Hunt, EJ. (1995). Laryngeal image analysis following botulinum toxin injections in spasmodic dysphonia. Journal of Otolaryngology, 24, 64-68. Wong et al 1995 Voice/SD 1

quantification by endoscopic video laryngeal images of pre and post laryngeal botox injection parameters in pts randomized to nonvocalization & vocalization groups postinjection 17 1 1 1 0 1 0 0 0 1 0 1 0 0 0 0 0 0 0 0 6

ADSD without prior laryngeal surgery, trauma, CA, RoRx, sensitivity to botox, other laryngeal path, or sig health probs

32

Adams, SG, Durkin, LC, Irish, JC, Wong, DLH, Hunt, EJ. (1996). Effects of Botulinum Toxin Type A Injections on Aerodynamic Measures of Spasmodic Dysphonia, Laryngoscope, 106, 296-300. Adams et al 1996 Voice/SD 1c

Effects of bilateral percutaneous laryngeal botox on aerodynamic measures of phonation in pts with ADSD 30 1 1 1 0 1 0 0 0 1 0 1 0 0 0 1 0 0 0 0 7 Pts with clinical dx of ADSD

33

Davidson, BJ, Ludlow, CL. (1996). Long-Term Effects Of Botulinum Toxin Injections In Spasmodic Dysphonia. Annals of Otology, Rhinology & Laryngology, 105, 1, 33-42. Davidson & Ludlow 1996 Voice/SD 1

Motor unit characteristics, muscle activation patterns, & cord movement characteristics in injected and noninjected thyroarytenoid muscles receiving botox for ADSD 6-38 mo. Postinj. 7 1 0 1 0 1 0 0 0 1 0 1 0 0 0 0 0 0 0 0 5

Pts with ADSD who had received 2-7 unilateral TA botox inj, ranging from 10-15 units per inj

34

Fisher, KV, Schere, RC, Owen, AS. (1996). Longitudinal Phonatory Characteristics After Botulinum Toxin Type A Injection. Journal of Speech and Hearing Research, 39, 968-980. Fisher et al 1996 Voice/SD 1

Quantification of glottic variability during 10-week period post botox injection 1 1 1 1 0 1 1 0 1 1 1 1 1 0 1 1 0 0 0 0 12

Single S with ADSD treated with botox

35

Inagi, K., Ford, CN, Bless, DM, Heisey, Dennis. (1996). Analysis of Factors Affecting Botulinum Toxin Results in Spasmodic Dysphonia. Journal of Voice, 10, 306-313. Inagi et al 1996 Voice/SD 1c

Retrospective study of differences in effectiveness of laryngeal botox for ADSD as a function of dosage & site of injection 64 1 1 1 0 1 1 0 1 1 1 0 0 0 0 1 0 0 0 0 9

Pts with ADSD with or without a tremor component, all who had > 1 botox injection

36

Koriwchak, M.J., Netterville, J.L., Snowden, T., Courey, M., & Ossof, R.H. (1996). Alternating unilateral botulinum toxin type A (Botox) injections for spasmodic dysphonia. Laryngoscope, 106, 1476-1481.

Koriwchak et. al.

1996 Voice/SD 1 1 Laryngeal Botox 18 1 1 1 0 1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 6

Patients with adductor SD dissatisfied with duration or severity of breathy voice following bilat. Botox. All pts had at least 2 bilat & 2 unilat injections

37

Liu, T.C., Irish, J.C., Adams, S.C., Durkin, L.C., & Hunt, E.J. (1996). Prospective study of patients' subjective responses to botulinum toxin injection for spasmodic dysphonia. Journal of Otolaryngology, 25, 66-74.

Liu et al

1996 Voice/SD 1c

Patients subjective diary responses to effect of unilateral or bilateral laryngeal botox on spasms, hoarseness, breathiness, volume problems, and dysphagia, completed from day before injection through post injection period. 31 1 1 1 0 1 1 0 0 1 1 0 0 0 0 1 0 0 0 0 8

Dx of SD without previous laryngeal surgery, trauma, or pathology who were medically safe for botox & who completed diary data


BT Injection



Laryngeal botox tx, standard with 2 randomly assigned groups, one that read aloud for 30 min postinjection, one that was silent for 30 min postinjection 1 1 1

Video image analysis, still frame None None

Quantitative measures of laryngeal images are less sensitive measures (of limited value) of botox tx than perceptual, acoustic or laryngeal aerodynamic measures. Absent


Botox as effective tx for ADSD. Purpose was to examine effect of inj on aerodynamic measures assuming tx would be effective 1

Measures of air pressure, avg. airflow, CV of airflow, & laryngeal resistance None None

Aerodynamic measures were useful in assessing voice production in SD. Air pressure, variability of airflow, & laryngeal resistance distinguished SD pts from normal Ss. Avg. airflow, laryngeal resistance, & CV of airflow were useful in tracking effects of tx over time (avg. airflow increased, & laryngeal resistance & variability of airflow decreased after inj).. They rec that aerodynamic measures be used in future outcome studies.

Normals were reliable over two testing sessions. No repeated measures for ADSD pts pre-inj.

Hyperkinetic (ADSD) SDStandard laryngeal botox rationale. This was not a tx study per se. 1 EMG, fiberoptic video None None

Although physiologic effects of botox are reversible, the reinervation process continues past 12 mo. postinj. Motor unit char. differed between inj & noninj muscles & were greater in pts <12 mo. postinj. Asymmatric cord motion was apparent in some pts Absent

Hyperkinetic (ADSD) SDStandard for bilat laryngeal botox for ADSD. 1

Kinematic & aerodynamic measures to track changes in voice + perceptual ratings of voice by clinicians & patient None None

Change in degree of glottal adduction over time can be observed even when vocal stability is present. Perceptual ratings of voice quality were related to laryngeal measures. Methods used may aid decisions about dose level & sources of perceptual ADSD for given patient

No reliability for EGG & aerodynamic data. Reliability of clinician perceptual data were reported (& in some instances, not very good)


Standard laryngeal botox tx (peroral) for ADSD with retrospective analysis of injection dose, site, and side on outcome 1 None

Pt ratings of duration of voice improvement & side effects None

1. Bilat single TA+LCA inj yielded longer intervals between injections than other inj types except bilat multiple TA+LCA inj. 2. Unilat multi TA+LCA inj increased duration of best voice & voice improvement more than did unilat inj of either TA or LCA. 3. For inj of TA, bilat inj prolonged dur of best voice & voice improvement. 4. Patterns of inj did not show sig diffs where both TA & LCA muscles were inj. 5. Variation of inj affected duration of voice improvement & improved duration largely due to prolonged best or optimal voice. MAIN conclusion is that initial tx should be a single unilat inj placed at posterior portion of TA & directed toward LCA so both muscle groups are affected. Absent

Hyperkinetic (ADSD) SDUnilateral injection hypothesized to reduce duration of breathy interval after botox injection in patient dissatisfied with breathiness

1

Patient diaries rating duration & severity of breathiness and good voice following botox

Patient judgments of "effectiveness" of injection.

None

Alternating unilateral injections reduce breathy interval by ~13 days and provide ~ 3.2 more days of strong voice per day of breathy voice than bilateral injections, BUT yield shorter duration of strong voice & higher failure rate (4.9% vs 1.1%). Conclude that alternating injections are useful in SD pts who have difficulty with breathy voice following bilateral injections. 17/18 judged unilateral inj to be effective; 1 preferred bilat inj & returned to it.

Absent

Hyperkinetic (SD) SDStandard unilateral or bilateral percutaneous botox. Diaries were felt to be valid outcome measure for tx

1

NonePatient diaries rating duration and magnitude of vocal spasm, hoarseness, breathiness, volume, & swallowing dimensions from pre injection to course of post injection benefits & side effects.

None

Most side effects resolve by 4-6 weeks; spasm relief persists beyond side effects; 84% have spasm relief; unilateral injections have fewer swallowing and loudness side effects than bilat; patient diaries are extremely useful outcome measure, and maybe one of the most valid outcome measure.

Patients self ratings over time


BT Injection


Random assignment of pts to vocalization & nonvocalization groups Not addressed II E RCS

This study really only looked at the video image analysis. They refer to a previous study that examined acoustic, perceptual & aerodynamic measures for the same Ss but those data not presented here. The results of this study basically indicate that the still image analysis was not sensitive to changes after botox, even though other measures indicated the injection was effective. The other study by these authors is the important one for the guidelines because this is really not a true study of the treatments efficacy (Wong et al '95).

Measures made pre-inj, & at 2-4 weeks and 10-12 weeks postinj. None discussed III E C

Poor description of pt sample. Data compared to a normal control group. No indication of reliability of measures & no indication about whether readings were blinded re pre vs post tx. Study really didn't examine effectiveness of tx but rather looked at effect of tx on aerodynamic measures relative to normal. Normals were tested on 2 occasions which is good (& no differences were found).

Unclear if judges of physio or fiberoptic studies were blinded to time post onset. The uninjected cord did serve as a control for comparisons with inj cord. None discussed NA NA

This was really not a tx effectiveness study. It examined physiologic effects of botox on the cords without regard to the clinical outcome for Ss. It can be assumed the inj were successful but this is not made explicit in the article. The study does demonstrate that the inj has physiologic effects on vocal cord function.

Pre vs post inj & longitudinal post inj data & within session variability measured against across session variability to validate longitudinal changes Not addressed IV E SS

Good sophisticated EGG & aerodynamic study documenting changes post botox & making a case for their potential to aid certain aspects of clinical decision making. I find it perplexing, however, that reliability of perceptual ratings is attended to ( with unreliability used as part of the case for using physiologic measures) but not reliability of the physiologic measures. Seems one can't use unreliability of one kind of measure to make a case for using another measure unless the other measure is more reliable than the indicted one.

Patient ratings over time course following multiple injections (total of 426 injections examined across 64 Ss. Successive injection strategy based on prior result, so no random assignment to treatments. Post-treatment breathiness duration reported. Most/all patients had some. IV O SCS

This is a retrospective outcome study based on patient self-reports across > 1 injection. Pts were not randomly assigned to treatments examined (different sites & sides) so true control is lacking. Each treatment based on outcome of last treatment so comparisons are confounded by clinical judgment on a case by case basis. It probably does represent fairly well the realities of clinical practice, however.

Results of unilateral injections compared to bilateral but no random assignment & all unlat injections came after bilateral; no return to bilat as part of design

The study really examined the side effect of breathiness. Data on swallowing difficulty also presented, with 6/12 patients with dysphagia after bilat injection reporting elimination of dysphagia after unilateral injection & only 2 with increased dysphagia after unilat injection

IV O SCS

A good outcome comparison study. Lacks randomization of treatments & some reliability data but good face validity for rationale and outcomes. All data based on patient report of sx & satisfaction, so social validity is high. The study does not establish that unilateral is better than bilateral injection for all pts with SD; it does suggest it is better for those dissatisfied with breathiness after bilateral injection.

Ratings over time by patients. No control group. No control for placebo effect. Ratings done for more than 1 injection so reliability might be improved for group data. No random assignment of Ss to groups

77% had reduced volume and 70% breathiness, 57% hoarseness, usually beginning by day 2, reaching max at day 5 & lasting 4-5 weeks & resolving in 4-5 weeks. Mild swallowing probs occurred in 53%, were max at 1.8 weeks, & resolved by 27 days

IV E C

1. Not specified if SD was adductor or abductor but assume it was ADD.2. No diff between males & females. 3. No diff between unilat vs bilat injection for benefits but unilat injections caused sig less swallowing & reduced volume probs problems. 4. 84% of injections analyzed (some Ss had > 1 injection) had relief of vocal spasms, with benefit lasting for avg. of 135 days, with max benefit beginning at 10 days & lasting for 42 days. For most Ss with mild-mod spasms, BT offered complete relief; sig. partial relief for those with more severe spasm. Authors suggest 15 units unilaterally are preferable to 2.5 units bilaterally.


BT Injection


38

Sedory Holzer, S.E. & Ludlow, C.L. (1996). The swallowing side effects of botulinum toxin Type A injection in spasmodic dysphonia. Laryngoscope, 106, 86-92.

Sedory Holzer & Ludlow 1996 Voice/SD 1 1c

Swallowing abnormalities in SD patients before & after botox injection as measured by laryngeal movement durations during spontaneous, dry, liquid syringe, & liquid cup swallows. 13 1 1 1 0 1 1 0 1 1 0 1 0 0 0 1 0 0 0 0 9

ADSD without prior surgical tx whose sx were not controlled with voice tx (+ 6 normal controls)

39

Tewary, AK. (1996). Correlation between clinical response and injection quality in treatment of spasmodic dysphonia. Journal of Laryngology and Otology, 110, 551-553. Tewary 1996 Voice/SD 1 1c

Relationship between clinical response & technical quality of laryngeal botox inj for SD 12 0 0 1 0 0 1 0 0 1 0 1 0 0 0 1 0 0 0 0 5

Pts with SD who had previously responded well to botox. 2 injections per patient were examined

40

Crevier-Buchman, L., Laccourreye, O., Papon, J.F., Nurit, D., & Brasnu, D. (1997). Adductor spasmodic dysphonia: case reports with acoustic analysis following botulinum toxin injection and acupuncture. Journal of Voice, 11, 232-237.

Crevier-Buchman et al

1997 Voice/SD 1

Acoustic parameters in response to laryngeal botox vs acupuncture for SD 2 1 1 1 1 1 1 0 1 1 0 0 0 1 0 1 0 0 0 0 10

ADSD for 2 years, without benefit from voice tx; one pt elected botox, the other refused and elected acupuncture.

41

Epstein, R., Stygall, J., & Newman, S. (1997). The short-term impact of botox injections on speech disability in adductor spasmodic dysphonia. Disability and Rehabilitation, 19, 20-25.

Epstein, Stygall, & Newman

1997 Voice/SD 1

Impact of laryngeal botox injection on speech disability of people with ADSD 40 1 1 1 0 0 0 0 1 1 1 0 0 0 1 1 0 0 0 0 8

Dx of ADSD

42

Maleca, R.J., Hogikyan, N.D., Bastian, R.W. (1997). A comparison of methods of botulinum toxin injection for abductory spasmodic dysphonia. Otolaryngology - Head and Neck Surgery, 117, 487-492.

Maleca, Higikyan, & Bastian

1997 Voice/SD 1 1

Compared results of 2 approaches to injecting PCA muscles to treat ABSD (retrocricoid vs transcricoid) 6 1 1 1 0 1 1 0 1 1 0 0 0 0 0 1 0 0 0 0 8

ABSD treated with both retrocricoid & transcricoid approaches to the PCA muscles who were available for the telephone survey method used in the study

43

Zwirner, P., Murry, T., & Woodson, G.E. (1997). Effects of botulinum toxin on vocal tract steadiness in patients with spasmodic dysphonia. European Archives of Otorhinolaryngology, 254, 391-395.

Zwirner, Murry, & Woodson

1997 Voice/SD 1cEffects of laryngeal botox for ADSD on upper vocal tract steadiness 16 1 1 1 1 1 1 0 1 1 1 0 0 0 1 0 0 0 0 0 10

Dx of ADSD; no prior botox; no prior surgery for SD; all failed speech tx. 10/16 SD Ss had laryngeal tremor (not criteria for admission to study)

44

Blitzer, A., Brin, M. F. & Stewart, C. F. (1998). Botulinum toxin management of spasmodic dysphonia (laryngeal dystonia): a 12-year experience in more than 900 patients. Laryngoscope, 108 (10), 1435-1441.

Blitzer, Brin, & Stewart

1998 Voice/SD 1 Laryngeal Botox 901 1 1 1 0 1 1 0 0 1 1 0 1 0 1 1 0 0 0 1 11

Adductor, abductor, & mixed spasmodic dysphonia (laryngeal dystonia)


BT Injection



Standard unilat or bilat laryngeal botox for ADSD. Aim of study was to examine side effects. 1

EMG & piezoelectric measures of swallowing (mylohyoid complex) duration

Patient ratings of swallowing difficulty None

1. Laryngeal mvt durations were increased prior to inj. only in those who reported pre injection swallowing probs (n=4). 2. 12/13 had swallowing probs for avg. of 11.9 days after injection (moderate-severe in 8/13), but none with aspiration.2. Those with mod-severe swallowing probs postinj had longer mvt durations postinj. 3 All 4 with swallowing probs preinj had severe probs postinj. 4. no relationship between age, dosage, & preinjection movement duration & change in movement duration postinjection.5. Increased mvt durations during swallowing can occur before & after botox, before because of incr muscle activity, after because of decr activity Absent


To compare technical adequacy of percutaneous bilateral TA injection to outcomes in pts known to have responded well to botox. 1 1 EMG

Pt ratings of side effects & voice quality None

Technically poor injections are assoc with decreased clinical response to botox Absent

Hyperkinetic (ADSD) ADSDBotox as tx of choice for SD; acupuncture as alternative to correct imbalance in energy regulation or dystonia

1 1 1

Acoustic data

None

NoneBoth Ss improved. Improvement after acupunture was comparable to improvement after botox; voice & speech parameters were maintained 1 year after acupuncture

Absent

Hyperkinetic (ADSD) ADSD Standard use of laryngeal botox for ADSD

1 1

None

Severity ratings by SLPs of muscle tension, breathiness, & overall voice.

Speech Disability Questionnaire (SDQ), a 28 item self-administered questionnaire that assesses handicap (only 23 items used for analysis)

Factors of social isolation, negative communication, & public avoidance were less prominent after injection. Voice ratings also improved but voice ratings did not correlate with SDQ findings. Conclude that impairment (as measured by voice ratings) does not necessarily predict disability and handicap.

Reliability for ratings of speech by 2 SLPs are provided. Disability Questionnaire given only pre & post injection & not repeated for any subsequent injection

Hyperkinetic (ABSD) ABSDTo compare outcome & preferences for transcricoid vs retrocricoid approaches to injecting PCA muscles for ABSD

1

Pt ratings of voice improvement, discomfort, side effects, & overall satisfaction



All pts satisfied with results from both techniques.2/6 felt voices were better with transcricoid approach; others reported no difference. Transcricoid approach assoc with less discomfort. 4/6 had more side effects with retrocricoid approach; 2/6 reported no difference. No dysphagia, infection, or breathing difficulty with either technique. OA satisfaction was high for both techniques. Senior author preferred transcricoid because technically easier, faster, & less stressful to pts..

Absent

Hyperkinetic (ADSD) ADSD Standard use of botox to tx ADSD

1

Acoustic data

Severity rating that captured "ability to communicate" and career/social changes

Severity rating that captured "ability to communicate" and career/social changes

Botox injections had no discernable effect on stability of upper vocal tract but did positively affect laryngeal stability Absent

Hyperkinetic (dystonic or tremor)

Primary or secondary laryngeal dystonia; focal, segmental cranial, all segmental, generalized

People with signs and symptoms of SD of sufficient severity to require symptom relief were treated with laryngeal Botox injections to weaken injected muscles and relieve spasms

1

Article states videostroboscopic exam, acoustic & aerodynamic measures, EMG, & perceptual measures are made but they are not reported in this article

Primary outcome measure reported is a rating of "% of normal function" made by patients, physicians, & SLPs; article implies patient ratings are reported. Ratings of overall severity, breathiness, aphonia, & voice tremor also made but not reported. Duration of benefit also reported. No report of disability,

just "% of normal function."

"Botulinum toxin A of the laryngeal hyperfunctional muscles has been found over the past 12 years to be the treatment of choice to control the dystonic symptoms in most patients with spasmodic dysphonia. "Adductor patients derived "90% of normal function benefit" for avg. of 15 weeks. Abductor patients derived 67% of normal function for avg. of 10.5 weeks

Absent


BT Injection


Physiologic measures and patient ratings of swallowing pre and postinjection. Results compared to a control group. Not clear if controls were assessed on two occasions or only one (probably only once) See study conclusions NA NA

1. No reliability reported for physiologic measures & no indication about blinding of raters of swallowing duration. 2. Documents presence & duration of swallowing probs before & after botox. Label of swallowing probs as "severe" seems excessive as no patient had aspiration. Authors say "it may not be necessary to reduce the dosage to prevent significant dysphagia" following injection because none has aspiration or "extreme" dysphagia.

Patients who rated outcome were not aware of ratings of technical quality of injections. Pts with poor result had previous or subsequent good result so we know they were botox responsive.

One week of weak breathy voice & "aspiration of fizzy drinks" in groups with good & technically poor injections & various voice results (I.e. all groups). IV O SCS

16 % of injections in this study were assoc with unsatisfactory results which the au attrib to his inexperience. All pts with unsatisfactory inj had a previous or subsequent satisfactory injection confirming likelihood that technical quality of inj was crucial factor. Poor S description & data quality re voice ratings.

No control except for pre tx vs post tx acoustic data None discussed IV O CSPoor study re control & psychometric adequacy. Acupuncture tx would not be replicable. Authors note that a certain psychological patient profile may be discovered for which acupuncture is satisfactory.

Pre vs post comparisons on ratings of voice and disability ratings. No control group None discussed except to not breathiness during first week postinjection IV O SCS

1. Postinjection effects measured at 1 week postinjection, a time when breathy, weak voice side effect may still be active, & maximum benefit not yet present, so any reduced disability likely to represent a minimal estimate of benefit. 2. The injection would be replicable but the Speech Disability Questionnaire is not provided, so the measure of effectiveness could not be replicated. 3. Unknown # of prior injections per subject.

All Ss received both treatments. Measures made after both treatments were completed

Patient report solicited and rated for severity. Most injections associated with some discomfort, more frequent & prominent in response to retrocricoid approach. 4/6 had more side effects with retrocricoid approach, including subcutaneous hematoma and neck discomfort. 2/6 felt side effects were equivalent

IV O SCS

Comparison based on patient ratings only but that may be the most valid measure of "social" validity. Study was retrospective in that phone interviews were conducted after both treatments were completed, so ratings were relative to one another and not made independently, a possible problem when injections are several months apart.

Findings for SD group compared to control group None discussed III E C

Study demonstrates laryngeal instability (as measured by SD of Fo) in ADSD as compared to controls, and improved stability (but still not normal) after botox. For SD group, F1 & F2 were not sig different from control preinjection (a trend toward instability was present for SD group) & there was no change postinjection. 10/16 SD Ss had evidence of laryngeal tremor. No data on reliability of perceptual ratings or acoustic results & no info on whether judges were blinded to patient or group status.

Baseline ratings of % of normal function, data regarding duration to onset of effect, peak effect, & duration of effect, and change in percent of normal function with treatment are provided. No placebo treatment. No blinded judgments.

In adductor patients, mild temporary breathiness (in 35%), coughing on fluids (15%); <1% had local pain/sore throat, slight blood tinged sputum, itch, or rash. In abductor patients, mild stridor in ~4%; ~ 10% had dysphagia; side effects usually lasted < 1 week

IV O SCS

A good outcome study that documents the effectiveness of this tx. The conclusion that botox is the treatment of choice for SD is not justified by the data reported because the study did not compare botox to other treatments (although they do report that it was effective after some other treatments had failed or lost their effect (i.e., recurrent laryngeal nerve resection, anterior commissure release).


BT Injection


45

Brin, M.F., Blitzer, A., Stewart, C. (1998). Laryngeal dystonia (spasmodic dysphonia): observations of 901 patients and treatment with botulinum toxin. Advances in Neurology, 78, 237-252.

Brin, Blitzer, & Stewart 1998 Voice/SD 1 Laryngeal Botox 901 1 1 1 0 1 1 0 0 1 1 0 1 0 1 1 0 0 0 1 11


46

Fisher, K.V., Giddens, C.L., & Gray, S.D. (1998). Does botulinum toxin alter laryngeal secretions and mucociliary transport? Journal of Voice, 12, 389-410.

Fisher, Giddens, & Gray

1998 Voice/SD 1 1 Laryngeal botox 29 1 1 1 1 1 1 0 0 1 0 0 0 0 0 1 0 0 1 1 10

ADSD patients receiving laryngeal botox

47

Garcia Ruiz, P.J., Espanol, C.C., Sanchez Bernardos, V., Astarloa, R., Sanabria, J., & Garcia de Yebenes, J. (1998). Botulinum toxin treatment for spasmodic dysphonia: percutaneous versus transoral approach. Clinical Neuropharmacology, 21, 3, 196-198.

Garcia Ruiz et al

1998 Voice/SD 1 1c

laryngeal botox - comparison of results from percutaneous vs transoral injection for ADSD 29 1 1 1 0 1 1 0 0 1 0 0 1 0 0 0 0 0 0 0 7

ADSD

48

Langeveld, T.P.M., Drost, H.A., & Baatenburg De Jong, R.J. (1998). Unilateral versus bilateral botulinum toxin injections in adductor spasmodic dysphonia. Annals of Otology, Rhinology, & Laryngology, 107, 280-284.

Langeveld et al

1998 Voice/SD 1

Comparisons of outcomes of unilateral versus bilateral laryngeal botox injections for ADSD 27 1 1 1 0 1 1 0 1 1 1 0 0 0 1 1 0 0 0 0 10

Dx of ADSD with no prior surgery or botox injection for SD. All pts received the identical unilateral dose (5 units) and bilateral dose (2.5 per cord)

49

Lundy, D.S., Lu, F.L., Casiano, R.R., & Xue, J.W. (1998). The effect of patient factors on response outcomes to botox treatment of spasmodic dysphonia. Journal of Voice, 12, 460-466.

Lundy et al


Adductor SD with at least 1 botox injection in a 5 year period. Those with voice tremor or other laryngeal pathology excluded.

50

Schonweiler, R., Wohfarth, R., Dengler, R., & Ptok, M. (1998). Supraglottal injection of botulinum toxin Type A in adductor type spasmodic dysphonia with both intrinsic and extrinsic hyperfunction. Laryngoscope, 108, 55-63.

Schonweiler, Wohfarth, Dengler, & Ptok


Adductor SD with visible glottal & supraglottal hyperactivity in laryngoscopy

51

Whurr, R., Lorch, M., Lindsay, M., Brookes, GB., Marsden, CD., & Jahanshahi, M. (1998). Psychological function in spasmodic dysphonia before and after treatment with Botulinum Toxin. Journal of Medical Speech-Language Pathology, 6, 81-92.

Whurr et al

1998 Voice/SD 1Psychological function in pts with SD before & after treatment with botox 46 1 1 1 1 1 0 0 1 1 1 0 1 0 1 0 0 0 0 1 11

Dx of SD inpts successively referred to a neurolaryngology clinic


BT Injection





1

See Blitzer, Brin & Stewart ('98) See Blitzer, Brin & Stewart ('98) See Blitzer, Brin &

Stewart ('98)

"Botulinum toxin A of the laryngeal hyperfunctional muscles has been found over the past 12 years to be the treatment of choice to control the dystonic symptoms in most patients with spasmodic dysphonia. "Adductor patients derived "90% of normal function benefit" for avg. of 15 weeks. Abductor patients derived 67% of normal function for avg. of 10.5 weeks

Absent


ADSD. Not a tx study per se. Examined possible side effect. Study based on fact that localized botulinum toxin disrupts cholinergic transmission & has potential to cause focal dysautonomia

1

Patient report of motor & sensory side effects None

None

Some pts (14%) receiving bilat percutaneous botox injections for SD report burning, tickling, or irritation of larynx/throat, excessive thick secretions, or dryness, sx that are consistent with but not diagnostic of the known effects of botox on cholingergic, autonomic transmission. These effects begin ~ 1 week after injection & persist for ~ 5 weeks

Absent


Percutaneous & transoral approaches each have advantages and disadvantages, but not known if transoral is as effective as percutaneous

1

Response to injection rated on 3 point scale (excellent to no response)

None

None

Transoral technique is more frequently successful (100% successful vs 80%) and mean response per treatment was superior. But they concluded that percutaneous is probably the initial selection because it is less complicated & uses fewer resources; transoral could be used in pts with poor response to percutaneous or inpts with severe or complicated ADSD.

Absent

Hyperkinetic (ADSD) ADSD To compare effectiveness of unilateral vs bilateral laryngeal botox for ADSD

1

None

Rating scales for intelligibility, fluency, breathiness, & swallowing probs

None

Unilateral & bilateral injections do not differ in duration of improvement or in occurrence of breathy dysphonia. Sig. more pts report swallowing probs after bilat injection. Most pts preferred bilat injection in spite of longer-lasting side effects. 85% of patients experienced positive effect of botox after both procedures.. 4 pts derived no benefit after either tx, but 3/4 derived benefit after dose was raised on subsequent injection. The overall success rate was 96%..

Reliability of rating scales not established

Hyperkinetic (ADSD)

SD (29% with dystonia elsewhere in body; 2 patients with Meige syndrome)

Botox as treatment of choice for SD. Purpose was to examine effect of gender, severity, associated movements, & dosage variables on outcome

1

Perceptual rating of "severity" by SLP

Patient rating of voice quality, length of response, & duration of breathiness

None

1. Length of response greater in males & following bilateral injections. 2. Breathiness duration longer in bilateral inj. 3 Older patients more severely affected, had higher likelihood of assoc. movements, & more often female; older patients had lower success rates.4. 72% of injections were bilateral 5. Mean dose per injection was 4.9 units total, with greater dose in bilateral injections. 6. Dose was greater in males & those with greater severity. 7. 78% of injections produced near normal voice by patient report; 9% produced no response. 8. Mean duration of response was 16 weeks. 9. 54% of injections assoc with breathiness lasting average of 1.4 weeks; those with breathiness responded longer than those without.

Absent

Hyperkinetic (SD) SD in all Ss. Meige syndrome in 2 Ss

Based on hypothesis that a "ventricular muscle" may contribute to hyperfunction in SD with supraglottal hyperfunction, bilateral injection of botox into ventricular folds was undertaken to determine effect on SD.

1

Videolaryngoscopic, videostroboscopic, acoustic, & patient self ratings of voice quality

None

None

Supraglottal injection in patients with SD with both glottal & supraglottal hyperfunction can normalize supraglottal activity and improve glottal voicing. Benefits lasted from 1 week-4 months. Uncertain if pathologic ventricular muscle activity is addressed or if effect is based on spread to thyroarytenoid muscle

See comments

Hyperkinetic (SD) SD Standard rational for botox for SD

1

Acoustic measures of avg. Fo & FoSD, total voicing time, nonvoicing time & sample duration. Three self-report questionnaires measuring psychological function

None None

Preinjection, 63% had no depression; 37% had mild-moderate depression. Post tx, voice quality & fluency improved. Somatic, anxiety, & phobia scales were sig improved postinj for male pts but not female pts.

Absent


BT Injection


See Blitzer, Brin & Stewart ('98) See Blitzer, Brin & Stewart ('98) IV O SCS

The data here are those presented by Blitzer, Brin & Stewart ('98) in a refereed article. This is a chapter that largely duplicates the article, although it details diagnostic evals, tx techniques for ADSD & ABSD, and reviews in some detail genetics & antibody responses. They also review decision making re dosage & different injection techniques, the difficulties distinguishing dystonic from essential laryngeal tremor. Of interest they state they recommend speech tx for all BTX pts "in order to relearn how to most effectively utilize their vocal muscles and breathing strategies after BTX therapy." They recommend 2-3 visits per year "to refresh the therapeutic exercises and recommendations." They present no data relative to this, however.

Side effects examined were not present before injections. All data based on patient report & pts served as their own "control." No comparison group.

Purpose of study was to examine the possible autonomic complications of botox. Data also reported on other side effects (e.g. pain (52%), swelling (7%), constriction (7%), numbness(3%)).

NA NA

A descriptive study of postinjection side effects which might reflect dysautonomia. In general, such side effects were infrequent & not severe. Results don't represent evidence of dysautomia, just the possibility of it. No pt had evidence of generalized dysautonomia after injection. Authors suggest vocal cord protection against drying is robust. Data on other side effects (e.g., pain) are useful.

Poor. No clear indication of how pts were assigned to treatments. Attempt made to do percutaneous followed by transoral but those who did well with percutaneous did not get transoral & those who did well with transoral were not switched to percutaneous. 10 had percutaneous; 9 had transoral; 10 had both.

1 pt developed stridor & resp. distress requiring trach after percutaneous injection; did well with transoral after that; 3 had moderate discomfort with transoral; both groups had similar incidence of transient aphonia.

IV O SCS

Poorly controlled retrospective study in which ratings of success are poorly described (without reliability data). It does seem to demonstrate that both percutaneous and transoral approaches can be successful in treating SD, and it suggests that transoral has fewer failures and more positive results when successful.

All Ss received both treatments with the second treatment not given until effects of initial treatment were absent

Presence and duration of postinjection breathiness & swallowing difficulty were measured. Breathiness occurred in 13/27 pts after unilateral injection, lasting for a mean of 15 days.16/27 pts had breathiness after bilat injection, lasting an average of 15 days. These differences were not stat. significant. Mild swallowing difficulty was sig more frequent after bilat injection, lasting 15 days in 15 patients vs 11 days in 9 patients after unilateral injection

III E SS

Pretty good study. 1. No reliability for rating scales used. 2. Unilateral injection always done first, so there is a possible confound by the order effect, especially regarding pts judgment about preferred tx (I.e., unilat vs bilat). 61% preferred bilat injection; 22% preferred unilat; 17% had no preference.

Treatment effect implied by changes in patient ratings following (often) several injections, but no true control Breathiness as a side effect discussed IV O SCS

This is a descriptive outcome study of botox treatment for a fairly large number of patients. No reliability data, no random assignment of patients to treatment conditions (dose, unilateral vs bilateral), and no comparison to other treatments. A useful descriptive outcome study relative to certain patient and treatment variables

7/8 Ss had voice therapy without improvement. No placebo tx. No comparison group. Agreement among video, acoustic, & self rating data in pre and post comparisons support benefit.

Mild swallowing difficulties for max of 14 days. Varying degrees of breathiness for 1-4 weeks. IV O SCS

Reliability of SD dx reported vaguely. Some judges doing stroboscopy ratings were blinded but reliability data not reported for those or acoustic ratings. Authors admit this did not compare to other injection techniques so its relative effectiveness to other techniques is not established, although they suggest it seems as effective as other techniques based on literature.

Pre vs postinj comparisons for acoustic & psych measures Not addressed IV O SCS

Ratings made preinj and at 6 moths post first inj, during which Ss had avg. of 3.2 inj. Psych analysis was not controlled for possible placebo effects and post inj questionnaires were not completed during a controlled point after inj (e.g., when effect was best), so results could be inflated or minimized. The acoustic analysis (done for only 16 Ss) demonstrated a sig reduction in speech duration and reduced SDFo, supporting benefit of the inj.


BT Injection


52

Whurr, R. Nye, C., & Lorch, M. (1998). Meta-analysis of botulinum toxin treatment of spasmodic dysphonia: a review of 22 studies. International Journal of Language & Communication Disorders, 33, 327-329.

Whurr, Nye, & Lorch

1998 Voice/SD 1Meta analysis of treatment effects of botox in laryngeal dystonia 245 1 1 1 1 0 0 0 0 1 1 1 1 0 1 1 0 0 0 1 11

Meta analysis of 22 studies using botox to treat SD

53

Cannito, M. P., Woodson, G., & Murry, T. (1999). Perceptual scaling of spasmodic dysphonia before and after BOTOX injection. Communication and its disorders: A science in progress. Proceedings of the 24th Congress of International Phoniatrics and LOgopedics Association, Vol. 1. Neimegen, the Netherlands: Neimegen University Press, 161-163.

Cannito, Woodson, & Murry

1999 Voice/SD 1c

Visual analog scale (VAS) ratings of voice & fluency attributes ADSD pre versus post botox injection in comparison to nondysphonic controls 42 1 1 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 4

ADSD

54

Finnegan, E.M., Luschei, E.S., Gordon, J.D., Barkmeier, J.M., & Hoffman, H.T. (1999). Increased stability of airflow following botulinum toxin injection. Laryngoscope, 109, 1300-1306.

Finnegan et. al.


Adductor SD, with or without associated vocal tremor

55

Fisher, K.V., Scheer, R.C., Swank, P.R., Giddens, C., & Patten, D. (1999). Electroglottographic tracking of phonatory response to Botox. Journal of Voice, 13, 203-218.

Fisher et.al.

1999 Voice/SD 1 1 Laryngeal Botox 5 1 1 1 0 1 1 0 1 1 1 1 1 0 1 1 0 0 0 0 12

Adductor SD

56

Bielamowicz, S & Ludlow, C.L. (2000). Effects of botulinum toxin on pathophysiology in spasmodic dysphonia. Annals of Otology, Rhinology & Laryngology, 109, 194-203.

Bielamowicz & Ludlow

2000 Voice/SD 1 1

Pre and post laryngeal botox injection EMG response of injected & noninjected laryngeal muscles & their relation to sx reduction 10 1 1 1 0 1 1 0 1 1 1 1 1 0 1 1 0 0 0 0 12

ADSD not previously treated with botox; no other speech or neuro signs

57

Courey, MS, Garrett, CG, Billante, CR, Stone, RE, Portell, MD, Smith, TL, & Netterville, JL (2000). Outcomes assessment following treatment of spasmodic dysphonia with botulinum toxin. Annals of Otology, Rhinology, & Laryngology, 109, 819-822. Courey et al 2000 Voice/SD 1

Prospective, nonrandomized study of consecutive pts undergoing their 1st tx for ADSD with botox. 38 1 1 1 0 1 1 0 0 1 0 0 0 0 0 0 0 0 0 1 7

DS of ADSD. No prior tx with botox

58

Gibbs, S.R., Blitzer, A. (2000). Botulinum toxin for the treatment of spasmodic dysphonia. Otolaryngologic Clinics-Voice Disorders and Phonosurgery I, 33:4, 879-894. Gibbs & Blitzer 2000 Voice/SD 1 Laryngeal Botox 901 1 1 1 0 1 1 0 0 1 1 0 1 0 1 1 0 0 0 1 11


59

Hertegard, S, Granqvist, S & Lindestad, P. (2000). Botulinum toxin injections for essential voice tremor. Annals of Otology, Rhinology, & Laryngology, 109, 204-209.

Granqvist & Lindestad

2000 Voice/EVT 1 1laryngeal botox for essential voice tremor 15 1 1 1 1 1 1 0 0 1 1 0 1 0 1 1 0 0 0 0 11

Essential voice tremor who received laryngeal botox injections

60

Smith, ME, Ford, CN. (2000). Resistance to botulinum toxin injections for spasmodic dysphonia. Archives of Otolaryngology Head Neck Surgery, 126(4), 533-535. Smith & Ford 2000 Voice/SD 1 Resistance to botox in 2 pts with SD 2 1 1 1 0 1 1 0 1 1 0 0 0 0 0 0 0 0 0 1 8 SD & tx with laryngeal botox


BT Injection


Hyperkinetic (SD) SD Standard use of botox to treat SD

1

Acoustic, aerodynamic, laryngeal, neurophysiologic data

Perceptual ratings

Psychosocial outcomes

The average ( 51 year old woman who benefited from injection after 4 days, with benefit for 10 weeks) treated SD patient in the 22 studies obtained 97% improvement as a result of the botox tx. Effect of treatment did not vary as a function of outcome measure examined or site of injection or time when effect was measured. Effect does diminish over time

Meta analysis, so variable

Hyperkinetic (SD) SD Standard use of botox to treat SD

1

Perceptual ratings of 4 aspects of voice (OA quality, breathiness, roughness, brokenness) & 4 aspects of fluency (OA fluency, tension/struggle, dusfluent syll., vocal spasms). Scale from very good/bad

Same as impairment

None

1. VAS as clinical research tool to quantify char of speech disorders & clinical changes seems valid, relaible, & functionally interpretatble. 2. Signif improvement in ADSD (all ratings but breathiness) 1 mo post inj in comparison to pre inj levels, but still less than control ratings. 3. Claims of disfluency in ADSD are supported by these findings

Listeners were blinded to pt pre vs post inj status and normal status. Intra & Interjudge reliability reported & were acceptable

Hyperkinetic (SD +/- tremor

Spasmodic dysphonia without other neuro. Disease

Part of double-blinded, randomized crossover design comparing thyroarytenoid injection to thyroarytenoid+sternohyoid & thyrohyoid injection

1

Measured mean airflow and coefficient of variation (COV) of airflow during phonation

None

None

After botox airflow increases and COV of airflow decreases. Increase in airflow stability could be due to increased stability of the laryngeal system & possibly respiratory system as well. Thus botox helps improve stability of laryngeal system.

Dx of SD was done by consensus. No reliability reported for airflow measures and uncertain if judges doing airflow measures were blinded.

Hyperkinetic (SD with videolaryngoscopic evidence of laryngeal spasm)

SD with head tremor in 1 patient

Treatment not intent of study. Purpose was to examine EGG (changes in glottal competence) in response to laryngeal Botox in Ss with SD in whom Botox tx was appropriate

1

EGG during syllable repetition task; perceptual ratings of severity by SLPs

none

none

There is a trend for reduced vocal fold contact during early postinjection period, followed by a reversal toward greater adduction over time. Injection response could be reliably assessed, was nonrandom, & was replicated in one patient. Data provide limited support for relationship between sx severity & postinjection changes in glottal competence.

Present


to examine changes in laryngeal muscle physiology in relation to sx relief in pts with ADSD following unilateral TA botox injection

1

EMG data Perceptual ratings of voice/speech re intelligibility & listener awareness

None

Muscle activation & spasmodic bursts decreased significantly postinjection in both injected & noninjected TA & CT muscles & reduction in bursts correlated with sx reduction. Results suggests changes in central pathophysiology are responsible for changes in speech sx following tx.

Present/absent

Hyperkinetic (ADSD) SD Standard Botox rationale 1Short Form 36-Item Health Survey & Voice Handicap Index

Short Form 36-Item Health Survey & Voice Handicap Index

Pts perception of their functional, physical, and emotional voice handicap was significantly improved 1 month post inj (re preinj status).Mental health and social functioning were also significantly improved. Pts perception of dysphonia also were lessened postinj. The outcomes "justify the continued treatment of SD with BTX." Absent




1

See Blitzer, Brin & Stewart ('98) See Blitzer, Brin & Stewart ('98) See Blitzer, Brin &

Stewart ('98) See Blitzer, Brin & Stewart ('98) Absent

Hyperkinetic (voice tremor)

Essential voice tremor

Examine effect of laryngeal botox on essential voice tremor

1

Subjective ratings of symptoms by patients, perceptual ratings of degree of tremor & occurrence of voice breaks, & acoustic analysis of connected speech & vowel prolongation

None

None

The treatment is successful in 50-65% of patients, depending on method of evaluation; conclude this is less successful than injections for ADSD (but no formal comparison). Effects could be verified with perceptual & acoustic analyses (I.e., perceptual rating of tremor degree & SD of fundamental frequency)

EMG-guided vs transoral fibroscopy guided route

Hyperkinetic (SD) SD Standard Botox rationale 1bioassay for antibodies to botox None None

The cases demonstrate that, although uncommon, resistance to botox can occur in the tx of SD Present


BT Injection


Meta analysis so variations among studies included None discussed NA NA

Minimal description of the relevant data in studies included and NO listing of the specific studies (I.e. no references), a major weakness. Note that subject characteristics checked as addressed were listed as being coded for analysis but the data themselves are not presented in the paper. So, the bottom line analysis results & conclusion is given and is positive but the source of the data and the data themselves are incomplete.

Listeners were blinded to group status & tx status None discussed except for finding that breathiness ratings increased post inj III E C

A good perceptual study. Strengths are VAS scale, use of control group, & use of expert listeners who were blinded to pt pre-post inj status or control S status. Results document improvement in all voice & fluency attributes post inj (except for breathiness, a known side effect), but also establish that ADSD is still inferior to controls post inj. Weakness is that post inj recording was done at only 1 pt in time (1 month), so may not have captured time of maximum benefit, at least for some Ss.

Pre-injection airflow data compared to post-injection airflow at 2, 4, and 8 weeks. Airflow data for SD Ss compared to normal control data. Stable baseline for airflow not reported for SD Ss or controls

Not reported III E C

Although part of a double-blinded crossover study the focus of this paper is really only on airflow after injection, not a comparison of the two treatments. Thus it tells us something about airflow after botox for SD but not differences in the two treatments. There are no data about "functional benefit" an, in fact, no real description of perceptual voice or speech characteristics before or after tx.

Pre-injection EGG & perceptual ratings of severity, & measures of same at weekly or biweekly intervals for 8 weeks postinj. Findings replicated for 1 S. Blinded EGG measures. Temporal and interrater reliability reported and acceptable. No control group so possibility of placebo effect can't be excluded.

Breathiness discussed III E SS

This study provides some physiologic support for reduced vocal cord contact following Botox injection; I.e., indirect evidence that hyperadduction of vocal cords assoc. with adductor SD is reduced by Botox. It does not address issues of functional benefit or disability.

Perceptual ratings and EMG interp. were blinded. Repeated measures pre & postinjection were not done. None discussed III E C

Good study re pathophysiology but also demonstrates effectiveness of injection perceptually & the relationship between physiologic & perceptual measures. Reliability of ratings not reported but ratings were blinded.

Pre vs post comparisonsPts who did not improve in post tx scores on VHI reported prolonged breathy voice as reason for poor outcome. IV O SCS

This is an important study because it documents components of functional limitation and disability pre and post botox tx. As a group botox led to reduced perception of functional, physical, & emotional voice handicaps & improved mental health & social functioning.

Not presented here See Blitzer, Brin & Stewart ('98) NA NA

This chapter contains a brief summary of the data from Blitzer, Brin & Stewart ('98).The chapter deals with botox for the tx of SD, including genetics, botox pharmacology, mechanism of action, preparation & toxicity, contraindications for use, antibody formation, diagnosis, injection technique, dosing, & results. There is nothing new here re data on tx outcome - a good overview chapter, however. The summary states "Botulinum toxin therapy has become the standard of care in the treatment of SD."

Not clear how the 15 Ss were identified (e.g., all cases seen, random selection, consecutive cases).Concordance among analysis methods was examined & positive patient ratings agreed with 2 or more of the acoustic or perceptual ratings in 47% of cases.

Not reported IV O SCS

A fairly good pre vs post treatment study that includes patient ratings, clinician perceptual ratings, and acoustic analysis. Reliability for clinician perceptual ratings are reported, but reliability of acoustic measures not reported. It is stated that most Ss had repeated injections but the source of data for study re multiple injections is not clear.

PresentThe study focuses on resistance to botox and demonstrates that it can occur. In a sense, this is a possible side effect of injections IV O CS

Not a treatment study per se. It demonstrates that it is possible for patients effectively treated with botox to develop resistance to it, with subsequent loss of tx effectiveness


BT Injection


61

Warrick, P., Dromey, C., Irish, J., & Durkin, L. (2000). The treatment of eesential voice tremor with botulinum toxin A: a longitudinal case report. Journal of Voice, 3, 410-421. Warick et al. 2000 Voice/EVT 1

Response to botox in a pt with essential voice tremor (EVT) 1 1 1 1 1 1 1 0 1 1 1 1 1 0 1 1 0 1 0 0 14

EVT unresponsive to pharmacologic tx; 12 yr Hx of sxs

62

Warrick, P., Dromey, C., Irish, J., Durkin, L., Pakiam, A., & Lang, A. Botulinum toxin for essential tremor of the voice with multiple anatomical sites of tremor: A crossover design study of unilateral versus bilateral injection. Laryngoscope, 110, 1366-1374. Warrick et al 2000 Voice/EVT 1c

Eval relative efficacy of unilat & bilat botox inj in tx of EVT 10 1 1 1 1 0 1 0 1 1 1 1 1 1 1 1 0 1 0 0 14

Dx of EVT or EVT-ADSD; no concurrent voice tx; pass hearing screen

63

Bielamowicz, S., Bidus, K., Squire, S., & Ludlow, C. L. (2001). Assessment of posterior cricoarytenoid botulinum toxin injections in patients with abductor spasmodic dysphonia. Annals of Otology, Rhinology, & Laryngology, 110, 406-412. Bielemowicz et al 2001 Voice/SD 1

Comparison of percutaneous posterolateral approach vs transnasal fiberoptic approach for tx of ABSD 15 1 1 1 0 0 1 0 1 1 1 1 1 0 1 1 0 0 0 11

ABSD confirmed by fiberoptic exam & speech/phonatory characteristics. No other neuro or speech disorders. No botox for 1 year prior to study

Count 22 3 53 Sum 4272Sum #1s 56 56 63 26 54 39 0 37 61 33 25 23 2 30 45 0 2 1 16

Count 1c 19 Mean 67.8 8.8Median 17 9Max 901 14Min 1 2% (Sum/60) 89% 89% 100% 41% 86% 62% 0% 59% 97% 52% 40% 37% 3% 48% 71% 0% 3% 2% 25%


BT Injection


Hyperkinetic (EVT) EVTIf EVT involves TA muscles, then it may respond to Botox, as does SD 1

Acoustic & aerodynamic recordings, + videoendoscopic eval

Info from pt about efficacy & side effects

Info from pt about efficacy & side effects

Botox reduced frequency & amplitude tremor 1-10 weeks post inj. Laryngeal resistance decreased & perceptual measures documented reduced vocal effort, tremor, & supraglottic hyperfunction. EVT "can be successfully attenuated with bilateral percutaneous injection of" botox into vocalis muscle. Present

Hyperkinetic - EVT or EVT-ADSD EVT or EVT-ADSD

EVT doesn't respond well to pharmacologic tx & some data suggest it may respond to botox 1

Acoustic, aerodynamic, & laryngoscopic data plus perceptual ratings by 6 SLPs of effort, tremor, & quality. Pts retrospectively rated satisfaction, OA voice improvement, reduction in tremor, & side effects.

None but might be reflected in pt ratings

None but might be reflected in pt ratings

Only small % of pts (3/10 with bilat inj, 2/9 with unilat inj) achieved benefit from botox based on acoustic measures. But, a majority benefitted from subjective reduction in vocal effort that may have been attrib to reduced airway resistance.

Perceptual ratings of speech & nasopharyngoscopy data were blinded. Intrarater reliability assessed.

Hyperkinetic (ABSD)ABSD (2 pts had VF tremor

Compare 2 tx techniques that have been used for ABSD 1

Blinded fiberscopic rating of ABD movement impairment & ratings of breathiness, harshness & tremor, & degree of difference between pre & post inj voice + counts of vowel breaks, breathy breaks, & tremor witin sentences. None None

11/15 pts reported benefit but they were not related to changes in sxs on blinded counts by SLPs. No sig reduction in # of breathy breaks with either technique & no difference between techniques. Thus, the inj provided limited benefits to pts, demo a need for more effective tx.

Reliability of fiberoptic ratings not reported. Mean ratings of SLPs used but reliability not reported.

52 16 5

83% 25% 8%


BT Injection


Pre vs post inj (2, 6 10, & 16 weeks) 6 weeks of breathiness reported by pt, but no dysphagia IV E SS

The converging evidence from several sources of data in this study is good. For example, reduced laryngeal resistance coincided with audio perceptual ratings of reduced effort & video ratings of reduced laryngeal tremor & supraglottic hyperfunction. (Dose was 2.5 units per cord.

Prospective open-label crossover study. Perceptual ratings of speech & nasopharyngoscopy data were blinded

Breathiness and swallowng probs were reported, with more having sig probs with breathiness than dysphagia (7/10 had ratings above mispoint of 10 point VAS re breathiness; 2/10 had similar ratings for dysphagia No differences in side effects for unilat vs bilat inj. Au note that EVT pts tend to be elderly & may be at greater risk for side effects than ADSD. III E C

Authors note botox "demonstrated remarkable effectiveness in reducing ETV in certain patients…" and most reported substantial subjective benefit. Reduced effort correlated with aerodynamic measures of airway resistance. Au attribute poor objective data benefits re ADSD to be product of different pathophysiology between the 2 disorders.

Present (prospective randomized crossover tx design)

One pt developed stridor which resolved without medical intervention. No other side effects. Authors note that "airway obstruction may be the primary limiting factor for the utlity of Botox for symptom control in patients with ABSD." II E RCS

81% of Ss had abductor movement impairment after 1st injection (injections were unilateral, with 2nd side done 2 weeks after the 1st), so inj generally met goal of reducing AB movement. No diff between techniques so they rec choice be directed by pt comfort or physician familiarity. Authors acknowledge that perceived effoort was not measured & that that may explain difference between subjective pt and SLP ratings. Authors offer a # of good explanations for limited benefits, incl S selection bias & uncertain or variable pathophysiology of ABSD. Seems important to me that 11/15 felt they benefitted

Count NA 5 5Count I 1Count II 4Count III 17Count IV 36Count A 0

Count E RCS 4Count E C 15

Count E SS 6Count O CS 3

Count O SCS 29Count O Q 1

Count O SBO 0