Acupuncture for diagnostic fiberoptic bronchoscopy: a prospective, randomized, placebo-controlled study.

Abstract

Patients usually fear fiberoptic bronchoscopy (FBS) and they report a low level of satisfaction after this examination. We evaluated the efficacy of acupuncture in decreasing patient anxiety before diagnostic FBS and in improving tolerance to the examination. In a prospective double-blind study, we enrolled 48 patients scheduled to undergo diagnostic FBS. Patients were randomly assigned to one of three groups. Group A (16 patients): standard FBS, with airway topic anesthesia; Group B (16 patients): standard FBS, with airway topic anesthesia and acupuncture treatment; Group C (16 patients): standard FBS, with airway topic anesthesia and sham acupuncture. EKG, non-invasive arterial pressure, and pulse oximetry were monitored on a routine basis. We evaluated patient anxiety before and after acupuncture and, at the end of FBS, the discomfort suffered during the examination by a 100-mm Visual Analog Scale (VAS). Patient satisfaction in Group A was 50% worse than in Group B (p = 0.04). We observed a strong, even if not statistically significant, tendency toward a lower pre-FBS anxiety in Group B. Patients in group C had values very close to those recorded in group A. We observed no adverse event and no differences in cardio-respiratory parameters in these three groups; in particular, we did not observe a respiratory depression in Group B. Acupuncture seems an effective resource for a Thoracic Endoscopic Room to improve patient tolerance to FBS.

Full text

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The American Journal of Chinese Medicine, Vol. 34, No. 3, 409–415
© 2006 World Scientific Publishing Company
Institute for Advanced Research in Asian Science and Medicine
409
Acupuncture for Diagnostic Fiberoptic
Bronchoscopy: A Prospective, Randomized,
Placebo-Controlled Study
Luca Cabrini,* Luigi Gioia,* Marco Gemma,* Giulio Melloni,† Angelo Carretta,†
Paola Ciriaco† and Armando Puglisi†
*Servizio di Anestesia e Rianimazione, †Chirurgia Toracica
Ospedale San Raffaele, Milano, Italy
Abstract: Patients usually fear fiberoptic bronchoscopy (FBS) and they report a low level of
satisfaction after this examination. We evaluated the efficacy of acupuncture in decreasing
patient anxiety before diagnostic FBS and in improving tolerance to the examination. In a
prospective double-blind study, we enrolled 48 patients scheduled to undergo diagnostic FBS.
Patients were randomly assigned to one of three groups. Group A (16 patients): standard
FBS, with airway topic anesthesia; Group B (16 patients): standard FBS, with airway topic
anesthesia and acupuncture treatment; Group C (16 patients): standard FBS, with airway topic
anesthesia and sham acupuncture. EKG, non-invasive arterial pressure, and pulse oximetry
were monitored on a routine basis. We evaluated patient anxiety before and after acupuncture
and, at the end of FBS, the discomfort suffered during the examination by a 100-mm Visual
Analog Scale (VAS).
Patient satisfaction in Group A was 50% worse than in Group B (p = 0.04). We observed
a strong, even if not statistically significant, tendency toward a lower pre-FBS anxiety in
Group B. Patients in group C had values very close to those recorded in group A. We observed
no adverse event and no differences in cardio-respiratory parameters in these three groups; in
particular, we did not observe a respiratory depression in Group B.
Acupuncture seems an effective resource for a Thoracic Endoscopic Room to improve
patient tolerance to FBS.
Keywords: Acupuncture; Fiberoptic Bronchoscopy; Patient Satisfaction; Anesthesia;
Sedation.
Correspondence to: Dr. Luca Cabrini, Terapia Intensiva Generale, Ospedale San Raffaele, via Olgettina 60, 20132
Milano, Italy. E-mail: cabrini.luca@hsr.it

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L. CABRINI et al.
410
Introduction
Fiberoptic bronchoscopy (FBS) is a widely used procedure in most western countries, where
it presents a high degree of technical standardization. On the other hand, the best strategy
for sedation during FBS is still a matter of debate and even the question whether to sedate
or not is of some concern (British Thoracic Society Bronchoscopy Guidelines Committee,
2001; Ernst et al., 2003). Some authors emphasized the benefits of pharmacological
sedation, particularly hemodynamic stability and patient comfort (Putinati et al., 1999;
Maltais et al., 1996; Clarkson et al., 1993; Rees et al., 1983). Other authors, showing
the efficacy of topical anesthesia alone, put forward the potential risks of sedation and
its cost and organization demand (Hatton et al., 1994; Lukomsky et al., 1981; Colt et al.,
1990). The variety of sedation schemes proposed clearly indicates how far we are from a
consensus on this topic (Simpson et al., 1986).
Some studies have evaluated non-pharmacological techniques to reduce patient anxiety
and discomfort during FBS, such as improving the quality of pre-FBS patient information
or letting the patient listen to music during FBS (Colt et al., 1999; Dubois et al., 1995). So
far, such techniques have failed to show significant effects.
Acupuncture proved effective when compared to pharmacological sedation in both
gastroscopy and colonoscopy (Melchart et al., 2002; Fanti et al., 2003; Cahn et al., 1978)
and it appears to be a potential technique to improve patient tolerance during FBS. To our
knowledge, no study has yet evaluated acupuncture in this setting.
In this prospective, randomized, placebo-controlled study, we evaluated the role of
acupuncture in reducing patient discomfort during FBS.
Materials and Methods
Formal approval for the study was obtained from the Ethical Committee of the Hospital
(Ospedale San Raffaele – Milano).
We enrolled 48 patients (age > 18 years; non-pregnant), who were admitted to the
Hospital and scheduled to undergo elective diagnostic FBS. All of them signed an informed
consent form. We excluded patients who were affected by psychiatric disorders and those
taking any sedative drug, since these could have hampered evaluation of discomfort
during FBS. Patients who had technical notions of acupuncture were excluded to maintain
blindness. Before enrolment, any condition that could make acupuncture impossible
(anatomical abnormalities) or dangerous (skin infection) were also excluded.
All FBS were performed through the trans-nasal passage by 4 senior thoracic surgeons
(GM, AC, PC, AP) and 3 senior nurses in the Thoracic Endoscopy Room.
Enrollment, randomization, acupuncture treatment and data recording were carried
out by two senior anaesthetists, who are qualified in acupuncture after a 4-year course
(LC, LG).
At their arrival at the Endoscopy Room, patients were asked to state the degree of
their anxiety on a 100-mm Visual Analog Scale (VAS) (0 = no anxiety; 100 = unbearable
anxiety).

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411 ACUPUNCTURE CAN IMPROVE TOLERANCE TO FBS
Mean arterial pressure (MAP), heart rate (HR) and pulse oximetry (SpO2) were
recorded every other 2 minutes throughout the study.
Patients were randomized to one of the following groups:
Group A (16 patients): no acupuncture. FBS was performed after nostril and throat
topical anesthesia with lidocaine 2% (up to 10 ml); further lidocaine was injected through
the bronchoscope during FBS, according to operator judgement.
Group B (16 patients): “true” acupuncture treatment for 20 minutes before FBS. Sterile,
disposable needles (Hwato, Suzhou Medical Appliance Factory, China) were inserted
bilaterally in the following points: LU 7 (Lie Que), PC 6 (Nei Guan), LI 4 (He Gu),
HT 7 (Shen Men), Auricular Shen Men. After insertion and just before FBS, needles were
manually rotated to evoke the typical acupuncture sensation (De Qi). Patients were left
supine in a quiet room for 20 minutes. Then they were moved to the Endoscopy Room,
where they had nostrils and throat topical anesthesia and FBS in the same way as Group A.
Needles were left in place throughout FBS.
Group C (16 patients): “sham” acupuncture. Acupuncture was performed just as in
Group B, but in bilateral points that are devoid of any known acupunctural sedative effects:
at the midpoint of the interdigital membrane between the 1st and 2nd finger both on the
dorsal and palmar aspect; on the ulnar aspect of the forearm, between the Heart and the
Small Intestine meridians both at 3 and 9 “cun” from the wrist, “elbow” auricular point.
In groups B and C, anxiety was also evaluated at the end of the 20-minute acupuncture,
just before FBS.
Ten minutes after FBS completion, patients were asked to assess the degree of
perceived discomfort on a 100-mm VAS (0 = no discomfort; 100 = unbearable discomfort).
Bronchoscopists and nurses were blinded to randomisation and had no technical notion of
acupuncture.
Statistical Analysis
On the basis of a study we had performed on acupuncture for colonoscopy (Fanti et al.,
2003), in which a Standard Deviation of 14 was found, we calculated 16 patients for every
Group to reach a power of 80% with a difference of 15 points for the discomfort VAS (our
primary end point).
Continuous variables, expressed as mean ± SD, were tested with ANOVA or repeated
measure ANOVA as appropriate. Post-hoc analysis was performed with Bonferroni
Adjustment.
Nominal values were tested with the Pearson Chi Square test. The Spearman Rho test
was employed for ordered values. Differences were considered significant when p < 0.05.
Results
Age (60 ± 11 ys in group A, 61 ± 12 ys in group B, 62 ± 10 ys in group C), gender
distribution (5/16 males in group A, 5/16 males in group B, 9/16 males in group C) and
clinical indication for FBS were not different among groups.

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L. CABRINI et al.
412
Baseline MAP, HR or SpO2 was not different among groups. Baseline anxiety exhibited
differences among groups, but these differences did not reach statistical significance
(Table 1).
After the 20-min acupuncture, the anxiety VAS exhibited a significant reduction in
group B (p < 0.0001; 95% CI 17–37) but not in group C. VAS changes after acupuncture
were significantly different between these two groups (p = 0.002). On the contrary, MAP
raised significantly after 20 minutes acupuncture in group C (p = 0.021; 95% CI 1–12), but
not in group B. MAP changes differed significantly between the two groups (p = 0.04), but
with a very low clinical relevance. Neither HR nor SpO2 were modified after 20-minute
acupuncture (Table 1).
MAP, HR and SpO2 changes were not different among groups throughout FBS and up
to 10 minutes after its completion.
The discomfort VAS administered ten minutes after the end of FBS differed significantly
among the groups: post-hoc analysis showed that only the difference between group B and
group A was significant (p = 0.048; 95% CI 0.5–35, Table 2).
No adverse event such as arrhythmia, angina, critical oxygen desaturation (SpO2 <
90) or severe arterial hypertension (defined as systolic arterial pressure > 200 mmHg or
diastolic arterial pressure > 120 mmHg) occurred in any patient. No complication related
to acupuncture occurred.
Table 2. Evaluation of Perceived Discomfort During FBS

Group A Group B Group C
Discomfort VAS 10 min after FBS 66.6 ± 28.0 44.2 ± 23.7* 61.7 ± 24.0
Values are expressed as mean ± SD. *: p < 0.05. The discomfort VAS administered ten minutes
after the end of FBS differed significantly among groups: post-hoc analysis showed that only the
difference between group B and group A was significant (p = 0.048; 95% CI 0.5–35).
Table 1. Baseline and Post Acupuncture Values of anxiety-VAS, MAP, HR, SpO2

Group A Group B Group C
Baseline



Anxiety VAS*
MAP (mmHg)
HR (/min)
SpO2 (%)
46.4 ± 24.1
97 ± 10
85 ± 19
97.4 ± 1.7
62.5 ± 25.2
102 ± 12
86 ± 11
96.7 ± 1.8
53.8 ± 23.3
97 ± 11
82 ± 12
97.0 ± 2.1

After 20-min
acupuncture

Anxiety VAS*
MAP (mmHg)
HR (/min)
SpO2 (%)
–
–
–
–
35.8 ± 15.1*
102 ± 14
80 ± 16
96.7 ± 1.9
54.2 ± 26.3
104 ± 16
79 ± 18
96.5 ± 2.4
Values are expressed as mean ± SD. *: p < 0.05. After the 20-min acupuncture the anxiety VAS exhibited a
significant reduction in group B (p < 0.0001; 95% CI 17–37) but not in group C. VAS changes after acupuncture
were significantly different between these two groups (p = 0.002). On the contrary, MAP increased significantly
after 20 minutes acupuncture in group C (p = 0.021; 95% CI 1–12), but not in group B. MAP changes differed
significantly between the two groups (p = 0.04), but with a very low clinical relevance. Neither HR nor SpO2 were
modified after 20-minute acupuncture. VAS: visual analog scale (0 = no anxiety, 100 = unbearable anxiety).

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413ACUPUNCTURE CAN IMPROVE TOLERANCE TO FBS
Discussion
The majority of patients experience FBS as a traumatic and unpleasant event, even if
adequate topical anesthesia is provided and the pain is relieved. The mucosal stimulation
by the bronchoscope and the sensation of impending asphyxia may yield prominent
cardiocirculatory stress that, especially when associated with concomitant hypoxia,
increases the risk of myocardial infarction and major arrhythmias (Matot et al., 1997; Davies
et al., 1997; Shrader et al., 1978; Pue et al., 1995). Also important, psychological suffering
should be considered before and during FBS (British Thoracic Society Bronchoscopy
Guidelines Committee, 2001; Lechtzin et al., 2002).
It is well known that the personnel performing FBS usually underestimate patient
discomfort (Putinati et al., 1999; Rees et al., 1983; Hatton et al., 1994). Hence, the systematic
employment of methods that measure patients’ perceived discomfort is mandatory (British
Thoracic Society Bronchoscopy Guidelines Committee, 2001; Lechtzin et al., 2002). Our
evaluation by a Visual Analog Scale satisfies this need.
In our study, acupuncture provided a relevant reduction of perceived discomfort in
patients undergoing diagnostic elective FBS. This clinically prominent result cannot be
ascribed to a “needle placebo effect”, since both control (A) and sham acupuncture (C)
groups reported similar levels of perceived discomfort. It should be noted that control
group (A) patients underwent the standard FBS protocol of our Hospital, in which only
topical anesthesia is provided. This is, to our knowledge, the most popular protocol
worldwide. Moreover, the similarity between group A and C rules out that the 20-minute
relax time span, that patients in group B and C experienced before FBS, was not responsible
for a better tolerability of the procedure in group B. In this respect, we think that it has
been correct to waive the 20-minute rest in group A patients for the purpose of our study.
Acupuncture almost halved anxiety VAS in group B. This effect is more evident when
compared with the same VAS in group A: this control group reported by chance a lower basal
VAS than group C and in particular than group B (even if not in a statistically significant
degree). However, “very anxious” group B patients reported a pre-examination anxiety
VAS lower than “calm” group A patients, even if it did not reach statistical significance.
The acupuncture points we chose are traditionally considered anxiolitic, cough
inhibiting, analgesic and bronchodilatatory (Maciocia, 1996). We avoided acupuncture
points on feet and on the face because of convenience.
A wide range (0.5–40%) in the incidence of adverse events during FBS has been
reported (Shrader et al., 1978; Pue et al., 1995). Our study was too small to allow a
thorough evaluation on this topic; however, the absence of respiratory depression after
acupuncture should be particularly noted, since this is the most feared and common side
effect of pharmacological sedation.
We did not perform any cost-effectiveness evaluation. The acupuncture though, does
not involve supplemental monitoring. Moreover a trained bronchoscopist can perform
acupuncture before the FBS, limiting the need for the anesthetist to an on-call basis. It
should be remembered that a basic knowledge of acupuncture is required together with a
respect of sterility in inserting needles.

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A group receiving a pharmacological sedation was not included, so we cannot compare
efficacy and safety of acupuncture to the drugs. Although a study with this aim would be
very interesting, a research evaluating a possible synergistic effect (allowing lower drug
dosages and less risk) could be more useful: as a matter of fact, even in our group B, the
mean discomfort VAS remained rather high.
In conclusion, our acupuncture protocol improved patient satisfaction for FBS.
Acupuncture seems an effective resource for a Thoracic Endoscopic Room.
Acknowledgment
We would like to thank the personnel of Thoracic Endoscopy Ambulatory (and in particular
to Mrs. Cinzia Lo Faro) for their endless patience and unvaluable assistance.
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