Downloaded from http://aim.bmj.com/ on May 30, 2015 - Published by group.bmj.com
Original paper
Does prior acupuncture exposure affect perception of blinded real or sham acupuncture? Caitlin R Dilli,1 Rebecca Childs,2 Julie Berk,3 M K Christian,4 Nancy Nguyen,4 R Preston Brown,3 Benzi M Kluger3
1
Colorado School of Traditional Chinese Medicine, Denver, Colorado, USA 2 Southwest Acupuncture College – Boulder, Boulder, Colorado, USA 3 Department of Neurology, University of Colorado Denver, Aurora, Colorado, USA 4 Center for Integrative Medicine, University of Colorado Hospital, Aurora, Colorado, USA Correspondence to Dr Benzi M Kluger, Department of Neurology, University of Colorado Denver, School of Medicine, Academic Office 1, Mail Stop B-185, 12631 East 17th Avenue, Aurora, Colorado 80045, USA; [email protected] Received 14 August 2013 Accepted 7 November 2013 Published Online First 28 November 2013
To cite: Dilli CR, Childs R, Berk J, et al. Acupunct Med 2014;32:155–159.
ABSTRACT Objective To determine if acupuncture-exposed and naïve participants differ in their perceptions of real and sham acupuncture under blinded conditions. Methods The setting was an outpatient clinic at the Colorado School of Traditional Chinese Medicine. Participants were between the ages of 18 and 90 years. Acupuncture-exposed participants had at least five prior acupuncture treatments, with one treatment in the month prior to the study date. Acupuncture-naïve participants had experienced no prior acupuncture treatments. Participants with dementia, cognitive impairment, or neuropathy were excluded. In total, 61 acupuncture-exposed and 59 acupuncture-naïve participants were blindfolded and received either real acupuncture or toothpick sham acupuncture treatment. Following treatment, participants completed a questionnaire rating the realness of the acupuncture and were asked how they made this determination. We used a previously developed scale rating treatments from 1 (definitely real needle) to 5 (definitely imitation needle) to assess outcome. Results Perceptions of the real treatment were rated as more real than sham treatments for all participants. Further analysis revealed that prior acupuncture exposure did not influence ratings of real treatments, but exposed participants rated sham treatments as significantly less real than naïve participants. Conclusions Acupuncture-naïve and exposed participants both reported different perceptions of real and sham acupuncture using a blindfolded toothpick protocol. This suggests that future trials should carefully monitor participant perceptions of treatments received, even for naïve individuals. Differences between groups further suggest that participants with significant and/or recent exposure to real acupuncture may introduce bias to blinded clinical acupuncture trials.
Dilli CR, et al. Acupunct Med 2014;32:155–159. doi:10.1136/acupmed-2013-010449
INTRODUCTION There has been widespread and increasing use of acupuncture to treat many medical conditions in Western societies.1 2 This has fuelled a growing interest in developing well-designed research trials to assess the efficacy of acupuncture. Blinded randomised controlled acupuncture trials have been designed using an array of control groups, such as standard care,3 waitlists,4 acupuncture performed off of channels or known therapeutic points,5 and noninvasive sham acupuncture treatments, including sham needle devices6–8 or toothpicks.9 The use of non-invasive sham acupuncture is generally preferred to invasive sham acupuncture at non-acupuncture points because of the potential for therapeutic non-specific needling effects.5 10 When performing double-blinded trials of acupuncture, it is essential that blinding issues do not bias results and that the effectiveness of blinding is reported for the real and placebo groups.11 While it is acknowledged that prior acupuncture exposure may affect participants’ perception of research acupuncture protocols,12 there is a need for adequately powered empiric studies to guide researchers in their inclusion or exclusion of these participants. In the absence of guidelines of evidence, current studies are mixed in their inclusion of participants in trials that consider acupuncture exposure, ranging from exclusion of participants with any acupuncture exposure,13 inclusion of participants regardless of acupuncture exposure,14 or setting an arbitrary cut-off point (for example, no acupuncture in the past 12 months).4 The primary objective of the current study was to determine whether acupuncture-exposed and naïve participants differed in their perception of real
155
Downloaded from http://aim.bmj.com/ on May 30, 2015 - Published by group.bmj.com
Original paper or sham acupuncture treatments. This study used the blindfolded, toothpick sham acupuncture protocol developed by Sherman et al.9 The protocol is appealing because it is inexpensive, reproducible and easy to learn. On the basis of initial piloting and conduct of this protocol for a randomised controlled trial for fatigue in Parkinson’s disease, we hypothesised that neither the acupuncture-exposed nor the naïve participants would be able to distinguish between real acupuncture and the toothpick sham acupuncture. A secondary objective of this study was to assess what strategies participants used to make their determinations with the goal of improving future sham methods. METHODS Setting, acupuncturists and training
Two US-trained and licensed acupuncturists, with an average of 11 years of experience, provided real acupuncture and toothpick sham acupuncture sessions at the clinic of the Colorado School of Traditional Chinese Medicine. Prior to the current study, the acupuncturists were trained on the toothpick and real protocol to maintain consistency of needling techniques and point location for an ongoing randomised controlled trial of acupuncture for fatigue in Parkinson’s disease. This included several pilot sessions to ensure consistency of insertion force, insertion depth, manipulation techniques and point location for the real and sham acupuncture treatments conducted on study personnel, as well as acupuncture-exposed and naïve volunteers until there was no consistently reported differences for either real or sham treatments. Participants and preparation
The study was approved by the Colorado Multiple Institutional Review Board and informed consent was obtained from all eligible participants. Sham acupuncture was explained to participants as ‘non-true acupuncture’ that differs from acupuncture by using non-traditional point locations or not inserting needles at all. Participants age 18–90 were recruited by advertisement. Inclusion criteria for the acupuncture-exposed group included at least five prior acupuncture treatments and at least one acupuncture treatment within 1 month of the study date. Acupuncture-naïve participants included those with no previous acupuncture treatments. Exclusion criteria for both groups included dementia, cognitive impairment, or neuropathy as these conditions were expected to interfere with the ability to perceive tactile stimulation or report ratings. A total of 61 acupuncture-exposed and 59 acupuncture-naïve participants were recruited for this cross-sectional study and randomised to receive either a single session of real or sham acupuncture in a pseudorandom and balanced fashion. The study was performed over 4 days, with 2 days each assigned for real or sham acupuncture to aid acupuncturists in consistency of their 156
treatments. Acupuncturists were blinded to the participant’s acupuncture exposure status. Each treatment room was supplied with two opaque containers, one with acupuncture needles and one with toothpicks in 25.4 mm (1-inch) needle guide tubes. Additional items in each room included a covered treatment table, alcohol swabs, facial tissue, blindfold and infrared heat lamp. Participants were instructed to wear loose clothing, eat a snack before arrival and refrain from wearing lotion. Real acupuncture protocol
The participant was instructed to roll up their sleeves above the elbows and trouser legs above the knees and lie face up on the table. Participants were then blindfolded. All acupuncture points were swabbed with alcohol. Acupuncture needles (Seirin, 36 gauge, 25.4 mm (1-inch)) were inserted to a depth of 6.35 mm (one-quarter of an inch) in the following order: GV20, GV24, CV6 (midline points), right LI10, right HT7 (upper extremity points), right ST36, right SP6 (lower extremity points), left LI10, left HT7 (upper extremity points), left ST36 and left SP6 (lower extremity points). For each point insertion, the needle was twisted three times to the right. These points were identical to those of the Parkinson’s disease study and were chosen to treat fatigue in this population. The depth of 6.35 mm was chosen to maintain a standard sensation across points and practitioners. After 15 min, the acupuncturist returned to the room to check on the participant. After 30 min, the acupuncturist removed the needles in the same order as they were inserted and swabbed each point with alcohol after removal, dropping needles into a sharps container after three removals. Toothpick protocol
The toothpick protocol used sham acupuncture points, located 12.7 mm (half an inch) lateral to the traditional acupuncture point, or to the right for midline points. After the participant rolled up their sleeves and trousers and was blindfolded, each point was swabbed with alcohol. Then, a toothpick in a guide tube was placed on the sham point and tapped on the skin. The guide tube was removed and the toothpick was twisted three times to the right. Then, the toothpick and guide tube were discarded into a waste container located in the treatment room and covered with tissues. The toothpicks were mock inserted the same order as the real acupuncture protocol. After 15 min, the acupuncturist checked on the participant. After 30 min, the acupuncturist mock removed the toothpicks by slowly pressing a new toothpick into the sham point and quickly removing it. This was performed in the same order as they were mock inserted. The toothpicks were discarded three at a time into a sharps container to mimic the sounds heard in a real acupuncture treatment.
Dilli CR, et al. Acupunct Med 2014;32:155–159. doi:10.1136/acupmed-2013-010449
Downloaded from http://aim.bmj.com/ on May 30, 2015 - Published by group.bmj.com
Original paper Post session questionnaire
Table 2 Realness ratings by group and condition (mean±SD)
Following each session, the participants completed a questionnaire rating their impression of the realness of the acupuncture received. We used the five-point rating scale from Sherman et al,9 which rates an acupuncture session as 1=definitely real needle, 2=probably real needle, 3=uncertain, 4=probably imitation needle and 5=definitely imitation needle. Subjects were also asked an open-ended question of how they made their determination. These answers were later classified into common themes and coded. Statistical analysis
Statistical analysis was performed using SAS V.9.3 (SAS Inc, Cary, North Carolina, USA). All data was checked for outliers, distributions and missing values. Wilcoxon ranked sum tests were used to make group comparisons for imitation ratings (ordinal data) and Student’s t test was used to make group comparisons for numeric data. χ2 tests (or Fisher’s exact test if any category had less than five observations) were used to check for differences between categorical variables. Spearman’s correlation was used for bivariate correlations. p Values
Original paper
Does prior acupuncture exposure affect perception of blinded real or sham acupuncture? Caitlin R Dilli,1 Rebecca Childs,2 Julie Berk,3 M K Christian,4 Nancy Nguyen,4 R Preston Brown,3 Benzi M Kluger3
1
Colorado School of Traditional Chinese Medicine, Denver, Colorado, USA 2 Southwest Acupuncture College – Boulder, Boulder, Colorado, USA 3 Department of Neurology, University of Colorado Denver, Aurora, Colorado, USA 4 Center for Integrative Medicine, University of Colorado Hospital, Aurora, Colorado, USA Correspondence to Dr Benzi M Kluger, Department of Neurology, University of Colorado Denver, School of Medicine, Academic Office 1, Mail Stop B-185, 12631 East 17th Avenue, Aurora, Colorado 80045, USA; [email protected] Received 14 August 2013 Accepted 7 November 2013 Published Online First 28 November 2013
To cite: Dilli CR, Childs R, Berk J, et al. Acupunct Med 2014;32:155–159.
ABSTRACT Objective To determine if acupuncture-exposed and naïve participants differ in their perceptions of real and sham acupuncture under blinded conditions. Methods The setting was an outpatient clinic at the Colorado School of Traditional Chinese Medicine. Participants were between the ages of 18 and 90 years. Acupuncture-exposed participants had at least five prior acupuncture treatments, with one treatment in the month prior to the study date. Acupuncture-naïve participants had experienced no prior acupuncture treatments. Participants with dementia, cognitive impairment, or neuropathy were excluded. In total, 61 acupuncture-exposed and 59 acupuncture-naïve participants were blindfolded and received either real acupuncture or toothpick sham acupuncture treatment. Following treatment, participants completed a questionnaire rating the realness of the acupuncture and were asked how they made this determination. We used a previously developed scale rating treatments from 1 (definitely real needle) to 5 (definitely imitation needle) to assess outcome. Results Perceptions of the real treatment were rated as more real than sham treatments for all participants. Further analysis revealed that prior acupuncture exposure did not influence ratings of real treatments, but exposed participants rated sham treatments as significantly less real than naïve participants. Conclusions Acupuncture-naïve and exposed participants both reported different perceptions of real and sham acupuncture using a blindfolded toothpick protocol. This suggests that future trials should carefully monitor participant perceptions of treatments received, even for naïve individuals. Differences between groups further suggest that participants with significant and/or recent exposure to real acupuncture may introduce bias to blinded clinical acupuncture trials.
Dilli CR, et al. Acupunct Med 2014;32:155–159. doi:10.1136/acupmed-2013-010449
INTRODUCTION There has been widespread and increasing use of acupuncture to treat many medical conditions in Western societies.1 2 This has fuelled a growing interest in developing well-designed research trials to assess the efficacy of acupuncture. Blinded randomised controlled acupuncture trials have been designed using an array of control groups, such as standard care,3 waitlists,4 acupuncture performed off of channels or known therapeutic points,5 and noninvasive sham acupuncture treatments, including sham needle devices6–8 or toothpicks.9 The use of non-invasive sham acupuncture is generally preferred to invasive sham acupuncture at non-acupuncture points because of the potential for therapeutic non-specific needling effects.5 10 When performing double-blinded trials of acupuncture, it is essential that blinding issues do not bias results and that the effectiveness of blinding is reported for the real and placebo groups.11 While it is acknowledged that prior acupuncture exposure may affect participants’ perception of research acupuncture protocols,12 there is a need for adequately powered empiric studies to guide researchers in their inclusion or exclusion of these participants. In the absence of guidelines of evidence, current studies are mixed in their inclusion of participants in trials that consider acupuncture exposure, ranging from exclusion of participants with any acupuncture exposure,13 inclusion of participants regardless of acupuncture exposure,14 or setting an arbitrary cut-off point (for example, no acupuncture in the past 12 months).4 The primary objective of the current study was to determine whether acupuncture-exposed and naïve participants differed in their perception of real
155
Downloaded from http://aim.bmj.com/ on May 30, 2015 - Published by group.bmj.com
Original paper or sham acupuncture treatments. This study used the blindfolded, toothpick sham acupuncture protocol developed by Sherman et al.9 The protocol is appealing because it is inexpensive, reproducible and easy to learn. On the basis of initial piloting and conduct of this protocol for a randomised controlled trial for fatigue in Parkinson’s disease, we hypothesised that neither the acupuncture-exposed nor the naïve participants would be able to distinguish between real acupuncture and the toothpick sham acupuncture. A secondary objective of this study was to assess what strategies participants used to make their determinations with the goal of improving future sham methods. METHODS Setting, acupuncturists and training
Two US-trained and licensed acupuncturists, with an average of 11 years of experience, provided real acupuncture and toothpick sham acupuncture sessions at the clinic of the Colorado School of Traditional Chinese Medicine. Prior to the current study, the acupuncturists were trained on the toothpick and real protocol to maintain consistency of needling techniques and point location for an ongoing randomised controlled trial of acupuncture for fatigue in Parkinson’s disease. This included several pilot sessions to ensure consistency of insertion force, insertion depth, manipulation techniques and point location for the real and sham acupuncture treatments conducted on study personnel, as well as acupuncture-exposed and naïve volunteers until there was no consistently reported differences for either real or sham treatments. Participants and preparation
The study was approved by the Colorado Multiple Institutional Review Board and informed consent was obtained from all eligible participants. Sham acupuncture was explained to participants as ‘non-true acupuncture’ that differs from acupuncture by using non-traditional point locations or not inserting needles at all. Participants age 18–90 were recruited by advertisement. Inclusion criteria for the acupuncture-exposed group included at least five prior acupuncture treatments and at least one acupuncture treatment within 1 month of the study date. Acupuncture-naïve participants included those with no previous acupuncture treatments. Exclusion criteria for both groups included dementia, cognitive impairment, or neuropathy as these conditions were expected to interfere with the ability to perceive tactile stimulation or report ratings. A total of 61 acupuncture-exposed and 59 acupuncture-naïve participants were recruited for this cross-sectional study and randomised to receive either a single session of real or sham acupuncture in a pseudorandom and balanced fashion. The study was performed over 4 days, with 2 days each assigned for real or sham acupuncture to aid acupuncturists in consistency of their 156
treatments. Acupuncturists were blinded to the participant’s acupuncture exposure status. Each treatment room was supplied with two opaque containers, one with acupuncture needles and one with toothpicks in 25.4 mm (1-inch) needle guide tubes. Additional items in each room included a covered treatment table, alcohol swabs, facial tissue, blindfold and infrared heat lamp. Participants were instructed to wear loose clothing, eat a snack before arrival and refrain from wearing lotion. Real acupuncture protocol
The participant was instructed to roll up their sleeves above the elbows and trouser legs above the knees and lie face up on the table. Participants were then blindfolded. All acupuncture points were swabbed with alcohol. Acupuncture needles (Seirin, 36 gauge, 25.4 mm (1-inch)) were inserted to a depth of 6.35 mm (one-quarter of an inch) in the following order: GV20, GV24, CV6 (midline points), right LI10, right HT7 (upper extremity points), right ST36, right SP6 (lower extremity points), left LI10, left HT7 (upper extremity points), left ST36 and left SP6 (lower extremity points). For each point insertion, the needle was twisted three times to the right. These points were identical to those of the Parkinson’s disease study and were chosen to treat fatigue in this population. The depth of 6.35 mm was chosen to maintain a standard sensation across points and practitioners. After 15 min, the acupuncturist returned to the room to check on the participant. After 30 min, the acupuncturist removed the needles in the same order as they were inserted and swabbed each point with alcohol after removal, dropping needles into a sharps container after three removals. Toothpick protocol
The toothpick protocol used sham acupuncture points, located 12.7 mm (half an inch) lateral to the traditional acupuncture point, or to the right for midline points. After the participant rolled up their sleeves and trousers and was blindfolded, each point was swabbed with alcohol. Then, a toothpick in a guide tube was placed on the sham point and tapped on the skin. The guide tube was removed and the toothpick was twisted three times to the right. Then, the toothpick and guide tube were discarded into a waste container located in the treatment room and covered with tissues. The toothpicks were mock inserted the same order as the real acupuncture protocol. After 15 min, the acupuncturist checked on the participant. After 30 min, the acupuncturist mock removed the toothpicks by slowly pressing a new toothpick into the sham point and quickly removing it. This was performed in the same order as they were mock inserted. The toothpicks were discarded three at a time into a sharps container to mimic the sounds heard in a real acupuncture treatment.
Dilli CR, et al. Acupunct Med 2014;32:155–159. doi:10.1136/acupmed-2013-010449
Downloaded from http://aim.bmj.com/ on May 30, 2015 - Published by group.bmj.com
Original paper Post session questionnaire
Table 2 Realness ratings by group and condition (mean±SD)
Following each session, the participants completed a questionnaire rating their impression of the realness of the acupuncture received. We used the five-point rating scale from Sherman et al,9 which rates an acupuncture session as 1=definitely real needle, 2=probably real needle, 3=uncertain, 4=probably imitation needle and 5=definitely imitation needle. Subjects were also asked an open-ended question of how they made their determination. These answers were later classified into common themes and coded. Statistical analysis
Statistical analysis was performed using SAS V.9.3 (SAS Inc, Cary, North Carolina, USA). All data was checked for outliers, distributions and missing values. Wilcoxon ranked sum tests were used to make group comparisons for imitation ratings (ordinal data) and Student’s t test was used to make group comparisons for numeric data. χ2 tests (or Fisher’s exact test if any category had less than five observations) were used to check for differences between categorical variables. Spearman’s correlation was used for bivariate correlations. p Values
