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Available online at www.sciencedirect.com

Journal of Acupuncture and Meridian Studies

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Research Ar t i c le

Laser Acupuncture in Open-Angle GlaucomaTreatment: A Retrospective Study of EyeBlood Flow

Marzio Vanzini 1,y, Michele Gallamini 2,*

1 Oculisticaviva (Bologna e Italy), Oculistica Viva Eye Clinic, Via Ugo Lenzi, 1, 40122 Bologna,Italy2 Eng e Medical Devices R&D, Freelance Researcher (Genova e Italy), Sal. Maggiolo di Nervi,7, 16167 Genova, Italy
Available online - - -
Received: Mar 20, 2018Revised: Aug 17, 2018Accepted: Nov 29, 2018

KEYWORDS

Laser acupuncture;Eye blood perfusion;Open-angle glaucoma;Ultra-low-level-laser

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orresponding author. Sal. Maggiolaly.-mails: marziovanzinistudio@[email protected] (M. Gallaminww.oculisticaviva.it.

ase cite this article as: Vanzini M,od Flow, Journal of Acupuncture

2005-2901 eISSN 2093-8152s://doi.org/10.1016/j.jams.2018.19 Medical Association of PharmaC-ND license (http://creativecom

AbstractGlaucoma patients can show blood flow anomalies at the eye vessels’ level. A causal rela-tionship is reasonably expected, but, so far, it has not been demonstrated. TraditionalChinese Medicine indicates that acupuncture can promote specific blood perfusion in spe-cific body districts. Ninety-eight patients with open-angle glaucoma were treated with anultralow light-level laser, according to a specific acupuncture protocol, and their bloodflow was measured before and after a 6-week treatment cycle. Doppler measurementsshowed significant modifications in both pulsatility and resistivity indexes. The most rele-vant outcome of this study is that the applied treatment demonstrated its effectivenessnot only in vasodilation but also in the perfusion control that seems to restore appropriatefunctionality. The protocol can therefore be applied in this and perhaps in other bloodperfusionerelated pathologies.

1. General

It is well known that in several eye pathologies,among them open-angle glaucoma, blood flow anomalies

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Gallamini M, Laser Acupunctureand Meridian Studies, https://doi

11.005copuncture Institute, Publishing smons.org/licenses/by-nc-nd/4.0/

can be observed that are deemed to be among concur-ring factors for the pathology itself [1-4]. Acupuncturetreatment, applied according to Traditional ChineseMedicine, can modify blood flow parameters and is wellknown [5].

Open-angle glaucoma patients reporting to the Oculis-tica Viva eye clinic are routinely treated with an ultralowlight-level laser (ULLLL), according to an acupunctureprotocol, and receive a color Doppler measurement bothbefore and after treatment. Such measurement, on such

in Open-Angle Glaucoma Treatment: A Retrospective Study of Eye.org/10.1016/j.jams.2018.11.005

ervices by Elsevier B.V. This is an open access article under the CC).

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Table 1 Selected acupoints.

Acupoints Location

BL1 Jingming Just above the inner canthus of the eyeLI1 Shangyang Just behind the corner of the nail on the

radial side of the index fingerLI4 Hegu In the middle of the 2nd metacarpal bone

on the radial sideLI 7 Wenliu 5 cun above the crease of the wrist.LI20 Yingxiang In the nasolabial groove, level with the

midpoint of the lateral border of the alanasi

ST1 Chengqi Below the pupil, between the eyeball andthe infraorbital ridge

GB1 Tongzijiao Slightly lateral to the outer canthus of theeye in a depression on the lateral side ofthe orbit

TB23 Sizhukong In a depression at the lateral end of theeyebrow

EX-HN5

Taiyang At temple, in a depression about 1 cunposterior to the midpoint between thelateral end of the eyebrow and the outercanthus of the eye.

2 M. Vanzini, M. Gallamini

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tiny vessels, does require a specific skill by the operator,and this study is a specific tribute to the skill of the late Dr.Cipriano Ridolfi, who collected most of the included data.The present study reports a retrospective analysis of theevidence provided by 98 patients at different glaucomastages.

2. Materials and methods

2.1. The sample

Ninety-eight subjects affected by open-angle glaucomareported to the Oculistica Viva ophthalmic clinic.

All patients, duly informed, gave their written consentboth to the treatment and to the data collection.

It is known that this pathology does not depend on thesex of the patient; all the data were therefore pooled in asingle sample.

2.2. Laser acupuncture treatment

Within 2 weeks following the first measurement, a 6weekly session treatment protocol was started. The treat-ment was applied by means of BioliteLP020� (RGMD SpA,Italy). The same operator, a certified acupunctureophthalmologist medical doctor (MD), performed onetreatment session weekly for 6 weeks.

The device features a ULLLL with a square-wave,modulated emission [6] whose effectiveness inacupuncture-derived treatments had been previouslydemonstrated [7].

The BioliteLP020� main characteristics are as follows:

� Laser emission wavelength: l Z 670 nm.� Radiated power: Peak 5 mW, Avg. 0.05 mW.� Spot surface: z 0.13 cm2.� Square-wave modulation: Frequency 100 Hz duty cycle1%.

2.3. Selected acupoints

The selection is the same that was successfully appliedin the treatment of amblyopia [8] and includes thefollowing:

� LI1, added for its well-known effectiveness in improvingblood flow in the cerebral arteries and in the centralretina arteries, useful in many eye pathologies.

� LI4, the master point for head and neck. It is well knownfor its effects on blood circulation, namely in the cere-bral and retinal arteries [9, 10].

� LI7, selected because we have experienced its supportof other LI points in the circulatory functions.

� LI20, selected because it is known for a specific channelto ST1 (stimulating the Qi flow to the face).

� BL1, ST1, GB1, TB23, and EX-HN5, added because theyare known to be specific to eye and vision pathologies.

The acupoint location is described in Table 1 and shownin Fig. 1.

Please cite this article as: Vanzini M, Gallamini M, Laser AcupunctureBlood Flow, Journal of Acupuncture and Meridian Studies, https://do

These criteria were derived from the specifically refer-enced documents and from several Traditional ChineseMedicine textbooks listed as general references [11e20].Unfortunately, some of the latter are out of print orgenerally not easy to find.

The points were stimulated bilaterally. Each of theselected points was stimulated with 20 half-second flashes(flash repetition rate: 1/sec) with Biolite�. The tip of theemitting probe was kept at some 30 mm from the skin (spotarea: 0.13 cm2) and perpendicular to the selectedacupoint.

2.4. Color Doppler measurements

The reproducibility of the central retina artery mea-surement has been demonstrated [21]. Measurements wereperformed using Antares (Siemens) with a VFX 9-4 probe.According to the Antares manual, its main performancesrelated to our measurement are as follows:

� Flow speed range 10e600 cm/sec.� Tolerance on flow (probe at 45�) 10%.

3. Measurements

The central retina artery measurements performed withAntares have provided the most used indexes [22e24],calculated from the flow speed [(peak systolic velocity, Psv)and (end diastolic velocity, Edv)]:

� Resistivity index (RI) (known also as the Pourcelotindex), defined as:

RIZðPsv � EdvÞ

Psv

in Open-Angle Glaucoma Treatment: A Retrospective Study of Eyei.org/10.1016/j.jams.2018.11.005

Figure 1 Selected acupoints.

Laser Acupuncture in Open-Angle Glaucoma Treatment 3

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or as the ratio between the difference of the maximum andminimum flow speeds and the maximum (diastolic) speed.

� Pulsatility index (PI), defined as:

PIZ2� ðPsv � EdvÞðPsv þ EdvÞ

or as the ratio between the difference of the maximum andminimum flow speeds and the mean flow speed.

Such parameters were measured for the central retinaartery [25].

4. Statistical analysis

Results were analyzed with the assistance of Dr. T. F.Piccinno, PhD (V.I.E. srl, Genoa). Analyses were performedwith R statistical software [26] and the lme4 package [27].

Please cite this article as: Vanzini M, Gallamini M, Laser AcupunctureBlood Flow, Journal of Acupuncture and Meridian Studies, https://doi

5. Participants

Ninety-eight participants with glaucoma were enrolled inthis study. Themean agewas 60.71� 13.15 (rangeZ 20e84).Females comprised 65% of the sample (N Z 64).

PI and RI measures were taken before and after thetreatment for each eye. The interval between the first andthe second measurements (D days) varied between 19 and1717 days (mean Z 209.42 � 253.86). Participants wereclustered in five quantiles, according to the valuesmeasured at the first measurement. Table 2 shows PI and RIvalue ranges for each quantile.

6. Main evidence

The data with the results of the measurements in Table 3show only a very small modification of the mean of PI and RI


Table 2 Analyzed values intervals.

Interval Pulsatility index (PI) Resistance index (RI)

Q1 PI < 0.85 RI < 0.61Q2 0.85 < PI < 1.05 0.61 < RI < 0.71Q3 1.05 < PI < 1.28 0.71 < RI < 0.78Q4 1.28 < PI < 1.46 0.78 < RI < 0.82Q5 PI > 1.46 RI > 0.82

Table 3 Average values modifications.

Values Pulsatilityindex

Resistanceindex

Pre Post Pre Post

Average 1,167 1,143 0,713 0,699Standard deviation 0,347 0,237 0,125 0,083Median 1,145 1,120 0,725 0,700Reference (*) 1,018 0,675

Akarsu C, Bilgili M.Y.K.dColor Doppler imaging in ocular hy-pertension and open-angle glaucoma Graefe’s Arch Clin ExpOphtalmol (2004).

Figure 2 Pulsatility index (PI


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scores. However, a quick look at the plot of the secondversus the first measurements shows an unexpectedbehavior (see Fig. 2). By applying the interocular traumatest (first invented by Joe Berkson at the Mayo Clinic: “Plotthe data, and if the result hits you between the eyes, it issignificant.”), we could not but be struck by the apparentclockwise rotation of the distribution and by the significantcontraction of the standard deviation of the measures. Thediagonal line showing the No Change reference furthersuggested a sort of normalizing effect that convinced us todeepen the statistical analysis along that line.

PI and RI are indexes currently used in blood flowmetryproportional to the arteries’ compliance and to the bloodflow rate. Akarsu and Bilgili (2004) demonstrated thenormal values for such parameters. The difference be-tween velocities [(peak systolic velocity, Psv) and (enddiastolic velocity, Edv)] probably grows with arterial stiff-ness, but an excessive artery compliance might affect theblood flow pressure negatively. For this reason, Akarsu andBilgili set a reference: the measured indexes should notexceed either the upper or the lower limit across the givenindications.

) and resistivity index (RI).


Figure 3 Pulsatility index (PI) and resistivity index (RI).


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It was immediately self-evident that a beneficial effectfollowed the laser-acupuncture treatment (see graphs inFig. 2); we then decided to examine deeper to make surethat there were no confounding factors. Statisticians, withappropriate tools and methods, demonstrated that

� age and gender were not introducing any statisticallysignificant difference and

� the beneficial effect was not significantly affected bythe differences in the time difference between the firstand second measurements.

For this purpose, we grouped the population into quan-tiles according to homogeneity indexes (Tables 2 and 3),and we plotted the measurements on a posttreatmentversus pretreatment graph (see Fig. 3) (see Fig. 4).


7. The statistical evaluation

Two linear mixed models were specified to predict PI andRI independently. Fixed effects were time of measurement(T1 before treatment, T2 after treatment), interval of thefirst measurement (Q1, Q2, Q3, Q4, and Q5), participant’sgender (male, female) and age (years), and the time dif-ference (days) between T1 and T2; the participant’s ID wasthe clustering variable. In addition, the interaction be-tween time of measurement and interval was included totest whether changes in the PI and RI scores after thetreatment varied between intervals. We hypothesized thatthe treatment could normalize the scores of RI and PI,reducing too-high scores and increasing too-low scores.

Linear mixed models are linear regression models, inwhich both fixed effects and random effects are specified


Figure 4 Modifications. PI Z pulsatility index; RI Z resistivity index.


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[28] (Hoox, 2010). A random effect is generally somethingthat can be expected to have a nonsystematic or unpre-dictable (thus considered random) influence on theoutcome variable. Introducing random effects in the modelallows generalizing over the idiosyncrasies of single clusters(in this case, participants). In this case, random effectscould be different levels of PI and RI across participants(intercepts) and different effects of the treatment acrossparticipants (slopes). Fixed effects, on the other hand, areexpected to have a systematic and predictable influence onoutcome variables. Whereas fixed effects exhaust all thelevels of a factor, random effects sample from the popu-lation of interest. If data are clustered, a linear mixedmodel that properly accounts for clustering provides morepower. The intraclass correlation coefficient (ICC) wascomputed to determine the proportion of total variance inPI and RI that was accounted for by participants’ differ-ences. The intraclass correlation coefficients were 0.50 and0.47 for PI and RI, respectively; these results suggested that


the specification of a linear mixed model was neededbecause the clustering (Hoox, 2010) accounted for morethan 5% of the variance of the outcome variables.

Null models, fixed effects with random intercept models,and fixed effects with random intercept and slope modelswere compared. The latter model had better goodness-of-fitwhen indexed by information indices [Akaike informationcriterion and Bayesian information criterion; smaller valuesindicate better fit), and therefore, we considered its results.Time and interval were significant predictors of both PI andRI. The interaction between time and interval significantlypredicted PI and RI; these results support the hypothesis ofnormalization of the scores after the treatment becausehigher scores tended to decrease toward normal values,whereas smaller scores tended to increase toward normalvalues (as shown in Graph 5).

Age (RI: b Z 0.0006, p Z 0.3; PI: b Z 0.0003, p Z 0.05)and gender (RI: b Z 0.013, p Z 0.49; PI: b Z 0.007,p Z 0.121) had no significant effect on the outcome


Table 4 Pulsatility index.

Statistics PI null model PI model A PI model B PI model C PI model D

Fixed effectsIntercept 1,147 0,642 *** 0,695 *** 0,700 *** 0,714 ***Time 0,342 *** 0,417 *** 0,421 *** 0,396 ***Interval:Q1 vs Q2 0,225 *** 0,229 *** 0,225 *** 0,227 ***Q1 vs Q3 0,403 *** 0,409 *** 0,407 *** 0,411 ***Q1 vs Q4 0,642 *** 0,644 *** 0,640 *** 0,643 ***Q1 vs Q5 0,898 *** 0,921 *** 0,921 *** 0,926 ***Age 0,001 0,001 0,001 0,000Gender 0,026 0,011 0,011 0,013Ddays 0 0 0 0Time*Q1 vs Q2 �0,222 *** �0,260 *** �0,257 *** �0,230 ***Time*Q1 vs Q3 �0,346 *** �0,415 *** �0,421 *** �0,390 ***Time*Q1 vs Q4 �0,548 *** �0,642 *** �0,653 *** �0,613 ***Time*Q1 vs Q5 �0,714 *** �0,892 *** �0,893 *** �0,851 ***Random effectsIntercept 0,044 0,007 0,000 0,000 0,000ID 0,033 0,033 0,031Corr 1 1 1Residual 0,045 0,021 0,011 0,011 0,011Goodness-of-fit:Deviance 50,8 �311,1 �448,4 �419,4 �352,3AIC 56,8 �281,1 �414,4 �385,4 �318,3BIC 68,7 �221,9 �347,2 �319,2 �254,5

AIC Z Akaike information criterion; BIC Z Bayesian information criterion; PI Z pulsatility index.*p < 0.05; **p < 0.01; ***p < 0.001.Number of observations: 383, groups: ID, 98.Model A Z fixed effects and random intercept. Number of observations: 383, groups: ID, 98.Model B Z fixed effects, random intercept and slope covariance. Number of observations: 383, groups: ID, 98.Model C Z Model B with Delta days <730. Number of observations: 363, groups: ID, 93.Model D Z Model B with Delta days <365. Number of observations: 315, groups: ID, 81.


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variables. The difference in days between T1 and T2 (RI:bZ �0.00002, pZ 0.01; PI; bZ �0.00005, pZ 0.27) had asignificantly negative effect on RI and no significant effect onPI. Each day produced an expected mean decrease of0.00002 in the RI score on average,whereas treatment (time)produced, on average, a much stronger increase of RI scores(0.1513) and PI scores (0.417). The same analyses wereperformed on two reduced samples [model C, included onlyparticipants tested twice in 2 years (D days <730); model D,included only participants tested twice in 1 year (D days<365)]; results were consistent across models, confirmingthat the changes of the outcome variables were not relatedto the time difference between the two measurements (T1and T2). Tables 4 and 5 show the results of the analysis.

8. Discussion

It is known that open-angle glaucoma bearers generallyshow poor blood-flow parameters. Our study aimed todemonstrate that a specific laser-acupuncture protocolcould ameliorate both the pulsatility and the RIs in open-angle glaucoma patients.

Restoring appropriate blood flow is obviously beneficialto the eye, but it is hard to demonstrate a therapeuticeffect of laser acupuncture over a complex pathology suchas open-angle glaucoma.


Given the variability of open-angle glaucoma conditions,the rather large cohort of patients that was examined couldafford a significant result only in terms of blood flow. Thesuggested further analysis of ophthalmic parameters thatcould support a conclusion in terms of therapeutic in-dications will be performed on more homogeneous andnumerically significant samples.

(1) Ultrasound Doppler measurements

Although the statistical significance is very high for bothindexes, the clinical meaning of these is worth a comment.Although there are few doubts about the RI giving the dif-ference between systolic and diastolic flows relative to thesystolic flow, the PI that is normalizing the same differenceto the average flow enjoys less consensus [23]. The PI is infact generally applied to larger vessels where a flowreversal can be observed. It might be worth it, however, toremark that, in our study, both indexes were behaving thesame way.

(2) Observed modifications

Measured values after the treatment show a trend to-ward standard reference values. If a modification could beexpected, as suggested by many acupunctural indications


Table 5 Resistivity index.

Statistics RI null model RI model A RI model B RI model C RI model D

Fixed effectsIntercept 0,706 0,527 *** 0,529 *** 0,530 *** 0,5279 ***Time 0,142 *** 0,151 *** 0,148 *** 0,1486 ***Interval:Q1 vs Q2 0,110 *** 0,110 *** 0,107 *** 0,108 ***Q1 vs Q3 0,190 *** 0,189 *** 0,186 *** 0,185 ***Q1 vs Q4 0,249 *** 0,248 *** 0,246 *** 0,246 ***Q1 vs Q5 0,305 *** 0,309 *** 0,303 *** 0,302 ***Age 0,000 0,000 0,000 * 0,000 *Gender 0,005 0,007 0,007 0,006Ddays 0,000 0,000 * 0,000 �0,000 *Time*Q1 vs Q2 �0,118 *** �0,121 *** �0,118 *** �0,120 ***Time*Q1 vs Q3 �0,189 *** �0,188 *** �0,185 *** �0,180 ***Time*Q1 vs Q4 �0,236 *** �0,242 *** �0,240 *** �0,239 ***Time*Q1 vs Q5 �0,244 *** �0,284 *** �0,281 *** �0,282 ***Random effectsIntercept 0,004 0,000 0,000 0,000 0,000ID 0,002 0,002 0,002Correlation 1,000 1,000 1,000Residual 0,005 0,002 0,001 0,001 0,001Goodness-of-fit:Deviance �828 �1312 �1431 �1365 �1174AIC �822 �1282 �1397 �1331 �1140BIC �810 �1223 �1330 �1265 �1076

AIC Z Akaike information criterion; BIC Z Bayesian information criterion; RI Z resistivity index.*p < 0.05; **p < 0.01; ***p < 0.001.Null model. Number of observations: 387, groups: ID, 98.Model A Z fixed effects and random intercept. Number of observations: 387, groups: ID, 98.Model B Z fixed effects, random intercept and slope covariance. Number of observations: 387, groups: ID, 98.Model C Z Model B with Delta days <730. Number of observations: 363, groups: ID, 93.Model D Z Model B with Delta days <365. Number of observations: 315, groups: ID, 81.


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[29 - 34] toward a higher perfusion or toward a reduction ofthe intraocular pressure [35] (although there is no formalconsensus yet [36, 37]), the regulatory effect that our studyreports would be in all respects a novelty worth a specificnote.

(3) Clinical relevance

Far from expressly conclusive remarks, we wish to pro-pose the possible action of laser acupuncture beyond thevasomotion effect and on the physiological flow controlmechanism, even more so because the choroid flow lacks aspecific autonomous flow control capable of reacting toblood or eye pressure anomalies, causing flow anomalies.

(4) Therapy implications

The measurements were started to focus on treatmentof the possible causes of open-angle glaucoma. The resultsare rather encouraging because they show a beneficial ef-fect on the blood flow parameters, lasting to the medium-term observation (206 days). It is worth indicating that noadverse effects were observed.


9. Conclusions

Far from suggesting a possible therapeutic value ofthis protocol for open-angle glaucoma, we concludethat the ULLLL acupuncture treatment is an effectiveway to reduce anomalies of blood flow in the centralartery of the retina in patients with open-angleglaucoma.

Acknowledgment

This study was made possible primarily by the skill anddedication of the late Dr. Cipriano Ridolfi, to whom we areindebted for his professionality and human touch in per-forming these measurements. The authors join his familyand assistants in the memory of a great medical doctor. Theauthors also thank Professor Carlo Chiorri of Genoa Uni-versity and VIE Srl for the statistical evaluation and Pro-fessor Lorenzo Derchi of Universita di Genova for advice insupport of understanding the clinical meaning of theDoppler measurements.



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Appendix A. Supplementary data

Supplementary data to this article can be found onlineat https://doi.org/10.1016/j.jams.2018.11.005.

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