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between treatment gro ups using Fisher's Exact tests.
RESULTS
One hundred and twelve patient s (57 act ive and
o
55 placebo) used the unit during the study. Becau se
Fig. 1- Electric current waveform of the Cranial Electrotherapy of various prot ocol violation s, twe lve patients ha d
Stimulator manufactured by Pain Suppression Labs, Inc. no evalua ble head aches . Th is reduced the number
Wayne, New Jersey 07470. of evaluable pat ient s to 100, active and 50
placebo.
A perfectly blinded study when using a stimulat Patient Characteristics. Th ere wer e no significant
ing instrument as a therap eutic agent is not possible. differences betwe en tre atment groups for
The placebo unit ran for 70 seconds before shutting tions of sex, or race. Age s ranged from 20 to
off but the current meter registered 1.0-4.0 mA for 70 years with a mean age of 41 for pati ents in the
20 minutes, the same as the active unit. Patients placebo group and 42 for patients in the active group.
were to ld that the sensation initially experienced Likewise there we re no significant
might disappear after about one minute or might between tr eatment groups for di agnosis.. average
last the full 20 minutes ; in any case, the electrodes severity, or avera ge num ber of headaches per
were to be maintained for the full 20 minutes. month. A majority of the patients in the active qroup
Although patients were informed that they might (52%) had headaches of 12-24 hours in average d ur a
receive a placebo unit, they did not know that the tion, while a m ajority of pati ents in th e pl acebo
unit turning off after 70 seconds of stimulation was group (54%) had headaches of less than 12 hours
to be the placeb o unit. in duration. The distributions of average duration of
Primary Efficacy Variables. Efficacy was based on headaches, categorized as less than 12 hours,
the g loba I evaluations of crania I electrothera py hours, an d grea ter than 24 hours , w ere significan tl y
units by the pat ients and the investigators, and on different (p = 0.004).
the reduction in headache severity scores after treat Global Evaluations. Globa l evaluations of t he
ment. The global evaluati ons were classified as effectiveness of the unit by the patients and inves
"highly effective, " "moderately effecti ve," "min i tigators are summ arized in Table 1. In th e active
mally effective," and " not effective." Headache sev group 36% of the pati ents evaluated th e unit as
erity was rated by ci rcling an integer score on an "highly effective" or " moderatel y
analog pain scale ranging fr om 0 (no pain) to 10 whereas only 16% of. pati ents in the plac ebo group
(maximum pain) . so evaluated the unit. Sixty-three perc ent of
Statistical Methods. A ll hypothesis tests were per pat ients in the olacebo qroup evaluate d th e as
formed using The Statistical Analys is Svst ern." All "not effective, " compared to on ly 38% of th e patie nts
P-values were based on two-tailed tests. Global in the active gr oup. There was a signifi cant difference
evaluations were compared between treatment betwe en treatment group s in the ord ered outcome s
g ro u ps using a catego rical dat a procedure." The for the patient g lo ba l evaluati ons (p = 0.006). The
ordered nature of the responses listed abo ve was investigator 's evaluation s were sim ilar to the
accounted for by using the RESPONSE function wi t h patient s' evalu ations.
scores 3, 2, and 0, respectively. Headache Severity Scores . Statistics for
For each hea dache , the change fr o m baseline in from pre -treatment to post-treatment in heada che
headache severity scores calculated using th e severity scores are given in Table 2. The m ean
sco re pri or to tr eatm ent and th e last post-treatme nt ity scor e by 2.1 foll owing use of the act ive
score. Av erages over multiole evaluable headaches unit and by 1. 2 use of th e pl acebo u nit.
were calculated t o give a single pre-treatment and This difference statistically sign ifi cant (p =
post-treatment severity score for each pati ent. Head 0.016). Anal ys is of perc ent age change fr om pre-treat
ache s were considered non-evaluabl e if one or m ent scores w as also stat istica lly sign ifi cant, (p =
protoc ol violat ion was evid ent. 0.011 ); treatm ent w ith th e active un it produce d an
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report , whi ch co n sistec or a revie w ot low level cra
of "freque ncy" and "amplitude" w indows of
nial stimu lation , no ev idence of important side
therapeut ic etficacv." :" Apparentl y, low level cur-
effects was fo und .