International Journal of Clinical Medicine, 2016, 7, 474-480

Published Online July 2016 in SciRes. http://www.scirp.org/journal/ijcm

http://dx.doi.org/10.4236/ijcm.2016.77052

Clinical Assessment of the Use of

Propinox Hydrochloride and Scopolamine
Hydrochloride in the Treatment of
Abdominal Colic: A Retrospective,
Comparative Study
Helio Rzetelna1,2,3,4,5, Carlos Frederico Porto Alegre Rosa5,6,7,8, Mario Kirzner1,4,9,
Lucas Pereira Jorge de Medeiros1,2,10, Camila Melo11, Marcia Gonçalves Ribeiro12,
Lisa Oliveira13, José Galvão Alves5,9, Mauro Geller12,13,14*
1
Gastroenterology Department, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil
2
Clinical Medicine Department, Centro Universitário Volta Redonda (UNIFOA), Volta Redonda, Brazil
3
Clinical Medicine and Gastroenterology Department, Universidade Estácio de Sá (UNESA) Rio de Janeiro, Brazil
4
Clinical Medicine Department, Escola de Medicina Souza Marques, Rio de Janeiro, Brazil
5
Inflammatory Bowel Diseases Outpatient Unit-18 ª enfermaria da Santa Casa da Misericórdia do Rio de
Janeiro, Rio de Janeiro, Brazil
6
Federação Brasileira de Gastroenterologia, São Paulo, Brazil
7
Grupo de Estudos de Doenças Inflamatórias Intestinais, Rio de Janeiro, Brazil
8
UNESA, Rio de Janeiro, Brazil
9
Gastroenterology Post-Graduation Program-PUC-Rio, Rio de Janeiro, Brazil
10
Neurology Post-Graduation Program, Universidade Federal do Estado do Rio de Janeiro (UERJ), Rio de Janeiro,
Brazil
11
Pharmacology Department—UFRJ, Rio de Janeiro, Brazil
12
Medical Genetics Service, IPPMG-Universidade Federal Rio de Janeiro, Rio de Janeiro, Brazil
13
Immunology Department, Teresópolis Medical School (UNIFESO), Teresópolis, Brazil
14
Clinical Immunology, Instituto de Pós-Graduação Médica Carlos Chagas (IPGMCC,) Rio de Janeiro, Brazil

Received 3 May 2016; accepted 12 July 2016; published 15 July 2016

Copyright © 2016 by authors and Scientific Research Publishing Inc.

This work is licensed under the Creative Commons Attribution International License (CC BY).
http://creativecommons.org/licenses/by/4.0/

Abstract
Objectives: The purpose of this study was to evaluate and compare the use of propinox hydrochlo-
ride and scopolamine hydrochloride in patients presenting abdominal colic (abdominal pain), in
*
Corresponding author.

How to cite this paper: Rzetelna, H., et al. (2016) Clinical Assessment of the Use of Propinox Hydrochloride and Scopola-
mine Hydrochloride in the Treatment of Abdominal Colic: A Retrospective, Comparative Study. International Journal of
Clinical Medicine, 7, 474-480. http://dx.doi.org/10.4236/ijcm.2016.77052
 H. Rzetelna et al.

terms of treatment efficacy and tolerability. Material & Methods: This was an analytical, retros-
pective, comparative study based on hospital records of outpatients treated at Serviço de Clínica
Médica do Hospital das Clínicas Costantino Otaviano (HCTCO) and at Santa Casa de Misericórdia do
Rio de Janeiro, from 1988-1998. Subjects were divided into two groups: patients from Group 1
were treated with propinox hydrochloride, while patients from Group 2 were treated with scopo-
lamine hydrochloride. Statistical analysis was performed using GraphPad Prism version 5.0. For
comparison of categorical variables, we used the chi-squared or Fisher’s test, while continuous va-
riables were analyzed using ANOVA or the Student’s T test. Results: A total of 1042 subjects were
included, of which 525 were allocated to Group 1 and 517 to Group 2. Mean treatment duration
was 9.166 days (±4.208) in Group 1 and 8.795 days (±5.052) in Group 2, with no statistically sig-
nificant difference in treatment duration between the two groups (p = 0.198). All subjects in Group
1 were treated with propinox 10 mg (2 coated tablets, three times per day) while all subjects in
Group 2 were treated with scopolamine hydrochloride 10 mg (2 coated tablets, three times per
day). There were no statistically significant between-group differences in weight, BMI, heart rate,
and respiratory rate at pre- and post-treatment; with the exception of higher post-treatment sys-
tolic blood pressure in Group 1, blood pressure measures also remained homogenous. Adverse
events were reported among both treatment groups with no significant between-group difference
in incidence (p = 0566). At pretreatment, pain intensity was more severe in Group 1 (p = 0.0257),
while at post-treatment, there was no statistically significant difference between the two treat-
ment groups (p = 0.895). There was a statistically significant improvement in pain intensity within
both treatment groups (χ2 = 631.4; df = 3; p < 0.0001 for Group 1 and χ2 = 554.3; df = 3; p < 0.0001
for Group 2). Conclusion: The results obtained in this study indicate a therapeutic equivalence
between propinox hydrochloride and scopolamine hydrochloride. Both treatments demonstrated
good efficacy and tolerability in the treatment of abdominal colic pain, in the population eva-
luated.

Keywords
Abdominal Colic, Propinox Hydrochloride, Scopolamine Hydrochloride

1. Introduction
The term abdominal colic is used to describe spasmodic abdominal pain, arising as a result of distension, in-
flammation, or obstruction. It is often characterized as a sharp, localized abdominal pain that increases, peaks,
and subsides. While it is often a benign complaint, it may also be a sign of a more significant pathology, there-
fore a careful medical history and physical examination are crucial to the approach for a differential diagnosis.
Treatment of abdominal colic includes pain relievers such as nonsteroidal anti-inflammatory drugs, as well as
antispasmodic agents.
Propinox hydrochloride, also known as pargeverine hydrochloride, is an antispasmodic that presents a dual
mechanism of pharmacologic action: musculotropic and anticholinergic. It functions as a musculotropic agent,
acting directly on the visceral smooth muscle cells and conferring its antispasmodic activity [1]-[9]. The anti-
cholinergic activity of propinox is derived from a moderate and non-selective blockade of muscarinic choliner-
gic fibers [1].
The pharmacological activity of propinox is exerted on the visceral smooth muscle cells of the digestive and
genitourinary tract [1]-[9]. Its antispasmodic activity at the intestinal level presents an efficacy two to three
times greater than papaverine. Its effects on digestive secretions are smaller than those produced by quaternary
ammonium compounds, thus the antisylagogue action is relatively weak. In the cardiovascular system, propinox
does not alter tensional values or heart rate. Additionally, there are no reported effects in the literature of effects
on the respiratory tract, at therapeutic doses [2]-[5]. Propinox is indicated in the treatment of spasmodic states of
the digestive, hepatobiliary, urinary or female genital tracts [1] [3].
Scopolamine hydrochloride is an anticholinergic drug that presents a high affinity for muscarinic receptors
located on the smooth muscle cells of the gastrointestinal tract. Its anticholinergic activity exerts a muscle relaxant

475
H. Rzetelna et al.

and spasmolytic effect. Scopolamine is derived from hyoscine, an alkaloid present in the leaves of the Duboisia
plant, native to Australia, with a pharmacological potency twice that of atropine [1].
The basis of the therapeutic action of scopolamine is blockade of the action of acetylcholine in parasympa-
thetic sites in smooth muscle and secretory glands. With this blockade, there is a decrease in motility of the uro-
genital and gastrointestinal tract, which renders scopolamine particularly useful in the treatment of spasms in
these regions, commonly observed in gastroenteritis, colitis, irritable bowel syndrome, diverticulitis, biliary and
urethtral colic, as well as in primary dysmenorrhea. It is also used in the prevention of gastrointestinal tract
spasms prior to invasive radiological and diagnostic procedures. Scopolamine also acts on the glands of the oral
cavity, gastrointestinal and respiratory tract, causing a reduction of activities and consequently of secretions [1]
[3]. Scopolamine hydrochloride is indicated in the treatment of spasms of the gastrointestinal tract, biliary tract
spasms and dyskinesias, and spasms of the genitourinary tract [1] [3] [15].

2. Objectives
The primary objective of this study was to evaluate the use of propinox hydrochloride in patients presenting ab-
dominal colic (abdominal pain), in terms of treatment efficacy and tolerability. The secondary study objectives
were to evaluate the use of scopolamine hydrochloride in patients presenting abdominal colic (abdominal pain),
in terms of treatment efficacy and tolerability, and to compare the results of the use of propinox hydrochloride
with those of scopolamine hydrochloride, in terms of treatment efficacy and tolerability.

3. Material & Methods

This was an analytical, retrospective, comparative study. The study population consisted of outpatients treated at
Serviço de Clínica Médica do Hospital das Clínicas Costantino Otaviano (HCTCO) and at Santa Casa de Mise-
ricórdia do Rio de Janeiro, from the period of 1988-1998, from which study data were drawn. After ethical
committee approval (approval no. 523-10), data present in the hospital records of each patient were analyzed in
order to fill in the clinical research form, including the results of physical exam (height, weight, heart rate, blood
pressure), medical history, demographic data, the results of any laboratory exams, and the identification, phar-
maceutical form, dosing and treatment duration with the study drug, in addition to the presence and severity of
abdominal pain. Inclusion criteria called for subjects of both genders, above 18 years of age, who were attended
at either hospital and prescribed treatment with either of the study drugs. Only data from subjects with at least
two hospital visits were included. The subjects were divided into two groups, according to the drug received.
Patients from Group 1 were treated with propinox hydrochloride, while patients from Group 2 were treated with
scopolamine hydrochloride.
Statistical analysis was performed using GraphPad Prism version 5.0. For comparison of categorical variables,
we used the chi-squared or Fisher’s test, while continuous variables were analyzed using ANOVA or the Stu-
dent’s T test. The primary efficacy endpoint was the percentage of subjects presenting resolution (absence) of
pain at the second hospital visit. Secondary endpoints included the percentage of subjects presenting mild, mod-
erate, or severe pain at the second hospital visit in relation to the first visit, record of any adverse effects during
the treatment period, and the results of any laboratory tests out of hospital reference range.

4. Results
A total of 1042 subjects were included, of which 525 were allocated to Group 1 and 517 to Group 2. Gender
distribution was homogenous between treatment groups (p = 0.386); Group 1 included a total of 268 (51.05%)
male subjects and 257 (48.95%) female subjects, while gender distribution in Group 2 was 278 (53.77%) male
subjects and 239 (46.23%) female subjects. Ethnicity distribution was also homogenous between treatment
groups (p = 0.732). Mean subject age in Group 1 was 51.65 (±7.56) while in Group 2 it was 54.4 (±7.56) (p <
0.001 for between-group difference).
Mean treatment duration was 9.166 days (±4.208) in Group 1 and 8.795 days (±5.052) in Group 2, with no
statistically significant difference in treatment duration between the two groups (p = 0.198). All subjects in
Group 1 were treated with propinox 10 mg (2 coated tablets, three times per day) while all subjects in Group 2
were treated with scopolamine hydrochloride 10 mg (2 coated tablets, three times per day).
The results of the physical exam performed pre- and post-treatment and the respective between-visit differ-
ences are summarized in Table 1. At pretreatment, there was no statistically significant between-group difference

476
 H. Rzetelna et al.

Table 1. Pre and Post-treatment physical exam.

Group 1 Between-visit Group 2 Between-visit
Variable Post-treatment Post-treatment
Pretreatment difference Pretreatment difference
Weight (kg) 67.18 (±11.44) 67.15 (±11.39) p = 0.284 68.19 (±11.25) 68.09 (±11.18) p = 0.0134
2
BMI (kg/cm ) 24.18 (±2.802) 24.5 (±4.945) p = 0.0582 24.11 (±2.54) 24.1 (±2.508) p = 0.435
Systolic blood
122.2 (±8.25) 122.4 (±8.67) p = 0.387 121.3 (±7.29) 121.3 (±7.304) p = 0.875
pressure (mmHg)
Diastolic blood
78.9 (±9.66) 78.23 (±9.89) p < 0.0001 78.16 (±8.17) 78.1 (±7.662) p = 0.781
pressure (mmHg)
Heart rate (bpm) 68.65 (±5.38) 68.28 (±4.93) p = 0.0178 68.23 (±5.45) 67.91 (±5.038) p = 0.057
Respiratory rate
16.58 (±1.59) 16.57 (±1,142) p = 0.974 16.61 (±1.71) 16.53 (±1.51) p = 0.172
(ipm)
Data are means (±SD) and p values.

in weight (p = 0.15); this finding was maintained post-treatment (p = 0.181). BMI did not vary significantly be-
tween treatment groups at either study visit (p = 0.675 for pretreatment and p = 0.099 for post-treatment). Pre-
treatment blood pressure measures did not vary between treatment groups (p = 0.669 for systolic blood pressure
and p = 0.1833 for diastolic blood pressure); at post-treatment, systolic blood pressure was higher (p = 0.0258)
among subjects in Group 1 while diastolic blood pressure was homogenous between treatment groups (p =
0.8105). Mean heart rate was homogenous between treatment groups at both pretreatment (p = 0.2114) and
post-treatment (p = 0.234). Respiratory rate was also homogenous between both groups (p = 0.725 for pretreat-
ment and p = 0.632 at post-treatment).
There was no statistically significant between-group difference in the number of subjects using concomitant
medications (p = 1.0). At pretreatment, 87 in each treatment group reported use of concomitant medications. At
post-treatment, this number reduced to 27 subjects in each treatment group.
Adverse events were reported among both treatment groups, with 133 subjects in Group 1 reporting adverse
events during the treatment period and 123 subjects in Group 2. The incidence of adverse events occurring dur-
ing the treatment period did not vary between treatment groups (p = 0.566). Table 2 summarizes the adverse
events by system and patient group.
Figure 1 summarizes the results of the assessments of pain severity pre and post-treatment. At pretreatment,
pain intensity was more severe in Group 1 (p = 0.0257), while at post-treatment, there was no statistically sig-
nificant difference between the two treatment groups (p = 0.895). There was a statistically significant improve-
ment in pain intensity within both treatment groups (χ2 = 631.4; df = 3; p < 0.0001 for Group 1 and χ2 = 554.3;
df = 3; p < 0.0001 for Group 2).

5. Discussion
Although this was a retrospective study with inherent limitations in data availability, the study drugs were well
tolerated in both treatment groups. This finding is consistent with data reported in the literature on clinical ad-
ministration of both agents.
Clinical safety and efficacy studies have demonstrated a good tolerability of propinox. De los Santos et al.
(1999) evaluated the efficacy and tolerability of propinox administered intravenously at doses of 10, 20, and 30
mg versus placebo in 350 patients presenting severe acute biliary pain. Propinox significantly and progressively
reduced pain at all doses employed, 20, 60, and 120 minutes after administration, with the highest results ob-
tained after 120 minutes at the doses of 20 mg and 30 mg. The drug was well tolerated at all doses, with no dro-
pouts due to adverse effects. Mouth dryness was the only adverse event that occurred more frequently among the
treated subjects as compared to the placebo group, and was observed only among patients receiving the doses of 20
and 30 mg. No significant changes in heart rate or blood pressure were observed among treated subjects [10].
Another clinical study evaluating the safety and efficacy of propinox by intravenous route used the same dos-
es of 10, 20, and 30 mg versus placebo in 400 patients presenting moderate to severe colic-type abdominal pain
secondary to a functional pathology (irritable bowel syndrome and dyspepsia). Propinox was more effective in
reducing pain compared to placebo at the three doses administered. In the assessment performed 120 minutes fol-
lowing drug administration, there was a significant difference in the percentage of subjects with pain reduction in

477
H. Rzetelna et al.

Abdominal Pain Intensity

300
250
200
150
100
50
0
No pain Mild Moderate Severe

Group 1 Pretreatment Group 1 Post-Treatment

Group 2 Pretreatment Group 2 Post-Treatment

Figure 1. Abdominal pain intensity at pretreatment and post-treatment.

Table 2. Pre- and post-treatment physical exam.

System affected Number of Subjects per Treatment Group

Group 1 Group 2
Cardiovascular system 7 7
Cardiovascular system/Nervous system 1 0
Endocrine system 43 42
Endocrine system/Cardiovascular system 1 4
Endocrine system/Nervous system 1 0
Endocrine system/Respiratory system 1 0
Endocrine system/Gastrointestinal tract 5 3
Nervous system 20 13
Nervous system/Gastrointestinal tract 1 1
Respiratory system 0 1
Gastrointestinal tract 28 25
Gastrointestinal tract/Endocrine system 2 2
Gastrointestinal tract/Nervous system 1 0
Urinary tract 21 23

Data are n.

favor of the 20 and 30 mg doses. The authors related dry mouth as the most frequent adverse event reported at
doses of 20 mg and 30 mg. No change in blood pressure or heart rate was observed among these subjects [11].
The efficacy and safety of propinox was assessed by Mezzotero et al. (1995) in the treatment of patients with
mild to moderate abdominal colic pain resulting from biliary, intestinal, renal-pelvic, urethral, or female genital
pathology (dysmenorrhea). One hundred and six subjects were treated with a dose of 10 mg administered orally.
Pain intensity decreased by 43% thirty minutes after administration of a single dose. The most frequently re-
ported adverse effects were flushing and pruritis. One subject developed a clinical picture of cutaneous allergy
with bipalpebral edema requiring parenteral administration of antihistamines [12].
The efficacy and tolerability of parenterally administered propinox was assessed by Olmos et al., (2003), at
the doses of 20 or 30 mg, among patients presenting with colonic spasm induced by colon exam among subjects
with irritable bowel. Both doses of propinox were effective in reversing the colonic spasm, increasing colonic
diameter, and reducing abdominal pain. The adverse events reported during the treatment were mild and transi-
tory, with a single case of blurred vision, one case of dry mouth and one of pruritis among the 30 subjects who

478
 H. Rzetelna et al.

underwent treatment [13].

An oral dose of 10 mg was used by Pulpeiro et al. (2000) to compare the analgesic efficacy and assess
changes in defecation rhythm, abdominal distension, frequency of pain crises, and sensation of incomplete
evacuation as compared to treatment with a placebo. The double-blind, randomized treatment period lasted 4
weeks and included 75 subjects with irritable bowel syndrome, with 4 daily doses of the study drug. The group
treated with propinox presented a significant and progressive reduction over the 28 day treatment period in in-
tensity of abdominal pain, weekly frequency of pain episodes, and abdominal distension, greater than that ob-
served in the group treated with placebo. The most frequent adverse effects were headaches, nausea, and dry
mouth, however no dropouts due to adverse effects were recorded [14].
Several clinical studies have been performed assessing the safety and efficacy of scopolamine. Ten placebo-
controlled clinical trials assessed this drug in the treatment of abdominal pain and discomfort, with a total of
3699 subjects, of which 911 received the drug in oral form (n = 868) or rectal form (n = 43) and 2788 subjects
received paracetamol, placebo, or a combination of scopolamine with other drugs. Treatment duration varied in
the studies from a single 20 mg dose with a 4 hour observation period to a three-month treatment period with a
dose of 10 mg four times per day. The maximum daily dose varied between 20 - 200 mg over 10 days. Scopo-
lamine was considered beneficial in all of these studies, with statistically superior efficacy over placebo in at
least one variable in each study [17]-[26]. Of these ten studies, seven included a small number of subjects (<50)
treated with the drug, and were performed prior to the establishment of the Good Clinical Practice and Interna-
tional Conference on Harmonisation Guidelines. Therefore, although the results of these seven studies were fa-
vorable, they are of limited value in assessing the efficacy of the drug.
Three more recent comparative studies, including 712 [17], 818 [21], and 1637 [23] subjects, respectively,
used doses between 30 and 60 mg and treatment duration varied between 4 days and 3 weeks, respectively. The
results of the first study demonstrated that scopolamine administered orally or rectally resulted in a significant
improvement of pain in comparison to treatment with placebo [21]. In a double-blind, comparative, randomized
study, parallel groups of patients with irritable bowel syndrome were treated with scopolamine + paracetamol,
scopolamine alone, paracetamol alone, or placebo over the course of four weeks. At the end of the treatment pe-
riod, 75% of the patients in the groups treated with scopolamine had significant improvement in symptoms, with
a statistically significant improvement in abdominal pain intensity in the groups treated with scopolamine com-
pared to subjects treated only with paracetamol or placebo [17]. In a clinical trial assessing 1637 subjects, the
efficacy and tolerability of three daily doses of scopolamine 10 mg, paracetamol 500 mg, a combination of the
two drugs, or placebo, was assessed over a three week treatment period. The intensity and frequency of the pain
decreased significantly in the scopolamine treatment groups as compared to placebo, and no difference was ob-
served between the active treatments [23].

6. Conclusion
The results obtained in this study indicate a therapeutic equivalence between propinox hydrochloride and sco-
polamine hydrochloride. Both treatments demonstrated good efficacy and tolerability in the treatment of abdo-
minal colic pain, in the population evaluated.

Acknowledgements
The authors would like to thank Renato Kaufman, Breno Lorch, Silvia Maciel, and Diane Bergamim, Natasha
Cytrynbaum, and Klaudia Ciszewianka for help with data retrieval, tabulation, and verification.

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