ABSTRACT STUDY DESIGN: The study was a Randomized Controlled

ABSTRACT

 

OBJECTIVE:

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To compare frequency of Hyperprolactinemia with Risperidone and
Olanzapine in patients with first episode psychosis

STUDY DESIGN:         

The study was a Randomized Controlled Trial
(RCT) conducted in Combined Military Hospital (CMH),Lahore over a period of six
months (1st Sep 2015 to 29 Feb 2016)

SUBJECTS AND METHODS

60 patients
who had psychosis as accompanying feature in any of the various psychiatric
illnesses according to ICD-10 diagnostic criteria were enrolled in this
Randomized controlled Trial. Fasting venous blood samples for serum prolactin
were collected between 0800 hrs and 1000 hrs at baseline (first visit). The
patients were then randomly assigned to receive risperidone or olanzapine by
lottery method. Serum prolactin levels were then collected at 3 months
follow-up visit. All samples were tested in labortary of Pathology department, CMH
Lahore for measurement of serum prolactin levels and results were verified by a
classified pathologist. Confounding variables were identified and excluded by
exclusion criteria.

RESULTS:

A total of 35 patients (58.33%)
developed hyperprolactinemia. The olanzapine group showed 13 out of 30 patients
(43.33%) and risperidone group showed 22 out of 30 patients (73.33%) with
raised prolactin levels with p-value of 0.018 indicating that the difference was
statistically significant.

CONCLUSION

Frequency of hyperprolactinemia is high
with risperidone than with olanzapine in first episode psychosis.

KEYWORDS

Hyperprolactinemia,
Psychosis, Antipsychotics

 

 

 

 

 

 

 

 

 

 

 

 

 

INTRODUCTION

Psychosis (delusions and/or hallucinations) is a feature
of many psychiatric disorders. In psychotic disorders such as Schizophrenia, Acute
and transient psychotic episode it is the primary symptom while in mood
disorders such as Depression, Bipolar affective disorder it occurs secondary to
mood disturbances.

Antipsychotics are the primary drugs
used to treat psychosis. These drugs are divided into two classes (Typical and
Atypical) based on their tendency to bind Dopamine (D2) receptors.

Typical antipsychotics bind with high
affinity while atypical are said to bind with low affinity. Antipsychotics including atypical are well
known to cause Hyperprolactinemia i.e. increased prolactin levels. Drugs having
high affinity for Dopamine D2 receptors (Haloperidol) have more tendency to
cause hyperprolactinemia1. Atypical antipsychotics due to their low
affinity for Dopamine D2 receptors are less commonly associated but not
completely free of hyperprolactinemic effects. Among atypical antipsychotics
risperidone and amisulpride affect prolactin levels more frequently while clozapine,
olanzapine, quetiapine are prolactin-sparing2, 3.

Prolactin
is secreted by anterior pituitary gland in a pulsatile manner. Secretion of
prolactin is regulated by dopamine, a hormone produced by hypothalamus.
Dopamine has inhibitory effect on secretion of prolactin. It acts on D2
receptors present in lactotrophs of anterior pituitary to decrease secretion of
prolactin. Antipsychotic drugs bind to D2 receptors and block this effect
causing increase in prolactin levels4.

Hyperprolactinemia
in short term causes galactorrhea, amenorrhea in women while raised prolactin
levels for prolonged period of time predisposes to osteoporosis and cardiovascular
disease.   These side effects in turn
lead to poor compliance5, 6.

A review
of the effects of antipsychotic medication on prolactin levels showed that the
incidence of hyperprolactinemia was 90% with haloperidol, 80% with pimozide,
62% with risperidone, 31% with olanzapine while clozapine, quetiapine and
ziprasidone were prolactin-sparing7.

A recent
study comparing effects of risperidone and olanzapine on plasma prolactin
levels both in short and long term showed that a significantly higher
percentage of patients developed hyperprolactinemia in the risperidone
treatment group (89%) compared with olanzapine treatment group (45%) at 3
months duration8.

The
rationale of this study is based on the fact that previous studies have yielded
inconsistent results regarding frequency of hyperprolactinemia in patients
treated with antipsychotic medication, risperidone and olanzapine9.
The occurrence of hyperprolactinemia with these two commonly used
antipsychotics (olanzapine and risperidone) needs to be clearly evaluated to
help clinicians choose the appropriate drug according to patient’s needs.

MATERIALS AND METHODS:

 60 subjects who were enrolled in this RCT were
patients of both gender, age ranging between 18-60 years (Mean+SD 36.77+9.686), who had psychosis as accompanying
symptom/feature in any of the various psychiatric illnesses according to ICD-10
diagnostic criteria and had normal serum prolactin levels (below 20 µg/L in
males and below 25 µg/L in females) at the start of study. Criteria
that excluded patients from the study included physiological conditions (eg; pregnancy, lactation), medical
disorders (e.g.
Pituitary tumors, Primary hypothyroidism, Adrenal insufficiency) and
concurrent medications (e.g.
metoclopramide, methyldopa, verapamil, dopamine agonists)
known to affect serum prolactin levels.

The study was conducted in Combined Military
Hospital (CMH), Lahore over a period of six months (1st Sep 2015 to
29 Feb 2016).

Ethical
approval was obtained from ethical research committee of the hospital and
formal written informed consent was obtained from all the patients included in
the study.

DATA
COLLECTION PROCEDURE:

 Demographic data was collected
regarding age, gender, occupation, education, marital status. Patients
suffering from various psychiatric illnesses were diagnosed by ICD-10 criteria after
history and mental state examination by resident/consultant psychiatrist. The
patients were randomly assigned to receive risperidone or olanzapine by lottery
method. Fasting venous blood samples for serum prolactin were collected between
0800 hrs and 1000 hrs at baseline (first visit) and then at 3 months follow-up
visit. Samples were sent to pathology department (CMH Lahore) for measurement
of serum prolactin levels and results verified by a classified pathologist.
Confounding variables were identified and excluded by exclusion criteria.

Data was analyzed using SPSS 19.0. Descriptive statistics was
used to calculate qualitative and quantitative variables. Mean and standard deviation was calculated for
quantitative variables (Age). Frequency and percentages were calculated for
qualitative variables (Gender, Hyperprolactinemia). Chi-square test was applied
to compare the frequency of Hyperprolactinemia between the two groups. P-value
of