LE Magazine November 2002
Page 3 of 4
Irritiable bowel syndrome
Enteric-coated peppermint-oil capsules
in the treatment of irritable bowel syndrome: a prospective,
randomized trial.
To determine the efficacy and tolerability of an
enteric-coated peppermint-oil formulation (Colpermin), we
conducted a prospective, randomized, double-blind,
placebo-controlled clinical study in 110 outpatients (66
men/44 women; 18 to 70 years of age) with symptoms of
irritable bowel syndrome. Patients took one capsule (Colpermin
or placebo) three to four times daily, 15-30 min before meals,
for one month. Fifty-two patients on Colpermin and 49 on
placebo completed the study. Forty-one patients on Colpermin
(79%) experienced an alleviation of the severity of abdominal
pain (29 were pain-free); 43 (83%) had less abdominal
distension, 43 (83%) had reduced stool frequency, 38 (73%) had
fewer borborygmi, and 41 (79%) less flatulence. Corresponding
figures for the placebo group were: 21 patients (43%) with
reduced pain (4 were pain-free), 14 (29%) with reduced
distension, 16 (32%) with reduced stool frequency, 15 (31%)
with fewer borborygmi, and 11 (22%) with less flatulence.
Symptom improvements after Colpermin were significantly better
than after placebo (P < 0.05; Mann-Whitney U-test). One
patient on Colpermin experienced heartburn (because of chewing
the capsules) and one developed a mild transient skin rash.
There were no significant changes in liver function test
results. Thus, in this trial, Colpermin was effective and well
tolerated.
J Gastroenterol 1997
Dec;32(6):765-8
Stress management for irritable bowel
syndrome: a controlled trial.
Thirty-five patients with irritable bowel syndrome were
randomized to receive treatment in a stress management
programme or conventional therapy which included the
antispasmodic Colpermin. The stress management programme
involved a median of six 40-min sessions with a
physiotherapist during which patients were helped to
understand the nature of their symptoms, their relationship to
stress and were taught relaxation exercises. Two-thirds of
those in the stress management programme found the programme
effective in relieving symptoms and experienced fewer attacks
of less severity. This benefit was maintained for at least 12
months. Few of those given conventional management had any
benefit. A stress management programme would appear to be of
value for patients with irritable bowel syndrome.
Digestion 1991;50(1):36-42
Delayed release peppermint oil
capsules (Colpermin) for the spastic colon syndrome: a
pharmacokinetic study.
Excretion of menthol (as glucuronide) from orally ingested
peppermint oil contained in Colpermin was compared with oil
contained in two soft gelatine capsules. Total 24 h urinary
excretion of menthol was similar in the two formulations in
healthy volunteers, but peak menthol excretion levels were
lower and excretion delayed with Colpermin. Menthol excretion
was reduced in ileostomy patients who took Colpermin and
moderate amounts of unmetabolized menthol were recovered from
the ileostomy effluent. This is consistent with Colpermin
being a delayed-release form of peppermint oil.
Br J Clin Pharmacol 1984
Oct;18(4):638-40
High-fiber diet supplementation in
patients with irritable bowel syndrome (IBS): a multicenter,
randomized, open trial comparison between wheat bran diet and
partially hydrolyzed guar gum (PHGG).
High-fiber diet supplementation is commonly used in IBS,
although it poses several management problems. Partially
hydrolyzed guar gum (PHGG) has shown beneficial effects in
animal and human studies, but its potential role in IBS
symptom relief has not been evaluated yet. We investigated
PHGG in IBS patients and compared it to a wheat bran diet.
Abdominal pain, bowel habits and subjective overall rating
were longitudinally evaluated in 188 adult IBS patients (139
women and 49 men) for 12 weeks. Patients were classified as
having diarrhea-predominant, constipation-predominant or
changeable bowel habits and were randomly assigned to groups
receiving fiber (30 g/day of wheat bran) or PHGG (5 g/day).
After four weeks, patients were allowed to switch group,
depending on their subjective evaluation of their symptoms.
Significantly more patients switched from fiber to PHGG
(49.9%) than from PHGG to fiber (10.9%) at four weeks. Per
protocol analysis showed that both fiber and PHGG were
effective in improving pain and bowel habits, but no
difference was found between the two groups. Conversely,
intention-to-treat analysis showed a significantly greater
success in the PHGG group (60%) than in the fiber group (40%).
Moreover, significantly more patients in the PHGG group
reported a greater subjective improvement than those in the
Fiber group. In conclusion, improvements in core IBS symptoms
(abdominal pain and bowel habits) were observed with both bran
and PHGG, but the latter was better tolerated and preferred by
patients, revealing a higher probability of success than bran
and a lower probability of patients abandoning the prescribed
regimen, suggesting that it can increase the benefits deriving
from fiber intake in IBS, making it a valid option to consider
for high-fiber diet supplementation.
Dig Dis Sci 2002
Aug;47(8):1697-704
Enteric-coated, pH-dependent
peppermint oil capsules for the treatment of irritable bowel
syndrome in children.
In a randomized, double-blind controlled trial, 42 children
with irritable bowel syndrome (IBS) were given pH-dependent,
enteric-coated peppermint oil capsules or placebo. After two
weeks, 75% of those receiving peppermint oil had reduced
severity of pain associated with IBS. Peppermint oil may be
used as a therapeutic agent during the symptomatic phase of
IBS.
J Pediatr 2001 Jan;138(1):125-8
Peppermint oil for irritable bowel
syndrome: a critical review and metaanalysis.
OBJECTIVE: Peppermint oil is the major constituent of
several over-the-counter remedies for symptoms of irritable
bowel syndrome (IBS). As the etiology of IBS is not known and
treatment is symptomatic, there is a ready market for such
products. However, evidence to support their use is sparse.
The aim of this study was to review the clinical trials of
extracts of peppermint (Mentha X piperita L.) as a symptomatic
treatment for IBS. METHODS: Computerized literature searches
were performed to identify all randomized controlled trials of
peppermint oil for IBS. Databases included Medline, Embase,
Biosis, CISCOM, and the Cochrane Library. There were no
restrictions on the language of publication. Data were
extracted in a standardized, predefined fashion, independently
by both authors. Five double blind, randomized, controlled
trials were entered into a metaanalysis. RESULTS: Eight
randomized, controlled trials were located. Collectively they
indicate that peppermint oil could be efficacious for symptom
relief in IBS. A metaanalysis of five placebo-controlled,
double blind trials seems to support this notion. In view of
the methodological flaws associated with most studies, no
definitive judgment about efficacy can be given. CONCLUSION:
The role of peppermint oil in the symptomatic treatment of IBS
has so far not been established beyond reasonable doubt. Well
designed and carefully executed studies are needed to clarify
the issue.
Am J Gastroenterol 1998
Jul;93(7):1131-5
Peppermint oil-caraway oil fixed
combination in non-ulcer dyspepsia--comparison of the effects
of enteric preparations.
Two hundred twenty three patients with non-ulcer dyspepsia
(dysmotility type dyspepsia or essential/idiopathic dyspepsia,
also in combination with irritable bowel syndrome) were
included in a prospective, randomized, reference- and
double-blind controlled multicentre trial to compare two
different preparations of a fixed combination of peppermint
oil and caraway oil. The aim of the trial was to evaluate the
equivalence of the efficacy and tolerability of these two
preparations. The test formulation consisted of the drug
combination in an enteric coated capsule containing 90 mg
peppermint oil and 50 mg caraway oil, while an enteric soluble
formulation containing 36 mg peppermint oil and 20 mg caraway
oil was used as the reference. The main target item defined
was the “difference in pain intensity between the
beginning and the end of therapy,” measured by the
patient on a visual analogue scale (0 = no pain, 10 =
extremely strong pain). In 213 patients (n = 108 on the test
preparation, n = 105 on the reference preparation) with mean
pain intensity baseline measurements of 6.1 points in the test
preparation group and 5.9 points in the reference group a
statistically significant decline in pain intensity was
observed in the two groups (-3.6 resP. -3.3 points; p <
0.001; two-sided one-sample t-test). Equivalent efficacy of
both preparations was demonstrated (p < 0.001; one-sided
t-test for equivalence). With respect to concomitant
variables, the results in both groups were also similar.
Regarding “pain frequency,” the efficacy of the test
preparation was significantly better (p = 0.04; two-sided
t-test for difference). Both preparations were well tolerated.
Despite the higher dose, the adverse event “eructation
with peppermint taste” was less frequent in the group
treated with the test formulation, due to the enteric coated
capsule preparation.
Pharmazie 1999 Mar;54(3):210-5
Hormones
Are autoimmune thyroid dysfunction and
depression related?
The objective of this study was to examine the relationship
between autoimmune thyroid disease and depression in
perimenopausal women. Thyroid function [TSH, free T4, and
thyroid peroxidase antibodies (TPO-Ab)] and depression (using
the Edinburgh Depression Scale) were assessed
cross-sectionally together with other determinants of
depression. The subjects were 583 randomly selected
perimenopausal women (aged 47 to 54 yr) from a community
cohort of 6,846 women. The main outcome measures were the
occurrence of thyroid dysfunction (abnormal free T4 and/or TSH
or elevated levels of TPO-Ab) and the concomitant presence of
depression according to the Edinburgh Depression Scale.
Neither biochemical thyroid dysfunction nor menopausal status
was related to depression. Apart from several psycho-social
determinants (the occurrence of a major life event, a previous
episode of depression, or financial problems), an elevated
level of TPO-Ab (> or = 100 U/mL) was significantly
associated with depression (odds ratio, 3.0, 95% confidence
interval, 1.3-6.8). We conclude that women with elevated
TPO-Ab levels are especially vulnerable to depression, whereas
postmenopausal status does not increase the risk of
depression.
J Clin Endocrinol Metab 1998
Sep;83(9):3194-7
High serum cholesterol levels in
persons with ‘high-normal’ TSH levels: should one
extend the definition of subclinical hypothyroidism?
OBJECTIVE: The association between established
hypothyroidism and high cholesterol levels is well known. The
aim of the present study was to investigate the effect of
thyroxine (T4) administration on cholesterol levels in
hypercholesterolemic subjects with TSH levels within the
normal range (‘high-normal’ TSH compared with
‘low-normal’ TSH). DESIGN AND METHODS: We determined
TSH levels in 110 consecutive patients referred for
hypercholesterolemia (serum cholesterol >7.5 mmol/l). Those
with ‘high-normal’ TSH (2.0-4.0 microU/ml) as well
as those with ‘low-normal’ TSH (0.40-1.99 microU/ml)
were randomly assigned to receive either 25 or 50 microg T4
daily for two months. Thus, groups A and B (low-normal TSH)
received 25 and 50 microg T4 respectively and groups C and D
(high-normal TSH) received 25 and 50 microg T4 respectively.
Serum T4, tri-iodothyronine (T3), TSH, free thyroxine index,
resin T3 uptake and thyroid autoantibodies (ThAab) as well as
total cholesterol, high and low density lipoprotein
cholesterol (HDL, LDL), and triglycerides were determined
before and at the end of the two-month treatment period.
RESULTS: TSH levels were reduced in all groups. The most
striking effect was observed in group D (TSH levels before:
2.77+/-0.55, after: 1.41+/-0.85 microU/ml, P < 0.01).
Subjects in groups C and D had a higher probability of having
positive ThAabs. A significant reduction in total cholesterol
(P < 0.01) and LDL (P < 0.01) was observed after
treatment only in group D. In those subjects in group D who
were ThAab negative, there was no significant effect of
thyroxine on cholesterol levels. CONCLUSIONS: Subjects with
high-normal TSH levels combined with ThAabs may, in fact, have
subclinical hypothyroidism presenting with elevated
cholesterol levels. It is possible that these patients might
benefit from thyroxine administration.
Eur J Endocrinol 1998
Feb;138(2):141-5
Low headache prevalence amongst women
with high TSH values.
The aim of this large cross-sectional population-based
study was to examine a possible positive or negative
association between thyroid dysfunction and headache. Between
1995 and 1997, all 92,566 adults in Nord-Trondelag County in
Norway were invited to participate in a health survey. A total
of 51,383 (56%) responded to a headache questionnaire, whereof
thyroid-stimulating hormone (TSH) was measured in 28,058
individuals. These included 15,465 women and 8,019 men above
40 years of age, 1,767 randomly selected individuals between
20 and 40 years of age, and 2,807 (97%) with thyroid
dysfunction. Associations between thyroid dysfunction and
headache were assessed in multivariate analyses, estimating
prevalence odds ratios (OR) with 95% confidence intervals
(CIs). High TSH values were associated with low prevalence of
headache. This was most evident amongst women with no history
of thyroid dysfunction. Amongst these, headache was less
probable (OR=0.5, 95% CI 0.3-0.7) if TSH > or = 10 mU/l
than in women with normal TSH (0.2-4 mU/l). In all age groups
between 40 and 80 years, TSH was lower amongst headache
sufferers, especially migraineurs, than in those without
headache complaints.
Eur J Neurol 2001 Nov;8(6):693-9
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