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November 2002

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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


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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