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Lycopus europaeus (Gypsywort): effects on the thyroidal parameters and symptoms associated with thyroid function.

Abstract

The aim of the prospective two-armed open study was to examine the effect of Lycopi europaei herba on thyroid function and on associated symptoms during a 3-month follow-up phase. The study population consisted of patients with a basal TSH <1.0mU/1 and hyperthyroidism-associated symptoms.

For the first time, the [T.sub.3]/[T.sub.4] excretion in 24 h urine was measured as a primary objective parameter. As secondary parameters, further hormones, the general condition and the symptoms associated with hyperthyroidism were registered.

The urinary [T.sub.4] excretion was significantly increased in Lycopus europaeus-treated patients (p = 0.032). It is supposed that renal mechanisms cause the increased [T.sub.4] excretion either by a modification within the glomeruli or by impaired reabsorption.

Symptoms being specific to the thyroid gland were diminished, as e.g. the increased heart rate in the morning. The Lycopus europaeus preparation showed a good tolerance.

These findings confirm positive effects of Lycopus europaeus in slight forms of hyperthyroidism.

[c] 2007 Elsevier GmbH. All rights reserved.

Keywords: Thyroid function; Hyperthyroidism; Lycopus europaeus (Gypsywort); Urinary [T.sub.3]/[T.sub.4] excretion

Introduction

Extracts from Lycopi europaei herba are traditionally used in patients with slight hyperthyroidism with vegetative-nervous disturbances as well as in tenseness and pain of the mammary gland (Karl, 1995). "Slight hyperthyroidism" was a clinical diagnosis long before exact measurements of the hormonal parameters became available.

In older experiments the activity of pituitary hormones was reduced by extracts of Lycopi europaei herba (Kemper and Loeser, 1961; Hoerhammer et al., 1962). Following oral application of an extract of Lycopus europaeus to euthyreotic rats tri-iodothyronine ([T.sub.3]), thyroxine ([T.sub.4]) and thyroid-stimulating hormone (TSH) levels were reduced (Winterhoff et al., 1994). Moreover, Lycopus extracts reduce the thyroid-stimulating effect of thyroid antibodies obtained from patients with Graves disease (Auf'mkolk et al., 1985a), inhibit the TSH effect (Auf'mkolk et al., 1985b) and affect the iodine metabolism as well as the iodine distribution (Hiller and Deglmann, 1955). In rats rendered hyperthyroid by administration of thyroxine the increase in heart rate and blood pressure was significantly reduced, presumably by the reduction of the beta-receptor density in the heart. In these experiments with low oral doses of Lycopus extract TSH and thyroid hormone levels remained unaffected by the treatment (Vonhoff et al., 2006).

In vitro partial [beta]-receptor agonistic effects were observed (Beer et al., 2004).

In clinical studies significant changes of thyroid parameters were not seen (Schilcher and Kammerer, 2003; Scheck and Biller, 2000; Kohler et al., 2004), though an improvement of cardiac parameters was reported in one observational study (Scheck and Biller, 2000).

These contradictory results obtained with high doses of Lycopus in most experimental studies and results in patients were the reason for the present observational study. This seemed to be of special interest due to the positive monograph of the drug in slight hyperthyroidism with vegetative-nervous disturbances (Kommission, 1990).

The active ingredients are not yet exactly identified. Amongst others the following constituents were isolated: hydroxy cinnamic and caffeic acid derivates (Rompel et al., 1999), lithospermic acid (Wagner et al., 1970), flavonoids, coumarins, tannins, saponins, sterols, terpenes (Hussein and Rodriguez, 2000), alcaloids and essential oils (Schilcher and Kammerer, 2003).

Several experiments have shown that oligomers of lithospermic acid might be involved into the antithy-roidal effect (Wagner et al., 1970).

Material and methods

The present study was performed as a prospective two-armed controlled study with a 3-months follow-up phase in the years 2003-2004.

From the patients included in the study (n = 68) the data of 62 patients were analyzed, because 6 patients withdrew their consent before the end of the in-patient treatment. It was possible to evaluate the urine samples of 59 patients, For 23 patients the time between inclusion into the study and the second urinary measurement was less than 12 days. These patients were excluded from the calculations because of violation of the study protocol. The follow-up phase was accomplished by 76% of the recruited patients: 5 more patients withdrew their consent during the follow-up phase, 3 patients could not be contacted again, 1 had major cardiac surgery and 1 developed allergic dermatitis of unclear etiology. 42 serum probes were able to be evaluated at the final visit.

The study included patients of the Department of True Naturopathy of Blankenstein Hospital, Hattingen, who were suffering from nervous inner restlessness, heart sensations or palpations and/or thyroid symptoms such as intense perspiration, pathological heat intolerance (preference for cool rooms), etc. with a basal TSH value <1.0mU/1 at the outset of the laboratory tests. Patients were excluded from the study if they had taken Lycopus europaeus preparations within the last 3 months, underwent a fasting therapy, took thyroxine preparations and/or thyreostatic drugs, had typical menopause disorders with hot flushes, were pregnant or nursing, had severe forms of hyperthyroidism, thyreotoxic crisis, communication problems or were insufficiently cooperative.

Due to practical reasons, the patients were allocated to the treatment groups in clusters according to the sequence of admission. The average observation period was 15.6 weeks.

Data were taken on admission (visit 1 = V1), on discharge from clinical treatment (V2), by phone interviews after a further period of 4 weeks (V3) as well as after 8 weeks (V4) and at the final examination (V5).

Classification into groups

Track I of the study (Lycopus europaeus, n = 33): A Lycopus europaeus preparation (Thyreo-loges N tablets (1)) with a daily dose of 1-0-1 tablets was administered to the patients from V1 to V5. One tablet contains 20 mg of Lycopi europaei herba.

Track 2 of the study (control, n = 29): These patients were neither administered a Lycopus europaeus preparation nor a "placebo".

Outcome measures

Main outcome measures: [T.sub.3] and [T.sub.4] excretion in 24 h urine at VI and V2.

Secondary outcome measures: serum-free tri-iodothyronine (f[T.sub.3]), free thyroxine (f[T.sub.4]), 17-beta-estradiol, testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin, average blood pressure and heart frequency on 3 consecutive days determined in the morning, at noon and in the evening at V1 and V2, serum TSH, Bf-S-scale (a validated questionnaire for pain, von Zeersen et al., 1970) and SF 12 (a validated questionnaire for qualitity of life, Bullinger and Kirchberger, 1998) at V1, V2 and V5, clinical symptoms (globus feeling, loss of weight, vision disturbances, heart sensations, stress-induced shortness of breath, restlessness, nervousness, prostation, fatigue) at V1, V2, V3, V4 and V5 and undesirable incidences.

Test parameter

f[T.sub.3], f[T.sub.4], TSH, 17-beta-estradiol, testosterone, FSH, LH and prolactin were measured by radioimmunoassay (RIA). The TSH values measured at the "screening" before inclusion in the study were determined again at V1 in order to avoid a distortion of results ("central tendency").

Urinary [T.sub.3]/[T.sub.4] excretion (Baisier et al., 2000): The urine samples were adjusted to a pH-value of 3.5 with concentrated HCl. About 4 ml extraction fluid (ethyl acetate) was added to 2.5 ml urine. After mixing thoroughly, aqueous and organic phases were separated by centrifugation (15min at 1000g). The extraction of the aqueous phase was repeated with further 4 ml extraction fluid (ethyl acetate), the organic phases combined and evaporated to dryness with nitrogen at 40[degrees]C. The residue was dissolved in 500 ml PBS buffer, mixed thoroughly and used in the RIA procedure. [T.sub.3] values were determined with the Amenex-M [T.sub.3] RIA kit from Ortho-Clinical Diagnostics Amersham, Catalog No. 829 5545, [T.sub.4] values with a similar kit, Catalog No. 874 4468. Always a blank value and a sample with known [T.sub.3] and [T.sub.4] content were included. The quality was checked by means of internal and external controls.

On admission thyreoglobulin (Trace, Kryptor, Brahms), the thyroid antibodies anti-TPO (Micro-titer-plate ELISA, Pharmacia), anti-TG (Micro-titer-plate ELISA, Pharmacia) and TSH-receptor antibodies (RIA, manual, Brahms) were determined, the iodine excretion in urine (24 h, by ICP-MS, Varian) measured.

The amount of [T.sub.3] and [T.sub.4] excreted within 24 h is calculated by multiplication of the concentration with the urine quantity (Burke and Shakespear, 1976).

To avoid misinterpretations values were referred to in grams of excreted creatinine.

Supplementary patients data

On admission the case history was acquired, physical examination and sonography of the thyroid gland were performed. At all times of assessment the tolerance, effectiveness/efficacy, adverse effects, deviations of the dosage and compliance were registered.

Statistics

The anthropometric and personal data as well as the secondary outcome measures are described by arithmetic mean, median, standard deviation and 95% confidence intervals.

After having verified the necessary presuppositions, i.e., normal distribution and homogeneity of variance, univariant analysis of variance (UNIANOVA) of the thyroid parameters in serum and in urine as well as of the blood pressure values was carried out (factors: treatment group, time of measurement; and twofold interdependency).

By logarithmic transformation of the excreted [T.sub.3] and [T.sub.4] quantities (each per g excreted creatinine) a Gaussian distribution with a good homogeneity of variance was achieved--no inhomogeneity of variance could be detected in this data record.

Descriptive statistic comparisons for non-normal distributed parameters were performed by non-parametric tests (Wilcoxon test (Wilcoxon et al., 1963), Friedman test (Friedman, 1937), U-test/Mann-Whitney test (Mann and Whitney, 1947) and H-test/Kruskal-Wallis (Kruskal and Wallis, 1953)) based on the 5% significance level.

The statistic package SPSS 12.0.1 (SPSS Inc., Chicago, USA) for Windows was used.

Results and discussion

Selected data characterizing the random sample

In total, 49 (79%) patients were female, 13 (21%) male. The mean age was 56 years in the treatment group and 59 years in the control group.

No differences between the treatment groups were detected concerning body weight and BMI distribution, observation period of the individual patients, thyroid morphology, TSH, f[T.sub.4], and f[T.sub.3] and iodine excretion in urine (Table 1).

All parameters of the thyroid-specific case history and the examination results showed no differences between the treatment groups.

Main measurement results

The [T.sub.3] excretion in urine did not show a significant difference between control group and Lycopus europaeus group levels. There is a tendency towards decreased [T.sub.3] excretion in urine under clinical naturopathic treatment in the control group, whereas it remains unchanged in the group being treated with Lycopus europaeus (Fig. 1).

The univariant variance analysis of the [T.sub.4] excretion in urine verifies a significant interdependency on the 5% significance level between the factors treatment group and time of measurement indicating a difference between control group and Lycopus europaeus group depending on the time of measurement (examination on admission versus examination on discharge) (Table 2).

The [T.sub.4] excretion in urine is increased (p = 0.032) under treatment with Lycopus europaeus (Fig. 2).

Secondary outcome measures

The treatment with Lycopus europaeus did not cause distinct changes to the f[T.sub.3], f[T.sub.4] and TSH concentrations in serum.

The statistic evaluation (without taking into consideration gender or phase of menstrual cycle) did not yield significant differences in the plasma values of 17-beta-estradiol, testosterone, FSH, LH, or prolactin. Similarly blood pressure, heart frequency, the somatic scale of the quality of life questionnaires (SF 12), clinical symptoms and the average of all documented symptoms (globus feeling, loss of weight, eye pains, heart sensations, shortness of breath under stress, restlessness, nervousness, loss of efficiency, fatigue) evaluated on the visual analog scales showed no treatment-related differences.

The physician assessed compliance as good or very good. Most patients assessed the efficacy of the therapy as good.

Six adverse events were noted: in three cases a connection with the intake of the preparation is unlikely or indeed impossible. In two cases it is improbable and in the last case it seems to be possible (subjective "disturbances of the cardiac rhythm" after an intake period of 7 weeks; reversible after discontinuation).

Discussion

Two factors were crucial for the conceptual design of the study: The study was performed at a naturopathic collective of patients, i.e. patients desiring naturopathic treatment (Beer et al., 2000). The authors are aware of the fact, which is also explicitly addressed in literature (Karl, 1995), that "latent hyperthyroidism in the naturopathic sense", which has been defined by clinical experience and is taken as a criterion for the present study, is not identical to "latent hyperthyroidism in conventional medicine" (TSH<0.3mU/1) (Thomas, 1992). However, conventional medicine also knows that a TSH value higher than 0.3mU/1 does not definitely exclude a functional disturbance: "Commencing functional disturbances of the thyroid gland, e.g., a thyroidal autonomy, might be present at an early stage, but is not usually of clinical relevance" (Thomas, 1992).

Of course, the "clinical relevance" depends on the point of view and has to be evaluated in a different manner depending on the parameter which are rated. The assessment may be different when it is based on a more objective parameter such as physiological-biochemical "standard values" or "anatomical-pathological" parameter, rather than on the subjective suffering of the patient (Karl, 1995).

Thus patients with appropriate clinical symptoms (cp. chapter 2) and a basal TSH value <1.0mU/1 were included in this observational study.

An observational study yielded no noticeable changes of thyroid parameters in the serum of humans treated with Lycopus europaeus, whereas a reduction of tachycardic episodes and an improvement of vegetative and psychic complaints was observed (Scheck and Biller, 2000). Therefore for our own investigation other test methods (e.g., urinary [T.sub.3] and [T.sub.4] excretion) were applied. These tests are available in the Netherlands and these parameters were determined in addition to the thyroid parameters conventionally used. The urinary excretion gives average values over a period of 24 h, whereas serum concentrations show some circadian fluctuations depending on the time of sampling.

The [T.sub.4] excretion in urine is significantly increased in the Lycopus europaeus group as compared to the control group, which was treated exclusively with other classical naturopathic procedures. Although this is a new and interesting finding the authors are aware of the fact that a result on the 5% significance level has to be interpreted with caution and restraint in respect of final evidence because of the missing randomization in an observational study. The [T.sub.3] excretion in urine slightly decreased in the control group, resulting in a comparative increase of the [T.sub.3] excretion in the Lycopus europaeus group.

Two effects have to be differentiated in general: On one hand the effects resulting from the clinical naturopathic treatment and on the other hand the significant resp. tendential effects caused by the additional intake of Lycopus europaeus. The effects of the clinical naturopathic treatment are described by a study on a large clinical population published by Beer et al. (2000) and Ostermann et al. (2002).

Concerning the assumed effects of Lycopus europaeus, the plasma values of [T.sub.3], [T.sub.4] in urine, TSH, clinical pathology and heart frequence in the morning will be discussed in the following. Several physiological mechanisms may cause increased [T.sub.4] excretion in urine (Voigt, 1996): The [T.sub.4] values and especially the free [T.sub.4] values in blood could have increased resulting from the treatment with Lycopus europaeus so that an increased excretion was measured. However the apparently unchanged f[T.sub.4] and TSH values contradict this interpretation, though this lack in difference might be due to circadian fluctuations of the free serum hormone concentrations and the resulting relatively high standard deviations of fT3 and f[T.sub.4].

Indeed a markedly increased daily urinary T4 excretion was observed in hyperthyroid patients as compared to euthyroid volunteers. The data suggest that renal elimination of free [T.sub.4] occurs by filtration and partial tubular reabsorption. In the case of clearly elevated f[T.sub.4] values in serum an increase of [T.sub.4] elimination can be expected (Orden et al., 1987). Thus a reduced renal excretion might be assumed as the consequence of reduced f[T.sub.4] values. But in our own clinical study free thyroid hormones in serum were unaffected by the treatment with the plant extract.

In some respect the reduced urinary thyroxine excretion resembles the findings in fasting subjects. Rollemann et al. (2000) observed a significant decrease in renal [T.sub.3] and [T.sub.4] excretion on the third day of fasting. At the same time the serum concentrations of total and free thyroxine were unchanged, total and free triiodothyronine in serum reduced, the TSH concentration was also reduced. The reduced renal clearance could only in part be explained by the lowered [T.sub.3] concentration in the blood. Other factors must be responsible for the lowered excretion of thyroid hormones in the urine. As a further mechanism an inhibited uptake of both thyroid hormones at the basolateral membrane of the proximal tubular cell was suspected, presumably as a consequence of lowered energy stores on the tubular cells or as a consequence of other factors such as ketoacidosis.

Indeed all iodothyronines are subject to tubular transport mechanisms besides glomerular filtration. The three iodothyronines with two iodine atoms in the phenolic ring of the thyronine molecule, T4, rT3 and 3',5'-T2, were mainly tubularly reabsorbed, whereas those with only one iodine atom in the phenolic ring, T3 and 3,3'-T2, were mainly tubularly secreted. It might be hypothesized that the number of iodine atoms in the phenolic ring determines the direction of the tubular transport (presence of 2 iodine atoms is associated with tubular reabsorption, and of one iodine atom with secretion), whereas the rate of tubular transport diminishes with a decreasing number of iodine atoms in the tyrosylic ring (Orden et al., 1987).

Thus it is evident that renal mechanisms are more likely to be the reason for the increased [T.sub.4] excretion under Lycopus treatment, presumably by an interference with tubular reabsorbtion, as only the [T.sub.4] excretion was concerned., whereas the [T.sub.3] excretion was unaffected.

It has to be critically mentioned that the ratio between f[T.sub.3] to [T.sub.4] and f[T.sub.4] to [T.sub.4] in serum was not differentiated and examined. F[T.sub.3] and f[T.sub.4] were determined, as these hormones reflect the supply of peripheral organs with thyroid hormones and are changed in pathological states of the thyroid.

In an additional randomized study the efficiency of Lycopus europaeus should be further examined, including the above-mentioned parameters.

This study shows for the first time a measurable change of thyroid-related hormone parameters in human beings.

Acknowledgment

We thank Co. Loges & Co. GmbH, Winsen and especially Dr. Biller, as well as the Laboratory Limbach, Heidelberg, for the financial support of the study.

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A.-M. Beer (a,*), K.R. Wiebelitz (a), H. Schmidt-Gayk (b,[dagger])

(a) Department of True Naturopathy, Ruhr-University Bochum, Im Vogelsang 5-11, 45527 Hattingen, Germany

(b) Laboratory Limbach, Im Breitspiel 15, 69126 Heidelberg, Germany

*Corresponding author. Tel.: +49 2324 396487; fax: +49 2324 396497.

E-mail address: andre.beer@klinik-blankenstein.de (A.-M. Beer).

([dagger]) Deceased.

(1) Pharm. Firm Loges, 21423 Winsen (Germany), E-mail: info@loges.com; http://www.loges.com
Table 1. Anthropometric data, duration of observation, anamnestic data-
arithmetic means and in brackets standard deviations

 LE CG

Age (years) 56.0 (10.5) 58.3 (12.7)
Female (number of patients) 28 21
Male (number of patients) 5 8
Weight (kg) 73.8 (13.3) 71.6 (14.2)
Size (cm) 167.0 (9.2) 165.5 (8.2)
BMI (Body Mass Index) (kg/[m.sup.2]) 26.7 (4.59) 26.3 (5.68)
Duration of clinical observation at hospital 12.6 (2.2) 12.0 (2.2)
 (V1-V2) (days)
Whole observation period (V1-V5) (days) 109.3 (12.9) 108.7 (10.1)

T4 in urine

 V1 V2

LE 2195,04 3672,94
CG 3772,63 2662,98

Fig. 1. [T.sub.3] values in urine depend on the treatment groups
(Lycopus europaeus; control) and the time of measurement.

Table 2. Results of the UNIANOVA applied on the logarithmic transformed
excreted [T.sub.4] quantities (per g excreted creatinine)

 Sum of the squares Arithmetic average
Source (Typ III) df of the squares F

Corrected model 0.674 (b) 3 0.225 1.732
Constant term 777.500 1 777.500 5991.165
Treatment group 0.015 1 0.015 0.114
Time of 0.005 1 0.005 0.035
 measurement
(Treatment 0.619 1 0.619 4.767
 group) x (time
 of measurement)
Error 8.825 68 0.130
Total 810.379 72
Corrected total 9.499 71
 variation

 Significance Partial Non-centrality Observed
Source p eta-square parameter acuity (a)

Corrected model 0.169 0.071 5.195 0.433
Constant term 0.000 0.989 5991.165 1.000
Treatment group 0.736 0.002 0.114 0.063
Time of 0.852 0.001 0.035 0.054
 measurement
(Treatment 0.032 0.066 4.767 0.576
 group) x (time
 of measurement)
Error
Total
Corrected total
 variation

(a) Calculated using p = 0.05.
(b) R-square = 0.071 (corrected R-square = 0.030); df = degrees of
freedom.

T4 in urine

 V1 V2

LE 2195,04 3672,94
CG 3772,63 2662,98

Fig. 2. [T.sub.4] values in urine depend on the treatment groups
(Lycopus europaeus; control) and the time of measurement.
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Author:Beer, A.-M.; Wiebelitz, K.R.; Schmidt-Gayk, H.
Publication:Phytomedicine: International Journal of Phytotherapy & Phytopharmacology
Geographic Code:4EUGE
Date:Jan 1, 2008
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