Volume 108, Issue 1 , Pages 72-73, January 2010
Intravaginal gel prepared from Dead Sea peloid for treating luteal-phase defect
Article Outline
Keywords: Dead Sea peloid, Intravaginal gel, Luteal-phase defect, Pelotherapy
Luteal-phase defect is associated with several gynecologic diseases and can be treated with ovulation-inducing agents, progesterone supplementation, and gonadotropin-releasing hormone agonists [1], [2], [3]. It has been recognized that mud applications promote increases in progesterone and estradiol concentrations in women with normal and women with insufficient hormonal functioning of the corpus luteum [4]. Routine intravaginal pelotherapy involves time-consuming techniques and special facilities. The aim of the present study was to determine the efficacy and relative safety of an intravaginal gel—designed for outpatient use—prepared from Dead Sea peloid in women with luteal-phase defect.
The present study was prospective, randomized (with a random-number table), single-blind, and placebo-controlled; it was approved by the Ethics Committee of the Kemerovo State Medical Academy. The 40 participants were women of reproductive age with luteal-phase defect according to basal body temperature (BBT) charts showing a luteal phase of 11
days maximum, mid-luteal progesterone levels less than 48nmol/L, and histologic abnormalities of the endometrium 2 or more days after evaluation of the mid-luteal progesterone level. The treatment group of 20 women administered a daily 30-minute intravaginal application of gel prepared from Dead Sea peloid (BiLiveMed+, Moscow, Russia) for 12days, starting on the seventh or eighth day of their menstrual cycle. The control group of 20 women administered placebo using the same protocol.
Clinical history was obtained and physical examination was performed in all cases. Transvaginal ultrasound (HS-2000, Honda Electronics, Toyohashi, Japan) was used to evaluate uterine and ovarian artery blood flow on days 18–22 of the menstrual cycle preceding treatment and of the cycle after pelotherapy. In addition, diagnostic hysteroscopy (Olympus, Tokyo, Japan) was performed before and after therapy on days 22–24 of the menstrual cycle, at which time endometrial biopsies were obtained.
Levels of estradiol, testosterone, prolactin, follicle-stimulating hormone, luteinizing hormone, and thyroid-stimulating hormone were determined using immunoassay kits (DSL, Webster, TX, USA) on days 5–6 of the menstrual cycle; the mid-luteal progesterone level was determined before and after therapy, and 3months later. Basal body temperature charts were assessed during 3 menstrual cycles before and immediately after pelotherapy. SPSS version 15.0 (SPSS, Chicago, IL, USA) was used for statistical analysis.
No adverse effects were observed in either group. Using BBT and endometrial biopsy data, the incidence of luteal-phase defect in the treatment group was found to be 55% lower in the menstrual cycle after pelotherapy. By contrast, only 20% of the participants in the control group returned to a biphasic menstrual cycle. Three months later, luteal-phase defect (based on BBT charts) was present in 40% of subjects in the treatment group, compared with 90% in the control group (P<0.001).
After pelotherapy, blood flow improved in both the ovarian and the uterine arteries on the side of the corpus luteum. The systodiastolic ratio decreased from 8.6±2.1 to 5.6±2.2 after treatment (P=0.019). On the opposite side, the resistance index increased from 0.85±0.1 to 0.98±0.2 after pelotherapy (P=0.013). Hormone levels are shown in Table 1.
Table 1. Hormone levels before and after treatment.a
| Hormone levels | Peloid (n=20) | Placebo (n=20) | ||||
|---|---|---|---|---|---|---|
| Before treatment | After treatment | Three months later | Before treatment | After treatment | Three months later | |
| ТSH, µIU/L | 1.55±0.50 | 1.61±0.45 | 1.60±0.60 | 1.67±0.50 | 1.70±0.50 | 1.65±0.65 |
| Prolactin, IU/L | 485±125 | 441±105 | 430±99 | 440±95 | 438±67 | 402±68 |
| FSH, IU/L | 7.2±2.2 b | 5.4±2.1 | 6.1±2.1 | 6.9±2.4 | 5.9±2.5 | 6.3±1.9 |
| LH, IU/L | 6.8±2.5 | 5.3±2.3 | 6.1±2.2 | 6.9±2.4 | 5.9±2.5 | 6.3±1.9 |
| Estradiol, pg/mL | 30.5±7.5 b | 57.6±7.4 c, d | 43.5±8.6 | 32.4±6.9 | 35.1±7.2 | 39.1±8.1 |
| Progesterone, nmol/L | 12.3±5.1 b | 25.7±5.5 c, d | 17.1±4.8 | 12.8±5.5 | 13.5±5.3 | 15.5±5.2 |
| Testosterone, nmol/L | 2.5±1.8 | 3.1±1.6 | 2.8±1.8 | 2.2±1.6 | 2.4±1.4 | 2.2±1.6 |
aValues are given as mean |
bP |
cP |
dP |
After pelotherapy, participants in the treatment group had higher serum progesterone and estradiol levels than before treatment, whereas such changes were not present in the control group. After 3months, a gradual decrease in estradiol and progesterone levels had occurred in the treatment group, although the levels remained significantly higher than before pelotherapy for each woman.
In women with luteal-phase defect, intravaginal gel prepared from Dead Sea peloid seems to promote improvement in ovarian artery flow on the side of the corpus luteum, in addition to increasing estradiol and progesterone levels significantly.
Conflict of interest
The authors have no conflicts of interest.
References
- . Luteal phase physiology and its relevance for steroids and human chorionic gonadotropin treatment. Gynecol Endocrinol. 2008;24(5):237–238
- . Luteal phase deficiency: what we now know. OBG Manage. 2003;15(8):41–61
- . GnRH agonist as novel luteal support: results of a randomized, parallel group, feasibility study using intranasal administration of buserelin. Hum Reprod. 2005;20(7):1798–1804
- . Effect of hyperthermic and isothermic mud application on hormonal function of normal and insufficient corpus luteum in women. Ann Acad Med Stetin. 1993;39:133–146
PII: S0020-7292(09)00508-6
doi:10.1016/j.ijgo.2009.08.027
© 2009 Elsevier B.V. All rights reserved.
Volume 108, Issue 1 , Pages 72-73, January 2010
