Menopausal Symptom Relief and Side Effects – Part 2

Definitions of Menopausal Symptoms (Operational Definitions)

Decreased libido: A lowered desire for sexual activity and less sexual satisfaction reported by menopausal women due to a decrease in circulating hormone levels as measured by the hormone replacement survey.⁹

Dry skin and hair: loss of moisture and elasticity of the skin and brittleness of the hair due to a decrease in circulating estrogen levels reported by menopausal women as measured by the hormone replacement survey.¹⁰

Foggy thinking: The experience of losing one’s train of thought or thought blockade, forgetfulness, and an inability to concentrate as well as in the past reported by menopausal women due to declining circulating estrogen levels as measured by the hormone replacement survey.¹¹

Hot Flashes: Intermittent feelings of warmth spreading over the body, followed by sweating and exhaustion as reported by menopausal women due to declining hormone levels as measured by the hormone replacement survey.⁹

Mood Swings: Feelings of well-being alternating with irritability and emotional lability as experienced by menopausal women due to fluctuating hormone levels as measured by the hormone replacement survey.¹²

Night sweats: Profuse sweating during sleep at night followed by chills as a consequence of hot flashes secondary to fluctuating hormones in menopausal women as measured by the hormone replacement survey.¹³

Sleep problems: Insomnia or a disruption in sleep due to vasomotor symptoms secondary to decreasing hormone levels in menopausal women as measured by the hormone replacement survey.¹⁴

Vaginal dryness: A decrease in vaginal lubrication in menopausal women secondary to decreasing estrogen levels as measured by the hormone replacement survey.⁹

Instrument

The original survey tool, titled The Apothecary Shop of Arizona, was intended to measure the presence and severity of women’s menopausal symptoms before and after treatment and side effects experienced with compounded BHRT and synthetic conjugated equine estrogen and progestin HRT. Permission to utilize this tool was obtained from Kristy A. Vigesaa, PharmD, who developed the survey as part of her residency project at Midwestern University in Arizona (KA Vigesaa, Personal communication, June 19, 2006).3 The tool consists of 18 questions and was originally used to determine if compounded BHRT relieved the symptoms of menopause and tolerance to the medication (low incidence of side effects). Secondarily, the tool was also used to compare menopausal symptom relief and tolerability with compounded BHRT to previously used synthetic prescription HRT. In the survey, relief was measured by asking participants to circle menopausal symptoms they had prior to taking compounded BHRT and the level of severity (none, mild, moderate, severe, extreme) of the symptom before and after initiation of HRT. Side effects of compounded BHRT and synthetic prescription products were measured by asking participants to circle the side effects listed that occurred with compounded BHRT, and then those previously experienced with synthetic prescription products.

To establish content validity, Vigesaa submitted a blueprint of the survey to a panel of four experts who were selected based on their expertise in the areas of clinical pharmacy and research, instrument content and development and menopause education relevant to her study. The experts reviewed the blueprint to determine the appropriateness, accuracy, and representativeness of the selected items (KA Vigesaa, personal communication, March 11, 2007). The items in the survey were reviewed for the consistency in relationship to the studies primary and secondary purposes. Appropriate reading level was established using the Classroom Reading Inventory.

The survey described above was used for the study. Questions regarding menopausal symptoms relief and side ef­fects for participants who had previously used commercially available HRT and were now using BHRT and questions regarding satisfaction with customer service at the Apothecary Shop were removed. Three questions were added for the purpose of obtaining more general information from participants regarding their overall hormone symptom relief and how much the side effects of HRT bothered them or interfered with their daily lives.

Background information collected for this study included age, length of time on HRT, and the type of hormone formulation used. The survey also included questions about the participant’s reasons for initiating HRT, the symptoms they experienced before and after taking HRT, as well as side effects related to HRT. In addition, participants were asked to list any prescription medications and herbal/vitamin supplements they were taking since some medications such as selective serotonin reuptake inhibitors, anxiolytics, sleep aids, and some over-the-counter herbal remedies may relieve some menopausal symptoms.^15,16 The hormone therapy survey included the variables shown in the table below.

Procedure

A list of all the possible brands of synthetic conjugated equine estrogen and/or progestin HRT were provided to pharmacists and the pharmacy technicians who were responsible for collecting prescriptions and dispensing medications at the front counter, so they gave surveys only to women meeting the inclusion criteria. The pharmacists or pharmacy technicians were responsible for distributing the packets containing the surveys and postage-paid envelopes addressed to the investigator, along with the consent letter inviting the women to participate. Also, if participants asked, they were instructed by the pharmacists or technicians that they had the option of completing the survey at the pharmacy and returning it to the pharmacists. Based on similar research in the past, data acquisition was expected to take approximately 6 to 8

weeks between the time needed to distribute 216 surveys and for the surveys to be returned to the investigator.³ The requisite number of surveys from the group one-bio was collected within this timeframe. However, due to the declining number of women using synthetic conjugated equine estrogen and progestin products, distribution of 108 surveys to the women in the group two-syn took an additional 18 weeks.¹⁷ The 15-item survey was estimated to take participants approximately 20 to 30 minutes during one data collection point. When returned, completed surveys were immediately stored in a locked file cabinet in the investigators home. Data were entered into the Statistical Package for the Social Sciences (SPSS 14.0, 2005) after all the surveys were reviewed for completeness.

Statistical Analysis

Prior to entering the data into the computer, the surveys were checked by the investigator for missing data, items to which the participant provided more answers then was required, and items for which the answer marked was unclear.⁸ There were a few surveys with only one missing value for each survey period these surveys were included in the statistical analysis for the study. The value 99 was entered into the SPSS to characterize missing values and 77 for “don’t know” for question five.

Demographic Data

A mean was reported for age (years) and duration (months) of HRT usage for both groups. Frequency (number of participants) was reported for those participants using the additional hormones dehydroepiandrosterone and testosterone in question one. In question one, participants had the option choices of dehydroepiandrosterone, testosterone, none, both, or don’t know. Frequencies were reported for the form (capsules/tablet, cream, suppository, vaginal cream) of HRT used in each group. In question three, participants circled all of the reasons why they initiated HRT, and these reasons are reported as proportions for each group in the Data Analysis and Interpretations section. Finally, in questions 14 and 15, participants were required to list other medicines, over-the-counter, and/or herbal supplements they were currently taking. Frequency of concurrent medications was calculated. Consequently, f-tests and Levene’s test were conducted between participants with concurrent medication usage and those who did not take concurrent medications to determine if significant differences exist between the two groups.¹⁹ An a priori [alpha] = 0.05 was set, which is the predetermined risk of making a type I error. In order to strengthen the meaning of the findings of this study, a power of .80 was used to lower the risk of making a type of II error. A power of .80 is the standard used when conduction a power analysis to determine sample size.⁸

Planned Analysis by Research Questions

1. Are there differences in menopausal symptom relief between women currently using compounded BHRT as compared to women currently using synthetic conjugated equine estrogen and/or progestin HRT?

Inferential statistical procedures using a two-sample t-test were used to measure the differences in each menopausal symptom relief between women currently using compounded BHRT compared to women currently using synthetic conjugated equine estrogen and/or progestin HRT.⁸ Relief from menopausal symptoms was measured at the ordinal-scale level. In order to measure relief, participants ranked the level of severity of their menopausal symptoms prior to HRT and at least one month after initiation of HRT in both group one-bio and group two-syn. Level of severity were ranked for each symptom as none, mild, moderate, severe, and extreme (scored 0 to 4). In addition, a paired difference t-test was used to determine if there was significant improvement within each group for each menopausal symptom. A two-sample t-test was used to determine if one group offered more significant relief from menopausal symptoms than the other group. To measure severity and occurrence of menopausal symptoms, frequencies and means were obtained for each group. Frequency was obtained for each menopausal symptom rated as moderate to extreme before HRT and then after HRT. The difference in the means were obtained using a severity scale of O (no symptoms) to 4 (extreme) for before HRT and after HRT for each group. Question 10 asked participants to rank overall relief of all menopausal symptoms; no relief, a little relief, moderate relief, a lot of relief, or complete relief (scored O to 4). Relief of menopausal symptoms was then calculated based on results from the two-sample t-test.

2. Are there differences in the side effects experienced between women currently using compounded BHRT as compared to women currently using synthetic conjugated equine estrogen and/or progestin HRT?

A comparison of the most commonly reported side effects of compounded BHRT and conjugated equine estrogen and/or progestin HRT were discussed as frequencies. Side effects were measured at the nominal level with numerical values assigned for coding purposes and data entry only. A two-sample t-test was used to analyze results from questions 12 and 13. In questions 12, participants were asked to rank the level of how much the side effects of HRT bothered them. In question 13, participants were asked to rank how much side effects interfered with their daily life. Participants ranked the level of how much their HRT bothered them or interfered with their daily lives as (scored O to 4):

0 = Not at all
1 = Severely
2 = Somewhat
3 = Extremely
4 = Moderately

Severity of side effects was measured at the ordinal-scale level.

References

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