Homeopathy

Homeopathy

PEP Topic 
Hot Flashes
Description 

The alternative medical system, homeopathy, was developed in Germany at the end of the 18th century. Supporters of homeopathy point to two unconventional theories: “like cures like,” the notion that a disease can be cured by a substance that produces similar symptoms in healthy people; and “law of minimum dose,” the notion that the lower the dose of the medication, the greater its effectiveness. Homeopathic remedies generally involve pills or elixirs containing an active ingredient, usually a plant or mineral substance.

Effectiveness Unlikely

Research Evidence Summaries

Clover, A., & Ratsey, D. (2002). Homeopathic treatment of hot flushes: A pilot study. Homeopathy, 91, 75–79.

doi:10.1054/homp.2002.0004
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Study Purpose:

The study intended to evaluate the efficacy of homeopathy in managing menopausal symptoms.

Intervention Characteristics/Basic Study Process:

Six homeopathic medications were  “most prescribed”: Amyl nitrosum, Calcium carbonate, Lachesis, Natrum mur, Pulsitilla, and Sepia.

Sample Characteristics:

Thirty-one (31) participants completed the initial consultation and one follow-up visit. Three groups of subjects were included:

  1. Menopausal symptoms/no cancer history (n = 11)
  2. Menopausal symptoms/breast cancer/no recent tamoxifen (n = 7)
  3. Menopausal symptoms/breast cancer/taking tamoxifen (n = 13)
  • Inclusion criteria: All women seen in an outpatient homeopathic clinic in Glasgow, Scotland.
  • Exclusion criteria: None

Study Design:

The study was an uncontrolled, pilot outcome study of homeopathic treatment of hot flashes, stratified for breast cancer (yes versus no) and tamoxifen use (yes versus no).

Measurement Instruments/Methods:

Questionnaires assessing frequency and severity of hot flushes and changes in conventional medications that might influence hot flushes were completed at initial consultation and at follow-up visits.

Results:

The number of participants that reported improvement in hot flush frequency and severity were as follows: Group 1: 8 (73%), 8 (73%) Group 2: 6 (86%), 6 (86%) Group 3: 10 (77%), 10 (77%). There was a “clinical impression of useful benefit."

Conclusions:

Study limitations included small sample size (31 participants), failure to indicate age of participants or cause of menopausal symptoms, use of unvalidated questionnaire,i nconsistent  follow-up, no descriptions of  homeopathic medications.

Jacobs, J., Herman, P., Heron, K., Olsen, S., & Vaughters, L. (2005). Homeopathy for menopausal symptoms in breast cancer survivors: A preliminary randomized controlled trial. Journal of Alternative and Complementary Medicine, 11, 21–27.

doi:10.1089/acm.2005.11.21
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Study Purpose:

This was a preliminary trial evaluating effectiveness of two types of homeopathy for treatment of menopausal symptoms in breast cancer survivors.

Intervention Characteristics/Basic Study Process:

At the initial visit, a homeopathic practitioner conducted a homeopathic evaluation of each participant and prescribed an individualized homeopathic medication that best matched the symptom profile for that participant. A homeopathic pharmacist randomized the participants tothree treatment groups:

  1. A placebo combination medicine and a verum single remedy
  2. A verum combination medicine and a placebo single remedy
  3. Two placebo medications

All study medications were donated by the Standard Homeopathic Company. The treatments were identical in taste, appearance, and odor and were dispensed in identical containers. The combination medicine was Hyland’s Menopause, which is sold over-the-counter in the United States. It contained three homeopathic medicines: Amyl nitrate, Sanguinaria canadensis, and Lachesis.

Participants were mailed a one-week daily hot flush diary to complete during the week prior to call.

Sample Characteristics:

Eighty-three (83) participants completed the initial homeopathic visit and were randomized into the three treatment groups. Of this total, 28 patients (33.7%) withdrew, including 11 who reported no relief from hot flashes, 7 who had a cancer recurrence or withdrew because of other illness, 5 who said the study was inconvenient, and 4 who were lost to follow up. Sixty-six (66) participants completed at least six months of the study (80.5%).

  • Inclusion criteria:
    • Women with a history of breast cancer who had completed all surgery, chemotherapy, and radiation treatment.
    • Tamoxifen use was allowed.
    • Participants had a history of hot flashes for at least one month, with an average of at least three hot flashes per day in the week prior to beginning treatment.
  • Exclusion criteria:
    • Other medications for the treatment of hot flashes, including specific vitamin regimens, herbs, estrogen or progestational agents, antidepressants, or sleep medications were not permitted.
    • Concurrent chronic health problems such as rheumatoid arthritis, asthma, heart disease, and inflammatory bowel disease and corticosteroid use.
    • Those expected to receive additional chemotherapy or radiation treatment within the next year were not allowed to participate.
    • Women who were pregnant or planned to become pregnant in the next year were also excluded.

Participants stratified by age (younger or older than 50 years), breast cancer staging, and use of tamoxifen.

Study Design:

The study was a randomized, double-blinded, placebo-controlled trial. Participants received controlled an individualized homeopathic single remedy, homeopathic combination medicine, or a placebo.

Measurement Instruments/Methods:

Homeopathic providers saw or called participants every two months for one year.

Results:

No significant difference was reported for the primary outcome measure, the hot flash severity score, or in the total hot flashes among the three groups in the univariate model adjusted for baseline, time, and tamoxifen use over the period of 1 year. The single remedy group had a lower severity score and fewer hot flashes as a whole, which was most marked during the first three months of the study, with a positive trend (p = 0.1) at three months compared to placebo. However, in the combination homeopathy group not receiving tamoxifen, there was a statistically significant increase in the hot flash severity score compared to placebo (p= 0.01) and a highly significant difference when compared to single homeopathic remedy (p= 0.001). Similarly, there was a highly significant increase in the total number of hot flashes in the combination group compared to placebo (p = 0.006) and compared to single remedy (p=0.002) in the group not receiving tamoxifen. There was also a statistically significant increase in headaches in the group receiving the homeopathic combination at 6 months (p = 0.04) and 12 months (p = 0.03). In the multivariate analysis, which included baseline values, time, age, last month in the study, and treatment group, the same statistically significant relationships between treatment group and tamoxifen/no tamoxifen were found for both severity score and total number of hot flashes.

Limitations:

The small sample size precludes definitive answers. Difficulty in retaining participants for one year was a major problem. Use of three arms made treatment decisions difficult, although the average number of remedy changes found over the one-year study period is not unusual in homeopathic practice. Use of the homeopathic combination medicine in an ongoing daily regimen, rather than as it is used in current over-the-counter treatment, was a major flaw in this study.

Thompson, E.A., & Reilly, D. (2003). The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients: A prospective observational study. Homeopathy, 92, 131–134.

doi:10.1016/S1475-4916(03)00035-3
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Study Purpose:

The study explored a homeopathic approach to treatment of estrogen-withdrawal symptoms in women with breast cancer.

Intervention Characteristics/Basic Study Process:

Active intervention was a homeopathic approach, which included a 60-minute consultation and the prescription of an individualized homeopathic remedy. A total of 25 remedies were used for the first prescription. Pulsatilla, Sepia, and sulfur were each used on more than three occasions for the first prescription.

Sample Characteristics:

The study enrolled: 45 participants who ranged in age from 34 to 71 years; just over half were aged 50–59 years.

  • Inclusion criteria:
    • 45 consecutive patients seen at the outpatient clinic at Glasgow Homeopathic Hospital with breast cancer and estrogen withdrawal symptoms 
    • 32 participants were taking tamoxifen
    • 21 had undergone adjuvant chemotherapy
    • 20 were taking medications such as antidepressants and clonidine
    • 3 had metastatic disease at study entry 
  • Exclusion criteria: None

Study Design:

This was a prospective observational study.

Measurement Instruments/Methods:

The study used a numerical self-rating scale, where 0 = no problem, and 10 = tremendous problem, to identify patient symptoms. Hot flashes were rated as the most common symptom (n = 38).

Results:

A data table showed significant improvement in hot flashes between baseline and last visit (p < 0.001).

Limitations:

The study used a small, convenience sample of consecutive patients, some of who were taking antidepressants (not specified) and clonidine, which may both be used to manage hot flashes. The length of study and schedule of follow up visits were not apparent. Assessment of hot flash frequency and severity was not the primary outcome measure of the study, only one of several symptoms assessed. Primary endpoint was the “effect on daily living” scores. Homeopathy regimens were not defined, which could pose a problem for study replication. Exact reduction in hot flashes was difficult to determine.


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