quality of life
Astrology is a subject that regularly crops up in the realm of so-called alternative medicine (SCAM). Thus we have dealt with it on several occasions, e.g.:
- Astrology determines mortality … torture the data until they confess!
- Astro-homeopathy: “a beautiful blend of Astrology and Homoeopathy”
Many SCAM proponents evidently believe that astrology works.
The question is, does astrology have any value at all in healthcare?
Several recent papers go some way in answering it.
The first paper evaluated the existing research base on correlates of belief in astrology and fortune-telling. the researchers conducted a scoping review to synthesize the available literature base on belief in astrology and to review the evidence for “fortune-telling addiction” using Arksey and O’Malley’s methodological framework. Databases of PubMed, ProQuest, EBSCO, and SCOPUS were searched for relevant studies published in peer-reviewed journals.
The search findings revealed the association of belief in astrology with cognitive, personality, and psychological factors such as thinking style, self-concept verification, and stress. Case studies on “fortune-telling addiction” have conceptualized it as a possible behavioral addiction and have reported symptoms such as distress, cravings, and salience.
The second study examined the relationship between Western zodiac signs and subjective well-being in a nationally representative American sample from the General Social Survey (N = 12,791). Well-being was measured across eight components:
- general unhappiness,
- depressive symptoms,
- psychological distress,
- work dissatisfaction,
- financial dissatisfaction,
- perceived dullness of one’s life,
- self-rated health,
- unhappiness with marriage.
Parametric and nonparametric analyses consistently revealed no robust associations between zodiac signs and any of the well-being variables, regardless of whether demographic factors were controlled for. The effect sizes were negligible, accounting for 0.3% or less of the variance in well-being, demonstrating that zodiac signs lack predictive power for well-being outcomes. An additional analysis revealed that astrological signs were no more predictive of than random numbers. Thus, a randomly generated number between 1 and 12 is statistically as predictive of one’s well-being as one’s zodiac sign.
The authors concluded that these findings challenge popular astrological claims about the influence of zodiac signs on well-being and quality of life.
The third paper reports a retrospective, single-center cohort study of 2545 adult patients with confirmed COVID-19 infection presenting to the emergency room over a 14-month period (September 2020 to November 2021). COVID-19 infectivity was determined based on polymerase chain reaction (PCR) testing. Western and Chinese Zodiac signs were designated using date of birth. Both Zodiac signs were evaluated for risk of infection and death.
Mortality rates across the zodiac and astrology signs showed no statistical difference using the 12-sample test for equality of proportions. Coincidentally, the mean age for the deceased was 74.5 years, and it was 53.9 years for those alive, resulting in a difference of 20.6 years. A two-sample t-test confirms that the observed difference of 20.6 years of age between the two groups is statistically significant with a p-value <0.05. The coefficient of the predictor age is statistically significant. The odds ratio estimate of age is 1.06, with the corresponding 95% confidence interval (CI) being (1.048, 1.073). This means that the odds of dying increase by 6% for every additional year.
The authors concluded that there was no statistical significance between Western and Chinese Zodiac signs and mortality or infections.
So, does astrology have any value in healthcare?
The answer is as simple as it is unsurprising:
No!
This systematic review and meta-analysis investigated the impact of quality of life (QoL) on mortality risk in patients with esophageal cancer.
A literature search was conducted using the CINAHL, PubMed/MEDLINE, and Scopus databases for articles published from inception to December 2022. Observational studies that examined the association between QoL and mortality risk in patients with esophageal cancer were included. Subgroup analyses were performed for time points of QoL assessment and for types of treatment.
Seven studies were included in the final analysis.
- Overall, global QoL was significantly associated with mortality risk (hazard ratio 1.02, 95% confidence interval 1.01–1.04; p < 0.00004).
- Among the QoL subscales of QoL, physical, emotional, role, cognitive, and social QoL were significantly associated with mortality risk.
- A subgroup analysis by timepoints of QoL assessment demonstrated that pre- and posttreatment global and physical, pretreatment role, and posttreatment cognitive QoL were significantly associated with mortality risk.
- Moreover, another subgroup analysis by types of treatment demonstrated that the role QoL in patients with surgery, and the global, physical, role, and social QoL in those with other treatments were significantly associated with mortality risk.
The authors concluded that these findings indicate that the assessment of QoL in patients with esophageal cancer before and after treatment not only provides information on patients’ condition at the time of treatment but may also serve as an outcome for predicting life expectancy. Therefore, it is important to conduct regular QoL assessments and take a proactive approach to improve QoL based on the results of these assessments.
Am I missing something here?
Isn’t this rather obvious?
The way this paper is written, some practitioners of so-called alternative medicine (SCAM) might feel that, by improving QoL (for instance, by some fancy aromatherapy, reflexology, etc.), they can significantly better the cancer prognosis.
Patients with a poor prognosis are more seriously ill and therefore have a lowe QoL. Assessing QoL might be a useful marker, but would it not be better to ask why the QoL is in some patients less than in others?
In the realm of so-called alternative medicine (SCAM), dental amalgam is a big topic. Therefore, we have discussed it several times before, e.g.:
- The EU will phase out the use of dental amalgam
- Long awaited: EU prohibits the use of dental amalgam
- Is removal of dental amalgam a good idea?
- Dental Amalgam
- Three Trends In “Alternative Dentistry” Part 3: Amalgam Removal and Avoidance
This study evaluated the changes of health complaints after removal of amalgam restorations in patients with health complaints attributed to dental amalgam fillings.
Patients with medically unexplained physical symptoms (MUPS) attributed to dental amalgam (Amalgam cohort) had all their amalgam fillings removed. The participants indicated an intensity of 11 local and 12 general health complaints on numeric rating scales before the treatment and at follow-up after 1 and 5 years.
The comparison groups comprising
- a group of healthy individuals
- a group of patients with MUPS without symptom attribution to dental amalgam
did not have their amalgam restorations removed.
In the Amalgam cohort, mean symptom intensity was lower for all 23 health complaints at follow-up at 1 year compared to baseline. Statistically significant changes were observed for specific health complaints with effect sizes between 0.36 and 0.68. At the 5-year follow-up, the intensity of symptoms remained consistently lower compared to before the amalgam removal. In the comparison groups, no significant changes of intensity of symptoms of health complaints were observed.
The authors concluded that, after removal of all amalgam restorations, both local and general health complaints were reduced. Since blinding of the treatment was not possible, specific and non-specific treatment effects cannot be separated.
This is an interesting study with a particularly long follow-up. Unfortunately, due to the study’s design, its results tell us very little about causality. The results are perfectly consistent with two entirely different explanations:
- Amalgam was the cause of MUPS and therefore removal of amalgam cured the problem permanently.
- Amalgam was not the cause of MUPS but the knowledge that the evil substance had finally been removed sufficed for MUPS to disappear.
It is to the credit of the authors that they consider both options.
A word of caution: amalgam removal can lead to a spike in Hg levels in the body!
Of all the forms of so-called alternative medicine (SCAM), Reiki is amongst the least plausible. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.
Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.
Despite its implausibility, Reiki is used for a very wide range of conditions. Some people are even convinced that it has positive effects on sexuality. But is that really so?
This randomised clinical trial was aimed at finding out. Specifically, its authors wanted to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress*. It was was conducted with women between the ages of 15–49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress.
The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).
The levels of sexual distress, sexual function, and sexual self-confidence of women in both groups were similar before the intervention, and the difference between the groups was not statistically significant (p > 0.05). After the Reiki application, the FSDS-R and ASEX mean scores of women in the experimental group significantly decreased, while their SSS mean score significantly increased, and the difference between the groups was statistically significant (p < 0.05).
The authors concluded that Reiki was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Healthcare professionals may find Reiki to positively enhance women’s sexuality.
Convinced?
I hope not!
The study has the most obvious of all design flaws: it does not control for a placebo effect, nor the effect of empaty/sympathy received from the therapist, nor the negative impact of learning that you are in the control group and will thus not receive any treatment or attention.
To me, it is obvious that these three factors combined must be able to bring about the observed outcomes. Therefore, I suggest to re-write the conclusions as follows:
The intervention was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Considering the biological plausibility of a specific effect of Reiki, the most likely cause for the outcome are non-specific effects of the ritual.
*[Sexual distress refers to persistent, recurrent problems with sexual response, desire, orgasm or pain that distress you or strain your relationship with your partner. Yes, I had to look up the definition of that diagnosis.]
Despite effective vaccines, there is still a need for effective treatments for COVID, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. This study tested whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc would improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.
Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.
A total of 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.
The authors concluded that, in this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.
In several ways I am puzzled by this study. On the other hand, I should congratulate the naturopathic authors for honestly reporting such a squarely negative result. One could, of course, argue that the study was under-powered and that thus the findings are not conclusive. However, the actual survival curve depicting the results show clearly that there was not even the tiniest trend for the supplement to show any effect. In other words, a larger sample would have most likely yielded the same result.
Participants randomised to the treatment arm received:
- Vitamin D3 50 000 units orally once on day 1 of the study (capsule).
- Vitamin K2/D3 120 μg/500 units orally two times per day for 21 days (liquid).
- Vitamin C/Zinc acetate 2 g/25 mg orally three times daily for 21 days (capsule).
I fail to understand why the researchers might have conceived the hypothesis that such a mixture would be effective. Only 90 of a planned 200 participants were enrolled in this study which ran between September 2021 and April 2022. I fail to understand why recruitment was so poor that the study eventually had to be aborted. My speculation is that the naturopaths in charge of running the trial were too inexperienced in conducting such research to make it a success.
The study was supported by the Ottawa Integrative Cancer Centre Foundation and by Mavis and Martin Sacher. All investigational products for this study were provided in-kind by New Roots Herbal. Perhaps in future these sponsors should think again before they support amateurs pretending to be scientists?
Mistletoe, an anthroposophical medicine, is often recommended as a so-callled alternative medicine (SCAM) for cancer patients. But what type of cancer, what type of mistletoe preparation, what dosage regimen, what form of application?
The aim of this systematic analysis was to assess the concept of mistletoe treatment in published clinical studies with respect to indication, type of mistletoe preparation, treatment schedule, aim of treatment, and assessment of treatment results. The following databases were systematically searched: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL, and “Science Citation Index Expanded” (Web of Science). The researchers assessed all studies for study types, methods, endpoints and mistletoe preparations including their ways of application, host trees and dosage schedules.
The searches revealed 3296 hits. Of these, 102 publications with a total of 19.441 patients were included. The researchers included several study types investigating the application of mistletoe in different groups of participants: cancer patients with any type of cancer were included as well as studies conducted with healthy volunteers and pediatric patients. The most common types of cancer were:
- breast cancer,
- pancreatic cancer,
- colorectal cancer,
- malignant melanoma.
Randomized controlled studies, cohort studies and case reports make up most of the included studies. A huge variety was observed concerning the type and composition of mistletoe extracts (differing pharmaceutical companies and host trees), ways of applications and dosage schedules. Administration varied widely, e. g. between using mistletoe extract as sole treatment and as concomitant therapy to cancer treatment. The researchers found no relationship between the mistletoe preparation used, host tree, dosage, and cancer type.
A variety of different mistletoe preparations was used to treat cancer patients. Due to the heterogeneity of the mistletoe preparations used, no comparability between different studies or within single studies using different types of mistletoe preparations or host trees is possible. Moreover, no relationship between mistletoe preparation and type of cancer can be observed. This results in a severely limited comparability of studies with regard to the different cancer entities and mistletoe therapy in oncology in general. Analyzing the methods sections of all articles, there are no information on how the selection of the respective mistletoe preparation took place. None of the articles provided any argument which type of preparation (homeopathic, anthroposophic, standardized) or which host tree was chosen due to which selection criteria. Considering preparations from different companies, funding may have been the reason of the selection.
Dosage or dosage regimens varied strongly in the studies. Due to the heterogeneity of dosage and dosage regimens within studies and between studies of the endpoints the comparability of the different studies is severely limited. Duration of mistletoe treatment varied strongly in the studies ranging from a single dose given on one day to the application of mistletoe preparations for several years. Moreover, the duration of treatment frequently varied within the studies. Mistletoe preparations were administered by different ways of application. Most frequently, the patients received mistletoe preparations subcutaneously. The second most common way was intravenous administration of mistletoe preparations. According to the respective manufacturers, this type of application is only recommended for Lektinol® and Eurixor®. Other preparations were given as off-label intravenous applications. No dosage recommendations from the respective manufacturers were available. Only in two studies the dose schedules were mentioned: according to the classical phase I 3 + 3 dose escalation schedule or in ratio to the body surface area.
The authors concluded that despite a large number of clinical studies and reports, there is a complete lack of transparently reported, structured procedures considering all fields of mistletoe therapy. This applies to type of mistletoe extract, host tree, preparation, treatment schedules as well as indication with respect of type of cancer and the respective treatment aim. All in all, despite several decades of clinical mistletoe research, no clear concept of usage is discernible and, from an evidence-based point of view, there are serious concerns on the scientific base of this part of anthroposophical treatment.
A long time ago, I worked as a junior doctor in a hospital where we used subcutaneous misteloe injections regularly to treat cancer. I remember being utterly confused: none of my peers was able to explain to me what preparation to use and how to does it. There simply were no rules and the manufacurer’s instructions made little sense. I suspected then that mistletoe therapy was a danerous nonsense. Today, after much research has been published on mistletoe, I do no longer suspect it, I know it.
I would urge every cancer patient to stay well clear of mistletoe and those practitioners who recommend it.
How often have we heard that, even if so-called alternative medicine (SCAM) does not improve the more tangible health outcomes, at least it does improve the quality of life of those who use it. But is that popular assumprion correct?
The present study investigated the use of SCAM and its relationship with health-related quality of life (HRQOL) in patients with type 2 diabetes mellitus. A total of 421 patients with type 2 diabetes mellitus who met the inclusion criteria were recruited in this cross-sectional study. The researchers recorded the use of SCAM, such as:
- supplements,
- Kampo,
- acupuncture,
- yoga.
HRQOL was assessed by EuroQOL.
A total of 161 patients (38.2%) with type 2 diabetes mellitus used some type of SCAM. The use of supplements and/or health foods was the highest among SCAM users (112 subjects, 26.6%). HRQOL was significantly lower in patients who used some SCAM (0.829 ± 0.221) than in those without any SCAM use (0.881 ± 0.189), even after adjustments for confounding factors [F(1, 414) = 2.530, p = 0.014].
The authors concluded that proper information on SCAM is needed for patients with type 2 diabetes mellitus.
We have often discussed whether SCAM use improves or reduces QoL. The evidence is mixed.
Some studies of often poor quality suggest that SCAM improves QoL, e.g.:
- Can massage improve the quality of life?
- The effect of acupuncture on myelosuppression and quality of life in women with breast cancer
- SCAM-Use and Quality of Life in Patients with Breast Cancer
- Acupuncture is said to improve the quality of life of migraineurs, but I am unconvinced
- Yoga improves quality of life, fatigue and sleep of breast cancer patients
However, other studies suggest that SCAM has no effect or even reduces QoL, e.g.:
- Mistletoe for cancer: Does it improve patients’ quality of life?
- Alternative therapies: do they really improve the quality of life of cancer patients?
- Chiropractic improves quality of life: another bogus claim?
- Homeopathy for cancer? Unsurprisingly, the evidence is not positive.
- Multidisciplinary versus chiropractic care for low back pain
- Use of alternative medicine hastens death of cancer patients
The authors of the present study contribute further evidence to the discussion:
Huo et al. evaluated HRQOL in 17,923 patients with bronchial asthma using the Behavioral Risk Factor Surveillance System, and showed that HRQOL was significantly lower in patients with than in those without the use of CAM [25]. Opheim et al. also demonstrated that HRQOL was significantly lower in inflammatory bowel disease (IBD) patients with than in those without the use of CAM [26]. These findings indicate that the use of some CAM is associated with lower HRQOL. Consistent with previous findings, HRQOL was significantly lower in patients with the use of some CAM than in those without any CAM in the present study.
The issue is obviously complex. Findings would depend on the type of patient and the form of SCAM as well on a multitude of other factors. Moreover, it is often unclear what was the cause and what the effect: did SCAM cause low (or high) QoL or did the latter just prompt the use of the former?
In view of this confusion, it is probably safe to merely conclude that the often-heard blanket statement that SCAM improves QoL is not nearly as certain as SCAM enthusiasts want it to be.
Anja Zeidler (born 1993) became known in 2012 as the most successful fitness personality in Switzerland. After joining the bodybuilding scene in Los Angeles, a phase of self-discovery followed. Anja published her development and became what one nowadays calls an ‘INFLUENCER’. As Managing Director and Content Director of her own company, Anja Zeidler GmbH, Anja has made a name for herself as a public figure far beyond the fitness market with her activities as a ‘Selflove Influencer’, blogger, book author, motivational speaker, presenter and expert in the food & health sector. Furthermore, she is completing a degree at the Academy of Naturopathy for Holistic Health.
About a year and a half ago, Anja Zeidler had a desmoid tumor removed from under her left breast – and now it was reported to be back. The conventional treatment methods are clear: another surgical procedure or radiation. But Zeidler said she wants to wait with such interventions. For the time being, she has decided to go her own way. She wants to “balance any imbalances” with her naturopathic doctor and wishes to fight the disease on her own and with a “positive mindset.”
“On a spiritual level, they say that tumors can be related to trauma. That’s why I’ve tried breathing exercises and cocoa ceremonies. With these methods, I get into my subconscious and get closer to traumas, which I am not aware of, and try to dissolve them. So far, blatant things have come up that I had long forgotten and repressed,” she says enthusiastically. In addition, Zeidler wants to give up refined sugar with immediate effect, keep better control of her diet in general – even in her stressful everyday life – and drink freshly squeezed celery and beetroot juice every morning. In addition, she relies on “natural capsules with and grape seed OPC.” “I’ve read in studies that certain types of fungi and strong antioxidants like OPC are supposed to fight tumor cells.” There I follow the motto: ‘if it doesn’t help, at least it does not harm.'”
Zeidler’s tumor is a desmoid tumor, an abnormal growth that arises from connective tissues. These tumors are generally not considered malignant because they do not spread to other parts of the body; however, they can aggressively invade the surrounding tissue and can be very difficult to remove surgically. These tumors often recur, even after apparently complete removal.
Zeidler commented: “I am convinced that with a positive mindset you can contribute extremely much to the healing process. If the checks reveal rapid growth, I will of course seek medical treatment. Then I would opt for radiation.”
The trouble with ‘influencers’ is that they are gullible and influence the often gullible public to become more gullible. Thus their influence might cost many lives. Personally, I hope that the young woman does well with her erstwhile refusal of evidence-based treatments. Yet, I fear that the ‘Academy of Naturopathy for Holistic Health’ will teach her a lot of BS about the power of natural cancer cures. The sooner she agrees to have her tumor treated based on evidence, the better her prognosis, I’m sure.
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155 mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients’ quality of life.
Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P = 0.50), NDS scores (P = 0.74), VAS scores (P = 0.17), and Neuro-QoL scores (P = 0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P < 0.001), NDS scores (P < 0.001), VAS scores (P < 0.001), and Neuro-QoL scores (P < 0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
The authors concluded that according to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
Our own study and systematic review of the effects of magnetic bracelets and similar devices suggested that the effects of such treatments are due to placebo responses. Therefore, I find the findings of this new study most surprising. Not only that, to be honest, I also find them suspect. Apart from the fact that the treatment has no biological plausibility, I have three main reasons for my skepticism.
- The authors stated that there was no distinguishable difference between the sham and SMF devices in terms of their appearance, weight, or texture, which helped to ensure that the study was double-blinded. This is nonsense, I am afraid! The verum device is magnetic and the sham device is not. It is hardly conceivable that patients who handle such devices for any length of time do not discover this simple fact and thus de-blind themselves. In turn, this means that a placebo effect can easily explain the outcomes.
- Authors who feel that their tiny study of a highly implausible therapy lends itself to concluding that their therapy ‘is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL’ can, in my view, not be taken seriously.
- Something that always makes me suspicious of clinical trials is a lack of a placebo response where one would normally expect one. In this study, the control group exhibits hardly any placebo response. Wearing a strap around your ankle that allegedly emits therapeutic radiation would result in quite a strong placebo effect, according to our own findings.
So, forgive me if I do not trust this study any further than I can throw it! And pardon me if I still think that our previous conclusion is correct: The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment.
Menopausal symptoms are systemic symptoms that are associated with estrogen deficiency after menopause. Although widely practiced, homeopathy remains under-researched in menopausal syndrome in terms of quality evidence, especially in randomized trials. The efficacy of individualized homeopathic medicines (IHMs) was evaluated in this double-blind, randomized, placebo-controlled trial in the treatment of the menopausal syndrome.
Group 1 (n = 30) received IHMs plus concomitant care, while group 2 (n = 30) had placebos plus concomitant care. The primary outcome measures were the Greene Climacteric Scale (GCS) total score and the menopause rating scale (MRS) total score. The secondary endpoint was the Utian quality of life (UQOL) total score. Measurements were taken at baseline and every month up to 3 months.
Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated-measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired t-tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 two-tailed. Between-group differences were nonsignificant statistically—GCS total score (F1, 58 = 1.372, p = 0.246), MRS total score (F1, 58 = 0.720, p = 0.4), and UQOL total scores (F1, 58 = 2.903, p = 0.094). Some of the subscales preferred IHMs significantly against placebos—for example, MRS somatic subscale (F1, 56 = 0.466, p < 0.001), UQOL occupational subscale (F1, 58 = 4.865, p = 0.031), and UQOL health subscale (F1, 58 = 4.971, p = 0.030). Sulfur and Sepia succus were the most frequently prescribed medicines. No harm or serious adverse events were reported from either group.
The authors concluded that, although the primary analysis failed to demonstrate clearly that the treatment was effective beyond placebo, some significant benefits of IHMs over placebo could still be detected in some of the subscales in the secondary analysis.
The article was published in the recently re-named JICM, a journal that, when it was still called JCAM, featured regularly on this blog. As such, the paper is remarkable: who would have thought that this journal might publish a trial of homeopathy with a squarely negative result?
Yes, I know, the surprise is tempered by the fact that the authors make much in the conclusions of their article about the significant findings related to secondary analyses. Should we tell them that these results are all but irrelevant?
Better not!
