anxiety
Bach Flower Remedies are popular despite a paucity of clinical trials testing their effectiveness. This is why I am excited each time a new trial emerges.
This study analyzed the effectiveness of Bach flower therapy compared to placebo in reducing perceived stress levels in primary health care nursing professionals. It was designed as a “pragmatic, parallel randomized clinical trial” conducted with 87 primary care nursing professionals with self-identified stress, from October 2021 to June 2022, in the cities of Osasco and São Paulo, Brazil. The intervention group (n=43) received the collective flower formula, and the placebo group (n=44) received only the diluent. Data analysis was performed using the linear mixed model, and effect size was measured by partial Eta squared, significance level 5%.
The results showed a significant reduction in perceived stress levels within groups (p=0.038). However, there was no significant difference between the study groups (p=0.750). Participants in the intervention group reported a greater perception of changes than participants in the placebo group, but without statistical significance (p=0,089).
The authors concluded that the floral formula was not more effective than the placebo formula in reducing perceived stress. There was a significant stress reduction among nursing professionals in both study groups, although with a small effect size.
I must congratulate the authors for their courage to report a squarely negative result [in a controlled clinical trial only the inter-group differences are relevant!]. At the same time I ought to criticize them for not being more straight about it. The conclusions should be much simpler:
THE FINDINGS SHOW NO SIGNIFICANT EFFECT OF BACH FLOWER REMEDIES.
And why might anyone think that such a treatment could cause a significant effect?
Search me!
Bach Flower remedies do not contain sufficient amounts of active ingredients to cause any health effects beyond placebo!
This means that the prior probability of such a study generating a positive finding is very close to zero. In turn, this means that research funds are more wisely spent elsewhere. One could easily be a bit more rigorous and argue that conducting clinicl trials on such hopeless topics is not ethical.
The American Society of Clinical Oncology (ASCO) and the Society for Integrative Oncology have collaborated to develop guidelines for the application of integrative approaches in the management of:
- anxiety,
- depression,
- fatigue,
- use of cannabinoids and cannabis in patients with cancer.
These guidelines provide evidence-based recommendations to improve outcomes and quality of life by enhancing conventional cancer treatment with integrative modalities.
All studies that informed the guideline recommendations were reviewed by an Expert Panel which was made up of a patient advocate, an ASCO methodologist, oncology providers, and integrative medicine experts. Panel members reviewed each trial for quality of evidence, determined a grade quality assessment label, and concluded strength of recommendations.
The findings show:
- Strong recommendations for management of cancer fatigue during treatment were given to both in-person or web-based mindfulness-based stress reduction, mindfulness-based cognitive therapy, and tai chi or qigong.
- Strong recommendations for management of cancer fatigue after cancer treatment were given to mindfulness-based programs.
- Clinicians should recommend against using cannabis or cannabinoids as a cancer-directed treatment unless within the context of a clinical trial.
- The recommended modalities for managing anxiety included Mindfulness-Based Interventions (MBIs), yoga, hypnosis, relaxation therapies, music therapy, reflexology, acupuncture, tai chi, and lavender essential oils.
- The strongest recommendation in the guideline is that MBIs should be offered to people with cancer, both during active treatment and post-treatment, to address depression.
The authors concluded that the evidence for integrative interventions in cancer care is growing, with research now supporting benefits of integrative interventions across the cancer care continuum.
I am sorry, but I find these guidelines of poor quality and totally inadequate for the purpose of providing responsible guidance to cancer patients and carers. Here are some of my reasons:
- I know that this is a petty point, particularly for me as a non-native English speaker, but what on earth is an INTEGRATIVE THERAPY? I know integrative care or integrative medicine, but what could possibly be integrative with a therapy?
- I can vouch for the fact that the assertion “all studies that informed the guideline recommendations were reviewed” is NOT true. The authors seem to have selected the studies they wanted. Crucially, they do not reveal their selection criteria. I have the impression that they selected positive studies and omitted those that were negative.
- The panel of experts conducting the research should be mentioned; one can put together a panel to show just about anything simply by choosing the right individuals.
- The authors claim that they assessed the quality of the evidence, yet they fail to tell us what it was. I know that many of the trials are of low quality and their results therefore less than reliable. And guidance based on poor-quality studies is misguidance.
- The guidelines say nothing about the risks of the various treatments. In my view, this would be essential for any decent guideline. I know that some of the mentioned therapies are not free of adverse effects.
- They also say nothing about the absolute and relative effect sizes of the treatments they recommend. Such information would ne necessary for making informed decisions about the optimal therapeutic choices.
- The entire guideline is bar any critical thinking.
Overall, these guidelines provide more an exercise in promotion of dubious therapies than a reliable guide for cancer patients and their carers. The ASCO and the Society for Integrative Oncology should be ashamed to have given their names to such a poor-quality document.
When I still worked as a clinician, I have looked after athletes long enough to know that they go for everything that promises to improve their performance. It is thus hardly surprising that Olympians would try all sorts of so-called alternative medicine (SCAM) regardless of whether the therapy is supported by evidence or not. Skeptics are tempted to dismiss all of SCAM for improving fitness. But is that fair? Is it true that no evidence evists for any of them?
The short answer to this question is NO.
Here I have looked at some of the possibilities and show you some of the Medline-listed papers that seem to support SCAM as a means of improving fitness:
Acupuncture
Ashwagandha
Balneology
Cupping
Ginkgo biloba
Ice
Kinesiology tape
Massage guns
Percussion massage
Sports massage
Tai massage
Vibrational massage
Yoga
Please do not mistake this for anything resembling a systematic review of the evidence; it is merely a list to give you a flavour of what is out there. And please don’t assume that the list is complete; I am sure that there is much more.
Looking at the articles that I found, one could get the impression that there is plenty of good evidence to support SCAM for improving fitness. This, however, would be wrong. The evidence for almost every of the above listed therapies is flimsy to say the least. But – as I stated already at the beginning – in my experience, this will not stop athletes to use them.
The BBC has repeatedly misled the public on matters related to so-called alternative medicine (SCAM). Examples include:
- Dangerous BS from the BBC
- The BBC, Michael Mosely, air ionization, depression, and an appalling lack of critical thinking.
Recently the BBC published an article about Ashwagandha. Here it is in its untouched beauty:
Ashwagandha is a herb (Withania somnifera) in the nightshade family, which also includes tomatoes and chilli peppers. It has been used in traditional Indian medicine (Ayurveda) for thousands of years to make preparations for treating various ailments, from infectious diseases, like tuberculosis, to pain and inflammation, baldness and hiccups. In classic Ayurvedic texts, it’s also described as a ‘mental strength promoter’ (or ‘Balya’).
While lots of research has been done on ashwagandha, studies for specific conditions can be sparser. Perhaps the most recent assessment of its use for stress and anxiety comes from a 2022 review of studies by the Cochrane Collaboration, which is internationally recognised for its high-standard medical reviews. Although the Cochrane researchers were only able to find 12 studies on the subject, which together tested the herb on just 1,002 participants, their findings did suggest that ashwagandha can lower stress and anxiety. The researchers rated the ‘certainty’ of the evidence as ‘low’ and called for more detailed studies, though.
The benefits of ashwagandha are thought to be related to natural steroids called withanolides, but this group includes hundreds of compounds, with tens having been isolated from ashwagandha so far. As with any herbal remedy, the combination of compounds and the exact concoction you get depends on how and where the plant is grown, and how it’s prepared. This means that not all supplements based on the same plant are equal.
Remember, too, that herbal doesn’t mean risk-free. For some people, ashwagandha causes drowsiness and more serious side effects aren’t unknown. It’s best to treat it like a drug and not ‘just’ a herb.
The review cited in the article is this one:
Clinical trial studies revealed conflicting results on the effect of Ashwagandha extract on anxiety and stress. Therefore, we aimed to evaluate the effect of Ashwagandha supplementation on anxiety as well as stress. A systematic search was performed in PubMed/Medline, Scopus, and Google Scholar from inception until December 2021. We included randomized clinical trials (RCTs) that investigate the effect of Ashwagandha extract on anxiety and stress. The overall effect size was pooled by random-effects model and the standardized mean difference (SMD) and 95% confidence interval (CIs) for outcomes were applied. Overall, 12 eligible papers with a total sample size of 1,002 participants and age range between 25 and 48 years were included in the current systematic review and meta-analysis. We found that Ashwagandha supplementation significantly reduced anxiety (SMD: −1.55, 95% CI: −2.37, −0.74; p = .005; I2 = 93.8%) and stress level (SMD: −1.75; 95% CI: −2.29, −1.22; p = .005; I2 = 83.1%) compared to the placebo. Additionally, the non-linear dose–response analysis indicated a favorable effect of Ashwagandha supplementation on anxiety until 12,000 mg/d and stress at dose of 300–600 mg/d. Finally, we identified that the certainty of the evidence was low for both outcomes. The current systematic review and dose–response meta-analysis of RCTs revealed a beneficial effect in both stress and anxiety following Ashwagandha supplementation. However, further high-quality studies are needed to firmly establish the clinical efficacy of the plant.
This review is NOT a Cochrane Review; what is more (and more important), it seem rather uncritical.
The BBC article seems to down-play the safety issue related to Ashwagandha. As we have discussed on this blog, Ashwagandha is far from harmless. In fact, Ashwagandha has been shown to be a herb with a high risk of hepatobiliary toxicity as well as heart problems.
So, why does the BBC misinform the public?
Search me.
We have discussed the LIGHTNING PROCESS before:
- The ‘Lightning Process’: implausible, unproven, hyped and expensive
- The ‘Lightning Process’ (LP), an effective therapy for ME?
Now, the BBC reports that it is promoted as a treatment of Long-COVID. Oonagh Cousins was offered a free place on a course run by the Lightning Process, which teaches people they can rewire their brains to stop or improve long Covid symptoms quickly. Ms Cousins, who contracted Covid in March 2020, said it “exploits” people.
Ms Cousins had reached a career goal many athletes can only dream of – being selected for the Olympics – when she developed long Covid. By the time the cancelled 2020 Olympic Games in Tokyo were rescheduled for 2021, Ms Cousins was too ill to take part. When she went public with her struggles, she was approached by the Lightning Process. It offered her a free place on a three-day course, which usually costs around £1,000.
“They were trying to suggest that I could think my way out of the symptoms, basically. And I disputed that entirely,” the former rower said. “I had a very clearly physical illness. And I felt that they were blaming my negative thought processes for why I was ill.” She added: “They tried to point out that I had depression or anxiety. And I said ‘I’m not, I’m just very sick’.
In secret recordings by the BBC, coaches can be heard telling patients that almost anyone can recover from long Covid by changing their thoughts, language and actions. Over three days on Zoom, the course taught the ritual that forms the basis of the programme. Every time you experience a symptom or negative thought, you say the word “stop”, make a choice to avoid these symptoms and then do a positive visualisation of a time you felt well. You do this while walking around a piece of paper printed with symbols – a ritual the BBC was told to do as many as 50 times a day.
In some cases the Lightning Process has encouraged participants to increase their activity levels without medical supervision, against official advice – which could make some more unwell, according to NHS guidelines. Lightning Process founder, Dr Phil Parker, who’s not a medical doctor but has a PhD in psychology of health, told us his course was “not a mindset or positive thinking approach,” but one that uses “the brain to influence physiological changes”, backed by peer-reviewed evidence. The coach on the course the BBC attended said “thoughts about your symptoms, your worry about whether it’s ever going to go – that’s what keeps the neurology going. Being in those kind of thoughts is what’s maintaining your symptoms. They’re not caused by a physical thing any more.”
___________________
As I pointed out previously, The Lightning Process (LP) is a therapy based on ideas from osteopathy, life coaching, and neuro-linguistic programming. LP is claimed to work by teaching people to use their brains to “stimulate health-promoting neural pathways”.
LP teaches individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns, and physical movements with the aim of improving a more appropriate response to situations.
Proponents of the ‘LP’ in Norway claim that 90% of all ME patients get better after trying it. However, such claims seem to be more than questionable.
- In the Norwegian ME association’s user survey from 2012 with 1,096 participants, 164 ME patients stated that they had tried LP. 21% of these patients experienced improvement or great improvement and 48% got worse or much worse.
- In Norway’s National Research Center in Complementary and Alternative Medicine, NAFKAM’s survey from 2015 amongst 76 patients 8 had a positive effect and 5 got worse or much worse.
- A survey by the Norwegian research foundation, published in the journal Psykologisk, with 660 participants, showed that 62 patients had tried LP, and 5 were very or fairly satisfied with the results.
Such figures reflect the natural history of the condition and are no evidence that the LP works.
Is there any evidence supporting the LP specifically for long COVID?
My Medline search retrieved just one single paper. Here is the abstract:
As a result of the COVID-19 pandemic, Long COVID (LC) is now prevalent in many countries. Little evidence exists regarding how this chronic condition should be treated, but guidelines suggest for most people it can be managed symptomatically in primary care. The Lightning Process is a trademarked positive psychology focused self-management programme which has shown to be effective in reducing fatigue and accompanying symptoms in other chronic conditions including Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. Here we outline its novel application to two patients with LC who both reported improvements in fatigue and a range of physical and emotional symptoms post-treatment and at 3 months follow-up.
Well, that surely convinced everyone! Except me and, of course, anyone else who can think critically.
So, I look further and find this on the company’s website:
Do you know how it feels to…
- …be exhausted and tired no matter how much rest you get?
- …be stuck with re-occurring pain, health symptoms and issues?
- …get so stressed by almost everything?
- …feel low and upset much of the time?
- …want a better life and health but just can’t find anything that works?
If any, or all, of these sound familiar then the Lightning Process, designed by Phil Parker, PhD, could be the answer that you’re looking for. There are lots of ways you can find out more about the suitability of the Lightning Process for you, have a look through below…
___________________________
Let me try to summarise:
- The LP is promoted as a cure for long-Covid.
- There is no evidence that LP is effective for it.
- The claim is that it has been shown to work for ME.
- There is no evidence that LP is effective for it.
- A 3-day course costs £1 000.
- Their website claims it is good for practically everyone.
Does anyone think that LP or its promoters are remotely serious?
Many forms of so-called alternative medicine (SCAM) involve touch, and touch is of critical importance: many studies have shown that it promotes mental and physical well-being.
A team of researchers conducted a pre-registered (PROSPERO: CRD42022304281) systematic review and multilevel meta-analysis encompassing 137 studies in the meta-analysis and 75 additional studies in the systematic review (n = 12,966 individuals, search via Google Scholar, PubMed and Web of Science until 1 October 2022) to identify critical factors moderating touch intervention efficacy.
Included studies always featured a touch versus no touch control intervention with diverse health outcomes as dependent variables. Risk of bias was assessed via small study, randomization, sequencing, performance and attrition bias.
The results show that touch interventions were especially effective in:
- regulating cortisol levels (Hedges’ g = 0.78, 95% confidence interval (CI) 0.24 to 1.31),
- increasing weight (0.65, 95% CI 0.37 to 0.94) in newborns,
- reducing pain (0.69, 95% CI 0.48 to 0.89),
- reducing feelings of depression (0.59, 95% CI 0.40 to 0.78),
- reducing state (0.64, 95% CI 0.44 to 0.84) or trait anxiety (0.59, 95% CI 0.40 to 0.77) for adults.
Comparing touch interventions involving objects or robots resulted in similar physical (0.56, 95% CI 0.24 to 0.88 versus 0.51, 95% CI 0.38 to 0.64) but lower mental health benefits (0.34, 95% CI 0.19 to 0.49 versus 0.58, 95% CI 0.43 to 0.73). Adult clinical cohorts profited more strongly in mental health domains compared with healthy individuals (0.63, 95% CI 0.46 to 0.80 versus 0.37, 95% CI 0.20 to 0.55).
The authors found no difference in health benefits in adults when comparing touch applied by a familiar person or a health care professional (0.51, 95% CI 0.29 to 0.73 versus 0.50, 95% CI 0.38 to 0.61), but parental touch was more beneficial in newborns (0.69, 95% CI 0.50 to 0.88 versus 0.39, 95% CI 0.18 to 0.61). Small but significant small study bias and the impossibility to blind experimental conditions need to be considered.
The authors concluded that leveraging factors that influence touch intervention efficacy will help maximize the benefits of future interventions and focus research in this field.
It seems obvious to me that these findings are relevant to several SCAMs, e.g.:
- acupuncture,
- Alexander technique,
- applied kinesiology,
- aromatherapy,
- Bowen technique,
- chiropractic,
- craniosacral therapy,
- cupping,
- Dorn method,
- Feldenkrais method,
- gua sha,
- kinesiology taping,
- lymph drainage,
- massage in all its variations,
- naprapathy,
- osteopathy,
- rebirthing,
- reflexology,
- Rolfing,
- shiatsu,
- slapping therapy,
- therapeutic touch.
This also means that the effects of these SCAMs will be at least to some extend non-specific, i.e. not related to the treatment per se but to touch. Finally, it means that clinical trials testing these SCAMs need to be designed such that the touch element is adequately accounted for.
- the intervention group participants received reiki remotely for 20 minutes for 4 consecutive days,
- the control group participants received no intervention.
A controlled clinical trial has the purpose of comparing outcomes of two or more treatments. Therefore, intra-group changes are utterly irrelevant. The only thing of interest is the comparison between the intervention and control groups. In the present study, this did not show a significant difference. In other words, distant Reiki had no effect.
This means that the bit in the conclusion telling us that Reiki helps students cope with test anxiety is quite simply not true.
This leaves us with the first part of the conclusion: Reiki is a safe and easy-to-practice method. This may well be true – yet it is meaningless. Apart from the fact that the study was not aimed at assessing safety or ease of practice, the statement is true for far too many things to be meaningful, e.g.:
- Not having Reiki (the control group) is a safe and easy-to-practice method.
- Going for a walk is a safe and easy-to-practice method.
- Cooking a plate of spagetti is a safe and easy-to-practice method.
- Having a nap is a safe and easy-to-practice method.
- Reading a book is a safe and easy-to-practice method.
(I think you get my gist)
To make the irony complete, let me tell you that this trial was published in Journal of Nursing Education. On the website, the journal states: The Journal of Nursing Education is a monthly, peer-reviewed journal publishing original articles and new ideas for nurse educators in various types and levels of nursing programs for over 60 years. The Journal enhances the teaching-learning process, promotes curriculum development, and stimulates creative innovation and research in nursing education.
I suggest that the journal urgently embarks on a program of educating its editors, reviewers, contributors and readers about science, pseudoscience, minimal standards, scientific rigor, and medical ethics.
In the previous two parts of this series (see here and here), we discussed the following SCAM diagnoses:
- adrenal fatigue,
- candidiasis hypersensitivity,
- chronic intoxications,
- chronic Lyme disease,
- electromagnetic hypersensitivity,
- homosexuality.
Today, I will add three further fake diagnoses to the list.
Leaky gut syndrome
Leaky gut syndrome is allegedly caused by the passage of harmful substances from the gut wall into the body. SCAM proponents claim it is the origin of many conditions, including multiple sclerosis and autism. However, there is no evidence to show that these claims are true. SCAM practitioners nevertheless recommend many types of SCAM to treat the non-existing entity, e.g. SCAM diets, supplements, etc. It goes without saying that none of them have been shown to be effective.
Multiple chemical sensitivity
Multiple chemical sensitivity is allegedly caused by a hypersensitivity to commonly used chemicals. The symptoms are vague such as headache, dizziness, fatigue. Even those who believe that the condition exist are unable to offer a generally accepted definition of the syndrome.
The SCAMs recommended include:
- Nutritional supplements
- Digestive aids
- Hormone balancing
- Detoxification
- Desensitization
- Eliminating occult infections
- Oxygen
- Immune stimulation
Naturally, none of them is supported by sound evidence.
Neurasthenia
In 1869, physician George Miller Beard developed a diagnostic profile for a mental disorder that appeared to be common in the US. Neurasthenia was allegedly characterised by migraines, fatigue, depression, and digestive problems.
The cure, according to Beard, was to flee the city – because it was the stresses of city life that caused the condition. Women were encouraged to rest, while men were asked to engage in outdoor activities. By the early 20th century, this mental disorder had become a status symbol, and it soon spread to other parts of the world. But this pandemic was short-lived: by 1930, neurasthenia had virtually disappeared from conventional medicine.
In SCAM, however, neurasthenia is still a well-establisged money earner. SCAM practitioners do not hesitate to recomment virually every SCAM under the sun for it. They all have one thing in common: they do not work.
This study evaluated and compared the effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients’ negative emotional states. This quas-experimental research design was carried out at the National Institute of Diabetes and Endocrinology’s Hospital in Cairo, Egypt. It included 200 Type 2 diabetes patients randomized into two equal groups, one for Qigong and one for Reiki techniques. A self-administered questionnaire with a standardized tool (Depression Anxiety Stress Scales [DASS[) was used in data collection. The intervention programs were administered in the form of instructional guidelines through eight sessions for each group.
The results showed that the two study groups had similar socio-demographic characteristics. After implementation of the intervention, most patients in the two groups were having no anxiety, no depression, and no stress. Statistically significant improvements were seen in all three parameters in both groups (p<0.001). The multivariate analysis identified the study intervention as the main statistically significant independent negative predictor of the patients’ scores of anxiety, depression, and stress. Reiki technique was also a statistically significant independent negative predictor of these scores.
The authors conclused that both Reiki and Qi-gong therapy techniques were effective in improving diabetic patients’ negative emotional states of anxiety, depression, and stress, with slight superiority of the Reiki technique. The inclusion of these techniques in the management plans of Type-2 diabetic patients is recommended.
This is an excellent example of how NOT to design a clinical trial!
- If your aim is to test the efficacy of Reiki, conduct a trial of Reiki versus sham-Reiki.
- If your aim is to test the efficacy of Qi-gong, conduct a trial of Qi-gong versus sham-Qi-gong.
- If you compare two therapies in one trial, one has to be of proven and undoubted efficacy.
- Comparing two treatments of unproven efficacy cannot normally lead to a meaningful result.
- It is like trying to solve a mathematical equasion with two unknowns.
- A study that cannot produce a meaningful result is a waste of resorces.
- It arguably also is a neglect of research ethics.
- Even if we disregarded all these flaws and problems, recommending therapies for routine use on the basis of one single study is irresponsible nonsense.
All this is truly elementary and should be known by any researcher (not to mention research supervisor). Yet, in the realm of so-called alternative medicine (SCAM), it needs to be stressed over and over again. The ‘National Institute of Diabetes and Endocrinology’s Hospital in Cairo’ (and all other institutions that produce such shameful pseudoscience) urgently need to get their act together:
you are doing nobody a favour!
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.]
