Many experts doubt that acupuncture generates the many positive health effects that are being claimed by enthusiasts. Yet, few consider that acupuncture might not be merely useless but could even make things worse. Here is a trial that seems to suggest exactly that.
This study evaluated whether combining two so-called alternative medicines (SCAMs), acupuncture and massage, reduce postoperative stress, pain, anxiety, muscle tension, and fatigue more than massage alone.
Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative SCAMs for three consecutive days. All participants were observed for up to 3 months. Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.
Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment. After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes.
The authors concluded tha no additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.
I recently went to the supermarket to find out whether combining two bank notes (£10 + £5) can buy more goods than one £10 note alone. What I found was interesting: the former did indeed purchase more than the latter. Because I am a scientist, I did not stop there; I went to a total of 10 shops and my initial finding was confirmed each time: A+B results in more than A alone.
It stands to reason that the same thing happens with clinical trials. We even tested this hypothesis in a systematic review entitled ‘A trial design that generates only ”positive” results‘. Here is our abstract:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
But why is this not so with the above-mentioned study?
Why is, in this instance, A even more that A+B?
There are, of course, several possible answers. To use my supermarket example again, the most obvious one is that B is not a £5 note but a negative amount, a dept note, in other words: A + B can only be less than A alone, if B is a minus number. In the context of the clinical trail, this means acupuncture must have caused a negative effect.
But is that possible? Evidently yes! Many patients don’t like needles and experience stress at the idea of a therapist sticking one into their body. Thus acupuncture would cause stress, and stress would have a negative effect on all the other parameters quantified in the study (pain, anxiety, muscle tension, and fatigue).
My conclusion: in certain situations, acupuncture is more than just useless; it makes things worse.
The aim of this RCT was to examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregiver to women with advanced breast cancer undergoing chemotherapy, targeted, and/or hormonal therapy.
Patient-caregiver dyads (N = 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (N = 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analysed using generalized estimating equations technique.
Reflexology was more successful than attention control in producing responses for pain with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants.
Adjusted odds ratios (ORs) of symptom responses for reflexology arm versus control (adjusted for age, number of comorbid conditions, depressive symptoms at baseline, and treatment type: chemotherapy with or without hormonal therapy versus hormonal therapy alone)
Symptom OR (95% CI) p value
Fatigue 1.76 (0.99, 3.12) 0.06
Pain 1.84 (1.05, 3.23) 0.03
Disturbed sleep 1.45 (0.76, 2.77) 0.26
Shortness of breath 0.58 (0.26, 1.30) 0.19
Remembering 0.96 (0.51, 1.78) 0.89
Lack of appetite 1.05 (0.45, 2.49) 0.91
Dry mouth 1.84 (0.86, 3.94) 0.12
Numbness and tingling 1.40 (0.75, 2.64) 0.29
Depression 1.38 (0.78, 2.43) 0.27
The authors concluded that home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology.
This is certainly one of the more rigorous studies of reflexology. It is well designed and reported. How valid are its findings? To a large degree, this seems to depend on the somewhat unusual statistical approach the investigators employed:
Baseline characteristics were summarized by study group for outcome values and potential covariates. The unit of analysis was patient symptom; multiple symptoms were treated as nested within the patient being analyzed, using methodology described by Given et al.  and Sikorskii et al. . Patient symptom responses were treated as multiple events, and associations among responses to multiple symptoms within patients were accounted for by specifying the exchangeable correlation structure in the generalized estimating equations (GEE) model. The GEE model was fitted using the GENMOD procedure in SAS 9.4 . A dummy symptom variable with 9 levels was included in the interaction with the trial arm to differentiate potentially different effects of reflexology on different symptoms. Patient-level covariates included age, number of comorbid conditions, type of treatment (chemotherapy or targeted therapy with or without
hormonal therapy versus hormonal therapy only), and the CES-D score at baseline. Odds ratios (ORs) and their 95% confidence intervals (CIs) were obtained for the essential parameter of study group for each symptom.
Another concern is the fact that the study crucially depended on the reliability of the 256 carers. It is conceivable, even likely, I think, that many carers from both groups were less than strict in adhering to the prescribed protocol. This might have distorted the results in either direction.
Finally, the study was unable to control for the possibly substantial placebo response that a reflexology massage unquestionably provokes. Therefore, we are not able to tell whether the observed effect is due to the agreeable, non-specific effects of touch and foot massages, or to the postulated specific effects of reflexology.
I have to admit that I had not heard of Dr Bernhoft before. I was alerted to him through the discussions about him on this blog. So, I had a look. What I found amazed me.
On his website, Bernhoft states the following:
Dr. Bernhoft is one of the nation’s leading practitioners in the field of environmental medicine. He comes to his expertise not only through extensive academic and professional training and decades as a practicing physician and surgeon, but also from the uniquely motivating perspective of having been a patient himself who had to fight desperately for his life and was literally forced to find a way to heal himself from an illness that left his MD colleagues at a loss for diagnosis and treatment…
His personal quest for survival carried him into cutting-edge advanced medicine, including gene-environment interactions. He found out that his gene which codes for an enzyme called MTHFR was hypoactive, and a second, which produces GSTM1 was absent, leaving him susceptible to poisoning by a wide range of metals and chemicals…
Because of his unique personal experience, combined with his outstanding professional credentials, he is one of the most effective spokespeople in the cause of environmental healing.
His ‘outstanding professional credentials’ consist of amongst others ‘28 peer reviewed medical articles‘, he claims. My Medline search located just 11:
- Cadmium toxicity and treatment. Bernhoft RA.ScientificWorldJournal. 2013 Jun 3;2013:394652. doi: 10.1155/2013/394652. Print 2013.PMID: 23844395 Free PMC article. Review.
- Mercury toxicity and treatment: a review of the literature.Bernhoft RA.J Environ Public Health. 2012;2012:460508. doi: 10.1155/2012/460508. Epub 2011 Dec 22.PMID: 22235210 Free PMC article. Review.
- Clinical detoxification: elimination of persistent toxicants from the human body.Genuis SJ, Sears ME, Schwalfenberg G, Hope J, Bernhoft R.ScientificWorldJournal. 2013 Jun 6;2013:238347. doi: 10.1155/2013/238347. Print 2013.PMID: 23844383 Free PMC article. No abstract available.
- Incorporating environmental health in clinical medicine.Genuis SJ, Sears M, Schwalfenberg G, Hope J, Bernhoft R.J Environ Public Health. 2012;2012:103041. doi: 10.1155/2012/103041. Epub 2012 May 17.PMID: 22675371 Free PMC article. No abstract available.
- Cholangitis after endoscopic sphincterotomy in patients with stricture of the biliary duct.Kracht M, Thompson JN, Bernhoft RA, Tsang V, Gibson RN, Blumgart LH.Surg Gynecol Obstet. 1986 Oct;163(4):324-6.PMID: 3764637
- Composition and morphologic and clinical features of common duct stones.Bernhoft RA, Pellegrini CA, Motson RW, Way LW.Am J Surg. 1984 Jul;148(1):77-85. doi: 10.1016/0002-9610(84)90292-7.PMID: 6742333
- Pigment sludge and stone formation in the acutely ligated dog gallbladder.Bernhoft RA, Pellegrini CA, Broderick WC, Way LW.Gastroenterology. 1983 Nov;85(5):1166-71.PMID: 6618107
- Vesicular transport of horseradish peroxidase during chronic bile duct obstruction in the rat.Renston RH, Zsigmond G, Bernhoft RA, Burwen SJ, Jones AL.Hepatology. 1983 Sep-Oct;3(5):673-80. doi: 10.1002/hep.1840030508.PMID: 6618434
- Peritoneovenous shunt for refractory ascites: operative complications and long-term results.Bernhoft RA, Pellegrini CA, Way LW.Arch Surg. 1982 May;117(5):631-5. doi: 0.1001/archsurg.1982.01380290081014.PMID: 7073482
- Biliary stricture.Way LW, Bernhoft RA, Thomas MJ.Surg Clin North Am. 1981 Aug;61(4):963-72. doi: 10.1016/s0039-6109(16)42492-8.PMID: 7280936
- The effects of a low level of dietary cadmium on blood pressure, ’24Na, ’42K, andwater retention in growing rats.Doyle JJ, Bernhoft RA, Sandstead HH.J Lab Clin Med. 1975 Jul;86(1):57-63.PMID: 1151143
The following are typical symptoms of hormone imbalance in both men and women:
- Hot flashes and night sweats
- Anxiety, depression, and irritability
- Low libido
- Memory lapses and trouble concentrating
- Weight gain
- Insomnia and sleep apnea
- Lack of muscle tone
Regardless of your age, gender, or specific symptoms, you can find relief with Bioidentical Hormone Replacement Therapy (BHRT).
Women’s Conditions Treated With Bioidentical Hormones
Robin A. Bernhoft, M.D. at the Bernhoft Center for Advanced Medicine specializes in Bioidentical Hormone balancing for women, which includes addressing the symptoms of hormonal imbalance and customizing individual treatment programs using Bioidentical Hormone Replacement Therapy. Robin A. Bernhoft, M.D. will test each woman’s hormone levels to determine deficiencies, dominances, and imbalances, and he will work closely with each woman to find the correct dosages to restore optimal health. Some of the conditions that Doctor Bernhoft uses Bioidentical Hormone Replacement Therapy to treat in women include:
ADRENAL FATIGUE SYNDROME
When you suffer from chronic or poorly managed stress, your adrenal glands do not release the level of cortisol you require to remain healthy and emotionally stable. You may struggle with anxiety, depression, insomnia, fatigue, cravings for sweets, and several other symptoms due to adrenal fatigue. Along with proper nutrition, balancing your hormones with Bioidentical Hormone Replacement Therapy helps you manage stress better by bringing your cortisol levels in balance.
Having too much of the estrogen hormone or an underactive thyroid may cause you to lose hair on your head, arms, legs, or pubic area. If you are diabetic, poor blood sugar control can also cause this problem. Robin A. Bernhoft, M.D. can take a quick blood test to determine if hormonal imbalance is causing this issue. If so, replacing your body’s lost hormones with Bioidentical ones can help you re-grow scalp and body hair.
ANXIETY AND DEPRESSION
When feelings of anxiety and depression are unrelated to a specific life event, they are often the result of unbalanced levels of estrogen, progesterone, and cortisol. You may feel weepy, irritable, nervous, guilty, and many other troublesome emotions. Having a hysterectomy or going through menopause tends to increase your risk of anxiety and depression. When anti-depressant medication doesn’t work, it’s more likely you’re experiencing hormonal depression that is treatable with Bioidentical Hormone Replacement Therapy.
Women who are approaching middle age complain of chronic headaches more often than younger women do. This is often because of pending menopause or being at a certain point in their menstrual cycle. An unbalanced amount of the hormone progesterone may also be the cause of this misery. If Robin A. Bernhoft, M.D. discovers a problem with your progesterone, he may recommend that you start Bioidentical Hormone Replacement Therapy along with a daily dose of the vitamin B12.
CHRONIC FATIGUE SYNDROME
It’s normal to feel tired when you are under stress or don’t get enough sleep, but chronic fatigue lasting throughout the day is probably a sign of hormonal imbalance. Unfortunately, it causes other problems such as irritability, depression, and lowered resistance to illnesses. Low estrogen levels are often the cause of severe fatigue in women. Balancing your hormones with Bioidentical Hormone Replacement Therapy gives you the energy you need to meet everyday responsibilities and enjoy satisfying relationships.
Cystitis, or bladder infections, occurs when bacteria from outside of the body enter through the urinary tract and cause an infection. Hormonal changes that begin in perimenopause may also cause recurring bladder infections. This is because the bladder, urethra, and vagina lose muscle tone and strength as levels of estrogen slowly decline. Fortunately, you can correct this imbalance by receiving Bioidentical Hormone Replacement Therapy. When the muscles near your bladder are stronger, it’s harder for bacteria to invade.
Uterine fibroids are masses of tissue that grow within the wall of your uterus, in it, or on it. It can result in irregular menstrual bleeding or uterine cancer in rare cases. Normally, estrogen stimulates cell growth in your body while progesterone balances it. Fibroids may be the result of unbalanced levels of estrogen, cortisol, xenoestrogens, and progesterone. Bringing all of these necessary hormones in balance with Bioidentical Hormone Replacement Therapy can help to reduce the risk of fibroids.
Insomnia, which is the consistent inability to fall or stay asleep, is both a cause and an effect of hormone imbalance. The hormonal changes of PMS, perimenopause, and menopause can all cause sleeplessness. Chronic insomnia can also make hormone imbalance worse. When your hormones are balanced through Bioidentical Hormone Replacement Therapy, it has a less inhibiting effect on your ability to fall asleep and stay asleep throughout the night.
IRRITABLE BOWEL SYNDROME
IBS is a term that describes pain with bowel movements, urge frequency, a feeling of incomplete bowel emptying, abdominal distension, and several other symptoms. Many women report worsening IBS symptoms just before their period starts. This may occur due to the fluctuation of estrogen and progesterone in the second half of the cycle. Having unbalanced levels of estrogen and progesterone can slow motility in the gut. However, balancing these hormones can greatly alleviate IBS.
LOW SEXUAL LIBIDO
Lack of desire for physical intimacy is due to an imbalance in the amounts of estrogen, progesterone, and testosterone in your body. When the latter two hormones start declining, it may cause estrogen dominance. This problem is also associated with weight gain, mood swings, and painful intercourse, all of which further decrease your libido. Balancing estrogen in your body so it doesn’t dominate other hormones is essential to restore your desire for sex.
Menopause is the clinical term for 12 consecutive months without a menstrual period. As you start menopause, your estrogen, progesterone, and testosterone hormones may fluctuate wildly. Although there are dozens of symptoms associated with menopause, the most common ones include hot flashes, night sweats, low libido, mood swings, and weight gain. Replacement therapy with Bioidentical Hormones can help eliminate or reduce multiple symptoms at the same time.
Although the average age of menopause is 51, you may begin perimenopause as early as your mid 30s. Common symptoms include breast tenderness, changes in the menstrual cycle, skin changes, sexual dysfunction, and loss of bone density. These problems occur due to decreasing levels of estrogen and other essential hormones as you age. If your blood work confirms hormonal imbalance, Bioidentical Hormone Replacement Therapy can help you feel more comfortable.
SYMPTOMS OF PRE-MENSTRUAL SYNDROME
In a normal menstrual cycle, estrogen rises for the first two weeks and then begins to fall. During the second half of the cycle, this process repeats itself with progesterone. If you’re highly sensitive to hormonal changes, you may experience worsening symptoms of PMS. Some of these include bloating, irritability, fatigue, tension, and weight gain. If your PMS symptoms are severe enough to interfere with your quality of life, consider Bioidentical Hormone Replacement Therapy with Doctor Robin A. Bernhoft.
You have a thyroid imbalance when your thyroid, which is a small nodule at the base of your neck, produces too little or too much of this hormone. When you go to a traditional doctor complaining of fatigue or difficulty losing weight, he or she may test your TSH level. However, this may not be enough to determine hormone imbalance. Robin A. Bernhoft, M.D. conducts several medical tests to see if you are a good candidate for Bioidentical Hormone Replacement Therapy.
Men’s Conditions Treated With Bioidentical Hormones
Robin A. Bernhoft, M.D. also specializes in Bioidentical Hormone Replacement Therapy for men, which includes addressing symptoms of hormonal imbalance and customizing individual treatment programs using Bioidentical Hormones. Robin A. Bernhoft, M.D. will apply the newest and most effective methods for restoring optimal hormone balance using Bioidentical Hormone Replacement Therapy. He offers medically supervised programs, which include the most advanced delivery methods to help bring hormone levels back into balance. His programs can also treat the symptoms of andropause, helping men regain their health and confidence. Some of the conditions Robin A. Bernhoft, M.D. uses Bioidentical Hormone Replacement Therapy to treat in men include:
Your adrenal glands release the hormone cortisol in response to stress, exercise, excitement, and low blood sugar. As you age, your body has a harder time balancing your cortisol levels. This can cause unrelenting fatigue, anxiety, sexual problems, and a wide range of other symptoms due to cortisol imbalance in your adrenal glands. Hormone restoration through Bioidentical Hormone Replacement Therapy can help speed up sluggish adrenal glands and provide you with more energy.
ALOPECIA (HAIR LOSS)
Dihydrotestosterone (DHT), which is part of the testosterone hormone, is responsible for hair loss on your scalp, face, chest, back, arms, legs, and groin area. When this hormone is unbalanced, it causes the follicles of your hair to regress and die. High levels of DHT can result in premature balding or thinning hair. If a full head of hair is important to you, remember that Bioidentical Hormone Replacement Therapy can stimulate hair growth.
By the time men reach age 70, they may have only 10 percent of the testosterone hormone they had at age 25. This explains why many men begin experiencing symptoms associated with low testosterone around age 40. Andropause is a term that describes the many physical and emotional changes that occur due to the imbalance of hormones. Testosterone replacement is essential to help you experience long-term symptom relief.
ANXIETY AND DEPRESSION
Low levels of testosterone cause an overall feeling of discontent in some men, which is the hallmark characteristic of hypogonadism. Balanced levels of this hormone are so essential that men with hypogonadism receive a diagnosis of clinical depression 400 times more often than men with normal hormone levels do. If you feel hopeless, low on energy, and irritable, ask Robin A. Bernhoft, M.D. to check your testosterone level. Bioidentical Hormone Replacement Therapy can help balance your hormones and improve your outlook on life.
When fatigue is chronic, you lack the energy to focus or keep up with everyday responsibilities. Declining levels of testosterone are often to blame for this problem. Chronic fatigue is also worsened by other symptoms of andropause, including night sweats, insomnia, sleep apnea, increased stress, and irritability. It’s important to note that all-day fatigue is different than feeling tired. Fortunately, balancing your testosterone and other hormones with Bioidentical Hormone Replacement Therapy helps to improve fatigue and all of its associated symptoms.
Cortisol, the stress hormone, can go into overdrive when you are under constant, unrelenting stress. This can cause daily headaches of varying intensity. The drop in testosterone starting at age 30 can also play a role in chronic headaches; Robin A. Bernhoft, M.D. can pinpoint an exact cause with a simple blood test. If your hormones are unbalanced, treatment with Bioidentical Hormone Replacement Therapy can help alleviate headache pain.
You have erectile dysfunction when you can’t get an erection at all or maintain one long enough for satisfying sexual activity. A diminished level of testosterone is the typical cause. This also happens when the brain fails to signal the release of nitrous oxide, which is responsible for blood flow to the penis. Too much of the stress hormone cortisol also plays a role in erectile dysfunction. Balancing testosterone and cortisol with Bioidentical Hormone Replacement Therapy can eliminate or improve this problem.
Gas, bloating, constipation, diarrhea, heartburn, belching, and slow digestion may all be related to imbalanced hormones in your body. Specifically, these problems could originate due to problems with normal thyroid functioning due to too much cortisol or estrogen. Many traditional doctors don’t treat digestion problems correctly because they don’t understand the connection to hormones. When diet, exercise, and medication aren’t working, consider replacing lost hormones through Bioidentical Hormone Replacement Therapy with Doctor Bernhoft.
Because testosterone normally replenishes itself while you are sleeping, struggling with insomnia lowers your testosterone production. This causes a vicious cycle because low testosterone levels cause many sleep disturbances, including insomnia and sleep apnea. While difficulty falling or staying asleep and decreased testosterone production are both normal signs of aging, you don’t have to allow them to affect your quality of life. Providing your body the testosterone it needs through Bioidentical Hormone Replacement Therapy can greatly improve restful sleep.
IRRITABLE BOWEL SYNDROME
Elevated stress levels and a weakened immune system can both cause IBS, which may present itself as abdominal pain, gas, bloating, or frequent diarrhea. In many cases, both stress and immune system deficiency are related to unbalanced levels of hormones. This can trigger an attack of IBS. Determining what triggers your symptoms, including certain foods and hormone imbalance, is the first step to helping you feel better. Bioidentical Hormone Replacement Therapy helps to balance the hormones responsible for triggering IBS symptoms.
The desire to have sex less often and erectile dysfunction are often related, but it’s possible to have one without the other. Testosterone stimulates the nerves in the brain to become sexually aroused, so this sensation naturally diminishes as you age. Smoking, drinking too much alcohol, and a poor diet are additional reasons your libido may be low. When combined with a healthy lifestyle, therapy with Bioidentical Hormones helps to improve your sexual desire and functioning.
Low testosterone, which your doctor may also refer to as male menopause, hypogonadism, or andropause, is the term used to describe the multitude of symptoms many men experience as they approach middle age. Your testosterone production actually starts declining one percent every year at age 30. Sexual dysfunction, mood problems, weight gain, and low energy are common problems associated with low testosterone that are correctable with Bioidentical Hormone Replacement Therapy.
Low thyroid levels in men can cause cold intolerance, fatigue, hair loss, weight gain, dry skin, and constipation; as many as one in seven men struggle with hypothyroidism. When the thyroid produces an excess of hormones, hyperthyroidism is the result. This condition has many additional symptoms, including muscle weakness, trembling hands, insomnia, and heart palpitations. Having your thyroid level checked by a hormone specialist such as Robin A. Bernhoft, M.D. and completing Bioidentical Hormone Replacement Therapy are essential to help you feel better.
Ojai, California Bioidentical Hormone Replacement Therapy specialist, Robin A. Bernhoft, M.D. at the Bernhoft Center for Advanced Medicine has helped countless men and women to overcome conditions related to hormonal imbalance or decline. Before beginning a Bioidentical Hormone Replacement Therapy program, Robin A. Bernhoft, M.D. tests the levels of all essential hormones in order to get to the root of patients’ imbalances. He then designs a personalized program using dosages that are unique to each patient. Vast numbers of men and women have been able to achieve peak levels of health with Doctor Bernhoft’s specialized Bioidentical Hormone Replacement Therapy programs.
Yes, I did try to find evidence for these claims. It’s a big job and a frustrating one too, as I was less than successful.
In this RCT tested the effectiveness of foot reflexology and slow stroke back massage on the severity of fatigue in 52 patients treated with hemodialysis. Foot massage and slow stroke back massage were performed during three weeks, two sessions each week, 5 sessions in total. At the end of intervention, data of two groups were collected and compared.
The results show that the fatigue in the group receiving foot reflexology massage decreased significantly more compared to slow stroke back massage group.
The authors concluded that reflexology massage is a safe and economical nursing intervention for decreasing fatigue in hemodialysis patients.
At first glance, this might be a fairly straight forward study comparing two different interventions. One treatment yields better results than the other one, and therefore, this therapy is deemed to be the more effective one.
So far, so good.
The problem is, however, that the authors did not draw the conclusion. Instead they stated that:
- Reflexology is safe.
- Reflexology is economical.
The first point is perhaps true but cannot be concluded from the data presented. Adverse effects were not mentioned; and even if they had been noted, 52 patients is a wholly inadequate size to say anything about safety.
The second point might also be correct, but cannot be named as a conclusion, because the study was not a cost evaluation.
All of this would be hardly worth mentioning – except for the fact that such sloppy errors and illogical conclusions happen with such embarrassing regularity in the realm of alternative medicine. I feel strongly that the ‘Journal of Complementary and Integrative Medicine‘ and all similar publications must get their act together. Publishing articles such as the one discussed here only makes them the laughing stock of real scientists.
Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients, and it is a symptom that is often difficult to treat. As always in such a situation, there are lots of alternative therapies on offer. Yet the evidence for most is flimsy, to put it mildly.
But perhaps there is hope? The very first RCT with a 2016 date to be reviewed on this blog investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.
Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.
Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.
The authors concluded that ‘IP may control moderate-severe CRF in breast cancer patients.’
The website of the manufacturer provides the following information on IP:
Inner Power is a functional food that provides various nutrients, such as zinc and copper. Zinc is a nutrient that your body needs to maintain your sense of taste. Zinc is also vital in keeping the skin and mucous membranes healthy and in regulating metabolism of proteins and nucleic acids. Copper helps the body form red blood cells and bones and regulates many enzymes that are found in the body. One pouch of Inner Power each day is the recommended daily serving.
- Consuming a large amount of the product will not cure any underlying disease or improve your health condition.
- Do not consume too much of the product because excessive zinc intake may inhibit the absorption of copper.
- Observe the recommended daily serving of the product. This product should not be given to infants or children.
The recommended daily serving of the product (1 pouch/day) contains 43% of the reference daily intake of zinc and 50% of the reference daily intake of copper. Inner Power is neither categorized as a food for special dietary use nor approved individually by the Ministry of Health, Labour, and Welfare. You should eat well-balanced meals consisting of staple foods, including a main dish and side dishes.
I cannot say that this inspires me with confidence.
What about the trial itself?
To be honest, I am not impressed. The most obvious flaw is, I think, that there was not the slightest attempt to control for placebo effects. As I pointed out so many times before: with the ‘A+B versus B’ design, one can make any old placebo appear to be effective.
Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by Borrelia infection transmitted by ticks. The most common early sign is an expanding area of redness beginning at the site of a bite about a week after a tick-bite. Fever, tiredness and headaches often follow. Later stages are characterised by more severe and remarkably variable illness.
Patients with medically unexplained or vague symptoms are sometimes told that they suffer from Lyme disease. These patients are commonly targeted by providers of alternative therapies who promise hope by claiming that their particular brand of quackery is effective for this chronic condition.
A recent review was designed to identify and characterize the range of unorthodox alternative therapies advertised to patients with a diagnosis of Lyme disease.
Internet searches using the Google search engine were performed to identify the websites of clinics and services that marketed non-antimicrobial therapies for Lyme disease. Subsequently the PubMed search engine was employed to identify any scientific studies evaluating such treatments for Lyme disease. Websites were included in this review, if they advertised a commercial, non-antimicrobial product or service that specifically mentioned utility for Lyme disease. Websites with patient testimonials (such as discussion groups) were excluded unless the testimonial appeared as marketing on a commercial site.
More than 30 different alternative treatments were identified. They fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapies; chelation and heavy metal therapies; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. The review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.
The authors concluded that providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.
Being a bacterial infection, Lyme disease can be successfully treated with oral or intra-venous antibiotics. But, of course, patients need to have the infection in order to benefit from antibiotic treatment. Those patients who don’t are easy targets for charlatans promising help from bogus treatments. It seems that an entire, profitable industry has developed around this situation.
I regularly used to ask alternative practitioners what diseases they are good at treating. In fact, we once ran an entire research project dedicated to this question and found that their own impressions were generally based on wishful thinking rather than on evidence. The libel case of the BCA versus Simon Singh then brought this issue into the focus of the public eye, and consequently several professional organisations of alternative practitioners seem to have advised their members to be cautious about making unsubstantiated therapeutic claims. This could have been an important step into the right direction – unless, of course, a clever trick had not been devised to bypass the need for evidence. Today, when I ask alternative practitioners ‘what do you treat effectively?’ I tend to get answers like:
- Alternative practitioners, unlike conventional clinicians, do not treat diseases.
- I treat the whole person, not just the disease.
- I treat people and their specific set of signs and symptoms, rather than disease labels (this actually is a quote from the comments section of one of my recent posts).
- I focus on the totality of the symptoms; disease labels are irrelevant in the realm of my therapy.
- Chiropractors adjust subluxations which are the root cause for most diseases.
- Acupuncturists re-balance life energies which is a precondition for healing to commence irrespective of the disease.
- Homeopaths treat the totality of symptoms so that the patient’s vital force can do the healing.
- etc. etc.
All of these statements are deeply rooted in the long obsolete notions of vitalism, i.e. the assumption that a vital energy flows in all living organisms and is responsible for our health irrespective of the disease we happen to suffer from. But what do the answers to my question ‘what do you treat?’ really mean? If we analyse the above responses critically, they seem to imply that:
- Conventional clinicians do not treat patients but merely disease labels.
- Alternative practitioners can successfully treat any disease or condition.
Ad 1 In my view, it is arrogant and grossly unfair to claim that alternative practitioners work holistically, while conventional health care professionals do not. I have pointed out repeatedly that any good medicine always has been and always will be holistic. High-jacking holism as a specific characteristic for alternative medicine is misleading and an insult to all conventional clinicians who do their best to practice good medicine.
Ad 2 By claiming that they treat the whole person irrespective of her disease, alternative practitioners effectively try to give themselves a ‘carte blanche’ for treating any disease or any condition or any symptom. If a child has asthma, a chiropractor will find a subluxation, adjust it with spinal manipulation, and claim that the child’s condition will improve as a consequence of his treatment – NEVER MIND THE EVIDENCE. If a person wants to give up smoking, an acupuncturist will use acupuncture to re-balance her yin and yang claiming that this intervention will make smoking cessation more successful – NEVER MIND THE EVIDENCE. If a patient suffers from cancer, a homeopath might find a remedy that promotes her vital energy claiming that the cancer will subsequently be cured – NEVER MIND THE EVIDENCE which in all of the three cases is negative.
The claim of alternative practitioners to not treat disease labels but the whole patient is doubtlessly attractive to consumers and it is also extremely good for business. On closer inspection, however, it turns out to be a distraction from the fact that alternative practitioners treat everything and anything, usually without the slightest evidence that their interventions generates more good than harm. It allows alternative practitioners to live in a fool’s paradise of quackery where they believe themselves to be protected from any challenges and demands for evidence.
Many cancer patients will suffer from severe, debilitating fatigue during the course of their illness. The exact cause of this common symptom is not entirely clear. Most likely it is due to a combination of the cancer and the treatments used to cure it. Managing cancer-related fatigue (CRF) is thus an important part of the palliative and supportive care of cancer patients. Acupuncture is often advocated for this purpose and many centres use it routinely. The question therefore is, does it work?
The most recent trial on this subject was aimed at assessing the effectiveness of maintenance acupuncture in the management of CRF; acupuncture or self-acupuncture/self-needling was compared with no such treatment. Breast cancer patients who previously had received acupuncture were randomized to have 4 acupuncturist-delivered weekly sessions, 4 self-administered weekly acupuncture sessions (self-needling); or no acupuncture at all. The primary outcome-measure was general fatigue, while mood, quality of life and safety served as secondary endpoints. In total, 197 patients were randomized: 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. The results failed to demonstrate significant inter-group differences in any of the parameters evaluated. The authors concluded that “maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture“.
But this is just one single of several available studies. Acupuncture-fans might suspect me of cherry-picking a largely negative study. If we want a fair verdict, we must consider the totality of the evidence. The aim of our systematic review was therefore to critically evaluate the effectiveness of acupuncture (AT) for CRF based on all the trial data available to us.
Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of them showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs failed to demonstrate an effect of AT over sham treatment.
Our conclusion had to be cautious: “Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT or nonspecific effects of care. Further research is required to investigate whether AT demonstrates specific effects on CRF”
There will, of course, be those who claim that no trial evidence is needed in this case; if a cancer-patient benefits from the treatment, she should have it regardless of whether it works as a placebo or has effects beyond that. I do sympathize with this attitude but should point out that there are a number of points to consider when making it:
2) There are other treatments against CRF; if we blindly advocate acupuncture, we might not offer the best option to our patients.
3) If we spend our limited resources on acupuncture, we might not afford treatments which are more effective.
4) If we are happy using acupuncture because it conveys a sizable placebo-effect, how will we make progress in finding treatments that are more effective?
It is therefore difficult to decide whether or not to recommend acupuncture for CRF. There are some arguments for both sides. Skeptics or critical thinkers or clinicians adhering to the principles of evidence-based medicine are unlikely to condone it, and some people might accuse them for cruelly and heartlessly denying severely ill patients help which they so badly need. Personally, I fail to see what is cruel or heartless in insisting that these patients receive the treatment which demonstrably works best – and that does not seem to be acupuncture.