Insomnia is a ‘gold standard’ indication for alternative therapies of all types. In fact, it is difficult to find a single of these treatments that are not being touted for this indication. Consequently, it has become a nice little earner for alternative therapists (hence ‘gold standard’).
But how good is the evidence suggesting that any alternative therapy is effective for insomnia?
Whenever I have discussed this issue on my blog, the conclusion was that the evidence is less than convincing or even negative. Similarly, whenever I conducted proper systematic reviews in this area, the evidence turned out to be weak or negative. Here are four of the conclusions we drew at the time:
- The evidence for acupuncture as a treatment of insomnia is plagued by important limitations, e.g. the poor quality of most primary studies and some systematic reviews. Those that are sensitive to such limitations, fail to arrive at a positive verdict about the effectiveness of acupuncture.
- We conclude that, because of the paucity and of the poor quality of the data, the evidence for the effectiveness of auricular acupuncture for the symptomatic treatment of insomnia is limited. Further, rigorously designed trials are warranted to confirm these results.
- The evidence for valerian as a treatment for insomnia is inconclusive.
- Evidence from RCTs does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders. (FACT, 2011, 16:195-99)
“But this ERNST fellow cannot be trusted, he is not objective!”, I hear some of my detractors shout.
But is he really?
Would an independent, high-level panel of experts arrive at more positive conclusions?
Let’s find out!
This European guideline for the diagnosis and treatment of insomnia recently provided recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations.
The findings and recommendations are as follows:
- Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence).
- A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence).
- Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence).
- Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).
I think, I can rest my case.
Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?
A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.
The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.
The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.
Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).
Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:
- Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
- The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
- The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
- It seems uncertain which essential oil is best suited for this indication.
- Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
- There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.
All in all, I think stronger evidence is required that aromatherapy is more that pampering.
According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.
In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.
Nelson’s homeopathic pharmacy has a proud history:
Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”
The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”
A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).
The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.
The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.
We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.
Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).
The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.
I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:
Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.
Bach Flower Remedies have no effect whatsoever!
Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.
Poor sleep quality during pregnancy is a frequent problem. Drug treatment can be problematic due to possible adverse effects for mother and embryo/foetus. Many pregnant women prefer natural treatments and assume that ‘natural’ equals harmless.
In the present study, the sedative effects of Bryophyllum pinnatum were investigated. This remedy is a phytotherapeutic medication predominantly used in anthroposophic medicine. In previous clinical studies on its tocolytic effect, B. pinnatum showed a promising risk/benefit ratio for mother and child. A recent analysis of the prescribing pattern for B. pinnatum in a network of anthroposophic physicians revealed sleep disorders as one of the most frequent diagnosis.
In this prospective, multi-centre, observational study, pregnant women suffering from sleep problems were treated with B. pinnatum (350mg tablets, 50% leaf press juice, Weleda AG, Arlesheim, dosage at physician’s consideration). Sleep quality, daily sleepiness and fatigue were assessed with the aid of standardised questionnaires, at the beginning of the treatment and after 2 weeks. Possible adverse effects perceived by the patients during the treatment were recorded.
The results show that the number of wake-ups, as well as the subjective quality of sleep was significantly improved at the end of the treatment with B. pinnatum. The Epworth Sleeping Scale decreased, indicating a reduction in tiredness during the day. There was, however, no evidence for a prolongation of the sleep duration, reduction in the time to fall asleep, as well as change in the Fatigue Severity Scale after B. pinnatum. No serious adverse drug reactions were detected.
From these data, the authors concluded that B. pinnatum is a suitable treatment of sleep problems in pregnancy. The data of this study encourage further clinical investigations on the use of B. pinnatum in sleep disorders.
Clinical trials of anthroposophic remedies, i.e. remedies which are based on the school of medicine founded by Rudolf Steiner, are very rare. Therefore this trial could be important.
B. pinnatum is a plant used in traditional Tai medicine against hypertension, and to some extend this makes sense: it contains cardiac glycosides which might help lowering elevated blood pressure. The reason for its use as a hypnotic, however, is not clear.
So, is B pinnatum really a ‘suitable treatment of sleep problems in pregnancy’? I doubt it for the following reasons:
- the effects documented in this study are far from convincing,
- we would need much more solid data to issue such a general recommendation,
- cardiac glycosides can cause very serious adverse effects,
- the sample size of the study is at least one dimension too small for assuming that it is safe,
- we know nothing about its potential to cause harm to the foetus.
Personally, I find it irresponsible to draw conclusions such as the ones above on the basis of data which are flimsy to the extreme. I ask myself, to what extend wishful thinking might be a regrettable characteristic for the entire field of anthroposophic medicine.
Since weeks I have been searching for new (2013) studies which actually report POSITIVE results. I like good news as much as the next man but, in my line of business, it seems awfully hard to come by. Therefore I am all the more delighted to present these two new articles to my readers.
The first study is a randomized trial with patients suffering from metastatic cancer who received one of three interventions: massage therapy, no-touch intervention or usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. The mean number of massage therapy sessions per patient was 2.8.
The results show significant improvement in the quality of life of the patients who received massage therapy after 1-week follow-up which was not observed in either of the other groups. Unfortunately, the difference was not sustained at 1 month. There were also trends towards improvement in pain and sleep of the patients after massage. No serious adverse events were noted.
The authors conclude that “providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings“.
The second study examined the effectiveness of a back massage for improving sleep quality in 60 postpartum women suffering from poor sleep. They were randomized to either the intervention or the control group. Participants in both groups received the same care except for the back massages. The intervention group received one 20-minutes back massage at the same time each evening for 5 consecutive days by a certified massage therapist. The outcome measure was the Pittsburgh Sleep Quality Index (PSQI). The results showed that the changes in mean PSQI were significantly lower in the intervention group than in controls indicating a positive effect of massage on sleep quality.
The authors’ conclusions were clear: “an intervention involving back massage in the postnatal period significantly improved the quality of sleep.”
Where I was trained (Germany), massage is not deemed to be an alternative but an entirely mainstream treatment. Despite this fact, there is precious little evidence to demonstrate that it is effective. Our own research has found encouraging evidence for a range of conditions, including autism, cancer palliation, constipation, DOMS and back pain. In addition, we have shown that massage is not entirely free of risks but that its potential for harm is very low (some might say that this was never in question but it is good to have a bit more solid evidence).
The new studies are, of course, not without flaws; this can hardly be expected in an area where logistical, financial and methodological problems abound. The fact that there are many different approaches to massage does not make things easier either. The new evidence is nevertheless encouraging and seems to suggest that massage has relaxing effects which are clinically relevant. In my view, massage is a therapy worth considering for more rigorous research.