Controversy continues over whether or not there is any real effect from acupuncture over and above that of placebo. However, this series of case studies may provide us with evidence from an unlikely source. Anticipation of clinical benefit is a major element of placebo, and clearly cognition is needed to experience this. This raises the question of how much placebo effect is experienced by a patient with dementia. These cases document reliably witnessed responses to acupuncture in patients with impaired cognition, which have been reproducible and maintained. Given the similarity of responses, it could be argued that these reports provide evidence of a ‘real’ effect of acupuncture, and raise the possibility of including patients with dementia in formal studies from which they might routinely be excluded.
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A controversy continues to rage over whether or not there is any real effect from acupuncture over and above that of placebo. Anticipation of benefit is a major element of placebo and clearly depends on intact cognition. We report three cases in which patients with dementia showed clear, sustained benefits from acupuncture, clearly temporally related to treatment, despite being unaware of receiving the treatment.
Three cases of apparently successful treatment responses in patients with dementia were identified serendipitously by British Medical Acupuncture Society members (NW, DL and PD). The cases were identified retrospectively through communications between the practitioners at academic meetings. No attempts have been made to actively identify further cases. The cases are individually described below.
The patient was a 77-year-old woman with a 42-month history of right-sided trochanteric bursitis. She had been under the care of a private orthopaedic surgeon and treated with five steroid injections over 2 years, resulting in only temporary relief of her symptoms. Her medical history of gastro-oesophageal reflux, resulting in intermittent episodes of iron deficiency anaemia, made the use of anti-inflammatory drugs problematic. She also had senile dementia, treated with donepezil, and had been noted to have had worsening of her cognitive function when treated with tramadol previously.
She was referred for consideration of acupuncture due to these difficulties and seen in January 2008 with her husband, who had power of attorney and was able to consent on her behalf. At this time, her Mini-Mental State Examination score was noted to be 17/30 and she was not taking any analgesics. She co-operated with an initial treatment, in the left lateral position. A 75 mm needle was used to dry needle to a depth of approximately 50 mm at GB30 and a 25 mm needle to a depth of 10 mm at a tender point over the right greater trochanter for 5–10 min. De qi was not elicited and no additional stimulation was performed. After the treatment, she moved from the bed and asked what was going to be done to her!
Then 3 weeks later, a letter was received from the husband expressing his gratitude for the treatment and saying that his wife remained pain free.
In April 2008, the patient presented again with increasing ‘niggling’ pains in her hip. She was unable to recall the previous treatment but was happy for it to be repeated, as above. This was the last treatment given, with no further attendances documented for pain management and no recorded worsening of her dementia, until her death in December 2010.
This patient was an 86-year-old woman who lived in a nursing home, seen in January 2011, with her daughter. There was a 6-month history of numbness and weakness in her right arm and hand, such that she was unable to hold a cup or grip her Zimmer frame. This resulted in several tea scalds and immobility. She had a 10-year history of Alzheimer's disease. It was difficult to elicit a clear history due to her cognitive impairment, but a diagnosis of a neural origin for her pain was made and a trial of acupuncture treatment, with family consent, was agreed. At her first treatment the patient was friendly but confused. She had spasm of trapezius on the right side and her C5–C6 facet joint appeared tight, although assessment was difficult due to her frailty and cognition.
Points BL10, GB21 and PC6 were selected, on the right side, and needled using 25 mm×0.30 mm needles for 10 min. De qi sensation was not apparent due to her mental state; she did not know she was being treated. The rationale was ease of access, with a range of local and classical pain points. This treatment was viewed as a therapeutic trial and the daughter given realistic expectations regarding outcome.
The patient was seen a week later when her daughter reported that her mother had not experienced symptoms in her hand for 3 days but the weakness in her grip was still present. The above treatment was repeated with total needle retention time 17 minutes for second treatment.
A review 10 days later revealed a huge improvement reported by nursing staff and her daughter. She was able to dress herself, hold her cup of tea and was mobilising with her Zimmer frame. The same treatment was repeated.
At 2 weeks later she was apparently symptom free, had not complained about her arm and had forgotten ever having a problem with it. She was treated again, with her daughter asked to report if the symptoms returned. In November 2012, her granddaughter reported that the symptoms never returned for her grandmother.
This patient was a 74-year-old woman with a history of severe bilateral osteoarthritis in her knees. As a result she was unable to manage the stairs or walk independently. She was seen at home in August 2001 at the request of her daughter, asking if acupuncture could help her. She had been diagnosed as having senile dementia in 1999, with documented scald injuries, requiring A/E attendance in 2000, as a result of her deteriorating mental state.
In August 2001, the after-hours service was contacted and advice given with respect to complaints of knee pain. It was noted that she was ‘crying in a lot of pain’ and ‘knee swollen and in pain’.
When visited she had been given cocodamol 8/500; she was on no other medication and was physically well. She was cooperative, did not recognise the attending general practitioner (GP) (PD) though he was known to her and her daughter was present.
On examination there was some tenderness around both knees with a mild effusion of the right knee. There was no abnormal warmth or redness.
Treatment with acupuncture was given to both knees at SP9, SP10, ST36 and GB34 for 20 min using 30 mm×0.25 mm needles to a depth of about 20 mm. De qi sensation was not apparent. She seemed unaware of the treatment, making repeated attempts to brush the needles away saying they were threads.
She was seen a month later, at her daughter's request. She had been able to walk independently, climbing up and down stairs for at least 3 weeks following the initial treatment, with no significant pain.
Treatment was repeated as above with a similar positive outcome reported by the daughter. Further acupuncture treatment was offered, but not subsequently requested.
A review of her case in 2012 revealed that she had remained mobile until a fractured neck of femur in 2002, regaining her mobility until she sustained a fractured distal radius falling from a ladder in 2010. No further treatment for knee osteoarthritis was documented.
These cases document reliably witnessed responses to acupuncture in patients with impaired cognition, which have been reproducible and maintained. Given the spontaneous identification of the cases and similarity of responses it could be argued that these reports provide evidence of a ‘real’ effect of acupuncture.
A large systematic review of 13 3-armed trials by Madsen et al1 covering over 3000 patients concluded that there was a small clinically irrelevant difference between real and placebo acupuncture (sham acupuncture) and suggested that the statistically significant needling effect could be attributed entirely to bias. This is disappointing, especially as in the current climate of evidence-based medicine, proof of a clinically relevant specific effect is becoming more important in order to commission new treatments. Given the difficulties in conducting and interpreting the outcomes of double-blind controlled trials in acupuncture the case studies reported above may provide us with evidence from an unlikely source.
The evidence produced by case reports is limited in its ability to demonstrate effectiveness of interventions in practice. There is no control for chance or natural history, and clear potential for selection and reporter biases.
There is very little published literature relating to the use of acupuncture for treatment of comorbidities in patients with dementia, or the placebo response in this group.
The placebo effect is a combination of conscious (anticipation of benefit) and unconscious (classical conditioning) responses resulting in a physiological response releasing various chemicals into the central nervous system, including serotonin, dopamine and opioids.2
Anticipation of benefit is a major element of placebo, and clearly cognition is needed to experience this. Neuroimagining was used by Pariente et al3 to show opioid release in the brain in response to expectation of effect and as a specific effect of acupuncture. This raises the question of which has the greatest clinical effect in a patient with dementia, and therefore limited expectation. It could be argued that in these circumstances the opioid release was solely due to the active treatment. Further evidence that the placebo response in dementia is limited or absent was provided by Benedetti et al.4
The impact of classical conditioning after repeated treatments could be argued to still occur, but would not be a factor in explaining the long-term benefits reported and is dependent on functioning short-term and long-term memory, which is clearly compromised in this group.
A series of papers5–7 looked at eliminating the psychosocial context in assessing the effect of various analgesics. Elimination of this context could be seen as a similar state experienced by patients with dementia. It concluded that all treatment, of which patients are aware, have a degree of placebo and if awareness is eliminated the analgesic effect is reduced.
Benedetti4 went on to specifically look at the implications of this in patients with dementia, comparing analgesic response in dementia and in normal subjects. He showed a reduction in overall analgesia due to limited placebo or psychosocial response in this group (figure 1).
A review paper by Benedetti et al2 subsequently concluded that ‘if prefrontal functioning is impaired, placebo responses are reduced or totally lacking, as occurs in dementia’. This is supported by Thompson et al8 in a neuroimaging study that demonstrated an overlap between the parts of the brain affected by dementia and the placebo response. This adds further evidence to the disappearance of placebo responses in dementia.
Possible explanations for the lack of published work in this area could relate to either problems with consent or validity of reported outcomes. Good clinical practice in research9 helps to overcome issues with informed consent; problems around measurement of effect through self-report or proxy reporting could be more complex. Placebo by proxy, as discussed by Grelotti et al,10 would need to be considered when assessing outcomes in this group.
These case reports and the evidence cited produce a strong argument for lack of placebo responses in this patient group. The biggest criticism of complementary therapies is that they only work through placebo mechanisms, so demonstration of effects in the absence of a placebo response would make a strong argument for real effects of treatment. Including patients with dementia in more formal prospective studies of acupuncture, from which they may routinely be excluded, may provide us with a way forward to demonstrate the acupuncture effect, in the absence of placebo responses.
This series of cases arose from a case study performed as part of the MSc in Western Medical Acupuncture at the University of Hertfordshire. Thanks to Mike Cummings for putting NW in touch with PD and DL to complete the case series with similar patient experiences and editorial assistance
Contributors DL and PD contributed case studies 2 and 3.
Competing interests None.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
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