Background

Depression is projected to become the second leading contributor to the global burden of disease by 2020 affecting about 121 million people worldwide (WHO 2006). Depression is an unfortunately common condition for which people often seek alternative treatment (Eisenberg et al 1993). Conventional treatments for depression, such as counselling, psychology and pharmacotherapy provide significant relief when patients complete their treatment. Such treatments are not always effective for all the depressed persons and acupuncture could serve as an adjunct to or substitution for the existing treatments, or as a means of maintaining health or preventing recurrence after remission. It is therefore important to map acupuncture’s strength and weakness to assess efficacy of this alternative treatment.

Research Question

Therefore, the following question arises:

Is acupuncture effective for depression? An in-depth critical appraisal of literature was undertaken to examine the strength of the evidence for and against the effectiveness of acupuncture as a treatment for depression.

Terminology

Depression is a common and potentially disabling disorder that is characterized by chronicity and recurrence (Hirschfield et al 1994). In clinical depression, people report a lack of interest in life and activities, which they used to enjoy. Contemporary Western psychiatry defines major depression as a persisting pattern of severe depressive episodes, with an episode defined as a severely depressed mood for at least two weeks, accompanied by a few additional symptoms including: changes in appetite, sleep disturbance, hypersomnia, weight loss or gain, fatigue, feelings of worthlessness or guilt, difficulty thinking, suicidal thoughts (Flaw et al 2001).

Historically, depression as a disease entity and psychology as a field of study have not existed in Chinese medicine. Traditional acupuncture practice is based on the concept of a vital force of energy (Qi), following around the body along the pathways (meridians). Stimulating the acupuncture points is considered to balance the opposite energy (yin and yang), ensure the energy flow and thus maintain or restore health. Diagnosis relies on the assessment of symptom and signs, including checking tongue, pulse, palpation and asking questions to formulate an individualised treatment regime.

In general, low moods and feeling anxious is considered to reflect a disruption of flow of qi, correction of which depends on a range of factors, thus, patients with conventional diagnosis of depression may be diagnosed with different syndromes and differentiations. Acupuncture treatment not only involves needles but also non- needles treatment like cupping, moxbustion and acupressure massage.

Even though there has never been a consistent and agreed framework for the practice of acupuncture, modern Chinese medical practitioners are able to understand and approach psychiatric disease classification such as major depression and create different diagnostic techniques with personal adaptions to fit the patient’s life experience and temperament.

Method of Literature Searching

Searches were made of Medline, Amed, books and journals. The following key words were used for the Amed and Medline research: “depression” “anxiety” “effective” “bipolar” “mental disorder”, plus “acupuncture”. In order to reflect most recent and current practices, only publications from the last 13 years were chosen for review, all literatures are in English or Chinese.

Method Research

Hugh et al (2007) stated that systematic reviews are clearly the best tools to summarise the available evidence on defined research question. Hugh et al (2007). Most available systematic reviews in acupuncture have focused on treatment effects investigated in randomised trials including Allen et al (1998), Allen et al (2006), Whiting et al (2008), Quash Smith et al (2005), Erich et al (2000), Roschke et al (2000), Zhang et al (2003), Shen et al (2005),Wenbin (2002), Fu et al (2002), Wang et al (2006) and Cheng et al (2007). Of 12 papers reviewed, 6 researches were conducted in China and 6 in Western societies. The reviews mainly used specific acupuncture, non-specific acupuncture, waiting list, sham acupuncture, laser acupuncture, acupuncture with antidepressants and acupuncture with psychotherapy interventions. But in Western research mainly used the first 5 interventions. While hundreds of randomised clinical trials and thousands of science of studies of acupuncture have been conducted, results are often equivocal and many challenges remain (Hugh et al 2007)

A single blind randomised controlled trial was conducted to establish whether acupuncture is effective for depression (Allen et al 1998). Three interventions were chosen such as specific acupuncture, non-specific acupuncture and waiting list control. 38 women aged from 18-45 were randomly allocated for 8 weeks treatment, each received two sessions a week for the first four weeks, followed by one session a week thereafter. The group receiving specific acupuncture responded significantly more successfully than the non-specific group. 50% of the specific group experienced remission following an eight -week intervention; whereas only 27% of the non-specific experienced remission. The author did not supply information on the waiting list group.

Several years later, a double blind randomised research was conducted by the nearly same team (Allen et al 2006) using the same interventions (specific acupuncture, non specific acupuncture and waiting list). 157 participants were recruited from the community and these were randomised into three groups. The specific acupuncture group received individual TCM treatment; the non-specific group using a comparable number of points but not specifically targeted to depressive symptom; the waiting-list condition involves waiting intervention for 8 weeks. After 8 weeks, all groups received the depression-specific acupuncture. Twenty patients terminated treatment before the completion of the 8 weeks intervention. The primary outcome was measured by the 17-item Hamilton rating scale. Response rates in acupuncture-treated patients were relatively low after 8 weeks. Specific group was 22% and 39% respectively, but the response rate reached an average 50% after 16 weeks (the specific intervention 36%, the non-specific intervention 51% and the waiting-list 62%) the remission rates for specific acupuncture, non-specific and waiting-list was 26%, 39% and 52% respectively. From the author’s conclusion, TCM manual acupuncture failed to support its efficacy as a monotherapy for major depression disorder.

So in two researches the same team achieved very different results. The sample size in the earlier study was relatively small and all the participants were all women it is therefore difficult to relate the findings to the general population. The sample size in the second study is large and the study design was improved. However, as the author mentions the outcomes could still be affected by the practitioners’ needle points selection and needle stimulation and these factors are attributable to training, style of intervention, experience and personal preference. The lack of a naturalistic setting could also affect the research outcome. As Hugh, et al (2007) said, to prevent bias acupuncture trials should involve randomisation and blind of practitioners, outcome assessors or analysts.

70 patients with major depression were randomly allocated in a trial conducted in Germany (Roschke et al 2000). Verum acupuncture, placebo acupuncture and control group were applied for the trial. All three groups were also pharmacologically treated with the antidepressant Mainserin. Acupuncture was given three times a week over a period of 4 weeks. The result showed that patient who experienced Mianserin with verum acupuncture improved slightly more than the control patients but there was no difference between the verum and placebo acupuncture groups.

The most recent analysis of the evidence on acupuncture in depression is that provided by the updated Cochrane review published in 2010 (Smith et al 2010). Thirty trials were allocated including trials in treating post stroke depression. It was concluded by the author that there was insufficient evidence to recommend the use of acupuncture for depression because of the high risk of bias in the most of trials.

The majority of trials published since 2000 have been conducted in China comparing acupuncture against antidepressants. The number of subjects studied ranged from 45 to 440, but most were relatively small with less than 100 participants who were mainly recruited from local hospitals. Acupuncture treatment varied from 4 to 6 weeks in duration and the number of sessions of treatment ranged from 10 to 40. The trials mainly used manual acupuncture and electro-acupuncture to compare antidepressants such as paxoxetime, amtriptyline, fluoxetine. The acupressure points were chosen from body, scalp and ear. The most used points are Bai hui (Du20), Yingtang (Ex-HN3), Taichong (Liv-3) Shengmen (HT7).

Zhang et al (2003) was a randomised trial of 460 participants receiving electro-acupuncture or medication (Amitripty line): participants recruited to the trials from in and out patients from Sichuan province, China. The age range was from 12 to 50 years old. The duration of depression was from 6 months to 4 years. Two groups of acupressure points were used alternatively. Treatment was given 6 out of 7 days. For the medication group, amitrityline was given at 25 mg three times a day in the first week, followed by 150 mg day over 3 weeks. All patients received three weeks of psychological treatments. The result showed that acupuncture was more effective than anti-depressant medication.

Wenbin (2002) randomised controlled trials of acupuncture versus medication (fluoxetine hydrochloride). Sixty-two participants were recruited to the trial with depressive psychosis from the in and out patient department of the second clinical medical college of Guangzhou university of TCM, China. Participants were aged from 19 to 51 years old with duration of depression from six months to six and half years. Participants received acupuncture based on the traditional TCM, syndrome differentiation. The main syndromes were diagnosed as heat and spleen deficiency; spleen and kidney yang deficiency and disorder of the chong and Ren meridians . Needles remained for 30 minutes each time. Acupuncture was administered daily for 8 weeks.

The control group was administered fluoxetine hydrochloride 20 mg per day for 8 weeks. A score of cured was defined as greater than 75% improvement. Reduction in symptoms was described as the difference before and after treatment at 8 weeks.

Clinical studies from China reported almost exclusively very positive results and this raises serious doubts about validity (Vickers et al 1998). Like other Asian countries, in China, acupuncture was not only socially and politically accepted, but also government supported and sanctioned as part of the solution to a massive public health crisis. As a result of this public health role most research on acupuncture was not focussed on trying to prove that it works but rather on how to promote it as part of the whole field of TCM. According to Hugh et al (2007) the acupuncture research in China was conducted partly for internal political consumption, it was also intended to show the West something of development of China, both modern and traditional.

Of 12 paper reviewed, only Allen et al (2006) and Whiting et al (2008) were double blind, Quash Smith et al (2005), Erich et al (2000), Roschk et al (2000), Allen et al (1998) Zhang et al (2007) and Shen et al (2005) were all single blind. It is unclear whether the 4 research trials conducted in China were blind. As Ann (2002) said, if the patient in a clinical trial is aware that he or she is receiving a new treatment there will be a psychological benefit, which affects his or her response. Ideally then each participant is “blind” and none of the directly involved parties knows which group the study members have been allocated to (study or control) in order to eliminate bias from assessment.

As White et al (2007) noted one of the greatest problems facing clinical trials of acupuncture historically has been the determination of the sample size. The debate over how to choose the proper sample size for a pilot acupuncture study is still ongoing. Most studies have had less than 80 participant and the only large scale studies are Allen et al (2006), Shen et al (2005) and Fu et al (2002) where the sample sizes were 460, 256 and 440 respectively.

Sample attrition refers to the loss of sample members before the post-test phases, which can be a serious problem in the analysis of data from experiments. The similarity of experimental and control groups maybe weakened if sample members drop potentially reducing the study’s external validity (generalisability) out of the study before the post tests, which affects the comparability of the group. Hence the outcome of the trial may be biased (Ann 2002). Wenbin (2002), unlike the other studies did not supply any information on dropped samples.

None of the papers referred to review by an ethics committee. As Green and Thorogood (2009) rightly point out, the role of this committee is primarily to consider the interests of research participants, but also to ensure that any proposed studies use appropriate designs for reaching a sound conclusion.

Appraisal of Methodology Used to Generate Evidence

The papers reviewed consisted mainly of quantitative research (including researches conducted in China and the West). Of course we can’t rule out that the possibility that some studies have been missed. The evidence generated can be described as that deriving from the philosophy of positivist, objective perspective, using standardized, structured techniques. Smith et al (1998) noted that positivism placed emphasis on reason and logic and was deemed to be positive because it offered an objective and true account of nature and society whereby humans would be able to understand the scientific laws which govern the world.

The methodology has improved both in general and in the area of acupuncture over the last two decades (Hugh et al 2007). Researchers performing a systematic review of acupuncture face multiple challenges in addition to issues related to subjectivity. Practice styles differ to a great extent and it is unclear whether different styles vary in their effects in general or for certain conditions. Although many clinical trials in acupuncture use standardised or semi-standardised treatments (Hugh et al 2007, outcomes may also rely on the skills and experience of acupuncturist. In a standardised treatment, all anticipants with the same diagnosis are treated in the same way and with the same frequency. Semi-standardised interventions use some points for all patients but allow flexibility regarding additional points, number of sessions and frequency. Many studies use standardised instruments, but many existing instruments are biomedical in origin, and may not accurately reflect the precepts of East Asian medicine.

According to Parahoo (2006), the limitations of quantitative research in understanding human phenomena and behaviour is that we can only study what is observable, we cannot always observe and measure concepts such as stress, hope, love, emotion and anxiety. Furthermore, we cannot understand deeper meanings that different people attach to concepts by asking questions that require a standardised “fixed” response, because these items can be interpreted differently.

According to Denzin and Lincoln (1994), as cited by David (2007) qualitative research means studying things in their natural settings, attempting to make sense of, or interpret, phenomena, in terms of the meanings that people bring to them. Qualitative research begins by accepting that there is a range of different way of making sense of the world and is concerned with discovering the meanings seen by these who are being researched and with understanding their view of the world rather than that of the research. Qualitative studies in acupuncture can be used to explore the patients’ perspective on treatment and services.

Therefore, acupuncture research should mix qualitative and quantitative methods to reflect its natural characteristic.

Conclusion

Investigating the effectiveness of acupuncture for depression is multi-faceted and progressive exercise, it ideally involves conducting a wide range of studies from experimental and non-experimental fields (Hugh,et al 2007). Non-experimental research could explore practitioner and patients’ experiences in a “real world” the diagnosis and treatment and the impact of these on outcome. In experimental studies, it is difficult to reflect the characteristic of acupuncture. Great attention should be given to methodological design including randomisation, blinding of practitioners and outcome assessors or analysts. As Rosa et al (2007) said acupuncture is a complex, mutimodal, interactive intervention. The patient, the practitioner and the treatment form an integral unit, a system in which an interactive process of diagnosis and treatment dynamically develops as part of a feedback loop. Treatment is generally tailored to the individual patient and continuously becomes adjusted to the clinical features, experience and response of the patient. Using clinical trials alone to investigate the effectiveness of acupuncture for depression is not therefore, sufficient. Mixed quantitative and qualitative methodology can refine the quality of research, and enable researchers to gathering more information.

Acupuncture practice in Western society only partially resembles the practice of traditional Chinese medicine in China. The diversity of outcomes between the results of clinical trials in China and of clinical trials conducted in Western societies could be down to differences in style, type of practitioner and setting of delivery. In order to integrate traditional Chinese medicine principles with scientific concepts, requires the finding of a common language and the development of a model that can generate testable hypotheses, map out the diversity of the treatment styles and to help the validity and reliability of the acupuncture assessment process.

It is too early to say whether acupuncture is effective for depression. However, as more people turn to acupuncture as a treatment for depression measuring the effectiveness of that treatment becomes more urgent. Data derived from clinical acupuncture practice is therefore required on every aspect of acupuncture patients and acupuncture treatments in order to design better studies that truly reflect real practice. All practitioners should contribute to this research by routinely collecting data prospectively and systematically on their patients and by reporting their successes (and their failures) with other practitioners. This will assist in the development of best practice guidelines and the design of treatment protocols and will guide the operationalisation of the Chinese medicine diagnostic process.

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