Randomized controlled trials

Randomized controlled trials (RCTs) were originally designed for testing drug treatments. While this has become a gold standard model for research in general, it is not necessarily a one-size-fits all design for any medically relevant treatment. This type of simplistic thinking does seem to be endemic to the conventional system and can even be seen in conventional treatment plans, i.e. treating many presentations of headache with the same methods.

Just like Chinese Medical practitioners choose different treatment plans (designs) based on more subtle and individualistic patterns, research scientists could better broaden range of evidence beyond conventional interventions by also adopting various models of evaluation that could be selected based on the intervention being investigated.

For this to happen, a paradigm shift would need to occur in conventional thinking. There is a hierarchical framework that gets applied to many things and creates judgments of something as superior or inferior. Currently, RCTs are seen as the superior form of research but if it could be seen as part of a system of designs that coexist together and each correlate to different applications in research, perhaps some equanimity with other forms of evidence could be achieved. Case studies and qualitative evidence would be among this list. Instead of being deemed inferior and cast aside, different research methods could be applied to new studies with a more individualized approach. This may even create more effective methods for obtaining accurate evidence.

Review: Acupuncture for obesity: A systematic review and meta-analysis

This review published in 2009 (Cho et al) reviewed 29 randomized controlled trials (RCTs) that compared acupuncture with a control group receiving no treatment, a placebo, pharmacological treatment, or non-pharmacological interventions. RCTs were only included if statistical heterogeneity was not observed. Acupuncture was analyzed to be favored to lifestyle modifications like dieting and exercising, as well as to placebo or sham treatment, and groups receiving no treatment. Improvement to the risk rates for a remission of obesity was also observed when acupuncture was used with diet than to when diet was used alone. Publication bias was identified. Minimal adverse effects were observed including redness, pain or discomfort, and bleeding in ears in an auricular acupuncture group. Bruising and abdominal discomfort after electroacupuncture was reported. This review concludes that acupuncture for obesity has some beneficial effect although there was insufficient data available with acceptable methodological quality and narrowed clinical heterogeneity. As a result, the study placed limited value on its findings and cannot conclusively answer if acupuncture should be widely recommended and which form of acupuncture is most effective.

 

Reference

Cho S.H., Lee J.S., Thabane L., Lee J. (2009). Acupuncture for obesity: A systematic review and meta-analysis. International Journal of Obesity, 33, 183-196. http://doi.org/10.1038/ijo.2008.269

Review: The effects of acupuncture on obesity: Anthropometric parameters, lipid profile, and inflammatory and immunologic markers

This study (Abdi et al, 2012) included 196 subjects from Quem Hospital in Mashhad, Iran with a body mass index (BMI) between 25 and 45 kg/m2. They were randomized into 2 groups of equal size. The case group received body acupuncture with manipulation and electroacupuncture while the control group received sham acupuncture with very superficial needling at inaccurate locations and disconnected electric lines. A standard point selection protocol was administered plus one of two sets of points chosen if patients had higher or lower energy. Each subject received two treatments per week for 6 weeks while on a low-calorie diet. After, a low-calorie diet with no treatment was continued for six weeks. Body weight (BW) and other anthropometric measurements, as well as blood samples were collected at the start of the trial, after six weeks, and after 12 weeks. 79 subjects in the case group and 82 subjects in the control group completed the 12 week trial. Analysis showed acupuncture was more effective in reduction of WC and HC than in the sham group and had lowered levels of immune-related inflammatory markers. Hs-CRP was not significantly changed in both the case and control groups. Acupuncture produces reduced levels of anti-heat shock protein antibodies while the control did not.

 

Reference

Abdi H., Zhao B., Darbandi M., Ghayour-Mobarhan M., Tavallaie S., Rahsepar A.A., Parizadeh S.M., Safariyan M., Nemeti M., Mohammadi M., Abbasi-Parizad P., Darbandi S., Akhlaghi S., Ferns G.A. (2012). The effects of acupuncture on obesity: anthropometric parameters, lipid profile, and inflammatory and immunologic markers. The Scientific World Journal, 2012, 603539. http://doi.org/10.1100/2012/603539

Review: Electroacupuncture Modulates Reproductive Hormone Levels in Patients with Primary Ovarian Insufficiency: Results from a Prospective Observational Study

This prospective case series study (Zhou et al, 2013) investigated the effects of acupuncture on serum FSH, E2, and LH levels and changes in menstruation in 11 female patients with Primary Ovarian Insufficiency (POI). Researchers used a commonly associated definition of POI as having reported amenorrhea for four or more months and elevated FSH levels measured at least twice. Patients stopped all medications that could influence reproductive hormones for one month before treatment. Electroacupuncture treatment was given daily, five times a week for four weeks and then once every other day, three times a week for two months. Reported symptoms and serum samples were collected at baseline, at the end of treatment, and at a three-month follow-up after treatment. Significant changes to E2, FSH, and LH were recognized after treatment when compared to baseline values and the effects were maintained at the time of follow-up. After treatment, all but one patient regained menstrual flow and two patients reported amenorrhea at follow-up. The study demonstrated that acupuncture could decrease FSH and LH levels, increase E2 levels, and help regain menstruation in women with POI with little to no side effects, however, the value of the study is limited as it had a small sample size and did not control for confounding factors. Also, symptoms of POI were subjectively reported and documented by researchers leading to possible bias in data documentation. Researchers suggest that further randomized control trials are needed to confirm the efficacy of results and investigate the mechanism of action of the associated outcomes.

 

Reference

Zhou K., Jiang J., Wu J., Liu Z. (2013). Electroacupuncture Modulates Reproductive Hormone Levels in Patients with Primary Ovarian Insufficiency: Results from a Prospective Observational Study. Evidence-Based Complementary and Alternative Medicine, 2013, 657234. http://doi.org/10.1155/2013/657234

Review: “I Felt Like It Was God’s Hands Putting the Needles In”: A Qualitative Analysis of the Experience of Acupuncture for Chronic Pain in a Low-Income, Ethnically Diverse, and Medically Underserved Patient Population

This qualitative analysis published in 2015 (Kligler et al) was conducted to understand the experience of acupuncture treatment in specifically low-income, ethnically diverse, and medically underserved populations as part of the parent trial, ADDOPT (Acupuncture to Decrease Disparities in Outcomes of Pain Treatment). Probe questions were asked in phone interviews to 37 participants of ADDOPT, 6 to 18 months after the trial completed. Participants for this study were recruited from two equal-size lists, generated from patients who demonstrated a significant improvement in pain and another from those who did not. 8 initial interviews were conducted and subjected to a preliminary analysis, after which several questions were added for the remaining 29 interviews. An inductive thematic analysis demonstrated that three main themes of the acupuncture experience were mentioned during the interviews. The participants’ decision-making process to try acupuncture was one theme. Willingness to try something new, feeling that medications were not working, and a sense of desperation were cited as factors. The treatment process experience was another theme. Participants described different ways that acupuncture was different than their usual medical experience. Patients didn’t feel that they needed to know how acupuncture worked in order for it to be effective but many patients felt that being open to the power of the mind would produce positive results. The third theme was the impact of acupuncture on their health. Many reported the positive effects acupuncture had on stress, depression, anxiety, sleep, and gynecological issues. One limitation mentioned by the researchers was the delay in time before interviews could be started after trial due to the need to ensure with quantitative analysis that an adequate sampling of responders and non-responders in the parent trial were included. This could have led to biased perspectives from participants. Cost and access were cited for further review to address acupuncture’s potential use for care in this patient population.

 

Reference

Kligler B., Buonara M., Gabison J., Jacobs E., Karasz A., McKee M.D. (2015). “I Felt Like It Was God’s Hands Putting the Needles In”: A Qualitative Analysis of the Experience of Acupuncture for Chronic Pain in a Low-Income, Ethnically Diverse, and Medically Underserved Patient Population. The Journal of Alternative and Complementary Medicine, 2015, 21(11):713-9. http://doi.org/10.1089/acm.2014.0376