Complementary Therapies in Medicine, Engredea News & Analysis
Nov. 30, 2011 12:32am
A meta-analysis published in the journal Complementary Therapies in Medicine found that 60% of infertile women became pregnant after taking Chinese herbs for four months, while only 30% became pregnant after taking drugs or undergoing in vitro fertilization for a year.
“Efficacy of Traditional Chinese Herbal Medicine in the management of female infertility: A Systematic Review” published in Complementary Therapies in Medicine, Volume 19, Issue 6, December 2011. The study was conducted at Discipline of General Practice, School of Population Health & Clinical Practice, The University of Adelaide, South Australia 5005, Australia.
To assess the effect of Traditional Chinese Herbal Medicine (CHM) in the management of female infertility and on pregnancy rates compared with Western Medical (WM) treatment.
We searched the Medline and Cochrane databases and Google Scholar until February 2010 for abstracts in English of studies investigating infertility, menstrual health and Traditional Chinese Medicine (TCM). We undertook meta-analyses of (non-)randomised controlled trials (RCTs) or cohort studies, and compared clinical pregnancy rates achieved with CHM versus WM drug treatment or in vitro fertilisation (IVF). In addition, we collated common TCM pattern diagnosis in infertility in relation to the quality of the menstrual cycle and associated symptoms.
Eight RCTs, 13 cohort studies, 3 case series and 6 case studies involving 1851 women with infertility were included in the systematic review. Meta-analysis of RCTs suggested a 3.5 greater likelihood of achieving a pregnancy with CHM therapy over a 4-month period compared with WM drug therapy alone (odds ratio = 3.5, 95% CI: 2.3, 5.2, p < 0.0001, n = 1005). Mean (SD) pregnancy rates were 60 ± 12.5% for CHM compared with 32 ± 10% using WM drug therapy. Meta-analysis of selected cohort studies (n = 616 women) suggested a mean clinical pregnancy rate of 50% using CHM compared with IVF (30%) (p < 0.0001).
Our review suggests that management of female infertility with Chinese Herbal Medicine can improve pregnancy rates 2-fold within a 4 month period compared with Western Medical fertility drug therapy or IVF. Assessment of the quality of the menstrual cycle, integral to TCM diagnosis, appears to be fundamental to successful treatment of female infertility.
To study the impact of De-qi (, obtaining qi) and psychological factors on the efficacy of acupuncture treatment for primary dysmenorrhea, with an attempt to explore the relationship among De-qi, psychological factors, and clinical efficacy.
The patients with primary dysmenorrhea were randomly assigned to a group of acupuncture with manual manipulation (manipulation group, n=67) and an acupuncture group without manipulation (non-manipulation group, n=64). Pain intensity and pain duration were used as measures for evaluating the therapeutic efficacy of the acupuncture treatment. De-qi, the sensations a patient experienced during the acupuncture treatment, was scored on a 4-point scale by the subjects. In addition, the psychological factors, including belief in acupuncture, the level of nervousness, anxiety, and depression, were quantitatively assessed. The personality of the subject was assessed using the Eysenck personality questionnaire (EPQ) and 16 personality factor questionnaire (16PF).
Complete data were obtained from 120 patients, 60 patients in each group. There were statistically significant differences in pain intensity (W=2410.0, P<0.01) and pain duration (W=3181.0, P<0.01) between the two groups. The number of De-qi acupoints (W=1150.5, P<0.01) and the average intensity of De-qi (W=1141.0, P<0.01) were significantly higher in the manipulation group as compared with their non-manipulation counterparts. The correlation coefficients between De-qi and therapeutic efficacy of acupuncture were greater than those between psychological factors and therapeutic efficacy.
Compared with the psychological factors, De-qi contributed more to the pain-relieving effect of acupuncture in subjects with primary dysmenorrhea. Moreover, manual manipulation is a prerequisite for eliciting and enhancing the De-qi sensations, and De-qi is critical for achieving therapeutic effects.
PMID: 21994026 [PubMed - as supplied by publisher]Source: PubMed
Ernst et al. claimed “acupuncture is neither a safe procedure nor superior to placebo.”
One of the last review articles on acupuncture research from Professor Edzard Ernst, prior to the announcement of his retirement, was met with broad dissatisfaction from the acupuncture research community, with concerns raised that he had presented a biased picture of the state of the science. A summary of the published letters rebutting Professor Ernst’s conclusions is presented below. We urge acupuncture researchers and practitioners to read Professor Ernst’s article in Pain (as well as the full complement of letters to the editor published in a subsequent issue of the journal (Witt et al.; Manheimer and Berman; Karst; Baumler; Usichenko; Henke 2011). For the sake of brevity, we summarize the letters to the editors.
A letter by Witt and colleagues found the article “highly misleading” and criticized the authors’ choice of evidence from different levels within the evidence hierarchy for different parts of the paper. In particular, the writers of the letter criticize the use of case studies to determine the safety of acupuncture and cite several larger-scale studies that had different results.
A letter by Manheimer and colleagues criticized Ernst et al.’s methods of data analysis and evaluation as neither systematic, reproducible, nor transparent and found Ernst et al.’s evaluation criteria for assessing the quality and results of systematic reviews to be poorly defined. The writers of the letter also suggest that Ernst et al. succumbed to presentation bias, presenting data in the Discussion section which were not included in the review.
A letter by Matthias Karst notes that the paper misinterprets one of the cited cases, and suggests that the paper’s other conclusions should be suspect, and also warns of a possible “efficacy paradox” which can lead to false positives when testing complex interventions by means of randomized controlled trials.
A letter by Baumler and colleagues pointed out several inconsistencies and accuses the authors of failing to incorporate basic scientific methodology. Specifically, the writers of the letter find the paper’s aim vague, study eligibility criteria absent, and (like Witt et al.) the choice of case reports in the assessment of acupuncture risk questionable. Like Manheimer et al., the letter-writers found Ernst et al.’s methods of determining the quality and outcome of each review unclear. The letter-writers determine that the paper is “not … based on a careful and scientific analysis of the literature.”
A letter by Usichenko and colleagues, like Witt et al. and Baumler et al., criticized the authors’ use of case studies to determine the adverse effects of acupuncture.
A letter by Christian Henke points out the relatively high instance of drug-related adverse events compared to acupuncture-related adverse events and criticizes Ernst et al.’s choice to include the conclusions of various acupuncture experiments in their discussion, despite the fact that conclusions of papers do not reflect statistical outcomes. The letter-writers also note that some important studies were overlooked.
Finally, a letter by James Mooney criticizes the authors’ addressing of the broad spectrum of acupuncture as little more than a single treatment. The letter-writers note that if only the highest-quality reviews are examined, the results are no longer condemning of acupuncture. Mooney also dismisses the authors’ conclusion that acupuncture should be questioned since it reduces pain in “some conditions while failing to work in many others,” noting that the same can be said about acetaminophen.
The authors’ response ran in the same issue of PAIN: Ernst E. Response from Author. Letters to the Editor / PAIN 152 (2011) 2184–2186. As of Oct 13, it is noted this is withdrawn at authors’ request.
Ernst E, Lee MS, Choi TY. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011 Apr;152(4):755-64.
Karst M. Comment on ''Acupuncture: does it alleviate pain and are there serious risks? A review of reviews" Ernst et al. [Pain 2011;152:755-764]. Pain. 2011 Sep;152(9):2181
Bäumler P, Irnich D. Pain. 2011 Sep;152(9):2181-2
Henke C. Pain. 2011 Sep;152(9):2183-4.
Manheimer E, Berman BM. Pain. 2011 Sep;152(9):2179-80Source: Society for Acupuncture Research
Study Suggests Acupuncture Can Improve Recovery, Physical Functioning in Stroke Patients
By Editorial Staff
Nearly five years ago, Emperor's College of Traditional Oriental Medicine received a $40,000 grant from The Center for Integrative Health, Medicine and Research to conduct a pilot study to determine the effectiveness of acupuncture in the rehabilitation of stroke patients.1 The results of that study have been published in the official journal of the American Society of Neurorehabilitation,2 and suggest that acupuncture provides "statistically significant" benefits in physical functioning and recovery when used as an adjunct to conventional stroke rehabilitation measures.
According to the Centers for Disease Control and Prevention, strokes are the third leading cause of death in the United States, and the leading cause of serious, long-term disability in adults. The American Heart Association estimates that between 500,000 and 750,000 strokes occur in the U.S. each year, with approximately 150,000 dying from the stroke itself or from related complications.
The Daniel Freeman Rehabilitation Center was the site of the acupuncture-stroke rehabilitation study.
The object of the pilot study was to address inconsistencies in the published literature with regard to whether acupuncture improves physical and mental abilities of stroke patients when combined with traditional Western rehabilitation procedures. While some trials have suggested that acupuncture provides no additional benefit in the rehabilitation of stroke patients, other studies have reported that stroke patients receiving acupuncture have demonstrated significant improvements in certain aspects, such as recovery of motor skills and overall physical functioning.
The study was conducted at the Daniel Freeman Rehabilitation Center's inpatient stroke rehabilitation unit in Los Angeles. In the trial, 29 patients who had suffered a stroke within the previous 60 days that resulted in hemiparesis (weakness on one side of the body) were randomized to either a control group or an acupuncture group. The control group received conventional stroke rehabilitation care (consisting of three hours of physical, occupational, and/or speech therapy, six days per week) for the duration of the inpatient stay. The acupuncture group received the same care as the control group, along with an additional 30 minutes of acupuncture therapy, seven days per week, for two weeks during the inpatient stay. Acupuncture was provided by eight licensed acupuncturists who had trained at Emperor's College and had a minimum of one year of clinical experience.
To ensure consistency, a standardized treatment protocol was used among all patients in the acupuncture group. Needles were inserted into specific points on the affected limb. Acupuncture points included Du 20, Du 19, Du 21, UB 7, GB 20, Du 14, Ren 6, Ren 12 and St 25.
Supplementary points for the upper limbs (LI 15, LI 11, SJ 5, LI 4, and Lu 7) and lower limbs (GB 31, St 36, GB 34, Sp 6, St 40, St 41, and Liv 3) were selected depending on the patient's condition. Within two weeks of the stroke episode, the acupuncturists added ba feng (an extra acupuncture point), Ren 23 and Ht 5 for aphasia; St 4, SI 18 and St 6 for facial paralysis; and UB 6 and GB 37 for vision problems.
To measure the effects acupuncture might have, the researchers used a tool that assessed aspects of physical performance in a person's upper and lower extremities, along with a functional independence scale that evaluated a person's ability to complete certain activities of daily living without assistance. Patients were evaluated at baseline (within three days of being admitted to the stroke rehabilitation unit) and after being discharged. At baseline and after the completion of the study, evaluations were performed by therapists who were blinded as to the randomization of each patient.
While a general analysis of the data appeared to show no real difference in physical performance scores between patients in the control and acupuncture groups, closer inspection revealed that acupuncture patients experienced "significantly greater" lower extremity motor function compared to the control group. Acupuncture patients also fared slightly better than control patients in terms of lower extremity joint pain.
Other improvements were seen when the researchers compared functional independence scores. While the average score of patients in the control group increased 8.5 points between baseline and discharge, the average score of acupuncture patients increased 11.2 points. In all seven activities of daily living measured on the scale, the average score of patients receiving acupuncture was between .1 and .8 points higher than control patients. The authors noted that "patients who received acupuncture as an adjunct to standard rehabilitation demonstrated significantly greater improvement in tub/shower transfer mobility and a trend for greater improvement in toilet transfer mobility."
In a discussion comparing the results of the pilot study to similar studies, the authors suggested that the reason previous trials of acupuncture and stroke rehabilitation have produced questionable results is because the tests used to measure acupuncture's effects are often not sensitive enough to detect subtle differences. They noted that while many studies used "global measures" of motor and physical function that showed no real benefit groups of control patients and acupuncture patients, "when subscores of these global measures were used, differences between groups were apparent."
Moreover, the authors reasoned that some tests used to measure the effects of acupuncture may be incompatible with acupuncture's physiologic mechanisms. Most studies have used intentionally selected stroke measurements that are recognized internationally. In the opinion of the scientists, however, "these instruments ... are not reasonably associated with the mechanisms that may account for acupuncture effectiveness."
"This pilot study is consistent with previous studies that have examined acupuncture treatment as an adjunct to conventional acupuncture treatment as an adjunct to conventional stroke rehabilitation," the researchers concluded. "When global measures are used, there are no differences in motor recovery or physical function associated with acupuncture. However, when more responsive measures are used, acupuncture effects are evident. Future work that investigates the efficacy and effectiveness of acupuncture treatment poststroke should incorporate levels of measurement that are sensitive to the physiologic mechanisms that may underlie acupuncture effects."
In a statement to Acupuncture Today, the authors elaborated on the results of their research, and outlined ways that future studies that examine the effectiveness of acupuncture in the rehabilitation of stroke patients should be conducted.
"This study provides important insight into the design of future post-stroke acupuncture clinical trials, particularly the selection of appropriate outcome measures," they wrote. "We believe that one of the problems in past investigations of acupuncture effectiveness after stroke is that outcome measures are used that look at gross changes in motor or functional ability that may be too far removed from the underlying mechanisms that may account for acupuncture effectiveness. Recent studies that are trying to understand the mechanisms that could explain how acupuncture works after stroke suggest that acupuncture induces changes in blood flow to the brain or may stimulate the production of growth factors that can help neurons survive. If that is the case, then studies need to use outcome measures that are more sensitive and can detect relevant changes in motor control that may lead to improved function. Our study demonstrated that when more sensitive measures are used these types of motor and functional changes can be detected."3
- Emperor's College receives grant to study acupuncture for stroke rehabilitation. Acupuncture Today, May 2000.
- Alexander DN, Cen S, Sullivan KJ, et al. Effects of acupuncture treatment on poststroke motor recovery and physical function: a pilot study. Neurorehabilitation and Neural Repair 2004;18(4):259-267.
- E-mail from Stanley Azen, PhD, to Acupuncture Today, February 11, 2005.
Stroke. 2010 Apr;41(4):e171-9. Epub 2010 Feb 18.
Acupuncture in poststroke rehabilitation: a systematic review and meta-analysis of randomized trials
Wu P, Mills E, Moher D, Seely D.
Department of Research & Clinical Epidemiology, the Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada.
BACKGROUND AND PURPOSE:
Acupuncture is a low-risk treatment with purported claims of effectiveness for poststroke rehabilitation. To comprehensively assess the efficacy of acupuncture in poststroke rehabilitation, we conducted a systematic review and meta-analysis of all randomized clinical trials of acupuncture for poststroke rehabilitation.
We searched 7 English and 2 Chinese databases from inception to September 2009. Eligible studies included randomized clinical trials that evaluated the clinical efficacy of acupuncture in adult patients with disability after stroke. We extracted data on trial quality, protocol, and outcomes assessed. A summary OR was calculated based on pooled dichotomous results. I(2) was used to infer heterogeneity and we conducted metaregression to determine if specific covariates explained heterogeneity.
Thirty-five articles written in Chinese and 21 articles written in English were included. The overall quality of the studies was "fair" and most studies were small (median n=86; range, 16 to 241). The majority (80%) of the studies reported a significant benefit from acupuncture; however, there was some evidence of publication bias. In 38 trials, data were available for meta-analysis and metaregression, yielding an OR in favor of acupuncture compared with controls (OR=4.33, 95% CI: 3.09 to 6.08; I2=72.4%). Randomization, modes of delivery, method of control, study source country, and reporting of randomization may explain some of the heterogeneity observed between the studies.
Randomized clinical trials demonstrate that acupuncture may be effective in the treatment of poststroke rehabilitation. Poor study quality and the possibility of publication bias hinder the strength of this recommendation and argue for a large, transparent, well-conducted randomized clinical trial to support this claim and implement changes to clinical practice.