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The 2010 projected total global market for nutraceuticals is in the neighborhood of $187 billion. US contribution to this number represents 32 percent, or about $21 billion, of which the majority of use focuses on the categories of weight loss, heart problems, and digestion.

Further, research-based evidence has proven sufficient to compel FDA approval for full and qualified dietary supplement health claims, such as those for calcium and vitamin D in osteoporosis, folic acid for neural tube birth defects, and plant sterols and stanols in coronary heart disease risk reduction. Additionally, research shows pharmaceutical drug treatments can interact with and/or deplete healthy levels of certain vitamins and minerals.

It is no wonder supplement use has moved out of the natural grocery aisle and into the examining room. In fact, “more than three-quarters of US physicians (79%) and nurses (82%) recommend dietary supplements to their patients,” according to the Healthcare Professionals Impact Study from the Council for Responsible Nutrition (CRN), released in early 2009. Many healthcare practitioners now offer supplements to their patients directly in the office.

Things You Should Have Learned in School?
Some clinical curricula, however, exclude significant instruction dedicated to nutrition and health, let alone objective information about assessing supplement quality and efficacy as linked to research-based recommendations.
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“Most healthcare practitioners end up choosing a supplement brand ‘by accident’ rather than as a result of personal research,” says Rick Liva, RPh, ND, and CEO of Vital Nutrients. “It’s unfortunate, because this is one of the most important aspects of a typical practice. Practitioners need to take time to educate themselves about the keys to supplement quality.”

Certain signs of poor quality are obvious—disease claims on marketing materials or labels or improper labeling altogether, such as the absence of a proper supplement facts box and missing “best by” or expiration date. Egregious mistakes signify ignorance or a general disregard for regulatory responsibility—both potential signs of poor quality control. But even when these unmistakably deficient brands are set aside, practitioners are still left with a dizzying array of product choices.

Indeed, most of the many dietary supplement manufacturers servicing clinicians maintain quality standards and meet basic requirements set out by the Dietary Supplement Health and Education Act (DSHEA). The question then becomes distinguishing superior quality among the options.

Good Manufacturing Practices (GMPs)
In the US, the FDA regulates dietary supplements via DSHEA. As required by DSHEA, FDA recently established dietary supplement good manufacturing practices (GMPs) to provide the baseline for quality standards among supplement manufacturers. GMPs, implemented in 2007 for rollout to all manufacturers by 2010, have the force of law. They are designed to ensure manufacturers follow procedures to keep products safe, effective, and free of harm. GMPs include requirements around the process of product supply, preparation, testing, and storage. GMPs also regulate the packaging and labeling of products.

Notwithstanding the soundness of the regulations, this is challenging terrain. Each area governed by 21 CFR Part 111 requires a sophisticated approach to implementing necessary practices in order to be in compliance. Over the next several months, we will explore several of these areas. Just to set the tone for this exploration, let’s start with exploring the identity of the ingredients a dietary supplement. The majority of ingredients in dietary supplement products originate in the natural world, and, in fact, in the food supply. These ingredients are gathered and processed by suppliers and are then sold to dietary supplement manufacturers. Each ingredient comes to the manufacturer with a certificate of analysis (COA). This COA confirms, among other things, the identity of the ingredient. The manufacturer is required to additionally confirm the identity of every received ingredient by conducting their own testing. So far, so good. However, as usual the devil resides in the details.
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21 CFR Part 111 requires that the method used to test identity be scientifically sound and that the manufacturer ingredient meet manufacturer pre-set specifications in order to be accepted for manufacturing. One of the challenges with this regulation is that there are many scientifically valid ways to verify identity, but not all of these methods are appropriate for all ingredients. Organoleptic testing, although a scientifically valid form of identity testing and an excellent way to identify certain cut and sifted herbal ingredients, is not appropriate for all materials. Certainly a powdered herbal standardized extract would not be a candidate for organoleptic testing. Even more a sophisticated testing method, such as near infrared spectroscopy (NIR) or Fourier transform near-infrared (FT-NIR), would not necessarily be appropriate for identifying this standardized herbal extract powder. Unless the NIR is accompanied by chemometric analysis, this method may leave a tracing for the powder that is not specific enough and may miss an adulterant. Adulterants are substances that mimic the desired ingredient’s tracing on NIR or FT-NIR, allowing a supplier to cut the ingredient with this other, often inert or unrelated, compound. Even more sophisticated identity testing, say chromatography with high-performance liquid chromatography (HPLC), thin layer chromatography (TLC), or gas chromatography (GC), which are typically quite accurate and sensitive to adulterants, can be inaccurate if the equipment has been properly calibrated, maintained, and controlled. Proper equipment operation speaks to the importance of utilizing qualified laboratories that practice good lab practices (GLP) in order to obtain reliable test results. Assuming that the right test and the right lab are in place, another area of concern is the sampling procedures. If the manufacturer accepts several containers of raw material, what method is used to obtain samples for testing? Are the samples truly representative of the entire shipment of raw material? Sampling is a complex process and one that leaves much leeway. This is quite relevant however, given the fact that many suppliers of raw materials are, in fact, brokers. They obtain the material from a variety of sources and mix all of this material into one lot. A sound sampling process will minimize the chances of missing an inferior or adulterated ingredient in the shipment.

While we have just begun to scratch the surface of the challenges of quality in the dietary supplement industry, it should already be abundantly clear how challenging it is to achieve reliable quality practices even for one component: identity. The willingness on the part of the manufacturer to utilize the best methods in order to address these areas of ambiguity and challenge is a hallmark of those suppliers with a commitment to quality manufacturing. Thankfully, these suppliers exist aplenty, and practitioners’ expectations for this level of quality products will reinforce their commitment to quality.

“Exploratory testing can be described as a martial art of the mind. It’s how you deal with a product that jumps out from the bushes and challenges you to a duel of testing. Well, you don’t become a black belt by reading books. You have to work on it.” —James Bach

With passing consideration, one might think that the process of testing a natural product’s quality is straightforward—a simple matter of confirming that the ingredients that are supposed to be in a product are, in fact, the only substances in the product. This path of thinking might continue to embrace the idea that the really only variable in the equation is how often one does the testing. If it were only that simple.

Ensuring the quality of the products that we consume and recommend to patients is anything but a straightforward task. This is particularly true for naturally derived products, which often contain hundreds of phytochemicals arranged in complex matrixes. The starting material is complex and subject to change under even the most innocuous conditions such as exposure to air, moisture, and light. Natural compounds are rather like moving targets which, nonetheless, require the arrows of analysis to consistently find their mark.

Natural compounds are rather like moving targets which, nonetheless, require the arrows of analysis to consistently find their mark.

This issue of the Natural Medicine Journal we debut a column on quality in which various aspects of quality assurance in the dietary supplement industry will be addressed. It will be a practitioner’s journey into the world of dietary supplement manufacturing. As we travel, we will learn the route, appreciate the landscape, and take some keepsakes back into our clinical practices. In order to start our journey, we need a trail guide.

Our guide is called Final Rule 21 Code of Federal Regulations (CFR), Part III. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 21 CFR Part 111 contains the regulations of the 1994 Dietary Supplement Health and Education Act. These regulations were established by the FDA to set requirements for validated manufacturing and quality processes in order to ensure product safety. The regulations provide explicit requirements regarding all areas of manufacture, including, but not limited to, physical plant hygiene, quality control requirements, record keeping, manufacturing requirements, ingredient and supplier qualifications, and analytical testing requirements. The guidelines are a hybrid of food safety regulations and pharmaceutical regulations and are more similar overall to pharmaceutical regulations. The regulations are, in fact, a very good trail guide when followed to their letter and spirit, and provide an excellent path toward quality dietary supplements.

Participants
158 total subjects (44 with pancreatic adenocarcinoma, 42 with gastric adenocarcinoma, 40 with gallbladder adenocarcinoma, and 32 with hepatocellular carcinoma); 25% were diagnosed with stage III and 71% with stage IV disease.

Inclusion criteria:
histopathology/cytopathologic confirmation of malignancy,
inoperable tumors, and
no prior chemotherapy or radiation treatment.

Treatment
Psorinum 6X was administered, up to 0.02 ml/Kg body weight orally (as liquid drops under the tongue) once daily for all participants. Conventional (eg, infection and pain control, electrolyte balancing, abdominal/pleural paracentesis) and homeopathic (ie, administration of homeopathic medicines on pathological indications) supportive measures were also administered.

Results of this study, which demonstrate a 19-38-fold improvement compared to conventional treatment in five-year survival of non-resectable pancreatic cancer are, to put it mildly, intriguing.

Outcome measures
Primary outcome measures were radiological tumor response and survival at 1, 2, 3, 4 and 5 years. Secondary outcome measure was assessment of side effects of Psorinum 6X.

Key Findings
Complete tumor response occurred in 33.33% of those diagnosed with stage III disease and 10.71% of those with stage IV. Partial response occurred in 41.03% and 33.93% respectively.

Five-year survival rates were 38.64% (pancreatic), 38.1% (gastric), 37.5% (gallbladder), and 43.75% (liver).

No adverse effects of Psorinum were observed, though a few participants had mild oral irritation and skin itching.

Clinical Implications
The cancer types considered in this study are among the most intractable and deadly malignancies. Conventional treatment of these conditions, though improving, is still of very limited effectiveness. For instance, in the last decade with the use of the standard first-line therapy gemcitabine, median overall survival for advanced pancreatic adenocarcinoma has increased from 3–4 months to 5–8 months,1 while 5-year survival of the non-resectable form is nearly unchanged at a dismal 1–2%.2,3 Roughly 80% of all pancreatic malignancies are inoperable at diagnosis.4 Therefore, results of this study, which demonstrate a 19–38-fold improvement compared to conventional treatment in five-year survival of non-resectable pancreatic cancer are, to put it mildly, intriguing.

Similar improvements in survival rates with Psorinum therapy were demonstrated in the other cancer types studied.

Caution should be taken, however, in interpreting these findings. Promising phase II trials are notorious for disappointing in the phase III setting. Independent verification in a controlled context is needed before an unqualified recommendation can be made.

Nevertheless, considering the very poor response of these cancers to conventional treatment and the apparent lack of toxicity and potential benefit of Psorinum therapy, it seems reasonable that clinicians with oncologic experience might offer this therapy to their patients on an individual basis.

Common homeopathic medicines such as Lycopodium 200C and Baryta carbonicum 200C were used supportively and prescribed on a pathologic (as opposed to individualized) basis. This is an important feature, as the complexity of individualized homeopathic prescribing is an obstacle both to its reproducibility in independent trials and its broad clinical adoption.

The author is currently working on a manuscript detailing the guidelines of the supportive homeopathic measures. Additionally, he will be publishing 3 detailed case reports involving Psorinum therapy, which will give further insight into the homeopathic supportive approach. Execution of this protocol is therefore likely to be feasible for practitioners in the near future.

The primary limiting factor of this study is the lack of a control for the effects of the supportive homeopathic measures. Since supportive homeopathic medicines were extensively used, it is quite possible the outcomes were due in part (or in chief) to their influence.

A phase III trial comparing Psorinum 6X plus conventional and homeopathic supportive care to 1) conventional treatment and 2) Psorinum 6X plus conventional (but not homeopathic) supportive care in treatment of advanced pancreatic cancer is currently underway.

Design
Fifty-three patients (45 women and 8 men) with diabetes were studied in a randomized controlled clinical trial and assigned into two groups: sour tea (Hibiscus sabdariffa) and black tea. Patients were instructed to consume one glass of the decoction (two spoonfuls of blended tea in a sachet weighing 2 g, placed in one glass of boiled water and boiled for 20–30 minutes) with 5 g sugar, twice daily; they also were instructed not to drink any other types of tea during the study. Tea consumption was continued for 1 month. Fasting blood samples were obtained before and after intervention, testing HDL, LDL, triglycerides, Apo-A1, Apo-B1-00, and Lp(a). 20.8% of the patients were only on diet therapy for their diabetes and the rest were either on insulin or oral hypoglycemic agents.

Key Findings
Hibiscus consumption reduced most of the lipids and lipoproteins and increased HDL, but black tea consumption only increased HDL.

Hibiscus consumption reduced most of the lipids and lipoproteins and increased HDL, but black tea consumption only increased HDL. The sour tea group averaged a 7.6% decrease in total cholesterol, 8.0% decrease in LDL, 14.9% decrease in triglycerides, 3.4% decrease in Apo-B100, 16.7% increase in HDL, 4.2% increase in Apo-A1, and no change in Lp(a). The black tea group averaged a 13% increase in HDL but did not see a significant change in other measures.

Commentary
Previous studies have been done on Hibiscus and dyslipidemia. Lin, et al, showed that drinking Hibiscus tea for 4 weeks reduced total cholesterol by 8.3%–14.4%.1 Animal studies have shown that rats with diabetes had a positive effect with Hibiscus on glucose and lipids.2 I reported on the effectiveness of Hibiscus tea in reducing systolic blood pressure in a recent column.

Hibiscus sabdariffa, or sour tea, is used in many parts of the world to make both cold and hot drinks. We might know it in English by the name Hibiscus or red sorrel. In Arabic it is called karkade, and in Iran it is mainly known as sour tea. It contains many constituents including alkaloids, L-ascorbic acid, anisaldehyde, anthocyanin, beta carotene, beta sitosterol, citric acid, cyaniding-3, rutinoside, delphinidin, galactose, gossypetin, hibiscetin, mucopolysaccharide, pectin, protocatechuic acid, polysaccharide, quercetin, stearic acid, and wax. The medicinal parts of the plant include the flower, calyx or sepal, leaves, stems, and seeds. The extracts of the sepal contain significant amounts of vitamin C, anthocyanins, and polyphenols, as well as the highest concentration of water-soluble antioxidants. Traditionally, it has been used in folk medicine for several health issues including high blood pressure, liver diseases, loss of appetite, circulation, and as a gentle laxative and diuretic.

In addition to its appealing flavor, smell and brightly colored appearance, we can add this simple tea to our medicinal options for hyperlipidemia and hypertension.

Main Outcome Measures
Various outcome data were collected, including length of hospitalization, need for postoperative analgesics, routine vital signs, and patient ratings of pain intensity and distress as well as anxiety and fatigue. Validated assessment metrics included the State-Trait anxiety Inventory Form Y-1, the Environmental Assessment Scale, and the Patient’s Room Satisfaction Questionnaire.

Key Findings
Post-study evaluation of data revealed that patients assigned to recovery rooms with foliage demonstrated significantly lower systolic blood pressure, perception of postoperative pain, anxiety, and fatigue than those in the control group. Validated surveys also revealed subjective increase in satisfaction with their assigned room, stating that the plants brightened the environment, reduced stress, and evoked more positive impressions of hospital employees engaged in their care.

Practice Implications
The true beauty of this study lies in its simplicity and elegance, reflective of nature itself. The investigators chose to evaluate postoperative pain after a common surgical procedure, and the intervention chosen was inexpensive, nontoxic, and required no randomized controlled trial or FDA approval prior to utilization.
Given the current clinical and fiscal need for alternatives to our conventional approach to pain management, this simple intervention holds promise as adjunctive analgesia for simple surgical procedures.
Given the current clinical and fiscal need for alternatives to our conventional approach to pain management, this simple intervention holds promise as adjunctive analgesia for simple surgical procedures.

This is not the first attempt to utilize the hospital environment as therapeutic modality. Architects and contractors across this country and abroad have been engaged in a revolutionary movement to redesign hospital buildings both inside and out, with more than 1,500 studies to date demonstrating that architectural design significantly influences rates of medical errors, clinical infections, accidental falls, and levels of stress in both patient and staff. As one example, researchers have documented that the simple addition of sunlight to a hospital room is associated with improvement in mood and affect, diminished mortality in cancer patients, reduced length of stay in patients with myocardial infarctions, and decreased analgesic use and costs after spinal surgery. The Center for Health Design, a non-profit based in California, has created the Pebble Project, a partnership of 44 hospitals to investigate the clinical and fiscal benefits of intelligent building design. Their data reveal lower noise levels, improved patient sleep, decreased staff turnover, reduced medication requirements, and declining drug errors. Given that the majority of our pharmaceutical medications have been extracted from living botanicals, it is poignant to consider that the original plant may prove a superior therapy in the long run. Future studies should be done to confirm this study’s findings and delineate what aspect of the live plant (eg, visual, olfactory, qi) might be responsible for improved outcomes.

Design
This open label study included 60 type 2 diabetes mellitus patients divided into 3 groups; 18 patients received sesame oil, 20 patients took a daily dose of glibenclamide (Glyburide), and 22 took both sesame oil and glibenclamide. The patients in the sesame group were supplied with sesame oil and instructed to use about 35 grams (about 2.4 tablespoons) per day in cooking or salad preparation for 60 days. Blood samples were collected at baseline and after 60 days of the experiment for analysis.

Key Findings
In this group of type 2 diabetics, sesame oil had a synergistic effect with glibenclamide. The combination therapy significantly lowered blood sugar and hemoglobin A1c more than either oil alone or drug alone did.
In those who received only sesame oil, total cholesterol dropped 20%, LDL cholesterol dropped 33.8%, and triglycerides dropped 14%. In those receiving both sesame oil and glibenclamide, these numbers were even better: 22%, 38% and 15% respectively. HDL increased 15.7% in the sesame oil patients and 17% in those receiving the combination of oil and drug.

The combination therapy significantly lowered blood sugar and hemoglobin A1c more than either oil alone or drug alone did.
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Practice Implications
This is not the first study to suggest that sesame oil supplementation is beneficial for diabetics. In a 2005 paper on rats with chemically induced diabetes, Ramesh et al reported that, after 42 days of eating a diet supplemented with 6% sesame oil, mean blood glucose dropped from approximately 322.61 mg/dL to 222.02 mg/dL.1 In 2007 Dhar et al, also using rats with chemically induced diabetes, reported that sesame lignans not only improved the lipid profile but significantly reduced the peroxidation of the LDL cholesterol.2

In 2006 Sankar et al reported the results from their pilot study on 40 hypertensive diabetics that found eating sesame oil caused significant effects in hypertensive diabetics medicated with atenolol and glibenclamide. The patients switched to sesame oil for cooking for 45 days at which point they switched to other oils like palm or peanut oils for another 45 days. During the sesame oil portion of the study, “Systolic and diastolic BP decreased remarkably. When oil substitution was withdrawn, BP values rose again.” During the sesame oil phase of the study, body weight, body mass index, girth of waist, girth of hip, and waist:hip ratio decreased. So did plasma glucose, hemoglobin A1c, total cholesterol, and LDL cholesterol and triglycerides.

Given these results it now seems reasonable to suggest a little experiment to your type 2 diabetic patients. Have them switch to eating only sesame oil for 8 weeks and see if their lipid profiles improve.
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Given the parameters that are improved by sesame oil, we must wonder whether it might benefit those with metabolic syndrome. Suggesting a similar experiment to those with metabolic syndrome might be worth considering.

As a side note, there has also been recent interest in sesame oil’s capacity to accelerate wound healing.4,5,6,7 Given that a common complication that diabetics suffer is poor wound healing, this action may also prove of useful for this patient population.

Design
One hundred twenty patients with polycystic ovarian syndrome (PCOS) and 14–16 months of infertility were studied in this randomized, controlled clinical trial. Patients were randomly assigned to receive either 1,500 mg/day metformin or 4 grams of myo-inositol plus 400 mcg folic acid daily. In patients where in whom pregnancy occurred, patients underwent ovulation induction with recombinant follicle stimulating hormone (r-FSH) (37.5 units/day) for a maximum of 3 attempts. The primary endpoint was restoration of spontaneous ovulation (measured by monitoring serum progesterone levels weekly and transvaginal ultrasound to confirm). Secondary endpoints included resistance to treatment (percentage of patients who did not restore spontaneous ovulation), pregnancy rate, and abortion rate.

The study demonstrated a statistically significant difference in restoration of spontaneous ovulation in patients taking myo-inositol over metformin.

Key Findings
Fifty percent of the patients who received metformin restored spontaneous ovulation, and 18.3% of these achieved pregnancy. Sixty-five percent of patients treated with myo-inositol restored spontaneous ovulation, and 30% of these achieved pregnancy. In the remaining patients who did not respond to monotherapy, r-FSH was added. In each of the 2 groups (metformin plus r-FSH group or myo-inositol and folic acid plus r-FSH group), 11 pregnancies occurred. The total pregnancy rates were 36.6% for patients receiving metformin and 48.4% for patients receiving myo-inositol. The study demonstrated a statistically significant difference in restoration of spontaneous ovulation in patients taking myo-inositol over metformin. There was an overall higher rate of pregnancy in the myo-inositol group, but the effect was not significant.

Practice Implications
One metabolic feature often observed in patients with PCOS is a defect in inositol metabolism. Inositol plays an important role in insulin and glucose metabolism. Inositol accelerates the dephosphorylation of glycogen synthase and pyruvate dehydrogenase, both rate-limiting enzymes of non-oxidative and oxidative glucose disposal. Supplying myo-inositol can accelerate glucose disposal and sensitize insulin action. This may decrease the hyperinsulinemic state that can prohibit proper luteinizing hormone (LH) secretion.

Previous studies have demonstrated that myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in patients with PCOS. This study is the first to compare the effectiveness of 2 insulin-sensitizing agents, inositol and metformin, in the treatment of chronic anovulation and infertility secondary to PCOS.

In this study, myo-inositol offered a significant advantage over metformin in restoration of spontaneous ovulation in patients with PCOS. This also resulted in a non-significant increase in pregnancy rate. In addition, patients on myo-inositol reported no side effects during the course of treatment. Myo-inositol should be considered as a first-line treatment in patients with PCOS experiencing chronic anovulation or infertility secondary to anovulation.

“Both unadjusted tests and linear regression models indicated that CAM users had lower average expenditures than nonusers. (Unadjusted: $3,79β7 versus $4,153, P=.0001; β from linear regression -$367 for CAM users.) CAM users had higher outpatient expenditures that which were offset by lower inpatient and imaging expenditures. The largest difference was seen in the patients with the heaviest disease burdens among whom CAM users averaged $1,420 less than nonusers, P<0.0001, which more than offset slightly higher average expenditures of $158 among CAM users with lower disease burdens.”

Practice Implications
This paper is the latest in a series from this team to evaluate insurance claims databases resulting after a 1996 insurance inclusion mandate for CAM providers in Washington state. The change in regulation required that health insurance companies operating within the state to provide access to every state-qualified class of healthcare providers. Earlier papers from the group found that overall claims were little affected by coverage of CAM providers due to smaller claim size compared to conventional medical claims. Those studies also found that CAM users tended to have higher morbidity than non-users.

Cost studies are few in CAM research. Cost minimization, the approach of this paper, analyzes which of 2 approaches to care is associated with lower overall expenditures, assuming comparable health outcomes between the two approaches. “CAM users” were those who had made claims for visiting any of the following CAM providers: acupuncturists, chiropractors, massage therapists, and naturopathic physicians. Average claims costs in this analysis were about 9% lower over 1 year among CAM users than non-users, showing lower inpatient and ancillary costs (e.g., imaging, laboratory) but higher outpatient visit costs.

The cost outcomes, while favorable to CAM provider use, are associated with and not demonstrably caused by CAM provider visits reflected in the claims. The smaller costs among CAM users may be generated by other health and lifestyle factors associated with going to CAM practitioners (e.g., newly acquired patient activation in the face of a chronic problem, surrendering conventional medical interventions due to therapeutic failures).
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Though coverage of CAM providers was made available, coverage was generally not equal to coverage of conventional providers, being restricted among different insurance companies by limits to the number of CAM visits, to a specified network of a providers, or to an overall CAM costs cap.
Not all CAM care costs are included in the data set; for example, dietary supplements, which may be a necessary part of CAM treatment, are typically not covered even if provider visits are.
Not all CAM care costs are included in the data set; for example, dietary supplements, which may be a necessary part of CAM treatment, are typically not covered even if provider visits are. The analysis was done in three impactful conditions—back pain, fibromyalgia, and menopausal symptoms—which all have somewhat uncertain etiologies. They are also conditions that are often refractory to conventional treatment, so findings again may not be generalized to all conditions. These conditions fall into the emerging research area of medically unexplained physical syndromes (MUPS), in which the lowest hanging fruit for CAM research targets may be found.

To answer the question of causation requires prospective intervention studies; however, matching patients in the comparison groups of users versus non-users on the basis of their total medical claims in the year prior to initiating CAM claims makes this study suggestive of a generalizable finding in future economic analyses. Patients without a year of claims prior to initiating CAM claims were not included in analysis.

Different providers types were not distinguished in the analysis on the basis that there were too few claims for any 1 provider type for valid interpretation of the data by discipline (personal communication with first author). The study thus provides little guidance to consumers in choosing a provider, but more confidence that doing something alternative may be a good choice. Claims costs in only 1 year were evaluated; savings from CAM use may come with prevention, and thus subsequent savings could not be addressed. The study did not include Medicaid, Medicare, or state program–covered patients—populations that may be more susceptible to improvement under CAM care due to historical lack of access to it.

Despite its limitations, this creative use of existing data provides some evidence that costs of CAM providers are not redundant to conventional care and that CAM provider use may well be cost-saving. As more such data has become available with increasing inclusion and longevity of CAM providers in insurance coverage over the last decade, replication of this study in other regions and conditions is increasingly possible and should be performed.

The winnowing down of 664 studies to a mere 10 that compared “real” to &quotsham” acupuncture may have selected for criteria that excluded studies that may have shown real and positive effects.
It may also be indicative of selection bias. For example, 18 studies used animals, 52 were uncontrolled trials, and 172 were excluded because they did not use sham or placebo control. One hundred twenty-one studies compared 2 different types of acupuncture treatment. It is possible that some of these studies may have demonstrated more favorable effects.

For example, in 1997, researchers Hopwood and Lewith published a preliminary study of 6 patients who had suffered strokes within 3 months of acupuncture treatment.2 Each patient was treated daily for 2 weeks with electroacupuncture, with a 2-week crossover period during which the patients were treated with placebo electrotherapy. A consistent rise in motor function as assessed by the Motricity Index was observed after the electroacupuncture treatments, leading the authors to conclude that acupuncture can have salutary effects on patients recovering from stroke.

It is notable that while the study authors did not find statistical significance to the results of their analysis, specific analyses of activities of daily living showed a slight trend toward improvement favoring those treated with real acupuncture versus sham acupuncture.

While this is an exhaustive overview of studies evaluating the effects of acupuncture on post-stroke recovery and an important study in the field, clearly more research is needed, especially where patients are offered treatment as close to their stroke as possible.

Design
Meta-analysis of randomized controlled trials comparing the effects of acupuncture with sham acupuncture. Ten of 664 potentially relevant studies met inclusion criteria. For acute and subacute stages post-stroke, authors included 7 trials.

Results
Meta-analysis of 5 studies that accessed functionality did not show a significant difference in favor of acupuncture, with high heterogeneity. A post-hoc sensitivity analysis of 3 trials with low risk of bias did not show beneficial effects of acupuncture on activities of daily living at the end of the intervention period. For the chronic stage after stroke, 3 trials tested effects of acupuncture on function according to Modified Ashworth Scale; all failed to show favorable effects.

Interpretation
Meta-analyses of data from rigorous randomized sham-controlled trails did not show a positive effect of acupuncture as a treatment for functional recovery after stroke. Few randomized sham-controlled studies have tested the effectiveness of acupuncture during stroke rehabilitation.

Discussion
According to the authors of this study, there are several possible explanations of these findings: acupuncture may be ineffective, existing studies may have been inadequately designed, or treatment may not have been properly administered. For example, several of the trials included patients treated more than 6 months post-stroke, which may be too long after injury to expect to see significant improvements. Additionally, treatment protocols varied significantly in terms of the types of acupuncture treatments applied, whether or not electro-acupuncture was included, number and frequency of visits, and other treatment variables.
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It is laudable that the authors did not use English language studies exclusively but instead did exhaustive research to include all clinically relevant trials they could find, including those from China, Japan, and Korea where acupuncture is used much more frequently than in the West for post-stroke treatment and often much closer to the stroke event than in the West, which could potentially yield more positive results.For example, over my 21-plus years as a licensed acupuncturist, I have only treated a relative handful of patients for post-stroke recovery, and all of them were at least 6 months past the dates of their strokes, significantly limiting expected treatment effectiveness.

While this meta-analysis is the most comprehensive I have reviewed, I have some concerns with the study design. In their interpretation, the authors admit that sham acupuncture is not inert and has been shown to cause physiological effects.1 The winnowing down of 664 studies to a mere 10 that compared “real” to “sham” acupuncture may have selected for criteria that excluded studies that may have shown real and positive effects.