Volume 11, Issue 2, March–April 2015, Pages 157–161
SPECIAL ISSUE ON NONLOCAL MIND
Evidence-based integrative medicine updates
Acupuncture for Knee Osteoarthritis, Chasteberry for Premenstrual Syndrome, Probiotics for Irritable Bowel Syndrome, Yoga for Hypertension, and Trigger Point Dry Needling for Plantar Fasciitis
Needle or Laser Acupuncture Does Not Improve Chronic Pain or Physical Function in Patients with Knee Osteoarthritis
Level 1 (likely reliable) evidence
J Am Med Assoc 2014;312(13):1313
Chronic knee pain is the most common reason older adults visit their primary care physicians.1
When more conventional treatments prove inadequate or pose unacceptable
risks, some patients turn to acupuncture for relief. Acupuncture points
may be stimulated using a variety of techniques, including needles,
low-level laser energy, or heat (moxibustion). High-quality evidence
supporting the benefits of any of these techniques for chronic knee pain
is lacking, and it is unknown how the effectiveness of laser
acupuncture compares to that of needle acupuncture.2
A guideline from the American College of Rheumatology (ACR) recommends
needle acupuncture as an option for patients with chronic
moderate-to-severe pain who are candidates for total knee arthroplasty
but are unwilling or unable to have the procedure done.3
The
present randomized trial compared needle or laser acupuncture to sham
laser acupuncture or no acupuncture in 282 patients with chronic knee
pain longer than three months aged 50 years or older.2
All patients had symptoms consistent with a clinical diagnosis of
osteoarthritis: knee pain for a majority of days with a severity score
≥4 (numeric rating scale 0–10) and morning stiffness lasting <30 min.
Researchers attempted to minimize performance bias by having
participants consent to acupuncture after randomization. Those
randomized to receive no acupuncture (control group) were led to believe
they were participating in an observational study (rather than a
controlled trial) and were, therefore, effectively blinded. Both
patients and practitioners were blinded to laser vs. sham laser group
allocation (the same red light appeared from both devices). No sham
needle group was included since practitioners could not be blinded and
sham needles may produce somatosensory effects.4
Family physicians, registered as medical practitioner acupuncturists by
the Medical Board of Australia, administered 20-min treatments one to
two times weekly for a total of 12 weeks. (No details regarding the
extent of their training in traditional Chinese acupuncture were
provided.) Practitioners chose from a standardized set of acupoints and
were permitted to choose some additional points at their discretion
based on clinical examination.
The
researchers found no significant differences in knee pain for needle
vs. laser acupuncture {mean difference [MD] = −0.3 [95% confidence
interval (CI) = −1.0 to 0.4]}, needle vs. sham laser [MD = −0.4 (−1.2 to
0.4)], or laser vs. sham laser [MD = −0.1 (−0.9 to 0.7)] at 12 weeks
based on intention-to-treat analysis with data imputed. The same was
true for all other measured outcomes: pain upon walking or standing,
physical function, quality of life, or mental or physical health. All
results were consistent when outcomes were reassessed at one year.
Compared to the untreated control group, needle and laser acupuncture
were both associated with a statistically significant improvement in
pain at 12 weeks (but not at one year).
The
findings in this carefully designed and conducted trial are consistent
with another high-quality study that found no significant improvement in
pain with traditional Chinese needle acupuncture vs. a sham needle
control.5
Moreover, a Cochrane review of 16 trials evaluating patients with
osteoarthritis (12 focusing on knee osteoarthritis) found clinically
significant improvement in pain and function with needle acupuncture in
comparison to waitlist control only, suggesting a placebo effect.6
A subsequent meta-analysis of six trials, however, found statistically
significant differences between real and sham acupuncture for patients
with knee osteoarthritis.7
Average effective sizes were small though, and performance bias may
have contributed to the favorable results, a limitation addressed in the
current study.
Vitex agnus-castus (chasteberry) may Improve symptoms in Women With PMS
Level 2 (mid-level) evidence
Planta Med 2013;79(7):562
Premenstrual syndrome (PMS) affects as many as 40% of all women,8 up to 8% of whom meet the criteria for the more severe premenstrual dysphoric disorder (PMDD).9 Over two-thirds of woman report symptoms of cyclical breast pain (e.g., mastalgia).10
Although the exact causes of PMS and PMDD remain obscure, latent
hyperprolactinemia, occurring premenstrually or in response to stress,
is associated with both conditions.11 Elevated prolactin can inhibit corpus luteal development and luteal phase progesterone secretion.12 By binding to dopamine-2 receptors, herbal extracts of Vitex agnus-castus may influence dopaminergic activity, leading to prolactin inhibition. 13 Given this physiological plausibility, numerous clinical trials have evaluated the effectiveness of Vitex for PMS or PMDD. Researchers set out to conduct a systematic review of this literature.
Of 12 randomized controlled trials (RCTs) they identified, eight investigated Vitex for PMS, two for PMDD, and two for latent hyperprolactinemia (with or without mastalgia). 14
All trials had uncertain blinding, lack of blinding, and/or uncertain
method of randomization. Due to heterogeneity in disorders, comparators,
endpoints, as well as missing data, meta-analysis was only attempted
for two of the eight PMS trials. Six different mono-preparations of Vitex
were used in eight trials (with the remaining four unspecified). Doses
were 20–40 mg dried fruit equivalent (though one PMS study used 180 mg)
given daily through all or part of two to six menstrual cycles. For PMS,
Vitex was associated with greater symptom relief than placebo
in five of six trials, pyridoxine (100 mg twice daily on cycle days
16–35) in one trial, and magnesium oxide (300 mg daily) in one trial.
(Pyridoxine and magnesium have both been studied for their effectiveness
against PMS with inconsistent results.) For PMDD, Vitex
appeared to be equivalent to fluoxetine (20–40 mg daily) in one trial
and inferior to it in another. For latent hyperprolactinemia, Vitex
was equivalent to bromocriptine (2.5 mg twice daily) for relief of
breast pain and reduction in serum prolactin levels (during days five)
in one trial. Adverse effects with Vitex were either absent or
mild. They occurred no more frequently than with placebo, pyridoxine, or
magnesium, and less frequently than with fluoxetine or bromocriptine.
The results of this review appear to support the efficacy and tolerability of Vitex
for PMS. This conclusion is consistent with findings of a previous
published systematic review, which investigated the effects of herbal
remedies, including Vitex, on PMS. 15Vitex
may also be a useful alternative to fluoxetine for PMDD, particularly
given its lower risk of adverse effects, though the evidence from this
review is mixed. Clinically important limitations of these trials
include their risk of bias, inconsistent dosages, and diversity of
preparations.
Probiotics may Improve Symptoms of Irritable Bowel Syndrome
Level 2 (mid-level) evidence
Am J Gastroenterol 2014;109:1547–1561
Irritable
bowel syndrome (IBS) and chronic idiopathic constipation (CIC) are
common functional disorders of the bowel occurring in 5–20% of the
population, depending on diagnostic criteria.16 and 17
Visceral hypersensitivity, disturbances in gasterointestinal (GI)
microflora, and low-grade mucosal inflammation have been proposed as
pathoetiologic mechanisms.18, 19 and 20 Research has shown that some pharmacologic therapies are effective, at least in the short-term (less than six months),21, 22 and 23 but no therapy is curative and many patients respond insufficiently.24 and 25
Potential alternatives to pharmacotherapy include probiotics (live or
attenuated microorganisms linked to favorable health effects in humans)
and prebiotics (undigested food constituents, such
fructo-oligosaccharide and inulin, that may stimulate the growth of
favorable gut flora). Synbiotics combine the two.
In the present systematic review and meta-analysis,26 researchers updated their earlier review of probiotics for IBS and added trials for CIC.27
A total of 43 randomized controlled trials (RCT) examining the effects
of probiotics, prebiotics or synbiotics in IBS or CIC on patients 16
years and older with duration of therapy ≥7 days were eligible for
inclusion.
For IBS,
probiotics were less likely to result in persistent or unimproved
symptoms compared to placebo in analysis of 23 trials with 2575 patients
[relative risk (RR) = 0.79 (95% CI: 0.70–0.89), NNT = 7 (4–13)]. These
results remained significant in a sub-group analysis of the 12 trials at
low risk of bias. In an analysis of 12 trials (1197 patients) using
combination products (two or more probiotic species) for this same
outcome, probiotics were again superior to placebo [RR = 0.81
(0.67–0.98), NNT = 8 (4–50)], but this was not the case for six trials
(422 patients) using only Lactobacillus species [RR = 0.75 (0.54–1.04)].
Probiotics had a greater effect on global symptoms or abdominal pain
scores than placebo in analysis of 25 comparisons with 2001 patients
[standard mean difference (SMD) = −0.25 (−0.36 to −0.14)]. Here again,
combination products [SMD = −0.24 (−0.37 to −0.12) in analysis of 15
trials with 1038 patients] fared better than Lactobacillus [SMD = −0.08
(−0.38 to 0.21) in analysis of six trials with 420 patients].
Bifidobacterium trended toward a beneficial effect [SMD = −0.46 (−0.92
to −0.00)] in analysis of three trials with 501 patients. Adverse
effects were more common for probiotics than placebo [RR = 1.21
(1.02–1.44), NNH = 35 (16–362)] in analysis of 24 trials with 2407
patients. Combining the results of the two trials evaluating synbiotics
for IBS (198 patients) showed no statistically significant effect. No
useable trial was found for prebiotics in IBS.
For
CIC, probiotics were associated with an increase in the mean number of
bowel movements per week compared to placebo [1.49 (1.02–1.96)] in
analysis of two trials with 165 patients. However, probiotics did not
significantly decrease the likelihood of treatment failures (in analysis
of two trials with 110 patients at high risk of bias). The one small
trial (60 patients) investigating prebiotics for CIC showed no benefit.
Synbiotics effectively decreased the likelihood of treatment failure in
an analysis of two trials with 166 patients at low risk of bias [RR =
0.78 (0.67–0.92), NNT = 5 (3–14)].
Overall,
these findings suggest that combination probiotics are safe and
effective for IBS with an NNT and NNH of seven and 35, respectively.
More research is needed to identify which individual species and strains
are the most beneficial and to establish the role of prebiotics and
synbiotics. There are currently too few trials investigating probiotics,
prebiotics, and synbiotics in CIC to judge their efficacy.
There is Insufficient Evidence to Determine the Effectiveness of Yoga for Reducing Blood Pressure in Normotensive and Hypertensive Patients
Level 3 (lacking direct) evidence
Altern Ther Health Med 2014;20(2):32
Hypertension
(HTN) is estimated to affect more than one billion people worldwide. It
accounts for 13% of all deaths, and seven million premature deaths per
year.28
While pharmacological management is used routinely and serves as the
mainstay of treatment, lifestyle interventions should be an integral
component of every anti-hypertensive strategy.29 Overactivation of the sympathetic nervous system from chronic stress is now a well-recognized risk factor for HTN,30 and 31
and the restoration of autonomic balance through the relaxation
response may be achievable through a variety of mind–body interventions.32
Yoga, the ancient Indian system of mind–body integration, encompasses a
variety of traditions or “paths”. Hatha yoga, the most commonly
practiced path in the West, combines meditation/relaxation techniques
(dhayana), breathing practices (pranayama), and physical postures
(asana).33
Numerous reviews have been published on the effects of relaxation-type
interventions (including yoga) on hypertension and other cardiovascular
risk factors.34, 35, 36, 37, 38, 39, 40 and 41
The authors of the present study state that theirs is the first attempt
to perform a comprehensive systematic review focused specifically on
the effects of strictly yogic interventions on blood pressure reduction
in normotensive and hypertensive individuals.42
The researchers identified 120 studies involving 6693 participants (36% hypertensive).42
These included 48 randomized controlled trials (RTCs), 30
non-randomized controlled trials, 39 cohort studies, and three case
reports on the following interventions: yogic relaxation, slow
breathing, integrated yoga techniques, breathing-focused biofeedback,
and use of the RESPeRATE device (specifically timed music to entrain
slow yoga-style breathing with prolonged exhalation). Meta-analysis was
not performed due to significant heterogeneity in study populations
(adolescents, adults, and older adults), patient condition (normotensive
and hypertensive), types of yoga interventions, and duration of
follow-up (one week to four years). Only 13 studies lasted more than six
months.
Among RCTs, there
was a significant decrease in blood pressure for yogic relaxation in
three of three trials, slow breathing in four of six trials, integrated
yoga practice in 15 of 25 trials, biofeedback in six of six trials, and
the RESPeRATE device in eight of eight trials. However, only 16 of these
trials included between-group comparisons. The wide variety of controls
consisted of progressive muscle relaxation, listening to slow music,
reading, lifestyle training, health education, art activity, salt
reduction, therapeutic exercise, physiotherapy, usual care, and
waitlist/no intervention.
While
on balance, the large number of studies included in this review
demonstrated favorable results, their wide heterogeneity and generally
poor methodological quality significantly compromise their reliability.
Two recently published systematic reviews incorporating only RCTs
arrived at essentially the same conclusion.43 and 44
Although it is certainly plausible that the calm, quiet, meditative
state achieved by experienced yoga practitioners could regulate blood
pressure, it remains unknown which aspects of the practice, if any, are
therapeutic. The vast diversity of yoga traditions and a current lack of
standardized research make it tough to develop evidence-based
guidelines or prescriptions for yoga as a lifestyle strategy for blood
pressure manage.42
Trigger Point Dry Needling May Reduce Pain in Patients With Plantar Fasciitis
Level 2 (mid-level) evidence
Phys Ther 2014;94(8):1083–1094.
Plantar
heel pain (plantar fasciitis) affects up to 7.5% of the general
population and accounts for about 8% of running injuries.45 and 46
The cause is unknown and probably multifactorial. Risk factors include
limitations of ankle dorsiflexion, overweight, and prolonged standing.47 Myofascial trigger points (MTPs) affecting muscles intrinsic and proximal to the foot may theoretically play an etiologic role.48
MTPs are points of skeletal muscle hyperirritability identifiable by a
tender nodule, the palpation of which leads to referred pain and
possibly motor and autonomic dysfunction.48
MTPs in gastrocnemius, tibialis posterior, popliteus, abductor
hallucis, peroneus longus, and flexor digitorum brevis muscles have been
found in patients with plantar fasciitis.49
Dry needling, one of several methods used to treat MTPs, involves the
insertion and vertical manipulation (in-and-out motion) of an
acupuncture needle (0.3 mm in diameter and 30–75 mm in length) directly
into MTPs.50
Having
previously conducted an inconclusive systematic review investigating
the effectiveness of trigger point dry needling for plantar fasciitis,51 researchers set out to conduct their own controlled trial.50
They randomized 84 patients (mean age 56 years) with plantar fasciitis
for ≥1 month to trigger point dry needling vs. sham needling for 30 min
once weekly for six weeks and followed them for an additional six weeks.
MTPs were identified using four criteria: (1) a tender point within a
taut band of skeletal muscle, (2) a characteristic pattern of referred
pain, (3) pain on sustained compression over the tender point, and (4) a
local twitch response elicited on dry needling of the taut band.
Non-penetrating acupuncture needles were used in the sham group.
Patients and researchers were blinded to group allocation, but not the
podiatrist administering the treatments. A visual analog scale (VAS,
range: 0–100 mm, with higher scores indicating more severe pain) was
used to measure changes in first-step morning pain, and the Foot Health
Status Questionnaire pain subscale (FHSQ, range: 0–100 points, with
lower scores indicating more severe pain) was used to assess changes in
general foot pain. Minimally important differences (MID) were considered
to be ≥19 mm and greater than or equal to symbol 13 points for VAS and
FHSQ, respectively.
The dry
needling group had higher VAS scores (mean difference = 9.2) and lower
FHSQ scores (mean difference = 7.3) at baseline. At six weeks, real dry
needling was associated with lower VAS scores [adjusted mean difference
(MD) = −14.4 mm (−23.5 to −5.2 mm)], and higher FHSQ scores [MD = 10
points (1–19.1)] compared to sham dry needling. These findings persisted
at 12 weeks. Based on the percentage of patients meeting the MID for
both outcomes, researchers reported a NNT = 4. There were no significant
between-group differences in foot function, foot health, or
health-related quality of life at six weeks or 12 weeks. The most
frequently treated muscles were the soleus, gastrocnemius, quadratus
plantae, flexor digitorum brevis, and abductor hallucis. There were
minor transitory adverse events in 32% of patients with dry needling vs.
<1% with sham needling (p < .05, NNH = 3).
The
researchers found statistically significant differences in first-step
heel pain and general foot pain at six weeks and 12 weeks, but the
average differences were not clinically significant (according to their
pre-established MID criteria). Still, the 95% confidence interval
included score changes exceeding the MID threshold. The use of sham
acupuncture may have mitigated the risk of performance bias among
patients, but not among practitioners implementing the treatment. It is
interesting to note that needles were not placed directly at the site of
pain, but at nearby trigger points that were theoretically contributing
to the pain. This was not, however, an acupuncture trial, since
traditional Chinese medical theory was not used to determine needle
placement.
References
Vitae
Richard Glickman-Simon, MD,
is a family physician, integrative medicine editor of DynaMed, and
assistant professor of public health and family medicine at Tufts
University School of Medicine in Boston, MA, and a contributor to
DynaMed in Ipswich, MA.
Jamey Wallace, ND, is the Chief Medical Officer at Bastyr Center for Natural Health in Seattle, WA.
Copyright © 2015 Elsevier Inc. All rights reserved.
Evidence-based integrative medicine updates
