Abstract
Randomized controlled trial of acupuncture versus sham acupuncture in autism spectrum disorder
Wong VC-N, Sun J-G. J Altern Complement Med. 2010;16(5):545–553.
In Traditional Chinese Medicine, the approach to autism is considered as lower intelligence due to ‘‘Heart meridian and Kidney meridian Yin–Yang imbalance,’’ resulting in communication problems, and ‘‘Liver meridian Yin–Yang imbalance,’’ leading to behavioral problems. This study aims to use a different approach in management of autism and to use an evidence-based approach to assess the efficacy of alternative medicine in improving the functional status of these children. The objective is to study the efficacy of a short intensive course of acupuncture vs sham acupuncture in improving the overall functional status of children with autism.
A total of 50 autistic children were recruited. The male-to-female ratio was 7.3:1 and their ages ranged between 3 and 11 years. The diagnosis of autism was made according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition; DSM-IV) and Autism Diagnostic Interview-Revised. Children were randomized evenly into 2 groups: a control group vs a tongue acupuncture treatment group. The children were matched by mental age, social class, severity of autism using CARS score, and functional status using the Functional Independence Measure of Children (WeeFIM). In both groups, the conventional educational and behavior model for autistic children was continued. Parents and assessors were blind to group allocation. The acupuncturist was not blinded to the allocation.
Outcome measures consisted of: (1) Griffiths Mental Developmental Scale (GMDS)—6 subscales (Locomotors, Personal-Social, Hearing and Speech, Eye–Hand coordination, Performance, and Practical reasoning); (2) Ritvo-Freeman Real Life Scale (RFRLS)—Sensory-Motor, Social, Affectual, Sensory Response, and Language; (3) Reynell Language Developmental Scale (RLDS)—Comprehension score, Comprehension Age, Expression score, Expression Age; (4) Symbolic Play Test (SPT)—total score and Mental Age; and (5) Functional Independence Measure for children (WeeFIM)—3 domains of mobility, self-care, and cognition. Outcome measures were performed by independent trained research assistants who were blinded to the treatment or control group. All children in both groups were assessed before acupuncture (week 0) and after acupuncture (week 9).
Tongue acupuncture consisted of 5 sessions per week over 8 weeks for a total course of 40 sessions. Acupuncture was applied to 5 specific acupoints on the tongue: 2 acupoints at the center of the tongue surface (TAC #1¼Run Ze’ [1 cm from the tongue tip] and TAC #2 ¼Guan Zhu’’ [0.5 cm from tongue tip]), and 3 acupoints at the bottom of the tongue (i.e., sublingual region; TAC #3¼Tian Men’’ [center of tongue base] and TAC #4 and TAC #5¼Di You’ [0.5 cm from tongue base on both sides]). The total acupuncture procedure lasted for <15 seconds. The control group received sham acupuncture only with the same points; the only difference was that the rough end of the acupuncture needle was used to touch the same 5 points on the tongue.
Both groups showed statistically significant improvement after treatment on all measures, although the active treatment group had better results in GMDS (eye–hand coordination, performance, and practical reasoning); RFRLS (sensory-motor, social, affectual, and language); RLDS (Comprehension Score and Comprehension Age); and Symbolic Play Test (Total Score and Mental Age). WeeFIM scores and functional quotient (self-care and cognition) were the only measures that showed a statistically significant difference between the 2 groups.
The results of this pilot study are interesting and might benefit from further investigation. Although results did not demonstrate major statistical difference between the groups, the tendency was favoring the intervention group. Researchers will have to contend with a few limitations: tongue acupuncture is not widely practiced in Western countries and might not be readily accepted; autism spectrum diseases refer to a broad spectrum of symptoms that require individualized treatments; daily treatments for autistic children can be challenging; and more sensitive measures are needed to assess the changes in function.
Effects of traditional Chinese acupuncture in post-viral olfactory dysfunction
Vent J, Wang DW, Damm M. Otolaryngol Head Neck Surg. 2010;142(4):505–509.
The aim of this study was to assess the impact of traditional Chinese acupuncture (TCA) on post-viral hypo- or anosmic patients and compare them with a control group treated with oral administration of a vitamin B complex. Consecutive patients with post-viral dysosmia were offered sessions of TCA from January to December 2008. Inclusion criteria were post-viral olfactory dysfunction (PVOD) that failed to improve or resolve for more than 6 months under oral administration of steroids, followed by topical application of steroid drops to the olfactory cleft. Exclusion criteria were all other conditions for loss of smell, previous surgery of the nose and the paranasal sinuses, and acute or chronic inflammatory nasal disease.
Fifteen patients (mean age, 63.1 years; range, 48–73 years) were treated with acupuncture for post-viral smell loss and did not improve under the described standardized treatment. The olfactory dysfunction had persisted for a mean 4.3 years (range, 2–10 years).
Acupuncture sessions were repeated weekly for 10 weeks. There were 10 insertion points of acupuncture needles per session and patient. The local puncture points were the Lung Meridians near the sternum, the Life points at the radial pulse/wrist area bilaterally, and local individual points indicated by the Ying and Yang imbalance. The following injection points were chosen: DuMai 16 and 20, Di 20, LU 7 and 9, Ma 36, and Ni 3. The needles were left in place for 30 minutes. Treated participants were compared with matched pairs with PVOD who had been treated with oral vitamin B complex (B1 = thiamine, B6 = pyridoxine, and B12 = cobalamine) over 12 weeks.
The olfactory function was evaluated by the Sniffin’ Sticks Test (Burghart GmbH, Wedel, Germany) before and after treatment. This test battery assessed olfactory function bilaterally and involved subtests for odor threshold, discrimination, and identification. The sum score of the subtest results (TDI score) was used as a measure of olfactory function, which allowed grouping of patients into anosmic (TDI score ≤15), hyposmic (TDI score 16-30), and normosmic (TDI score >30) groups. Treatment success was defined as an increase in TDI scores of at least 6 points.
The mean (standard deviation [SD]) TDI score of the acupuncture group was 13.5 (5.4) before treatment and 17.9 (6.5) after completion of acupuncture treatment. The matched pairs treated with vitamin B complex improved in TDI score from 13.0 (3.5) to 15.8 (4.8) points. The χ2 test revealed a significantly better outcome in olfactory function in patients undergoing acupuncture compared with patients receiving a vitamin B complex (P = .02).
The results of this pilot study may not show statistically significant differences between the 2 groups; however, the results are encouraging for a condition that has been resistant to steroids and not responsive to usual medical care.
Acupuncture for primary dysmenorrhoea: a systematic review
Cho SH, Hwang EW. BJOG. 2010;117(5):509–521.
Several databases were searched up to July 2008. A manual search was also conducted of relevant journals and symposia and conference proceedings; personal contact was also made with the authors of the published studies, if necessary, to request additional data.
Review was restricted to RCTs (quasi-randomized trials were excluded) that compared acupuncture with a control group—which included no treatment, placebo treatment, or pharmacological or non-pharmacological treatments—to assess the efficacy of acupuncture for the treatment of primary dysmenorrhea. No restriction was imposed on studies with respect to language, publication type, blinding, and the type of design. Crossover trials were included as long as outcome data were available for each treatment segment prior to the crossover.
Studies included were focused on women of reproductive age with primary dysmenorrhea. Studies of women with secondary dysmenorrhea, associated with identifiable pelvic pathology or with the presence of an intrauterine device, were excluded. Both traditional acupuncture (classical meridian points) and contemporary acupuncture (non-meridian or trigger points) were included if the points of stimulation were acupuncture-related. Studies that assessed the combined effect of acupuncture with other therapies or compared different forms of acupuncture with each other were excluded.
The primary outcomes were pain relief for dichotomous data, measured as the number of women with pain relief, reduced pain, or no improvement, or improvement in symptoms for continuous data measured either by visual analog scale or other scales. The secondary outcomes assessed were adverse effects from treatment (incidence and type of side effect).
Study abstraction and quality assessment of all studies were undertaken by 2 reviewers following the detailed descriptions of these categories as described in the Cochrane Handbook for Systematic Reviews of Interventions. An initial search identified 66 potentially relevant articles. Thirty articles were initially excluded because they did not meet inclusion criteria. The remaining 36 studies were further evaluated with regard to randomization and additional 9 studies were excluded (5 did not mention randomization and 4 trials were quasi-randomized). The remaining 27 studies, involving 2960 subjects, met the inclusion criteria and were systematically reviewed. Most of the studies were conducted in mainland China, 3 in Korea, and 1 in Canada.
The types of acupuncture technique used in the trials included body acupuncture, warm acupuncture, auricular acupuncture, auricular acupressure, electroacupuncture, electrical auricular acupuncture, and acupoint injection. Various acupuncture points were used; SP 6 was commonly selected in 17 trials. Acupuncture interventions were usually introduced 3–7 days prior to the onset of menstruation and continued for approximately 7 days. The periods of treatment ranged from 1 day to 3 menstrual cycles.
All included trials did not provide clear descriptions of their method of allocation concealment; 24 studies did not blind participants, acupuncturists, or outcome assessments; 14 trials used insensitive and subjective criteria to measure women with pain relief, reduced pain, or no improvement.
For acupuncture compared with pharmacological treatment, traditional acupuncture was statistically significantly superior to pharmacological treatment for responder rate, with reduced dysmenorrhea pain in 5 comparisons; however, no significant difference between the 2 groups was reported in another 5 studies. Three RCTs reported that auricular acupressure was statistically significantly more effective than pharmacological treatment. The combination of auricular acupuncture and auricular acupressure, electroacupuncture, or acupoint injection was also statistically significantly more effective than pharmacological treatment. Three RCTs reported that traditional acupuncture was significantly superior to pharmacological treatment when measured by visual analog scale and pain severity score scale.
For acupuncture compared with herbal medicine, 3 RCTs reported that traditional acupuncture was significantly better than herbal medicine; electrical auricular acupuncture, auricular acupuncture, and warm acupuncture studies showed significant reduction in pain compared with the herbal medicine group. Two studies reported on symptom improvement: one study indicated significant improvement while the other study reported no significant difference between the 2 groups.
For acupuncture vs sham acupuncture, 3 studies reported reduced pain within both groups from baseline; however, only 1 study reported significantly better pain relief in the acupuncture treatment group than in the sham acupuncture group.
For acupuncture vs other interventions, 1 study reported a significant difference between acupuncture and wait-list control, and no significant difference between auricular acupressure treatment and moxibustion therapy or psychological therapy.
This review found promising evidence for the use of acupuncture in the treatment of primary dysmenorrhea compared with pharmacological treatment or herbal medicine. However, results should be interpreted with caution due to the poor methodological quality of the studies. The authors also identify several major limitations: (1) the trials satisfying the inclusion criteria were clinically and methodologically heterogeneous with respect to the severity of pain, participants, acupoints selected, type of acupuncture variants, control groups used, and outcomes examined; (2) the follow-up length and timing of outcome assessment also differed, as did the treatment schedules and frequency; (3) the types of acupuncture used in the trials differed; and (4) the techniques of acupuncture varied.
Moxibustion for cancer care: a systematic review and meta-analysis
Lee MS, Choi TY, Park JE, Lee SS, Ernst E. BMC Cancer. 2010;10:130.
The aim of this systematic review was to critically evaluate all of the available randomized clinical trials (RCTs) regarding the effectiveness of any type of moxibustion as adjunct therapy during cancer care. Several major databases were searched from inception through to February 2010. Prospective RCTs were included if moxibustion was used as the sole treatment or as an adjunct to other treatments for patients having any type of cancer and if clinically relevant outcomes were assessed. No language restrictions were imposed.
All articles were read by 3 independent reviewers and data from the articles were validated and extracted according to predefined criteria. Risk of bias was assessed using the Cochrane classification in 4 criteria: sequence generation, blinding, incomplete outcome measures, and allocation concealment.
The searches identified 515 potentially relevant articles of which 510 studies were excluded. All 5 remaining included trials originated from China. One study was later excluded because of insufficient data. The types of cancer treated within the trials were gastric cancer (n = 1), nasopharyngeal carcinoma (n = 2), and various cancers (n = 2). The objective outcome measures were survival rate, response rate, side effects of chemotherapy, and quality of life. All RCTs used indirect moxibustion.
Four RCTs reported response rate for moxibustion as an adjunctive of chemotherapy compared with chemotherapy. All 4 studies failed to show favorable effects of moxibustion on response rate. Subanalysis also failed to show favorable effects of moxibustion on response rate in patients with nasopharyngeal carcinoma. Two RCTs assessed the occurrence of side effects of chemotherapy. Both studies showed favorable effects of moxibustion plus chemotherapy compared with chemotherapy. A meta-analysis showed significantly less frequency of nausea and vomiting from chemotherapy for the moxibustion group. Two RCTs tested the effects of moxibustion on quality of life compared with chemotherapy or morphine injection. The effect was equivocal with one RCT reporting favorable effects of moxibustion compared with morphine injection, while the other RCT failed to generate positive effects compared with chemotherapy.
This review favors the use of moxibustion for the identified side effects of chemotherapy. However, in this review, all of the studies were burdened with a high risk of bias, so results and conclusions should be interpreted with caution. The authors identify several limitations of conducting moxibustion studies. Studies may have been incorrectly designed or the treatment may not have been administered optimally.
Reduction of chronic non-specific low back pain: a randomized controlled clinical trial on acupuncture and baclofen
Zaringhalam J, Manaheji H, Rastqar A, Zaringhalam M. Chin Med. 2010;5:15.
Eighty-four men, aged 50-60 years, with non-specific chronic LBP were recruited. A qualified musculoskeletal physiotherapist screened all participants for inclusion/exclusion criteria. Patients met inclusion criteria if they had (1) lumbar or lumbosacral pain for 6 months or longer; (2) no radiation of LBP to other regions; (3) normal neurological signs of lumbosacral nerves including deep tendon and plantar reflexes, voluntary motor function, straight leg raise, and sensory function; (4) no acupuncture treatment in the past 6 months; (5) absence of significant pathology such as bone fracture or severe psychiatric conditions; (6) stable health; and (7) all participants experienced ongoing pain, the intensity of which did not change over the course of a day.
Patients were excluded if they had any of the following: (1) major trauma or systemic disorders; (2) conflicting or ongoing co-interventions (drugs and/or alternative treatments); (3) prior use of acupuncture for LBP in the past 6 months; (4) refusal to be randomized; (5) protrusion or prolapse of 1 or more intervertebral disks with concurrent neurological symptoms; (6) prior vertebral column surgery; (7) infectious spondylopathy; (8) LBP secondary to an inflammatory, malignant, or autoimmune disease; (9) congenital deformation of the spine (except for slight lordosis or scoliosis); or (10) compression fracture caused by osteoporosis.
Participants were randomly assigned to 4 groups: control, acupuncture, baclofen, and baclofen plus acupuncture. Participants' assignments were concealed in sealed opaque envelopes that were opened by the acupuncturist before treatment. Treatment course for all groups was 5 weeks. The control group did not receive any treatment for chronic pain. All participants were advised to maintain their normal lifestyle and not to start any new medications. Acupuncture treatment was performed by a certified acupuncturist twice a week for 5 weeks. Acupuncture protocol used in this study was consistent with the neurohumoral mechanism theory of acupuncture. Each patient was needled bilaterally, coupled with electrical stimulation at 4–6 Hz, at the following acupoints: Shenshu (BL 23), Dachangshu (BL 25), Panguanshu (BL 28), Ciliao (BL 32), Kunlun (BL 60), Huantiao (GB 30), and Yanglingquan (GB 34). Needles were left in place for 20–25 minutes. Baclofen was orally administered 30 mg/d (15 mg bid).
Primary outcomes were pain intensity quantified with a 10-cm visual analog scale (VAS, 0–100 mm), and self-reported pain disability assessed with an Iranian version of the Roland Morris Questionnaire (RMQ). VAS scores were measured immediately before the first treatment and at 1, 2, 3, 4, 5, and 10 weeks after the first treatment. RMQ scores were measured immediately before the first treatment and at 5 and 10 weeks after the first treatment.
Of the 125 respondents, 84 (67.2%) met the inclusion criteria for participants. Four participants dropped out from the trial during the treatment due to lack of time and pain from acupuncture. Of the remaining 80 participants who completed the study, no significant difference was reported in baseline variables such as age, disease, VAS, and RMQ scores between groups.
VAS scores for pain intensity decreased significantly in all treatment groups; however, the exact time course varied. Acupuncture significantly decreased the pain intensity after 5 weeks of treatment and this effect was stable up to the 10th week of the study. VAS in the acupuncture group decreased significantly at 2, 3, 4, and 5 weeks compared with baseline (P < .001) and 1 week of treatment (P = .02). Moreover, acupuncture reduced pain intensity more than baclofen at 2, 3, 4, and 10 weeks of treatment. The baclofen plus acupuncture group showed a significant reduction in VAS at all time points of this study (P < .001). VAS scores were significantly lower in the baclofen plus acupuncture group than those in the acupuncture group (P = .04).
RMQ scores in the acupuncture and baclofen plus acupuncture groups significantly decreased at both 5 and 10 weeks compared with baseline (P < .001). There were significant decreases in RMQ scores in the acupuncture and baclofen plus acupuncture groups compared with the baclofen group at 5 (P < .001) and 10 weeks (P < .001). RMQ scores in the baclofen plus acupuncture group were also significantly lower than those in the acupuncture group throughout the study (P = .04).
This is another study confirming the beneficial effect of acupuncture for the treatment for chronic LBP. Prior work reported that baclofen is effective for immediate pain relief, whereas acupuncture is effective to treat long-term pain. In this study, baclofen (30 mg/d orally) reduced the pain intensity mainly in the first 2 weeks. The combined acupuncture and baclofen treatment was more effective to treat non-specific chronic LBP than either treatment alone.