While the most important knowledge about Chinese medicine comes from the clinic, not the laboratory. It is still helpful to see what clinic studies have to say about the effectiveness of Chinese medicine.
HEADACHE
Loh L, Nathan PW, Schott GD and Zilkha KJ (1984). Acupuncture versus medical treatment for migraine and muscle tension headaches, J Neurol Neurosurg Psychiat 47:333-337.
TYPE OF STUDY: Acupuncture was compared to standard drug therapy for treatment of migraine and muscle tension headaches.
RESEARCH DESIGN: Forty-eight patients with chronic migraine and muscle tension headaches (mean duration 19 years), were randomly assigned to receive either acupuncture or standard drug therapy. After 3 months of treatment, each was asked to cross-over to the other therapy for an additional 3 month period, but only 29 agreed.
Acupuncture was administered at a minimum of 6 needle sites per treatment session with variation of treatment point selection based on examination of the patients. Patients in the drug therapy group were asked to continue taking the medications they had been using prior to entering the study. Patients assessed their headaches at the end of each 3 month treatment phase according to whether there was no, slight, moderate, or great benefit from their treatment. Patients kept a log of medications consumed throughout the study. At the end of the study, they were asked which treatment they preferred.
RESULTS: Twenty-four of 41 patients (59%) who received acupuncture reported benefits from treatment, with 16 (39%) reporting moderate or great improvement. Nine of 36 patients (25%) who received drug therapy benefited from treatment, with 4 (11%) reporting moderate or great improvement. Of the 29 patients that received both treatments, there was a greater preference for the acupuncture treatment. A greater decrease in use of pain medication was reported by the acupuncture group.
IMPORTANCE OF THE STUDY: These findings indicate that a relatively simple course of acupuncture can produce better relief than standard drug therapy in patients with long-term histories of chronic headaches.
LOW-BACK PAIN
Study 1
Laitinen J (1976) Acupuncture and transcutaneous electric stimulation in the treatment of chronic sacrolumbalgia and ischialgia, AmerJ Chin Med 4:169-175.
TYPE OF STUDY: Acupuncture was compared to standard therapy (TENS) for treatment of chronic low-back pain.
RESEARCH DESIGN: One hundred patients with chronic low back pain (average duration approximately 4 years), who had not responded to previous treatment with analgesics, sedatives, physical therapy and/or surgery, were assigned to receive either acupuncture or TENS. Acupuncture was administered at 2 bilateral points during 2 – 10 treatment sessions. TENS (50 Hz, 1 msec) was applied at the same points for the same duration as acupuncture, once a week.
Patient self-assessments of sleeplessness due to pain, invalidity, use of analgesics or sedatives, and physician evaluation of each patient were assessed at baseline and again after treatment and at 2 and 6 month follow-ups.
RESULTS: The groups were comparable at baseline. The acupuncture group showed overall better improvements than the TENS group after treatment and at the 2 and 6 month follow-ups. According to physician evaluation, there was complete or moderate improvement of the pain in 58% of the acupuncture group versus 46% of the TENS group. Patient self assessments of their improvements were 65% vs 55% after treatment, 56% vs 40% at 2 months follow-up and 33% vs 21% at 6 months.
IMPORTANCE OF THE STUDY: Acupuncture performed as well or better than standard therapy (TENS) for patients with chronic low back pain who had already failed other therapies, including surgery.
Study 2
MacDonald AJR, Macrae KD, Master BR and Rubin AP (1983) Superficial acupuncture in the relief of chronic low back pain, Ann Roy Coil Surg Eng 65:44-46.
TYPE OF STUDY: Acupuncture was compared to placebo treatment for alleviation of chronic low-back pain.
RESEARCH DESIGN: Seventeen patients with chronic low-back pain of multiple etiologies (over one year duration), and who had failed conventional therapy, were randomly assigned to receive either acupuncture treatment or placebo treatment with a disconnected TENS unit. Acupuncture consisted of the shallow insertion of a variable number of needles at variable points, as determined by palpation for each patient. The duration of treatment was varied and the electrical stimulation was added depending upon the response of the patients.
The mock TENS treatment was applied at points selected by the same methods, and for variable duration of treatment depending upon the response of the patients. Patients recorded their daily pain levels during the week prior to each treatment using a visual analogue scale. Pain associated with various activities was also recorded on the day before each treatment using visual analogue scales. The degree of improvement was rated on the day after each treatment on a 0 – 10 scale. Patient mood, activity, appetite, sleep and anxiety, as well as clinical signs, including gait, mobility, leg raises and reflexes were also assessed before and after treatments.
RESULTS: The 2 treatment groups were comparable at baseline. The acupuncture group improved significantly on most assessments, while the placebo group showed only minimal improvements. These changes were significant for acupuncture compared to placebo treatment for pain relief (77% vs 30%), activity pain score reduction (52% vs 6%), physical signs reduction (97% vs 27%) and severity and pain area reduction (74% vs 19%); the combined average reductions were 71% vs 21%.
IMPORTANCE OF THE STUDY: These findings demonstrate clear and significant benefits of acupuncture treatment for chronic back pain patients, all of whom had back pain for over a year, and all of whom had failed previous orthodox treatments. This study, in which acupuncture significantly out-performed placebo treatment, supports the use of acupuncture as a method of helping treat and rehabilitate chronic back pain patients.
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OSTEOARTHRITIS
Junniia SYT (1982) Acupuncture superior to Piroxicam(tm) in the treatment of osteoarthritis, Amer JAcupunct 10: 341-346.
TYPE OF STUDY: Acupuncture was compared to standard non-steroidal anti-inflammatory medication for the treatment of a variety of osteoarthritic conditions.
RESEARCH DESIGN: Sixteen patients with osteoarthritis of the hip, knee, or humeroscapular joint, confirmed by X-ray, were treated with acupuncture and compared to a group of 16 patients with similar conditions who had been previously treated by the author with the NSAJD, Piroxicam. Piroxicam was taken daily over a 4 month period.
Acupuncture was administered weekly at 5-8 unilateral points for each affected joint, the number and location of the points varying according to the joint affected. The number of acupuncture treatment sessions varied according to the response of the patient, at a mean of 4.8 treatment sessions. The duration of osteoarthritis, and prior use of medications, were recorded at baseline. Pain and general osteoarthritic condition were assessed on visual scales at baseline and at 2, 4, 6, 12 and 16 weeks after onset of treatment.
RESULTS: The two groups were comparable at baseline in terms of age, gender, location of osteoarthritis, duration of condition, prior use of medication and pain level.
At 2 weeks into treatment, both groups showed a comparable percent improvement (around 30%), but after this time greater improvements were detected in the acupuncture group.
At the final 16 week assessment, the mean decreases in pain level were 32% and 61% for the medication and acupuncture groups, respectively. In the medication group, 31% described themselves as free of symptoms or much better; 50% of the acupuncture group made similar self-assessments.
IMPORTANCE OF THE STUDY: A relatively short course of acupuncture treatment performed better than a course of standard non-steroidal anti-inflammatory medication for osteoarthritis of the hips, knees and shoulders.
FIBROMYALGIA
Deluze C, Bosia L, Zirbs A, Chantraine A and Vischer TL (1992) Electroacupuncture in fibromyalgia: results of a controlled trial Brit Med J 305:1249-1252.
TYPE OF STUDY: Electroacupuncture was compared to sham electroacupuncture for treating pain and morning stiffness related to fibromyalgia.
RESEARCH DESIGN: Thirty-six patients with chronic symptoms of fibromyalgia were randomly assigned to receive 6 treatments over a period of 3 weeks of either electroacupuncture or sham electroacupuncture. Electroacupuncture, at clearly perceivable levels, was administered through needles at 4-10 points; sham treatment consisted of much weaker electrical stimulation through 4-10 needles inserted more shallowly at non-point sites.
For outcomes measures, general pain level was recorded on a 100 mm visual analogue scale and pain threshold (amount of pressure required to elicit pain), was assessed using a pressure gauge. Quantitative measures of analgesic medication use regional pain, sleep quality and morning stiffness as well as patient and physician evaluations of the patient’s overall state were also recorded. All evaluations were made at baseline, and after the course of treatment.
RESULTS: All measures in the electroacupuncture group showed significant improvements from before to after treatment, except for morning stiffness which almost reached a significant level of change. No measures showed significant improvement from before to after treatment in the sham treatment group.
When the electroacupuncture group was compared to the sham treatment group, all measures showed significant (pain threshold, pain levels, morning stiffness, patient and physician assessments) or approached significant improvements (use of analgesic medications, regional pain scores, sleep quality).
IMPORTANCE OF THE STUDY: Electroacupuncture provided pain relief and functional improvement for patients with the chronic, complex and generally difficult to treat condition known as fibromyalgia. The finding that a relatively short course of treatment could produce clear changes indicates that acupuncture represents a promising therapeutic option for this condition.
POST-OPERATIVE PAIN
Martelete M and Fiori AMC (1985) Comparative study of the analgesic effect of transcutaneous nerve stimulation (TNS), electroacupuncture (EA) and meperidine in the treatment of postoperative pain, Acupunct Electro-Ther Res IntJ 10:183-193.
TYPE OF STUDY: Electroacupuncture (EA) as adjuvant treatment to meperidine (opioid medication) was compared to transcutaneous nerve stimulation (TNS) as adjuvant to meperidine and to meperidine alone for alleviation of post-operative pain.
RESEARCH DESIGN: Seventy-two patients (age 15-60) were selected as representative of 4 different surgical populations (upper or lower abdominal, rectal and lumbar). The 18 patients in each group were randomly assigned to receive meperidine, TNS plus meperidine, or EA plus meperidine postoperatively. In the recovery room, pain intensity was estimated on a visual analog scale (VAS) 15 minutes after its onset.
The meperidine group then received up to 5 equal injections at 15 minute intervals, with need determined at each interval by VAS score. The TNS and EA groups received 30 minutes of stimulation (at the same current intensity and frequency), following which they received meperidine injections as needed. One hour after the last dosage of meperidine for each group, pain intensity was again evaluated and the analgesic procedure was repeated.
RESULTS: In all four surgery groups, there was a trend for the TNS and EA groups to experience greater pain relief than the group receiving meperidine alone. Also, in all surgical types, EA treated patients required less meperidine in the second phase of the study than did the other two groups, indicating that EA induced a longer lasting analgesia than TNS.
IMPORTANCE OF THE STUDY: EA was found to be an effective adjuvant to analgesic medication for alleviating post-operative pain. It also proved to be a more effective adjuvant than TNS.
STROKE
Johanssonk, Lindgren I, Widner H, Wiklund I and Johansson BB (1993) Can sensory stimulation improve the functional outcome in stroke patients? Neurology 43:2189-2192.
TYPE OF STUDY: A combined course of manual acupuncture and electroacupuncture, provided as a supplement to standard care physiotherapy and occupational therapy, was compared to standard care alone for promoting the recovery of stroke patients.
RESEARCH DESIGN: Seventy-eight stroke patients (mean age 75 years), were randomly assigned to groups receiving standard rehabilitative care with or without acupuncture. For the acupuncture group, treatment was begun within 10 days of stroke onset and continued twice a week for 10 weeks. At each session a total of 10 needles were placed at traditional acupuncture points on the paralyzed and non-paralyzed sides.
Electrical stimulation was applied at 4 needles on the paralyzed side. Patients in both groups received standard individualized stroke rehabilitation on a daily basis. Activities of daily living (ADL), balance, motor function and quality of life were assessed prior to starting treatment and at 1, 3, 6 and 12 month follow-up times.
RESULTS: While both groups of patients improved over time, those treated with acupuncture recovered faster and to a greater extent than those who were not needled. Significant differences between the groups were seen at 1 and 3 months in walking and balancing abilities.
Acupuncture treated patients also scored significantly better in ADL at 12 months following stroke and, over the course of the year, spent on average approximately half the number of days in hospital and nursing homes (88 days for acupuncture patients; 161 days for control patients).
The reduction in number of days required for institutionalized care was estimated to represent a savings of $26,000 per acupuncture patient. (For additional data from this study, see Scand J Rehab Med Suppl 29:87-96,1993.3)
IMPORTANCE OF THE STUDY: This large scale study clearly indicates that recovery from stroke can be significantly enhanced by an experimental course of supplemental acupuncture. It also demonstrates that acupuncture treatment can result in a major reduction in rehabilitation costs.
ASTHMA
Taslikin DP, Bresler DE, Kroening RJ, Kerschner H, Katz RL and Coulson A (1977) Comparison of real and simulated acupuncture and isoproterenol in methachoilne induced asthma. Annals Allergy 39:379-387.
TYPE OF STUDY: Manual acupuncture was compared to control needling, standard medication (isoproterenol aerosol), placebo medication (saline aerosol) and no treatment for reversing experimentally induced bronchospasm in patients with bronchial asthma.
RESEARCH DESIGN: Twelve subjects with mild to moderate bronchial asthma (22 years mean duration) were studied in a crossover design during three sessions spaced at least one week apart. At the first session, a variety of pulmonary function tests were performed to determine baseline values and to assess individual bronchodilator responses to the asthma medication, isoproterenol. When pulmonary function returned to baseline subjects inhaled graded doses of the asthma inducing drug, methacholine, to assess the degree of vasoconstriction and to determine the spontaneous course of recovery.
In the second and third sessions, patients inhaled their predetermined doses of methacholine followed either by medication (isoproterenol) or placebo medication (saline), or by acupuncture or control needling in a randomly ordered fashion so that each patient was evaluated twice for the acute ameliorative effects of medication and of acupuncture.
All acupuncture patients were needled at the same points. Control needling matched acupuncture in number of needles (6) and in areas of the body, but each control point was at a site that contained no classical acupuncture point. Pulmonary function was assessed at intervals over a 2 hour period. Patients and treatment assessors were blinded to the real or simulated treatment in each experimental session.
RESULTS: Following experimentally induced bronchoconstriction, neither control needling nor saline inhalent produced any significant improvement in volume or flow rate of inhaled air when compared to no treatment. In contrast, both acupuncture and isoproterenol inhalent significantly improved 3 parameters of pulmonary function, although the drug spray was more effective than acupuncture.
IMPORTANCE OF THE STUDY: Acupuncture counteracted experimentally induced bronchospasm to a greater extent than could be attributable to a placebo effect. In light of the adverse side effects related to maintenance asthma medication, acupuncture should be considered as a viable treatment option
DEPRESSION
Luo H, Jia Y and Than L (1985) Electro-acupuncture vs. amitriptyline in the treatment of depressive states, J Trad Chin Med 5:3-8.
TYPE OF STUDY: Electroacupuncture was compared to antidepressant medication (amitriptyline) as a therapeutic intervention for depression.
RESEARCH DESIGN: Forty-seven patients diagnosed as clinically depressed (5-6 months mean duration) were randomly assigned to treatment groups receiving acupuncture or medication. Acupuncture patients received electrical stimulation via needles inserted at two points, on the scalp and forehead, for 1 hour each day (except Sundays) for 5 weeks.
Medication patients received the same initial dosage of amitriptyline 3 times per day for one week, after which the dosage was increased during 4 weeks as a function of behavioral changes and side effects. Each patient was tested at weekly intervals using standard psychiatric rating scales. The severity of depression at onset of treatment was statistically similar for both groups. In addition, patients were interviewed by two psychiatrists at the onset and at completion of treatment who independently assessed therapeutic effectiveness by categories of cured, markedly improved, improved and non-improved.
RESULTS: After 5 weeks of treatment, 19 of 27 patients (70%) in the acupuncture group and 13 of 20 patients (65%) in the medication group were assessed as cured or markedly improved. The Hamilton Depression Scale (that rates 24 symptoms) and the Clinical Global Impression (CGI) ratings of severity of disease and general improvement revealed significant improvements in both treatment groups.
No between group differences were detected. The CGI index also found significantly fewer side effects in the acupuncture treatment group.
IMPORTANCE OF THE STUDY: The findings indicate that acupuncture is an effective alternative to amitriptyline for treatment of clinical depression. Acupuncture may be a particularly useful therapeutic option for patients who experience side effects from antidepressant medication.
MENOPAUSE
Wyon Y, Lindgren R, Lundeberg T and Hammar M (1995) Effects of acupuncture on climacteric vasomotor symptoms, quality of life, and urinary excretion of neuropeptides among postmenopausal women, Menopause 2:3-12.
TYPE OF STUDY: A combined treatment of electroacupuncture and manual acupuncture was compared to superficial manual needling for reducing hot flashes, increasing quality of life and altering levels of vasoactive peptides in postmenopausal women.
RESEARCH DESIGN: Twenty-four women at least 1 year post-menopause, who agreed to try acupuncture as an alternative to the hormone therapy they initially sought for vasomotor symptoms, were randomized into two treatment groups. One group received low frequency electroacupuncture at 4 points on the lower back and manual acupuncture at 8 additional points.
The other group was treated at the same 12 points with superficial (subcutaneous) needling which is believed to elicit a weaker peripheral stimulation than either electroacupuncture or manual acupuncture with intramuscular needling. Each treatment, lasting 30 minutes, was given twice a week for 2 weeks and once a week for another 6 weeks.
All women kept a daily diary of the number and severity of hot flashes covering the period from 1 month before to 3 months after treatment. During the same time period, women completed visual analog scale questionnaires on psychological well-being, sleep patterns and menopausal symptoms other than hot flashes.
Occurrence and intensity of symptoms were also rated by a physician or nurse who were unaware of the treatment group assignment.
Urine samples were collected for analysis of peptides known to have direct and indirect effects on blood vessels.
RESULTS: Of the 21 women who completed the study, the number of hot flashes decreased significantly by >50% in both groups at the end of the 8 week treatment period.
At 3 month follow-up, the decrease persisted in the electroacupuncture group, whereas the frequency of flashes tended to increase again in the superficial needling group. Ratings of menopausal symptoms on a before/after treatment basis showed significant decreases in the scores of both the women and the physicians for the electroacupuncture but not the superficial needling group.
No significant changes occurred in the psychological well-being or sleep dysfunction scores for either group. Both groups showed marked decreases in urinary levels of calcitonin generelated peptide, a potent vasodilator, during the treatment period but the levels returned toward baseline during the follow-up period.
IMPORTANCE OF THE STUDY: This is the first controlled study suggesting that acupuncture is an effective treatment for regulating the hot flashes and related symptoms that frequently characterize the post-menopausal period.
The findings (for both frequency of hot flashes and urinary peptide levels) also suggest that superficial needling at acupuncture points, rather than serving as an adequate control treatment, may also be an effective means (albeit less so than electroacupuncture) for regulating post-menopausal symptoms.
