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Anesth Analg 2003;96:493-497
© 2003 International Anesthesia Research Society


ANESTHETIC PHARMACOLOGY

Minute Sphere Acupressure Does Not Reduce Postoperative Pain or Morphine Consumption

Masatomo Sakurai, MD*, Muhammad-Irfan Suleman, MD*, Nobutada Morioka, MD*, Ozan Akça, MD*, and Daniel I. Sessler, MD*,{dagger}

*Outcomes Research® Institute and Department of Anesthesiology, University of Louisville, Louisville, Kentucky; and {dagger}Ludwig Boltzmann Institute, University of Vienna, Vienna, Austria

Address correspondence and reprint requests to Daniel I. Sessler, MD, Outcomes Research® Institute, 501 E. Broadway, Ste. 210, Louisville, KY 40202. Address e-mail to sesslerdan{at}aol.com


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Minute sphere acupressure has been used for more than 2000 yr and remains popular in Japan. The points most relevant to abdominal surgery are those associated with meridian flows crossing or originating in the abdomen. We tested the hypothesis that minute sphere therapy reduces pain and analgesic requirements after open abdominal surgery. Participating patients were given standardized desflurane and fentanyl anesthetic. On completion of surgery, they were randomly assigned to untreated control or minute sphere acupressure at the Neiguan, Zusanli, Sanyinjiao, and Gongsun points. Each site was covered with bulky gauze dressings so that patients could not determine their assignments. Postoperative pain was treated with IV morphine via a patient-controlled analgesia pump. Our primary a priori end-points were pain and opioid consumption on the first postoperative morning. Data are reported as median (25th percentile, 75th percentile). Fifty-three patients (30 controls and 23 minute spheres) completed the study. Morphine requirements (47 mg [27, 58] vs 41 mg [25, 69]) and pain scores (29.5 mm [16, 59] vs 40 mm [22, 58]) were similar in the control and acupressure groups. These data provide an 80% power for detecting a 50% difference in morphine consumption at an {alpha} of 0.05. Minute sphere treatment at the Neiguan, Zusanli, Sanyinjiao, and Gongsun points thus failed to provide analgesia after abdominal surgery.

Minute sphere therapy is a form of acupuncture. We tested whether minute spheres placed on three acupressure points relevant to abdominal surgery reduced pain and morphine requirements after abdominal surgery. Treatment and control patients received a similar covering. Neither pain nor morphine requirements were different between the groups.


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
More than 25 million patients undergo surgery each year in the United States. Postoperative pain not only is a serious problem for these patients, but often increases the duration of hospitalization. Opioids or nonsteroidal antiinflammatory drugs remain the most common treatment for postoperative pain. However, many of these drugs are expensive, and all are associated with complications such as respiratory depression (1) and gastrointestinal problems. Even small reductions in the requirement for conventional analgesic drugs would thus be of considerable clinical importance.

Oriental medicine has been used to treat pain for more than 4000 yr (2). These treatments are based on meridian lines that describe the flow of energy through the human body. Across these putative energy flow pathways are several station points. Stimulation of these areas is thought to beneficially influence the patterns of energy flow for the associated meridian (3,4). The putative beneficial effects of acupuncture, for example, are mediated by stimulation of these points.

Common oriental medical techniques include acupuncture, moxibustion, acupressure, and Chinese herbs (5). An analgesic method that has been used for more than 2000 years is application of minute spheres to stimulate acupressure points along relevant meridians. The small spheres can be made of wood, stone, or metal. Among the benefits of this technique are convenience and low cost. Furthermore, the treatments are noninvasive and rarely produce complications.

Minute sphere acupressure remains popular in hospitals of oriental medicine in Japan to improve muscle pain and stiffness (6). However, no double-blinded studies evaluating this treatment for analgesia have been performed. The points most relevant to abdominal surgery are those associated with meridian flows crossing or originating in the abdominal area. We therefore tested the hypothesis that application of minute spheres to the Neiguan, Zusanli, Sanyinjiao, and Gongsun points reduces pain and analgesic requirements after open abdominal surgery.


    Methods
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
With approval from the Human Studies Committees at the University of Louisville Hospital and written, informed consent, we enrolled 71 patients. All were ASA physical status I or II and were scheduled for elective abdominal surgery. We excluded patients who had conditions in which pain perception was affected, such as diabetes mellitus, any kind of neurological or psychiatric disease, dysautonomia, and thyroid disorders; we also excluded patients who used preoperative analgesics and those scheduled for regional anesthesia.

Before the induction of anesthesia, all participants were instructed in the use of a 100-mm visual analog scale (VAS) for scoring their postoperative pain. On this scale, 0 mm indicates no pain, and 100 mm indicates the worst imaginable pain.

General anesthesia was induced by the IV administration of propofol (3 mg/kg) and succinylcholine (1.5 mg/kg). The trachea was intubated, and mechanical ventilation was adjusted to maintain an end-tidal carbon dioxide partial pressure near 35 mm Hg. Muscle relaxation was maintained with rocuronium, which was titrated to provide one or two twitches in response to supramaximal electrical stimulation of the ulnar nerve at the wrist.

Anesthesia was maintained with volatile anesthesia (desflurane, isoflurane, or sevoflurane) in 30%–40% oxygen (balance nitrogen) and fentanyl. The volatile anesthetic and fentanyl were titrated to maintain the bispectral index between 40 and 60. Active surface warming was used to keep the core temperature normothermic (>36°C).

Patients were randomly assigned to treatment with minute spheres or to no treatment (control group). Group assignments were based on computer-generated codes that were kept sealed in sequentially numbered envelopes until completion of surgery. The spheres were stainless steel and 1 mm in diameter (Sakamura Laboratory, Kyoto, Japan).

On completion of surgery, minute spheres were applied in appropriate patients only by our experienced acupuncturists (MS or NM) (6). A single sphere was positioned bilaterally at each of the following points (3):

Neiguan (pericardium, line 6 in the US system): this point is located between the tendons of the palmaris longus and flexor carpi radialis muscles, a bit proximal to the transverse crease of the wrist. Although located on the arm, it is among the most important points affecting abdominal pain.
Zusanli (stomach, line 36 in the US system): this point is located one finger’s breadth lateral to the lower border of the tuberositas tibiae, just below the knee joint. Zusanli is one of the points most influencing symptoms originating in the median abdominal region.
Sanyinjiao (spleen, line 6 in the US system): this point is located just above the medial malleolus, dorsal to the posterior border of the tibia. Sanyinjiao also is one of the most effective points for the abdominal region. This point is located at the crossing of three different meridian lines: stomach, spleen, and urinary bladder.
Gongsun (spleen, line 4 in the US system): this point is located in the depression distal to and below the base of the first metatarsal bone, on the medial side of the foot. This is also an effective point for general complaints regarding the abdominal area. The Gongsun point also affects energy flow through the stomach meridian.

After the spheres were taped to the above sites, the entire region was covered with a bulky gauze bandage that was in turn covered by a clear plastic adhesive. The adhesive was of a single-use type that could not be reapplied. It was thus readily apparent to the investigators if the dressing had been removed at any point. A similar bulky dressing was applied to patients not assigned to minute sphere therapy.

Surgeons were not permitted to observe whether spheres or a placebo bandage was applied. They thus remained blinded to treatment. The patients were similarly blinded because the sphere or placebo bandage was applied well before emergence from general anesthesia (the spheres were too small to be palpated through the gauze bandage). The attending anesthesiologists were not blinded, but because the spheres were applied at the end of surgery, these anesthesiologists had no effect on the study outcomes. Postoperative pain was treated with IV administration of morphine via a patient-controlled analgesia pump. The pump was loaded with morphine sulfate and set to a 2-mg bolus and 6-min lockout period; no background infusion was used.

All standard anesthesia monitors were used. Core temperature was measured in the distal esophagus. Morphometric characteristics and ASA status were recorded. We also recorded the total intraoperative dose of fentanyl (µg) and the duration of anesthesia and surgery.

Our primary a priori end-points were pain on the first postoperative morning and opioid consumption in the period between the end of surgery and the first postoperative morning. Pain was evaluated with a VAS. Postoperative morphine sulfate consumption was recorded by the patient-controlled analgesia pump.

Secondary end-points were the incidence of postoperative nausea and vomiting (PONV) and the consumption of antiemetic drugs; both were recorded on the first postoperative morning. Other analgesics given concurrently with morphine and their doses were recorded as well. At the end of treatment, patients were asked to guess to which group they had been assigned. Investigators who were fully blinded to treatment evaluated all end-points.

Continuous outcomes in the two treatment groups were compared by using Wilcoxon’s ranked sum tests because the values were not normally distributed; nominal end points were compared by using {chi}2 or Fisher’s exact tests. Results are presented as number of patients or median (25th percentile, 75th percentile); P < 0.05 was considered statistically significant.


    Results
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Among the 71 patients who enrolled in the study, 2 unblinded the study by removing their coverings, 10 were not given postoperative morphine, 1 went home on the day of surgery, and 1 required an extreme amount of morphine (218 mg). In four additional patients, we failed to obtain critical postoperative data. Fifty-three patients (30 controls and 23 minute spheres) thus completed the study. Only data from these 53 patients were included in the analysis; however, results were similar when the excluded patients were retained in the analysis.

Morphometric and demographic characteristics were similar in each group, as was intraoperative fentanyl use (Table 1). The fraction of patients requiring analgesics in addition to morphine was similar in the control group (53%) and the minute spheres group (48%). Other analgesics used included ketorolac, meperidine, oxycodone, and acetaminophen; their use was distributed evenly among the groups.


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Table 1. Potential Confoundersa
 
Patients were unable to reliably guess to which group they had been assigned. The incidence of PONV and the consumption of antiemetic drugs were similar in the groups as well (Table 2, Fig. 1). Morphine requirements (47 mg [27, 58] for control versus 41 mg [25, 69] for minute spheres) and pain scores (29.5 mm [16, 59] for control versus 40 mm [22, 58] for minute spheres) on the first postoperative morning did not differ in the treatment groups (Table 2, Figs. 2 and 3). Our results provide an 80% power for detecting a 50% difference in morphine consumption between the control and minute sphere groups at an {alpha} level of 0.05.


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Table 2. Major Results
 


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Figure 1. Nausea scores for the control and minute sphere groups. Data are plotted as the medians with 25th and 75th percentiles. Asterisks indicate outliers. The groups were not significantly different.

 


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Figure 2. Morphine consumption in the control and minute sphere groups. Data are plotted as the medians with 25th and 75th percentiles. The asterisk shows an outlier. The groups were not significantly different.

 


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Figure 3. Pain scores for the two groups plotted as the medians with 25th and 75th percentiles. The groups were not significantly different.

 

    Discussion
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Among the many thousands of articles published about acupuncture, most are difficult to interpret because randomization, blinding, or both are simply inadequate. In fact, only a handful meet current standards for clinical trials (712). The results of these studies are mixed, with some demonstrating modest benefit while others fail to identify any effect whatsoever. In this respect, the few fully double-blinded studies differ from the large number of inadequately blinded ones that nearly always report substantial benefit.

For example, we have previously reported that bilateral electrical stimulation of the lateralization-control point reduces anesthetic requirements (12). Although the reduction was highly statistically significant, the magnitude of the difference was only 11% ± 7%. Auricular acupuncture of the Shen Men, Thalamus, Tranquilizer, and Master Cerebral points also reduced anesthetic requirements by 8.5% ± 7%, an amount that again was of questionable clinical importance (11). Another study evaluated 14 intradermal needles that were inserted 2.5 cm to the left and right of the T9 to L3 spinal vertebrae. Acupuncture with intradermal needles increased the fraction of patients with good pain relief, reduced morphine consumption by 50%, decreased the incidence of postoperative nausea by 20%–30%, and reduced plasma cortisol and epinephrine concentrations by 30%–50% (13). In contrast, electro-acupuncture at the Zusanli, Yanglingquan, and Kunlun acupuncture points on the legs failed to reduce anesthetic requirements at all (10).

Application of minute spheres to acupoints is an alternative to needle insertion, electrical stimulation, intradermal needles, and digital acupressure. Acupressure with minute spheres is similar in concept to the acupressure beads used at the Nei-Guan (pericardium, P.6) point for treatment of nausea and vomiting. However, the beads we used were far smaller than those used for the treatment of nausea and vomiting. Treatment at the P.6 points has been variously reported as effective (14) or ineffective (15,16). Although this was not statistically significant, those patients given minute sphere therapy in our study had almost 70% fewer vomiting episodes than the control group. This observation suggests that a larger study may have found that minute sphere therapy was beneficial for preventing PONV. Minute gold beads are also sometime implanted in efforts to treat chronic diseases, including arthritis (17). However, technically adequate studies of this treatment have not been published.

Our study is among few that are fully blinded evaluating acupuncture or acupressure. We were able to achieve full double blinding by positioning the minute spheres before patients recovered from anesthesia, out of view of the surgeons and follow-up investigators. Evaluation of the patients’ impression about their treatment confirmed that blinding was adequate. The results of our study were clear: we failed to identify any significant changes in morphine requirement or in pain scores in the patients treated with minute spheres. We thus conclude that perioperative application of minute spheres to the Neiguan, Zusanli, Sanyinjiao, and Gongsun points does not provide clinically important analgesia after open abdominal surgery.

A limitation of our study is that we evaluated only four acupressure sites. Although these sites were chosen to optimize analgesia after abdominal surgery, it remains possible that superior analgesia could have resulted from stimulation of other sites. An additional limitation is that abdominal surgery produces considerable postoperative pain. Treatment with minute spheres may have proven more effective in patients with less intense pain. Finally, the results may have been more encouraging had we used needle or electrical stimulation. In other words, there may not have been any problem with the four sites we chose or with the pain intensity; instead, our results may simply indicate only that acupressure with minute spheres per se is ineffective.

In summary, patients were randomly assigned to an untreated control group (n = 30) or to minute sphere acupressure (n = 23) at the Neiguan, Zusanli, Sanyinjiao, and Gongsun points. Morphine requirements and pain scores were similar in the control and treatment groups. Minute sphere treatment at the selected points thus failed to provide analgesia after abdominal surgery.


    Acknowledgments
 
Supported by the Jewish Hospital Foundation (Louisville, KY), National Institutes of Health Grant GM 58273 (Bethesda, MD), the Joseph Drown Foundation (Los Angeles, CA), and the Commonwealth of Kentucky Research Challenge Trust Fund (Louisville, KY). None of the authors has any personal financial interest related to this study.

The authors appreciate the assistance of Nancy Alsip, PhD, and Gilbert Haugh, MS.


    References
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 

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  5. Porkert M. The theoretical foundation of Chinese medicine: systems of correspondence. Cambridge, MA: MIT Press, 1974.
  6. Hyodo M. [Statistical evaluation of the "minute metallic sphere therapy" on pain and stiffness of the muscles]. Masui 1971; 20: 363–8.[Medline]
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  8. Gupta S. The effect of pre-emptive acupuncture treatment on analgesic requirements after day-case knee arthroscopy. Anaesthesia 1999; 54: 1204–7.[Medline]
  9. Fireman Z. Acupuncture treatment for irritable bowel syndrome: a double-blind controlled study. Digestion 2001; 64: 100–3.[ISI][Medline]
  10. Morioka N, Akça O, Doufas AG, et al. Electro-acupuncture at the Zusanli, Yanglingquan, and Kunlun points does not reduce anesthetic requirement. Anesth Analg 2002; 95: 98–102.[Abstract/Free Full Text]
  11. Taguchi A, Sharma N, Ali S, et al. Auricular acupuncture at the shen men, thalamus, tranquilizer, and master cerebral points reduces anesthetic requirement. Anaesthesia 2002; 57: 1159–63.[ISI][Medline]
  12. Greif R, Laciny S, Mokhtarani M, et al. Transcutaneous electrical stimulation of an auricular acupuncture point decreases anesthetic requirement. Anesthesiology 2002; 96: 306–12.[ISI][Medline]
  13. Kotani N, Hashimoto H, Sata Y, et al. Preoperative intradermal acupuncture reduces postoperative pain, nausea and vomiting, analgesic requirement, and sympathoadrenal responses. Anesthesiology 2001; 95: 349–56.[ISI][Medline]
  14. Fan CF, Tanhui E, Joshi S, et al. Acupressure treatment for prevention of postoperative nausea and vomiting. Anesth Analg 1997; 84: 821–5.[Abstract]
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  16. Agarwal A, Pathak A, Gaur A. Acupressure wristbands do not prevent postoperative nausea and vomiting after urological endoscopic surgery. Can J Anaesth 2000; 47: 319–24.[Abstract/Free Full Text]
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Accepted for publication October 9, 2002.




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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press