Study: Acupuncture vs. Metoclopramide for Postoperative Gastroparesis Syndrome

reference

Sun BM, Luo M, Wu SB, et al. Acupuncture versus metoclopramide in the treatment of postoperative gastroparesis syndrome in abdominal surgery patients: a randomized controlled trial.J Chin Integr Med.2010;8(7):641-644.

design

This is a randomized controlled trial of 63 patients from the Eastern Hepatobiliary Surgical Hospital of the Second Military Medical University, Shanghai, China, 2004-2007, with postoperative gastroparesis syndrome (PGS) treated with acupuncture or metoclopramide (Reglan). 32 patients received acupuncture, 22 men and 10 women. Metoclopramide was administered to 31 patients, 24 men and 7 women. The acupuncture points were CV/RN12 (Zhongwan) and bilaterally ST36 (Zusanli), which were treated with a mild supplement, P6 (Neiguan), which was treated with stimulation, and SP6 (Sanyinjiao), which was treated with an amplification technique. All 7 needles were left in for 30 minutes once daily. Metoclopramide was administered 20 mg IM three times daily. PGS was confirmed by radiographic visualization of meglumine diatrizoate.

Outcome measures were gradations of improvement assessed as:

• Erholung: kein Ausfluss von Magensaft, keine Übelkeit oder Erbrechen nach Entfernung der Magensonde und der Patient konnte halbflüssige Nahrung zu sich nehmen;
• Wirksam: verminderte Magensaftmenge, Übelkeit ohne Erbrechen, Magensonde vorhanden; Und
• Unwirksam: Keine Abnahme des Magensaftvolumens, immer noch Übelkeit und Erbrechen, Magensonde noch vorhanden; PGS war 9–10 Tage + 6–7 Tage vorhanden.

At baseline, baseline age, stomach volume, and absence of diabetes were not significantly different between treatment arms.

Key findings

Of the acupuncture patients, 29 were classified as recovered and 3 as effective after a therapeutic treatment frequency of 6.58 + 4.26. Of the metoclopramide patients, 10 were classified as recovered, 12 as effective, and 9 as ineffective.

Previous research

1. PGS ist in China definiert¹ anhand von 7 Diagnosekriterien:
2. Übelkeit, Erbrechen, Blähungen und Schüttelfrost nach einer flüssigen oder halbflüssigen Diät
3. Magendrainageflüssigkeit > 600 ml/Tag für 6 oder mehr Tage
4. Keine mechanische Magenobstruktion
5. Verminderte oder fehlende gastrointestinale Motilität
6. Fehlen von Störungen des Wasser-, Elektrolyt- und Säure-Basen-Gleichgewichts
7. Fehlen von Medikamenten, die die Kontraktion der Magenmuskulatur beeinträchtigen
8. Fehlen von Krankheiten, die PGS verursachen können (z. B. Typ-1- und Typ-2-Diabetes-induzierte Neuropathie)

The chosen acupuncture points are clinically significant for gastric disorders - anterior mu of the stomach, regulation of gastric qi and abdominal expansion on the receptacle meridian (CV/RN12); to calm Shen (mind/mood), calm nausea and vomiting, and regulate Qi (PC6); 3. Yin meridian crossing in the lower leg to transform moisture, spread Qi, regulate abdominal expansion (SP6); and to control gastric peristalsis at both the upper and lower ends and to regulate Qi and blood in weak and deficient conditions (ST36).^2,3,4The last three points have been examined in several clinical studies and are widely used in clinical practice. The use of CV/RN12 was unique to the current study.

Two animal studies examined these points and the physiological mechanism. Hu et al. (1996) gave large mice 654-2 solution (anisodamine) and showed that acupuncture of ST36 improved gastric motility while TFP (trifluoperazine) blocked this response.⁵Needles manipulated for 5 minutes had little effect, but needles held for 25 minutes improved gastric motility. Anisodamine is an anticholinergic, alpha-1-adrenergic receptor agonist, and tropane alkaloid from the nightshade family used in China to treat circulatory shock.⁶TFP is a schizophrenic antipsychotic drug with central antiadrenergic, antidopaminergic and mild anticholinergic effects, used for agitation, severe nausea and vomiting, but carries the risk of tardive dyskinesia. Ouyang et al. 2002 used PC6 and ST36 to study gastric motility in 7 female hunting dogs, which had eight pairs of electrodes implanted in the gastric serosa and a duodenal cannula to assess gastric emptying.⁷The researchers found that acupuncture of these two points normalized gastric slow waves in the distal stomach bilaterally, increased spike bursts in the distal stomach, significantly increased vagal activity, and significantly decreased sympathovagal balance. Improving gastric slow-wave rhythmicity and antral contractile spike activity significantly accelerated gastric emptying after 15 minutes (P< 0.02), 45 minutes (P< 0.02) and 90 minutes (P<0.04). Both animal studies confirmed the effect of acupuncture on gastric emptying and the ability of TFP to block the acupuncture response.

Four studies have been conducted in humans with diabetic gastroparesis. Zhang et al. randomly assigned 72 cases of diabetic gastroparesis to treatment with Motilium 10 mg three times daily 30 minutes before meals or acupuncture.⁸The selected points were LI11 (Quchi), LI4 (Hegu), CV12 (Zhongwan), ST36 (Zusanli), ST40 (Fenglong), SP9 (Yinlingquan), SP6 (Sanyinjiao), SP10 (Xuehai), and SP8 (Diji). for 10 days. The effectiveness rate was 91% for acupuncture and 77% for motilium control (P<0.05). In 2007, Sun and Wang reported 41 cases of PGS divided into three groups treated with 1) needle warming with moxibustion (n=17), 2) acupuncture plus auricular acupuncture (n=12), or 3) routine acupuncture.⁹Each therapy was rated 100% successful, but the first group required 7.2 + 3.8, the second group 9.8 + 4.6, and the third group 15.2 + 3.8 treatments to achieve success in all patients. Therefore, moxibustion warming needles required the fewest treatments to be effective. In 2008, Wang et al. on electroacupuncture (EA) of ST36 and LI4 or sham EA as a control in 19 randomized diabetic patients with symptoms of gastroparesis for more than 3 months.¹⁰The treatment, which consisted of 4 sessions over 2 weeks, significantly improved gastric emptying at the end of the trial and in the 2 weeks thereafter, without any notable adverse events or significant change in cholesterol and glucose laboratory findings. Zeng and Chai compared acupuncture and motilium for diabetic gastroparesis.¹¹Needling was performed daily for 2 weeks (n=30) at CV12 (zhongwan), ST36 (zusanli), PC6 (neiguan) and SP6 (sanyinjiao). Motilium (10 mg 3 times daily, 30 minutes before meals) was administered for 2 weeks (n=30). Each group received treatment for 2 cycles (i.e. 4 weeks). The effective rate was 93.3% in the acupuncture group and 73.3% in the motilium group (P<0.05).

Zhang and Yan divided 102 cases evenly and randomly into oral omeprazole (dose not specified) or Danshen compound (Salvia miltrorrhiza) injected into ST36 (zusanli) and BL21 (weishu).¹²Acupuncture injection was effective in 96% versus 76% for omeprazole (P< 0.01) after 2 weeks. The diverse components of theS. miltrorrhizaConnections have not been characterized.

Pfab et al. (2011) compared PC6 (Neiguan) acupuncture with standard motility-promoting medications (metoclopramide, cisapride, and erythromycin) in 30 mechanically ventilated intensive care patients with a gastric residual volume (GRV) > 500 ml for more than 2 days after surgery.¹³Success was defined as GRV < 200 ml per 24 hours. After 5 days, 80% of the acupuncture group developed food tolerance versus 60% of the medication group. The drug group showed no increase in feed balance until the 6th day.

After 5 days, 80% of the acupuncture group developed food tolerance versus 60% of the medication group.

Metoclopramide is an antiemetic and gastroprokinetic agent used to facilitate gastric emptying in gastroparesis. The U.S. Food and Drug Administration has approved it for short-term use (i.e., 4-12 weeks), although it is often used for longer periods in clinical practice. It binds to dopamine D2 receptors as a receptor antagonist and is a mixed 5-HT3 antagonist and 5-HT4 agonist. D2 activity contributes to the prevention of nausea and vomiting in the central nervous system, and 5-HT4 action may contribute to its antiemetic effect. Its prokinetic action increases the peristaltic tone and amplitude of the jejunum and duodenum and relaxes the pyloric sphincter and duodenal bulb.¹⁴

Effects on practice

PGS commonly occurs after resections of the stomach, pancreas, duodenum, gallbladder, and/or liver and affects 2–19% of patients. PGS delays patient recovery, successful removal of the feeding tube and subsequent oral feeding, and hospital discharge, thereby increasing healthcare costs, slowing patient recovery, and preventing adequate nutrition. According to this medium-sized study, acupuncture was more effective than the commonly prescribed metoclopramide.

Based on our current knowledge, the use of bilateral acupuncture of ST36 alone or PC6 alone or in combination with points such as SP6, PC6 or CV/RN12 in postoperative gastroparesis should provide patient benefit. All of these points are easy to locate and relatively safe to needle or otherwise stimulate. It also appears that 30 minutes of needle retention is more effective than the 5 minutes commonly used in current clinical practice.

restrictions

In the current study, neither the randomization method nor the clinical status of each subject before gastrectomy surgery, the exact number of treatment days before the clinical outcome assessment, or whether the reference index system was previously validated were defined. The qualifications and bias control of those providing treatment and clinical assessment were not described. Some of these details may have been lost in the translation from Chinese to English. The other key difference in this study from the clinical practice of traditional acupuncture is that the patient's tongue and pulse diagnosis and other clinical symptoms did not dictate the point location; All patients in the treatment group received acupuncture at the same 7 points. The 2011 study in Germany used three standard medications and also showed greater and faster benefits from acupuncture compared to traditional medications, confirming the results of the reviewed study.